Horizon Pharma, Inc. v. Dr. Reddy's Labs., Inc.
| Decision Date | 10 July 2017 |
| Docket Number | Case No. 11-2317 (MLC) (DEA) |
| Parties | HORIZON PHARMA, INC. and POZEN INC., Plaintiffs, v. DR. REDDY'S LABORATORIES, INC., et al., Defendants. |
| Court | U.S. District Court — District of New Jersey |
REDACTED AMENDED MEMORANDUM OPINION :
A. Infringement ......................................................................................................................... 6
B. Written Description .............................................................................................................. 7
C. Enablement / Utility ............................................................................................................. 8
D. Obviousness ......................................................................................................................... 9
A. Written Description (Uncoated Naproxen) ...................................................................... 11
B. Written Description (Sustained Release Formulations) ................................................... 23
C. Infringement ....................................................................................................................... 27
A. Obviousness ....................................................................................................................... 31
B. Enablement ......................................................................................................................... 59
C. Written Description (Uncoated PPI) ................................................................................. 62
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 IIProduct does not infringe the 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.
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...
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