Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Horizon Pharma, Inc. v. Dr. Reddy's Laboratories, Inc.

United States District Court, D. New Jersey

July 10, 2017

HORIZON PHARMA, INC. and POZEN INC., Plaintiffs,
v.
DR. REDDY'S LABORATORIES, INC., et al., Defendants.

          REDACTED AMENDED MEMORANDUM OPINION

          MARY L. COOPER, United States District Judge.

         I. Background .............................................................................................................................. 2

         II. Legal Standards ....................................................................................................................... 6

         A. Infringement ......................................................................................................................... 6

         B. Written Description .............................................................................................................. 7

         C. Enablement / Utility ............................................................................................................. 8

         D. Obviousness ......................................................................................................................... 9

         III. Infringement and Related § 112 Challenges to the '285 Patent ...................................... 10

         A. Written Description (Uncoated Naproxen) ...................................................................... 11

         B. Written Description (Sustained Release Formulations) ................................................... 23

         C. Infringement ....................................................................................................................... 27

         IV. Obviousness and Related § 112 Challenges ..................................................................... 31

         A. Obviousness ....................................................................................................................... 31

         B. Enablement ......................................................................................................................... 59

         C. Written Description (Uncoated PPI) ................................................................................. 62

         V. Conclusion ............................................................................................................................. 65

         I. Background

         This is a patent dispute between Plaintiffs Horizon Pharma, Inc. and Pozen Inc. (together, “Horizon”) and two groups of generic drug manufacturers: (1) Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd. (“DRL”); and (2) Mylan, Inc.; Mylan Pharmaceuticals Inc.; and Mylan Laboratories Ltd. (“Mylan, ” and together with DRL, “Defendants”). Horizon holds New Drug Application (“NDA”) No. 022511 for Vimovo, a branded drug product whose active pharmaceutical ingredients are naproxen and esomeprazole magnesium. (Dkt. 421 at 6.)[1]

         This case arises out of Defendants' submission of Abbreviated New Drug Applications (“ANDAs”) to the FDA pursuant to the Hatch-Waxman Act, 21 U.S.C. § 355(j), for the purpose of obtaining FDA approval for the commercial manufacture, use, import, offer for sale, and sale of a generic version of Vimovo. Specifically, DRL filed ANDA No. 202461 (“DRL ANDA I”) and ANDA No. 204206 (DRL ANDA II”). Mylan filed ANDA No. 204920 (“Mylan ANDA”). Based on submissions by the parties in the pre-trial order, all three ANDAs relate to tablets containing 375 mg or 500 mg of naproxen and 20 mg esomeprazole magnesium. (Dkt. 421 at 7-8.)[2] All three ANDAs included so-called “Paragraph IV” certifications that the products would not infringe Horizon's patents and/or that those patents are invalid or unenforceable. (Id.) The Paragraph IV certifications covered U.S. Patent No. 6, 926, 907 (“the '907 patent”) and No. 8, 557, 285 (“the '285 patent”) (together, the “Asserted Patents”). In response to those Paragraph IV certifications, Horizon asserted infringement of claims 5, 15, 52, and 53 of the '907 patent.[3] Horizon has also asserted claims 1 through 4 of the '285 patent.[4]

         Mylan has stipulated that its ANDA product would infringe the Asserted Patents. (Dkt. 421 at 8.) DRL has admitted that its DRL ANDA I Product would infringe the Asserted Patents. (Id.) We previously granted summary judgment in DRL's favor that its ANDA II Product does not infringe the '907 patent. (Dkt. 380). Accordingly, the only infringement dispute at trial was whether DRL's ANDA II Product infringes the '285 patent. Most of the trial was focused on Defendants' contentions that claims in the Asserted Patents are invalid under 35 U.S.C. § 103 and/or § 112.

         We held a six day bench trial on those issues from January 12-20, 2017 and heard closing arguments on May 17, 2017.[5] We heard live testimony from seven witnesses. Dr. John Plachetka, called by Horizon, was the named inventor on the Asserted Patents. (Tr. 15- 192.) Dr. David Metz, called by Defendants, was qualified as an expert in gastroenterology, including the treatment of acid peptic disorder. (Tr. 260-396.) Dr. Arthur Kibbe, called by Defendants, was qualified as an expert in pharmaceutical formulation and development. (Tr. 408-565.) Dr. Michael Mayersohn, called by Defendants, was qualified as an expert on pharmacokinetics and pharmacodynamics. (Tr. 569-603; Tr. 610-707.) Dr. Robert Williams, III, called by Horizon, was qualified as an expert in pharmaceutical formulation. (Tr. 716-842; Tr. 849-1017.) Dr. David Taft, called by Horizon, was qualified as an expert in pharmacokinetics. (Tr. 1018-1102.) Dr. David Johnson, called by Horizon, was qualified as an expert in gastroenterology. (Tr. 1108-1266.) The parties also submitted designated deposition testimony from Brian Ault (DTX-1393); Mark Sostek (DTX-1396); Jeff Sherman (DTX-1397); Dennis McNamara (DTX-1398); Abhijit Desmukh (PTX-581); John Horn (PTX-582); T. Sudhakar Koudinya (PTX-583); Snehalatha Movva (PTX-584); and Badri Viswanathan (PTX-585).[6]

         This opinion follows the parties' division of the relevant legal issues raised at trial and addresses the interrelated infringement and § 112 issues in Section III, infra, and the interrelated obviousness and § 112 issues in Section IV, infra. In support of their arguments, Horizon and Defendants submitted separate post-trial briefs on the issues addressed in Section III (dkt. 489-2; dkt. 489-3) and Section IV (dkt. 489; dkt. 489-1).

         For the reasons below, we conclude that DRL's ANDA II Product infringes the '285 patent and that the asserted claims are not invalid under 35 U.S.C. § 103 and/or § 112. Accordingly, we will grant judgment in Horizon's favor and issue an appropriate order.

         II. Legal Standards

         A. Infringement

         The standard for patent infringement is set forth in 35 U.S.C. § 271, which states that “whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.” 35 U.S.C. § 271(a). The burden to prove infringement rests with the patentee who must prove infringement by a preponderance of the evidence. Medtronic, Inc. v. Mirowski Family Ventures, LLC, 134 S.Ct. 843, 846 (2014). To prove infringement, the patentee must show that an accused product is within the claim limitations of the patent-in-suit either literally or under the doctrine of equivalents. See Warner Jenkinson Co., Inc. v. Hilton Davis Chem. Co., 520 U.S. 17, 21 (1997); Amgen Inc. v. F. Hoffman La Roche Ltd., 580 F.3d 1340, 1374 (Fed. Cir. 2009). In a Hatch-Waxman case, the actual act of infringement is the filing of an ANDA to obtain approval to engage in the commercial manufacture, use, or sale of a patented drug or method of use. 35 U.S.C. § 271(e)(2). Specifically, § 271(e)(2)(A) provides that it shall be an act of infringement to submit an ANDA “if the purpose of such submission is to obtain approval . . . to engage in the commercial manufacture, use, or sale of a drug . . . claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.”

         The infringement analysis is a two-step process in which we must: (1) determine the scope and meaning of the disputed patent claim terms; and (2) compare the properly construed claims to the allegedly infringing product or device. Advanced Steel Recovery, LLC v. X-Body Equip., Inc., 808 F.3d 1313, 1316 (Fed. Cir. 2015).

         B. Written Description

         A patent specification must contain “a written description of the invention.” 35 U.S.C. § 112(a). To satisfy that requirement, “the specification must describe an invention understandable to [a] skilled artisan and show that the inventor actually invented the invention claimed.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). “The purpose of the written description requirement is to prevent an applicant from later asserting that he invented that which he did not.” Amgen Inc. v. Hoechst Marion Roussel, 314 F.3d 1313, 1330 (Fed. Cir. 2003). The requirement thus mandates that the applicant “recount his invention in such detail that his future claims can be determined to be encompassed within his original creation.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1561 (Fed. Cir. 1991).

         The “hallmark of written description is disclosure, ” and the test for its sufficiency is “whether the disclosure . . . reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad, 598 F.3d at 1351. “It is the specification itself that must demonstrate possession” and analysis of the adequacy of the written description “requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. at 1351-52. The disclosure must “allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.” Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002).

         “There is no rigid requirement that the disclosure contain ‘either examples or an actual reduction to practice.'” Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1308 (Fed. Cir. 2015) (quoting Ariad, 598 F.3d at 1352). Rather, “the proper inquiry is whether the patentee has provided an adequate description that ‘in a definite way identifies the claimed invention' in sufficient detail such that a person of ordinary skill would understand that the inventor had made the invention at the time of filing.” Id. at 1308. Moreover, “an applicant is not required to describe in the specification every conceivable and possible future embodiment of his invention.” See Cordis Corp. v. Medtronic AVE, Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003). The challenging party must show lack of adequate written description by clear and convincing evidence to rebut the patent's presumption of validity. Alcon Research Ltd. v. Barr Labs., Inc., 745 F.3d 1180, 1188- 91 (Fed. Cir. 2014).

         C. Enablement / Utility

         35 U.S.C. § 112 requires applicants to describe the manner of making and using the invention “in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the same . . . .” The Federal Circuit has explained that “the how to use prong of section 112 incorporates as a matter of law the requirement of 35 U.S.C. § 101 that the specification disclose as a matter of fact a practical utility for the invention.” Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1323 (Fed. Cir. 2005) (citing In re Cortright, 165 F.3d 1353, 1356 (Fed. Cir. 1999)). As a result, “an applicant's failure to disclose how to use an invention may support a rejection under . . . section 112 . . . when there is a complete absence of data supporting the statements which set forth the desired results of the claimed invention.” Id. (internal quotations omitted). Conversely, “a specification disclosure which contains a teaching of the manner and process of making and using the invention . . . must be taken as in compliance with the enabling requirement of the first paragraph of [section] 112 unless there is reason to doubt the objective truth of the statements contained therein which must be relied on for enabling support.” Id. The challenging party bears the burden of showing by clear and convincing evidence that the specification lacks adequate enablement. ALZA Corp. v. Andrx Pharms., 603 F.3d 935, 940 (Fed. Cir. 2010).

         D. Obviousness

         Under 35 U.S.C. § 103, a “patent may not be obtained . . . if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.” “Obviousness is a question of law, which depends on several underlying factual inquiries.” See Senju Pharm. Co. v. Apotex Inc., 717 F.Supp.2d 404, 418 (D. Del. 2010), aff'd, 485 Fed. App'x 433 (Fed. Cir. 2012). Those inquiries include the scope and content of the prior art, differences between the prior art and the claims at issue, and the level of ordinary skill in the pertinent art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) (quoting Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966)). We also consider as part of the obviousness analysis “secondary considerations, ” including commercial success, long felt but unsolved needs, and failure of others. Id. “A nonmovant may rebut a prima facie showing of obviousness with objective indicia of nonobviousness.” Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1311 (Fed. Cir. 2006). “Although secondary considerations must be taken into account, they do not necessarily control the obviousness conclusion.” In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011).

         “[A] patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” Id. at 418; see also Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011). Instead, proof of obviousness requires proof that a person of ordinary skill in the art (“POSA”) “would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and . . . would have had a reasonable expectation of success in doing so.” Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009). A POSA would interpret prior art references “using common sense and appropriate perspective.” Unigene Labs., 655 F.3d at 1361. The party challenging the validity of the patent must prove obviousness by clear and convincing evidence. See Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 719 F.3d 1346, 1352 (Fed. Cir. 2013)

         III. Infringement and Related § 112 Challenges to the '285 Patent

         The only infringement question at trial was whether DRL's ANDA II Product infringes claims 1, 2, 3, and 4 of the '285 patent. See Section I, supra. Horizon submitted evidence that DRL's ANDA II Product satisfies each limitation of the asserted claims. In response, Defendants offer a pair of arguments in the alternative. One argument (and, per Defendants, the “better decision” for us to reach) is that the asserted '285 patent claims are invalid for lack of written description on two distinct grounds. The other is that DRL's ANDA II Product cannot infringe the '285 patent if we construe the claims such that they survive the written description challenges. In this section, we reject both written description challenges and conclude that DRL's ANDA II Product infringes the '285 patent.

         A. Written Description (Uncoated Naproxen)

         Defendants' first written description challenge involves two primary contentions. First, Defendants contend that claim 1 of the '285 patent encompasses formulations that include naproxen that is released immediately. Second, they contend that the '285 patent specification discloses a coordinated release product that does not permit the immediate release of naproxen. This purported disconnect between the scope of the claims and the specification forms the basis of the written description challenge. This section consequently proceeds in two parts. First, we review the parties' evidence and arguments related to the scope of the '285 patent claims and the written description of the invention in the '285 patent specification. Second, we assess whether the '285 patent claims are adequately described by the patent specification under the applicable legal standards.

         1. Parties' Evidence and Arguments

         (i) Scope of the '285 patent claims

         Claim 1 of the '285 patent reads:

A pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of:
(a) esomeprazole, wherein at least a portion of said esomeprazole is not surrounded by an enteric coating; and
(b) naproxen surrounded by a coating that inhibits its release from said unit dosage form unless said dosage form is in a medium with a pH of 3.5 or higher; wherein said unit dosage form provides for release of said esomeprazole such that upon introduction of said unit dosage form into a medium, at least a portion of said esomeprazole is released regardless of the pH of the medium.

('285 patent at col. 22, lines 8-14.)

         Any product alleged to infringe claim 1 must, of course, satisfy the enteric coated naproxen claim limitation set forth in subsection (b). The question before us is the scope of claim 1 as it pertains to uncoated naproxen that may be released into the body immediately regardless of pH level.[7] The plain language of claim 1 does not explicitly restrict the amount of uncoated naproxen that may be present in the claimed formulation and indeed the parties agree that the claim encompasses formulations that have at least some uncoated naproxen. The real dispute between the parties is whether claim 1 limits how much uncoated naproxen may be present in the claimed formulation. Broadly, Defendants urge us to adopt the “plain meaning” of the claim, which “imposes no limitation on the amount of naproxen that may be outside the enteric coating.” (Dkt. 489-2 at 12.) Horizon argues that the claim covers formulations that contain uncoated naproxen so long as it is less than a “therapeutically effective amount.”[8] (Dkt. 489-3 at 16-17.)

         Defendants' proposed reading of claim 1 is straightforward: the plain language of the claim imposes no limitation on the amount of uncoated naproxen that may be present in claimed formulations, and it would be improper to read in such a limitation. (Dkt. 489-2 at 12-14.) Defendants argue that a POSA “would recognize that any amount of naproxen outside the enteric coating (and that could fit in a “unit dosage form”) would be covered by the '285 patent claims.” (Id. at 12.) They note that Horizon expert Dr. Williams testified that a POSA would understand the term “comprising” to permit the inclusion of additional elements. (Id.; Tr. 821:6-25.) Dr. Williams also explained, in his infringement analysis, that he could “ignore” uncoated naproxen given the “comprising” language. (Tr. 855:12-24.)

         Defendants submit that their interpretation is consistent with the history of the '285 patent because Horizon deliberately removed the claim limitation related to uncoated naproxen. (Dkt. 489-2 at 8-9.) As Defendants explain, the '285 patent differs somewhat from the earlier-issued '907 patent. Claim 1 of the '907 patent restricts the amount of uncoated naproxen that may be present by requiring NSAID surrounded by a coating that prevents the release of “essentially any NSAID . . . unless the pH of the surrounding medium is 3.5 or higher.” ('907 patent at col. 20, lines 8-32.) Allegedly to avoid infringement of the '907 patent, DRL formulated its ANDA II Product with some naproxen outside of the enteric coated core of the tablet. (Dkt. 489-2 at 7.) As part of this litigation, we previously construed the term “essentially any NSAID” to mean “the minimum amount of NSAID released by an enteric coated dosage form, or tablet.” (Dkt. 380 at 18-22.) Because DRL's ANDA II product [redacted], we concluded that DRL's ANDA II Product does not infringe the '907 patent. (Id. at 22-23.) Horizon was later granted the '285 patent, which does not contain the “essentially any NSAID” language that formed the basis of our non-infringement finding for the '907 patent.

         Horizon disagrees with Defendants' proposed reading of claim 1 of the '285 patent, and urges us to interpret the claim to limit the amount of permissible uncoated naproxen to less than a “therapeutic amount.”[9] Dr. Williams testified that a POSA would understand the claim to allow only “less than a therapeutic amount” of uncoated naproxen. (Tr. 821:15-822:7.) Horizon also points to a decision from the Patent Trial and Appeal Board (“PTAB”) denying Inter Partes review of the '285 patent and purportedly supporting Horizon's “therapeutic amount” limitation.[10] The PTAB concluded that claim 1 of the '285 patent “does not exclude the presence of additional naproxen outside of the coating” and “does not exclude a unit dosage form that has an amount of naproxen outside the coating that is not therapeutically effective.” (PTX-351 at 13.) Consequently, the PTAB rejected the argument that claim 1 “encompass[ed] a composition where the vast majority of the naproxen, i.e., a therapeutically effective amount, would be outside the coating.” (PTX-351 at 12.)

         Defendants argue that Horizon's proposed therapeutic amount limitation is inconsistent with an FDA Citizen's Petition filed by Horizon. (Dkt. 489-2 at 26-27; DTX-1248.) In that petition, Horizon argued to the FDA that “locating any naproxen outside the enteric coated core will result in the immediate release of at least some portion of the naproxen at the same time as esomeprazole is released. Any portion of the generic product's naproxen that is released prematurely in the stomach will act both topically and systemically without the benefit of the raised gastric pH produced by the esomeprazole component.” (DTX-1248 at 7 (emphasis added).) In the same petition, Horizon argued that esomeprazole/naproxen combination tablets with uncoated naproxen “could subject patients to significantly increased risk of potentially fatal side effects.” (DTX-1248 at 7; Tr. 436:19-437:5.) Because Horizon has separately argued to the FDA that any amount of uncoated naproxen might pose a safety risk, Defendants claim that Horizon's therapeutic amount limitation is not credible. Defendants further argue that a therapeutic amount limitation does not make sense because the FDA rejected the notion that the sequential release of esomeprazole and naproxen in Vimovo is clinically significant. (DTX-1250 at 7; Tr. 358:11-23; Tr. 462:10-23.)

         Defendants also ask us to reject Horizon's proposed therapeutic amount limitation because it was not raised during discovery. (Dkt. 489-2 at 18.) Dr. Williams did not explicitly propose a therapeutic amount limitation in his deposition. Instead, Dr. Williams testified at his deposition that some amount of naproxen outside of an enteric coating might pose a safety issue but did not quantify how much. (Tr. 855:19-858:11.) Moreover, Defendants claim that Horizon “admitted” that the “plain meaning of the '285 patent claims applied and they had no limitation on the amount of naproxen that could be outside of an enteric coating.” (Id. at 15.) They point to statements in Horizon's invalidity contentions that “the disclosed dosage forms [in the '285 patent] may include additional naproxen outside the coating.” (DTX-1333 at 48-49.)

         Horizon in turn rejects the relevance of its Citizen's Petition to understanding the scope of the '285 patent claims. They argue that the relevant time period for our analysis is the priority date, and that any statements made in the Citizen's Petition (which was submitted years later) should not bear on our analysis. (Dkt. 489-3 at 25.) Horizon also notes that its Citizen's Petition merely “requested that the FDA require testing to ensure that products containing non-enteric coated naproxen were as safe as those that contained only enteric coated naproxen.” (Id.; DTX-1248 at 2.)

         (ii) Invention as described

         Defendants submit that the '285 patent specification discloses a “coordinated release” product that does not immediately release any NSAID (e.g., naproxen). The first part of Defendants' argument-that the '285 patent specification discloses a coordinated release product-is not particularly controversial. The title of the '285 patent is “Pharmaceutical Compositions for the Coordinated Delivery of NSAIDS” and the patent itself notes that the invention is directed to “pharmaceutical compositions that provide for the coordinated release of an acid inhibitor and an [NSAID] . . . .” ('285 patent at col. 1 lines 20-23.) As explained by defense expert Dr. Kibbe, “coordinated release” is the mechanism by which a formulation achieves “coordinated delivery.” (Tr. 420:11-422:12.)

         Evidence from both sides also indicates that coordinated release refers here to sequential delivery. The '285 patent itself discloses “the coordinated release of therapeutic agents, i.e., for the sequential release of acid inhibitor followed by analgesic.” ('285 patent at col. 6, lines 23-35.) Dr. Kibbe and Horizon expert Dr. Williams both described coordinated release as sequential release. (Tr. 420:20-421:7; Tr. 861:9-12.) The description of the invention offered by the named inventor, Dr. Plachetka, also supports this view. Dr. Plachetka explained that the coordinated delivery is the immediate release of the proton pump inhibitor followed by the release of the NSAID when the pH rises to a certain level. (Tr. 43:22-44:10.) According to Dr. Plachetka, “[t]he whole point of the idea here is to get acid inhibition before the administration of the NSAID . . . .” (Tr. 134:4-5.)

         The parties disagree on Defendants' second contention-namely, that the '285 patent specification does not describe formulations where some naproxen is released immediately. Dr. Kibbe testified that there were no teachings in the '285 patent specification related to formulations where naproxen is released before esomeprazole. (Tr. 431:19-432:5.) He also said that “[t]here is no support for any release of naproxen until the enteric coat comes off.” (Tr. 437:11-17.) In Dr. Kibbe's view, a product that releases even some naproxen early cannot have a coordinated release within the meaning of the patent specification. (Tr. 422:14-423:16.)

         Defendants point to our previous statements regarding the '907 patent specification as evidence of the nature of the invention disclosed in the '285 patent specification. Both Dr. Kibbe and Dr. Williams noted that the specifications of the two patents are essentially the same. (Tr. 419:9-22; Tr. 856:14-17.) We did observe earlier in this litigation discussing the '907 patent:

The ‘907 patent's distinction from prior art is the “coordinated drug release . . . [and reduction of] intragastric acid levels to a non-toxic level prior to the release of NSAID.” The specification does not contemplate an embodiment that releases a small amount of NSAID before the GI tract reaches a pH of 3.5 or above, nor does the specification state that releasing a small amount of NSAID would be “acceptable or part of the invention.”

(Dkt. 380 at 19) (internal citations omitted).[11]

         Defendants also point to Horizon's FDA Citizen's Petition as evidence that the invention disclosed in the '285 patent does not extend to formulations that immediately release some naproxen. In that petition, Horizon told the FDA that a formulation with some uncoated naproxen (i.e., DRL's ANDA II Product) “obviates VIMOVO's careful design and allows release of a measureable amount of naproxen before the gastroprotective benefits of esomeprazole can take effect” and “that VIMOVO's design is intended to produce a sequential delivery of gastroprotective esomeprazole before systemic (or local) exposure to naproxen.” (DTX-1248 at 2, 5.) In Defendants' view, these statements are evidence that Horizon viewed any early release of naproxen as antithetical to the key aspect of the invention-that is, delaying the release of naproxen until after the esomeprazole can take effect. (Dkt. 489-2 at 25-26.) In sum, Defendants argue that coordinated release is the “central feature” of the invention disclosed in the specification and that formulations with uncoated naproxen are “not the invention and even . . . contrary to it.” (Dkt. 489-2 at 19.)

         To illustrate how the '285 patent claims encompass formulations that do not have a coordinated release, Defendants offered an example of a hypothetical product containing a 50 mg naproxen core surrounded by an enteric coating, an esomeprazole layer immediately above, and an outer layer with 49 mg of naproxen. Defendants submit that this product cannot be considered to have a “coordinated release” because nearly half of the naproxen is released immediately. (Dkt. 489-2 at 23.) They argue that such a formulation is fundamentally at odds with what Dr. Plachetka says he invented. (Tr. 134:4-5.)

         Dr. Williams disagreed with Defendants and testified that a formulation with some uncoated naproxen would still have a coordinated release. (Tr. 884:4-12.) Horizon likewise rejects Defendants' use of a hypothetical formulation, which, in their view, “in no way represent[s] any of Defendants' ANDA products” and for which there is no evidence “that a person of skill in the art exercising any sort of reason would actually contemplate making or using them.” (Dkt. 489-3 at 15.) Horizon argues that “even if Defendants' unrealistic, hypothetical embodiments fell within the literal scope of the claims, one of skill in the art would understand them to be unreasonable and inoperable embodiments and would not pursue them.” (Id.)

         2. Analysis

         We turn now to the question of whether the '285 patent claims are adequately described by the '285 patent specification. As summarized above, the parties dispute both the scope of the claimed invention and the adequacy of the written description. As to the scope of the claims, we agree with Defendants that claim 1 of the '285 patent-whose only naproxen-related limitation relates to enteric coated naproxen-does not limit the amount of uncoated naproxen that may be present in claimed formulations.[12] It is well understood in patent law that the term “comprising” does not exclude additional elements in addition to the elements named in the claim. See Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1344-45 (Fed. Cir. 2003) (“Comprising is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.”). The language of the claim itself does not preclude uncoated naproxen. We are not persuaded by Horizon's argument that we should read in a “therapeutic amount” limitation on uncoated naproxen, particularly as that interpretation finds little support in the claim language, specification, or anywhere else. See Omega Eng'g, Inc, v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003) (noting “heavy presumption that claim terms carry their full ordinary and customary meaning” (internal quotations omitted)).

         We disagree with Defendants, however, that the '285 patent specification precludes the inclusion of uncoated naproxen in the formulations it describes. The specification itself is silent on whether the formulation can include uncoated naproxen in addition to the enteric coated naproxen present in the claimed formulation. Defendants point out, fairly, that the '285 patent specification describes a product whose embodiments “preferably” provide for coordinated drug release such that “the acid inhibitor is released first and the release of NSAID is delayed until after the pH in the GI tract is risen.” ('285 patent at col. 4, lines 45-51.) It is likewise true that the specification explains that the invention is at least in part directed toward resolving injuries associated with NSAIDs being released “before the pH of the gastrointestinal tract can be raised . . . .” (Id. at col. 1, lines 60-64.) We agree that these and other statements in the specification might counsel a POSA against incorporating uncoated naproxen when formulating the described invention. Indeed, Horizon expert Dr. Williams expressed skepticism about a hypothetical formulation that contained uncoated naproxen because he did not “know why someone would want to do this” when the patent was “about preventing the release of . . . of the therapeutic amount of NSAID from that enteric coating until the pH is above 3.5.” (Tr. 883:12-24.)

         That the specification can be read to convey a preference for formulations without uncoated naproxen, however, does not warrant invalidating the claims under § 112(a). To hold otherwise would be to invalidate the claims simply because they encompass less preferable embodiments-a reading of § 112(a) that we find incompatible with patent law principles. See, e.g., Cordis Corp. v. Medtronic AVE, Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003) (“an applicant is not required to describe in the specification every conceivable and possible future embodiment of his invention”); Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367, 1371 (Fed. Cir. 2005) (“a patentee typically claims broadly enough to cover less preferred embodiments as well as more preferred embodiments, precisely to block competitors from marketing less than optimal versions of the claimed invention”); Golight, Inc. v. Wal-Mart Stores, Inc., 355 F.3d 1327, 1331-32 (Fed. Cir. 2004) (“An applicant is not necessarily required by 35 U.S.C. § 112 . . . to describe more embodiments than its preferred one, and . . . [it has] outright rejected the notion that disclosure of a single embodiment necessarily limits the claims.”)

         We note that Defendants have offered an unusual written description challenge here that appears to have little support in the law. Rather than allege that a specific element of the claim lacks support in the specification, Defendants argue that the claim is invalid for merely allowing the possibility of the addition of uncoated naproxen in view of the specification. The question of whether a POSA would view the '285 patent specification (and Defendants' other extrinsic evidence) as limiting the plain language of the claim to preclude the presence of uncoated naproxen would seem a more natural fit for claim construction proceedings. The law of written description requires us to evaluate whether the four corners of the specification “reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad, 598 F.3d at 1351-52. Our inquiry is therefore whether the '285 patent specification would reasonably convey to a POSA that Dr. Plachetka had possession of the “invention”-here a combination drug product featuring enteric coated naproxen and an uncoated proton pump inhibitor (“PPI”). As Dr. Williams explained at trial, those elements are indeed present and described in the specification. (Tr. 812:17-824:10.) Whether there is extrinsic evidence, such as Horizon's FDA Citizen's petition, suggesting that the presence of uncoated naproxen was against the spirit of the invention does not bear on our written description analysis. Because Defendants have not demonstrated by clear and convincing evidence that any element of the claimed invention lacks written description support, we decline to invalidate the '285 patent on those grounds.

         B. Written Description (Sustained Release Formulations)

         Defendants' second written description challenge arises out of the use of the term “inhibits” in claim 1 of the '285 patent. In their view, the use of the word “inhibits” extends the scope of the claim to include “sustained release” formulations while the specification discloses only “delayed release” formulations. As above, we first review the parties' evidence and arguments related to the scope of the claims and the description in ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.