BTG INTERNATION LIMITED v. AMNEAL PHARMACEUTICALS LLC, decided May 14, 2019, Claim Interpretation

U.S. Patent No. 8,822,438 is directed to treating cancer (pages 7-8). “Treatment” was interpreted to include eradication, removal, modification, management, or control of a tumor or primary, regional, or metastatic cancer cells or tissue and the minimization or delay of the spread of cancer (page 15). The claims, specification, and prosecution history teach that “treatment” includes both anti-cancer effects and reduction in side effects of a different cancer drug, not just anti-cancer effects (pages 15-16). The claim recites a therapeutically effective amount where such amount is taught in the specification as being effective for treating, so any definition must encompass the full range of therapeutic agent’s effects (page 16). The specification indicates that a therapeutic agent may be an anti-cancer agent or a steroid, suggesting a meaning broader than just anti-cancer (pages 16-17). The prosecution history shows use to reduce toxicity of other drugs as treatment (pages 17-18).

Hindsight: For something as basic as “treatment” in pharmaceuticals, a definition broad enough to include reduction in side effects may be useful. Providing alternatives in the specification may help broaden the meaning.