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.
According to Verrilli, the Federal Circuit’s interpretation is incorrect because nothing in the text of the statute limits § 271(e)(1)’s application to pre-market activities or generic products.
Despite his belief that the Federal Circuit erred in Classen, Verrilli offers three reasons why the Supreme Court should deny certiorari: (1) the Federal Circuit’s decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., sufficiently clarified and narrowed the Classen holding; (2) it is unclear whether the safe harbor applies to the types of patents at issue in the case; and (3) the petitioners are not entitled to the safe harbor protection regardless of the Supreme Court’s interpretation of the provision.
According to its amicus brief, the Solicitor General believes “the Federal Circuit has since clarified that its ruling in [Classen] does not limit application of the safe harbor provision to pre-approval activities relating to the marketing of generic drugs.” In Momenta, the Federal Circuit held that post-approval studies performed for the FDA fall within § 271(e)(1)’s safe harbor. The court explained that Classen did not turn on the “artificial distinction” between pre- and post-approval activities. Rather, Classen held that 271(e)(1) “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.” Because the Federal Circuit clarified Classen and recognized that 271(e)(1) was not limited to pre-approval activities for generic drugs, Verrilli claims there is “no practical reason” for the Supreme Court to intervene.
Another reason the Solicitor General gives for passing on the GSK appeal is the unsettled question of whether section 271(e)(1) applies to patented research methods, such as the patents at issue in Classen. The Solicitor recognizes that the statute refers to any “patented invention” but expresses doubt as to whether Congress meant for the safe harbor to protect drug makers from patent infringement claims relating to patented research tools In fact, the Federal Circuit has held that 271(e)(1) does not exempt the use of a patented research apparatus from infringement claims. Because this argument could decide the case without implicating Classen’s section 271(e)(1) interpretation, Verrilli urges the Supreme Court to withhold its review.
Finally, the Solicitor General argues that the Supreme Court should not hear this case because its opinion would not affect the outcome. While Verrilli disagrees with the Federal Circuit’s interpretation of the safe harbor provision, he does not disagree with the Federal Circuit’s reversal of the district court’s safe harbor ruling. According to the amicus brief, GSK’s “participation” in the government study was part of its regular business. “The fact that public health authorities ultimately gathered data about [GSK’s] sales does not mean that [GSK’s] alleged infringement of [Classen’s] patents retroactively became ‘reasonably related to the development and submission of information’ under the FDCA [Federal Food, Drug, and Cosmetic Act].” The Solicitor General argues that the allegedly infringing uses of the patented methods occurred in “the routine conduct of [GSK’s] business” and should not have implicated 271(e)(1)’s safe harbor provision; these uses were not “reasonably related to the development and submission of information under” a federal drug law. If Classen can ultimately prove these facts, Verrilli explains that section 271(e)(1)’s safe harbor will not protect GSK from infringement and thus this case will not provide an adequate forum for the Supreme Court to interpret that provision.