Opinion
05 Civ. 1321 (WHP).
January 12, 2007
Raymond N. Nimrod, Esq., Jenner Block LLP, Chicago, IL, Counsel for Plaintiffs.
Steven L. Underwood, Esq., James A. Mitchell, Esq., Price, Heneveld, Cooper, DeWitt Litton, LLP, Grand Rapids, MI, Counsel for Defendants.
MEMORANDUM AND ORDER
McNeil-PPC, Inc. ("McNeil"), Merck Co., Inc. ("Merck") and Johnson Johnson Merck Consumer Pharmaceuticals Co. (collectively, the "Plaintiffs") bring this action pursuant to the Hatch-Waxman Act, 35 U.S.C. § 271(e)(2), against Perrigo Company, L. Perrigo Company and Perrigo Research Development Company (collectively, the "Defendants" or "Perrigo"). Plaintiffs accuse Perrigo of infringing U.S. Patent No. 5,817,340 (the "`340 patent") by filing Abbreviated New Drug Application ("ANDA") No. 77-355 with the United States Food and Drug Administration (the "FDA"). Presently before this Court is Plaintiffs' motion for summary judgment dismissing Defendants' counterclaims of invalidity and inequitable conduct. For the reasons set forth below, Plaintiffs' motion is granted in part and denied in part.
BACKGROUND
The factual background of this action is set forth in this Court's Order dated July 27, 2006 (the "July 27 Order"), familiarity with which is assumed. McNeil-PPC, Inc. v. Perrigo Co., 443 F. Supp. 2d 492 (S.D.N.Y. 2006). In addition, the following facts pertain to the present motion. The `340 patent claims a solid oral dosage of aluminum hydroxide or magnesium hydroxide (the "antacids") and famotidine. Famotidine is a guanidinothiazole compound that inhibits acid secretion in the stomach by interfering with histamine receptors in the stomach lining. (Declaration of Kristopher R. Kiel, dated Oct. 18, 2006 ("Kiel Decl."), Ex. 1: `340 Patent col. 51, 11. 31-32.) Aluminum hydroxide and magnesium hydroxide neutralize acid already present in the stomach. McNeil, 443 F. Supp. 2d at 496. When combined in a solid oral dosage, famotidine and antacids are used to treat gastric disorders arising from acid secretion, such as acid indigestion. McNeil markets this combined dosage as Pepcid Complete. McNeil, 443 F. Supp. 2d at 496.
McNeil filed the `340 patent application on December 1, 1992 with Edward John Roche ("Roche"), Susan Decoteau ("Decoteau") and Eleanor Freeman ("Freeman") as the named inventors. McNeil, 443 F. Supp. 2d at 496. These named inventors, along with McNeil employee John Dubek ("Dubek"), worked together on a joint venture formed by Merck and Johnson Johnson. (Declaration of Steven L. Underwood, dated Nov. 9, 2006 ("Underwood Decl.") Ex. B: Transcript of Deposition of Edward Roche, dated Jan. 18, 2006 ("Roche Dep.") at 32-36; Defendants' Statement Pursuant to Local Rule 56.1 ("Def. 56.1 Stmt.") ¶¶ 1-2.) This team purportedly discovered that famotidine degrades when exposed to antacids in the solid form, yielding a therapeutically ineffective product with unknown properties. (`340 Patent col. 1, ll. 26-30; col. 2, ll. 41-49; col. 2, ln. 61 — col. 3, ln. 2.) The `340 patent teaches a method for preventing famotidine degradation.
Before the `340 patent application was filed, McNeil's famotidine supplier, Yamanouchi Pharmaceutical Co., provided McNeil with test results regarding famotidine's stability in an aqueous solution (the "Yamanouchi report"). (Plaintiffs' Statement Pursuant to Local Rule 56.1 ("Pl. 56.1 Stmt.") ¶¶ 74-75.) The Yamanouchi report showed that famotidine degrades in water at high and low pH as a result of the hydrolysis reaction. (Pl. 56.1 Stmt. ¶ 76; Def. 56.1 Stmt. ¶ 88.) McNeil did not disclose the Yamanouchi report to the Examiner. (Def. 56.1 Stmt. ¶ 98.)
Independent composition claim 1 of the `340 patent recites as follows:
1. A solid oral dosage form for the treatment of gastrointestinal disorders comprising a therapeutically effective amount of impermeably coated famotidine granules for the treatment of gastric disorders and pharmacologically acceptable salts thereof; and a therapeutically effective amount of aluminum hydroxide or magnesium hydroxide wherein the oral dosage form has said coated famotidine granules and the aluminum hydroxide or magnesium hydroxide in contact with each other, but separated by said impermeable coating on the famotidine granules which is impermeable to the aluminum hydroxide or magnesium hydroxide.
(`340 Patent col. 14, ll. 39-49.) Independent method claim 5 recites as follows:
5. A method for manufacturing a solid oral dosage form comprising: a) forming granules containing famotidine for the treatment of gastric disorder; b) coating the granules with a coating impermeable to aluminum hydroxide or magnesium hydroxide to form impermeably coated famotidine granules; c) mixing a therapeutically effective amount of aluminum hydroxide or magnesium hydroxide with a therapeutically effective amount of impermeably coated famotidine granules and pharmaceutically acceptable excipients to form a compression mixture; then d) pressing the compression mixture to form a solid oral dosage form.
(`340 Patent col. 15, ln. 6 — col. 16, ln. 2.) The specification details several embodiments of the invention. In the preferred embodiment, granulated famotidine is coated with an impermeable material that protects the famotidine from the antacids. (`340 Patent col. 9, ll. 7-12.) The specification details two variations on this embodiment. In Examples I and V, the coated famotidine granules and the antacids are interspersed throughout a single-layer tablet. (`340 Patent col. 9, ln. 39 — col. 10, ln. 60; col. 13, ln. 52 — col. 14, ln. 37.) Examples II and III depict two-layer embodiments in which the coated famotidine granules comprise one layer and the antacids comprise the other layer. (`340 Patent col. 10, ln. 63 — col. 12, ln. 51.)
Example IV does not specify whether it embodies a one-layer tablet or a two-layer tablet. (`340 Patent col. 12, ln. 55 — col. 13, ln. 48.)
The specification identifies 23 coatings that are suitable for protecting the famotidine granules. (`340 patent col. 7, ln. 52 — col. 8, ln. 27.) Four of these coatings contain polyvinylpyrrolidone ("PVP"). Defendants assert that Plaintiffs were aware prior to the submission of the `340 patent application that PVP degrades famotidine. (Def. 56.1 Stmt. ¶¶ 66-68.)
The Patent Office repeatedly rejected McNeil's original claims, primarily on grounds of obviousness. McNeil, 443 F. Supp. 2d at 497. On September 18, 1997, Roche submitted a declaration to the Examiner setting forth the results of a test he conducted exposing famotidine to antacids. McNeil, 443 F. Supp. 2d at 498. By combining 10mg of uncoated famotidine granules with 200mg of aluminum hydroxide or magnesium hydroxide in a single layer tablet, Roche observed a 25-70% degradation in the famotidine. When impermeably coated famotidine granules were substituted for the uncoated granules, approximately 2% degradation occurred.McNeil, 443 F. Supp. 2d at 498. The Patent Office deemed the Roche declaration "persuasive as to unexpected results in stability over the prior art for the dosage form tested therein, i.e., coated granule solid oral dosage form containing famotidine and aluminum or magnesium hydroxide." McNeil, 443 F. Supp. 2d at 498. The `340 patent issued on October 6, 1998.
Also relevant to the present motion is U.S. Patent No. 5,260,072 (the "`072 patent"), which lists Roche, Decoteau and Freeman as inventors. (Kiel Decl. Ex. 9.) The `072 patent claims a method of taste-masking medicaments by rotogranulation with a preferred particle size ranging from 5-75 microns, a binder ranging from 50-150 microns, and a carrier ranging from 5-75 microns, before application of a coating. (`072 patent col. 3, ll. 1-14; col. 9, ln. 39 — col. 10, ln. 10.) Although the `072 patent's specification identifies famotidine as a suitable medicament for this rotogranulation method, the method was not included in the `340 patent. (`072 patent col. 7, ll. 48-49.)
On October 29, 2004, Perrigo filed ANDA No. 77-355 to obtain permission from the FDA to market a generic tablet containing 10mg of coated famotidine in one layer and 165mg of magnesium hydroxide in a separate layer. Perrigo certified to the FDA that the `340 patent was invalid and would not be infringed by Perrigo's proposed tablet. On February 3, 2005, Plaintiffs filed this action alleging that the ANDA willfully infringes the `340 patent and requesting attorneys' fees pursuant to 35 U.S.C. § 285. On December 2, 2005, Defendants moved for summary judgment on grounds of non-infringement and invalidity. In the July 27 Order, this Court construed the `340 patent's claims, awarded summary judgment to Plaintiffs on the issue of infringement and denied Defendants' motion for summary judgment on invalidity.
On September 20, 2006, Perrigo filed its Amended Answer and Counterclaim, asserting counterclaims for invalidity, non-infringement and inequitable conduct. In particular, Perrigo counterclaims that: (1) the `340 patent is invalid for failure to name Dubek as an inventor under 35 U.S.C. § 102(f); (2) the `340 patent is invalid for failure to disclose the rotogranulation method described in the `072 patent under the enablement and best mode requirements of 35 U.S.C. § 112; (3) the `340 patent is unenforceable because Plaintiffs failed to disclose the Yamanouchi report during patent prosecution; and (4) the `340 patent is invalid because the inclusion of PVP in the patent violates § 112's enablement requirement. Perrigo avers that each of these alleged misrepresentations and omissions constitutes inequitable conduct.
DISCUSSION
I. Summary Judgment StandardSummary judgment is warranted "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c); see also Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247 (1986); Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986). The materiality of disputed facts is determined by the governing substantive law. Dister v. Cont'l Group, Inc., 859 F.2d 1108, 1114 (2d Cir. 1988). Material facts are those that "affect the outcome of the suit under the governing law [while] an issue of fact is `genuine' if the evidence is such that a reasonable jury could return a verdict for the non-moving party." Shade v. Hous. Auth. of New Haven, 251 F.3d 307, 314 (2d Cir. 2001). The burden of demonstrating the absence of any genuine dispute as to a material fact rests with the moving party. Adickes v. S.H. Kress Co., 398 U.S. 144, 157 (1970); Grady v. Affiliated Cent., Inc., 130 F.3d 553, 559 (2d Cir. 1997). In determining whether there is a genuine issue as to any material fact, "the evidence of the non-movant is to be believed, and all justifiable inferences are to be drawn in his favor." Liberty Lobby, 477 U.S. at 255.
If the moving party meets its initial burden, the non-moving party must then come forward with "specific facts showing that there is a genuine issue for trial." Fed.R.Civ.P. 56(c);Carlton v. Mystic Transp., Inc., 202 F.3d 129, 133 (2d Cir. 2000). The non-moving party must "do more than simply show there is some metaphysical doubt as to the material facts," Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986), and "may not rely on conclusory allegations or unsubstantiated speculation," Scotto v. Almenas, 143 F.3d 105, 114 (2d Cir. 1998). "The mere existence of a scintilla of evidence in support of the [non-movant's] position will be insufficient." Liberty Lobby, 477 U.S. at 248. Instead, the non-movant must offer "concrete evidence from which a reasonable juror could return a verdict in [its] favor."Liberty Lobby, 477 U.S. at 252. Where it is apparent that no rational finder of fact "could find in favor of the non-moving part[ies] because the evidence to support [their] case is so slight," summary judgment should be granted. Gallo v. Prudential Residential Servs., Ltd., 22 F.3d 1219, 1223 (2d Cir. 1994).
II. Inequitable Conduct Standard
A patent may be unenforceable if it is the product of inequitable conduct. "Inequitable conduct occurs when a patent applicant breaches his or her `duty of candor and good faith' to the PTO." Novo Nordisk Pharms., Inc. v. Bio-Technology Gen. Corp., 424 F.3d 1347, 1359 (Fed. Cir. 2005) (quoting 37 C.F.R. § 1.56(a)); see also Bruno Indep. Living Aids, Inc. v. Acorn Mobility Servs., Ltd., 394 F.3d 1348, 1351 (Fed. Cir. 2005). "Inequitable conduct requires proof that a patent applicant did not disclose material information to the PTO with intent to deceive." CFMT, Inc. v. YieldUp Int'l Corp., 349 F.3d 1333, 1340 (Fed. Cir. 2003) (citing Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 872 (Fed. Cir. 1988)). Inequitable conduct may include an "affirmative misrepresentation of a material fact, failure to disclose material information, or submission of false material information, coupled with an intent to deceive." Molins PLC v. Textron, Inc., 48 F.3d 1172, 1178 (Fed. Cir. 1995); see also CFMT, 349 F.3d at 1340. The Federal Circuit has explained that "to survive summary judgment, [the party propounding the inequitable conduct defense must] introduce evidence from which a trier of fact could find materiality and intent by clear and convincing evidence." Abbott Labs., v. TorPharm, Inc., 300 F.3d 1367, 1379 (Fed. Cir. 2002).
The inequitable conduct analysis is performed in two steps: "first, a determination of whether the [conduct] meets a threshold level of materiality and intent to mislead, and second, a weighing of the materiality and intent in light of all the circumstances to determine whether the applicant's conduct is so culpable that the patent should be held unenforceable." Purdue Pharma L.P. v. Boehringer Ingelheim GMBH, 237 F.3d 1359, 1366 (Fed. Cir. 2001) (internal quotations and alterations omitted). If one claim of a patent is found unenforceable on grounds of inequitable conduct, the entire patent is unenforceable. J.P. Stevens Co. v. Lex Tex Ltd., 747 F.2d 1553, 1561 (Fed. Cir. 1984).
Material references may include any information that a reasonable patent examiner would find important in deciding whether the proposed claims are patentable. Digital Control Inc. v. Charles Mach. Works, 437 F.3d 1309, 1314-16 (Fed. Cir. 2006);Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 1234, 1236 (Fed. Cir. 2003). Information that is merely cumulative of references already before the examiner is not material. Mentor H/S, Inc. v. Med. Device Alliance, Inc., 244 F.3d 1365, 1378 (Fed. Cir. 2001).
"Intent need not, and rarely can, be proven by direct evidence." Merck Co. v. Danbury Pharmacal, Inc., 873 F.2d 1418, 1422 (Fed. Cir. 1989). "Rather, in the absence of a credible explanation, intent to deceive is generally inferred from the facts and circumstances surrounding a knowing failure to disclose material information." Bruno Indep., 394 F.3d at 1354 (citingParagon Podiatry Lab., Inc. v. KLM Labs. Inc., 984 F.2d 1182, 1193 (Fed. Cir. 1993)). An inference of intent to deceive is based on the totality of the circumstances, including the nature of the conduct and the presence or absence of good faith. Li Second Family L.P. v. Toshiba Corp., 231 F.3d 1373, 1379-80 (Fed. Cir. 2000); Perseptive Biosys., Inc. v. Pharmacia Biotech., Inc., 225 F.3d 1315, 1321-22 (Fed. Cir. 2000). Gross negligence alone is insufficient to establish intent. Kingsdown, 863 F.2d at 876; see also Baxter Int'l, Inc. v. McGaw, Inc., 149 F.3d 1321, 1329 (Fed. Cir. 1998).
"As a general principle, materiality and intent are balanced — a lesser quantum of evidence of intent is necessary when the omission or misrepresentation is highly material, and vice versa." Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1358 (Fed. Cir. 2003); see also Li Second Family, 231 F.3d at 1378; Digital Control, 437 F.3d at 1315-16. "At the same time, however, there must be some threshold showing of intent to be balanced; [courts] will not find inequitable conduct on an evidentiary record that is completely devoid of evidence of the patentee's intent to deceive the [USPTO]." Amgen, 314 F.3d at 1358.
III. Inventorship
Defendants counterclaim for invalidity and inequitable conduct based on Plaintiffs' failure to name Dubek as an inventor of the `340 patent. A patented invention may be the work of two or more joint inventors. 35 U.S.C. § 116. To qualify as a joint inventor, one must "(1) contribute in some significant manner to the conception or reduction to practice of the invention, (2) make a contribution to the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the full invention, and (3) do more than merely explain to the real inventors well-known concepts and/or the current state of the art." Pannu v. Iolab Corp., 155 F.3d 1344, 1351 (Fed. Cir. 1998); see also Acromed Corp. v. Sofamor Danek Group, 253 F.3d 1371, 1379 (Fed. Cir. 2001). "[O]ne does not qualify as a joint inventor merely by assisting the actual inventor after conception of the claimed invention." Ethicon, Inc. v. United States Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998). "Conception is the formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice." Ethicon, Inc., 135 F.3d at 1460 (quoting Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986)). "An idea is sufficiently `definite and permanent' when `only ordinary skill would be necessary to reduce the invention to practice, without extensive research or experimentation.'" Ethicon, Inc., 135 F.3d at 1460 (quoting Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994)).
"[I]f nonjoinder of an actual inventor is proved by clear and convincing evidence, a patent is rendered invalid." Pannu, 155 F.3d at 1349 (internal citations omitted). "There is a presumption that the inventors named on an issued patent are correct, so misjoinder of inventors must be proven by clear and convincing evidence." Fina Oil Chem. Co. v. Ewen, 123 F.3d 1466, 1472 (Fed. Cir. 1997); see also Hess v. Advanced Cardiovascular Sys., Inc., 106 F.3d 976, 980 (Fed. Cir. 1997). Uncorroborated testimony alone cannot constitute clear and convincing proof. BJ Servs. Co. v. Halliburton Energy Servs., 338 F.3d 1368, 1373 (Fed. Cir. 2003); Price v. Symsek, 988 F.2d 1187, 1194 (Fed. Cir. 1993). What is required is "corroborating evidence of a contemporaneous disclosure that would enable one skilled in the art to make the invention." Burroughs Wellcome, 40 F.3d at 1228; see also Univ. of Colo. Found., Inc. v. Am. Cyanamid Co., 342 F.3d 1298, 1308 (Fed. Cir. 2003); Thompson v. Haynes, 305 F.3d 1369, 1384 (Fed. Cir. 2002). "Whether the co-inventor's testimony has been sufficiently corroborated is evaluated under a `rule of reason analysis," which requires that an "evaluation of all pertinent evidence . . . be made so that a sound determination of the credibility of the inventor's story may be reached.'" Linear Tech. Corp. v. Impala Linear Corp., 379 F.3d 1311, 1327 (Fed. Cir. 2004) (quoting Price, 988 F.2d at 1195). Ethicon, Inc., 135 F.3d at 1464. "The determination of whether a person is a joint inventor is fact specific, and no bright-line standard will suffice in every case." Fina Oil, 123 F.3d at 1473.
Here, there are disputed issues of material fact precluding summary judgment on Perrigo's inventorship counterclaims. To demonstrate Dubek's status as a joint inventor, Defendants proffer a lab notebook entry authored by Dubek on April 1, 1992 in connection with his work on the Merck-Johnson Johnson joint venture. (Underwood Decl. Ex. M at 164.) See Singh v. Brake, 222 F.3d 1362, 1369-70 (Fed. Cir. 2000) (entries in lab notebooks may serve as corroborating evidence of conception). The notebook entry reads:
The group working on the project, Edward J. Roche PhD, John J. Dubek, Susan M. [Decoteau], and Eleanor M. Freeman have come to the conclusion that some sort of a barrier protection must be placed between the Famotidine and the Antacid to ensure stability of the Famotidine. Roche, Dubek, [Decoteau], and Freeman are also considering filing for patent of "Polymer coated rotor granulated Famotidine along with Antacid" combination products.
(Underwood Decl. Ex. M at 164 (emphasis added).) Additionally, in December 1991, Dubek submitted a research paper on the degradation of famotidine while attending the Philadelphia College of Textiles Science. (Underwood Decl. Ex. S.) Certain portions of the `340 patent are very similar to — and in fact may have been copied from — the text of Dubek's paper. (Underwood Decl. Ex. T: Transcript of Deposition of Hal Woodrow, dated Jan. 26, 2006, at 139-46.) This evidence creates an issue of fact regarding whether Dubek made a contribution to the conception of the claimed invention "that is not insignificant in quality." See Pannu, 155 F.3d at 1351.
Plaintiffs contend that Dubek is not a joint inventor because he currently disavows inventorship. (See, e.g., Kiel Decl. Ex. 19: Transcript of Deposition of John Dubek, dated Feb. 15, 2006, at 96.) At trial, the Court will consider evidence regarding Dubek's role on the Merck-Johnson Johnson team to determine whether Dubek contributed to the conception of the `340 patent. If Dubek did play some significant role, then the Court may explore Dubek's motivation for his current disclaimer of inventorship. In any event, there are disputed issues of material fact regarding Dubek's contributions which require denial of summary judgment on the issue of invalidity. Further, misrepresentations regarding inventorship are considered material for purposes of inequitable conduct. PerSeptive Biosystems, Inc. v. Pharmacia Biotech, Inc., 225 F.3d 1315, 1321 (Fed. Cir. 2000).
Defendants have also raised disputed issues of material fact regarding Plaintiffs' intent. According to Defendants, Dubek was denied inventorship status because his inclusion as an author would have endangered the `340 patent application. In March 1992 — nine months before the `340 patent application was submitted — Decoteau, Freeman and Roche submitted the application for the `072 patent. (Kiel Decl. Ex. 9.) The `072 patent claims a method of masking the taste of famotidine by rotogranulating active material with a binder and carrier material and coating such rotogranulations with a taste masking polymer coating. (`072 patent col. 9, ln. 39 — col. 10, ln. 10.) According to Defendants, disclosing the `072 application to the `340 Examiner might have prompted the Examiner to reject the `340 patent on grounds of obviousness. This is because, as explained in the July 27 Order, famotidine's purported bitter taste may establish a motivation to combine the prior art to create the dosage forms claimed in the `340 patent. McNeil, 443 F. Supp. 2d at 517-18.
In the prosecution of a patent, a prior invention is excluded from the definition of prior art if it was authored by the inventors named in the patent application. 35 U.S.C. § 102. Thus, so long as Decoteau, Freeman and Roche authored the `340 patent, the `072 application was excluded from the prior art, and disclosure of the `072 application to the `340 Examiner was unnecessary. Including Dubek among the `340 patent's inventors, on the other hand, would have required disclosure of the `072 application. Defendants have therefore posited a specific and plausible motivation for the exclusion of Dubek. Defendants have also submitted evidence that Roche was an experienced inventor who understood his duty of candor before the PTO. Although in the aggregate this evidence does not support a strong inference of intent, it is sufficient to create an issue of fact warranting trial. See, e.g., Digital Control, 437 F.3d at 1320 (affirming district court's finding of intent in part because the inventor was "extremely experienced" and "had a motive to mislead the PTO"). Accordingly, Plaintiffs motion for summary judgment on the inventorship-related inequitable conduct counterclaim is denied.
IV. `072 Patent Rotogranulation Method
Defendants allege that Plaintiffs failed to enable the `340 patent, and concealed the `340 patent's best mode, by omitting the `072 rotogranulation method from the `340 patent. Defendants also allege that this non-disclosure constitutes inequitable conduct.
A. Enablement
Section 112, paragraph 1, provides:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.35 U.S.C. § 112.
The enablement requirement demands that the patent specification allow "those skilled in the art to make and use the invention as broadly as it is claimed without undue experimentation." In re Cortright, 165 F.3d 1353, 1356 (Fed. Cir. 1999). The fact that some experimentation is necessary does not preclude enablement, but if unduly extensive experimentation is necessary, the claim will fail. W.L. Gore Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1557 (Fed. Cir. 1983). The Federal Circuit has held:
It is true . . . that a specification need not disclose what is well known in the art. However, that general, oft-repeated statement is merely a rule of supplementation, not a substitute for a basic enabling disclosure. It means that the omission of minor details does not cause a specification to fail to meet the enablement requirement. However, when there is no disclosure of any specific starting material or any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art.Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997) (internal citations omitted).
Defendants allege that the `340 patent is not enabled unless it describes a method for "completely" coating the famotidine granules. (Counterlcaim ¶¶ 24-25.) Defendants further assert that the rotogranulation method described in the `072 patent is required to achieve such a "complete" coating. (Counterclaim ¶¶ 22, 25.) Plaintiffs purportedly failed to enable the `340 patent pursuant to § 112 because the `072 rotogranulation method is not described in the `340 patent.
During claim construction, Defendants urged this Court to define "impermeably coated famotidine granules" to mean granules with coating that is "completely impermeable to the antacid and prevents any contact or interaction between any of the famotidine and any of the antacid." McNeil, 443 F. Supp. 2d at 510. This Court rejected Defendants' proposed construction, holding that "the specification reveals that the inventors contemplated at least some interaction between the famotidine and the antacids."McNeil, 443 F. Supp. 2d at 510. The Court determined that "Perrigo's proposed construction also contradicts the principle that claims be construed in the way that one of ordinary skill in the art would understand them" because "Plaintiffs asserted, without objection from Defendants, that the coating procedures identified by the parties cannot achieve 100% coating on each famotidine granule." McNeil, 443 F. Supp. 2d at 511.
"[I]n keeping with the statutory mandate, [the] precedent is clear that the parameters of a section 112 inquiry are set by the claims." Bayer AG v. Schein Pharma., Inc., 301 F.3d 1306, 1315 (Fed. Cir. 2002) (quoting Zygo Corp. v. Wyko Corp., 79 F.3d 1563, 1567 (Fed. Cir. 1996)). In analyzing a § 112 allegation, the Court is guided by its construction of the claims. Abbott Labs. v. Torpharm, Inc., 300 F.3d 1367, 1378 (Fed. Cir. 2002). This Court has unequivocally held that the `340 claims allow for some imperfections in the coating of famotidine granules. Yet Defendants contend that the claims are not enabled unless a flawless coating is achieved. The contention is frivolous. Moreover, even if a perfect coating were required to enable the `340 patent, Defendants have failed to demonstrate that the `072 patent claims such a coating. Indeed, despite numerous opportunities over the course of this litigation, Defendants have identified no coating method that is capable of applying a perfect coating to the famotidine. For these reasons, summary judgment is appropriate dismissing Defendants' `072 rotogranulation method enablement counterclaim.
B. Best Mode
A patent's specification must "set forth the best mode contemplated by the inventor of carrying out his invention." 35 U.S.C. § 112. Thus, if an inventor has a way of practicing the invention that is better than all other ways, it must be disclosed in the patent specification. See N. Telecom Ltd. v. Samsung Elecs. Co., 215 F.3d 1281, 1286 (Fed. Cir. 2000). The quid pro quo nature of the patent system underlies the best mode requirement; an invention is protected by a patent in exchange for public disclosure of the best mode of practicing the invention. Eli Lilly Co. v. Barr Labs., Inc., 251 F.3d 955, 963 (Fed. Cir. 2001). "`[T]he best mode requirement . . . is intended to ensure that a patent applicant plays fair and square with the patent system'" and does not "conceal from the public preferred embodiments of [his] invention which [he] ha[s] in fact conceived." Evans Med. Ltd. v. Am. Cyanamid Co., 11 F. Supp. 2d 338, 359 (S.D.N.Y. 1998) (quoting Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1209-10 (Fed. Cir. 1991)).
Assessing compliance with the best mode requirement requires a two-pronged factual inquiry. First, it must be determined whether the inventor had a best mode of practicing the invention when the patent application was filed. Nobelpharma AB v. Implant Innovations, Inc., 141 F.3d 1059, 1064 (Fed. Cir. 1998); United States Gypsum Co. v. Nat'l Gypsum Co., 74 F.3d 1209, 1212 (Fed. Cir. 1996). This is a subjective inquiry, which focuses on "the inventor's state of mind at the time of filing." Eli Lilly, 251 F.3d at 963. Second, it must be determined whether the best mode was disclosed in sufficient detail to allow a person of ordinary skill in the art to practice it. Nobelpharma, 141 F.3d at 1064;United States Gypsum, 74 F.3d at 1212. This inquiry is objective and looks to the "scope of the claimed invention and the level of skill in the art." Eli Lilly, 251 F.3d at 963.
There is evidence to support Defendants' contention that the inventors considered the `072 rotogranulation method involving a small particle size, binder and carrier to be the best mode for preparing famotidine granules. According to documents that Plaintiffs submitted to the Examiner during the prosecution of the `072 patent:
Applicants' discovery is that by using a fine particulate (from 5 to 75 microns) carrier with a particulate medicament and binder that spherical granules may be formed. These granules are particularly easy to coat with a suitable coating composition thereby providing stable coated granules, which can be formed into chewable tablets . . . [T]he use of larger carriers produces granules that are not well suited to being coated for taste masking of a medicament . . .
(Underwood Decl. Ex. U at 20156.) The "discovery" of the method was presented to the Examiner as a basis for acceptance of the `072 patent. (Underwood Decl. Ex. U at 20156.)
Also, Decoteau — a named inventor of both the `072 and the `340 patents — submitted a declaration to `072 Examiner asserting that "[g]ranules produced with fine particulate carriers [like those claimed in the `072 patent] provide superior taste masking." (Underwood Decl. Ex. H: Declaration of Susan Papile, dated Mar. 10, 1992 ("Papile Decl.") ¶ 6.) This level of taste masking is achieved through superior coating. (Papile Decl. ¶¶ 4-7.) Because the `340 patent is based on separating famotidine and antacids using a coating, the factfinder could conclude that the `340 inventors believed that ideal separation is achieved using the `072 method. Further, the parties do not dispute that the particulars of the `072 method are absent from the `340 patent's specification. Defendants have therefore raised genuine issues of disputed fact regarding the alleged best mode violation. See Nobelpharma, 141 F.3d at 1066; N. Telecom, Inc. v. Datapoint Corp., 908 F.2d 931, 940-41 (Fed. Cir. 1990). Likewise, "[b]ecause disclosure of the best mode is statutorily required . . . failure to disclose the best mode is inherently material and . . . reaches the minimum level of materiality necessary for a finding of inequitable conduct." Old Town Canoe Co. v. Confluence Holdings Corp., 448 F.3d 1309, 1322 (Fed. Cir. 2006) (quoting Consol. Aluminum, 910 F.2d at 808).
Plaintiffs contend that the `072 method of using small particles in a rotogranulation process was merely a routine detail in the art when the `340 application was filed. "[T]he best mode requirement does not extend to `routine details' apparent to one of ordinary skill in the art." Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1331-32 (Fed. Cir. 2002); see also Young Dental Mfg. Co. v. Q3 Special Prods., Inc., 112 F.3d 1137, 1144 (Fed. Cir. 1997). "Because routine details are apparent to one of ordinary skill, they need not be disclosed."Young Dental, 112 F.3d at 1144. Citing the deposition testimony of Metin Celik, Defendants' granulation expert, Plaintiffs contend that a person of skill in the art could create substantially spherical famotidine granules without reference to the `072 patent. (Kiel Decl. Ex. 5: Transcript of Deposition of Metin Celik, dated Aug. 18, 2006, at 154-56.) Yet a best mode defect is not cured "merely because a technique is generally known in the art . . ." Wahl Instr., Inc. v. Acvious, Inc., 950 F.2d 1575, 1580 (Fed. Cir. 1991); see also Dana Corp. v. IPT Ltd. P'ship, 860 F.2d 415, 420 (Fed. Cir. 1988) (invalidating patent for best mode violation even when undisclosed method was known in the art). While Plaintiffs argue that one of skill in the art was capable of producing spherical famotidine granules, there are disputed issues of fact regarding whether the `072 rotogranulation method is uniquely advantageous for producing spherical granules.
Finally, Plaintiffs assert that in March 1992, the inventors published a foreign counterpart to the `072 patent with the European Patent Office. (Kiel Decl. Ex. 10.) Because this happened before the `340 patent application was filed, Plaintiffs contend that the failure to disclose the `072 rotogranulation method in the `340 patent was neither material nor intentional. However, "whether the inventor concealed [the best mode] is a function of . . . how one skilled in the art would have understood his disclosure." Chemcast Corp. v. ARCO Indus. Corp., 913 F.2d 923, 927 (Fed. Cir. 1990). In the context of a § 112 challenge, merely publishing a patent application in Europe is not necessarily sufficient to notify a person skilled in the art of the invention. See In re Howarth, 654 F.2d 103, 107 (C.C.P.A. 1981) (holding that disclosure of information in Rhodesia, Panama and Luxembourg was insufficient to enable a patent under § 112);cf. Ajinomoto Co. v. Archer-Daniels-Midland Co., 228 F.3d 1338, 1346 (Fed. Cir. 2000) (no best mode violation because the evidence at trial showed that one of ordinary skill in the art would have known the purported best mode that was disclosed in a scientific publication). There are disputed issues of fact regarding whether publishing the `072 patent in Europe was sufficient to render the information contained therein immaterial to a reasonable patent examiner.
Similarly, regarding scienter, if the inventors determined that a disclosure of the `072 patent in Europe might go undetected by one of skill in the art in the United States, then nothing about that disclosure would negate Plaintiffs' alleged intent to deceive the Examiner. Defendants have proffered sufficient evidence from which a reasonable factfinder could infer a threshold level of intent. The same inventors are responsible for the `072 and the `340 patents. These inventors were thus "intimately familiar" with the `072 rotogranulation method, and there are disputed issues of fact regarding whether they understood the materiality of that method. Critikon, Inc. v. Becton Dickinson Vascular Access, Inc., 120 F.3d 1253, 1256-57 (Fed. Cir. 1997) (intent may be inferred where inventors were "intimately familiar" with, and understood the materiality of, an undisclosed reference); see also Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 1239-42 (Fed. Cir. 2003) (same); Baxter Int'l, Inc. v. McGaw, Inc., 149 F.3d 1321, 1329-30 (Fed. Cir. 1998) (same); Labounty Mfg., Inc. v. Int'l Trade Commission, 958 F.2d 1066, 1076 (Fed. Cir. 1992) (same).
For these reasons, summary judgment is denied with respect to Defendants' best mode counterclaims.
V. Yamanouchi Report
Defendants allege that Plaintiffs' failure to disclose the Yamanouchi report constitutes inequitable conduct. This is because the `340 patent was granted based on the Roche declaration, which set forth "unexpected" data regarding famotidine degradation in the solid form. McNeil, 443 F. Supp. 2d at 498. The degradation resulted from hydrolysis. (Def. 56.1 Stmt. ¶ 87.) When Plaintiffs submitted their unexpected results to the Examiner, they had already received the Yamanouchi report, which disclosed famotidine degradation due to hydrolysis in an aqueous solution. Defendants assert that the hydrolysis of famotidine in an aqueous solution suggests that famotidine may hydrolyze in a tablet as well. Therefore, Defendants claim that the results disclosed in the Roche declaration were not "unexpected," and that the Examiner would not have allowed the `340 patent based on the Roche declaration had she known about the Yamanouchi report.
The parties dispute the materiality of the Yamanouchi report. Regardless of the report's materiality, however, Perrigo has failed to make the required showing that the `340 patent's inventors intended to deceive the Examiner. N. Telecom, Inc., 908 F.2d at 940 ("[W]e need not reach the question of materiality, for absent the element of intent the [district] court's holding of inequitable conduct was legal error.") Intent to deceive cannot be inferred from an omission alone. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 1001 (Fed. Cir. 2006); Abbott Labs., 300 F.3d at 1380; N. Telecom, Inc., 908 F.2d at 940. And Perrigo mischaracterizes the evidence it proffers to show the inventors' intent. Quoting Roche's deposition testimony, Perrigo contends that "at least one of the inventors [of the `340 patent] expected that `there would be issues' with the stability of famotidine in developing the alleged invention of the `340 patent" based on his knowledge of the Yamanouchi report. (Def. 56.1 Stmt. ¶ 100.) Yet the testimony identified by Perrigo does not pertain to the solid dosage form claimed in the `340 patent. Roche was asked by Perrigo's attorney "what made those other dosage forms problematic," referring to dosage forms other than the solid form. (Roche Dep. at 98 (emphasis added).) Roche responded as follows:
Well, with the liquid form, as I said, there was some data, proprietary data from Yamanouchi indicated that famotidine had limited stability in aqueous media. Generally, most liquid products, OTC products and Rx products contain water. So we — there was some expectation based on that proprietary that there would be issues.
(Roche Dep. at 98-99.) Clearly, Roche's "expectation . . . that there would be issues" refers only to a liquid mixture of famotidine and antacids. Perrigo has identified no evidence that Plaintiffs or the `340 patent's inventors considered the Yamanouchi report relevant to the solid dosage form. Because the `340 patent claims only a solid form, summary judgment is appropriate with respect to the counterclaim based on non-disclosure of the Yamanouchi report.
Perrigo also mentions the research paper Dubek submitted to his professor in 1991. (Underwood Decl. Ex. S.) Although Dubek's paper cites the Yamanouchi report, it does not explain how the report predicts the level of famotidine degradation that was revealed in the Roche declaration. This is crucial because, from the perspective of the PTO, the unexpected aspect of Roche's declaration was not the mere presence of famotidine degradation, but the amount of degradation that was observed in comparison to previous experiments. The reference to the Yamanouchi report in Dubek's paper is insufficient to meet the threshold of materiality or intent required to show inequitable conduct.
In its opposition brief, Perrigo suggests that the Yamanouchi report renders the `340 patent invalid on obviousness grounds. Yet the Yamanouchi report, which focuses on data from an aqueous solution, would, at most, motivate one of skill in the art to conduct further investigation of the hydrolysis of famotidine in the solid form. Plaintiffs argue that the mere suggestion in the prior art that further research is necessary is insufficient as a matter of law to establish obviousness under 35 U.S.C. § 103.See, e.g., Gillette Co. v. S.C. Johnson Son, Inc., 919 F.2d 720, 725 (Fed. Cir. 1990). Perrigo ignores Plaintiffs' contention and, therefore, the argument is deemed conceded. See Jessamy v. City of New Rochelle, 292 F. Supp. 2d 498, 515 n. 21 (S.D.N.Y. 2003).
VI. PVP
The `340 patent's specification lists 23 suitable coatings for the famotidine granules. (`340 patent col. 7, ln. 52 — col. 8, ln. 27.) Four of these coatings contain PVP, a substance which, according to Perrigo, degrades famotidine. Perrigo alleges that since the `340 patent's invention was the prevention of famotidine degradation through an impermeable coating, use of a coating which itself degrades famotidine renders the patent non-enabled under § 112 and constitutes inequitable conduct.
Plaintiffs counter that Defendants must show "that all of the disclosed alternative modes are insufficient to enable the claims" in order to invalidate the patent for lack of enablement.Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1361 (Fed. Cir. 1998); see also Durel Corp. v. Osram Sylvania, Inc., 256 F.3d 1298, 1308 (Fed. Cir. 2001) ("If the disclosure enables a person of ordinary skill in the art to make a particular metal oxide coating from at least one of the suggested precursors, the enablement requirement for that oxide coating is satisfied."). Thus, "[t]he enablement requirement is met if the description enables any mode of making and using the invention." Johns Hopkins, 152 F.3d at 1361 (internal quotations omitted). The majority of the coatings specified in the `340 patent do not include PVP. Plaintiffs argue that as a result, the `340 patent is enabled, and Defendants have failed to demonstrate that inclusion of PVP in the `340 patent is material.
Defendants do not respond to Plaintiffs' argument in their opposition brief. At the prompting of the Court, Perrigo's counsel did purport to address Johns Hopkins at oral argument. However, Perrigo's response was unclear and appeared to treat its PVP counterclaim in terms of best mode rather than enablement. (Tr. at 56.) The response is therefore inapposite. "Federal courts may deem a claim abandoned when a party moves for summary judgment on one ground and the party opposing summary judgment fails to address the argument in any way." Jessamy, 292 F. Supp. 2d at 515 n. 21 (internal quotations omitted); see also Sylvester v. City of New York, 385 F. Supp. 2d 431, 441 (S.D.N.Y. 2005) (granting defendant's motion for summary judgment where "[t]he plaintiffs failed to respond to the defendants' argument");Charlotten v. May Dep't Stores Co., No. 97 Civ. 8962 (HB), 1998 WL 635547, at *4 (S.D.N.Y. Sept. 16, 1998) (granting summary judgment on a claim when the non-movant failed to address arguments raised in the movant's brief).
CONCLUSION
For the foregoing reasons, Plaintiffs' motion for summary judgment is granted in part and denied in part. Specifically, Plaintiffs' motion is granted with respect to Defendants' `072 rotogranulation method enablement, Yamanouchi report and PVP-related counterclaims. Plaintiffs' motion is denied with respect to Defendants' `072 rotogranulation best mode and inventorship-related counterclaims.SO ORDERED.