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Sanofi Mature IP v. Mylan Labs., Ltd.

United States Court of Appeals for the Federal Circuit

February 5, 2019, Decided

2018-1203

Opinion

 [*989]  O'Malley, Circuit Judge.

This appeal involves U.S. Patent No. 8,927,592 ("the '592 patent"), which is assigned to Sanofi Mature IP ("Sanofi").1 In an inter partes review requested by Mylan Laboratories Limited, the U.S. Patent Trial and Appeal Board ("Board") invalidated claims 1-5 and 7-30 of the '592 patent. Mylan Labs. Ltd. v. Aventis Pharma S.A., IPR2016-712, 2017 Pat. App. LEXIS 11720, 2017 WL 4221400, at *2 (P.T.A.B. Sept. 21, 2017) ("'592 Decision"). The Board also denied Sanofi's contingent motion to amend claims 27-30. Id. Sanofi appeals the Board's denial of its motion. Because we conclude that the Board improperly placed the burden of proof on Sanofi to establish that its proposed claims were patentable and applied the wrong claim [**2]  construction in its analysis, we vacate its denial of the motion and remand for further proceedings consistent with this opinion.

I. Background

A. The '592 Patent

According to the '592 patent, prostate cancer is generally treated with hormone deprivation. '592 patent, col. 1, ll. 35-43. This can include surgery, e.g. castration. Id. But if prostate cancer metastasizes, i.e. spreads to other parts of the body, then castration is ineffective. And while other forms of hormone deprivation exist, the '592 patent explains that they do not "improve[] . . . survival time." Id. at col 1, ll. 40-43. Chemotherapy drugs, such as docetaxel, are therefore used, in combination with estramustine or prednisone, to treat castration resistant, metastatic prostate cancers. Id. at col. 1, ll. 62-65. Even then, however, patients can become resistant to docetaxel treatments. Id. at col. 2, ll. 11-13. These patients are then left with "limit[ed] . . . possible treatment options." Id.

The '592 patent purports to provide these patients—"patients with castration resistant metastatic prostate cancer who have been previously treated with docetaxel"—with a new treatment option. Id. at col. 2, ll. 18-24. This treatment involves administering an antitumoral agent, cabazitaxel, [**3]  in combination with a corticoid such as prednisone or prednisolone. Id. at col. 3, ll. 1-5.

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757 Fed. Appx. 988 *; 2019 U.S. App. LEXIS 3529 **

SANOFI MATURE IP, Appellant v. MYLAN LABORATORIES LIMITED, Appellee

Notice: THIS DECISION WAS ISSUED AS UNPUBLISHED OR NONPRECEDENTIAL AND MAY NOT BE CITED AS PRECEDENT. PLEASE REFER TO FEDERAL RULES OF APPELLATE PROCEDURE RULE 32.1 GOVERNING THE CITATION TO UNPUBLISHED OPINIONS.

Prior History:  [**1] Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. IPR2016-00712.

Disposition: VACATED AND REMANDED.

CORE TERMS

preamble, proposed claim, patients, survival, cabazitaxel, patentable, administering, prostate cancer, castration, prednisone, amend, docetaxel, resistant, recited, apneas, sleep, burden of proof, prednisolone, comprising, metastatic, corticoid, effective, hormone, vacate

Business & Corporate Compliance, US Patent & Trademark Office Proceedings, Patent Law, US Patent & Trademark Office Proceedings, Patent Law, Claims & Specifications, Claims, Evidence, Burdens of Proof, Allocation, Administrative Law, Judicial Review, Reviewability, Exhaustion of Remedies, Jurisdiction & Review, Agency Adjudication, Review of Initial Decisions, Jurisdiction & Review, Standards of Review, De Novo Review, Substantial Evidence, Claims, Claim Parts, Preambles