Supreme Court Asked to Look at Bioequivalence Safe Harbor
The Supreme Court has been asked to review a Federal Circuit Appeals Court ruling that a statutory safe harbor does not apply to a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA approval. Attorneys Amy Hayden and Ewa Davison (Fenwick & West) write in an online blog post that the safe harbor provision at issue exempts certain pharmaceutical-related activities from patent infringement, saying that it “shall not be an act of infringement to make, use, or sell 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.”
The post notes that several drug manufacturers, including Momenta and Amphastar, sought to market generic versions of Lovenox (enoxaparin), an anticoagulant. FDA made ongoing ANDA approval contingent on bioequivalence testing for each batch of generic enoxaparin to show conformance with the United States Pharmacopeia standard. A dispute arose when Momenta alleged that Amphastar’s enoxaparin bioequivalence testing infringed its patent and sued Amphastar two days after it received FDA approval to market its generic Lovenox.
The appeals court rejected Amphastar’s argument that the bioequivalence testing did not infringe Momenta’s patent because it is protected by the safe harbor. The attorneys write that the court relied primarily on an earlier decision that held that the safe harbor does not apply to information that may be routinely reported to FDA long after marketing approval has been obtained.
The Federal Circuit determined that the information generated as each batch of drug substance is tested is routinely recorded and retained and thus not within the safe harbor scope. A contrary conclusion, the court said, would “result in manifest injustice,” by expanding the safe harbor to include activities related to ongoing commercial manufacture and sale.
Amphastar and other companies sued by Momenta argue that the Federal Circuit’s exclusion of routine testing from the safe harbor is nowhere supported in the law and conflicts with Supreme Court precedent mandating that the safe harbor be broadly construed to cover the entire statutory scheme of regulation. They also say that enoxaparin bioequivalence testing satisfies the safe harbor requirements because it is performed solely for purposes reasonably related to the development and submission of information to FDA.
The attorneys say that Momenta has countered that Amphastar’s post-approval bioequivalence testing is not “solely” and “reasonably related to the development and submission of information” to FDA. It says that while Amphastar is legally required to hold batch testing records for at least one year, the information generated is used to select enoxaparin batches for commercial sale, not to make an affirmative submission to FDA. Momenta also says that Amphastar and other generic competitors are not required to use Momenta’s patented process, but could use any “suitable means” to test generic enoxaparin batches.