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Ranbaxy and Vertex Settle Lexiva® IPR

November 24, 2013

Ranbaxy recently settled an inter partes review (IPR) proceeding, using a USPTO patent trial to avoid potentially costly Hatch-Waxman litigation. Ranbaxy Laboratories, Ltd v. Vertex Pharms., Inc., IPR2013-0024. Ranbaxy, an Indian-based company which develops and markets generic drugs, challenged the validity of Vertex’s U.S. Patent No. 6,436,989 for Lexiva®, an HIV protease inhibitor.  Vertex had previously asserted the ‘989 Patent against Mylan, in the district of Delaware on August 22, 2012 (Civ. No. 12-1065-RGA), but Ranbaxy was not a party to the litigation. Rather, a few months after the litigation had started, Ranbaxy filed a petition at the USPTO challenging all of the ‘989 patent claims as obvious over several prior art combinations. IPR2013-00024 (Paper No. 1).

The Board instituted the proceeding on March 5, 2013. (Paper No. 16). In finding “a reasonable likelihood that Ranbaxy would prevail with respect to at least” one claim, the Administrative Patent Judge undertook a “lead compound” analysis and determined that prior art provided an express reason for a skilled artisan to modify the lead compound to enhance its solubility, and therefore its bioavailability, by “forming a phosphate ester salt … by derivitizing a free hydroxyl positioned similarly to that of the free hydroxyl of [the lead compound],” with a reasonable expectation of success. (Id. at pp. 7-14).

On October 31, 2013, the parties jointly filed a motion to terminate the IPR, informing the Board that the parties had reached an agreement resolving the dispute and any potential Hatch-Waxman litigation on the patent between these parties. See Paper No. 69, pg. 1, emphasis added. Thus, only a few months after the proceeding was instituted, the parties were able to resolve the IPR, including any future potential litigation.

Interestingly, Mylan, who was sued only two months before Ranbxy’s petition was filed, did not elect to pursue an IPR proceeding involving the ‘989 Patent. Moreover, the Delaware Court denied Vertex’s motion to stay the litigation against Mylan pending the competition of the IPR with Ranbaxy. Vii Healthcare Co. et al. v. Mylan, Inc., Civ. No. 12-1065-RGA, (D. I. 59). Thus, Mylan’s litigation regarding the validity of the ‘989 patent will continue in the district court under the evidentiary burden of proving invalidity by clear and convincing evidence, whereas Ranbaxy’s preemptive petition effectively resolved its dispute with Vertex without resort to district court ANDA litigation. Generic drug applicants can thus advantageously use IPR in a strategy for resolving patent disputes based on the listing of patents in the Orange Book, as an alternative to district court litigation under the Hatch-Waxman Act.

Associate

Azy Kokabi

Email: akokabi@sughrue.com

Azy Kokabi focuses her practice on patent infringement litigation in Federal Courts, with particular experience in Hatch-Waxman patent infringement litigations. Ms. Kokabi’s practice also involves patent office trials, with a particular emphasis on inter partes review. Ms. Kokabi, a registered patent attorney, has served as counsel in multiple interference proceedings and related matters, before the Board of Patent Appeals and Interferences and the Court of Appeals for the Federal Circuit.

Ms. Kokabi also prosecutes patent applications covering biotechnology and medical devices, and has been involved in a number of reexamination proceedings and reissue applications before the United States Patent and Trademark Office. Prior to joining Sughrue Mion, Ms. Kokabi worked at a boutique law firm, where she focused on interference practice. She also served at the U.S. Patent and Trademark Office as an Examiner, where she was responsible for examining patent applications related to medical devices and surgical bandages and interned for the Honorable Judge Rader at the Court of Appeals for the Federal Circuit.