The Amphastar case is concerned with the § 271(e)(2) Hatch-Waxman “safe harbor.”
35 U.S.C. § 271(e)(1) [Hatch-Waxman Act safe harbor] states that it “shall not be an act of infringement to … use … 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[.]”
Amphastar and others petitioned the Supreme Court on May 17, 2016 presenting the question: “Whether the safe harbor protects a generic drug manufacturer’s bioequivalence testing that is performed only as a condition of maintaining FDA approval and is documented in records that must be submitted to the FDA upon request.”
The Supreme Court denied Certiorari on October 3, 2016. [Order List]
Amphastar argued that the US Court of Appeals for the Federal Circuit (CAFC) interpreted the Safe Harbor provision of § 271(e)(1) too narrowly. The CAFC denied Amphastar safe harbor immunity from Momenta’s patent covering the only approved test for showing bioequivalence of Lovenox.
Amphastar Pharmaceuticals, Inc., et al. v. Momenta Pharmaceuticals, Inc., et al., No. 15-1402
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Battle of Lovenox Generics Brought to Supreme Court [Bloomberg BNA 5/20/2016]
Cert. Petition:No. 15-1402 (May 17, 2016)
