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ARTICLE · 08 MARCH 2016

Pharmaceutical Preservative Patent Survives Indefiniteness Challenge

The defendants also argued that the claim term related to the U.S. Pharmacopoeia was indefinite.

United StatesIntellectual Property

Senju Pharma. Co. Ltd. v. Lupin Ltd.,
(D.N.J. November 18, 2015)

Applying the Supreme Court of the United States' new indefiniteness standard from Nautilus v. Biosig, the U.S. District Court for the District of New Jersey held three claim terms in a patent on a stabilized, opthalmic nonsteroidal anti-inflammatory drug (NSAID) not invalid for indefiniteness. Senju Pharma. Co. Ltd. v. Lupin Ltd., 2015 Markman 7302183 (D.N.J. 2015) (Simandle, C.J.). The court also construed the transitional phrase "consisting essentially of" as it relates to the addition of unclaimed active ingredients to a pharmaceutical formulation patent.

The case centered on a patent for bromfenac, an NSAID sold in eye-drop form for relieving pain and swelling associated with cataract surgery. In particular, this patent claimed a formulation of bromfenac that included a stabilizing surfactant, tyloxapol. The Markman hearing involved the construction of four claim terms: "in an amount sufficient

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