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ARTICLE · 08 JULY 2019

Federal Circuit Agrees "Pharmaceutical Composition" May Be Toxic

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The claim construction determinations in Mayne Pharma International Pty. Ltd. V. Merck Sharp & Dohme Corp. may leave stakeholders in the pharmaceutical space scratching their heads

United StatesIntellectual Property
Courtenay Brinckerhoff
Courtenay Brinckerhoff
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The claim construction determinations in Mayne Pharma International Pty. Ltd. V. Merck Sharp & Dohme Corp. may leave stakeholders in the pharmaceutical space scratching their heads, and highlights that it’s rarely possible to anticipate and avoid every claim construction issue that may be raised in a patent challenge. Indeed, a district court had agreed with the patent owner that the term “pharmaceutical composition” excluded toxic compositions and that the claimed pharmacokinetic profiles are achieved in humans. Nevertheless, both the USPTO Patent Trial and Appeal Board (PTAB) and the Federal Circuit construed the claims more broadly. 

The Patent At Issue 

The patent at issue was Mayne’s U.S. Patent 6,881,745, directed to “Pharmaceutical compositions for poorly soluble drugs.” The court treated claim 9 as representative:

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