Patents and Postapproval Batch Testing - Pharmaceutical Technology

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Patents and Postapproval Batch Testing
Can postapproval FDA filings immunize pharma companies from patent lawsuits?

Pharmaceutical Technology
Volume 36, Issue 12

Whether one can reconcile these two decisions, the Supreme Court could very well end up resolving the issue. GSK filed a petition for certiorari asking the Supreme Court to clarify "[w]hether the Federal Circuit's interpretation of 271(e)(1) [in Classen], which arbitrarily restricts the safe harbor to preapproval activities, is faithful to statutory text that contains no such limitation, and decisions of this Court rejecting similar efforts to impose extratextual limitations on the statute" (14). The Supreme Court may welcome the opportunity to provide its guidance on the scope of Hatch–Waxman's safe harbor—an issue the high court has addressed twice before (15)—especially in light of this seeming inconsistency in Federal Circuit precedent in this area of the law.

Kevin Murphy is a partner with the New York office of Frommer Lawrence and Haug LLP. Andrew Nason is an associate in the DC office of the same firm,
. The views expressed in this article are solely those of the authors and are not to be attributed to Frommer Lawrence and Haug LLP or any of its clients.


1. Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 669-71 (1990).

2. 35 U.S.C. � 271(e)(1) (2012).

3. 659 F.3d 1057, 1060, 1070 (Fed. Cir. 2011).

4. Ibid. at 1060.

5. Ibid. at 1070-72.

6. Ibid. at 1070.

7. 686 F.3d 1348 (Fed. Cir. 2012).

8. Ibid. at 1351.

9. Ibid. at 1353.

10. Ibid. at 1352-53.

11. Ibid. at 1354-55.

12. Ibid. at 1361-76.

13. Ibid. at 1357-58.

14. Petition for a Writ of Certiorari at i., GlaxoSmithKline v. Classen Immunotherapies, Inc., No. 11-1078 (U.S. Feb. 28, 2012).

15. Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 206-07 (2005); Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990).


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