IP Law Daily Vitamin Health infringed Bausch & Lomb’s patent on retinal health nutritional supplement
Tuesday, July 26, 2016

Vitamin Health infringed Bausch & Lomb’s patent on retinal health nutritional supplement

By Robert Margolis, J.D.

Eight nutritional supplements sold by Vitamin Health, Inc., infringed a patent owned by Bausch & Lomb Inc. and Wyeth LLC (collectively, "Bausch & Lomb") for a nutritional supplement intended to promote retinal health, the federal district court in Rochester, New York, has held (Bausch & Lomb Inc. v. Vitamin Health, Inc., July 25, 2016, Feldman, J.).

Bausch & Lomb alleged that Vitamin Health infringed U.S. Patent Nos. 6,660,297 ("the ‘297 patent") and 8,603,522 ("the ‘522 patent"). The ‘297 patent, the only one at issue in the court’s decision, is a composition patent disclosing a "nutritional or dietary supplement composition" that reduces the risk of developing late stage or advanced age-related macular degeneration. The disclosed inventions stemmed from a ten-year study sponsored by the National Eye institute ("NEI") of the National Institutes of Health, which concluded that a nutritional supplement with certain doses of particular vitamins had a "protective effect" on eye health. The inventors of the ‘297 and ‘522 patents developed their inventions based on the NEI study.

Bausch & Lomb contended that Vitamin Health made and sold vitamin supplements that used, either literally or via equivalent formulations, Bausch & Lomb’s patented inventions. Claims 1, 19, and 31 of the ‘297 patent, for example, disclosed compositions of nutrients, quantified in terms of the recommended dietary allowance, intended to be taken daily. Bausch & Lomb alleged that certain of Vitamin Health’s products contained nutrient compositions that fall within the precise ranges disclosed by those claims, and thus literally infringed the ‘297 patent.

Busch & Lomb also asserted claims for false advertising and unfair competition in violation of the Lanham Act. 15 U.S.C. §1225(a). Bausch & Lomb sought summary judgment on its infringement claim concerning the ‘297 patent.

Patent infringement. In its Markman decision, the court construed a disputed term in the ‘297 and ‘522 patents—the phrase "on a daily dosage basis"—to mean "the total amount to be ingested in a day." Bausch & Lomb thus argued that Vitamin Health’s product labels and website contained instructions about amounts to be taken daily, and that those instructions met the "daily dosage" term in the ‘297 patent. The court agreed with Bausch & Lomb, finding that "no reasonable jury" could conclude that the term "daily dosage" is not found in Vitamin Health’s eight products.

The court rejected Vitamin Health’s assertion that the "printed matter" doctrine barred the court from considering the labels on its products. Under the printed matter doctrine, printed matter that was separate from the patentable invention (e.g., a label), is not patentable. Because the court was relying on Vitamin Health’s labels only to provide the context in which Vitamin Health intended its products to be used, it found Vitamin Health’s invocation of the doctrine unpersuasive.

The court also rejected Vitamin Health’s indefiniteness argument as to the "daily dosage" term because "infringement and invalidity" of a patent are separate issues, and even if the term were indefinite in a manner relevant to invalidity, "invalidity … is not a defense to infringement itself," the court noted, citing Commil USA, LLC v. Cisco Systems, Inc., ___ U.S. ___, 135 S.Ct. 1920, 1928 (2015).

As to whether Vitamin Health’s products infringed the ‘297 patent, Vitamin Health raised several arguments that the precise compositions of its products fell outside certain of that patent’s claims. The court rejected every one of those arguments.

The Court’s Markman decision had also construed the term "approximately 6 to 10 times the RDA of vitamin A in the form of beta-carotene"—which was included in claim 1 of the ‘297 patent— to mean "an amount of vitamin A in the form of beta-carotene that comes reasonably close to 6 to 10 times the RDA for vitamin A, but not less than 5 times the RDA for vitamin A."

Vitamin Health contended that four of its products did not infringe claim 1 because those products contained 5 times the RDA for vitamin A, and the court’sMarkman construction should be interpreted as excluding that composition. Vitamin Health argued that the limiting phrase "not less than 5 times the RDA for vitamin A" does not extend to the "explicitly-stated lower limit." The court held that Vitamin Health’s interpretation "defies logic" and "is belied by the construction’s unambiguous language."

The court also considered Vitamin Health’s arguments based on the amounts of lutein in its products to be contentions that claims 19 and 31 of the ‘297 patent were invalid for lack of written description and enablement. Because infringement "is an entirely separate question capable of determination without regard to" a patent’s validity, Medtronic, Inc. v. Cardiac Pacemakers, Inc., 721 F.2d 1563, 1583 (Fed. Cir. 1983), the court held that it "need not address Vitamin Health’s invalidity contentions."

The case is No. 13-CV-6498.

Attorneys: Damien N. Dombrowski (Fitzpatrick, Cella, Harper & Scinto) and Jerauld E. Brydges (Harter, Secrest, and Emery, LLP) for Bausch & Lomb Inc. and Wyeth LLC. Brian S. Tobin (Carlson, Gaskey & Olds, PC) and Peter J. Weishaar (McConville, Considine, Cooman & Morin, PC) for Vitamin Health, Inc.

Companies: Bausch & Lomb Incorporated; Wyeth LLC; Vitamin Health, Inc.

MainStory: TopStory Patent NewYorkNews

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