shutterstock_96589270The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) amended Section 351(k) of the Public Health Service Act (42 U.S.C. § 262(k)) in providing ways to obtain licenses for certain biological products via abbreviated applications from the Food and Drug Administration (“FDA”) in order to market biosimilar products or interchangeable products for therapeutic uses.

In a recent case involving Apotex’s proposed biosimilar product to Amgen’s Neulasta® (pegfilgrastim). Amgen sought a preliminary injunction to enforce the Biologic Price Competition and Innovation Act (BPCIA) provision that requires an applicant to give notice 180 days before marketing an FDA-licensed product. In Amgen v. Sandoz, a divided Federal Circuit held that “the 180-day period runs from post-licensure notice.” In that case, the biosimilar applicant defaulted on the statutory process for exchanging patent information and channeling patent litigation (“information exchange”) required by 42 U.S.C. § 262(l), by not providing the reference product sponsor with a copy of the biosimilar application, as required by 42 U.S.C. § 262(l)(2)(A).
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Section 27 of the America Invents Act, passed on September 16, 2011, requires the USPTO to conduct a study on genetic testing and provide Congress with recommendations for providing confirmatory genetic diagnostic testing where those tests or the information needed to conduct those tests are covered by patents and exclusive licenses. Confirmatory genetic diagnostic testing is “the performance of a genetic diagnostic test, by a genetic diagnostic test provider, on an individual solely for the purpose of providing the individual with an independent confirmation of results obtained from another test provider’s prior performance of the test on the individual.”
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On July 21, 2015, the Federal Circuit issued its decision in Amgen v. Sandoz in-terpreting two key provisions in the Biologics Price Competition and Innovation Act (BPCIA).1 The case involved Sandoz’s Zarxio, a biosimilar drug to Amgen’s Neupogen and the first approved abbreviated biologics license application (ABLA) under the provisions of the BPCIA. Judges Newman, Lourie, and Chen were on the panel.
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In a previous blog post, we discussed the Federal Circuit’s reluctance to relinquish control of claim construction after the Supreme Court’s Teva1 ruling as exemplified in the Enzo2 decision. The trend continues with the Federal Circuit’s decision in Teva on remand from the Supreme Court just last month. A divided panel still found the asserted claims, specifically the term “molecular weight,”3 indefinite and therefore invalid, reversing the district court.4 The Supreme Court in Teva agreed with Teva that the Federal Circuit precedent5 of reviewing all aspects of claim construction de novo is inconsistent with Fed. R. Civ. P. 52(a)(6), which provides that factual findings of the district court may only be set aside if “clearly erroneous.”6 The Court explained that claim construction is ultimately a question of law, but subsidiary factual findings must be given deference and reviewed under the “clear error” standard of review.7 Also, while Teva was pending, the Supreme Court issued the Nautilus II8 decision, which modified the Federal Circuit’s “insolubly ambiguous” standard for indefiniteness under 35 U.S.C. § 112, ¶2 to a more stringent “reasonable certainty” standard.9
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