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Articles

Fish's Terry Mahn Quoted in Bloomberg BNA's Pharmaceutical Law & Industry Report "Biosimilars Policy, Patents, Antitrust, Drug Compounding Among Year's Key Topics"

January 10, 2014

Articles

Fish's Terry Mahn Quoted in Bloomberg BNA's Pharmaceutical Law & Industry Report "Biosimilars Policy, Patents, Antitrust, Drug Compounding Among Year's Key Topics"

January 10, 2014

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Terry G. Mahn (DC) was quoted in Bloomberg BNA’s Pharmaceutical Law & Industry Report.

“2014 should see measurable progress and clarity from FDA on the biosimilar pathway under the BPCIA,” Terry Mahn, of Fish & Richardson’s Washington office, said. “We know that multiple biosimilar candidates are undergoing clinical testing and comparative analysis to compete with the blockbuster biologics, some of which are coming off patent protection,” he said, adding that the FDA is behind in getting information and guidance out to industry because it is learning on the job just like the biosimilar applicants themselves.

‘Skinny’ Labeling. Mahn predicted that in 2014, brands will start to fight back against so-called “skinny-labeled” generics by bringing infringement suits against generics.

“As compound patents expire, more and more drug development is being protected by method of use patents,” he said. “Under Hatch-Waxman, generics are allowed to carve use patents out of their labels—i.e. ‘skinny’ their labels—and still receive an AB rating from the FDA, provided they do not market their drugs for the patent-protected use.”

Because an AB-rated generic is fully substitutable for the brand for all approved uses, such skinny labeling effectively nullifies the brand’s method of use patent, he said. This practice costs brand manufacturers billions in lost profits on new drug discoveries every year, he said.

To read the entire article, click here.

Reproduced with permission from Pharmaceutical Law & Industry Report, 12 PLIR 56, 1/10/2014. Copyright 2014 by The Bureau of National Affairs, Inc. ( 800-372-1033 ) http://www.bna.com/

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