The Solicitor General has urged the U.S. Supreme Court to deny GlaxoSmithKline's ("GSK's") pending certiorari petition in GlaxoSmithKline v. Classen Immunotherapies, Inc., case number 11-1078 The issue facing the Supreme Court should it grant GSK's petition is whether the Federal Circuit correctly interpreted 35 U.S.C. § 271(e)(1)'s safe harbor as applying to only pre-market approval of generic counterparts. In its amicus brief submitted late last week, the Solicitor General explained that there is no need to clarify the safe harbor provision and voiced concerns that the Classen case would not be the proper vehicle to do so should the Supreme Court feel the need.
The dispute between GSK and Classen involves three patents, U.S. Patent Nos. 6,638,739, 6,420,139, and 5,723,283, which relate to methods of optimizing vaccine immunization schedules to decrease the risk of developing chronic immune-mediated disorders. Classen sued a number of defendants, including GSK, alleging infringement of its patents through various vaccination research projects. GSK's allegedly infringing activities related to its participation in a government study that evaluated a suggested association between the timing of childhood vaccinations and the risk of developing type 1 diabetes. GSK argued, and the district court agreed, that such activity was within section 271(e)(1)'s safe harbor because the information was ultimately submitted to FDA. On appeal, the Federal Circuit reversed, holding that section 271(e)(1) "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained." Classen Immunotherapies, Inc. v. Biogen Idec at 1070. The Federal Circuit further explained, "§ 271(e)(1) is directed to premarketing approval of generic counterparts before patent expiration." Id. at 1071.
In the amicus brief, United States Solicitor General Donald Verrilli expressed his belief that the Federal Circuit's interpretation of § 271(e)(1) in Classen was incorrect. 35 U.S.C. 271(e)(1) reads:
It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.