Heralded as a less expensive, faster way to challenge patents, inter partes review (IPR) before the US Patent Trial and Appeal Board (PTAB) has proven remarkably popular. IPR was first available on September 12 2012, and within days, the first petitions challenging patents listed in the US Food and Drug Administration Orange Book (small molecule drug patents) were filed. Seven years on and close to 500 such petitions have been filed. The data is insightful: the number of petitions filed per fiscal year peaked in 2015 and has since fallen; the institution rate has dropped from 87% in fiscal year 2013 to 62% in fiscal year 2019; survival rates vary by claim type – with compound claims, unsurprisingly, proving the strongest; novelty challenges have been few and generally unsuccessful; and 63% of final written decisions have been appealed to the US Court of Appeals for the Federal Circuit, which has affirmed almost all of them.

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    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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