Hatch-Waxman Safe Harbor Could Get Supreme Court Review
This article was originally published in The Pink Sheet Daily
Executive Summary
High court invites the Solicitor General to submit a brief after GlaxoSmithKline seeks review of a Federal Circuit finding that the safe harbor provision barring infringement claims only pertains to actions to obtain generic approvals; the ruling held GSK’s participation in a study on immunization schedules infringed Classen patents.
GlaxoSmithKline PLC may get a hearing before the Supreme Court as to whether it infringes Classen Inmmunotherapies Inc.’s patents on a method for determining a vaccine immunization schedule. On June 25 the court invited the Solicitor General to submit a brief expressing the views of the United States on the case.
At issue is the scope of the safe harbor provision of the Hatch-Waxman Act barring infringement claims. GSK petitioned the court to review a decision by the U.S. Court of Appeals for the Federal Circuit that limited the Section 271(e)(1) provision “to activities conducted to obtain pre-marketing approval of generic counterparts of patented inventions.”
GSK argues that the words “pre-marketing approval” and “generic” do not appear in the safe harbor provision and that certain information should not be excluded from the statute based on whether the research was conducted pre- or post-approval.
The Federal Circuit initially ruled that Classen’s patents were not patentable subject matter. But after the Supreme Court ruled in Bilski v. Kappos that the Federal Circuit’s test for determining what processes may be patented was too narrow it remanded the case for further consideration. On remand, the Federal Circuit found that Classen’s invention is patent-eligible and that GSK’s activities were excluded from the safe harbor (Also see "Bilski's Broad Sweep: Federal Circuit Says Vaccination Schedule Analysis Is Patentable" - Pink Sheet, 31 Aug, 2011.).
Classen’s patents state the method of determining the immunization schedule with the lowest risk for later occurrence of chronic immune-mediated disorders. Classen claimed GSK infringed its patents by participating in a study to evaluate an association between the administration schedules for childhood hepatitis B or influenza vaccinations and the later development of type 1 diabetes. GSK said the study concluded that there was no such association. Biogen IdecInc. and Merck & Co. Inc. were also named as defendants in the Federal Circuit litigation. The Federal Circuit upheld a district court decision’s grant of summary judgment for Merck, saying there was no evidence that Merck was involved in the study.
Ruling Could Hinder Development of New Medicines, PhRMA Says
The case has broad ramifications for the pharmaceutical industry. The Pharmaceutical Research and Manufacturers of America asserted in an amicus brief in support of GSK that the Federal Circuit’s decision threatens to hinder the development of new medicines and new uses for drugs. The association notes that FDA frequently requires manufacturers to conduct post-approval clinical trials to assess the safety and efficacy of an approved drug and that there are many situations in which a manufacturer would present additional information to the agency after obtaining approval.
“Innovator manufacturers develop and submit information to obtain marketing approval from the FDA just as generic manufacturers do, yet the Federal Circuit’s ruling suggests that only the latter group should receive protection,” PhRMA states. “But federal law provides a level playing field for innovators in this area, and they should not be denied the protection against infringement that the statute confers on all developers and submitters of FDA information – generic and innovator alike.”
In its brief opposing GSK’s position, Classen asserts that extending the safe harbor provision to encompass regulatory requirements after FDA approval “would provide pharmaceutical and medical device manufacturers with a complete defense to a claim of patent infringement that would last throughout the life of the patent or the life cycle of the drug or device, whichever expired first.”