Wednesday, February 20, 2013

Copying in ANDA Case Not Compelling Evidence of Nonobviousness

Following a bench trial, the court found that plaintiff's hepatitis drug patent was invalid as obvious even though defendant admitted to copying. "While some cases have declared that copying can be a forceful secondary consideration of nonobviousness in ANDA cases . . . this Court has concluded that in the Hatch-Waxman context, 'a showing of copying . . . is not compelling evidence [of nonobviousness].' Although [plaintiff] suggests that copying should be given more weight here since there were a number of other FDA-approved drugs to treat hepatitis B that [defendant] could have copied, at least one district court . . . has rejected copying as a compelling consideration in an ANDA case, even where the defendant could have chosen to copy another drug in the relevant market. . . . [I]n light of the incentive provided by the Hatch-Waxman Act for a company like [defendant] to copy entecavir, the force of that bare choice is diminished, as compared to what it might suggest in an industry without such a regulatory scheme."

Bristol-Myers Squibb Company v. Teva Pharmaceuticals USA Inc., et. al., 1-10-cv-00805 (DED February 11, 2013, Order) (Burke, M.J.).

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