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Articles

Fish’s Terry Mahn Quoted in Bloomberg BNA’s Pharmaceutical Law & Industry Report “Takeda, Colcrys Investors Appeal Ruling Upholding FDA’s Approval of Competing Drug”

February 18, 2015

Articles

Fish’s Terry Mahn Quoted in Bloomberg BNA’s Pharmaceutical Law & Industry Report “Takeda, Colcrys Investors Appeal Ruling Upholding FDA’s Approval of Competing Drug”

February 18, 2015

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Terry G. Mahn (DC) was quoted in Bloomberg BNA’s Pharmaceutical Law & Industry Report, “Takeda, Colcrys Investors Appeal Ruling Upholding FDA’s Approval of Competing Drug.” Japanese drugmaker Takeda Pharmaceutical Co., which makes the gout drug Colcrys (colchicine), and Elliott Associates LP, which has a right to royalties from Takeda’s Colcrys sales, are appealing a district court’s ruling that upheld the Food and Drug Administration’s approval of a competing gout treatment (Takeda Pharm. U.S.A., Inc. v. Burwell, D.C. Cir., Nos. 15-5021, 15-5022, appeal docketed 1/26/15; Elliott Associates LP v. Burwell, D.C. Cir., Nos. 15-5022, appeal docketed 1/26/15).

Terry G. Mahn, with Fish & Richardson in Washington, told Bloomberg BNA Jan. 28 that Jackson’s holding ‘‘threatens to gut the patent certification provisions in the 505(b)(2) application approval process for certain drugs.’’

‘‘The whole idea behind the Hatch-Waxman ‘right of reference’ was to ‘compensate’ the brand in some way for the use of its proprietary information for the benefit of a third party. That compensation arrangement was the patent certification process,’’ Mahn said.

‘‘If FDA can use brand data ‘already in its head’ for the benefit of a third party without regard to the patent certification process, Hatch-Waxman’s statutory balance starts to fall apart,’’ he added.

To read the entire article, click here.

Reproduced with permission from Pharmaceutical Law & Industry Report, 13 PLIR 130, 1/30/15. Copyright 2015 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com.

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