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ARTICLE · 17 MARCH 2014

Federal Circuit Finds Easy Solution To Avodart Solvate Written Description Question

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Are claims that recite a "solvate" of a chemical compound invalid for lack of written description if the patent does not describe any specific solvates?

United StatesIntellectual Property
Courtenay Brinckerhoff
Courtenay Brinckerhoff
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Are claims that recite a "solvate" of a chemical compound invalid for lack of written description if the patent does not describe any specific solvates? In GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., the Federal Circuit said No, and upheld the district court's determination that the defendants had not proven that the claims were invalid.

The Patent at Issue

The patent at issue was GSK's U.S. Patent 5,565,467, which claims

17β-N-(2,5- bis(Trifluoromethyl))phenylcarbamoyl-4-aza-5α-androst-1-en-3-one or a pharmaceutically acceptable solvate thereof.

The claimed compound also is known as dutasteride.

The defendants had sought FDA approval of generic versions of GSK's Avodart® and/or Jalyn" products, which contain dutasteride and are approved for the treatment of benign prostatic hyperplasia. Thus, the underlying patent litigation was ANDA litigation brought pursuant to 35 USC § 271(e)(2).

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