Opinion
Civil Action 2:17-cv-03984 (RMB) (JBC)
10-05-2023
MICROSPHERIX LLC, Plaintiff, v. MERCK SHARP & DOHME CORP., MERCK SHARP & DOHME B.V., ORGANON USA, INC., AND ORGANON USA, LLC Defendants.
Christopher R. DeCoro Sam Kwon KIRKLAND & ELLIS LLP Brian D. Sieve, P.C. Marcus E. Sernel, P.C. Eric D. Hayes, P.C. Tasha F. Gerasimow Xaviere Giroud Sadaf Misbah Tareq M. Alosh KIRKLAND & ELLIS LLP Diva R. Hollis KIRKLAND & ELLIS LLP Cynthia S. Betz Mark M. Makhail MCCARTER & ENGLISH, LLP Y. Ernest Hsin (admitted pro hac vice) GIBSON, DUNN & CRUTCHER LLP Mark Reiter (admitted pro hac vice) Veronica S. Moyé Betty X. Yang (admitted pro hac vice) Ashbey N. Morgan (admitted pro hac vice) GIBSON, DUNN & CRUTCHER LLP Andrew P. Blythe (admitted pro hac vice) Nathaniel R. Scharn (admitted pro hac vice) GIBSON, DUNN & CRUTCHER LLP
Christopher R. DeCoro Sam Kwon KIRKLAND & ELLIS LLP
Brian D. Sieve, P.C. Marcus E. Sernel, P.C. Eric D. Hayes, P.C. Tasha F. Gerasimow Xaviere Giroud Sadaf Misbah Tareq M. Alosh KIRKLAND & ELLIS LLP
Diva R. Hollis KIRKLAND & ELLIS LLP
Cynthia S. Betz Mark M. Makhail MCCARTER & ENGLISH, LLP
Y. Ernest Hsin (admitted pro hac vice) GIBSON, DUNN & CRUTCHER LLP
Mark Reiter (admitted pro hac vice) Veronica S. Moyé Betty X. Yang (admitted pro hac vice) Ashbey N. Morgan (admitted pro hac vice) GIBSON, DUNN & CRUTCHER LLP
Andrew P. Blythe (admitted pro hac vice) Nathaniel R. Scharn (admitted pro hac vice) GIBSON, DUNN & CRUTCHER LLP
JOINT FINAL PRETRIAL ORDER
HON. JAMES B. CLARK, III, U.S.M.J., UNITED STATES DISTRICT JUDGE
The following shall constitute the Final Pretrial Order pursuant to Rule 16, Federal Rules of Civil Procedure. This Final Pretrial Order shall govern the conduct of the trial of this case. Amendments to this Order will be allowed only in exceptional circumstances to prevent manifest injustice. See Fed.R.Civ.P. 16(e). The parties (together, “the parties”) are Plaintiff Microspherix LLC (“Microspherix”) and Defendants Merck Sharp & Dohme Corp., Merck Sharp & Dohme B.V., Organon USA, Inc., and Organon USA, LLC (collectively, “Organon”). Counsel are urged to move to amend in a timely fashion any portion of the Order that must be changed or modified between the filing of the Order and the trial date.
APPEARANCES:
Counsel for Microspherix: Brian D. Sieve, P.C. Marcus E. Sernel, P.C. Eric D. Hayes, P.C. Tasha F. Gerasimow Xaviere Giroud
Counsel for Organon: Cynthia S. Betz Mark M. Makhail MCCARTER & ENGLISH, LLP Four Gateway Center 100 Mulberry St.
Sadaf Misbah Tareq M. Alosh KIRKLAND & ELLIS LLP 300 N. LaSalle Dr. Chicago, IL 60654 (312) 862-2000 bsieve@kirkland.com msernel@kirkland.com ehayes@kirkland.com tasha.gerasimow@kirkland.com xaviere.giroud@kirkland.com sadaf.misbah@kirkland.com tareq.alosh@kirkland.com Christopher R. DeCoro Sam Kwon KIRKLAND & ELLIS LLP 601 Lexington Avenue New York, NY 10022 (212) 446-4800 christopher.decoro@kirkland.com sam.kwon@kirkland.com Diva R. Hollis KIRKLAND & ELLIS LLP 1301 Pennsylvania Ave, N.W. Washington, D.C. 20004 (202) 389-5000 diva.hollis@kirkland.com
Newark, New Jersey 07102 Tel: (973) 622-4444 cbetz@mccarter.com mmakhail@mccarter.com Y. Ernest Hsin (admitted pro hac vice) GIBSON, DUNN & CRUTCHER LLP 555 Mission Street San Francisco, CA 94105 Tel: (415) 393-8200 ehsin@gibsondunn.com Mark Reiter (admitted pro hac vice) Veronica S. Moyé Betty X. Yang (admitted pro hac vice) Ashbey N. Morgan (admitted pro hac vice) GIBSON, DUNN & CRUTCHER LLP 2001 Ross Avenue, Suite 2100 Dallas, TX 75201 Tel: (214) 698-3100 mreiter@gibsondunn.com vmoye@gibsondunn.com byang@gibsondunn.com anmorgan@gibsondunn.com Andrew P. Blythe (admitted pro hac vice) Nathaniel R. Scharn (admitted pro hac vice) GIBSON, DUNN & CRUTCHER LLP 3161 Michelson Drive Irvine, CA 92612 Tel: (949) 451-3800 ablythe@gibsondunn.com nscharn@gibsondunn.com
I. JURISDICTION AND BRIEF SUMMARY OF THE CASE
1. This is an action for patent infringement arising out of the patent laws of the United States, 35 U.S.C. §§ 101 et seq. This Court has jurisdiction over the subject matter of this action pursuant to 28 U.S.C. §§ 1331 and 1338(a). For purposes of this action only, personal jurisdiction is not disputed by either party.
2. Microspherix alleges that Organon is now and has been directly and/or indirectly infringing U.S. Patent Nos. 8,821,835 (“the '835 patent”), 9,636,401 (“the '401 patent”), and 9,636,402 (“the '402 patent”) (collectively, the “Patents-in-Suit”), and that the infringement is willful. Microspherix seeks in its prayer for relief damages, and a finding that this case is exceptional entitling it to reasonable attorneys' fees and expenses.
3. Microspherix asserts the following claims: claims 1 and 16 of the '835 patent; claims 1, 13, 16, 18, and 20 of the '401 patent; and claims 6 and 9 of the '402 patent. Following rulings on IPR estoppel and other pretrial issues, Microspherix expects to further streamline its asserted claims for trial to no more than 6 claims. [Organon's Position: Organon requests that Microspherix identify the 6 claims it will assert at trial by October 6.]
4. Organon denies infringement, has asserted counterclaims of noninfringement and invalidity, and asserts additional affirmative defenses in law and equity. Organon further contends that the Asserted Claims are anticipated and/or rendered obvious by the prior art, are invalid because others invented the claimed invention first, invalid because Dr. Kaplan derived the invention from another, and invalid because they fail to satisfy the written description and enablement requirements. Organon seeks a finding that this case is exceptional entitling it to reasonable attorneys' fees and expenses.
5. The Court will conduct a hearing to address IPR estoppel and Daubert issues regarding the opinions of Microspherix's damages expert, Kimberly Schenk, on October 13, 2023. On IPR estoppel, Microspherix expects to call Mr. Eugene Lhymn and Organon expects to call Ms. Andrea Davis to testify. With respect to the Daubert issue, Ms. Schenk will be available for the hearing and can address any of the Daubert issues raised by Organon in its letter dated August 11, 2023 and counsel will be prepared to present argument on these issues.
6. At the pretrial conference, Microspherix plans to discuss whether the Court will require it to call foundational or custodial witnesses (live or via deposition) to lay a foundation for the admission of documents authored and produced by Defendants, as well as FDA communications regarding Organon products, prior to admission with expert witnesses. Microspherix would prefer that the parties agree to the admissibility of such documents via experts without the need to call live witness, records custodians, or play depositions solely for purposes of establishing foundation or other admissibility requirements. Such an approach will streamline the trial significantly. Organon believes that, to the extent there are questions about admissibility of documents, such questions depend on the nature of the document and the purpose for which Microspherix intends to introduce it. Accordingly, Organon cannot agree to Microspherix's categorical proposal. For example, several FDA documents Microspherix may seek to introduce are objectionable under, inter alia, Federal Rules of Evidence 403 and 802, and Microspherix may seek to introduce them through witnesses who are not qualified to analyze them.
A. Microspherix's Positions on Issues to be Presented to the Jury
7. Organon does not have a cognizable derivation argument. Organon's argument that the asserted Kaplan patent claims are “derived” from Organon's commercial Nexplanon product after 2012 assumes that Microspherix cannot claim priority for its asserted claims back to any of its priority filings in 2000, 2001, 2002 or 2003. To the extent Organon is able to prove such lack of priority on the basis of lack of written description-which would equate to establishing lack of written description in the patents as issued-then it follows that Organon will have proven invalidity under 35 U.S.C. §112. Thus, there is no separate or legally cognizable derivation defense. Moreover, Organon should be precluded from arguing or suggesting that any effort to draft claims to cover the Nexplanon product is improper. See, e.g., PIN/NIP, Inc. v. Platte Chem. Co., 304 F.3d 1235, 1247 (Fed. Cir. 2002) (“[I]t is legitimate to amend claims or add claims to a patent application purposefully to encompass devices or processes of others.”); Seagen Inc. v. Daiichi Sankyo Co., 2022 WL 2789901, at *7 (E.D. Tex. July 15, 2022) (“The Federal Circuit and courts in this District have found that there is nothing unusual or improper about drafting claims to cover a competitor's product, as long as there is a basis in the pending application, even if that claim has never appeared before in the family.”). These arguments ignore the law, would confuse the jury, and should be precluded.
8. The other issues raised by Organon in paragraphs 10-13 below were first introduced into a draft of the Joint Pretrial Order the day before its submission was due, and Microspherix thus does not seek to substantively respond to the issues herein. All of these issues are belatedly and improperly raised at this time. The Court already addressed the “pores” issue referenced in paragraph 11 that was raised by Organon in its letter to the Court dated August 11, 2023, and Organon's counsel agreed this was an infringement (not claim construction) issue that could be revisited at the close of Microspherix's case. 9/19/23 Tr. at 65:14-22. The other issues (while meritless in any event) could and should have been raised via summary judgment or other such motion practice, and thus have been waived as a result of Organon's failure to seek leave to do so consistent with Judge Bumb's Scheduling Order of March 16, 2023 (Dkt. 200) and Text Order of September 7, 2023 (Dkt. 223) (reminding of September 8 deadline and indicating argument on all such motions would be heard at a conference on September 19).
B. Organon's Positions on Issues to be Presented to the Jury
9. Organon's Derivation Defense. Microspherix may not decide which defenses Organon can present to the jury, and may not preclude Organon from presenting its derivation defense simply because the asserted patents may also be invalid on another basis, such as lack of enablement and written description under § 112. The patent laws codify derivation at 35 U.S.C. § 102(f) (pre-AIA). Although there are overlapping factual and legal issues, this is a separate invalidity defense from lack of enablement and insufficient written description, both of which are codified at 35 U.S.C. § 112. Additionally, Organon included its derivation defense in its invalidity contentions, and Microspherix has long been on notice of it. As reflected in the jury instructions, derivation requires evidence of (1) prior conception of the invention by another inventor in the United States; and clear and convincing evidence of (2) communication of that conception to Dr. Kaplan. D.I. 246, Proposed Preliminary Jury Instruction No. 23. Accordingly, Organon's evidence will show that Dr. Kaplan drafted his claims to attempt to cover Nexplanon after the concept of Nexplanon had been communicated to him. Microspherix has no basis to preclude Organon from presenting evidence to support its defense under § 102(f), and may not through this Pretrial Order obtain summary judgment in disguise as to Organon's derivation defense.
10. Microspherix's Arguments Not Disclosed in its Infringement Contentions.
Microspherix should not be permitted to present testimony and argument regarding infringement theories that were not disclosed in its infringement contentions, including testimony and argument that (1) the entire Nexplanon implant is the claimed “marker component,” (2) the free volume (i.e., the microscopic space between molecules) of Nexplanon's EVA skin constitutes the claimed “pores” or “openings,” or (3) any element is met under the doctrine of equivalents. TQ Delta, LLC v. ADTRAN, Inc., 2019 WL 4346530, at *2 (D. Del. Sept. 12, 2019) (“Opening expert reports are not the appropriate time to disclose new infringement allegations.”). To that end, a Microspherix's infringement contentions must state “specifically where each limitation of each asserted claim is found.” L. Pat. R. 3.1(c) (emphasis added). Specificity is likewise required for arguments under the doctrine of equivalents, as Local Patent Rule 3.1(e) requires patentees to state “whether each limitation of each asserted claim is alleged to be literally present or present under the doctrine of equivalents.” L. Pat. R. 3.1(e) (emphasis added); Razor USA LLC v. DGL Grp., Ltd., 2022 WL 44627, at *6 (D.N.J. Jan. 5, 2022) (“Courts in this district have emphasized that a general assertion of infringement under a doctrine of equivalents theory does not satisfy the requirements of Local Rule 3.1(e).”). None of the above-mentioned arguments was specifically disclosed in Microspherix's infringement contentions as required, and therefore may not be presented to the jury. Eagle View Techs., Inc. v. Xactware Sols., Inc., 2017 WL 5886004, at *4 (D.N.J. Nov. 29, 2017) (“[A] mere reservation of the right to assert [an infringement theory] is insufficient to satisfy the exacting requirements of L. Pat. R. 3.1.”). Organon proceeded through fact discovery and into expert discovery-including in preparing its Rule 30(b)(6) witnesses for deposition and preparing its opening expert reports-based on the disclosure in Microspherix's infringement contentions, and is severely prejudiced by Microspherix's untimely shift in its infringement theories, which must be stricken. EagleView Techs., Inc. v. Xactware Sols., Inc., 485 F.Supp.3d 505, 532 (D.N.J. 2020) (Bumb, C.J.) (“[T]he Court's Local Patent Rules are designed to prevent gamesmanship.”). Additionally, Microspherix's untimely disclosure of these infringement theories deprived Organon of the ability to seek case claim constructions for pores and openings under the deadlines of the Court's scheduling order.
Microspherix's new marker component argument is directly contrary to the stipulated construction for that term-“the part of the seed/strand that includes a marker” (D.I. 174)-which is another reason this untimely argument should be precluded. Organon could not have predicted that Microspherix would contradict the construction it stipulated to.
11. Construction of “Pores” and “Openings” in Light of Microspherix's Prosecution Disclaimer. Organon did not have the opportunity to address Microspherix's new argument on pores and openings at claim construction, and Microspherix has disclaimed through argument before the PTAB the literal scope of the claims as to these elements. In particular, during inter partes review proceedings in which it preserved the patentability of the asserted claims over the grounds alleged therein, Microspherix argued that the same EVA skin that it now accuses as containing pores or openings-embodied in the De Nijs patent covering Implanon-did not have pores or openings. The Court should therefore construe the terms pores and openings to clarify that free volume is not within the scope of these elements. O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1361 (Fed. Cir. 2008 (“[A] court has the duty to resolve the parties' claim construction disputes so the issues are not litigated before the jury.”); LMT Mercer Grp., Inc. v. Maine Ornamental, LLC, 2014 WL 183823, at *21 (D.N.J. Jan. 16, 2014) (same)). The Court has indicated that it plans to resolve this claim construction dispute before the case is given to the jury for deliberations.
12. Willful Infringement. Microspherix has stated that it intends to prove willfulness by pointing to a variety of Merck patent documents that purportedly show Merck was aware of certain unasserted patents, because Organon received notice of the patents through Microspherix's complaint, and because Organon has not produced and relied on an opinion of counsel in this litigation. None of these is a legally permissible argument for willfulness, and there is no actual evidence of willful infringement in the case. Nonetheless, the suggestion of willful infringement and instruction on that issue are potentially inflammatory and would be prejudicial to Organon, and should therefore excluded under Federal Rule of Evidence 403. First, defendant Merck's alleged awareness of unasserted patent documents related to Dr. Kaplan (as a result of their being cited on Merck's patent documents) is not evidence of willful infringement of the Asserted Patents. See Plexxikon Inc. v. Novartis Pharms. Corp., 2021 WL 2224267, at *8 (N.D. Cal. June 2, 2021) (precluding reliance on evidence suggesting knowledge of patents that were “not the asserted ones”). Second, the mere filing of a complaint is insufficient to demonstrate willful infringement. Wrinkl, Inc. v. Facebook, Inc., 2021 WL 4477022, at *8 (D. Del. Sept. 20, 2021) (“But if all that is required [to prove willfulness] is the filing of a complaint and a plausible allegation of infringement, then every case would be a willful infringement case.”). As such, multiple courts in this circuit that have concluded after detailed analysis that a defendant's knowledge of the Asserted Patents for willfulness cannot be “based solely on the content of . . . a prior version of the complaint filed in the same lawsuit.” ZapFraud, Inc. v. Barracuda Networks, Inc., 528 F.Supp.3d 247, 24952 (D. Del. 2021); Wrinkl, 2021 WL 4477022, at *5-8; iFITInc. v. Peloton Interactive, Inc., 2022 WL 609605, at *2 (D. Del. Jan. 28, 2022); see also Beteiro, LLC v. BetMGM, LLC, 626 F.Supp.3d 789, 803 n.9 (D.N.J. 2022), appeal docketed No. 22-2278 (Fed. Cir. Sept. 29, 2022). Third, as codified in 35 U.S.C. § 298, patentees are categorically precluded from arguing that failure to produce an opinion of counsel is a basis for willful infringement. 35 U.S.C. § 298 (“The failure of an infringer to obtain the advice of counsel with respect to any allegedly infringed patent, or the failure of the infringer to present such advice to the court or jury, may not be used to prove that the accused infringer willfully infringed the patent or that the infringer intended to induce infringement of the patent.”). Yet Microspherix attempts to make that exact, statutorily prohibited argument. Accordingly, Microspherix should not be permitted to argue willful infringement, and the jury should not be instructed on it.
13. Proposed Final Jury Instructions on “Communications With Court” (D.I. 246, Proposed Instruction Nos. 14 & 34). Organon believes this instruction unnecessarily suggests that the jury should communicate with the Court during deliberations, and should not be included in the final jury instructions.
II. STIPULATED FACTS
The parties stipulate to the following facts, which require no proof at trial. The parties reserve their right to supplement this list of facts.
A. The Parties
14. Plaintiff Microspherix is a Florida corporation having a principal place of business at 21283 Rockledge Lane, Boca Raton, Florida 33428 in Palm Beach County.
15. Dr. Edward Kaplan formed Microspherix in 2001 and is the sole owner of Microspherix.
16. Defendant Merck Sharp & Dohme Corp. is a corporation organized and existing under the laws of the State of New Jersey, having a principal place of business at One Merck Drive, Whitehouse Station, New Jersey 08889-0100.
17. Defendant Merck Sharp & Dohme B.V. is incorporated in the Netherlands with a place of business at Waarderweg 39, 2031 BN Haarlem, Netherlands.
18. Defendant Organon USA, LLC is a corporation organized and existing under the laws of the State of New Jersey, having a principal place of business at 30 Hudson Street, Jersey City, New Jersey, 07302.
19. Defendant Organon USA, Inc. was a corporation organized under the laws of the State of New Jersey, formerly having a principal place of business at 2000 Galloping Hill Road, Kenilworth, New Jersey, 07033 and One Merck Drive, Whitehouse Station, New Jersey 08889-0100. Organon USA, Inc., is no longer an existing entity and was merged into Organon USA, LLC on October 15, 2020.
20. Organon USA, LLC is presently the “Labeler Name” for Nexplanon in the National Drug Code Directory.
21. Schering-Plough acquired Organon BioSciences from Akzo Nobel in 2007.
22. Merck & Co., Inc. and Schering-Plough Corporation merged in 2009.
23. Merck & Co., Inc. spun off Organon & Co. in 2021.
B. The Patents-in-Suit
24. U.S. Patent No. 8,821,835 (“the '835 patent”) is entitled “Flexible and/or Elastic Brachytherapy Seed or Strand.”
25. The '835 patent was issued by the U.S. Patent and Trademark Office (“USPTO”) on September 2, 2014.
26. U.S. Patent Application No. 13/916,916 (“the '916 application”) that led to the '835 patent was filed on June 13, 2013.
27. The '916 application states that it is a continuation of U.S. Patent Application No. 12/823,700, filed on June 25, 2010.
28. U.S. Patent Application No. 12/823,700 states that it is a continuation of U.S. Patent Application No. 10/665,793, filed on September 19, 2003.
29. U.S. Patent Application No. 10/665,793 states that it is a continuation-in- part of U.S. Patent Application No. 09/861,326.
30. U.S. Patent Application No. 10/665,793 states that it is also a continuationin-part of U.S. Patent Application No. 09/861,196.
31. U.S. Patent No. 9,636,401 (“the '401 patent”) is entitled “Flexible and/or Elastic Brachytherapy Seed or Strand.”
32. The '401 patent was issued by the USPTO on May 2, 2017.
33. U.S. Patent Application No. 14/473,159 (“the '159 application”) that led to the '401 patent was filed on August 29, 2014.
34. The '159 application states that it is a continuation of the '916 application.
35. U.S. Patent No. 9,636,402 (“the '402 patent”) is entitled “Flexible and/or Elastic Brachytherapy Seed or Strand.”
36. The '402 patent was issued by the USPTO on May 2, 2017.
37. U.S. Patent Application No. 14/711,658 (“the '658 application”) that led to the '402 patent was filed on May 13, 2015.
38. The '658 application states that it is a continuation of the '159 application.
39. Provisional Application No. 60/412,050, listed as Related U.S. Application Data on the face of the '835, '401, and '402 patents, was filed on September 19, 2002.
40. Provisional Application No. 60/249,128, listed as Related U.S. Application Data on the face of the '835, '401, and '402 patents, was filed on November 16, 2000.
41. Edward J. Kaplan is the named inventor of the '835, '401, and '402 patents.
42. Microspherix LLC is the assignee of the '835, '401, and '402 patents.
C. Inter Partes Review
43. Petitions were filed for inter partes review (IPR) of the '835 patent on February 9, 2018, of the '401 patent on December 29, 2017, and on the '402 patent on December 22, 2017.
44. The Patent Trial and Appeal Board held that Petitioner did not show that claims 1-4, 9-12, and 14-20 of the '835 patent, claims 1-5 and 9-25 of the '401 patent, and claims 6 and 9 of the '402 patent are unpatentable, but did show that claims 1-5, 7, 8, and 10-19 of the '402 patent are unpatentable based on the grounds presented in the petitions.
45. The Federal Circuit affirmed the Board's decisions.
D. Claim Construction
46. On September 8, 2020, the parties in the Joint Claim Construction Statement (Dkt. 94) agreed that the terms below should be construed as follows:
Claim Term
Agreed Definition
“encapsulated” '402 Patent claims 6 and 9
“enclosed or contained within”
“seed” '835 Patent claims 1, 16
“implant shaped to pass through a needle bore”
“strand” '401 Patent claims 1, 13, 16, 18, 20 '402 Patent claims 6 and 9
“elongated implant”
47. On March 1, 2022 the Court entered the following stipulated claim constructions:
Claim Term
Agreed Definition
“marker component”
“the part of the seed/strand that includes a marker”
'401 Patent claims 1, 13, 16, 18, and 20 '835 Patent claims 1 and 16
(D.I. 174)
“radio-opaque” and “radiopaque”
“capable of visualization by conventional x-ray
'402 Patent claims 6 and 9
imaging”
'835 Patent claim 16
(D.I. 174)
48. On February 27, 2023, the Court ordered that the claim terms listed below be construed as follows:
Claim Term
Ordered Construction
“target tissue” '401 Patent claims 1, 13, 16, and 18 '835 Patent claims 1 and 16
“tissue targeted for treatment into which implant is implanted” (D.I. 194)
“seed, for implantation into a subject” '835 Patent claims 1 and 16
Plain and ordinary meaning (D.I. 194)
“strand for administration of a therapeutic agent to a subject in need thereof” '402 Patent claims 6 and 9
Plain and ordinary meaning (D.I. 194)
“strand for implantation into a subject” '401 Patent claims 1, 13, 16, and 18
Plain and ordinary meaning (D.I. 194)
“therapeutic agent” '402 Patent claims 6 and 9 '401 Patent claims 1, 13, 16, 18, and 20 '835 Patent claims 1 and 16
Plain and ordinary meaning (D.I. 194)
“prophylactic agent” '401 Patent claims 1, 13, 16, 18, and 20 '835 Patent claims 1 and 16
Plain and ordinary meaning (D.I. 194)
“hollow interior” '401 Patent claims 1, 13, 16, 18, and 20 '835 Patent claims 1 and 16
Plain and ordinary meaning (D.I. 194)
“[marker component] . . . having a substantially continuous wall bounding a hollow interior” '401 Patent claims 1, 13, 16, and 18 '835 Patent claims 1 and 16
Plain and ordinary meaning (D.I. 194)
“[marker component] . . . having a substantially continuous wall along the length, the substantially continuous wall bounding a hollow interior” '401 Patent claim 20
Plain and ordinary meaning (D.I. 194)
Claim Term
Ordered Construction
“polymeric coating” '402 Patent claims 6 and 9
Plain and ordinary meaning (D.I. 194)
“rod” '402 Patent claims 6 and 9
Plain and ordinary meaning (D.I. 194)
“flexible” '401 Patent claims 1 and 16
Not indefinite; Plain and ordinary meaning (D.I. 194)
“marker” '401 Patent claims 1 and 16 '835 Patent claims 1, 3, 4, 10, 16, 17, and 20
Plain and ordinary meaning (D.I. 194)
“radio-opaque material” '402 Patent claims 6 and 9
Plain and ordinary meaning (D.I. 194)
“agent . . . selected from the group consisting of . . . radiopaque” '835 Patent claim 16 “radio-opaque” and “radiopaque”
Plain and ordinary meaning (D.I. 194) Plain and ordinary meaning (D.I. 194)
49. On June 5, 2017, Microspherix filed a lawsuit alleging infringement of the Patents-in-Suit.
50. Nexplanon is x-ray visible.
51. Implanon was approved by the FDA on July 17, 2006.
52. Nexplanon was approved by the FDA on May 31, 2011.
53. The Implanon implant comprises an ethylene-vinyl acetate (“EVA”) core containing etonogestrel dispersed therein, and a polymer skin of EVA surrounding that core, with the implant having open ends.
54. The Nexplanon implant comprises an ethylene-vinyl acetate (“EVA”) core containing etonogestrel and barium sulfate dispersed therein, and a polymer skin of EVA surrounding that core, with the implant having open ends.
55. Etonogestrel is a synthetic biologically active metabolite of a synthetic hormone (desogestrel).
56. The original new drug application for Implanon was submitted to the FDA on September 30, 2003.
57. The supplemental NDA for Nexplanon was submitted to the FDA on July 29, 2009.
III. PLAINTIFF'S CONTESTED FACTS
Microspherix's statement of the facts it intends to prove at trial is attached as Exhibit 3. Microspherix reserves the right to revise these contested facts in response to the Court's orders and other rulings, or as otherwise appropriate.
IV. DEFENDANT'S CONTESTED FACTS
Organon's statement of the facts it intends to prove at trial is attached as Exhibit 4. Organon reserves the right to revise these contested facts in response to the Court's orders and other rulings, or as otherwise appropriate.
V. FACT WITNESSES AND SUMMARY OF TESTIMONY
Absent leave of Court, only the witnesses listed herein will be permitted to testify at the time of trial. The listing of a witness on a party's witness list does not require the party to call that witness to testify, either in person or by deposition. In the event a party seeks to call a substitute witness, the parties agree they will make an application to the Court to amend the Joint Final Pretrial Order.
A. Plaintiff's Fact Witnesses
1. Fact Witnesses Who Will Be Called for Live Testimony
Witness
Summary of Testimony
Edward Kaplan c/o Kirkland & Ellis, LLP 300 N. LaSalle Dr., Chicago IL 60654
Dr. Kaplan is a practicing physician and a named inventor on the patents asserted against Organon. In general, Dr. Kaplan will testify regarding the history of his inventions and protecting those inventions with patents, the conception of the inventions in the asserted patents, the use of a radiopaque marker to help localize an implanted medical device in a patient's body, and his efforts to use and commercialize the inventions. Dr. Kaplan will also discuss his formation of Microspherix LLC and his assignment of the asserted patents to Microspherix.
2. Fact Witnesses Who May Be Called for Live Testimony
Witness
Summary of Testimony
Patrea Pabst c/o Kirkland & Ellis, LLP 300 N. LaSalle Dr., Chicago IL 60654
Patrea Pabst is a practicing patent attorney who was involved in the prosecution of the Asserted Patents. Plaintiff may call Ms. Pabst to testify to the prosecution of the Asserted Patents.
Umer Raffat
Mr. Raffat is a Senior Managing Director at Evercore ISI. Plaintiff may call Mr. Raffat to testify regarding his knowledge of Organon, Nexplanon, the market for Long-Acting Reversible Contraceptives (“LARC”), and the value of the patented technology to Organon.
3. Fact Witnesses Who May Be Called by Deposition
Information concerning Plaintiff's witnesses who may be called by deposition is attached as Exhibit 5A.
Witness
Summary of Testimony
Lisa French
Ms. French was the Unit Lead for Organon's U.S. Women's Health Business and the former Associate Vice President at Merck. Plaintiff may call Ms. French to testify on financial matters regarding the Accused Product.
Witness
Summary of Testimony
Jill Freymuller
Ms. Freymuller is the Associate Director of U.S. Regulatory and Global Product Strategy at Organon. Plaintiff may call Ms. Freymuller to testify on regulatory issues regarding the Accused Product.
Ruud Groenewegen
Mr. Groenewegen is the Quality Compliance Lead at Organon. Plaintiff may call Mr. Groenewegen to testify regarding the manufacturing and development of the Accused Product.
Simon Holland
Mr. Holland is the Vice President of Women's Health at Organon. Plaintiff may call Mr. Holland to testify regarding the development of the Accused Product.
Ed Saltus
Mr. Saltus is the Director of Global Regulatory Affairs at Merck. Plaintiff may call Mr. Saltus to testify on regulatory issues regarding the Accused Product.
Earyn Thornton
Ms. Thornton is the Associate Director of Litigation at Organon. Plaintiff may call Ms. Thornton to testify on information provided to, received from, and relied upon by Organon from financial analysts, and facts regarding product liability litigation involving Implanon.
Harm Veenstra
Mr. Veenstra is the Associate Director of Global Technical Operations at Merck. Plaintiff may call Mr. Veenstra to testify on the development of the Accused Product.
Edio Zampaglione
Mr. Zampaglione is Vice President of Global Medical Affairs and Outcomes Research at Organon. Plaintiff may call Mr. Zampaglione to testify on the development of the Accused Product.
4. Plaintiff's Objections to Defendants' Witness List
Plaintiff objects to Defendants calling any witness by deposition unless the witness is unavailable pursuant to Federal Rule 32. Plaintiff further objects to Defendants' decision to list all its potential fact witnesses as “may call,” without designating any specific “will call” fact witnesses in the pretrial order. This approach essentially equates to nondisclosure, is inconsistent with both the intent and purpose of the pretrial disclosure requirements, and unduly prejudices the Plaintiff's ability to effectively prepare for trial. Plaintiff reserves the right to seek appropriate relief from the Court if the Defendants persist with this gamesmanship.
Plaintiff reserves the right to object to Defendants' use of any witness or testimony that violates the Federal Rules of Evidence, the Federal Rules of Civil Procedure, the Local Rules of Civil Practice and Procedure of the United States District Court for the District of New Jersey, the Pretrial Order entered in this case, and any existing or future rulings or orders of the Court (including rulings on motions in limine). Plaintiff further objects to Defendant presenting expert testimony that exceeds the scope of opinions disclosed under Fed.R.Civ.P. 26(a)(2)(B).
B. Defendants' Fact Witnesses and Objections to Plaintiff's Witness List
1. Defendants' Objections to Plaintiff's Witness List
Organon objects to Microspherix's identification of Patrea Pabst to the extent Microspherix intends to offer testimony regarding alleged standard practice or commonplace practices among patent prosecution attorneys as improper expert testimony. Organon objects to Microspherix's identification of Umer Raffat as improper expert testimony and because Mr. Raffat was not timely disclosed as required under Rule 26. Further, Microspherix has indicated that it intends to call Mr. Raffat to provide damages opinions without having submitted an expert report as required under Federal Rule of Civil Procedure 26 and the scheduling order or otherwise demonstrating that Mr. Raffat's analysis satisfies the requirements of Federal Rule of Evidence 702.
2. Plaintiff's Responses to Defendants' Objections to Plaintiff's Witness List
Any complaints about untimeliness are entirely of Organon's own making, as the need to potentially call Mr. Raffat results from unfounded evidentiary objections and Organon's prior discovery abuse as detailed in a letter to the Court dated May 16, 2023.
3. Fact Witnesses Who Will be Called for Live Testimony
Witness
Summary of Testimony
Simon Holland
Historical and current business and marketing efforts and decisions for Organon's women's health portfolio, including Implanon and Nexplanon; sales and marketing for Implanon and Nexplanon; Merck and Organon's knowledge of and relationship to Microspherix; relationship between Merck, Organon, and other related entities; clinical training program for Implanon and Nexplanon
Ruud Groenewegen
Conception and reduction to practice of X-ray visible Implanon, including Organon's development, design, research, and testing efforts; decisions surrounding the addition of barium sulfate and new applicator; characteristics and testing of Implanon and Nexplanon, including the manufacturing process; non-infringing alternatives
Ed Saltus
Conception and reduction to practice of X-ray visible Implanon, including Organon's development, design, research, and testing efforts; decisions surrounding the addition of barium sulfate and new applicator; regulatory strategy and history of Implanon and Nexplanon; regulatory submissions and correspondence regarding Implanon and Nexplanon in the United States; regulatory aspects of the development of Implanon and Nexplanon
Harm Veenstra
Conception and reduction to practice of X-ray visible Implanon, including Organon's development, design, research, and testing efforts; decisions surrounding the addition of barium sulfate and new applicator; characteristics and testing of Implanon and Nexplanon, including the manufacturing process; development of Nexplanon, including the '037 patent
4. Fact Witnesses Who May be Called for Live Testimony
Witness
Summary of Testimony
Edio Zampaglione
Regulatory strategy and history of Implanon and Nexplanon; regulatory submissions and correspondence regarding Implanon and Nexplanon in the United States; regulatory aspects of the development of Implanon and Nexplanon; clinical training programs for Implanon and Nexplanon
Lisa French
Sales and marketing for Implanon and Nexplanon; Merck and Organon's knowledge of and relationship to Microspherix; relationship between Merck, Organon, and other related entities
Jill Freymuller
Regulatory strategy and history of Implanon and Nexplanon; regulatory submissions and correspondence regarding Implanon and Nexplanon in the United States; regulatory aspects of the development of Implanon and Nexplanon
Any witness included on Microspherix's witness list
Organon incorporates by reference the summaries included in Organon's witness list.
5. Fact Witnesses Who May Be Called by Deposition
See Exhibit 5B.
Witness
Summary of Testimony
Edward Kaplan
The asserted patents, including the state of the art at the time the applications for the asserted patents were filed, any work that led to the alleged inventions claimed therein, and financial matters related to alleged damages.
VI. EXPERT WITNESSES
Any expert not listed in this portion of the Joint Pretrial Order shall not be permitted to testify at the time of trial. The curriculum vitae of each expert expected to testify at the time of trial is attached to this Final Pretrial Order as Exhibit 6. The curriculum vitae or summary of the expert's qualifications may be read into the record at the time the expert takes the stand, and no opposing counsel shall be permitted to question the qualifications of the expert unless the basis of the objection is set forth in this Final Pretrial Order.
A. Plaintiff's Expert Witnesses
1. Expert Witnesses Who Will Be Called for Live Testimony
Witness
Summary of Testimony
Mansoor Amiji c/o Kirkland & Ellis, LLP 300 N. LaSalle Dr., Chicago IL 60654
Dr. Amiji is a University Distinguished Professor and Professor of Pharmaceutical Science at Northeastern University. Dr. Amiji will testify regarding the inventions claimed by the Asserted Patents, why the claims of the Asserted Patents are not anticipated or obvious over the prior art, and why the claims of the Asserted Patents are supported and enabled by the specifications of the Asserted Patents.
Michael Cima c/o Kirkland & Ellis, LLP 300 N. LaSalle Dr., Chicago IL 60654
Dr. Cima is a Professor of Materials Science and Engineering at the Massachusetts Institute of Technology (“MIT”). Dr. Cima will testify regarding his analysis of the level of skill of a person of ordinary skill in the art, the Asserted Claims, the Asserted Patents, Nexplanon, proof of infringement, and lack of acceptability and availability of Organon's alleged non-infringing alternatives.
Kimberly Schenk c/o Kirkland & Ellis, LLP 300 N. LaSalle Dr., Chicago IL 60654
Ms. Schenk is a Certified Public Accountant and Vice President at Charles River Associates, a consulting firm that provides litigation support services. Ms. Schenk will testify regarding damages owed to Microspherix in the event Organon is found liable for infringement of the Asserted Patents at trial.
Louis Weinstein c/o Kirkland & Ellis, LLP 300 N. LaSalle Dr., Chicago IL 60654
Dr. Weinstein is a former obstetrics and gynecology physician and is currently a gynecologist at the Barrier Island Free Medical Clinic. Dr. Weinstein will testify regarding objective indicia of non-obviousness related to the Asserted Patents from the perspective of a prescriber of the Accused Product and acceptability and availability of Organon's alleged non-infringing alternatives.
Sousan Sheldon c/o Kirkland & Ellis, LLP 300 N. LaSalle Dr., Chicago IL 60654
Dr. Sheldon is a former official at the U.S. Food and Drug Administration (“FDA”) where she served in both FDA's Center for Drug Evaluation and Research and Center for Devices and Radiological Health. Dr. Sheldon will testify regarding the FDA's regulatory review process, the regulatory history of Implanon and Nexplanon, and the lack of acceptability and availability of Organon's alleged non-infringing alternatives.
B. Defendants' Expert Witnesses and Objections to Plaintiff's Expert Witness List
1. Defendants' Objections to Plaintiff's Expert Witness List
Organon objects to the admissibility of Kimberly Schenk's testimony and certain opinions of Louis Weinstein under Daubert, including for the reasons discussed in their letter filed on August 11, 2023. Both experts have offered opinions they are not qualified by knowledge, skill, experience, training, or education as required under Federal Rule of Evidence 702 to offer opinions on, including Ms. Schenk's opinions related to regulatory and medical matters and Dr. Weinstein's opinions related to the number of patients who would have declined to use Implanon but would have otherwise used Nexplanon, as those opinions are not based on sufficient facts or data as required under Federal Rule of Evidence 702. Additionally, Ms. Schenk's opinions are not the product of reliable principles and methods (or the reliable application thereof) and are not based on sufficient facts or data. Defendants further object to the testimony of Drs. Louis Weinstein and Sousan Sheldon, as these experts' reports dated July 14, 2023 and August 4, 2023 were not timely served as required under Federal Rule of Civil Procedure 26 and the stipulated expert disclosure schedule. D.I. 200. Additionally, Dr. Weinstein's purported testimony regarding objective indicia of non-obviousness should be precluded, as he establishes no nexus to the claimed invention.
Microspherix indicated at the September 19, 2023 hearing that it may not call Drs. Weinstein and Sheldon in its case-in-chief. See D.I. 244 at 67:16-19. Organon objects to Microspherix's calling either expert in its rebuttal case, as their testimony relates to damages issues. Specifically, these experts' testimony relates to Microspherix's argument that there were no acceptable noninfringing alternatives, which Microspherix's damages expert opined on affirmatively in her opening report (served on June 2, 2023) in connection with her reasonable royalty analysis and Georgia Pacific factors 9, 10, and 15 (Schenk Opening Report ¶¶ 206-232, 247), and which Microspherix's infringement expert Dr. Michael Cima also opined on affirmatively in his opening report (also served on June 2, 2023). Cima Opening Report ¶¶ 4, 25, 259-260. Microspherix did not serve Dr. Weinstein's expert reports purporting to support this analysis until the rebuttal and reply round of expert reports on July 14, 2023 and August 4, 2023, and did not serve Dr. Sheldon's expert report purporting to support his analysis until the reply round of expert reports on August 4, 2023, however. As noted above, these reports should be stricken, and these experts should not be permitted to testify at all. To the extent they are permitted to testify regarding damages issues, such as noninfringing alternatives, however, they must do so in Microspherix's case-in-chief on damages.
Finally, Dr. Cima should not be permitted to testify regarding the purported level of ordinary skill in the art, as that is not relevant to his infringement analysis.
Microspherix contends that certain of Organon's challenges to the admissibility of Microspherix's experts' testimony are waived because they were not specifically identified in Organon's August 11, 2023 letter (D.I. 223). However, Organon previewed in that letter that it “intend[ed] to move to strike and/or exclude additional portions of Microspherix's expert reports and will do so in the form of motions in limine per Judge Clark's recommendation.” Id. at 1 n.1. Although the Court has indicated that it will not entertain motions in limine, Organon maintains- and for the avoidance of doubt, does not waive-its objections to the admissibility of the expert testimony identified above.
2. Plaintiff's Responses to Defendants' Objections To Plaintiff's Expert Witness List
Chief Judge Bumb's Orders of March 16, 2023 (Dkt. 200) and September 7, 2023 (9/7/2023 Text Order) made clear that the parties needed to seek leave to raise any Daubert issues by letter no later than September 8, 2023. Microspherix agrees that certain challenges were timely raised by Organon with respect to Ms. Schenk's opinions, and this Daubert challenge is scheduled to be addressed by Chief Judge Bumb at a hearing scheduled for October 13, 2023. Microspherix also will be prepared to address the issues raised with respect to the timing of the service of the various reports at this hearing on October 13, as it agrees this issue was also timely raised in Organon's August 11, 2023 letter. On the other hand, Organon has not previously sought leave of court to file, or otherwise alerted the court to, any Daubert challenges to the substance of the opinions of Drs. Weinstein, Sheldon, or Cima. As a result, Microspherix believes that all such challenges (which are meritless in any event) have been waited and should not be considered by the Court at this time.
3. Expert Witnesses Who Will Be Called for Live Testimony
Witness
Summary of Testimony
Kinam Park
Non-infringement; non-infringing alternatives
Edith Mathiowitz
Invalidity; prior commercial use; conception and reduction to practice of X-ray visible Implanon, including Organon's development, design, research, and testing efforts; development of Nexplanon, including the '037 patent
Mark Seigel
Knowledge and practices of healthcare providers and patients with respect to contraceptives, including Implanon and Nexplanon; damages
Mark Schwartz
Regulatory history of Implanon and Nexplanon; non-infringing alternatives; damages
Christopher Vellturo
Damages
4. Expert Witnesses Who May Be Called for Live Testimony
Witness
Summary of Testimony
Andrea Davis
IPR estoppel
VII. EXHIBITS
The parties agree that only the exhibits listed on the parties' exhibit lists shall be introduced at the time of trial. The parties are not required to list exhibits that will be used, if at all, only for impeachment purposes.
A. Plaintiff's Exhibits
A list of Microspherix's exhibits that it may offer into evidence, including Organon's objections and a key to those objections, is attached at Exhibit 7A.
B. Defendant's Exhibits
A list of Organon's exhibits that it may offer into evidence, including Microspherix's objections and a key to those objections, is attached at Exhibit 7B.
VIII. LEGAL ISSUES
A. Plaintiff's Statement of the Legal Issues in this Case
Microspherix's statement of the legal issues in this case is attached at Exhibit 8A.
B. Defendant's Statement of the Legal Issues in this Case
Organon's statement of the legal issues in this case is attached at Exhibit 8B.
IX. MISCELLANEOUS
A. Order of Presentation
Subject to the Court's approval, the parties have agreed as follows:
1. Microspherix will present its opening statement first, followed by Organon's opening statement.
2. Microspherix has the burden of proof on patent infringement and damages. As such, Microspherix will present its case-in-chief on those issues first, followed by Organon's casein-chief in response to Microspherix.
3. Organon has the burden of proof on invalidity. As such, invalidity will be part of Organon's case-in-chief.
4. Microspherix will then present its case in response to Organon's invalidity case [Microspherix's Position: and then, as needed, rebuttal with respect to issues first raised in Organon's case, including potentially evidence relating to non-infringing alternatives]. [Organon's Position: For the avoidance of doubt, Microspherix will not be permitted to present evidence in its rebuttal case evidence related to infringement and damages (including noninfringing alternatives), which are issues for which Microspherix bears the burden of proof. See, e.g., MHL Custom, Inc. v. Waydoo USA, Inc., 1:21-cv-00091-RGA, Updated Final Joint Pretrial Order, D.I. 212, at 20-21 (D. Del. 2023) (rejecting stipulated proposal that patentee be permitted to present a reply on infringement and damages and limiting patentee's rebuttal case to invalidity); Eagle View Techs., Inc., v. Xactware Solutions, Inc., No. 1:15-cv-07025, Proposed Joint Final Pretrial Order, D.I. 674, at 10-11 (D.N.J. June 3, 2019) (patentee's rebuttal case limited to validity); AstraZeneca Pharms. LP v. Sandoz Inc., No. 14-cv-03547-RMB-KMW, Joint Final Pretrial Order, D.I. 308, at 23 (D.N.J. 2016) (patentee's rebuttal case limited to validity); Sun Pharma Global FZE v. Lupin Ltd., No. 3:18-cv-2213-FLW-TJB, D.I. 223, Final Pretrial Order, at 74 (D.N.J. 2021) (patentee's rebuttal case limited to invalidity and unenforceability, defendant permitted rebuttal case on secondary considerations); Forest Laboratories, LLC f/k/a Forest Laboratories, Inc. et al v. Prinston Pharmaceutical Inc., 2:17-cv-10230-ES-MAH, Revised Sealed Final Pretrial Order (Public Redacted Version), at 60 (D.N.J. 2021) (patentee's rebuttal case limited to validity, defendant permitted rebuttal case on secondary considerations). Alternatively, to the extent Microspherix is permitted to address infringement and damages in its rebuttal case, including callings Drs. Sheldon and/or Weinstein for the first time on those issues, Organon is permitted a rebuttal case on invalidity and to respond to Drs. Sheldon and/or Weinstein. See, e.g., Supernus Pharms., Inc. v. TWI Pharms., Inc., No. 15-369 (RMB) (JS), Joint Final Pretrial Order, D.I. 235-2, at 170 (ECF page 69 of 172) (D.N.J. March 28, 2017) (plaintiff's rebuttal case entailed infringement and validity, defendant permitted a reply case on invalidity); ViaTech Technologies, Inc. v. Adobe Inc., 1:20-cv-00358-RGA-JLH, Amended Final Pretrial Order, D.I. 267, at 21-22 (D. Del. 2023) (patentee's rebuttal case entailed infringement, willfulness, and damages, defendant permitted rebuttal case on invalidity and other defenses).]
5. Microspherix's Statement on the Order of Presentation of Expert Witnesses: Microspherix has not yet decided whether to call Dr. Weinstein (an OB/GYN) or Dr. Sheldon (an FDA expert) in its case-in-chief or its rebuttal case. Both of these witnesses address among other issues those relating to non-infringing alternatives, which is an issue on which Organon bears the burden of proof. See, e.g., SPEX Techs. v. Apricorn, Inc., 2020 WL 1289546, at *2 (C.D. Cal. Jan. 21, 2020) (“The accused infringer bears the burden of proving the existence of non-infringing alternatives.”). Microspherix certainly has no intention of presenting any duplicative testimony in its rebuttal case, but to the extent Organon presents evidence on non-infringing alternatives that Microspherix has not addressed in its case-in-chief, Microspherix reserves the right to call one or both of these witnesses in rebuttal.
6. Organon's Statement on the Order of Presentation of Expert Witnesses: The issue of which non-infringing alternatives were available at the time of the hypothetical negotiation and their impact on the hypothetical negotiation is part of the reasonable royalty analysis. Droplets, Inc. v. Yahoo! Inc., 2021 WL 9038509, at *10-11 (N.D. Cal. Apr. 27, 2021) (disagreeing with SPEX because non-infringing alternatives are relevant to two of the Georgia-Pacific factors); RSB Spine, LLC v. DePuy Synthes Sales, Inc., No. CV 19-1515-RGA, 2022 WL 17084156, at *4 (D. Del. Nov. 18, 2022) (holding that, for a “royalty analysis under the Georgia-Pacific factors, a defendant does not have a burden of proving non-infringing alternatives). Microspherix bears the burden of proving damages, including what the reasonable royalty should be. Transclean Corp. v. Bridgewood Servs., Inc., 290 F.3d 1364, 1376 (Fed. Cir. 2002) (the patentee “had the burden of proving the amount of reasonable royalty damages it is entitled to recover”). Microspherix's opening damages and technical reports acknowledge this, as both-out of necessity-address noninfringing alternatives, and Ms. Schenk considers these non-infringing alternatives as part of the Georgia Pacific factors she uses to determine the purported reasonable royalty rate. Schenk Opening Report ¶¶ 206-232, 247; Cima Opening Report ¶¶ 4, 25, 259-260. Drs. Sheldon's and Weinstein's expert reports attempt to support this earlier analysis of noninfringing alternatives, but Dr. Weinstein's reports were not served until the rebuttal and reply round of expert reports on July 14, 2023 and August 4, 2023, and Dr. Sheldon's expert report was not served until the reply round of expert reports on August 4, 2023, however. It would be improper and unfair to permit Drs. Sheldon and Weinstein to testify regarding noninfringing alternatives in Microspherix's rebuttal case while providing Organon no opportunity to respond to their testimony. Although these experts' reports should be stricken in their entirety, if they are not stricken, they must provide their opinions purporting to support Ms. Schenk's analysis and opinions (to the extent they are not excluded) in Microspherix's affirmative case.
B. Time Allotted to Each Party
1. Subject to the Court's approval, the parties will limit their opening statements to 30 minutes each.
2. Subject to the Court's approval, the parties will have equal time to present their cases.
3. Subject to the Court's approval, the parties will provide closing statements of up to 60 minutes for Microspherix (which may choose to reserve some of that time for rebuttal) and 60 minutes for Organon.
4. Trial will last up to two weeks, from October 16, 2023 to October 27, 2023.
C. Witnesses
5. The parties agree that any fact witnesses, except for a party representative attending trial, appearing in person shall be sequestered until he/she testifies, and any trial testimony preceding the testimony of that fact witness cannot be disclosed to that witness directly or indirectly. The parties agree that all witnesses may be present for opening statements.
6. Expert witnesses may be present in the courtroom at any time during trial.
7. The parties agree that witnesses will not discuss their testimony or otherwise communicate with counsel while they are on cross-examination.
D. Trial Stipulations
8. Witnesses. By 6:00 pm Eastern Time three calendar days before the expected trial day on which a witness will be called to testify, each party will identify by email to the opposing party the witnesses it intends to call on that trial day, the anticipated order in which those witnesses will be called, and whether those witnesses will be called live or by deposition (if by deposition designations are to be played in court). For example, for witnesses expected to be called on Monday, October 16, 2023, notice shall be given by 6:00 pm Eastern Time on Friday, October 13, 2023.
9. Playing of Deposition Designations. All portions of the testimony designated by any party will be played at the same time, including the parties' affirmative designations and counter-designations. All designated testimony will be introduced in the sequence in which the testimony was originally given.
10. Documents. Legible photostatic or other copies of documents (or portions thereof) may be marked for identification, and offered and received in evidence at the trial, with the same force and effect as the originals, subject to correction should error appear and subject to any and all objections as could be made to the original thereof. The originals of such copies shall be available for inspection at the trial upon reasonable notice.
11. Exhibits
a. Any exhibit listed by a party may be offered as an exhibit by that party or by another party, subject to any evidentiary objections by the opposing party.
b. Any exhibit, once admitted at trial, may be used equally by any party, subject to the Federal Rules of Evidence.
c. The parties agree that the listing of an exhibit by a party does not waive any objections that such party may have to the use of the same exhibit by another party.
d. The parties agree that any description of a document or other material on an exhibit list is provided for convenience only and shall not be used as an admission or otherwise as evidence regarding the document or material.
e. The parties agree they will not dispute the authenticity of any document that was produced during discovery, which on its face appears to have been authored by an employee or officer of the producing party, or by a third-party engaged by the producing party in the ordinary course of business, and that such documents shall be deemed prima facie authentic, subject to the right of the party against whom
such a document is offered to adduce evidence to the contrary and subject to any contrary determination or ruling by the Court.
f. Plaintiff's demonstratives will be designated with PDX numbers.
g. Defendant's demonstratives will be designated with DDX numbers.
h. The parties agree that if any party removes or otherwise withdraws an exhibit from its Exhibit List, another party may amend its Exhibit List to include that same exhibit. The parties also agree that the parties may make objections to such exhibit, other than an objection based on untimely listing.
12. Deposition Designations.
a. The introducing party will identify the particular designated deposition testimony (by page and line) from its previous designations that is actually intended to be played or read at trial, or a disclosure that all pages and lines previously designated will be played, by 6:00 p.m. Eastern Time three calendar days before introducing the deposition testimony. For avoidance of doubt, if the introducing party intends to play or read designated testimony on Tuesday, October 17, 2023, notice shall be given by 6:00 p.m. Eastern Time on Saturday, October 14, 2023. The advanced notification provision for designations does not apply to designations to be used for impeachment during cross-examination.
b. By 6:00 p.m. Eastern Time two calendar days before introducing the deposition testimony, the other party will identify any specific pages and lines from its counter-designations or the other party's designations that the other party has not elected to play at trial that the counter-designating party wishes to be introduced, pursuant to Fed.R.Civ.P. 32(a)(6), and any testimony to which it continues to
object. For avoidance of doubt, if the introducing party intends to play or read designated testimony on Tuesday, October 17, 2023, notice of counterdesignations and remaining objections shall be given by 6:00 p.m. Eastern Time on Sunday, October 16, 2023.
c. By 8:00 p.m. Eastern Time two days before introducing the deposition testimony, the introducing party will identify any counter-designated testimony to which it continues to object. For avoidance of doubt, if the introducing party intends to play or read designated testimony on Tuesday, October 17, 2023, remaining objections to counter-designated testimony shall be given by 8:00 p.m. Eastern Time on Sunday, October 16, 2023.
d. By 9:00 p.m. Eastern Time two days before introducing the deposition testimony, the parties shall meet and confer to resolve any objections to designated deposition testimony. For avoidance of doubt, if the introducing party intends to play or read designated testimony on Tuesday, October 17, 2023, the parties shall meet and confer by 9:00 p.m. Eastern Time on Sunday, October 16, 2023.
e. If objections to disputed testimony are not resolved by this process, the parties shall present such objections to the Court on the afternoon before the day the testimony is expected to be played by the jury for resolution by the Court.
f. If a party opts to introduce deposition testimony, any counter-designation of that same witnesses' testimony must be submitted in the same medium. Any objections or attorney colloquy included in the designated testimony shall be removed unless required to clarify the record (i.e., discussion of scope of 30(b)(6) testimony).
g. The party electing to introduce deposition testimony shall be responsible for putting together the video file of the deposition designations and any counter designations, and the video files must be exchanged by 8:00 p.m. Eastern Time the day before the deposition testimony will be introduced, and shall revise the video file as necessary based on the Court's rulings on any objections.
13. Exhibits Introduced Through Deposition Designations. If designated testimony to be played in open court includes the use of an exhibit to which a party has asserted an objection, such objections will be handled in the same manner as the procedures set forth for the resolution of objections to exhibits to be used on direct examination pursuant to Section IX.D, Paragraph 14 below.
14. Exchange of Exhibits for Direct Examination or Opening Statements.
a. For exhibits to be used in connection with direct examination of witnesses, both fact and expert, each party will provide to the opposing party a list of all exhibits to be used, including previously admitted exhibits but excluding demonstrative exhibits, by 6:00 p.m. Eastern Time two calendar days before they will be used at trial. For demonstrative exhibits to be used in connection with direct examination of witnesses, both fact and expert, each party will provide to the opposing party a copy of the demonstrative exhibit one calendar day before it will be used at trial. For example, for exhibits to be used in a direct examination of a witness who is disclosed as testifying on Monday, October 16, 2023, the witness' exhibits, excluding demonstrative exhibits, shall be disclosed by 6:00 p.m. Eastern Time on Saturday, October 14, 2023 and demonstrative exhibits shall be disclosed by 6 p.m. Eastern Time on Sunday, October 15, 2023. The identification shall be by
email, except if demonstrative exhibits cannot be sent via email due to size limitations, they may be alternatively sent via FTP or by courier on a DVD, CD or USB drive. The party receiving identification of exhibits intended for use in direct examination will inform the identifying party of any objections by 8:00 p.m. Eastern Time the same day the exhibits are disclosed. The parties will meet and confer as soon as possible thereafter to resolve such objections, but in any event by 9:00 p.m. Eastern Time that same day.
b. For any demonstrative exhibit and any trial exhibit that will be excerpted or displayed in connection with opening statements: each party will provide to the opposing party a copy of the demonstrative exhibit and a list of all exhibits that will be excerpted or displayed by 12:00 PM Eastern Time two days before opening statements. The exchange shall be by email, except if demonstrative exhibits cannot be sent via email due to size limitations, they may be alternatively sent via FTP or by courier on a DVD, CD or USB drive. The opposing party will inform the party identifying the exhibits of any objections by 4:00 p.m. Eastern Time that same day, and the parties will meet and confer as soon as possible thereafter to resolve such objections, but in any event by 7:00 p.m. Eastern Time that same day. If good faith efforts to resolve the objections fail, the party objecting to the demonstratives may bring its objections to the Court's attention prior to the opening statement.
c. The party seeking to use a demonstrative exhibit will provide a color representation of the demonstrative to the other side in PDF, PowerPoint, or some other commonly viewable format via email. However, for video or animations,
the party seeking to use the demonstrative will provide it to the other side via FTP or on a DVD, CD, or USB drive if it cannot be sent via email due to size limitations. For irregularly sized physical demonstrative exhibits, the party seeking to use the demonstrative will provide a color representation as a PDF of 8.5 x 11 inch copies of the exhibits and make the original available for inspection by the opposing party.
d. There is no obligation to disclose demonstratives that will be created during live testimony or that will be used or created during cross examination.
e. The advanced notification provision for exhibits does not apply to exhibits to be used during cross-examination, whether for impeachment or to be offered into evidence.
f. Any party may use an exhibit that is listed on the other party's exhibit list, subject to the other party's opportunity to object to its introduction and subject to all applicable evidentiary objections. Any exhibit, once admitted at trial, may be used equally by any party, subject to the Federal Rules of Evidence.
15. Objections to Exhibits to be used on Direct Examination. If good faith efforts to resolve the objections fail, the party objecting to the exhibits may bring its objections to the Court's attention prior to or when the exhibit is offered into evidence.
16. Protective Order. The Court has entered a Discovery Confidentiality Order to safeguard the confidentiality of certain of the parties' business and technical information, as well as that of third parties. The parties anticipate that the majority of the trial will be open to the public and not sealed unless a party specifically requests that a particularly sensitive portion be sealed. If a party makes such a request, it shall be responsible for bringing the issue promptly to the Court's attention for a ruling so as not to delay the trial.
E. Other Stipulations and Agreements
17. Pursuant to Federal Rule of Civil Procedure 615, the parties may each have one corporate representative attend the entire trial, including any closed portions. The corporate representative need not have been listed in the Protective Order. However, if a corporate representative is not listed in the Protective Order, that representative may not have access to the other party's confidential information except for that presented at trial. The corporate representatives must agree to maintain in confidence the confidential information of the opposing party and all third parties that is presented during any closed portion of the trial, and to use such information only in connection with this litigation and not for any other purpose.
18. The parties will not offer any arguments, evidence, or testimony, or solicit the same, regarding the parties' use or alleged use, or the presence in the courtroom, of jury consultants, jury studies, focus group studies, or shadow juries.
19. The parties propose playing the Federal Judicial Center's video “The Patent Process: An Overview for Jurors” as part of the Court's preliminary jury instructions. The time for this video will not be charged against either party's trial presentation time.
X. JURY TRIALS
1. Trial is scheduled to commence on October 16, 2023 and may proceed until October 27, 2023 (D.I. 201, 244).
2. Microspherix expects that it will need no more than 12 hours to present its case (including cross examination), excluding opening and closing statements. Organon expects that it will need approximately 24 hours to present its case (including cross examination), excluding opening and closing statements.
CONCLUDING CERTIFICATION
We hereby certify by the affixing of our signatures to this Final Pretrial Order that it reflects the efforts of all counsel and that we have carefully and completely reviewed all parts of this Order prior to its submission to the Court. Further, it is acknowledged that amendments to this Joint Final Pretrial Order will not be permitted except where the Court determines that manifest injustice would result if the amendment is not allowed.
Entry of the foregoing Joint Final Pretrial Order is hereby APPROVED this 5th day of October 2023.
EXHIBIT 3
PLAINTIFF MICROSPHERIX'S STATEMENT OF CONTESTED FACTS
To the extent Microspherix's list of legal issues in Exhibit 8A contains contested facts, those issues are incorporated herein by reference. Likewise, should the Court determine any issue identified by Microspherix as a contested fact is more appropriately considered a legal issue, Microspherix incorporates such issue(s) into Exhibit 8A. By including a fact here, Microspherix does not assume the burden of proof or production with regard to the facts that are Organon's burden to prove.
The following statement of contested facts that remain to be litigated is based on the parties' pleadings, documentary and testimony evidence, and on Microspherix's current understanding of Organon's claims and defenses. Microspherix reserves the right to modify or supplement the issues of fact to be litigated in light of any pretrial rulings by the Court.
Microspherix contends that the issues of fact (or mixed questions of fact and law) that remain to be litigated at trial and decided by the jury are as follows:
I. DR. KAPLAN'S INVENTIONS
1. Edward Kaplan conceived of the inventions of the '401, '402, and '835 patents and reduced them to practice at least as early as November 16, 2000.
2. The inventions disclosed in the Patents-in-Suit relate to a novel drug delivery implant that enables controlled release of therapeutic agents with a radiopaque marker that can be visualized for localization and removal.
3. A person of ordinary skill in the art (“POSA”) pertinent to the Asserted Patents is someone with a Master's degree and several years of experience in pharmaceutics, bioengineering, mechanical engineering, and/or materials science, or, alternatively, a Ph.D. in the same field, and may have also had experience working with or designing implants from use humans. A person without the indicated degrees having extensive experience working with these types of implants in the field could also qualify as a POSA.
II. ACCUSED PRODUCT
4. Defendant Merck Sharp & Dohme Corp. is involved in the business of researching, developing, designing, manufacturing, distributing, supplying, selling, marketing and/or introducing into interstate commerce, either directly or indirectly through third parties, Nexplanon.
5. Defendants Organon USA, Inc. and Organon USA, LLC, are and were, at all relevant times, engaged in the business of researching, developing, designing, manufacturing, distributing, supplying, selling, marketing and/or introducing in interstate commerce, either directly or indirectly through third parties or related entities, Nexplanon.
6. Nexplanon contains a radiopaque marker and is thus x-ray visible. Nexplanon replaced a predecessor product named Implanon that did not contain a radiopaque marker and was not x-ray visible.
7. Organon ceased marketing and distribution for Implanon in the United States on or before December 1, 2012.
8. Nexplanon was approved by the FDA on May 31, 2011 and commercialized soon thereafter.
9. The Nexplanon implant comprises a marker component that allows for the location of the implant to be determined within a target tissue.
10. The marker component of the Nexplanon implant has a substantially continuous wall bounding a hollow interior.
11. The Nexplanon implant comprises a therapeutic and/or prophylactic agent disposed within the hollow interior.
12. The Nexplanon implant is in the shape of a rod or cylinder.
13. The Nexplanon implant has open ends.
14. The Nexplanon implant has pores.
15. The Nexplanon implant does not include a radioisotope.
16. The Nexplanon implant has a polymeric coating.
17. Barium sulfate is a high Z material.
18. When used according to the current FDA approved label, the Nexplanon implant is inserted into the inner side of the non-dominant upper arm using the Nexplanon applicator.
19. The Nexplanon implant has a length of 40 mm and a diameter of 2 mm.
20. Health care providers in the United States must attend a mandatory company sponsored training program before they can order and receive Nexplanon.
III. INTER PARTES REVIEW
21. Defendants petitioned for inter partes review (IPR) of the '835 patent on February 9, 2018.
22. Defendants petitioned for IPR of the '401 patent on December 29, 2017.
23. Defendants petitioned for IPR of the '402 patent on December 22, 2017.
A. Defendants' IPR Grounds
24. The grounds asserted in each of Defendants' petitions for IPR included Schopflin (U.S. Patent No. 4,021,497); De Nijs (U.S. Patent No. 5,150,718); Zamora (U.S. Patent No. 6,575,888); and Brem (5,626,682).
25. The Schopflin patent asserted by Defendants during IPR is the same Schopflin patent asserted by Defendants in this litigation.
26. The Patent Trial and Appeal Board (PTAB) held that the Asserted Claims of the '835 patent patentable over Schopflin.
27. Within one month of the PTAB instituting IPR on each of the Asserted Claims, Defendants filed a motion to supplement each of their petitions by introducing the Crittenden (U.S. 6,197,324) and Lee (U.S. 5,629,008) patents into evidence.
28. The Crittenden and Lee patents are the same patents asserted by Defendants in this litigation.
29. The PTAB denied Defendants' motions to introduce Crittenden and Lee in each IPR. The PTAB noted that Crittenden and Lee are U.S. patent references, and held that both Crittenden and Lee could have reasonably been found by Defendants when filing each petition for IPR. The PTAB additionally held that Defendants could have discovered both Crittenden and Lee with a diligent search prior to filing each petition for IPR.
B. PTAB Determinations
30. During IPR of each patent, Defendants argued that none of the Asserted Claims of the '835, '401, and '402 patents properly claim priority to the earliest provisional application- Provisional Application No. 60/249,128 (the “'128 Provisional”)-filed by Dr. Kaplan on November 16, 2000. Defendants argued that the '128 Provisional does not adequately support the Asserted Claims under 35 U.S.C. § 112.
31. The PTAB determined that all Asserted Claims of the '835, '401, and '402 patents are supported under Section 112 by the disclosure of the '128 Provisional. Thus, the PTAB held that each of the Asserted Claims are entitled to a priority date of at least November 16, 2000.
32. Defendants also contended that the De Nijs patent covers Implanon, the predecessor to the Accused Product Nexplanon in this litigation.
33. Like Nexplanon, Defendants and its expert asserted the De Nijs has pores. Specifically, Defendants and their expert during IPR argued that De Nijs inherently, or necessarily, releases a drug through pores in its polymeric wall. However, other background references submitted by Defendants show that the polymer used in De Nijs-i.e., EVA-does not necessarily, or always, have pores.
34. In fact, Defendants and their expert acknowledged during IPR that diffusion and release of a drug from an polymeric implant can occur either: (i) between the macromolecular chains of the polymer; (ii) through pores in the polymer's structure; or (iii) both of the foregoing.
35. Defendants and its expert also asserted that the inclusion of a radiopaque material-namely barium sulfate, the same radiopaque material that is used in the Accused Product-into the implant of De Nijs would have been obvious to a skilled artisan and would reduce or eliminate difficult localization and retrieval of contraceptive implants. Defendants asserted that both localization and difficult retrieval of implants were problems recognized in the art.
36. The PTAB held that De Nijs has pores. However, the PTAB upheld the validity of the Asserted Claims because the inclusion of barium sulfate into implants would not have been obvious as of the time that Dr. Kaplan invented the claimed inventions, and specifically noted that its holding was irrespective of whether De Nijs has pores or openings. Specifically, the PTAB held that a skilled artisan would not have been motivated to include barium sulfate into implants given its known toxicity and concerns in the art with barium sulfate leaching from polymers.
C. Defendants' IPR Statements
37. Defendants and its expert asserted that contraceptive implants were widely known to skilled artisans prior to Dr. Kaplan's invention of the asserted claims.
38. In each of their petitions for IPR, Defendants purported to apply the “broadest reasonable construction” of claim terms “in light of the specification.” The only terms that Defendants actually identified as requiring a construction was the claim limitation of a “seed” and “encapsulated,” as recited in the '835 and '401 patents (respectively).
39. Defendants and their expert asserted that the inclusion of a radiopaque material- namely barium sulfate, the same radiopaque material that is used in the Accused Product-in the polymeric core of De Nijs constituted “a marker component configured to allow for the determination of the position of a seed within a target tissue,” as is claimed in the '835 and '401 patents.
40. Defendants and their expert did not limit their arguments concerning “target tissue” based on De Nijs's implant-a contraceptive implant like Nexplanon-having a systemic effect on a patient, as they do now. Nor did Defendants and its expert assume or argue, as they do now, that the term “target tissue” limited the claimed inventions to implants that only affect the tissue into which the implant is implanted.
41. Contrary to their present assertions, Defendants and their expert asserted that De Nijs's teaching of etonogestrel-the same drug used in the Accused Product-constitutes “a therapeutic agent,” as is claimed in the in the '835, '401, and '402 patents.
42. Contrary to their present assertions, Defendants and their expert also asserted that De Nijs's teaching of etonogestrel-the same drug used in the Accused Product-constitutes a therapeutic agent that is a “hormone,” as is claimed in the '835, '401, and '402 patents.
43. Contrary to their present assertions, Defendants and their expert also asserted that De Nijs's teaching of etonogestrel-the same drug used in the Accused Product-constitutes a therapeutic agent that “exerts an effect on [a] subject's physiology following release,” as is claimed in the '401 patent.
44. Contrary to their present assertions, Defendants and their expert asserted that the inclusion of a radiopaque material- namely barium sulfate, the same radiopaque material used in the Accused Product-in the polymeric core of De Nijs constitutes “[a] marker component having a length extending along a centerline of the marker component between a first end and second end and having a substantially continuous wall bounding a hollow interior,” as is claimed in the '835 and '401 patents.
45. Contrary to their present assertions, Defendants and their expert asserted that De Nijs's teaching of etonogestrel in the core of its implant constitutes “an agent that is disposed with a hollow interior,” as is claimed in the '835 and '401 patents.
46. Defendants did not argue or assume that that the claim term “hollow interior” requires an implant with a hollow space to have existed at some point during the manufacture of such an implant, as they do now.
47. Contrary to their present assertions, Defendants and their expert asserted that that De Nijs's outer membrane constitutes as “polymeric coating,” as is claimed in the '402 patent.
48. Defendants did not argue or assume that the claim term “polymeric coating” requires an implant in which a polymeric layer is applied subsequent to manufacturing the implant's core material, as they do now. To the contrary, Defendants and their expert acknowledged that coextrusion of two polymers results in a polymeric coating, as is claimed in the '402 patent, where the outer layer of one of these two polymers is a “polymeric coating.”
49. Like Nexplanon, De Nijs teaches manufacturing implants by using coextrusion processes using at least two polymers.
50. Implanon and Nexplanon are both manufactured using the same coextrusion process using two polymers.
51. Contrary to their present assertions, Defendants and their expert during IPR argued that openings in De Nijs's outer membrane constitute “at least one opening within a substantially continuous wall adapted to allow an agent to pass out of the hollow interior,” as is claimed in the '835, '401, and '402 patents.
52. Contrary to their present assertions, Defendants and their expert during IPR argued that openings in the open ends of De Nijs's implant constitute “at least one opening within a substantially continuous wall adapted to allow an agent to pass out of the hollow interior,” as is claimed in the '835, '401, and '402 patents.
53. Contrary to their present assertions, Defendants and their expert during IPR argued that openings in De Nijs's outer membrane constitute “at least one opening within a substantially continuous wall adapted to allow an agent to pass out of the hollow interior,” as is claimed in the '835 and '401 patents.
54. Defendants also submitted numerous background references with its IPR petitions as evidencing the state of the art and features known in the prior art.
55. One of these background references, Dash, is an article published in the Journal of Pharmacological and Toxicological Methods published in 1998.
56. Dash discloses that barium sulfate was a radiopaque marker known in the art no later than 1998.
57. Dash is incorporated into the specification of each of the Asserted Patents.
IV. INFRINGEMENT
58. The Nexplanon implant literally infringes claims 1, 13, 16, 18, and 20 of the '401 patent, claims 6 and 9 of the '402 patent, and claims 1 and 16 of the '835 patent (the “Asserted Claims”).
59. The Nexplanon implant infringes the Asserted Claims under the doctrine of equivalents.
60. Organon has, without authority, made, used, offered for sale, sold and/or imported in the United States the Nexplanon implant thereby infringing the Asserted Claims of the Patents-in-Suit.
61. Organon's infringement of the Patents-in-Suit has been willful. Organon acted with knowledge of the Patents-in-Suit and without a reasonable basis for a good faith belief that it would not be liable for infringement of the Patents-in-Suit.
62. Organon was aware of the scope and coverage of the Patents-in-Suit and acknowledged the risk of infringement, but chose to proceed with its infringing activities.
63. Organon made no attempts and had no plans to design around or otherwise avoid infringement of the Patents-in-Suit.
64. All of the Asserted Claims have been or are being infringed by Organon and its predecessors, and Organon is liable for the infringement of any of the Asserted Claims, at least in view of the reasons set forth in the reports of Plaintiff's experts that were presented during this case and in view of testimony of Plaintiff's experts from this case.
V. VALIDITY
65. The Patents-in-Suit are valid and enforceable.
66. The asserted claims of the '835 patent are supported by the disclosures of Application No. 09/861,196, filed on May 18, 2001, Application No. 09/861,326, filed on May 18, 2001, Application No. 10/665,793, filed on September 19, 2003, Application No. 12/823,700, filed on June 25, 2010, Provisional Application No. 60/412,050, filed on September 19, 2002, and Provisional Application No. 60/249,128, filed on November 16, 2000 (collectively, the “'835 patent parent applications”), and are entitled to their earlier priority dates.
67. The asserted claims of the '401 patent are supported by the disclosures of Application No. 13/916,916, filed on June 13, 2013, Application No. 09/861,196, filed on May 18, 2001, Application No. 09/861,326, filed on May 18, 2001, Application No. 10/665,793, filed on September 19, 2003, Application No. 12/823,700, filed on June 25, 2010, Provisional Application No. 60/412,050, filed on September 19, 2002, and Provisional Application No. 60/249,128, filed on November 16, 2000, and are entitled to their earlier priority dates.
68. The asserted claims of the '402 patent are supported by the disclosures of the '401 patent's parent applications and Application No. 14/473,159, filed on August 29, 2014, Application No. 13/916,916, filed on June 13, 2013, Application No. 09/861,196, filed on May 18, 2001, Application No. 09/861,326, filed on May 18, 2001, Application No. 10/665,793, filed on September 19, 2003, Application No. 12/823,700, filed on June 25, 2010, Provisional Application No. 60/412,050, filed on September 19, 2002, and Provisional Application No. 60/249,128, filed on November 16, 2000, and are entitled to their earlier priority dates.
69. The '401 patent application filed on August 29, 2014, and Dr. Kaplan reasonably and diligently prosecuted his application before the USPTO resulting in issuance of the '401 patent on May 2, 2017.
70. The '402 patent application was filed on May 13, 2015, and Dr. Kaplan reasonably and diligently prosecuted his application before the USPTO resulting in issuance of the '402 patent on May 2, 2017.
71. The '835 patent application was filed on June 13, 2013, and Dr. Kaplan reasonably and diligently prosecuted his application before the USPTO resulting in issuance of the '835 patent on September 2, 2014.
72. Organon does not have any “intervening rights” related to the invention claimed by the Asserted Claims of the Patents-in-Suit.
73. No combinations of any references previously disclosed by Organon anticipate or render the the Asserted Claims of the Patents-in-Suit obvious.
74. Organon is estopped from arguing the Asserted Claims of the Patents-in-Suit are invalid as anticipated or obvious over U.S. Patent No. 6,197,324 (“Crittenden”) alone or in combination with U.S. Patent No. 5,629,008 (“Lee”).
75. The Asserted Claims of the Patents-in-Suit are not anticipated or obvious over Crittenden alone or in combination with Lee, including, but not limited to, because Crittenden and Lee, alone or in combination, fail to teach or render obvious each limitation of the Asserted Claims, there is no motivation to combine Crittenden and Lee, and a POSA would not have a reasonable expectation of success in combining Crittenden and Lee.
76. Organon is estopped from arguing the Asserted Claims of the Patents-in-Suit are invalid as obvious over U.S. Patent No. 4,012,497 (“Schopflin”) alone or in combination with “Development and Evaluation in Vivo of a Long-Term Delivery System for Vapreotide, a Somatostatin Analogue” published in Volume 52, Issues 1-2 (pages 205-13) of the Journal of Controlled Release on March 2, 1998 (“Rothen-Weinhold”).
77. The Asserted Claims of the Patents-in-Suit are not anticipated or obvious over Schopflin alone or in combination with Rothen-Weinhold, including, but not limited to, because Schopflin and Rothen-Weinhold, alone or in combination, fail to teach or render obvious each limitation of the Asserted Claims, there is no motivation to combine Schopflin and Rothen-Weinhold, and a POSA would not have a reasonable expectation of success in combining Schopflin and Rothen-Weinhold.
78. Dr. Kaplan conceived of and reduced to practice the inventions claimed in the Asserted Claims of the Patents-in-Suit before Nexplanon was commercially available.
79. Organon did not conceive of and reduce to practice the invention claimed by the Asserted Claims of the Patents-in-Suit in the United States prior to Dr. Kaplan.
80. Organon abandoned, suppressed, and/or concealed its alleged prior invention of the Asserted Claims of the Patents-in-Suit.
81. The Asserted Claims of the Patents-in-Suit are not invalid based on any alleged prior invention by Organon.
82. The specifications of the Patents-in-Suit provide adequate written description for the full breadth of the Asserted Claims.
83. The '835 patent's parent applications provide adequate written description for the full breadth of the asserted claims of the '835 patent. The'401 patent's parent applications provide adequate written description for the full breadth of the asserted claims of the '401 patent. The'402 patent's parent applications provide adequate written description for the full breadth of the asserted claims of the '402 patent.
84. The specifications of the Asserted Claims of the Patents-in-Suit enable the full scope of the asserted claims of the Patents-in-Suit.
85. The '835 patent's parent applications enable the full scope of the asserted claims of the '835 patent. The '401 patent's parent applications enable the full scope of the asserted claims of the '401 patent. The '402 patent's parent applications enable the full scope of the asserted claims of the '402 patent.
86. All of the Asserted Claims of the Patents-in-Suit are valid at least in view of the reasons set forth in the reports of Microspherix's experts presented during this case and in view of the testimony of Microspherix's experts from this case.
87. Implanon implants were difficult to locate and remove, or unable to be located and thus removed from patients' bodies, due in part to the fact that Implanon was not radiopaque.
88. Ultrasound and magnetic resonance imaging (MRI) were not always successful in localizing Implanon implants, including but not limited to those that had migrated from the insertion site.
89. The Nexplanon implant is effectively the same as the Implanon implant except for the addition of barium sulfate, a radiopaque marker.
90. Radiopacity makes Nexplanon visible on x-ray, which adds an important modality by which the implant can be localized.
91. Dr. Kaplan's patented technology solved a long-felt industry need for a radiopaque contraceptive implant.
92. Dr. Kaplan's patented technology went against the grain of conventional wisdom and met with industry skepticism.
93. Due to the inventions of the Patents-in-Suit, Implanon was rapidly replaced by Nexplanon in the market.
94. Due to the inventions of the Patents-in-Suit, Nexplanon has been commercially successful.
95. By March 19, 2003, Organon did not reduce to practice in the United States an x-ray visible Implanon product.
96. U.S. Patent No. 8,722,037 (the “'037 patent”) is entitled “X-ray Visible Drug Delivery Device.”
97. U.S. Patent Application No. 10/592,725 (the “'725 application”) that led to the '037 patent was filed on March 14, 2005 based on the filing date of PCT/EP2005/051150.
98. The named inventors for the '037 patent are Harm Veenstra and Wouter De Graff.
99. Harm Veenstra was hired by Organon on January 15, 2000 and has since resided in the Netherlands.
100. Harm Veenstra did not start working on the project related to an x-ray visible Implanon product until 2002.
VI. DAMAGES
101. Microspherix is entitled to damages beginning on the date of first infringement under 35 U.S.C. § 284.
102. Microspherix is entitled to a reasonable royalty between 10% and 15% of Merck's and Organon's net revenue from sales of Nexplanon in the U.S. from September 2, 2014 to May 18, 2021, resulting in reasonable royalty damages of approximately $313 million to $470 million.
103. Organon had no non-infringing alternative on the market during the damages period.
104. No non-infringing alternatives existed during the relevant damages period.
105. The Implanon implant with the Nexplanon applicator was not on the market during the relevant damages period.
106. The Implanon implant with the Nexplanon applicator is not an acceptable noninfringing alternative.
107. The Nexplanon implant with closed ends was not on the market during the relevant damages period.
108. The Nexplanon implant with closed ends is not an acceptable non-infringing alternative.
EXHIBIT 4
EX. 4: DEFENDANTS' STATEMENT OF CONTESTED FACTS
I. PROCEDURAL HISTORY
1. On October 18, 2017, Microspherix filed an amended complaint in this lawsuit alleging that Nexplanon infringes claims from the Asserted Patents, including claim 14 of the '835 patent.
2. On February 9, 2018, Organon filed a petition for inter partes review of the '835 patent, arguing that, applying the broadest reasonable interpretation standard, the challenged claims were obvious over U.S. Patent No. 5,150,718 to De Nijs (“De Nijs”) in view of U.S. Patent No. 4,012,497 to Schopflin (“Schopflin”).
3. Implanon is the predecessor product to Nexplanon.
4. The implant in Implanon differs from the implant in Nexplanon only in that 3 mg of ethylene vinylacetate (“EVA”) in the Implanon implant's core have been replaced by 12 mg of barium sulfate.
5. The EVA skin of the Implanon implant is the same as the EVA skin of the Nexplanon implant.
6. De Nijs covers the Implanon implant.
7. Applying Microspherix's interpretation of the claims from the amended complaint, as well as the broadest reasonable interpretation standard, Organon instructed its expert, Dr. Robert Langer, to assume that “even very small openings like those through which diffusion may occur constitute pores.”
8. On March 7, 2018, Microspherix served its infringement contentions in this case, in which Microspherix did not take a stance as to whether Nexplanon's EVA skin contained openings or pores but stated merely that it would “seek discovery regarding . . . whether the polymeric coating of Nexplanon contains ‘openings,' e.g. pores.”
9. Microspherix alleged in its infringement contentions that the unsealed ends of the Nexplanon implant were the claimed openings or pores.
10. Microspherix never sought discovery regarding whether the EVA skin of Nexplanon contains pores.
11. Microspherix never amended its infringement contentions, and never took a stance in its infringement contentions as to whether Nexplanon's EVA skin contains pores or openings in the form of pores.
12. In its infringement contentions, Microspherix alleged that barium sulfate was the claimed “marker component.”
13. Microspherix never amended its infringement contentions, and never took a stance in its infringement contentions that the entire Nexplanon implant is the marker component.
14. Other than to superficially reference doctrine of equivalents in its infringement contentions, Microspherix failed to allege infringement under the doctrine of equivalents.
15. Microspherix filed its patent owner's preliminary response and its patent owner's response for the '835 patent inter partes review after it filed its infringement contentions in this case.
16. In its patent owner's preliminary response and its patent owner's response for the '835 patent inter partes review, Microspherix argued that the EVA skin of De Nijs, which is the same EVA skin as the accused Nexplanon implant, did not disclose pores.
17. In its final written decision for the inter partes review of the '835 patent, the Patent Trial and Appeal Board did not reject Microspherix's argument regarding pores, and found the alleged claims to be patentable in view of the grounds presented in the petition, including obviousness over De Nijs.
18. In its final written decision for the inter partes review of the '402 patent, the Patent Trial and Appeal Board found unpatentable all claims that did not require “pores or cavities” or “open ends.”
19. In its final written decision for the inter partes review of the '402 patent, the Patent Trial and Appeal Board's analysis of claim 6, which includes the term “pores,” relied on the EVA skin of De Nijs not containing pores, and thereby agreed with Microspherix's argument before the PTAB that pure EVA does not have pores.Microspherix asserts claims 1 and 16 of the '835 patent; claims 1, 13, 16, 18, and 20 of the '401 patent; and claims 6 and 9 of the '402 patent (collectively, the “Asserted Claims”).
II. NON-INFRINGEMENT
20. Organon has not and currently does not directly, indirectly or under the doctrine of equivalents infringe any Asserted Claim of any Asserted Patent.
21. Nexplanon does not infringe any Asserted Claim or any Asserted Patent.
22. Nexplanon does not have a target tissue as claimed in the Asserted Claims.
23. Nexplanon is implanted in the arm.
24. The vascular system of the arm is not targeted for treatment by Nexplanon.
25. Nexplanon affects organs that are not in the arm: the pituitary gland, the hypothalamus, the mammary glands, and the female reproductive tract.
26. Nexplanon does not treat the arm.
27. Nexplanon does not treat the vascular system.
28. Etonogestrel is the contraceptive agent in Nexplanon.
29. Etonogestrel affects organs that are not in the arm: the pituitary gland, the hypothalamus, the mammary glands, and the female reproductive tract.
30. Etonogestrel does not treat the vascular system.
31. Nexplanon does not have a marker component as claimed in the Asserted Claims.
32. The whole Nexplanon implant is not the part of the Nexplanon implant including a marker.
33. The EVA skin of Nexplanon cannot be part of the claimed marker component.
34. The EVA skin of Nexplanon does not include barium sulfate or another marker.
35. The Nexplanon implant does not have, and never had, a hollow interior as claimed in the Asserted Claims.
36. Nexplanon is not and never was hollow.
37. Nexplanon does not have and never had a space to be filled.
38. Nexplanon is a single, solid flow of polymer without any internal voids.
39. Nexplanon's EVA skin and core are formed simultaneously.
40. Nexplanon's molten skin and molten core are welded together during coextrusion.
41. Nexplanon does not have a structure that performs substantially the same function, in the substantially same way, to achieve substantially the same result as the hollow interior as claimed by the Asserted Claims.
42. Nexplanon does not have a polymeric coating as claimed in the Asserted Claims.
43. Nexplanon's EVA skin is not coated onto or otherwise applied to a pre-existing core.
44. Nexplanon does not have a structure that performs substantially the same function, in substantially the same way, to achieve substantially the same result as a polymeric coating as claimed by the Asserted Claims.
45. Nexplanon's EVA skin does not have pores as claimed in the Asserted Claims.
46. Nexplanon's EVA skin does not have openings in the form of pores as claimed in the Asserted Claims.
47. Nexplanon's EVA skin is comprised entirely of EVA.
48. Nexplanon's EVA skin is not impregnated with a drug.
49. Microspherix clearly and unmistakably argued during inter partes review proceedings for the '835 patent that “pure EVA does not have pores.”
50. Microspherix argued during inter partes review proceedings for the '835 patent that the selective permeability of EVA to small molecules does not meet the “pores” element of the Asserted Claims.
51. The Patent Trial and Appeal Board accepted Microspherix's argument that EVA does not have pores.
52. The Patent Trial and Appeal Board's analysis for the '402 patent relies on Microspherix's argument that pure EVA, such as the EVA skin in De Nijs, does not have “pores” as recited in the Asserted Claims.
53. Organon has not and currently does not induce infringement, knowingly or otherwise, of any Asserted Claim of any Asserted Patent.
54. Organon has not willfully infringed and currently does not willfully infringe the Asserted Claims.
55. Organon was not aware of the Asserted Patents before Microspherix filed the complaint in this lawsuit.
56. Organon made prior commercial use of Nexplanon more than one year before the effective filing date of what is claimed by the Asserted Claims.
57. None of the Asserted Claims may claim priority to any of the applications or patents from which the Asserted Patents are continuations or continuations-in-part.
58. U.S. Patent No. 8,722,037 to Veenstra (“Veenstra”) covers the Nexplanon implant.
59. Veenstra was filed on March 19, 2004.
60. Veenstra was first published on May 15, 2008.
61. Premarketing regulatory review of Nexplanon began in July 2009.
62. Nexplanon was approved and marketed in the United States in November 2011.
III. INVALIDITY
63. All of the Asserted Claims are invalid.
64. The Asserted Patents cannot claim priority to U.S. Patent Application No. 60/249,128 (“'128 patent application”).
65. The '128 patent application does not provide written description support for the Asserted Claims.
66. The application resulting in Crittenden was filed on June 15, 1998.
67. U.S. Patent No. 6,197,324 to Crittenden (“Crittenden”) issued on March 6, 2001.
68. U.S. Patent No. 5,629,008 to Lee issued on May 13, 1997.
69. Crittenden and Lee are prior art to the Asserted Claims and the Asserted Patents.
70. Crittenden was published prior to the date of invention of the purported inventions of the claims of each of the Asserted Patents.
71. Lee was published prior to the date of invention of the purported inventions of the claims of each of the Asserted Patents.
72. to Crittenden incorporates by reference Lee.
73. All of the Asserted Claims are anticipated by Crittenden, which incorporates and therefore includes the disclosure in Lee.
74. All of the Asserted Claims are obvious over Crittenden and Lee.
75. A POSITA would have been motivated to combine Crittenden and Lee and would have had a reasonable expectation of success in doing so.
76. On the priority date of each Asserted Patent, there was a sufficient motivation for a person of ordinary skill in the art to modify the teachings of Crittenden and Lee to obtain what is claimed by the Asserted Patents, to the extent that Crittenden and Lee do not anticipate the Asserted Claims.
77. The application resulting in Crittenden was filed on June 15, 1998.
78. U.S. Patent No. 4,012,497 to Schopflin (“Schopflin”) issued on March 15, 1977.
79. Alexandra Rothen-Weinhold et al., “Development and Evaluation in Vivo of a Long-Term Delivery System for Vapreotide, a Somatostatin Analogue,” 52 J. Controlled Release 205 (1998) (“Rothen-Weinhold”) was published in 1998.
80. Schopflin and Rothen-Weinhold are prior art to the Asserted Claims and the Asserted Patents.
81. Schopflin was published prior to the date of invention of the purported inventions of the claims of each of the Asserted Patents.
82. Rothen-Weinhold was published prior to the date of invention of the purported inventions of the claims of each of the Asserted Patents.
83. All of the Asserted Claims are obvious over Schopflin and Rothen-Weinhold.
84. A POSITA would have been motivated to combine Schopflin and Rothen-Weinhold and would have had a reasonable expectation of success in doing so.
85. On the priority date of each Asserted Patent, there was a sufficient motivation for a person of ordinary skill in the art to modify the teachings of Schopflin and Rothen-Weinhold to obtain what is claimed by the Asserted Patents.
86. There are no secondary considerations that weigh against a finding that any of the Asserted Claims are obvious over the prior art.
87. The secondary considerations that Microspherix has identified do not have a nexus to the Asserted Claims.
88. The commercial success of Nexplanon does not have a nexus to the Asserted Claims.
89. There is no nexus between the Asserted Claims and how the inclusion of barium sulfate in the Nexplanon implant impacted release of Etonogestrel.
90. A skilled searcher conducting a reasonably diligent search under the circumstances would not have discovered: (1) Crittenden alone, (2) Crittenden in view of Lee, and (3) Schopflin in combination with Rothen-Weinhold.
91. The specification of the '402 patent does not provide written description support for claims 6 and 9 of the '402 patent.
92. The specification of the '401 patent does not provide written description support for claims 1, 13, 16, 18, and 20 of the '401 patent.
93. The specification of the '835 patent does not provide written description support for claims 1 and 16 of the '835 patent.
94. The specification of the Asserted Patents does not provide written description support for implants outside the field of brachytherapy.
95. The specification of the Asserted Patents does not provide written description support for the use of all known agents, markers, and biocompatible components in the seeds or strands claimed in the Asserted Claims..
96. The specification of the Asserted Patents does not provide written description support for non-biodegradable polymeric implants.
97. The specification of the Asserted Patents does not provide written description support for the use of barium sulfate as a marker.
98. The specification of the Asserted Patents does not provide written description support for the combinations of elements covered by the Asserted Claims.
99. The specification of the '402 patent does not enable claims 6 and 9 of the '402 patent.
100. The specification of the '401 patent does not enable claims 1, 13, 16, 18, and 20 of the '401 patent.
101. The specification of the '835 patent does not enable claims 1 and 16 of the '835 patent.
102. The specification of the Asserted Patents does not enable the full set of potential combinations of the elements of the Asserted Claims.
103. The specification of the Asserted Patents does not enable the inclusion of barium sulfate into implants with openings.
104. The specification of the Asserted Patents does not explicitly mention barium sulfate or how to handle barium sulfate toxicity.
105. Microspherix argued repeatedly, and successfully, to the Patent Trial and Appeal Board that barium sulfate posed a significant toxicity risk when included in drug-eluting implants.
106. The specification of the Asserted Patents does not enable implants that release agent for three years.
107. The statement in the specification of the Asserted Patents that modulation of the release rate can be achieved by using an “appropriate” biocompatible material is insufficient to tell a person of ordinary skill in the art how to vary a release rate between 10 minutes and 3 years.
108. The Asserted Claims should be unenforceable against Organon because of Microspherix's unreasonable delay in prosecution of the Asserted Claims.
109. The first provisional patent application to which the Asserted Patents purport to claim priority is U.S. Patent App. No. 60/249,128 (“'128 patent application”).
110. The '128 patent application was filed on November 16, 2000.
111. Microspherix and/or Dr. Kaplan first sought claims that were not expressly limited to “brachytherapy” or implantation in a “target tissue” thirteen years after the '128 patent application was filed.
112. Microspherix and/or Dr. Kaplan first sought claims that were not expressly limited to “brachytherapy” or implantation in a “target tissue” after Nexplanon was launched in the United States.
113. Microspherix and/or Dr. Kaplan first sought claims that were not expressly limited to “brachytherapy” or implantation in a “target tissue” after Microspherix and/or Dr. Kaplan became aware of Nexplanon.
114. Dr. Kaplan filed the application for the '835 patent on June 13, 2013.
115. Dr. Kaplan was aware of Organon's invention of the Nexplanon implant prior to drafting the claims for the '835 patent.
116. Dr. Kaplan filed the application for the '401 patent on August 29, 2014.
117. Dr. Kaplan filed the application for the '402 patent on May 13, 2015.
118. Dr. Kaplan was aware of the Organon's invention of the Nexplanon implant prior to drafting the claims for the '401 and '402 patents.
119. Microspherix derived the alleged invention claimed by the Asserted Patents from Organon.
120. Microspherix first disclosed prior art in the field of contraception fifteen years after the '128 patent application was filed.
121. Organon began developing the Nexplanon implant in 1999.
122. The development of Nexplanon was a multi-national effort that included persons in the United States.
123. Organon continued to develop, test, seek regulatory approval, and endeavor to commercialize Nexplanon through its launch in 2011.
124. Organon developed intervening rights in the claimed technology between 2000 and 2011.
125. Organon invented what is claimed by the Asserted Claims before Microspherix.
126. Organon employees conceived of an x-ray-visible Implanon implant prior to November 16, 2000.
127. To the extent Microspherix's contentions that Nexplanon meets each element of an Asserted Claim are credited, x-ray-visible Implanon as conceived prior to November 16, 2000 would also meet each element of that Asserted Claim.
128. Organon employees communicated conception of an x-ray-visible Implanon implant to employees working in West Orange, New Jersey, prior to November 16, 2000.
129. Organon reduced its invention of an x-ray-visible Implanon implant to practice by at least March 2004.
130. Organon employees, including those in the United States, diligently pursued an x-ray-visible Implanon implant from before November 16, 2000 to 2004.
131. Organon employees in the United States diligently continued working on obtaining Food and Drug Administration authorization for an x-ray-visible Implanon implant from before November 16, 2000 to March 2004.
IV. DAMAGES
132. Microspherix is entitled to no damages.
133. If the fact finder determines Organon is liable, Microspherix is entitled to no more than $7.8 million.
134. As of the hypothetical negotiation date, whether September 2014 or May 2017, Implanon was an available and acceptable noninfringing alternative.
135. As of the hypothetical negotiation date, whether September 2014 or May 2017, Merck and/or Organon would not have expected to lose 10%-30% of Nexplanon revenue if Merck and/or Organon switched to Implanon.
136. As of the hypothetical negotiation date, whether September 2014 or May 2017, the parties would not have agreed to a reasonable royalty of 10%-15%.
137. As of the hypothetical negotiation date, whether September 2014 or May 2017, Implanon with the next generation applicator, or Implanon Plus, was an available and acceptable noninfringing alternative.
138. As of the hypothetical negotiation date or soon thereafter, whether September 2014 or May 2017, Nexplanon with sealed ends was an available and acceptable noninfringing alternative.
139. The incremental value of continuing to sell Nexplanon as of the date of the hypothetical negotiation was no more than $15.5 million.
140. The X-ray visibility did not and does not drive demand for Nexplanon.
EXHIBIT 5A
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