As of July 20, 2017, there have been at least 363 IPR petitions filed against patents that were listed in the FDA Orange Book, and 74 IPR petitions filed against patents that have been identified as reading on FDA Purple Book (CDER) listed biologic drugs. Of these 437 drug patent IPRs, 116 resulted in a final written decision (“FWD”). There are a number of lessons to be learned from these FWDs. We highlight here five of the most interesting:

– Eighty-Five Percent of Drug Patent FWDs Concerned Patents That Have Also Been Litigated

– Patent Claims Have Been Found Unpatentable in More Than Fifty Percent of Drug Patent FWDs

– Sixty-Two Percent of Drug Patent FWDs Have Been Duplicative FWDs With Identical Outcomes

– Drug Patents Challenged in Duplicative FWDs Are More Likely to be Found Unpatentable

– Challenged Claims in Biologic Drug Patents Are More Likely to be Found Unpatentable

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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. Corinne has a B.Sc. honors degree in Human Genetics.
Ha Kung Wong has extensive experience litigating a wide variety of pharmaceutical cases, including those concerning biologics used to treat rheumatoid arthritis and autoimmune disorders. He also has extensive experience consulting, conducting due diligence and licensing pharmaceutical portfolios. Ha Kung has a B.S. in Biochemistry and a B.S. in Chemistry.


    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( 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 ( 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 BiologicsHQ database.


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