Opinion
Civil No. 03-1421 (DRD), Patent Infringement.
March 31, 2005
OPINION AND ORDER
Plaintiffs, Abbott Laboratories, Fournier Industrie et Santé and Laboratoires Fournier S.A., collectively hereinafter "Plaintiffs", filed three, presently consolidated, actions against defendant, Cipher Pharmaceuticals, Ltd., hereinafter "Cipher or Defendant", pursuant to the Hatch-Waxman Act, 21 U.S.C. § 355, and 35 U.S.C. § 271(e) (2). Plaintiffs allege, in all three actions, that Defendant's fenofibrate product, which is the subject of a New Drug Application pending before the Food and Drug Administration ("FDA"), infringes U.S. Patent Nos. 6,277,405 ("the '405 patent"), 6,589,552 ("the '552 patent"), and 6,652,881 ("the '881 patent"), collectively hereinafter "the patents-in-suit", which are all allegedly owned by Fournier Industrie et Santé and Laboratoires Fournier S.A. and exclusively licensed by Abbott Laboratories. In general, Plaintiffs seek injunctive relief, requiring that Cipher Pharmaceuticals, Ltd. be prohibited from commercially manufacturing, selling, using, or importing the fenofibrate compositions claimed in all three patents.
Plaintiffs filed their first action on April 21, 2003 (Docket No. 1), alleging infringement of the '405 patent under 35 U.S.C. § 271(e)(2)(A) and then filed their second action on October 2, 2003 (Docket No. 15), alleging infringement of the '552 patent under 35 U.S.C. § (e)(2)(A). On November 10, 2003, Plaintiffs moved to have the cases consolidated. On February 5, 2004, Plaintiffs filed a third action against Defendants, alleging infringement of the '881 patent under 35 U.S.C. § 271(e)(2)(A). Consequently, on February 13, 2004 Defendants moved to have the third action consolidated with the first two actions (Docket No. 44). During a discovery conference held on April 6, 2004, the Court consolidated the third action with the previous two (Docket No. 55).
Fenofibrate is useful as a lipid and cholesterol lowering agent for treatment of adults with increased triglyceride levels. See Complaint (Docket No. 1).
Pending before the Court is Cipher's Motion for Summary Judgment on Noninfringement on Dissolution for U.S. Patent Nos. 6,277,405 B1, 6,589,552 B2, and 6,652,881 B2 (Docket No. 62) filed on June 4, 2004. Defendant sustains that their proposed fenofibrate-containing capsule drug product, cannot as a matter of law infringe certain asserted claims of U.S. patent nos. 6,277,405 B2, 6,652,881 B2 and claims 24-25 and 49-50 of U.S. patent no. 6,652,405 B2.
Defendant's motion relates only to claims that contain a particular dissolution profile.
Defendant avers that the patents asserted by Plaintiffs relate to a narrow, specific set of fenofibrate pharmaceutical compositions, which must be made with certain starting materials, including micronized fenofibrate; form granulates on inert solid supports; and dissolve at certain rates in certain dissolution media. Specifically, the claimed dissolution features of such compositions are the subject of Defendant's motion for summary judgment. Defendant sustains that the dissolution claims require: 1) A dissolution profile of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes; 2) As measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia; and 3) In a dissolution medium constituted by water with 2% by weight polysaturate 80 or 0.025 M sodium lauryl sulfate (the "Claimed Dissolution Profile"). Defendant has had an independent laboratory test its capsules, the results being that Cipher's fenofibrate capsules do not release fenofibrate at the dissolution rates required by all '405 and '881 patent claims, as well as claims 24-25 and 49-50 of the '552 patent. Furthermore, Defendant sustains that the dissolution test results conclusively demonstrate that all strengths of Cipher's capsules are well outside the Claimed Dissolution Profile required by the patents-in-suit. Accordingly, Defendant contends that Plaintiffs will never be able to prove that Cipher's proposed product infringes, either "literally" or under the "doctrine of equivalents", any of the dissolution claims. Since Plaintiffs will not be able to prove an essential element of their case, for the dissolution claims, Defendant respectfully requests the Court to enter, in favor of Cipher's summary judgment of noninfringement on all dissolution claims of the patents-in-suit.
"Literal infringement is found only if each and every element of the claim is exactly present in the accused product." Cipher's Memorandum of Law in Support of its Motion for Summary Judgment, Docket No. 62, p. 11; see also Shelley K. Cole v. Kimberly-Clark Corporation, 102 F. 3d 524, 532 (C.A. Fed., (Ariz.), 1996).
"Infringement under the doctrine of equivalents is found only when the accused product possesses each claim element, or the substantial equivalent to each claim element." Cipher's Memorandum of Law in Support if its Motion for Summary Judgment, Docket No. 62, p. 11; citing Zelinski v. Brunswick Corp., 185 F. 3d. 1311, 1316 (C.A. Fed., (Ill.), 1999).
On August 16, 2004, Plaintiffs filed a Brief in Opposition to Cipher's Motion for Summary Judgment of Noninfringement on Dissolution for U.S. Patent Nos. 6,277,405 B1, 6,589,552 B2, and 6,652,881 B2 (Docket No. 102). Plaintiffs aver that Defendant's dissolution tests were based on expired material and not the product that Cipher would be authorized to manufacture and sell if it receives FDA approval. Plaintiffs sustain that Defendant's tests simply do not provide the Court any basis to make an infringement analysis due to the fact that pharmaceutical products, particularly the gelatin capsules used in the products, change over time and that these changes can affect the dissolution of the active substance, for example, fenofibrate. Plaintiffs further sustain that their expert, Dr. Stephen Byrn, examined Cipher's dissolution test data as well as the capsules of the expired product and concluded that Cipher's dissolution tests data are not reliable. Consequently, Plaintiffs' expert, went on to obtain fresh gelatine capsules and conducted dissolution tests taking into account the effect of gelatin cross-linking in Cipher's hard gelatin capsules. The tests allegedly demonstrate that the composition and dissolution profile of Cipher's proposed product are equivalent to the claimed composition and dissolution profile. For these reasons, Plaintiffs contend that since issues of material fact are evident, summary judgment should be denied.
Section 301(a) of the Food, Drug and Cosmetic Act, prohibits the sale of any drug that is expired or "adulterated" because there is no assurance that once the expiration date has passed that the drug has the purported safety, strength, quality and purity issues. 21 U.S.C. § 331(a) (2004); see also Docket No. 102, ¶ 2.
See Plaintiff Brief in Opposition, Docket No. 102, ¶ 3.
See Declaration of Dr. Stephen R. Byrn, Docket No. 102, ¶ 21.
On August 20, 2004, Defendant filed a Consolidated Reply Brief in Support of its Motion for Summary Judgment of Noninfringement on Dissolution for U.S. Patent Nos. 6,277,405 B1, 6,589, 552 B2, and 6,652,881 B2 (Docket No. 120). Defendant avers that Plaintiffs have no relevant evidence to support their case on the dissolution element, and thus failed to meet their burden of production. Defendant further avers that Plaintiffs failed to dispute Cipher's claim construction of the dissolution profile elements, and since they concede that they cannot produce evidence that demonstrates that Cipher's fenofibrate capsules literally infringe the dissolution elements of the patents-in-suit, Plaintiffs have resorted to an infringement theory solely based on the doctrine of equivalents. Defendant alleges that Plaintiffs' infringement theory fails as a matter of law, for several reasons. First, Defendant states that the dissolution claim elements have several limitations relating to how ( European Pharmacopoeia methods) and when ( 5, 10, 20 and 30 minute times), data must be collected to create the required dissolution profile. On the other hand, the data relied upon by Plaintiffs, for their equivalent infringement theory, was not gathered by adhering to the rules set forth in the European Pharmacopoeia. Defendant contends that Plaintiffs failed to collect the 5 minute data and that the data they did collect fails to correspond to the 5, 10, 20, and 30 minute time markers, required by the patent claims. Defendant alleges that if such data is allowed to preclude summary judgment, it would effectively allow Plaintiffs to vitiate such claim limitations, which in turn would violate the "All Elements Rule" as a matter of law. Second, Defendant contends that the legal doctrine of "prosecution history" estoppel precludes a finding of equivalence. Defendant sustains that this is so, given Plaintiffs' repeated arguments to the PTO that any deviation from the European Pharmacopoeia method in gathering dissolution data, rendered the data unusable for purposes of comparison to the patent claims, and that the products of the Deboeck patent were outside the scope of the claimed invention. Third, Defendant contends that Plaintiffs' allegations regarding Defendant's dissolution testing on expired capsules, is a red herring. Defendant sustains that there is no dispute with regards to the fact that Cipher's European Pharmacopoeia — compliant test results show that the capsules tested dissolved well outside the patented range. Plaintiffs merely complain about the fact that the capsules used for testing by the Defendant, were old. Defendant avers that before the instant case even began, Plaintiffs had whole capsules from Cipher, that were "unexpired", and apparently did no testing on them. Finally, Defendant sustains that if the only reason this Court is precluded from entering summary judgment, is whether freshly made capsules will give the same dissolution results as the capsule tests described in Cipher's opening brief, Defendant is willing to make and re-submit fresh capsules for testing according to the European Pharmacopoeia method, to demonstrate that its capsule results will not change, and will continue to fall well outside the claimed dissolution profile required by the patent-in-suit. Since Plaintiffs have failed to create a legally cognizable fact dispute on the dissolution elements of the patents-in-suit, Defendant respectfully requests the Court to enter, in favor of Cipher's summary judgment of noninfringement on all dissolution claims of the patents-in-suit.
"Under the all elements rule, there can be no infringement under the doctrine of equivalents if even on limitation of a claim or its equivalent is not present in the accused device . . .". Cipher's Consolidated Reply Brief in Support if its Motion for Summary Judgment, Docket No. 120, p. 5; quoting Lockheed Marin Corp., v. Space Sys./Loral, Inc., 324 F3d 1308, 1321(C.A. Fed. (Cal.), 2003).
On December 21, 2004, Defendant submitted a Motion for Leave to File Under Seal Cipher's "Defendant Cipher Pharmaceuticals Ltd's Motion for Leave to Supplement its Motion for Summary Judgement" (Docket No. 164 (Docket No. 167 was submitted with Docket No. 164)), a Motion for Leave to File Under Seal "Cipher's Supplemental Submission of Dissolution Data in Support of its Motion for Summary Judgment" (Docket No. 165 (Docket No. 168 was submitted with Docket No. 164)) and a Motion for Leave to File Under Seal "Cipher's Statement of Uncontested Material Facts for its Supplemental Submission in Support of its Motion for Summary Judgment with Attachment of Supplemental Declarations of Dr. Ian W. French, Dr. Eli Shefter and Paul J. Molino" (Docket No. 166 (Docket No. 169 was submitted with Docket No. 166)). The Court granted all three motions on January 1, 2005 (Docket No. 170).
On August 27, 2004, Plaintiffs filed a Surreply in Opposition to Cipher's Motion for Summary Judgment of Noninfringement on Dissolution for U.S. Patent Nos. 6,277,405 B1, 6,589, 552 B2, and 6,652,881 B2 (Docket No. 131). Plaintiffs first contention is that Defendant has not shown that Cipher's product does not infringe. First, Plaintiffs aver that Defendant has not refuted the fact that the products Cipher used for testing, were expired and cross-linked. On the other hand, Plaintiffs aver that Defendant attempts to shift its burden on summary judgment to Plaintiffs by asserting that Plaintiffs received samples of the product well in advance of its expiration, being able to conduct tests on the product prior to its expiration. Plaintiffs sustain that such assertion is without merit, since the products allegedly received "well in advance" of their expiration date, were in fact received only a few weeks before their expiration. Moreover, Plaintiffs allege that they were unaware of the products expiration issue, until July 2004 when Plaintiffs learned during discovery that the samples were well past their expiration date. Plaintiffs contend that Cipher could have addressed this issue by conducting dissolution tests on unexpired products from the beginning. Instead, Cipher tested long expired products in order to take advantage of the cross-linking and deliberately delay the dissolution of fenofibrate from its product. Plaintiffs sustain that although in Defendant's Consolidated Reply Brief (Docket No. 120, p. 10), Cipher offers to produce fresh samples, the offer comes too late. Plaintiffs aver that since it's Cipher's burden to test and produce unexpired products in support of its motion for summary judgment and at this stage, there is no evidence in the record with respect to the testing of any product Cipher could sell in the marketplace, Cipher's summary judgment should be denied based on that fact alone.
Plaintiffs indicate that the cross-linking "advantage" pertains to the dissolution times of cross-linked fenofibrate capsules being significantly longer than the dissolution times of fresh fenofibrate capsules. See Plaintiffs' Surreply, p. 5, Docket No. 131.
Second, Plaintiffs aver that Cipher's dissolution profiles are not reliable due to the fact that, when gelatin cross-linking occurs, i.e., the dissolution times of the cross-linked fenofibrate capsules are significantly longer than the dissolution times of fresh fenofibrate capsules. Plaintiffs sustain that this is exactly what occurred when Cipher tested the dissolution of its expired capsules, and is why the tests do not support a finding of noninfringement. The heavily cross-linked Cipher capsule sealed the active fenofibrate ingredient within the capsule in Cipher's dissolution test. Plaintiffs insist that Cipher's tests are simply not indicative of its product's performance and do not support a finding of noninfringement on summary judgment.
"Cipher's statement that dissolution testing is "designed to evaluate how an entire intact drug product may behave when taken by patients" is simply irrelevant. This may be true when referring to non-expired product, but does not apply to a cross-linked capsule product." Plaintiffs' Surreply, footnote no. 4, Docket No. 131. ( Internal citation omitted).
Third, Plaintiffs sustain that, Dr. Byrn's testing establishes that Cipher's product infringes under the doctrine of equivalents. Plaintiffs aver that the issue in question is whether Cipher's proposed product infringes the patents-in-suit under the doctrine of equivalents. The parties' experts disagree on the proper way to test Cipher's product and whether the resulting dissolution profiles are reliable. Consequently, this disagreement presents disputed fact issues that cannot be resolved on summary judgement. Moreover, Plaintiffs sustain that the parties dispute the equivalence of the dissolution profile of Cipher's fenofibrate capsule product obtained by Dr. Byrn, but the record as it stands with respect to Dr. Byrn's conclusion of infringement is undisputed. Plaintiffs indicated that Dr. Byrn stated that the adjusted dissolution profile for Cipher's product is equivalent to the claimed dissolution profile, since the values obtained at the 6.5 minute mark are "not substantially different from at least 10% dissolved fenofibrate at 5 minutes." Plaintiffs sustain that, Contrary to Cipher's contention, their proof of equivalents does not "vitiate" any claim requirement. Whether or not the claim term is vitiated, depends on whether Plaintiffs testing differs insubstantially from the claimed requirement of testing the entire capsule. Plaintiffs aver that due to the fact that Cipher's capsule was cross-linked, in order to accurately determine the dissolution of Cipher's product, Dr. Bryn resorted to the testing of the contents and the dissolution profile, based on capsule disintegration times. Plaintiffs contend that any difference between testing the contents of a cross-linked capsule and an entire unexpired capsule is insubstantial. Regarding Cipher's argument, that the absence of the 5 minute data in Dr. Byrn's testing would "vitiate" the literal language of the claim, Plaintiffs contend that rather than "vitiating" a claim element, Dr. Byrn's testing shows a dissolution profile that is not substantially different from the literal requirements of the claim. Dr. Byrn's testing, compared to the literal claim requirement of at least 10% dissolution at 5 minutes, showed fenofibrate dissolution well in excess of 10% at 6.5 minutes. Plaintiffs sustain that "[t]he mere fact that the claims include numeric limits 'does not, by itself, preclude [the patentee] from relying on the doctrine of equivalents." Moreover, Plaintiffs state that any analysis of infringement under the doctrine of equivalents necessarily deals with subject matter that is not in the literal scope of a claim. Plaintiffs further explain that infringement under the doctrine of equivalents is highly fact specific. For example, regarding whether the accused device is insubstantially different from the claimed invention, is considered a question of fact, the resolution of which requires a traditional infringement analysis. Plaintiffs sustain that Cipher's heavy reliance on prior decisions that are factually dissimilar is misplaced.
See Dr. Eli Shefter's Reply Declaration, ¶ 7, Docket No. 123; see also Dr. Stephen Byrn's Declaration, ¶ 32, Docket No. 102.
"Infringement under the doctrine of equivalents is found only when the accused product possesses each claim element, or the substantial equivalent to each claim element." Emphasis ours; Cipher's Memorandum of Law in Support if its Motion for Summary Judgment, Docket No. 62, p. 11; citing Zelinski v. Brunswick Corp., 185 F. 3d. 1311, 1316 (C.A. Fed. (Ill.), 1999).
See Plaintiff's Surreply in Opposition, p. 8, Docket No. 131; quoting Abbot Lab. v. Dey, L.P., 287 F.3d 1097, 1107-1108 (C.A. Fed. (Ill.), 2002).
See Plaintiff's Surreply in Opposition, p. 8, Docket No. 131; quoting Eagle Comtronics, Inc. v. Arrow Communications Labs, Inc., 305 F.3d 1303, 1317 (C.A. Fed. (N.Y.), 2002).
"For example, Lockheed involved a means plus function claim under 35 U.S.C. § 112(6), and the rate schedule discussed in that case is not comparable to any element of the present claims. Furthermore, Cipher neglects to explain that the court's characterization in Evans that a substantially 1:1 ratio could not encompass a range of equivalents between 0.90:1 to 1:1 was based on specific factual testimony of an expert in that case — a stage these proceeding[s] have not even reached." See Plaintiff's Surreply in Opposition, footnote no. 6, Docket No. 131; citations omitted.
Plaintiffs second contention is that there is no prosecution history estoppel. Plaintiffs sustain that Cipher repeatedly makes the incorrect assertion that, plaintiffs are not entitled to any range of equivalents since Fournier surrendered all equivalents regarding dissolution testing based on arguments made to the PTO during the prosecution of the patents-in-suit, and that such fiction is unsupported. Plaintiffs state that in order for Fournier to have surrendered all equivalents regarding dissolution testing, based on arguments Fournier made to the PTO, Fournier must have "clearly and unmistakably" indicated that the claims did not extend to testing the contents of a capsule product in the situation where extensive cross-linking has occurred. Plaintiffs aver that Fournier did not argue that its claimed invention differed from the prior art based on whether the entire product or the contents of a cross-linked capsule were tested. On the other hand, the argument was that in order to properly compare the dissolution profile of the prior art compounds to the dissolution profile of the claimed composition, the same dissolution media had to be used, otherwise the results would not be comparable. Plaintiffs sustain that such arguments are distinguishable from arguing that the appropriate comparison requires conducting the dissolution test on the entire product, instead of its contents. Consequently, Fournier surrendered nothing relating to the testing of the entire capsule or contents. Regarding Cipher's arguments about the Deboeck patent, Plaintiffs aver that such arguments are nothing more than an exercise in confusion. Plaintiffs reiterate the fact that Fournier's arguments distinguishing Deboeck before the PTO, do not relate to whether the entire product or the contents from a cross-linked capsule is tested. Furthermore, Plaintiffs contend that Cipher's statements implying that the Deboeck patent discloses its product are incorrect and irrelevant, since it is undisputed that such patent does not describe Cipher's proposed fenofibrate capsule formulation. In addition, Plaintiffs sustain that the fact that Cipher is licensed under the Deboeck patent, is irrelevant to whether there is prosecution history estoppel. In sum, Fournier's arguments to the PTO about the Deboeck patent do not form any basis for finding prosecution history estoppel.
See Plaintiff's Surreply in Opposition, p. 9, Docket No. 131; quoting Cordis Corp. v. Medtronic Ave., Inc., 339 F.3d 1352, 1358 (C.A. Fed. (Del.), 2003).
Plaintiffs sustain that, "[b]oth Cipher's founder, Ian French and Galephar's founder, Arthur Deboeck, admitted this fact at their deposition." See Plaintiff's Surreply in Opposition, p. 10, Docket No. 131; also see Ian French's Deposition, 54:6-56:14, Exhibit 1 and Arthur Deboeck's Deposition, 57:3, Exhibit 2.
For the reasons stated above, Plaintiffs submit to this Court, that Cipher's proposed product infringes the patents-in-suit under the doctrine of equivalents and that there are genuine issues of material fact that preclude brevis disposition as a matter of law, and as such Cipher's motion for summary judgement should be denied.
The Court agrees with Plaintiffs' arguments, pertaining to there being issues of material fact which preclude judgment as a matter of law. For this reason, the Court hereby DENIES Cipher's Motion for Summary Judgment on Noninfringement on Dissolution for U.S. Patent Nos. 6,277,405 B1, 6,589,552 B2, and 6,652,881 B2 (Docket No. 62) The Court Explains.
II. Summary Judgment Standard
Summary judgment is appropriate when "the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." FED. R. CIV. P. 56. Pursuant to the language of the rule, the moving party bears the two-fold burden of showing that there is "no genuine issue as to any material facts," and that the mover is "entitled to judgment as a matter of law." Vega-Rodriguez v. Puerto Rico Tel. Co., 110 F.3d 174, 178 (1st Cir., 1997). After the moving party has satisfied this burden, the onus shifts to the resisting party to show that there still exists "a trial worthy issue as to some material fact." Cortes-Irizarry v. Corporación Insular, 111 F.3d 184, 187 (1st Cir., 1997). A fact will be deemed "material" if it potentially could affect the outcome of the suit. Id. Moreover, there will only be a "genuine" or "trial worthy" issue as to such a "material fact," "if a reasonable fact-finder, examining the evidence and drawing all reasonable inferences helpful to the party resisting summary judgment, could resolve the dispute in that party's favor." Id.
The non-movant must affirmatively show that "sufficient evidence supporting the claimed factual dispute [exists] to require a jury or judge to resolve the parties' differing versions of truth at trial." First Nat. Bank of Ariz. v. Cities Service Co., 391 U.S. 253, 288-89, 88 S.Ct. 1575, 1592-93, 20 L.Ed.2d 569 (1968), reh'g denied, 393 U.S. 901, 89 S.Ct. 63, 21 L.Ed.2d 188 (1968). The non-movant cannot rest upon mere allegations or denial of the pleadings. Fed.R.Civ.P. 56(e). Local Rule 56 for the District of Puerto Rico, clearly states that if a party, in this case the defendant, does not oppose a motion for summary judgment "[a]ll material facts set forth in the statement required to be served by the moving party shall be deemed to be admitted." Local Rule 56. This does not mean that summary judgment will be granted automatically, just because the defendant failed to file an opposition. Mendez v. Banco Popular de Puerto Rico, 900 F.2d. 4, 7 (1st Cir., 1990). "If the adverse party does not so respond, summary judgment, if appropriate, shall be entered against the adverse party." Fed.R.Civ.P.56(e); see also NEPSK, inc. v. Town of Houlton, 283 F.3d. 1, 7-8 (1st Cir., 2002) ( Emphasis added). Although summary judgment is not granted automatically "the nonmoving party does waive the right to object to the material facts set forth by the movant." Feliciano Rivera v. Medical Geriatric Admin. Serv., 254 F.Supp. 2d 237, 239 (D.C.P.R., 2003). However, notwithstanding that there is no opposition to a summary judgement, the Court must entertain the motion on the merits and may not grant the same as a sanction even if there is no opposition on file. De la Vega v. San Juan Star, 377 F.3d 111 (1st Cir., 2004).
At all times during the consideration of a motion for summary judgment, the Court must examine the entire record "in the light most flattering to the non-movant and indulge all reasonable inferences in the party's favor." Maldonado-Denis v. Castillo-Rodriguez, 23 F.3d 576, 581 (1st Cir., 1994). There is "no room for credibility determinations, no room for the measured weighing of conflicting evidence such as the trial process entails, [and] no room for the judge to superimpose his own ideas of probability and likelihood. . . ." Greenburg v. Puerto Rico Mar. Shipping Auth., 835 F.2d 932, 936 (1st Cir., 1987). In fact, "[o]nly if the record, viewed in [this] manner and without regard to credibility determinations, reveals no genuine issue as to any material fact may the court enter summary judgment." Cadle Co. v. Hayes, 116 F.3d 957, 960 (1st Cir., 1997).
Issues of motive and intent as to the conduct of any party will normally preclude the Court from granting summary judgment. Mulero-Rodriguez v. Ponte, Inc., 98 F.3d 670, 677 (1st Cir., 1996) (reversing summary judgment and emphasizing that "determinations of motive and intent . . . are questions better suited for the jury") (internal quotation marks omitted) (citation omitted); see also Tew v. Chase Manhattan Bank, N.A., 728 F.Supp. 1551, 1555 (S.D.Fla., 1990) ("Certain issues such as fraud, intent, and knowledge lend themselves to trial, rather than summary judgment. These matters can often only be proved by reliance upon circumstantial evidence except in the rare case where there is uncontroverted proof of a 'smoking gun.'"). However, "even in cases where elusive concepts such as motive or intent are at issue, summary judgment may be appropriate if the nonmoving party rests merely upon conclusory allegations, improbable inferences [or] unsupported speculation." Ayala-Gerena v. Bristol Myers-Squibb Co., 95 F.3d 86, 95 (1st Cir., 1996).
III. Uncontested Material Facts A. The Parties
1. Plaintiff, Abbott Laboratories purports to be a corporation organized under the laws of the State of Illinois, having its headquarters and principal place of business at Abbott Park, Illinois 60064. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 1.)
2. Plaintiffs Fournier Industrie et Sante, formerly known as Fournier Innovation et Synergie, and Laboratories Fournier S.A. purport to be French corporations with their principal place of business at 42 Rue de Longvic, 21300 Chenôve, France.(Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 2.)
3. Defendant Cipher is a corporation organized and existing under the laws of Barbados, having its principal place of business at Lauriston, Collymore Rock, St. Michael, Barbados. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 3.)
B. Jurisdiction and Venue
4. This action arises under the Patent Laws of the United States, 35 U.S.C. § 1 et seq., and in particular 35 U.S.C. § 271 (e)(2)(A).(Defendant's Statement of Uncontested Facts, Docket
No. 62 ¶ 4.)
5. This Court has subject matter jurisdiction over these actions pursuant to 28 U.S.C. § 1338. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 5.)
6. This Court has personal jurisdiction over Cipher under 32 L.P.R.A. App. III, Rule 4.7(a) or, in the alternative, Fed.R.Civ.P. 4(k)(2). (Plaintiffs' Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 6.)
7. Venue for this action is proper in this District under 28 U.S.C. § 1391. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 7.)
Fenofibrate
8. The drug products at issue involve a molecule known as fenofibrate, identified in U.S. patent no. 4,058,552 (the "fonfibrate patent"). (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 8.)
9. Fenofibrate has been off-patent since the Fenofibrate patent expired in 1994. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 9.)
Cipher's Fenofibrate-Containing Capsule Drug Product
10. On December 24, 2002, Cipher submitted New Drug Application No. 21-612 to the United States Food and Drug Administration, for approval to market in the United States fenofibrate-containing drug capsules in 50, 100, 150, and 160 mg strengths.(Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 11.)
11. In connection with NDA NO. 21-612, Cipher submitted a "paragraph IV certification" to each of the patents-in-suit, stating that those patents would not be infringed by the manufacture, sale or use of Cipher's fenofibrate capsules for which NDA No. 21-612 was submitted, pursuant to 21 U.S.C. § 355(b)(2)(A)(iv). Cipher also notified Plaintiffs via letter, confirming that Cipher had submitted a paragraph IV certification to the patents-in-suit. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 12.)
12. U.S. patent no. 5,545,628 ("the Deboeck patent") was issued on August 13, 1996, before Fournier applied for any of the patents-in-suit. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 14.)
13. Cipher is the licensee of the Deboeck patent. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 15.)
The patents-In-Suit
14. The '405 and '552 patents are both entitled "Fenofibrate pharmaceutical Composition Having Bioavailability And Method For Preparing It"; the '881 patent is entitled "Fenofibrate Pharmaceutical Composition having High Bioavailability."(Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 16.)
15. Fournier is the assignee and owner of the patents-in-suit. (Plaintiffs' Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 17.)
16. Abbott is the exclusive licensee of the patents-in-suit. (Plaintiffs' Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 18.)
17. The patents-in-suit contain two figures comparing dissolution rates for the claimed invention and prior art fenofibrate-containing pharmaceutical compositions. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 19.)
'405 Patent
18. The '405 patent was issued on August 21, 2001. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 20.)
19. The '405 patent contains thirteen total claims, of which claim 1 is the only independent claim. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 21.)
20. Independent claim 1 of the '405 patent reads:
A composition comprising a hydrosoluble carrier and micronized fenofibrate having a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to European Pharmacopoeia, in a dissolution medium constituted sodium lauryl sulfate. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 22.)
21. The "Background of the Invention" section of the '405 patent states: "There is thus a need to improve fenofibrate bioavailability in order to attain, over very short periods of time, a level close to 100% (or, in any case, better than the following limits: 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes in a medium consisting of 1200 ml of water to which 0.025M sodium is added, with a blade rotating speed of 75 rpm), and this even when dissolution media having a low surfactant content are used." (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 24.)
22. In connection with Example 4 of the '405 patent, the patent states:"The results clearly show that the compositions of the invention have a distinctly improved dissolution compared to prior art compositions."(Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 25.)
'552 Patent
23. The '552 patent was issued on July 8, 2003. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 26.)
24. Dependent claim 24 of the '552 patent reads:
The composition of claim 1, wherein the composition has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using a rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium comprising water with 2% by weight polysorbate 80. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 27.)
25. Dependent claim 25 of the '552 patent reads:
The composition of claim 1, wherein the composition has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using a rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium comprising water with 0.025 M sodium lauryl sulfate. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 28.)
26. Dependent claim 49 of the '552 patent reads:
The composition of claim 31, wherein the composition has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using a rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium comprising water with 25% by weight polysorbate 80. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 29.)
27. Dependent claim 50 of the '552 patent reads:
The composition of claim 31, wherein the composition has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using a rotating blade method at 75 rpm according to the European Pharmacopoeia, in dissolution medium comprising water with 0.025 sodium lauryl sulfate. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 30.)
28. The "Background of the Invention" section of the '552 patent states: "There is thus a need to improve fenofibrate bioavailability in order to attain, over very short periods of time, a level close to 100% (or, in any case, better than the following limits: 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes in a medium consisting of 1200 ml of water to which 0.025M sodium lauryl sulfate sodium is added, with a blade rotation speed of 75 rpm), and this even when dissolution media having a low surfactant content are used."(Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 31.)
'881 Patent
29. The '881 patent was issued on November 25, 2003. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 32.)
30. The '881 patent contains forty-one total claims, and claims 1, 6, 11, 15, 22, 27, 32, and 37 are independent claims.(Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 33.)
31. Independent claim 1 of the '881 patent reads:
A composition comprising micronized fenofibrate, wherein the composition has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or with 0.025 M sodium lauryl sulfate. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 34.)
32. Independent claim 6 of the '881 patent reads:
An orally administrable tablet comprising micronized fenofibrate, wherein the tablet has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or a dissolution medium constituted by water with 0.025 M sodium lauryl sulfate. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 36.)
33. Independent claim 11 of the '881 patent reads:
A composition comprising micronized fenofibrate and at least one polymer, wherein the composition has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 505 in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or 0.025 M sodium lauryl sulfate. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 38.)
34. Independent claim 15 of the '881 patent reads:
A composition comprising at least one inert carrier and one or more outer layers comprising at least one inert carrier and one or more outer layers comprising micronized fenofibrate, wherein the composition has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water with 2% weight polysorbate 80 or 0.025 M sodium lauryl sulfate. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 40.)
35. Independent claim 22 of the '881 patent reads:
A composition comprising granulates which comprise micronized fenofibrate, wherein the composition has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water with 2% weight polysorbate 80 or a dissolution medium constituted by water with 0.025 M sodium lauryl sulfate. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 42.)
36. Dependent claim 23 through 26 of the '881 patent all depend from, and incorporate the elements and limitations of, independent claim 22. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 43.)
37. Independent claim 27 of the '881 patent reads:
An orally administrable tablet comprising granulates, wherein the granulates comprise micronized fenofibrate, and wherein the tablet has a dissolution of at least 105 in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or a dissolution medium constituted by water with 0.025 M sodium lauryl sulfate. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 44.)
38. Independent claim 32 of the '881 patent reads:
An orally administrable capsule comprising granulates, wherein the granulates comprise micronized fenofibrate, and wherein the capsule has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using a rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium comprising water with 2% by weight polysorbate 80 or a dissolution medium comprising water with 0.025 M sodium lauryl sulfate. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 46.)
39. Dependent claim 37 of the '881 patent reads:
A granulate comprising micronized fenofibrate, wherein the granulates has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water 2% by weight polysorbate 80 or a dissolution medium constituted by water with 0.025 M sodium lauryl sulfate. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 48.)
40. The "Background of the Invention" section of the '881 patent states: "To improve the dissolution profile of fenofibrate and its bioavailability, thereby reducing the dose requiring to be administered, it would be useful to increase its dissolution so that it could attain a level close to 100%." (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 50.)
41. The "Background of the Invention" section of the '881 patent states: "There is thus need to improve fenofibrate availability in order to attain, over very short periods of time, a level close to 100% (or, in any case, better than the following limits: 10% in 5 minutes, 20% in 10 minutes, 50% ion 20 minutes and 75% in 30 minutes in a medium consisting of 1000 ml of water of which 0.025M sodium lauryl sulfate is added, with a blade rotation speed of 75 rpm), and this even when dissolution media having a low surfactant are used." (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 51.)
Background of the patents-in-suit
42. On January 9, 1998, Fournier filed a patent application, which later resulted in a U.S. patent No. 6,074,670 ("the '670 patent"), that was assigned Serial No. 09/005, 128 ("the '670 Application"). (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 52.)
43. Fournier later filed at least three "continuation" patent application that stemmed from and claimed priority to the '670 Application: "the '405 Application"; "the '552 Application"; and the '881 Application." (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 53.)
44. Fournier is the assignee of U.S. Patent No. 4,895,726 that issued to Curtet, et al., on January 22, 1990. (Plaintiffs' Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 54.)
45. In an Office Action dated August 7, 1998, the United States Patent Trademark Office ("PTO") stated that Curtet "teaches a fenofibrate solid dosage form with improves bioavailability . . . The solid dosage form reaches a maximum dissolution of 96% . . . The examiner notes that the applicants disclose a total dissolution of 95.9%." (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 55.)
46. In an Office Action dated June 25, 1999, the PTO rejected several of the claims of the claimed invention in the '670 Application "as being unpatentable over the combined teachings of Temeljotov et al., Solubization and Dissolution Enhancement for Sparingly Soluble Fenofibrate, Acta Pharma . . . (1996); Curtet et al., (U.S. Pat. No. 4,895,726, collectively "Curtet"); and Deboeck et al., (U.S. Pat. No. 5,545,628, collectively "Deboeck")." (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 56.)
47. In an office Action dated June 25, 1999, the PTO also stated that the dissolution rate exhibited by the pharmaceutical preparation taught by Temeljotov "overlap[ped] the present invention." (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 57.)
48. In a December 4, 1998, Response and Amendment, Fournier "respectfully disagree[d]" with the PTO, stating that "a fair comparison cannot be made based on the teaching in Curtet since the dissolution medium is not the same as in the present invention." (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 58.)
49. In a November 17, 1999, Reply under 37 C.F.R § 1.111, Fournier state that its claimed dissolution profile was "measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or with 0.025 M sodium lauryl sulfate," and that Temeljotov used "0.1 M sodium lauryl sulfate, 37°C, 50 rpm, and Apparatus 2" of the U.S. Pharmacopoeia, not the European Pharmacopoeia. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 59.)
50. The '405 Application, assigned Serial No. 09/572, 330, was filed on May 18, 2000, and eventually issued as the '405 patent. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 62.)
51. In an Office Action dated September 26, 2000, pending claims 20, 24 and 35 were rejected by PTO examiners Thurman K. page and Brian K. Seidleck "under the judicially created doctrine of obviousness-type double patenting." (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 63.)
52. In an Office Action dated September 26, 2000, the PTO further rejected claims 20, 24, and 35 "under 35 U.S.C. § 102(b) as being anticipated by Temeljotov et al., Solubilization and Dissolution for Sparingly Soluble Fenofibrate, Acta Pharm. 46 pp. 131-136 (1996)." In an Initial Office Action dated September 26, 2000, the PTO rejected claims 20, 24, and 35 "under 35 U.S.C. § 103(a) as being unpatentable over the combined teachings of Temeljotov et al., Solubilization and Dissolution for Sparingly Soluble Fenofibrate, Acta Pharm. 46 pp. 131-136 (1996); Curtet et al., (U.S. Pat. No. 4,895,726, collectively "Curtet"); and Deboeck et al., (U.S. Pat. No. 5,546,628, collectively "Deboeck")." (Plaintiffs' Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 64.)
53. In a May 18, 2000, preliminary amendment submitted to the PTO, Fournier retained claims 20 and 24 of the original application, and added new claim 35. Independent claim 20 recites:
A composition comprising fenofibrate having a dissolution of at least 10% in 5 minutes, 20% in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or with 0.025 M sodium lauryl sulfate. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 67.)
54. On March 21, 2001, the PTO issued a "Notice of Allowability" with an "Examiner's Amendment" for Application Ser. No. 09/572, 330 which issued as the '405 patent. (Plaintiffs' Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 68.)
The '552 Patent
55. The '552 Application, assigned Application No. 10/126, 875, was filed on April 22, 2002, and eventually issued as the "552 patent. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 69.)
56. In an Office Action dated September 10, 2002, the Examiner stated:
Claims 1-7, 10-22, 25-31 are rejected under 35 U.S.C. 103(a) as being unpatentable over Curtet et al., (U.S. Pat. No. 4,895,726), (collectively, "Curtet").
Curtet teach a fenofibrate composition comprising fenofibrate granules in combination with solid surfactant, wherein the fenofibrate and solid surfactant have been co-micronized; a hydrosoluble carrier and a hydrophillic polymer, wherein the fenofibrate/solid surfactant mixture granules have a mean particle size of less than 15 microns (see entire reference, particularly, column 1, lines 1-68); (col.2, lines 1-68); examples and claims. The fenofibrate/surfactant mixture granules are filled into gelatin capsules. Curtet teach polyvinylpyrolidone as the hydrophillic polymer employed. The hydrosoluble carrier taught is lactose (col. 2, lines 1-12). The preferred solid surfactant is sodium lauryl sulfate in a recommended amount of between 0.5% and 7% (col. 1, lines 52-58). Additional excipients, such as magnesium stearate and starch may be added (col. 2, lines 1-4), Curtet do not teach the exact claimed ranges, but does teach overlapping amounts of fenofibrate and a hydrophillic polymerpolyvinylpyrolidone is contained in an amount of 7 mg (col. 3, lines 21-32). Curtet teach various dissolution rates using a rotating-vane apparatus, wherein the dissolution rates using a rotating-vane apparatus, wherein the dissolution medium comprises water and 0.1M sodium lauryl-sulfate (col. 3, lines 34-68 through col. 4, lines 1-63). The values and curve obtained after 20 minutes are plotted in Fig. 1. Additionally, Curtet teaches comparison results of T 50%, i.e., the time required for 50% of the fenofibrate to dissolve (col. 3, lines 52-60). The burden is shifted to the applicant to show some criticality of the specified dissolution rates and mediums, since Curtet does in fact teach a similar composition, obtaining similar dissolution rates as instantly claimed, with a dissolution medium of water and 0.1 M sodium lauryl-sulfate and therefore Curtet could also contain the exact desired dissolution rates if the same dissolution mediums in similar amounts were used." (Plaintiffs' Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 70.)
The '881 Application
57. The '881 Application, assigned Application No. 10/288, 425, was filed on November, 6, 2002, and eventually resulted in the '881 patent. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 71.)58. In an Office Action dated February 19, 2003, the PTO rejected claims 1-41 of the '881 patent. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 72.)
59. In an Initial Office Action dated February 19, 2003, the PTO stated:
With regards to the limitations of dissolution rates, the prior art teaches a co-micronized fenofibrate composition, which provides a dissolution rate of approximately 95% to 96% of dissolved fenofibrate obtained after 20 minutes, using a rotating-vane apparatus as specified in the European Pharmacopoeia, wherein the dissolution medium comprises water and 0.1 M sodium lauryl-sulfate . . .
There is no significant distinction observed between the prior art and the instant invention since the prior art teaches the same composition in a similar formulation for the same intended purpose as that desired by the applicant. Curtet teaches a fenofibrate dissolution rate which clearly reads on the instantly claimed dissolution rates.
Furthermore, in the absence of showing the criticality of the claimed dissolution rates, it is deemed that one of ordinary skill in the pharmaceutical art would determine suitable dissolution rates through routine or manipulative experimentation for obtaining the desired purpose. The burden is shifted to the applicant to show some criticality of the specified dissolution rates and mediums, since Curtet does in fact teach a similar composition, obtaining similar dissolution rates as those instantly claimed. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 73.)
60. In a June 25, 2003, Request for Reconsideration under 37 C.F.R. § 1.111 submitted to the PTO, the Applicant, Fournier, stated that "neither Curtet nor Kerc disclose or suggest the presently claimed composition having a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes." (Plaintiffs' Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 74.)
Dissolution Testing on Cipher's Proposed Fenofibrate Product
61. The dissolution testing results of Analytical Solutions was reviewed by Dr. Eli Shefter, an expert in pharmaceutical formulations and a member of the USP committee focusing on dissolution. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 80.)
62. Analytical Solutions reported the above results from its dissolution testing of capsules. (Plaintiffs' Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 82.)
The Present Actions
63. On April 21, 2003, Fournier and Abbott filed suit against Cipher (Civil No. 03-2067) alleging infringement of the '405 patent under 35 U.S.C. § 271(e)(2)(A). (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 83.)
64. On October 2, 2003, Fournier and Abbott filed suit against Cipher (Civil No. 03-1421) alleging infringement of the '552 patent under 35 U.S.C. § 271(e)(2)(A). (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 84.)
65. On February 5, 2004, Fournier and Abbott filed suit against Cipher (Civil No. 04-1089) alleging infringement of the '881 patent under 35 U.S.C. § 271(e)(2)(A). (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 85.)
66. On February 13, 2004m Cipher moved to have case no. 04-1089 consolidated before this Court, along with case nos. 03-1421 and 03-2067, which were previously consolidated before this Court. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 86.)
67. During the parties' April 6, 2004, discovery conference, this Court consolidated case no. 04-1089 with case nos. 03-1421 and 03-2067. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 87.)
Plaintiffs' Additional Uncontested Facts
68. In a letter dated April 3, 2003, Cipher provided three 30-count bottles of Cipher's proposed 50 mg capsule product from Lot. Nos. 17D01, 17D012, and 18D01 to Plaintiffs pursuant to a confidentiality agreement. (Plaintiffs' Statement of Additional Material Facts Submitted in Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 88.)
69. In a letter dated April 3, 2003, Cipher provided one 90-count bottles of Cipher's proposed 100 mg capsule product from Lot. No. 5E01 to Plaintiffs pursuant to a confidentiality agreement. (Plaintiffs' Statement of Additional Material Facts Submitted in Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 89.)
70. In a letter dated April 3, 2003, Cipher provided one 90-count bottles of Cipher's proposed 150 mg capsule product from Lot. No. 7E012 to Plaintiffs pursuant to a confidentiality agreement. (Plaintiffs' Statement of Additional Material Facts Submitted in Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 90.)
71. In a letter dated April 3, 2003, Cipher provided three 30-count bottles of Cipher's proposed 160 mg capsule product from Lot. No. 24E01 to Plaintiffs pursuant to a confidentiality agreement. (Plaintiffs' Statement of Additional Material Facts Submitted in Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 91.)
72. Dissolution testing by Analytical Solutions was conducted on lots of Cipher's proposed capsule product on the following dates: Lot. No. 24E01 on April 27-28, 2004, May 7, 2004, and May 10, 2004; Lot No. 7E012 on April 29-30, 2004, May 11, 2004, May 13, 2004; Lot No. 5E01 on May 3-4, 2004, May 12, 2004, and May 17, 2004; Lot No. 17D01 on May 5-6, 2004 and May 18-19, 2004. (Plaintiffs' Statement of Additional Material Facts Submitted in Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 95.)
IV. Contested Facts Fenofibrate
1. In early pharmaceutical compositions using fenofibrate, fenofibrate was mixed with inert ingredients or excipients. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 10.)
Cipher's Fenofibrate-Containing Capsule Drug Product
2. In addition to providing the Notice Letters, on April 3, 2003, Cipher, through its counsel and pursuant to a Confidentiality Agreement, sent counsel for Abbott and Fournier samples of Cipher's proposed fenofibrate capsule drug product, including finished capsules in all strengths, the active drug substance, capsule shells, and confidential NDA documents describing Cipher's proposed product and the process for making it. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 13.)
'405 Patent
3. Dependent claims 2 through 13 of the '405 patent all depend from, and incorporate the elements and limitations of, independent claim 1. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 23.)
'881 Patent
4. Dependent claims 2 through 5 of the '881 patent all depend from, an incorporate the elements and limitations of, independent claim 1. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 35.)
5. Dependent claims 7 through 10 all depend from, and incorporate the elements and limitations of, independent claim 6. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 37.)
6. Dependent claims 12 through 14 all depend from, and incorporate the elements and limitations of, independent claim 11. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 39.)
7. Dependent claims 16 through 21 of the '881 patent all depend from, and incorporate the elements and limitations of, independent claim 15. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 41.)
8. Dependent claims 28 through 31 of the '881 patent all depend from, and incorporate the elements and limitations of, independent claim 27. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 45.)
9. Dependent claims 33 through 36 all depend from, and incorporate the elements and limitations of, independent claim 32. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 47.)
10. Dependent claims 38 through 41 all depend from, and incorporate the elements and limitations of, independent claim 37. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 49.)
Background of the patents-in-suit
11. In 1998, before Fournier applied for the patents-in-suit, Fournier made a fenofibrate composition that it marketed and patented in U.S. patent no. 4,895,726, which was issued to Curtet et al. in 1990. (the "Curtet patent" or "the '726 patent"). (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 54.)
12. In a November 17, 1999, Reply under 37 C.F.R. § 1.111, Fournier stated that the Deboeck patent's product did not fit the required dissolution profile because "Curtet's formulation and Deboeck's formulation are bioequivalent and show similar bioavailabilities. . . . Since the present invention exhibits an improved bioavailability when compared to Curtet, it also exhibits an improved bioavailability when compared to Deboeck." (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 60.)
13. In the May 1, 2000, at the Reasons for Allowance issued by the PTO, the PTO allowed the '670 patent claims to issued because "the present fenofibrate composition exhibits an improved dissolution and bioavailability profiles as compared to the prior art." (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 61.)
The '405 Application
14. In an Office Action dated September 26, 2000, the PTO stated that the claims of the '405 patent were "unpatentable over the combined teachings of Temeljotov . . ., Curtet . . ., and Deboeck . . ." (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 65.)
15. In a January 26, 2001, Response and Amendment submitted to the PTO, Fournier stated: "Since Curtet's Lipanthyl® 200M has reduced bioavailability compared to the present invention, Applicants respectfully submit that Deboeck's fenofibrate compositions also have reduced bioavailability compared to the present invention, since Deboeck's dissolution profile is similar to that for Curtet's Lipanthyl® 200M." (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 66.)
The '881 Application
16. In a June 25, 2003, Request for Reconsideration under 37 C.F.R. § 1.111 submitted to the PTO, Fournier stated that in Curtet, the dissolution test was conducted using "a rotating vane or continuous flow cell where the dissolution medium is water with 0.1 M sodium lauryl sulfate," conditions different from the rotating blade method with 0.025M sodium lauryl sulfate. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 75.)
17. In a June 25, 2003, Request for Reconsideration under 37 C.F.R. § 1.111, Fournier stated that to perform a valid comparison of dissolution profiles, it was "necessary" to do the comparison "using the same method." (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 76.)
18. In a June 25, 2003, Request for Reconsideration under 37 C.F.R. § 1.111 submitted to the PTO, Fournier stated: "If Curtet and Kerc were combined, one skilled in the art would be motivated to produce a formulation having . . . a dissolution profile that is significantly lower that the claimed dissolution profile." (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 77.)
Dissolution Testing on Cipher's Proposed Fenofibrate Product
19. Dissolution testing was performed on all four capsule strengths that Cipher proposed to market in its NDA by Analytical Solutions, Inc. ("Analytical Solution"), an independent third-party laboratory based in Research Triangle Park, North Carolina. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 78.)
20. All of the Cipher fenofibrate capsules tested by Analytical Solutions conform to and were manufactured according to the specifications and methods set forth in NDA No. 21-612, and are representative of the product Cipher will market in the United States pursuant to its NDA. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 79.)
21. Dissolution testing on samples of Cipher's fenofibrate capsules was performed using the rotating blade method at 75 rpm, according to the European Pharmacopeia, in each of the two dissolution media identified in the '405, '552 and '881 patents (2% by weight polysorbate 80 and 0.025M sodium lauryl sulfate). For each dissolution medium specified in the patents-in-suit, Analytical Solutions performed two independent runs on Cipher's proposed product, in all dosage strengths. (See Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 81, Table 1, which shows Analytical Solution's results from its dissolution testing of Cipher's fenofibrate capsules.)
22. According to the above data in Table 1, Analytical Solutions reported the following results from its dissolution testing capsules: Cipher's fenofibrate capsules exhibited, across all dosage strengths, the following average dissolution percentages: (a) at 5 minutes, 0.3% dissolution; (b) at 10 minutes, 0.7% dissolution; at 20 minutes, 2.5% dissolution; and (d) at 30 minutes, 4.9% dissolution. (Defendant's Statement of Uncontested Facts, Docket No. 62 ¶ 82.)
Contested Facts from Plaintiffs' Statement of Addition Facts Cipher Products
23. In a letter dated April 3, 2003, Cipher offers no information regarding the provision samples of the capsules used in any size of Cipher's proposed capsule product. (Plaintiffs' Statement of Additional Material Facts Submitted in Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 92.)24. The dates of testing and manufacturing dates of the lot numbers tested by Analytical solutions are summarized in an enclosed chart: (See Plaintiffs' Statement of Additional Material Facts Submitted in Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 93, for the testing and manufacturing chart.)
25. The recommended shelf life for Cipher's proposed fenofibrate capsule product is 24 months. (Plaintiffs' Statement of Additional Material Facts Submitted in Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 94.)
The '552 Application
26. In a Response and Amendment Under 37 C.F.R. § 1.111 dated November 6, 2002, the Applicant stated:
This Response is submitted in reply to the Office Action dated September 10, 2002, for which a response is due on or before December 10, 2002.
* * *
Applicants thanks Examiner Sheik for indicating that claims 8, 9, 23, 24, and 32-56 are allowed.
Please amend the application without prejudice as follows.
* * *
After entry of the amendment, claims 1-7 and 9-58 are pending.
Claim 1 has been amended to include the subject matter of allowed claim 8; and claim 8 has been cancelled without prejudice. Since claim 1 has been amended to include the subject matter of allowed claim 8, Applicants respectfully submit that the rejection of claims 1-7, 10-22, and 25-31 under 35 U.S.C. § 103 over Curtet (U.S. Patent No. 4, 895, 726) is no [sic] moot because all the previously rejected claims depend (directly or indirectly) from claim 8. In view thereof, Applicants respectfully request that the rejection under § 103 be withdrawn. (Plaintiffs' Statement of Additional Material Facts Submitted in Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 96.)
27. In a Notice of Allowability dated August 11, 2003, the Examiner allowed pending claims 1-41 of Application Ser. No. 10/288, 425. (Plaintiffs' Statement of Additional Material Facts Submitted in Response to Defendant's Statement of Uncontested Facts, Docket No. 102 ¶ 97.)
V. Analysis
After careful review, the Court finds that the Defendant has failed to meet its burden to establish an absence of a genuine controversy of material facts. Contrariwise, the Court, finds genuine issues of material facts, which preclud the issuance of brevis disposition; hence the Court DENIES Cipher's Motion for Summary Judgment on Noninfringement on Dissolution for U.S. Patent Nos. 6, 277, 405 B1, 6, 589, 552 B2, and 6, 652, 881 B2 (Docket No. 62) . (The presence of genuine issues of material fact impede the granting of Summary Judgement Vega Rodriguez v. Puerto Rico Telephone, 110 F.3d 178.)
The first genuine issue of material fact in controversy present is whether or not Cipher's fenofibrate capsule infringes under the doctrine of equivalents. Defendants contend that the data relied upon by Plaintiffs, for their equivalent infringement theory, was not gathered by adhering to the rules set forth in the European Pharmacopoeia and that if such data is allowed to preclude summary judgment, it would allow Plaintiffs to vitiate claims limitations, which in turn would vitiate the "All Elements Rule". In addition, Defendants allege that Plaintiffs failed to collect the 5 minute data and that the data they did collect fails to correspond to the 5, 10, 20, and 30 minute time markers, required by the patent claims. Regarding this issue Plaintiffs contend that the parties' experts disagree on the proper way to test Cipher's product and whether the resulting dissolution profiles are reliable. Consequently, Plaintiffs sustain that this disagreement presents disputed fact issues that cannot be resolved on summary judgment. Plaintiffs aver that due to the fact that Cipher's capsules were expired and cross-linked, in order to accurately determine the dissolution of Cipher's product, Dr. Byrn resorted to the testing of the contents and the dissolution profile, based on capsule disintegration times. Dr. Byrn stated that the adjusted dissolution profile for Cipher's product is equivalent to the claimed dissolution profile, since the values obtained at the 6.5 minute mark are "not substantially different from at least 10% dissolved fenofibrate at 5 minutes." Plaintiffs sustain that, Contrary to Cipher's contention, their proof of equivalents does not "vitiate" any claim requirement. Whether or not the claim term is vitiated, depends on whether Plaintiffs testing differs insubstantially from the claimed requirement of testing the entire capsule. Plaintiffs contend that any difference between testing the contents of a cross-linked capsule and an entire unexpired capsule is insubstantial. Regarding Cipher's argument, that the absence of the 5 minute data in Dr. Byrn's testing would "vitiate" the literal language of the claim, Plaintiffs contend that rather than "vitiating" a claim element, Dr. Byrn's testing shows a dissolution profile that is not substantially different from the literal requirements of the claim. Dr. Byrn's testing, compared to the literal claim requirement of at least 10% dissolution at 5 minutes, showed fenofibrate dissolution well in excess of 10% at 6.5 minutes.
The second genuine issue of material fact in dispute present is whether or not the legal doctrine of "prosecution history" estoppel precludes a finding of equivalence. Defendant contends that the doctrine of prosecution history estoppel does in fact preclude a finding of equivalence, given Plaintiffs' repeated arguments to the PTO that any deviation from the European Pharmacopoeia method in gathering dissolution data, rendered the data unusable for purposes of comparison to the patent claims, and that the products of the Deboeck patent were outside the scope of the claimed invention. Plaintiffs sustain that there is no prosecution history estoppel. Plaintiffs aver that Cipher's assertion that, Plaintiffs are not entitled to any range of equivalents due to allegedly surrendering all equivalents regarding dissolution testing based on arguments made to the PTO during the prosecution of the patents-in-suit, is an unsupported fiction. Plaintiffs state that in order for Fournier to have surrendered all equivalents regarding dissolution testing, based on arguments Fournier made to the PTO, Fournier must have "clearly and unmistakably" indicated that the claims did not extend to testing the contents of a capsule product in the situation where extensive cross-linking has occurred. Plaintiffs aver that Fournier did not argue that its claimed invention differed from the prior art based on whether the entire product or the contents of a cross-linked capsule were tested. On the other hand, the argument was that in order to properly compare the dissolution profile of the prior art compounds to the dissolution profile of the claimed composition, the same dissolution media had to be used, otherwise the results would not be comparable. Plaintiffs sustain that such arguments are very different from arguing that the appropriate comparison requires conducting the dissolution test on the entire product, instead of its contents. Consequently, Fournier surrendered nothing relating to the testing of the entire capsule or contents. Regarding Cipher's arguments about the Deboeck patent, Plaintiffs aver that such arguments are nothing more than an exercise in confusion. Plaintiffs reiterate the fact that Fournier's arguments distinguishing Deboeck before the PTO, do not relate to whether the entire product or the contents from a cross-linked capsule is tested. Furthermore, Plaintiffs contend that Cipher's statements implying that the Deboeck patent discloses its product, are incorrect and irrelevant, since it is undisputed that such patent does not describe Cipher's proposed fenofibrate capsule formulation. In addition, Plaintiffs sustain that the fact that Cipher is licensed under the Deboeck patent, is irrelevant to whether there is prosecution history estoppel. In sum, Plaintiffs aver that Fournier's arguments to the PTO about the Deboeck patent do not form any basis for finding prosecution history estoppel.
The third genuine issue of material fact in dispute present is whether Defendant's tests are reliable, since the capsules that were used had already expired in time. Defendant contends that Plaintiffs' allegations regarding Defendant's dissolution testing on expired capsules, is a red herring. Defendant sustains that there is no dispute with regards to the fact that Cipher's European Pharmacopoeia — compliant test results show that the capsules tested dissolved well outside the patented range. Plaintiffs merely complain about the fact that the capsules used for testing by the Defendant, were old. Defendant avers that before the instant case even began, Plaintiffs had whole capsules from Cipher, that were "unexpired", and apparently did no testing on them. Defendant further sustains that if the only reason this Court is precluded from entering summary judgment, is whether freshly made capsules will provide the same dissolution results as the capsule tests described in Cipher's opening brief, Defendant is willing to make and re-submit fresh capsules for testing according to the European Pharmacopoeia method, to demonstrate that its capsule results will not change, and will continue to fall well outside the claimed dissolution profile required by the patent-in-suit. First, Plaintiffs aver that Defendant has not refuted the fact that the products Cipher used for testing, were expired and cross-linked. On the other hand, Plaintiffs sustain that Defendant's assertion regarding the fact that Plaintiffs received samples of the product well in advance of its expiration, being able to conduct tests on the product prior to its expiration, is without merit, since the products allegedly received "well in advance" of their expiration date, were in fact received only a few weeks before their expiration. Plaintiffs contend that Cipher could have addressed this issue by conducting dissolution tests on unexpired products from the beginning. Instead, Cipher tested long expired products in order to take advantage of the cross-linking and deliberately delay the dissolution of fenofibrate from its product. Second, Plaintiffs sustain that although in Defendant's Consolidated Reply Brief (Docket No. 120, p. 10), Cipher offers to produce fresh samples, the offer comes too late. Plaintiffs aver that since it is Cipher's burden to test and produce unexpired products in support of its motion for summary judgment and since at this stage, there is no evidence in the record with respect to the testing of any product Cipher could sell in the marketplace, Cipher's summary judgment should be denied based on that fact alone. Third, Plaintiffs aver that Cipher's dissolution profiles are not reliable due to the fact that, when gelatin cross-linking occurs, the dissolution times of the cross-linked fenofibrate capsules are significantly longer than the dissolution times of fresh fenofibrate capsules. Plaintiffs sustain that this is exactly what occurred when Cipher tested the dissolution of its expired capsules, and is exactly why the tests do not support a finding of noninfringement. The heavily cross-linked Cipher capsule, sealed the active fenofibrate ingredient within the capsule in Cipher's dissolution test. Plaintiffs insist that Cipher's tests are simply not indicative of its product's performance and do not support a finding of noninfringement on summary judgment.
On December 21, 2004, Defendant submitted a Motion for Leave to File Under Seal Cipher's "Defendant Cipher Pharmaceuticals Ltd's Motion for Leave to Supplement its Motion for Summary Judgement" (Docket No. 164 (Docket No. 167 was submitted with Docket No. 164)), a Motion for Leave to File Under Seal "Cipher's Supplemental Submission of Dissolution Data in Support of its Motion for Summary Judgment" (Docket No. 165 (Docket No. 168 was submitted with Docket No. 164)) and a Motion for Leave to File Under Seal "Cipher's Statement of Uncontested Material Facts for its Supplemental Submission in Support of its Motion for Summary Judgment with Attachment of Supplemental Declarations of Dr. Ian W. French, Dr. Eli Shefter and Paul J. Molino" (Docket No. 166 (Docket No. 169 was submitted with Docket No. 166)). The Court granted all three motions on January 1, 2005 (Docket No. 170).
Plaintiffs indicate that the cross-linking "advantage" pertains to the dissolution times of cross-linked fenofibrate capsules being significantly longer than the dissolution times of fresh fenofibrate capsules. See Plaintiffs' Surreply, p. 5, Docket No. 131.
"Cipher's statement that dissolution testing is "designed to evaluate how an entire intact drug product may behave when taken by patients" is simply irrelevant. This may be true when referring to non-expired product, but does not apply to a cross-linked capsule product." Plaintiffs' Surreply, footnote no. 4, Docket No. 131. ( Internal citation omitted).
VII. CONCLUSION
Although the Defendant did in fact re-submit fresh capsules for testing, it is evident that whether or not freshly made capsules provide the same dissolution results as the expired capsule tests, is not the only reason this Court is precluded from entering summary judgment. The Court finds that Defendant failed to meet its burden to establish the absence of a genuine controversy of material facts. There are genuine issues of material fact which require the weighing of expert testimony as related above. The court clarifies that at the Summary Judgement level, the trial court must examine the evidence "in the light most flattering to the non-movant and indulge all reasonable inferences in the party's favor" Maldonado Dennis v. Castillo Rodriguez 23 F. 3d. at 561. Therefore, the Court hereby DENIES Cipher's Motion for Summary Judgment on Noninfringement on Dissolution for U.S. Patent Nos. 6,277,405 B1, 6,589,552 B2, and 6,652,881 B2 (Docket No. 62). Consequently, Cipher's Motion for Summary Judgment for Noninfringement of U.S. Patent No. 6,652,881 B2, at Docket No. 8 in Civil Case No. 04-1089 is DENIED as Duplicative.