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Pfizer piled on more challenges to the validity of Roche’s patents covering the breast cancer therapy Herceptin Jan. 30, filing two new petitions for trials to the patent board ( Hospira, Inc. v. Baughman , P.T.A.B., No. IPR2017-00804, 1/30/17 ; Hospira v. Baughman , P.T.A.B., No. IPR2017-00805, 1/30/17 ).
That brings to five the number of petitions New York-based Pfizer’s subsidiary Hospira has filed in the past 10 days with the Patent and Trademark Office’s Patent Trial and Appeal Board to challenge some of Roche subsidiary Genentech’s Herceptin patents. The petitions seek inter partes review (IPR), an administrative patent challenge process created by the America Invents Act. The new IPR petitions question the validity of two patents related to the administration and dosage of Herceptin.
Hospira has a drug candidate for a biosimilar—a highly similar and likely less expensive version—of Herceptin, and in November 2016 announced that its biosimilar had met its primary goal in a phase III comparative safety and effectiveness study. In September, a U.K. court ruled in favor of Hospira and denied Genentech’s efforts to extend its protection for Herceptin through additional patents to prevent the launch of Hospira’s biosimilar candidate in that country 10 LSLR, 8/19/16 . Pfizer said in its IPR petitions Genentech is trying to do the same thing in the U.S.
“Pfizer is trying to clear the way toward a launch” of its own Herceptin biosimilar, Elizabeth Krutoholow, a Bloomberg Intelligence analyst, told Bloomberg BNA in a Jan. 31 e-mail. But she noted Pfizer hasn’t yet submitted its biosimilar application to the Food and Drug Administration. Krutoholow said Mylan could receive approval of its Herceptin biosimilar by Sept. 3 and, once the situation concerning Roche’s patents is clear, could be the first to launch a Herceptin biosimilar.
Competition for the Herceptin market from biosimilars by Mylan, Pfizer and other companies is expected to be fierce. Herceptin had global sales of $6.5 billion in 2015, according to Roche’s financials.
The latest Pfizer IPR petitions challenge U.S. Patent Nos. 6,627,196 and 7,371,379, both directed to the “treatment of disorders characterized by the overexpression of ErbB2 [gene]” by administering “an antibody that binds ErbB2.” They describe methods of administration and dosage for Herceptin.According to the petition on the ‘196 patent, the availability, safety and effectiveness of Herceptin (rhuMAb HER2) was well known from the time it reached the market in 1998. “The Herceptin Label would not only encourage a person of ordinary skill in the art at the time of the alleged invention [to] try extending the dosing interval for rhuMAb HER2 with a reasonable expectation of success, but the disclosed half-life information could be used to determine—using well-known pharmacokinetics equations—the appropriate loading and maintenance doses for such an extended interval,” the petition said.Pfizer made similar arguments in its petition concerning the ‘379 patent.The asserted claims of the ‘196 and ‘379 patents should be invalidated as obvious, the petitions said, asking the PTAB to institute a review.A spokeswoman for Roche, which is based in Switzerland, didn’t immediately respond to Bloomberg BNA’s e-mail request for comment.
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