On July 19, 2018, co-counsel WilmerHale and Fish & Richardson secured a total victory for client Gilead Sciences, Inc. (Gilead) when the USPTO’s Patent Trial and Appeal Board (PTAB) denied institution of the tenth straight petition for inter partes review (IPR) of patents directed to Gilead’s Hepatitis C products, including the blockbuster drugs Sovaldi®, Harvoni® and Epclusa®, which have revolutionized the standard of care for patients suffering from Hepatitis C.

Starting in October of 2017, the Initiative for Medicines, Access & Knowledge, Inc. (I-MAK), an organization that has challenged the validity of Gilead's patents worldwide, filed 10 separate IPR petitions challenging eight different patents relating to sofosbuvir-based drugs, including Sovaldi®, Harvoni® and Epclusa®. In these challenges, I-MAK alleged that the claims of the patents were unpatentable in view of a wide array of prior art. WilmerHale and Fish & Richardson responded to the petitions by identifying the insufficiencies in I-MAK's arguments and explaining the patentability of the claimed inventions at the first opportunity provided by the PTAB. As a result, the PTAB denied each petition, determining that I-MAK had not presented a case where a single claim was likely invalid. The series of 10 for 10 denials by the PTAB across eight patents is particularly notable because the PTAB’s IPR institution rate for pharmaceutical patents is generally about 60%.

The legal team consisted of Dave Bassett, Vinita Ferrera, David Cavanaugh and Emily Whelan of WilmerHale and Dorothy Whelan, Michael Kane and Chad Shear of Fish & Richardson.