News

The March 2017 statistics issued by the United States Patent Trial and Appeal Board (PTAB) report that across all technologies, all challenged patent claims are found patentable in only 19 percent of inter partes review (IPR) final written decisions.1 This is an improvement over a low point of in only 13 percent of decisions between late 2015 and early 2016, but this percentage does little to assuage concerns that PTAB is a patent “death squad.” But there is good news for the pharmaceutical industry. The data concerning drug patents is more favorable: a smaller percentage of drug patent IPRs are instituted, and a higher percentage of drug patent IPRs survive final written decisions with all instituted claims intact. The initial data for IPR challenges to patents that are identified as reading on CDER-listed Biologic Drugs (Biologic Drug IPRs) is also looking promising. While the dataset remains very small, Biologic Drug patents are holding up in institutions and in final written decisions.

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Corinne Atton has experience litigating cases concerning a wide range of pharmaceuticals and biotechnology, including DNA sequences, DNA sequencing technologies, recombinant polypeptides, enzyme inhibitors, and antidiabetic drugs. She has a B.Sc. honors degree in Human Genetics.

Methodology

Information contained in the Venable 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 Venable Fitzpatrick BiologicsHQ database.

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