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 to stabilize the first component" and "stable"; "satisfies the preservative efficacy of U.S. Pharmacopoeia as follows," followed by certain contamination benchmarks; and "consisting essentially of."

The defendants argued that the first set of terms, "sufficient to stabilize the [bromfenac]" and "stable" were indefinite because the claim did not provide any way of determining how much extra stability the tyloxapol needed to provide. The court disagreed. Instead, the court relied on a stability test from the examples that demonstrated specific storage conditions and the minimum stability results necessary to qualify as stable. The court held that the disclosure in the example defined the claim terms well enough to meet the Nautilus standard.

The defendants also argued that the claim term related to the U.S. Pharmacopoeia was indefinite. The term contained an internal contradiction because it referred to the U.S. Pharmacopoeia, but the contamination benchmarks listed corresponded to the European Pharmacopoeia. While the defendants contended that a person having ordinary skill in the art could not determine which Pharmacopoeia the patent meant, the court held that it could correct this inconsistency as an "obvious error". The court interpreted the standards as being the European Pharmacopoeia based on the fact that the patent's examples only contained references to the European standards.

Finally, the parties also disputed the meaning of the transitional phrase, "consisting essentially of." The parties agreed that the transitional phrase limited additional elements to those "that do not affect the basic and novel properties of the invention." However, they disagreed over whether the addition of unclaimed active ingredients necessarily affected the invention's basic and novel properties. Ultimately, the court sided with Defendants, holding that the addition of other active ingredients did not necessarily alter the invention's novel properties.

Pharmaceutical Preservative Patent Survives Indefiniteness Challenge

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