FDA Marketing Exclusivity Periods Limited To Same Active Moiety

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining the zone of FDA market exclusivity periods. The case originated from Otsuka’s Citizen’s Petition asserting that  FDA had improperly approved Alkermes’s Section 505(b)(2) application for Aristada® (aripiprazole lauroxil) before expiration of the exclusivity periods for Otsuka’s Abilify Maintena® (aripiprazole) product.

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CAFC Vacates USPTO Single Reference Obviousness Rejection For Inadequate Showing Of Expectation of Success

In a split decision with Judge Lourie dissenting, the Federal Circuit vacated an obviousness rejection that had been affirmed in an ex parte appeal to the USPTO Patent Trial and Appeal Board. The decision was rendered in In re Stepan Co., where the majority found inadequate explanation of the reasonable expectation of success elements of obviousness, and also found that the PTAB had “improperly shifted to Stepan the burden of proving patentability.”
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Federal Circuit Provides More Guidance On Biosimilar Patent Litigation

In Amgen Inc. v. Hospira, Inc.the Federal Circuit held that Amgen could not obtain discovery related to activities that might infringe a patent that it had not asserted in its biosimilar patent litigation against Hospira. In particular, the court held that it lacked jurisdiction—under the collateral order doctrine—over the district court’s denial of Amgen’s motion to compel discovery regarding the cell-culture medium Hospira uses to make its biosimilar product. The court also held that Amgen had failed to show its “clear and indisputable’” right to the information as required for a writ of mandamus.

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Federal Circuit Criticizes PTAB Reliance On Routine Testing

In Honeywell International, Inc. v. Mexichem Amanco Holdings S.A. DE C.V., the Federal Circuit vacated the decision of the USPTO Patent Trial and Appeal Board that invalidated Honeywell’s patent in an inter partes reexamination proceeding. The court’s decision could be important to applicants and patent owners facing obviousness rejections based on inherency and routine testing.


Any opinions expressed in this article are personal to the author and do not reflect the views of Foley & Lardner LLP, its partners, or its clients.


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A Look At The USPTO Patent Eligible Subject Matter Report

On July 24, 2017, the USPTO issued a 48-page report on Patent Eligible Subject Matter. The report summarizes key court decisions interpreting and applying 35 USC § 101, international views on eligible subject matter, and public comments and recommendations for addressing recent changes in this foundational issue of U.S. patent jurisprudence. While some have criticized the USPTO Patent Eligible Subject Matter report for failing to take a position on the issues or suggest any solutions, others have commended the concise summary of where things stand today. Continue reading this entry