In Classen Immunotherapies v. Biogen, a patent eligibility case on remand from the Supreme Court, the Federal Circuit Court of Appeals decided last week that the 35 USC 271 patent safe harbor “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.”
Congress passed the Drug Price Competition and Patent Term Restoration Act (“Hatch-Waxman Act”) in 1984. The act included two critical provisions for pharmaceutical manufacturers: a patent term extension to allow for the FDA approval timeline, and a generic drug development safe harbor.
The infamous safe harbor, 35 USC 271 states: It shall not be an act of infringement to make, use, offer to sell, or sell within 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.
Classen claimed that Biogen and GlaxoSmithKline (GSK) infringed upon its methods of immunization patents by participating in post-approval studies "to evaluate suggested associations between childhood vaccinations ... and risk of developing type 1 diabetes; and to determine whether timing of vaccinations influences risk."
Biogen and GSK countered that they were protected under Section 271, but Classen asserted that the Section 271 safe harbor only applied to activities conducted to obtain pre-marketing approval of generic counterparts of patented inventions.
The Federal Circuit Court of Appeals agreed, finding, "Classen is correct, for [Section] 271(e)(1) provides an exception to the law of infringement in order to expedite development of information for regulatory approval of generic counterparts of patented products."
Judge Kimberly Moore disagreed, noting in her dissent that, "the question is not whether Congress intended to protect pre-approval activity - but whether the enacted legislation covers more than just pre-approval activity. The language Congress chose to enact and that was signed by the President is plain on its face. There is no "pre-approval" limitation."
What do you think? Should the Section 271 safe harbor be limited to pre-approval activities?
- Classen Immunotherapies v. Biogen IDEC et al (Federal Circuit Court of Appeals)
- 35 U.S.C. 271 (FindLaw)
- Diamond v. Diehr (FindLaw's CaseLaw)
- Classen Immunotherapies v. Biogen: The Broad, Broad Scope of Statutory Subject Matter (Patently-O)