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Novartis Pharmaceuticals Corp. v. West-Ward Pharmaceuticals International Ltd.

United States Court of Appeals, Federal Circuit

May 13, 2019

NOVARTIS PHARMACEUTICALS CORPORATION, NOVARTIS AG, Plaintiffs-Appellees
v.
WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED, Defendant-Appellant

          Appeal from the United States District Court for the District of Delaware in No. 1:15-cv-00474-RGA, Judge Richard G. Andrews.

          Christina A. L. Schwarz, Venable LLP, New York, NY, argued for plaintiffs-appellees. Also represented by Nicholas N. Kallas, Shannon Keough Clark, Laura Katherine Fishwick, Susanne Flanders, Jared Levi Stringham.

          David Zimmer, Goodwin Procter LLP, Boston, MA, argued for defendant-appellant. Also represented by Keith A. Zullow, Cindy Chang, Steven J. Bernstein, Michael B. Cottler, New York, NY; Natasha Elise Daughtrey, Los Angeles, CA; William M. Jay, Washington, DC.

          Before Stoll, Plager, and Clevenger, Circuit Judges.

          Stoll, Circuit Judge.

         West-Ward Pharmaceuticals International Ltd ("West-Ward")[1] appeals the decision of the United States District Court for the District of Delaware holding that claims 1-3 of U.S. Patent No. 8, 410, 131 would not have been obvious in view of the prior art. We conclude that the district court did not err in its nonobviousness determination and affirm.

         Background

         Novartis Pharmaceuticals Corp. and Novartis AG (collectively, "Novartis") own the '131 patent, which claims methods of using the compound everolimus to treat advanced renal cell carcinoma ("RCC"). Everolimus is the active ingredient in Novartis's Afinitor product. West-Ward's predecessor in interest filed an Abbreviated New Drug Application ("ANDA") seeking to manufacture and sell generic versions of Afinitor, and Novartis filed this patent infringement suit in response. After a bench trial, the district court ruled that West-Ward failed to prove by clear and convincing evidence that claims 1-3 of the '131 patent are invalid as obvious. Novartis Pharm. Corp. v. West-Ward Pharm. Int'l Ltd., 287 F.Supp.3d 505, 518 (D. Del. 2017) ("Decision"). West-Ward appeals the district court's nonobvious-ness ruling.

         I. Advanced RCC and the '131 Patent

         Advanced RCC is a cancer of the kidneys that has spread to other parts of the body. As of February 19, 2001-the priority date of the '131 patent-advanced RCC carried a poor prognosis and was known to be unpredictable and difficult to treat. At that time, the only FDA-approved drug for treating advanced RCC was the im-munostimulant interleukin-2, which was associated with poor response rates and toxicity in patients. Interferon alpha, another immunostimulant, was also administered to some patients in practice and was likewise shown to have poor response rates and toxicity. Numerous clinical trials investigating a wide range of treatment strategies for advanced RCC failed. Various chemotherapies, hormonal therapies, and immunotherapies had been unsuccessful. The prior art explained that "[a]dvanced RCC is characterized by a high level of resistance to all treatment modalities that have been studied." J.A. 2058. Cancer drugs in general had high failure rates for treatment of advanced RCC in clinical trials, with more than 70% of cancer drugs failing during phase II, and a majority of cancer drugs failing during phase III.

         The '131 patent covers methods of administering the compound everolimus to inhibit the growth of advanced RCC tumors. Claims 1-3 are at issue here. Everolimus is recited in claim 1 as formula I:

1. A method for inhibiting growth of solid excretory system tumors in a subject, said method consisting of administering to said subject a therapeutically effective amount of a compound of formula I
wherein
R1 is CH3,
R2 is -CH2-CH2-OH, and X is =O.
2.The method of claim 1 wherein the solid excretory system tumor is an advanced solid excretory system tumor.
3. The method of claim 1 wherein the solid excretory system tumor is a kidney tumor.

'131 patent col. 17 l. 43-col. 18 l. 29 (as amended by Certificate of Correction).

         II. mTOR Inhibitors

         Everolimus belongs to a class of compounds called mTOR inhibitors. These compounds bind intracellularly to and form a complex with the FK506 binding protein ("FKBP-12"). This complex then binds to and inhibits the activity of the mammalian target of rapamycin (mTOR) enzyme. By February 2001, the prior art disclosed that (1) compounds called mTOR inhibitors produced effects, such as inhibition of hypoxia-inducible factor 1 ("HIF-1"), that were hypothesized to inhibit tumor growth; (2) evero-limus was an mTOR inhibitor; and (3) temsirolimus, another mTOR inhibitor, had shown responses in RCC patients in phase I clinical trials. There was no data on the efficacy of everolimus to treat any type of cancer, let alone to treat advanced RCC.

         At the time of the priority date of the '131 patent, mTOR inhibitors were known in the art to have a variety of beneficial properties. Rapamycin, the first mTOR inhibitor, was known to have antimicrobial, immunosuppres-sive, and antitumor activities. Its poor solubility, however, precluded its development as an anti-cancer agent. Temsirolimus, another mTOR inhibitor and a derivative of rapamycin, was also known to exhibit antitumor properties. Temsirolimus showed improved solubility over ra-pamycin and demonstrated positive ...


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