Wednesday, November 13, 2013

Pharmaceutical Resources, Inc. v. Roxane Laboratories, Inc. case brief

Pharmaceutical Resources, Inc. v. Roxane Laboratories, Inc. case brief summary
253 Fed. Appx. 26 (2007)

Plaintiff patent holder appealed from the United States District Court for the District of New Jersey's a grant of summary judgment of invalidity of the asserted claims in two patents in favor of the defendant, an alleged infringer. The patents concerned stable flocculated suspensions of megestrol acetate and methods for making such suspensions.

Both of the patents shared a common specification. The patent holder formulated a generic version of a third party's patented product. It sought to design around the third party's patent claims by utilizing other surfactants and wetting agents, using a much wider range of ingredients. The patent holder received a series of patents on its flocculated suspensions, including the two patents in suit. The alleged infringer moved for summary judgment, asserting that the claims of the two patents were invalid and unenforceable for lack of enablement.


  • The patent holder had sought extremely broad claims (using the wide range of ingredients) in a field of art that it acknowledged was highly unpredictable, and thus had a high burden to meet. 
  • A large part of the asserted claims' scope was thus directed toward inoperative embodiments. 
  • The number of inoperative combinations was significant when assessing the experimentation that an ordinarily skilled artisan would need to practice the claimed invention. 
  • The patent holder's enablement arguments were legally insufficient to raise a genuine issue of material fact as to whether the claims were enabled.

The judgment of the lower court was affirmed. The asserted claims of the two patents were invalid as a matter of law for lack of enablement.

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