Gilead Defeats Mylan's Inter Partes Review Directed to Four Patents Protecting Blockbuster HIV Therapies
For the first time, the USPTO has denied institution of trials on all challenged claims in an inter partes review (“IPR”) of patents protecting pharmaceutical salts and prodrugs.
Fitzpatrick, Cella, Harper & Scinto and co-counsel secured wins for Gilead Sciences, Inc., defeating Mylan Pharmaceuticals’ challenges to four patents that protect Gilead’s blockbuster anti-HIV medicine, tenofovir disoproxil fumarate (“TDF”). TDF is recognized by the World Health Organization as one of the “essential medicines for the treatment and prevention of HIV.” TDF is sold as Viread® and forms the basis for the fixed-dose combination drugs Truvada®, Atripla®, Complera® and Stribild®. TDF is the fumarate salt of tenofovir disoproxil, which is itself a prodrug of tenofovir. The challenged patents cover the salt and the prodrug.
On December 9 and 17, 2014, the Patent Trial and Appeal Board (“PTAB”) rejected Mylan Pharmaceuticals’ petitions, filed in June 2014, for IPR of the Gilead patents. After Gilead’s attorneys from Fitzpatrick and co-counsel Irell & Manella, submitted Patent Owner’s Preliminary Responses, the PTAB declined to institute IPR proceedings on any challenged claims in those four petitions, finding no reasonable likelihood that Mylan would prevail on any of the challenged claims.
A win at this stage of the IPR proceedings is very uncommon for patent owners, as the PTAB infrequently declines to institute IPRs on all challenged claims—the PTAB’s latest statistics show that approximately 77 percent of IPR petitions are granted for at least one of the challenged claims. Gilead’s win is in contrast to another earlier challenge to a different prodrug, where the PTAB instituted an IPR on, and ultimately found obvious, patent claims protecting fosamprenavir, a prodrug used to treat HIV. Gilead’s win also marks the first denial of an IPR petition on a patent claim directed to a pharmaceutical salt.
The Fitzpatrick attorneys representing Gilead are Robert S. Schwartz, Ph.D.; Christopher P. Borello; Natalie D. Lieber; Scott A. McMurry, Ph.D. and Ed Sunwoo. 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. Fitzpatrick also represented Gilead in the prior litigations on the same patents, obtaining favorable settlements for Gilead in each.