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Pharmaceutical industry

Momenta Pharmaceuticals Sees Path to FDA Approval for Generic Copaxone

Strategic Insights

— 2 min read

Momenta Pharmaceuticals announced that the US Supreme Court has vacated a 2013 decision by the Court of Appeals for the Federal Circuit, which had found several patents for Copaxone (20 mg injection) invalid due to being indefinite. The Supreme Court has sent the case back to the Court of Appeals for the Federal Circuit to be reheard under a new standard of deference to the district court's findings of fact on issues of claim interpretation. Momenta believes the patents should be held invalid under the new standard and plans to aggressively pursue the case on remand. The company remains optimistic that the FDA will approve its Abbreviated New Drug Application (ANDA) for M356, a generic version of Copaxone, which could provide patients with a more affordable treatment option for multiple sclerosis.

Key Takeaways:

  • The US Supreme Court has vacated a 2013 decision by the Court of Appeals for the Federal Circuit, which had found several patents for Copaxone (20 mg injection) invalid due to being indefinite.
  • The Supreme Court has sent the case back to the Court of Appeals for the Federal Circuit to be reheard under a new standard of deference to the district court's findings of fact on issues of claim interpretation.
  • Momenta believes the patents should be held invalid under the new standard and plans to aggressively pursue the case on remand.
  • The company expects the Court of Appeals to rehear the case and issue a new decision within a year.
  • Momenta remains optimistic that the FDA will approve its Abbreviated New Drug Application (ANDA) for M356, a generic version of Copaxone, which could provide patients with a more affordable treatment option for multiple sclerosis.
  • M356 is a generic version of Copaxone (glatiramer acetate injection) developed in collaboration with Sandoz and currently under review by the FDA.
  • Copaxone is prescribed for patients with relapsing-remitting multiple sclerosis, a chronic disease of the central nervous system characterized by inflammation and neurodegeneration.
  • Copaxone is one of the leading products marketed for treating multiple sclerosis.

Statistics:

  • The case involved 9 patents, including 8 listed in the FDA Orange Book and 1 non-Orange Book patent.
  • The Court of Appeals for the Federal Circuit is expected to rehear the case and issue a new decision within a year.
  • If approved, M356 could provide patients with a more affordable treatment option for multiple sclerosis.
  • Copaxone is prescribed to patients with relapsing-remitting multiple sclerosis, a disease that affects approximately 2.3 million people worldwide.
  • Momenta's M356 is currently under review by the FDA.

Sources:

  • Momenta Pharmaceuticals
  • Contify.com

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