Gilead Defeats Mylan's IPR Challenges to Four Patents

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December 2014

Irell & Manella helped secure wins for biotechnology company Gilead Sciences Inc., defeating challenges brought by Mylan Pharmaceuticals to four Gilead patents related to the HIV drug tenofovir disoproxil fumarate (TDF), which is sold alone as Viread® and also forms the basis of the fixed-dose combination drug Truvada® and the single tablet regimens Atripla, Complera® and Stribild®. TDF is a key anti-HIV drug, recognized by the World Health Organization as one of the "essential medicines for the treatment and prevention of HIV." 

On December 9 and 17, the Patent Trial and Appeal Board (PTAB) rejected Mylan Pharmaceuticals’ petitions filed in June 2014 for inter partes review (IPR) of the four Gilead patents. The PTAB declined to institute IPR proceedings on all four petitions, ruling Mylan was unlikely to prevail on any of the claims challenged in the petitions. A win at this stage of the proceedings is uncommon for patent owners, as the U.S. Patent and Trademark Office rarely declines to institute IPRs. More than 75 percent of IPR petitions are granted and proceed to trial.

The Irell team representing Gilead Sciences includes Gary Frischling, Keith Orso and David McPhie.

The cases are Mylan Pharmaceuticals Inc. v. Gilead Sciences, Inc. (IPR2014-00885; IPR2014-00886; IPR2014-00887; and IPR2014-00888), pertaining to U.S. Patent Nos. 5,922,695; 5,935,946; 5,977,089; and 6,043,230.