Case 1:14-cv-02758-PAC Document 177-2 Filed 02/08/19 Page 1 of 19
`Case 1:14-cv-02758-PAC Document 177-2 Filed 02/08/19 Page 1 of 19
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`EXHIBIT 2
`EXHIBIT 2
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`

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`Case 1:14-cv-02758-PAC Document 177-2 Filed 02/08/19 Page 2 of 19
`Case 1:14-cv-02758-PAC Document 167 Filed 04/11/17 Page 1 of 18
`USDC SDNY
`DOCUMENT
`ELECTRONICALLY FILED
`DOC #: _________________
`DATE FILED:April 11, 2017
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`
`Kowa Company, Ltd., et al.,
`
`Plaintiffs,
`
`14-CV-2758 (PAC)
`
`v.
`
`Amneal Pharmaceuticals, LLC
`
`Defendant.
`
`FINDINGS OF FACT AND
`
`CONCLUSIONS OF LAW
`
`HONORABLE PAUL A. CROTTY, United States District Judge:
`
`This is a Hatch-Waxman patent infringement litigation initiated by Plaintiffs Kowa
`
`Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan Chemical Industries, Ltd.
`
`(collectively, "Plaintiffs"), manufacturers of the cholesterol-lowering drug Livale, against
`
`defendant Amneal Pharmaceuticals, LLC ("Amneal"), a generic drug manufacturer. Plaintiffs
`
`allege that Amneal's proposed Abbreviated New Drug Application ("ANDA-) product would
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`infringe U.S. Patent No. 5,856,336 ("the "336 patent"). Amneal concedes infringement of claims
`
`1 and 2 of the '336 patent, but contends that the patent is invalid on the grounds of obviousness-
`
`type double patenting over claims 1 and 5 of U.S. Patent No. 5,872,130 ("the '130 patent").1
`
`After considering the parties" arguments, memoranda of law, and proposed findings of
`
`fact and conclusions of law, and evaluating the evidence produced at trial, including the
`
`Plaintiffs commenced this litigation against eight defendants, each of which was a generic drug manufacturer, and
`asserted infringement of the '336 patent in six of the actions. By the time the Court held a ten-day bench trial from
`January 17 through January 30, 2017, with closing arguments held on February 3, 2017, only four of the eight
`defendants remained. One defendant settled mid-trial; another settled post-trial. Now, only Amneal still challenges
`the '336 patent. Both Ainneal and Apotex challenge the validity of the '993 patent, but Amneal concedes
`infringement.
`
`

`

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`documentary record and witness testimony, the Court determines that Amneal has failed to satisfy
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`its burden of proof of demonstrating invalidity for three reasons.
`
`First, since the '336 patent was issued and originally expired earlier than the '130 patent,
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`there can be no double patenting. The span of the '336 patent was extended by a Hatch-Waxman
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`Patent Term Extension, which provides patent-holding manufacturers extended protection. This
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`protection is an integral part of the legislation which allows generic drug manufacturers expedited
`
`access to the market. But the extension of the '336 patent term has nothing to do with, and is not
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`invalidated by, the obviousness-type double patenting doctrine.
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`Second, even if the '130 patent were available as an obviousness-type double patenting
`
`reference, Amneal has failed to meet its burden of establishing by clear and convincing evidence
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`that the '336 patent claims are obvious in view of the '130 patent claims. A person of ordinary
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`skill in the art at the time would not have had a reasonable expectation of success in modifying
`
`the pitavastatin sodium in the '130 patent by substituting calcium for sodium and preparing the
`
`pitvastatin calcium salt claimed by the '336 patent, nor would it have been obvious to do so.
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`Third, assuming urguendo that Amneal had satisfied its burden of demonstrating
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`obviousness-type double patenting, the objective secondary considerations evidence of non-
`
`obviousness presented by Plaintiffs would rebut Amneal's prima facie case.
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`The '336 patent is valid.
`
`2
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`

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`Case 1:14-cv-02758-PAC Document 167 Filed 04/11/17 Page 3 of 18
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`I. (cid:9)
`
`THE PARTIES
`
`FINDINGS OF FACT
`
`1. Plaintiff Kowa Company, Ltd. ("KCL") is a Japanese corporation with its
`
`corporate headquarters and principal place of business in Aichi, Japan.'` (Compl. ¶ 2, ECF 2).3
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`Plaintiff Kowa Pharmaceuticals America, Inc. ("KPA") is a wholly-owned subsidiary of KCL
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`organized under the laws of Delaware, with its corporate headquarters and principal place of
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`business in Montgomery, Alabama. (Id.). Plaintiff Nissan Chemical Industries, Ltd. ("NCI") is
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`a Japanese corporation with its corporate headquarters and principal place of business in Tokyo,
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`Japan. (Id. ¶ 3). Plaintiffs are manufacturers, researchers, developers, and marketers of the
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`cholesterol-lowering drug Livaloa. (Id. ¶ 4).
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`2. Defendant Amneal is incorporated in Delaware, with a place of business in
`
`Bridgewater, New Jersey. (Id. ¶ 5; Answer ¶ 5, ECF 17). Amneal filed an ANDA with the Food
`
`and Drug Administration ("FDA") under 21 U.S.C. § 355(j), seeking approval to market 1 mg, 2
`
`mg, and 4 mg tablets comprising pitavastatin calcium. (Compl. ¶ 20; Answer ¶ 20). The ANDA
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`filing contains a paragraph IV certification under 21 U.S.C. § 355(j)(2)(A)(vii)(1V) respecting
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`the '336 patent. (Answer II 21).
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`II. (cid:9)
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`THE '336 PATENT
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`3. The '336 patent is assigned to NCI. (Compl. ¶ 13). KCL is NCI's licensee for
`
`the -336 patent, and KPA holds a license from KCL for the *336 patent. (Id.).
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`2 The Court has made its findings or conclusions based upon its own review of the evidence and the law, even
`though it may utilize the parties' submissions. To the extent that any finding of fact may be considered a conclusion
`of law, or vice versa, each should be considered as such.
`
`All ECF citations in these Findings of Fact and Conclusions of Law refer to the electronic docket of the Amneal
`action, 14-CV-2758.
`
`3
`
`(cid:9)
`(cid:9)
`

`

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`4. Plaintiffs assert that Amneal's proposed ANDA product would infringe the "336
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`patent. (Tr. at 14; 25; 1785-86). Amneal does not dispute that its proposed ANDA product
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`would infringe claims 1 and 2 of the '336 patent, but contends that such claims are invalid for
`
`obviousness-type double patenting over claims 1 and 5 of the "130 patent. (Tr. at 14; 16; 25; 44-
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`46; 353; 1775-76).
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`5. Plaintiffs maintain that the '130 patent may not be used as a reference to
`
`invalidate the '336 patent, and that Amneal has otherwise failed to meet its burden of proof of
`
`establishing invalidity. (Tr. at 17-18; 1785-91).
`
`A. (cid:9)
`
`The '336 Patent Claims
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`6. (cid:9) The '336 patent, "Quinoline Type Mevalonolactones," consists of two claims:
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`claim 1 describes the chemical compound of the calcium salt of pitavastatin; claim 2 describes a
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`method of reducing certain lipid disorders through administration of an effective amount of the
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`compound of formula A as defined in claim 1. (PTX-142).
`
`7. The '336 patent covers Livalo®. (PTX-0170 at KN001333523-615).
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`B. (cid:9)
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`The '130 Patent Claims
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`8. Claim 1 of the '130 patent describes several chemical compounds, including the
`
`sodium salt of pitavastatin. (PTX-290). Claim 5 describes a method of reducing certain lipid
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`disorders through administration of an effective amount of the compound of formula A as
`
`defined in claim I. (PTX-290).
`
`C. (cid:9)
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`Prosecution History of the '336 and '130 Patents
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`9. The "336 and "130 patents arose from the same U.S. patent application, filed on
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`August 19,1988, which claimed priority to a Japanese application filed on August 20,1987.
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`(PTX-142; PTX-290).
`
`4
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`

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`Case 1:14-cv-02758-PAC Document 167 Filed 04/11/17 Page 5 of 18
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`10. The '336 and '130 patents have the same inventors and are both assigned to NCI.
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`(PTX-142; PTX-290).
`
`11. Two United States Patent and Trademark Office (-USPTO") Examiners each
`
`examined the claims of the '336 and '130 patents on two separate occasions, and found the
`
`claims in condition for allowance. (PTX-0170 at KN001333506, KN00133513 (re: the '336
`
`patent application); PTX-0131 at KN000838907, KN000838919 (re: the '130 patent
`
`application)).
`
`12. In each application, the USPTO mailed a Notice of Allowability on September 30,
`
`1998. (PTX-0170 at KN00133515-17 (re: the '336 patent application); PTX-0131 at
`
`KN000838922 (re: the '130 patent application)).
`
`13. The '336 patent issued on January 5, 1999; and the original expiration date was
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`January 5, 2016. (PTX-142).
`
`14. The '130 patent issued on February 16, 1999; and expired on February 16, 2016.
`
`(PTX-290).
`
`15. Plaintiffs terminally disclaimed the '336 patent over U.S. Patent No. 5,824,259
`
`("the '259 patent"), resulting in a shortened patent term and earlier expiration date of December
`
`29. 2015 for the '336 patent. (PTX-0170 at KN001333621-22).
`
`16. Based on the FDA regulatory review period for Livale, Plaintiffs requested and
`
`obtained a Hatch-Waxman Patent Term Extension under 35 U.S.C. § 156 of 1,823 days for the
`
`'336 patent (the -PTE"). (PTX-0170 at KN001333523-615).
`
`17. As extended by the PTE, the '336 patent will expire on December 25, 2020.
`
`(PTX-0170 at KN00133619-20).
`
`5
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`

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`Case 1:14-cv-02758-PAC Document 177-2 Filed 02/08/19 Page 7 of 19
`Case 1:14-cv-02758-PAC Document 167 Filed 04/11/17 Page 6 of 18
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`18. The '130 patent expired after the 136 patent's original expiration date, but before
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`the '336 patent term expires pursuant to the PTE. (PTX-290). The chronology may be
`
`represented as follows:
`
`Issued
`
`Jan. 5, 1999
`
`Original Expiration
`after Terminal
`Disclaimer
`
`Dec. 29, 2015
`
`Original
`Expiration
`
`Jan. 5, 2016
`
`Expiration after
`Patent Term
`Extension
`
`Dec. 25, 2020
`
`'336 Patent
`
`111•11•11=1111k
`
`'130 Patent
`
`Issued
`
`Feb 16, 1999
`
`Expired
`
`Feb. 16, 2016
`
`a (cid:9)
`
`Comparison of the '336 Patent Claims With the '130 Patent Claims
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`19. The '336 patent claims the calcium salt of pitavastatin, while the '130 patent
`
`claims the sodium salt of pitavastatin. (Tr. at 673:21-674:6). The claims are set forth below.
`
`The '336 Patent
`
`The '130 Patent
`
`1. A compound of the formula,
`
`1 (cid:9)
`
`A compound of the formula:
`
`Z---Cl I( 01-1)-Cll,---CIR 0—C112--COO.14.Ca.
`
`IA I
`
`6
`
`

`

`Case 1:14-cv-02758-PAC Document 177-2 Filed 02/08/19 Page 8 of 19
`Case 1:14-cv-02758-PAC Document 167 Filed 04/11/17 Page 7 of 18
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`wherein c-Pr is cyclopropvl, and Z is —(11(011)—C11;
`( 1 1(011)—( 11,—0001 1, —111(011)—CH,— CH(011)-
`(112—cooNa, —(110)11)—(11„—C11(011)----CH„—
`00012 (wherein 12 is C,,, alkyl), or
`
`HO
`
`O.
`
`c
`
`2. A method for reducing hyperlipidemia,
`hyperlipoproteinemia or atherosclerosis, which
`comprises administering an effective amount of
`the compound of formula A as defined in claim 1.
`
`5. A method for reducing hyperlipidemia,
`hyperlipoproteinemia or atherosclerosis, which
`comprises administering an effective amount of the
`compound of formula A as defined in claim 1.
`
`I. (cid:9)
`
`JURISDICTION
`
`CONCLUSIONS OF LAW
`
`20. This action arises under United States patent law, 35 U.S.C. §§ 271(e)(2), 271(b),
`
`271(c), and 281-283. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331
`
`and 1338(a). Venue is proper under 28 U.S.C. §§ 1391(b)-(c) and 1400(b). Personal jurisdiction
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`over Amneal in New York is proper pursuant to N.Y. C.P.L.R. §§ 301 and 302(a), and because
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`Amneal is doing business in this jurisdiction. An actual controversy pursuant to 28 U.S.C. §
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`2201 exists concerning the validity of claims I and 2 of the 336 patent.
`
`H. (cid:9)
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`PRESUMPTION OF PATENT VALIDITY AND THE BURDEN OF PROOF
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`21. Patents are presumed valid, and each patent claim is "presumed valid
`
`independently of the validity of other claims." See 35 U.S.C. § 282(a).
`
`22. -A party seeking to invalidate a patent for obviousness-type double patenting-
`
`bears the burden of demonstrating "facts supporting a conclusion of invalidity by clear and
`
`convincing evidence." Ahhvie Inc. v. Mathilda & Terrence Kennedy Inst. of Rheumatology
`
`7
`
`(cid:9)
`(cid:9)
`

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`Case 1:14-cv-02758-PAC Document 167 Filed 04/11/17 Page 8 of 18
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`Trust, 956 F. Supp. 2d 429, 474 (S.D.N.Y. 2013), aff'd, 764 F.3d 1366 (Fed. Cir. 2014); see 35
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`U.S.C. § 282(a).
`
`CLAIMS I AND 2 OF THE '336 PATENT ARE NOT INVALID UNDER THE
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`DOCTRINE OF OBVIOUSNESS-TYPE DOUBLE PATENTING
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`A. (cid:9)
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`The Obviousness-Type Double Patenting Doctrine
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`23. An inventor is permitted to obtain "a patent- for his invention. 35 U.S.C. § 101.
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`The doctrine of non-statutory, or -obviousness-type," double patenting was judicially developed
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`to prevent the unjustified extension of a patent term "via the patenting of an obvious variation of
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`the original patent.- Id. at 473 (citing Eli Lilly & Co. v. Teva Pharm. USA, Inc., 619 F.3d 1329,
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`1341-42 (Fed. Cir. 2010)); sec also Gen. Foods Corp. v. Studiengesellschqft Kohle mbH, 972
`
`F.2d 1272, 1282 (Fed. Cir. 1992).
`
`24. The doctrine was designed to "prevent claims in separate applications or patents
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`that do not recite the same invention, but nonetheless claim inventions so alike that granting both
`
`exclusive rights would effectively extend the life of patent protection.- In re Hubbell, 709 F.3d
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`1140, 1145 (Fed. Cir. 2013) (internal quotations and citations omitted).
`
`25. The analysis proceeds in two steps. Abbvie, 956 F. Supp. 2d at 474. The court
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`first construes the earlier patent's claims and the later patent's claims, and determines the
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`differences. Id. Then, considering the claims "as a whole," it determines whether those
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`differences render the claims in the second patent -patentably distinct- from the claims in the
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`earlier patent. Id.
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`26. The inquiry is a question of law premised on underlying findings of fact. See id.
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`8
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`Case 1:14-cv-02758-PAC Document 167 Filed 04/11/17 Page 9 of 18
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`27. Two claims are not patentably distinct if the later claim would have been
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`obvious to a person of ordinary skill in the art based on the earlier claim, in light of the prior art.
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`Id.; see Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1361-62 (Fed. Cir. 2009).
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`28. Thus, to find a patent invalid based on obviousness-type double patenting, a court
`
`must conclude that a person of ordinary skill in the art (-POSA-) would have had a reasonable
`
`expectation of success in making the later invention in light of the prior art. See, e.g., In re
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`Kaplan, 789 F.2d 1574, 1579-80 (Fed. Cir. 1986) (all "proper" rejections of patent validity
`
`based on the doctrine "rest on the fact that a patent has been issued and later issuance of a second
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`patent will continue protection, beyond the date of expiration of the first patent, of . . . a mere
`
`variation of that invention which would have been obvious to those of ordinary skill in the
`
`relevant art.-).
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`29. -[l]n the chemical context," a finding that two claimed compounds are not
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`patentably distinct -requires identifying some reason that would have led a chemist to modify the
`
`earlier compound to make the later compound with a reasonable expectation of success.- Otsuka
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`Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1297 (Fed Cir. 2012).
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`30. "[Pjredictability is a vital consideration in the obviousness analysis." Id. at 1298
`
`(citing KSR Intl Co. v. Teleflex, Inc., 550 U.S. 398, 421 (2007)).
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`B. (cid:9)
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`The Obviousness-Type Double Patenting Doctrine Does Not Invalidate the
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`Hatch-Waxman Act's Provision of Patent Term Extension to the '336 Patent
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`31. In 1984, Congress passed the Hatch-Waxman Act (the "Act-), titled the Drug
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`Price Competition and Patent Term Restoration Act of 1984, P.L. 98-417, to "make available
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`more low cost generic drugs.- H.R. Rep. No. 98-857, pt. 1, at 14 (1984), reprinted in 1984
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`U.S.C.C.A.N. 2647, 2647; see 36 U.S.C. § 156.
`
`9
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`

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`Case 1:14-cv-02758-PAC Document 167 Filed 04/11/17 Page 10 of 18
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`32. The Act "emerged from Congress' efforts to balance two conflicting policy
`
`objectives: to induce name-brand pharmaceutical firms to make the investments necessary to
`
`research and develop new drug products, while simultaneously enabling competitors to bring
`
`cheaper, generic copies of those drugs to market.- Mvlan Pharms., Inc. v. Shalala, 81 F. Supp.
`
`2d 30, 32 (D.D.C. 2000) (citations omitted).
`
`33. The Act thus permits generic drug manufacturers seeking FDA approval to file
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`ANDAs that incorporate and rely on safety and efficacy data of prior applicants, "frequently the
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`holder[s] of a patent on the product." Merck & Co., Inc. v. Kessler, 80 F.3d 1543, 1546 (Fed.
`
`Cir. 1996). Testing and marketing of generic drugs "bioequivalent" to the -pioneer drug" are
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`dramatically expedited, and the policy objective of providing consumers more and lower-cost
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`generic drugs is furthered. Mylan, 81 F. Supp. at 31; see also Kessler, 80 F.3d at 1546.
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`34. In exchange for conferring this expedited treatment for generic producers and the
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`public, and for the delay in obtaining FDA approval, which prevents marketing of the patented
`
`drug while approval is pending, the Act provides patent holders a limited extended protection
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`term through a patent term extension period (a "Hatch-Waxman PTE"). See Kessler, 80 F.3d at
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`1547 (-This restoration period . . . ameliorates the loss incurred when patent terms tick away
`
`while the patented product is awaiting [FDA] regulatory approval for marketing." (internal
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`citations and quotations omitted)); see also 35 U.S.C. § 156.
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`35. An owner of multiple patents covering a regulated pharmaceutical product may
`
`choose which patent will be extended. See 35 U.S.C. § 156(c)(4); Merck & Co., Inc. v. Hi-Tech
`
`Pharmacal Co., Inc., 482 F.3d 1317, 1323 (Fed. Cir. 2007).
`
`36. When specified conditions are met, statutory grant of a Hatch-Waxman PTE is
`
`mandatory. See Merck, 482 F.3d at 1322.
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`10
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`37. Amneal does not challenge the Hatch-Waxman PTE granted to the '336 patent.
`
`38. Merck controls this action. In Merck, to overcome a rejection of its '413 patent
`
`based on obviousness-type double patenting over claims of an earlier-expiring patent, Merck
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`terminally disclaimed the '413 patent over its earlier-expiring patent, making the two
`
`coterminous. See Merck, 482 F.3d at 1318-19. Merck subsequently obtained a Hatch-Waxman
`
`PTE for the '413 patent, and later asserted the '413 patent against the defendant. See id. at
`
`1319-21. The Federal Circuit rejected the defendant's argument that permitting the extension
`
`would eradicate the terminal disclaimer's effect. See id. at 1318,1324. It held that the extension
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`"may be applied to a patent subject to a terminal disclaimer .. . filed to overcome an
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`obviousness-type double-patenting rejection.- Id. at 1318. The Court explained that a Hatch-
`
`Waxman PTE does not -improperly uncouple- a patent from its terminal disclaimer: "[t]he
`
`expiration date of the patent set by the terminal disclaimer remains in place. The computation of
`
`a Hatch-Waxman patent term extension is from the expiration date resulting from the terminal
`
`disclaimer and not from the date the patent would have expired in the absence of the terminal
`
`disclaimer." Id. at 1322-23. Thus, despite the obviousness of the "413 patent's claims over the
`
`claims of Merck's earlier-expiring patent, the Court permitted the Hatch-Waxman PTE to extend
`
`the '413 patent past the expiration date in the terminal disclaimer. See id. at 1323 ("The purpose
`
`of the terminal disclaimer—to prevent extension of patent term for subject matter that would have
`
`been obvious over an earlier filed patent—remains fulfilled by virtue of the fact that the date from
`
`which any Hatch-Waxman extension is computed is the terminally disclaimed date.-).
`
`39. A similar procedural history exists here: Plaintiffs selected the '336 for a Hatch-
`
`Waxman PTE, and terminally disclaimed it over their earlier-expiring '259 patent.
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`11
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`40. It was never possible for Plaintiffs to terminally disclaim the '336 patent over
`
`the'130 patent, the expiration date of which was after both the '336 patent's original expiration
`
`date and its terminal disclaimer date.
`
`41. Under the Federal Circuit's holding in Merck, Amneal cannot rely on the later-
`
`expiring '130 patent to invalidate the PTE granted to the '336 patent. See Merck, 482 F.3d at
`
`1318-23.
`
`42. Amneal relies on Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208
`
`(Fed. Cir. 2014) for the proposition that actual expiration dates control whether one patent may
`
`be used as an obviousness-type double patenting reference for another. See Gilead, 753 F.2d at
`
`1215-17 (holding that a later issued, but earlier expiring patent could serve as a reference to
`
`invalidate an earlier issued, but later expiring patent, where patents had common owner).
`
`43. Accordingly, Amneal contends that since the '130 patent's expiration date is
`
`earlier than the '336 patent's expiration date as extended by the PTE, the '130 patent may be
`
`used as an obviousness-type double patenting reference.
`
`44. While Gilead clarified that the obviousness-type double patenting analysis
`
`requires a comparison of patent expiration dates, rather than patent issue dates, it did not address
`
`Hatch-Waxman PTEs. See id.
`
`45. Nor did the other decision relied on by Amneal, In re Fallaux, 564 F.3d 1313
`
`(Fed. Cir. 2009), address Hatch-Waxman PTEs. There, the Federal Circuit held that the Board of
`
`Patent Appeals and Interferences erred in applying the "one way test" instead of a "two way test"
`
`in analyzing obviousness-type double patenting. See id. at 1319.
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`12
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`46. Amneal cites In re Fallaux for one sentence of dicta that reads: "[i]n some cases
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`there may still be the possibility of an unjust time-wise extension of a patent arising from patent
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`term adjustment under § 154 or patent term extension under § 156." Id.
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`47. This language does not control; indeed, it does not even persuade. Amneal does
`
`not contest the validity of the PTE granted to the '336 patent, nor contend that it was unjust in
`
`any way. Moreover, the holding of In re Fallaux is irrelevant as to the effect a Hatch-Waxman
`
`PTE may have on the obviousness-type double patenting analysis.
`
`48. Accordingly, the obviousness-type double patenting doctrine does not invalidate
`
`the PTE granted to the '336 patent; and the '130 patent cannot serve as an obviousness-type
`
`double patenting reference. See Merck, 482 F.3d at 1318-23.
`
`C. (cid:9)
`
`Even if the '130 Patent Were a Proper Obviousness-Type Double Patenting
`
`Reference, Amneal Has Not Presented Clear and Convincing Evidence of
`
`Obviousness-Type Double Patenting
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`49. Even assuming that the '130 patent is a proper reference, Amneal still fails to
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`satisfy its burden to establish by clear and convincing evidence that the claims of the '336 patent
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`are invalid for obviousness-type double patenting over the claims of the '130 patent.
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`50. In conducting the obviousness-type double patenting analysis, the Court
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`determines the differences between the claims of the asserted reference patent and the claims of
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`the later patent.4 See Abbvie, 956 F. Supp. 2d at 474. The Court then determines whether those
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`Claim construction is not at issue in this action. See ECF 75 at 1-2 (this Court's November 4, 2015 Opinion and
`Order, issued after holding a Markman hearing, finding that claim construction is not necessary for either the '336
`patent or U.S. Patent No. 6,465,477 (no longer at issue in this litigation), as "Defendants have failed to raise an
`actual dispute regarding the proper scope of either patent claim").
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`13
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`differences render the claims of the later patent -patentably distinct" from the claims of the
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`reference patent. See id.
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`51. Amneal has not proved that the claims of the '336 patent are not patentably
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`distinct from - or that they are obvious in light of - the claims of the '130 patent.
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`1. (cid:9)
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`The Claims of the '130 and '336 Patents
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`52. Claim 1 of the '130 patent and claim 1 of the '336 patent claim different organic
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`chemical compounds.
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`2. (cid:9)
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`The Claims are Patentably Distinct and Amneal's Evidence of Alleged
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`Obviousness is Not Persuasive
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`53. Amneal relies on the testimony of Dr. Anthony Palmieri III for the proposition
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`that the claims of the '336 patent (describing the pitavastatin calcium salt) are obvious in view of
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`the claims of the '130 patent (describing the pitavastatin sodium salt). (Tr. at 45:18-46:4;
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`1777:19-1778:19).
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`54. But Dr. Palmieri does not have any degrees in chemistry or organic chemistry, nor
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`have any of his publications been directed towards chemistry or organic chemistry. (Tr. at 693-
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`95). Instead, his research and teaching are in pharmacy or pharmaceutics. (Tr. at 651-55).
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`Despite the fact that both the '130 and '336 patents are titled -Quinoline Type
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`Mevalonolactones," Dr. Palmieri conceded during cross-examination that he "could not recall
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`what a lactone was on the day of my deposition.- (Tr. at 699:19-20; see Palmieri Depn. Tr. at
`
`148 ("I don't, I don't recall. It's irrelevant to my. my conclusions in my reports .. . Any good
`
`scientist would go back to a reference."). Additional excerpts from Dr. Palmieri's deposition
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`demonstrated an inability to explain the difference between an enantiomer and a diastercomer
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`without requesting to first consult a reference, a position that he -st[ood] by" at trial. (Tr. at
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`14
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`(cid:9)
`(cid:9)
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`697-98; see Palmieri Depn. Tr. at 33-35 (-I don't recall sitting here today . I have a general
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`understanding . .. but I would want to go back to a general reference to be certain.-)). After
`
`taking a break in his deposition questioning, Dr. Palmieri was then able to provide an answer but
`
`claimed not to have consulted with counsel. (Tr. at 697-98, 722, 725-27; see Palmieri Depn. Tr.
`
`at 36-40).
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`55. Dr. Palmieri opined that it would have been obvious for a POSA to substitute
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`calcium for sodium in the pitavastatin sodium compound of claim I of the '130 patent, to prepare
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`the pitavastatin calcium compound of claim 1 of the '336 patent. (Tr. at 671-72; 675).
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`56. This opinion was largely based on the Berge reference (DTX-1245), which Dr.
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`Palmieri cited for the proposition that it was well-known in the art that sodium and calcium were
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`mutually interchangeable, frequently used, pharmaceutically acceptable salts. (Tr. at 671-74).
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`57. He testified that "a person looking at Berg[e] and through knowledge and
`
`experience would quickly understand that the two salt forms are essentially the same, you know,
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`and commonly used." (Tr. at 674:15-18).
`
`58. The Berge reference states, however, that -[c]hoosing the appropriate salt . • can
`
`be a very difficult task, since each salt imparts unique properties to the parent compound" and
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`that "[u]nfortunately, there is no reliable way of predicting the influence of a particular salt
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`species on the behavior of the parent compound." (DTX-1245 at PITADEF00000956).
`
`59. Further, one of Amneal's experts testified that pitavastatin sodium is distinct from
`
`pitavastatin calcium. (Test. of Dr. Kevin Roberts, Tr. at 823-24).5
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`5 Dr. Roberts opined this as part of his testimony regarding the '993 patent.
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`15
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`60. Dr. Palmieri also testified that a POSA would have had a "reasonable expectation
`
`of success in preparing calcium salts from the salts of the '130 patent claims" motivated by a
`
`desire "to improve solubility and other properties of the drug." (Tr. at 674-75).
`
`61. Another of Amneal's experts, who is an organic chemist and a professor of
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`chemistry, testified that "calcium salts are less soluble than sodium salts," and that "chemists
`
`would appreciate that the calcium salt is most likely to be le[ss] soluble.- (Test. of Dr. Jonathan
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`Sessler, Tr. at 1003; 101415).6
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`62. The Court cannot credit Dr. Palmieri's opinion that a POSA would have had a
`
`desire to substitute calcium for the sodium in the '130 patent, nor a reasonable expectation of
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`success in preparing calcium salts from the sodium salts of the '130 patent, to improve solubility.
`
`63. Dr. Palmieri's testimony does not suggest a credible reason to modify the
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`pitavastatin sodium in claim 1 of the '130 patent to make the pitavastatin calcium in claim 1 of
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`the '336 patent, nor does it sufficiently explain why a POSA would have had a reasonable
`
`expectation of success in doing so. His testimony that it would have been obvious to substitute
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`calcium for sodium does not satisfy Amnears burden of proving, by clear and convincing
`
`evidence, that claims of the '336 patent and the claims of the '130 patent are not patentably
`
`distinct.
`
`D. (cid:9)
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`Secondary Considerations
`
`64. Finally, even if Amneal had satisfied its burden of establishing a prima facie case
`
`of obviousness, Plaintiffs' objective evidence of non-obviousness would rebut such a case. See
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`Eli Lilly and Co. v. Tem Parenteral Meds. Inc., 689 F.3d 1368, 1381 (Fed. Cir. 2012).
`
`" Dr. Sessler stated this while testifying regarding the '993 patent.
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`16
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`65. Based on Dr. Bell's testimony, which the Court credits, Plaintiffs demonstrated
`
`that Livale provides advantages for, and meets long-felt needs of, certain patient
`
`subpopulations; that Livale has experienced commercial success; and that the marketing and
`
`promotion of Livale is directly tied to its unique features — specifically, its use of a non-
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`CYP450 metabolic pathway, which results in fewer drug-to-drug interactions. (Tr. 1528-1554).
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`66. The pitavastatin calcium compound in claim 1 of the '336 patent is embodied in
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`Livalo, and claim 2 covers its use in accordance with its approved label.
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`67. Plaintiffs have thus established a nexus between the '336 patent claims and the
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`success of Livalov. See Demaco Corp. v. F. Von. Langsdorff Licensing Ltd., 851 F.2d 1387,
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`1392 (Fed. Cir. 1988) ("A prima facie case of nexus is generally made out when the patentee
`
`shows both that there is commercial success, and that the thing (product or method) that is
`
`commercially successful is the invention disclosed and claimed in the patent."); see also Crocs,
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`Inc. v. Int '1 Trade Comm 'n., 598 F.3d 1294, 1310-11 (Fed. Cir. 2010).
`
`68. It is anomalous that so many defendants are seeking to use the ANDA process for
`
`the patented product Livalov and yet maintain that Livale has failed to achieve commercial
`
`success. The Court notes that five former defendants in this litigation involving the '336 patent
`
`have settled, indicative of industry acquiescence which "constitutes a strong showing of [the
`
`'336 patent's] validity." Moore Bus. Forms, Inc. v. Wallace Computer Servs., Inc., No. S88-359,
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`1989 WL 222974, at *17 (N.D. Ind. Dec. 14, 1989).
`
`69. Amneal has not rebutted Plaintiffs' showing of nonobviousness. Amneal has
`
`failed to prove by clear and convincing evidence that any of the '130 patent claims render either
`
`claim 1 or claim 2 of the '336 patent obvious under the doctrine of obviousness-type double
`
`patenting.
`
`17
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`CONCLUSION
`
`For the foregoing reasons, the Court concludes that Amneal has