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Mylan Nabs AIA Review Of 2 Patents For Teva's Copaxone
By Kelly Knaub
Law360, New York (August 26, 2015, 6:25 PM ET) -- The Patent Trial and Appeal Board granted Mylan Pharmaceuticals Inc.’s request for America Invents Act reviews of two patents licensed to Teva Pharmaceuticals USA Inc. for its multiple sclerosis drug Copaxone, saying Tuesday the patents are likely invalid as obvious.
In two separate decisions, the board said it will institute the inter partes reviews for U.S. Patent Nos. 8,399,413 B2 and 8,232,250 B2 at the request of Mylan, which filed the petition against the patents' assignee, Yeda Research & Development Co. Ltd.
“Upon considering the petition and preliminary response, we determine that petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of claims 1-20,” the PTAB said in the decision for the ‘413 patent. “Accordingly, we institute an inter partes review of those claims.”
Copaxone — a drug that earned $3.1 billion in sales last year — is at the heart of the U.S. Supreme Court's claim construction ruling known as Teva, which involved a different patent challenged by Sandoz Inc. In June, the Federal Circuit invalidated that patent on remand.
Sandoz has U.S. Food and Drug Administration approval for its version of Copaxone, while Mylan said in a statement Tuesday that it is waiting for the agency’s final approval.
"We believe that the patents at question are invalid and are pleased that, in instituting an inter partes review on all claims, the PTO has determined that there is a reasonable likelihood of prevailing on the invalidity assertion,” Mylan CEO Heather Bresch said. “We believe our generic version of Copaxone 40mg/mL represents an exciting first-to-file opportunity for Mylan."
Teva spokeswoman Nancy Leone said in an emailed statement that it is important to note that the two "Orange Book" patents, which expire in 2030, remain valid and enforceable.
She added that Teva is currently in litigation against all the filers of abbreviated new drug applications concerning the patents, and that the trial is scheduled for September 2016. The 30-month stays of FDA approval for the ANDAs are not affected by the IPR decisions and should remain in place through February 2017 according to the Hatch-Waxman Act, Leone said.
Mylan’s PTAB petitions show that it is a defendant in two pending suits brought by Teva over the two patents, in Delaware and West Virginia federal courts. Other defendants Teva has targeted over the patents include Sandoz, Dr. Reddy’s Laboratories Ltd., Synthon Pharmaceuticals Inc. and Amneal Pharmaceuticals LLC in Delaware, New Jersey and North Carolina federal courts.
“Teva is confident Copaxone will remain a proprietary, global market leading product for reduction in the frequency of relapses in [relapsing-remitting multiple sclerosis] patients over the product’s life cycle,” Leone said. “We believe that patients, physicians and payers will continue to value the efficacy, safety and tolerability of Copaxone.”
According to the decisions, RRMS is one of five main forms of multiple sclerosis, which is a chronic, autoimmune disease of the central nervous system. Patients who suffer from RRMS experience sporadic exacerbations or relapses and periods of remission, the decisions said.
The patents-in-suit are U.S. Patent Numbers 8,399,413 B2 and 8,232,250 B2.
Mylan is represented by Jeffrey W. Guise of Wilson Sonsini Goodrich & Rosati PC and Brandon M. White of Perkins Coie LLP.
