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Two decisions over the past year could have significant implications in how serial inter partes review petitions are handled by the Patent Trial and Appeal Board going forward. The first, General Plastic Industrial Co. v. Canon Kabushiki Kaisha, which laid out a seven-factor test to determine whether the PTAB will use its discretion not to review serial IPR petitions, was recently designated “precedential” by the PTAB. The second, the U.S. Supreme Court’s April 24, 2018, decision in SAS Institute Inc. v. Iancu, where the court held that the PTAB must determine the patentability of all challenged claims in a petition and can no longer issue final written decisions on only a partial list of challenged claims, could also have implications for how serial petitions are considered by the PTAB going forward. This article reviews how serial IPRs on patents covering biologic drugs could be affected by these decisions, based on trends over the last few years.

Bob Schwartz has extensive experience litigating biotechnology and pharmaceutical patents, including those relating to antibodies, protein biochemistry, molecular biology, genomics and proteomics.  Bob has a B.S. in Biology and a Ph.D. in Biochemistry.  As a Principal Investigator of grant-funded research he published more than 40 articles in peer-reviewed publications and 7 book chapters.
Fred Millet has litigated a variety of patents with a focus on biotechnology, chemistry, and pharmaceuticals, in particular concerning HIV/AIDS treatments.  Fred has a B.S. degree in Chemical Engineering.                                                             

METHODOLOGY

Information contained in the Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics Graphics are compiled from information contained in the Fitzpatrick BiologicsHQ database.

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