Case 1:14-cv-02758-PAC Document 136 Filed 02/21/17 Page 1 of 14
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`UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
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`
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.,
`
`
`Plaintiffs,
`
`v.
`
`Amneal Pharmaceuticals, LLC,
`
`
`Defendants.
`
`Civil Action No. 14-CV-2758 (PAC)
`
`
`AMNEAL PHARMACEUTICALS, LLC’S PROPOSED FINDINGS OF FACT AND
`CONCLUSIONS OF LAW REGARDING INVALIDITY OF CLAIMS 1 AND 2 OF THE
`’336 PATENT FOR OBVIOUSNESS-TYPE DOUBLE PATENTING
`
`
`
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`
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`
`
`

`

`
`
`I. 
`
`II. 
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`Case 1:14-cv-02758-PAC Document 136 Filed 02/21/17 Page 2 of 14
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`TABLE OF CONTENTS 
`INTRODUCTION ............................................................................................................................. 1 
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`PROPOSED FINDINGS OF FACT REGARDING ODP ....................................................... 1 
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`A. 
`
`B. 
`
`C. 
`
`D. 
`
`E. 
`
`The ’336 Patent ....................................................................................................................... 1 
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`The ’130 Patent ....................................................................................................................... 2 
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`Comparison of the ’336 patent claims and the ’130 patent claims .................................. 2 
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`Secondary Considerations ..................................................................................................... 4 
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`Summary .................................................................................................................................. 5 
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`III. 
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`PROPOSED CONCLUSIONS OF LAW REGARDING ODP ............................................... 5 
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`ii
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`Case 1:14-cv-02758-PAC Document 136 Filed 02/21/17 Page 3 of 14
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`TABLE OF AUTHORITIES
`
`
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`Page(s)
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`
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`Cases
`
`Abbvie v. Kennedy,
`764 F.3d 1366 (Fed. Cir. 2014) .............................................................................................................. 7, 8
`
`Abuelhawa v. United States,
`556 U.S. 816 (2009) ..................................................................................................................................... 8
`
`Boehringer Ingelheim v. Barr Labs.,
`592 F.3d 1340 (Fed. Cir. 2010) .............................................................................................................. 8, 9
`
`Eli Lilly v. Barr Labs.,
`251 F.3d 955 (Fed. Cir. 2001) .................................................................................................................... 8
`
`In re Fallaux,
`564 F.3d 1313 (Fed. Cir. 2009) ............................................................................................................ 9, 10
`
`Gilead v. Natco Pharma Ltd.,
`753 F.3d 1208 (Fed. Cir. 2014) ................................................................................................... 6, 7, 8, 10
`
`Janssen Biotech v. Celltrion Healthcare,
`No. 15-10698, 2016 WL 5698362 (D. Mass. Sept. 28, 2016) ............................................................. 10
`
`Merck & Co. v. Hi-Tech Pharmacal Co., Inc.,
`482 F.3d 1317 (Fed. Cir. 2007) ....................................................................................................... 8, 9, 10
`
`In re Schneller,
`397 F.2d 350 (1968) .................................................................................................................................... 8
`
`In re Van Ornum,
`686 F.2d 937 (CCPA 1982) ........................................................................................................................ 8
`
`Statutes
`
`35 U.S.C. §101 .................................................................................................................................................... 7
`
`35 U.S.C. §103 .................................................................................................................................................... 4
`
`35 U.S.C. §156 ..................................................................................................................................... 1, 8, 9, 10
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`iii
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`Case 1:14-cv-02758-PAC Document 136 Filed 02/21/17 Page 4 of 14
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`I.
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`INTRODUCTION
`1.
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`Amneal contends that Claims 1 and 2 of U.S. Patent No. 5,856,336 (“the ’336
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`patent”) are invalid over claims 2 and 5, respectively, of U.S. Patent No. 5,872,130 (“the ’130
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`patent”) under the doctrine of Obviousness-Type Double Patenting (“ODP”).
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`2.
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`The facts relating to this defense and the scientific conclusions based on those facts
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`are largely undisputed. Amneal’s expert witness, Dr. Anthony Palmieri, testified that Claim 1 of the
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`’336 patent is an obvious variant of claim 1 of the ’130 patent, and that claim 2 of the ’336 patent is
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`an obvious variant of claim 5 of the ’130 patent. Plaintiffs did not present any evidence to refute
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`those facts or conclusions. Plaintiffs did present certain evidence relating to secondary
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`considerations of non-obviousness, which is addressed below in section II.D.
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`3.
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`Plaintiffs contend that as a matter of law, the ’130 patent is not a proper ODP
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`reference against the ’336 patent. The Court’s findings of fact are set forth first below, followed by
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`the Court’s conclusions on the disputed issue of law.
`
`II.
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`PROPOSED FINDINGS OF FACT REGARDING ODP
`A.
`4.
`
`The ’336 Patent
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`The ’336 patent is assigned to Nissan Chemical Industries, Ltd. (“Nissan”), and
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`issued on January 5, 1999. (DTX-0032 at 9114.) The named inventors are Yoshihiro Fujikawa,
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`Mikio Suzuki, Hiroshi Iwasaki, Mitsuaki Sakashita, and Masaki Kitahara. (Id.)
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`5.
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`The ’336 patent originally was going to expire on December 29, 2015, but Nissan
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`requested and obtained 1,823 days of Patent Term Extension (“PTE”) pursuant to 35 U.S.C. §156,
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`in view of FDA regulatory review of Livalo®. Nissan terminally disclaimed the ’336 patent over U.S.
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`Patent No. 5,854,259. (PTX-0170 at KN001333621.) Thus, the ’336 patent does not expire until
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`December 25, 2020.
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`1
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`

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`Case 1:14-cv-02758-PAC Document 136 Filed 02/21/17 Page 5 of 14
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`6.
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`The ’336 patent contains two claims, and both are asserted against Amneal. Claim 1
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`claims the calcium salt of pitavastatin; claim 2 claims a method of reducing certain lipid disorders by
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`administering the calcium salt of pitavastatin. (DTX-0032 at 9130.)
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`B.
`7.
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`The ’130 Patent
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`The ’130 Patent is also assigned to Nissan, and has the same named inventors as the
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`’336 patent. (DTX-0264, front page.) The ’130 patent issued on February 16, 1999. (DTX-0264,
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`front page.) The ’130 patent expired on February 16, 2016, which is several months after the original
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`expiration date of the ’336 patent, but over four years before the actual expiration date of the ’336
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`patent after patent term extension. These dates can be represented on a timeline as follows:
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`8.
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`Claim 1 of the ’130 patent claims several compounds, including the sodium salt of
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`pitavastatin. Claim 5 claims a method of reducing certain lipid disorders by administering any of the
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`compounds of claim 1. (Id. at 39:25 – 40:14, 40:26-31.)
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`C.
`9.
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`Comparison of the ’336 patent claims and the ’130 patent claims1
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`Below, the ’336 patent claims are set forth beside claims 1 and 5 of the ’130 patent.
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`
`
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`1 There are no claim construction disputes relating to the ’336 or ’130 patents.
`2
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`Case 1:14-cv-02758-PAC Document 136 Filed 02/21/17 Page 6 of 14
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`The ’336 Patent
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`1. A compound of the formula,
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`
`The ’130 Patent
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`A compound of the formula:
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`1.
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`
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`A method for reducing
`2.
`hyperlipidemia, hyperlipoproteinemia or
`atherosclerosis, which comprises
`administering an effective amount of the
`compound of formula A as defined in
`claim 1.
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`
`
`
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`A method for reducing
`5.
`hyperlipidemia, hyperlipoproteinemia or
`atherosclerosis, which comprises
`administering an effective amount of the
`compound of formula A as defined in
`claim 1.
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`10.
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`As Dr. Palmieri explained, the only difference between claim 1 of the ’336 patent and
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`claim 1 of the ’130 patent is that the ’336 patent claims the calcium salt of pitavastatin, while the ’130
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`patent claims, among other things, the sodium salt of pitavastatin. (Tr. at 673:21–674:6.)2 This is
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`undisputed.
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`11.
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`Dr. Palmieri further explained that it was well-known in the art that sodium and
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`calcium salts were mutually interchangeable, were among the most frequently used pharmaceutically
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`2 The “∆” symbol in claim 1 of the ’336 patent and the “c-Pr” symbol in claim 1 of the ’130 patent both stand for the
`same thing, a cyclopropyl group. (Tr. at 673:8–17.)
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`3
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`Case 1:14-cv-02758-PAC Document 136 Filed 02/21/17 Page 7 of 14
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`acceptable salts, and would have been among the set of normal choices for making statin salts. (Tr.
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`at 666:10–669:14, 670:12–672:8; DTX-1245; DTX-1256; DTX-1257.) He also explained that a
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`POSA3 would have had a reasonable expectation of success in preparing the calcium salt from the
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`sodium salt, and that such preparation would have been a routine exercise. (Tr. at 674:25–675:12.)
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`Dr. Palmieri also explained that the only difference between claim 2 of the ’336 patent and claim 5
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`of the ’130 patent is which salt is used.4 Plaintiffs offered no evidence or argument to the contrary.
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`12.
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`Accordingly, Dr. Palmieri concluded that claim 1 of the ’336 patent is not patentably
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`distinct from claim 1 of the ’130 patent. (Tr. at 674:7–12.) He also concluded that claim 2 of the ’336
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`patent is not patentably distinct from claim 5 of the ’130 patent. (Tr. at 676:9–15.) Plaintiffs offered
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`no evidence or argument to the contrary.
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`D.
`13.
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`Secondary Considerations
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`Plaintiffs’ evidence of secondary considerations does not counter the undisputed
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`evidence that the claims of the ’336 patent are patentably indistinct from the claims of the ’130
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`patent. Plaintiffs relied on attributes of Livalo® to attempt to demonstrate various secondary
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`considerations of non-obviousness, but that evidence was directed at rebutting a separate defense of
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`obviousness under 35 U.S.C. §103. That defense did not rely on prior art disclosing the sodium salt
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`of pitavastatin.5
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`14.
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`Plaintiffs did not offer any evidence attributing the attributes or alleged commercial
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`success of Livalo® to the calcium salt of pitavastatin used in Livalo®, as opposed to the sodium salt
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`or any other salt. None of Plaintiffs’ five secondary considerations witnesses testified about
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`3 Dr. Palmieri would have reached the same conclusions under any of the proffered definitions of a person of a POSA
`for the ’336 patent. (Tr. at 658:18–660:1.)
`4 Notably, the ’336 patent relies on data obtained from testing of the sodium salt to support claims to the calcium salt
`and its use to reduce lipid disorders. (DTX-0032 at 17:63-65 (identifying “compound I-51” as the sodium salt) and at
`Tables 2 and 3 (testing I-51).) This is further evidence of the interchangeability of sodium and calcium salts and methods
`of using them.
`5 Amneal did not assert that §103 defense. Another defendant, Sawai, did, but Sawai is no longer in the case.
`Accordingly, the §103 defense is no longer in the case.
`
`
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`4
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`

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`Case 1:14-cv-02758-PAC Document 136 Filed 02/21/17 Page 8 of 14
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`attributes of the calcium salt as compared to any other salt of pitavastatin. (See, e.g., Tr. at 1449:23–24
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`(Dr. Miller admitting that he did not discuss the salt form); Tr. at 1471:1–1472:7 (revealing that
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`when Dr. Gotto was asked about pitavastatin calcium, he spoke about pitavastatin in general, not the
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`calcium form).)
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`15.
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`Plaintiffs’ secondary considerations evidence was an attempt to show that
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`pitavastatin calcium was not obvious over prior statins. Such evidence is not probative of the
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`question presented by the ODP defense, as it does not relate to the sole difference between the
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`invention of the ’130 patent and the claims of the ’336 patent, namely the salt form of pitavastatin.
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`Accordingly, I find that the evidence of alleged secondary considerations does not outweigh the
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`undisputed evidence in support of obviousness of the ’336 patent claims over the ’130 patent claims.
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`E.
`16.
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`Summary
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`The ’130 patent and the ’336 patent have the same inventors, and the same assignee.
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`Thus, the ’130 patent meets the common inventor/assignee requirement for an ODP reference.
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`17.
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`Claim 1 of the ’336 patent is not patentably distinct from claim 1 of the ’130 patent.
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`Rather, it is an obvious variant. The evidence on this is undisputed, clear, and convincing.
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`18.
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`Claim 2 of the ’336 patent is not patentably distinct from claim 5 of the ’130 patent.
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`Rather, it is an obvious variant. The evidence on this is also undisputed, clear, and convincing.
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`III.
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`PROPOSED CONCLUSIONS OF LAW REGARDING ODP
`19.
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`Amneal’s ODP defense presents a disputed question of law. Amneal contends that
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`the ’130 patent is a proper ODP reference against the ’336 patent because the ’130 patent expires
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`first. Plaintiffs’ contend that the ’130 patent is not available as an ODP reference, because absent the
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`PTE applied to the ’336 patent, the ’336 patent would have expired after the ’130 patent.
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`20.
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`As detailed below, Federal Circuit precedent suggests that if two patents are
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`commonly owned or have the same inventors, the earlier one to expire is a proper ODP reference—
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`5
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`Case 1:14-cv-02758-PAC Document 136 Filed 02/21/17 Page 9 of 14
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`regardless of how the two patents ended up with different expiration dates. This simple rule is
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`consistent with the critical function of the longstanding doctrine of ODP—making sure that once a
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`patent expires, the public is free to practice the claimed invention and obvious variants thereof.
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`Accordingly, for the reasons explained below, I conclude that the ’130 patent is available as an ODP
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`reference against the ’336 patent.
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`21.
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`The Federal Circuit’s recent decision in Gilead v. Natco Pharma Ltd., 753 F.3d 1208
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`(Fed. Cir. 2014) is instructive here. In Gilead, as in this case, the reference patent issued later, but
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`expired before, the asserted patent. Id. at 1210. The patents were not part of the same family, and
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`had different priority dates, so by operation of the governing statute (the URAA), they had different
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`expiration dates. Id.
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`22.
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`The patentee argued that the later-issued but earlier-expiring patent was not a proper
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`ODP reference. Id. at 1211. The district court agreed with the patentee, reasoning that any
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`“extensions of the patent terms at issue were not unlawful because the extensions were not a result
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`of gamesmanship, but instead were a result of changes to patent laws.” Id.
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`23.
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`The Federal Circuit disagreed, holding that the later-issued but earlier-expiring patent
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`was a proper ODP reference. Id. at 1217. The court explained that ODP “has always been
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`implemented to effectively uphold” the “bedrock principle of our patent system that when a patent
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`expires, the public is free to use not only the same invention claimed in the expired patent but also
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`obvious or patentably indistinct modifications of that invention.” Id. at 1214. Responding to the
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`patentee’s arguments, the court indicated that for ODP, “the date that really matter[s]” is the patent
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`expiration date, and that “in light of the principles reflected in our prior case law…it is the
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`comparison of Gilead’s patent expiration dates that should control, not merely the issuance dates.”
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`Id. at 1215.
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`6
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`Case 1:14-cv-02758-PAC Document 136 Filed 02/21/17 Page 10 of 14
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`24.
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`Considering the interplay between the longstanding ODP doctrine and the more
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`recent URAA statute, the Gilead court noted that “Congress could not have intended to inject the
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`potential to disturb the consistent application of the doctrine of double patenting by passing the
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`URAA.” Id. at 1216. The court further noted that “[p]ermitting any earlier expiring patent to serve as
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`a double patenting reference for a patent subject to the URAA guarantees a stable benchmark that
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`preserves the public’s right to use the invention (and its obvious variants) that are claimed in a
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`patent when that patent expires.” Id. at 1216 (emphasis added). Notably, since Gilead, the Federal
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`Circuit has again reaffirmed the continued vitality of ODP, “mak[ing] explicit what was implicit in
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`Gilead: the doctrine of obviousness-type double patenting continues to apply where two patents that
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`claim the same invention have different expiration dates.” Abbvie v. Kennedy, 764 F.3d 1366, 1374
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`(Fed. Cir. 2014).
`
`25.
`
`In view of the holding and reasoning of Gilead, I conclude that the ’130 patent
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`qualifies as a proper ODP reference because it expires before the ’336 patent. Under Gilead, the
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`actual expiration dates of a reference patent and an asserted patent control whether the reference
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`patent is available as an ODP reference.
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`26.
`
`This approach makes sense in view of the purpose of the doctrine of ODP. The
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`longstanding ODP doctrine is grounded in section 101 of the patent statute and effectuates bedrock
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`patent law and policy by preventing anyone from obtaining a second, later-expiring patent on the
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`same invention or obvious variant thereof. Abbvie v. Kennedy, 764 F.3d 1366, 1372 (Fed. Cir. 2014). A
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`“crucial purpose of the doctrine” is “to prevent an inventor from securing a second, later expiring
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`patent for the same invention.” Id. at 1373. The Supreme Court has repeatedly reaffirmed the
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`importance of the ODP doctrine. Id. at 1372. Accordingly, “[f]ederal Courts for over a century have
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`applied the principles of the doctrine as a means to preserve the public’s right to use not only the
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`7
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`Case 1:14-cv-02758-PAC Document 136 Filed 02/21/17 Page 11 of 14
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`exact invention claimed by an inventor when his patent expires, but also obvious modifications of
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`that invention that are not patentably distinct improvements.” Gilead, 753 F.3d at 1212.
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`27.
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`Further, under the holding and reasoning of Gilead, it does not matter that the ’336
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`patent expires later than the ’130 patent only due to PTE. In general, I must presume that Congress
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`acted with ODP case law in mind. See, e.g., Abuelhawa v. United States, 556 U.S. 816 (2009) (“As we
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`have said many times, we presume legislatures act with case law in mind.”). Nothing in the text or
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`legislative history of 35 U.S.C. §156 suggests that Congress intended to upend, curtail, or create a
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`PTE exception to the ODP doctrine by enacting 35 U.S.C. §156. The Gilead court made a similar
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`observation regarding enactment of the URAA. Gilead, 753 F.3d at 1216.
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`28.
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`In addition, for nearly five decades, both before and after the 1984 enactment of 35
`
`U.S.C. §156, the Federal Circuit and its predecessor have repeatedly explained that ODP guards
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`against a timewise extension of patent rights, regardless of how that extension comes to pass. See In
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`re Schneller, 397 F.2d 350 (1968) (stating that “[t]he fundamental reason for the rule [against ‘double
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`patenting’] is to prevent unjustified timewise extension of the right to exclude granted by a patent no
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`matter how the extension is brought about.”) (emphasis removed); In re Van Ornum, 686 F.2d 937,
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`943–44 (CCPA 1982) (quoting In re Schneller); Boehringer Ingelheim v. Barr Labs., 592 F.3d 1340, 1347
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`(Fed. Cir. 2010) (quoting and citing In re Van Ornum and In re Schneller); Eli Lilly v. Barr Labs., 251
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`F.3d 955, 967–68 (Fed. Cir. 2001) (same). Although these statements were not overtly addressing
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`PTE, they further suggest that it does not matter how the ’130 patent came to expire before the ’336
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`patent, the fact that it does expire first means that it is a proper ODP reference.
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`29.
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`Plaintiffs argue that Merck & Co. v. Hi-Tech Pharmacal Co., Inc., 482 F.3d 1317 (Fed.
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`Cir. 2007) controls here and that under Merck, a patent cannot be a proper ODP reference if it
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`would have expired later absent PTE extending the life of the asserted patent. I am not persuaded.
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`8
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`Merck did not address the interplay between ODP and PTE, and did not address how to determine
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`whether a commonly-owned patent is a proper ODP reference.
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`30.
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`In Merck, the issue was not the availability of a patent as a ODP reference. In fact,
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`ODP was not the defense being litigated. Rather, the defendant moved to dismiss arguing that the
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`asserted patent had already expired. Id. at 1320. The asserted patent had been the subject of a
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`terminal disclaimer and had been awarded PTE. Id. at 1318–19. Absent the PTE, the asserted patent
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`would have already expired at the time of the complaint. Id. at 1320. The accused infringer argued
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`that the PTE was nullified by the terminal disclaimer and thus that the patent had already expired. Id.
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`31.
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`The Federal Circuit disagreed, and held that PTE can be tacked on to the date of
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`terminal disclaimer. Id. at 1324. In reaching its holding, the court acknowledge that a terminal
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`disclaimer prevents extension of patent term for obvious variants. Id. at 1323. It also noted that §156
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`gives the patentee the choice of which of its related patents to extend via PTE. Id.
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`32.
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`Plaintiffs argue that under Merck, a reference patent that only expires before the
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`asserted patent due to PTE on the asserted patent cannot qualify as an ODP reference. But Merck
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`did not address that issue. Merck did not even discuss the policy or purpose of the ODP doctrine, or
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`the interplay between ODP and PTE. That is because the sole issue in Merck was whether terminal
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`disclaimers nullify PTE.
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`33. Moreover, subsequent Federal Circuit decisions suggest that Merck should be
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`interpreted narrowly, and that Merck does not foreclose the possibility that PTE can give rise to
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`ODP problems. First, the court in Boehringer narrowly interpreted Merck, declining to read it as
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`permitting a retroactive terminal disclaimer. Boehringer, 592 F.3d. at 1349–50. Second, two years after
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`Merck, the Federal Circuit explicitly stated that PTE can give rise to ODP problems. See In re Fallaux,
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`564 F.3d 1313, 1319 (Fed. Cir. 2009). Specifically, the court stated that “[i]n some cases there may
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`still be the possibility of an unjust time-wise extension of a patent arising from patent term
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`9
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`Case 1:14-cv-02758-PAC Document 136 Filed 02/21/17 Page 13 of 14
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`adjustment under §154 or patent term extension under §156.” Id. Although this statement is not part
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`of the holding in Fallaux, it undercuts Plaintiffs’ reliance on Merck.
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`34.
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`Plaintiffs have suggested that PTE cannot work to render the ’336 patent invalid. But
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`PTE did not attach to the ’336 patent by mere operation of law. Nissan enjoyed the full term of the
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`’130 patent, while affirmatively petitioning the FDA and USPTO to obtain almost five years of PTE
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`on the ’336 patent. (PTX-0170 at KN001333523–3620.) Nissan knew that any PTE beyond
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`February 16, 2016 would extend the ’336 patent beyond the ’130 patent. And Nissan knew how
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`similar the claims in the two patents were. In fact, Nissan stated in its terminal disclaimer that it was
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`refusing to disclaim any portion of its PTE. (PTX-0170 at KN001333621–22.) Thus, Nissan itself
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`invited the risk that its PTE would run afoul of ODP. Cf., Janssen Biotech v. Celltrion Healthcare, No.
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`15-10698, 2016 WL 5698362 at *3 (D. Mass. Sept. 28, 2016). This is precisely the kind of unjustified
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`timewise extension of patent life and consequent violation of the “bedrock principle of our patent
`
`system” that ODP exists to prevent. Gilead at 1214.
`
`35.
`
`In summary, I conclude that as a matter of law, the ’130 patent is available as an
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`ODP reference against the ’336 patent. Further, based on my underlying findings of fact and
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`conclusions of law detailed above, I conclude that claims 1 and 2 of the ’336 patent are invalid for
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`ODP in view of claims 1 and 5 of the ’130 patent.
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`10
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`Case 1:14-cv-02758-PAC Document 136 Filed 02/21/17 Page 14 of 14
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`Dated: February 21, 2017
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`Respectfully submitted,
`
`/s/ Steven A. Maddox
`Steven A. Maddox (Pro Hac Vice)
`Jeremy J. Edwards (Pro Hac Vice)
`Matthew C. Ruedy (Pro Hac Vice)
`Kaveh Saba (Pro Hac Vice)
`Maddox Edwards PLLC
`1900 K Street N.W., Suite 725
`Washington, D.C. 20006
`(202) 830-0707
`smaddox@meiplaw.com
`jedwards@meiplaw.com
`mruedy@meiplaw.com
`ksaba@meiplaw.com
`
`Attorneys for Defendant
`Amneal Pharmaceuticals, LLC
`
`11
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`