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Articles

Fish’s Terry Mahn Quoted in Bloomberg BNA’s Pharmaceutical Law & Industry Report “Biosimilars Policy, Accelerating Medical Breakthroughs Among Year’s Key Topics”

January 23, 2015

Articles

Fish’s Terry Mahn Quoted in Bloomberg BNA’s Pharmaceutical Law & Industry Report “Biosimilars Policy, Accelerating Medical Breakthroughs Among Year’s Key Topics”

January 23, 2015

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Terry G. Mahn (DC) was quoted in Bloomberg BNA’s Pharmaceutical Law & Industry Report, Legal/Regulatory Outlook.

New Ways to Challenge Patents. ‘‘In 2015, we expect to see more bio/pharma cases filed under the America Invents Act’s IPR procedures. As compared to Hatch-Waxman litigation, IPR would be a much a cheaper way to invalidate an Orange Book patent and may also lead to a quicker resolution. IPR could be a vehicle for non first-to-file generics to trigger 180 day-exclusivity or a forfeiture of exclusivity.’’

Generic Drug Labeling. Mahn said the generic drug labeling rule is ‘‘long overdue’’ but added that 2015 may ‘‘be the year that something finally happens with new FDA rules that will put generics at the same risk as pioneers under state failure to warn laws.”

State Biosimilar Laws. Mahn said that in 2015, biosimilar applicants will likely continue their efforts to keep their BLA and manufacturing data out of the hands of the pioneers, ‘‘mainly because they view the BPCIA confidentiality provisions to be inadequate as compared to a court protective order.’’

Under the BPCIA, if confidential access is refused, Mahn said, the pioneer can bring a declaratory judgment action for infringement of any composition or method patent (but not for process patents) pursuant to 35 USC 271(e)(2)(C)(ii). And, he said, the FDA would still be required to process the BLA, regardless of whether the patent exchange process is ever initiated. ‘‘We expect this to be the next battleground between pioneers and biosimilar applicants,’’ he said.

To read the entire article, click here.

Reproduced with permission from Pharmaceutical Law & Industry Report, 13 PLIR 79, 1/16/2015. Copyright 2015 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com.

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