On February 17, the Federal District Court in the Central District of California dismissed the antitrust claims in a lawsuit between generic manufacturer Amphastar Pharmaceuticals, Inc. (Amphastar) and Aventis Pharma S.A. and Aventis Pharmaceuticals, Inc. (collectively, “Aventis”). Amphastar had alleged that Aventis engaged in anticompetitive conduct and unfair competition by obtaining and enforcing its patents through fraud and frivolously filing a citizen’s petition with the FDA. The court dismissed the claims because they either could not survive Noerr-Pennington immunity or failed to assert an antitrust injury.
Aventis holds the patent to enoxaparin, an anti-clotting drug that it sells under the brand-name Lovenox. In 2003, generic drug-maker Amphastar filed an Abbreviated New Drug Application (ANDA) with the FDA, requesting the right to market a generic version of the drug. As part of the application, Amphastar alleged that Aventis’ patent was invalid and would not be infringed by manufacture, use, or sale of the generic drug. Aventis then sued Amphastar for patent infringement, triggering a 30-month stay on the FDA’s decision on the ANDA under the Hatch- Waxman Act. Aventis also filed a citizen’s petition with the FDA, arguing that because enoxaparin’s molecular structure and chemical composition are not yet fully known (i.e., the drug is not “fully characterized”), Amphastar would have to establish that its manufacturing process was the same as Aventis’ in order to establish that it has the same active ingredient. If it could not do this, Aventis argued, Amphastar should have to submit to the full FDA approval process for new drugs.
Amphastar counterclaimed, alleging that Aventis’ lawsuit was sham litigation, filed for the purpose of delaying Amphastar’s market entry. It also claimed that the citizen’s petition was frivolous because Aventis had changed its manufacturing process many times and therefore its assertion that a different manufacturing process would preclude evaluating “sameness” was materially false.
Regulatory activities are generally protected by the Noerr-Pennington Doctrine, which immunizes First Amendment activities—such as filing a lawsuit and petitioning the government—from antitrust scrutiny. Here, however, the court held that Amphastar’s allegation of fraud on the PTO was insufficient because it had failed to plead adequately that the patent suit caused injury to competition that had harmed Amphastar. To demonstrate antitrust injury, Amphastar needed to allege that it was a competitor or ready to be a competitor in the market; according to the court, Amphastar never pled these facts and therefore failed to meet its burden of pleading antitrust injury.
The court also dismissed Amphastar’s allegations regarding the FDA petition, and held, among other things, that the filing of the citizen petition did not meet the standards necessary for the sham exception to Noerr-Pennington to apply.