Case 1:14-cv-02758-PAC Document 137 Filed 02/21/17 Page 1 of 14
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`
`UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
`
`
`
`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 POST-TRIAL BRIEF REGARDING
`INVALIDITY OF CLAIMS 1 AND 2 OF THE ’336 PATENT FOR
`OBVIOUSNESS-TYPE DOUBLE PATENTING
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`
`
`
`
`

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`Case 1:14-cv-02758-PAC Document 137 Filed 02/21/17 Page 2 of 14
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`
`I. 
`
`II. 
`
`TABLE OF CONTENTS
`
`BACKGROUND: THE ’336 PATENT AND THE ’130 PATENT ......................................... 1 
`
`ARGUMENT ....................................................................................................................................... 2 
`
`A. 
`
`B. 
`
`C. 
`
`The ’336 Claims Are Patentably Indistinct from the ’130 Claims. .................................. 3 
`
`Plaintiffs’ Evidence of Secondary Considerations Misses the Mark. .............................. 5 
`
`The ’130 Patent Is a Proper ODP Reference Against the ’336 Patent. .......................... 6 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`Under Gilead, Actual Expiration Dates Control Whether a Patent Is
`Available as an ODP Reference. ............................................................................. 7 
`
`There Is No PTE “Exception” to ODP. .............................................................. 7 
`
`Plaintiffs Seek to Misapply Merck v. Hi-Tech. ..................................................... 9 
`
`ODP Is a Problem of Plaintiffs’ Own Making. .................................................. 10 
`
`III. 
`
`CONCLUSION ................................................................................................................................. 10 
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`
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`ii
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`Case 1:14-cv-02758-PAC Document 137 Filed 02/21/17 Page 3 of 14
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Abbvie v. Kennedy,
`764 F.3d 1366 (Fed. Cir. 2014) ..................................................................................................... 3, 6, 8, 9
`
`Abuelhawa v. United States,
`556 U.S. 816 (2009) ..................................................................................................................................... 8
`
`Boehringer Ingelheim Int’l GmbH v. Barr Labs., Inc.,
`592 F.3d 1340 (Fed. Cir. 2010) ....................................................................................................... 3, 8, 10
`
`Eli Lilly v. Barr Labs.,
`251 F.3d 955 (Fed. Cir. 2001) .................................................................................................................... 8
`
`In re Fallaux,
`564 F.3d 1313 (Fed. Cir. 2009) ................................................................................................................ 10
`
`Gilead v. Natco Pharma Ltd.,
`753 F.3d 1208 (Fed. Cir. 2014) ..................................................................................................... 6, 7, 8, 9
`
`In re Hubbell,
`709 F.3d. 1140 (Fed. Cir. 2013) ................................................................................................................. 6
`
`Janssen Biotech v. Celltrion Healthcare,
`No. 15-10698, 2016 WL 5698362 (D. Mass. Sept. 28, 2016) ............................................................. 10
`
`Merck v. Hi-Tech Pharmacal Co., Inc.,
`482 F.3d 1317 (Fed. Cir. 2007) ............................................................................................................ 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. §103 ........................................................................................................................................... 3, 5, 6
`
`35 U.S.C. §121 .................................................................................................................................................... 3
`
`35 U.S.C. §156 ..................................................................................................................................... 1, 8, 9, 10
`
`Pub. L. 98–417, title II, § 201(a), Sept. 24, 1984, 98 Stat. 1598 ................................................................... 8
`
`
`
`iii
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`Case 1:14-cv-02758-PAC Document 137 Filed 02/21/17 Page 4 of 14
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`Claims 1 and 2 of the ’336 patent are invalid for obviousness-type double patenting over
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`claims 1 and 5 of the ’130 patent. The salient facts established at trial are undisputed, and
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`demonstrate by clear and convincing evidence that the claims of the ’336 patent are patentably
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`indistinct and obvious variants of the claims of the ’130 patent.
`
`The only real dispute over obviousness-type double patenting is purely legal. Plaintiffs
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`contend that the ’130 patent is not available as a reference against the ’336 patent. The Court should
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`reject Plaintiffs’ legal argument because it is contrary to Federal Circuit guidance and seeks to
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`countermand the very bedrock principles and public policy objectives of patent law that the doctrine
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`of obviousness-type double patenting exists to protect.
`
`I.
`
`BACKGROUND: THE ’336 PATENT AND THE ’130 PATENT
`
`A.
`
`The ’336 Patent
`
`The patent subject to Amneal’s obviousness-type double patenting (“ODP”) challenge is
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`U.S. Patent No. 5,856,336 (“the ’336 patent”). The ’336 patent contains two claims. Claim 1 claims
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`the calcium salt of pitavastatin, and claim 2 claims a method of reducing certain lipid disorders by
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`administering that salt. (DTX-0032 at 9130.) The ’336 patent is assigned to Nissan Chemical
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`Industries, Ltd. (“Nissan”). It issued on January 5, 1999, and its named inventors are Yoshihiro
`
`Fujikawa, Mikio Suzuki, Hiroshi Iwasaki, Mitsuaki Sakashita, and Masaki Kitahara. (Id. at 9114.)
`
`The ’336 patent was originally going to expire on January 5, 2016. (PTX-0170 at
`
`KN001333527, -617.) But in September 2009, Nissan applied for Patent Term Extension (“PTE”)
`
`pursuant to 35 U.S.C. §156, in view of FDA regulatory review of Livalo®. (PTX-0170 at
`
`KN001333523.) The PTO granted this request in April 2013, extending the ’336 patent by 1,823
`
`days, and setting the new expiration date at January 1, 2021. (PTX-0170 at KN00133616–20.)
`
`Thereafter, in July 2013, Nissan terminally disclaimed the ’336 patent over U.S. Patent No.
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`5,854,259. (PTX-0170 at KN001333621–22.) In its terminal disclaimer, Nissan stated that it was
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`1
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`

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`Case 1:14-cv-02758-PAC Document 137 Filed 02/21/17 Page 5 of 14
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`refusing to disclaim any portion of its PTE. (PTX-0170 at KN001333621–22.) Accordingly, the ’336
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`patent is not set to expire until December 25, 2020.
`
`B.
`
`The ’130 Patent
`
`The reference patent for ODP is U.S. Patent No. 5,872,130 (“the ’130 patent”). The ’130
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`Patent has the same assignee (Nissan), and the same named inventors as the ’336 patent. (DTX-
`
`0264, front page.) The ’130 patent issued on February 16, 1999. (DTX-0264, front page.) The ’130
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`patent expired on February 16, 2016, which is after the original expiration date of the ’336 patent,
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`but more than four years before the actual expiration date of the ’336 patent after PTE. The lives of
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`the ’336 and ’130 patents are depicted graphically below:
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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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`
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`compounds of claim 1. (Id. at 39:25–40:14, 40:26–31.)
`
`II.
`
`ARGUMENT
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`The evidence presented at trial relating to ODP stands unrebutted. Amneal’s expert witness,
`
`Dr. Anthony Palmieri, testified that Claim 1 of the ’336 patent is a patentably indistinct and obvious
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`variant of claim 1 of the ’130 patent, and that claim 2 of the ’336 patent is a patentably indistinct and
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`
`
`2
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`

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`Case 1:14-cv-02758-PAC Document 137 Filed 02/21/17 Page 6 of 14
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`an obvious variant of claim 5 of the ’130 patent. Plaintiffs did not present any evidence to refute Dr.
`
`Palmieri’s facts, reasoning, or conclusions.
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`Plaintiffs’ evidence of secondary considerations is essentially irrelevant to ODP, because it
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`does not address the factual nature of the ODP comparison, i.e., the obviousness of the calcium salt
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`(and its claimed use) over the sodium salt (and its otherwise identically claimed use). Rather, it
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`speaks to a factually unrelated and legally separate defense of obviousness under 35 U.S.C. §103.
`
`That §103 defense is not at issue in this case, because its sole proponent has settled.
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`The only real dispute over ODP in this case is Plaintiffs’ legal contention that the ’130 patent
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`cannot be an ODP reference against the ’336 patent.1 The Court should reject Plaintiffs’ contention,
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`because it is at odds with Federal Circuit guidance and contrary to the core purpose of the ODP
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`doctrine, which is to preserve the public’s fundamental right to practice a patentee’s claimed
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`invention and its obvious variants after the patentee’s first patent claiming that invention expires.
`
`A.
`
`The ’336 Claims Are Patentably Indistinct from the ’130 Claims.
`
`The ODP analysis involves construing the claims in both patents, determining the
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`differences, then determining whether those differences render the claims patentably distinct. Abbvie
`
`v. Kennedy, 764 F.3d 1366, 1374 (Fed. Cir. 2014). The latter part of this analysis is analogous to an
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`obviousness analysis under 35 U.S.C. §103. Id. at 1378. Here, the parties did not raise any claim
`
`construction issues, so the ordinary meaning of the claim terms applies. (D.I. 75.)
`
`The claims to be compared are displayed side-by-side below.
`
`
`
`
`1 Plaintiffs have never contended that the “safe-harbor” provision of 35 U.S.C. §121 applies in this case. Nor could they.
`Section 121 only applies to applications filed as a result of a restriction requirement by the patent office. See, e.g.,
`Boehringer Ingelheim Int'l GmbH v. Barr Labs., Inc., 592 F.3d 1340, 1352 (Fed. Cir. 2010). But the parent application of the
`application that matured into the ’130 patent was not subject to a restriction requirement.
`3
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`

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`Case 1:14-cv-02758-PAC Document 137 Filed 02/21/17 Page 7 of 14
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`The ’336 Patent
`
`
`1. A compound of the formula,
`
`
`The ’130 Patent
`
`A compound of the formula:
`
`
`1.
`
`
`
`
`
`
`
`
`
`
`
`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.
`
`
`
`
`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.
`
`
`(DTX-0032 at MYLAN(Pitav)009130; DTX-0264 at 39:25–40:14, 40:26–31.)
`
`
`The only difference between the claims of the ’336 patent and those of the ’130 patent is
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`that the ’336 patent claims the calcium salt of pitavastatin and a method of using it, whereas the ’130
`
`patent claims the sodium salt of pitavastatin and an (otherwise identical) method of using it.2 Dr.
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`Palmieri’s testimony to that effect is unrebutted and undisputed. (Tr. at 673:21–674:6; 676:5–8.)
`
`Dr. Palmieri testified that it was well-known in the art that sodium and calcium salts were
`
`mutually interchangeable, were among the most frequently used pharmaceutically acceptable salts,
`
`and would have been among the set of normal choices for making statin salts. (Tr. at 666:10–669:14,
`
`
`2 The “∆” symbol in claim 1 of the ’336 patent and the “c-Pr” in claim 1 of the’130 patent both stand for the same thing,
`a cyclopropyl group. (Tr. at 673:8–17.)
`
`
`
`4
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`Case 1:14-cv-02758-PAC Document 137 Filed 02/21/17 Page 8 of 14
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`670:12–672:8; DTX-1245; DTX-1256; DTX-1257.) He also explained that a POSA3 would have had
`
`a reasonable expectation of success in preparing the calcium salt from the sodium salt, and that such
`
`preparation would have been a routine exercise. (Tr. at 674:25–675:12.) Plaintiffs offered no
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`evidence or argument to the contrary.4
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`Accordingly, Dr. Palmieri concluded that claim 1 of the ’336 patent is not patentably distinct
`
`from claim 1 of the ’130 patent. (Tr. at 674:7–12.) He also concluded that claim 2 of the ’336 patent
`
`is not patentably distinct from claim 5 of the ’130 patent. (Tr. at 676:9–15.) Again, Plaintiffs offered
`
`no evidence or argument to the contrary.
`
`B.
`
`Plaintiffs’ Evidence of Secondary Considerations Misses the Mark.
`
`Plaintiffs’ evidence of secondary considerations is factually irrelevant to the ODP
`
`comparison at issue. The comparison at play for ODP is sodium salt of pitavastatin versus calcium
`
`salt of pitavastatin. Plaintiffs’ secondary considerations evidence does not speak to that comparison.
`
`Instead, Plaintiffs’ secondary considerations evidence sought to distinguish pitavastatin from other
`
`statins.5 Plaintiffs did not offer any evidence attributing the properties or alleged commercial success
`
`of Livalo® to the particular salt of pitavastatin used in Livalo®. This mismatch came about because
`
`Plaintiffs were attempting to rebut a separate defense of obviousness under 35 U.S.C. §103. That
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`separate defense did not rely on prior art disclosing the sodium salt of pitavastatin.6
`
`
`3 Dr. Palmieri would have reached the same conclusions under any of the proffered definitions of a POSA for the ’336
`patent. (Tr. at 658:18–660:1.)
`4 Notably, the ’336 patent relies on data obtained from testing 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 Plaintiffs have failed to establish the sufficiency of any of their alleged secondary considerations of non-obviousness.
`See Defendants Amneal’s and Apotex’s Proposed Findings of Fact and Conclusions of Law Regarding Anticipation and Obviousness of the
`Asserted “Form A Claims” of U.S. Patent No. 8,557,993 at Sections IV(G) and V(B)(5).
`6 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.
`
`
`
`5
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`

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`Case 1:14-cv-02758-PAC Document 137 Filed 02/21/17 Page 9 of 14
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`Indeed, none of Plaintiffs’ five secondary considerations witnesses testified about attributes
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`of the calcium salt as compared to any other salt of pitavastatin. (See, e.g., Tr. at 1449:23–24 (Dr.
`
`Miller admitting that he did not discuss the salt form); Tr. at 1471:1–1472:7 (revealing that when Dr.
`
`Gotto was asked about pitavastatin calcium, he spoke about pitavastatin in general, not the calcium
`
`form).) Thus, even if credited, the evidence of alleged secondary considerations does not outweigh
`
`the undisputed evidence that the ’336 patent claims are obvious variants of the ’130 patent claims.
`
`C.
`
`The ’130 Patent Is a Proper ODP Reference Against the ’336 Patent.
`
`ODP is grounded in 35 U.S.C. §101 of the patent statute and effectuates bedrock patent law
`
`and policy by preventing anyone from obtaining a second, later-expiring patent on the same
`
`invention or obvious variant thereof. Abbvie, 764 F.3d at 1372. A “crucial purpose of the doctrine” is
`
`“to prevent an inventor from securing a second, later expiring patent for the same invention.” Id. at
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`1373. The Supreme Court has repeatedly reaffirmed the importance of the ODP doctrine. Id. at
`
`1372. Accordingly, “[f]ederal Courts for over a century have applied the principles of the doctrine as
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`a means to preserve the public’s right to use not only the exact invention claimed by an inventor
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`when his patent expires, but also obvious modifications of that invention that are not patentably
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`distinct improvements.” Gilead v. Natco Pharma Ltd., 753 F.3d 1208, 1212 (Fed. Cir. 2014).
`
`As an initial matter, the ’130 patent and the ’336 patent have the same inventors and the
`
`same assignee. Thus, the ’130 patent meets the common inventor/assignee requirement for an ODP
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`reference. See, e.g., In re Hubbell, 709 F.3d. 1140, 1146 (Fed. Cir. 2013).
`
`Plaintiffs contend that the ’130 patent is not available as an ODP reference, because absent
`
`the PTE applied to the ’336 patent, the ’336 patent would have expired after the ’130 patent. Thus,
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`when it comes to alleging infringement, Plaintiffs contend that the expiration date that really matters
`
`is 2020. But when it comes to whether their patent runs afoul of ODP, Plaintiffs contend that the
`
`expiration date that truly matters is the 2015 expiration date that Plaintiffs successfully petitioned to
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`6
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`Case 1:14-cv-02758-PAC Document 137 Filed 02/21/17 Page 10 of 14
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`supersede. Plaintiffs’ argument is a counterfactual affront to Federal Circuit guidance and the core
`
`purpose of the ODP doctrine.
`
`1.
`
`Under Gilead, Actual Expiration Dates Control Whether a Patent Is
`Available as an ODP Reference.
`
`
`The actual expiration dates of the reference patent and the asserted patent control whether
`
`the reference patent is available as an ODP reference. Gilead v. Natco Pharma Ltd., 753 F.3d 1208
`
`(Fed. Cir. 2014). In Gilead, as in this case, the reference patent issued later, but expired before, the
`
`asserted patent. Id. at 1210. The two patents were not part of the same family, and had different
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`priority dates, so by operation of statute (the URAA), they had different expiration dates. Id.
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`The patentee argued that the later-issued but earlier-expiring patent was not a proper ODP
`
`reference. Id. at 1211. The district court agreed with the patentee, reasoning that any “extensions of
`
`the patent terms at issue were not unlawful because the extensions were not a result of
`
`gamesmanship, but instead were a result of changes to patent laws.” Id.
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`The Federal Circuit disagreed, holding that the later-issued but earlier-expiring patent was a
`
`proper ODP reference. Id. at 1217. The court explained that ODP “has always been implemented to
`
`effectively uphold” the “bedrock principle of our patent systems that when a patent expires, the
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`public is free to use not only the same invention claimed in the expired patent but also obvious or
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`patentably indistinct modifications of that invention.” Id. at 1214. The court indicated that for ODP,
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`“the date that really matter[s]” is the patent expiration date, and that “in light of the principles
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`reflected in our prior case law…it is the comparison of Gilead’s patent expiration dates that
`
`should control, not merely the issuance dates.” Id. at 1215 (emphasis added).
`
`2.
`
`There Is No PTE “Exception” to ODP.
`
`Plaintiffs argue essentially that PTE cannot lead to invalidity under ODP. But no case has
`
`ever so held, and decades of apellate and Supreme Court precedent point in the opposite direction.
`
`
`
`7
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`

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`Case 1:14-cv-02758-PAC Document 137 Filed 02/21/17 Page 11 of 14
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`Congress created PTE in 1984 as part of the Hatch-Waxman Act. See 35 U.S.C. §156. Pub.
`
`L. 98–417, title II, § 201(a), Sept. 24, 1984, 98 Stat. 1598. By 1984, the ODP doctrine was well-
`
`established. See, e.g., Gilead, 753 F.3d at 1212 (noting application of ODP by federal courts “for over
`
`a century”); see also Abbvie, 764 F.3d at 1372 (citing Supreme Court cases from the 1800’s as having
`
`“reaffirmed the prohibition on double patenting).
`
`Congress is presumed to act with the case law in mind. See, e.g., Abuelhawa v. United States, 556
`
`U.S. 816 (2009) (“As we have said many times, we presume legislatures act with case law in mind.”)
`
`Yet nothing in the text or legislative history of 35 U.S.C. §156 suggests that Congress intended to
`
`upend, curtail, or create a PTE exception to the ODP doctrine by enacting 35 U.S.C. §156.
`
`Over 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 against a timewise extension
`
`of patent rights regardless of how that extension comes to pass. See In re Schneller, 397 F.2d 350 (1968)
`
`(stating that “[t]he fundamental reason for [ODP] is to prevent unjustified timewise extension of the
`
`right to exclude granted by a patent no matter how the extension is brought about.”) (emphasis
`
`removed); In re Van Ornum, 686 F.2d 937, 943–44 (CCPA 1982) (quoting In re Schneller); Boehringer,
`
`592 F.3d at 1347 (quoting and citing In re Van Ornum and In re Schneller); Eli Lilly v. Barr Labs., 251
`
`F.3d 955, 967–68 (Fed. Cir. 2001) (same). Although these statements were not overtly addressing
`
`PTE, they further suggest that the Federal Circuit would not create a PTE exception to ODP.
`
`Notably, the Gilead court employed precisely this reasoning when it considered the
`
`analogous interplay between ODP and the URAA statute. Specifically, the Gilead court concluded
`
`that “Congress could not have intended to inject the potential to disturb the consistent application
`
`of the doctrine of double patenting by passing the URAA.” Id. at 1216. In so doing, the court
`
`stressed that any earlier-expiring patent should be a proper ODP reference, because focusing on
`
`
`
`8
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`Case 1:14-cv-02758-PAC Document 137 Filed 02/21/17 Page 12 of 14
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`expiration dates provides a “stable benchmark that preserves the public’s right to use the invention
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`(and its obvious variants) that are claimed in a patent when that patent expires.” Id. at 1216.
`
`Notably, since Gilead, the Federal Circuit reaffirmed the continued vitality of ODP, to “make
`
`explicit what was implicit in Gilead: the doctrine of obviousness-type double patenting continues to
`
`apply where two patents that claim the same invention have different expiration dates.” Abbvie, 764
`
`F.3d at 1374. Accordingly, it does not matter how the ’130 patent came to expire before the
`
`commonly-owned ’336 patent, the fact that it expires first means that it is a proper ODP reference.
`
`3.
`
`Plaintiffs Seek to Misapply Merck v. Hi-Tech.
`
`Plaintiffs argue that Merck v. Hi-Tech Pharmacal Co., Inc., 482 F.3d 1317 (Fed. Cir. 2007)
`
`controls, and that under Merck, a patent cannot be a proper ODP reference if it would have expired
`
`later absent PTE extending the life of the asserted patent. Plaintiffs are incorrect.
`
`Merck did not address the interplay between ODP and PTE or the policy or purpose of the
`
`ODP doctrine. Nor did Merck address the proper test for availability of a patent as a ODP reference.
`
`In fact, ODP was not being litigated at all in Merck.
`
`The sole issue in Merck was whether a terminal disclaimer nullifies PTE. The asserted patent
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`had been the subject of a terminal disclaimer and had been awarded PTE. Id. at 1318–19. Absent the
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`PTE, the asserted patent would have already expired at the time of the complaint. Id. at 1320. The
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`accused infringer moved to dismiss on the pleadings, arguing that the PTE was nullified by the
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`terminal disclaimer and thus that the patent had already expired. Id.
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`The Federal Circuit disagreed, and held that PTE ran from the expiration date set by the
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`terminal disclaimer. Id. at 1324. In reaching its holding, the court acknowledged that a terminal
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`disclaimer prevents unjust extension of patent term for obvious variants. Id. at 1323. It also noted
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`that §156 gives the patentee the choice of which of its related patents to extend via PTE. Id.
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`
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`9
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`Case 1:14-cv-02758-PAC Document 137 Filed 02/21/17 Page 13 of 14
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`Subsequent Federal Circuit decisions show that Merck should be interpreted narrowly, and
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`that Merck does not stand for the notion advanced here by Plaintiffs that PTE cannot cause a patent
`
`to run afoul of ODP. 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. Moreover, two years after
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`Merck, the Federal Circuit explicitly stated that “[i]n some cases there may still be the possibility of an
`
`unjust time-wise extension of a patent arising from patent term adjustment under §154 or patent
`
`term extension under §156.” In re Fallaux, 564 F.3d 1313, 1319 (Fed. Cir. 2009).
`
`4.
`
`ODP Is a Problem of Plaintiffs’ Own Making.
`
`During closing argument, the Court inquired whether PTE attached to the ’336 patent
`
`merely by operation of law. (Tr. at 1781:2–14.) The answer is “no.” Nissan affirmatively petitioned
`
`the PTO to obtain almost five years of PTE on the ’336 patent. (PTX-0170 at KN001333523–3620.)
`
`Nissan knew how similar the claims in the ’130 and ’336 patents were, and it knew that extending
`
`the ’336 patent beyond February 16, 2016 would extend the ’336 patent beyond the ’130 patent. In
`
`other words, Nissan invited the risk that its PTE would run afoul of ODP. Cf. Janssen Biotech v.
`
`Celltrion Healthcare, No. 15-10698, 2016 WL 5698362 at *3 (D. Mass. Sept. 28, 2016).
`
`III. CONCLUSION
`
`
`The ’130 patent is available as an ODP reference against the ’336 patent because it expired
`
`first and the two patents have the same assignee and inventors. The fact that the ’130 patent expires
`
`before the ’336 only due to PTE on the ’336 patent does not change the result. There is no PTE
`
`exception for ODP. Nor should there be. To hold otherwise would strip the public of its right to
`
`practice expired inventions and obvious variants thereof. ODP exists to prevent that result.
`
`Accordingly, claims 1 and 2 of the ’336 patent are invalid for obviousness-type double patenting 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 137 Filed 02/21/17 Page 14 of 14
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`Dated: February 21, 2017
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`Respectfully submitted,
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`/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
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`Attorneys for Defendant
`Amneal Pharmaceuticals, LLC
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