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Claims Are Invalid Because an Advertisement Disclosed the Invention in a Printed Publication Before the Critical Date

November 19, 2009

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Last Month at the Federal Circuit - December 2009

Judges: Mayer (concurring), Lourie (author), Prost

[Appealed from: E.D. Texas, Judge Clark]

In Iovate Health Sciences, Inc. v. Bio-Engineered Supplements & Nutrition, Inc., No. 09-1018 (Fed. Cir. Nov. 19, 2009), the Federal Circuit affirmed the district court’s SJ order holding claims 1, 2, 5, 7, 8, 9, and 18 of U.S. Patent No. 6,100,287 (“the ’287 patent”) invalid as anticipated under 35 U.S.C. § 102(b) because the claimed invention was disclosed in a printed publication before the critical date.

The ’287 patent claims the use of nutritional supplements containing a ketoacid and an amino acid that is either cationic (positively charged) or dibasic (containing two basic groups) to enhance muscle performance or recovery from fatigue. Plaintiff Iovate Health Sciences, Inc. (“Iovate”) sued Bio-Engineered Supplements & Nutrition, Inc. and Medical Research Institute (collectively “BSN”), asserting infringement of the ’287 patent by certain of BSN’s nutritional products. The allegedly infringing products contain arginine alpha-ketoglutarate and are advertised to enhance muscle strength or resistance to muscle fatigue. The district court granted BSN’s motion for SJ, holding the asserted claims of the ’287 patent invalid under § 102(b) as anticipated by advertisements for Twinlab® Mass Fuel and Weider’s VICTORYTM Professional Protein published in Flex magazine before the critical date. Each ad included a list of ingredients, directions for administering the dietary supplement orally to humans, and marketing claims and testimonials from bodybuilders extolling the virtues of the product. The district court held that the ads established a public use and offer for sale under § 102(b), for they showed an actual product and stated that it was available for purchase in health food stores, in gyms, or through catalog.

On appeal, the Federal Circuit first considered whether the ads disclosed all the limitations of the asserted claims. The Court agreed with BSN that the Professional Protein ad disclosed each and every limitation of the claims asserted by Iovate. The Court found that there was no dispute that the Professional Protein ad disclosed a composition comprising a cationic or dibasic amino acid (ornithine) and a ketoacid (alpha-ketoglutarate) as well as the additional limitations found in the asserted dependent claims. The Court found it was also undisputed that the ad disclosed the administration of the nutritional supplement for the purpose of enhancing muscle performance or recovery from fatigue.

To avoid anticipation, the Court found that Iovate relied on conclusory expert testimony and attempted to increase the specificity of the language used in the claims’ preamble, “[a] method for enhancing muscle performance or recovery from fatigue.” The Court held that even assuming that the preamble limited the claims, there was no evidence that those skilled in the art of nutritional supplements used the term  “enhancing muscle performance” to exclude increasing muscle strength. The Court found that both the patent specification and Iovate’s infringement allegations referred to muscle strength as a proxy for this term, and Iovate repeatedly included BSN’s advertising claims of enhancing muscle strength to support its allegations of infringement by BSN’s products. Therefore, the Federal Circuit found no error in the district court’s finding that the Professional Protein ad’s statements regarding faster postexercise muscle recuperation and recovery were synonymous with “increasing muscle performance after muscle performance has been decreased by exercise,” especially given the absence of any time limit for recovery in the claims.

Iovate also sought to avoid anticipation by reading an effectiveness requirement into the preamble. But the Federal Circuit held that the ’287 patent claims did not restrict the administration of the claimed amino acid and ketoacid composition to any specific dosage or amount, or even an “effective amount.” Slip op. at 8-9. The Court found that the claims did not require any further measurement or determination of any result achieved by administering the claimed composition. Thus, the Federal Circuit held that the ad’s disclosure of a certain composition taken for a certain purpose sufficed for the purpose of anticipation. Furthermore, by looking into the instructions and the users’ quotations in the Professional Protein ad, the Court found that the ad taught taking a supplement containing the claimed ingredients as advertised was effective for increasing muscle performance and recovery after exercise. Thus, the Federal Circuit held that the Professional Protein ad disclosed each and every claim limitation.

Next, the Federal Circuit considered whether the Professional Protein ad enabled one of skill in the art to practice an embodiment of the claimed invention in June 1996. The Court found that all one of ordinary skill in the art would need to do to practice an embodiment of the invention would be to mix together the known ingredients listed in the ad and administer the composition as taught by the ad. The Court had already rejected Iovate’s argument that the claims required administering an effective amount of the claimed composition, but noted that the ad nevertheless taught the amount of protein an active athlete needs per day per kilogram of body weight and that Professional Protein should be taken once before and once after exercise. In addition, the Court found that the ’287 patent specification listed numerous pre-1996 publications teaching acceptable clinical dosages of the two claimed components, and also listed pre-1996 publications teaching the effects of the components’ administration on humans. Thus, the Federal Circuit held that the district court correctly concluded that a person of skill in the art, combining his or her knowledge of the art with the advertisement’s suggestions, would have considered the advertisement to be enabling.

In a brief concurring opinion, Judge Mayer noted that he also believed the products were on sale more than one year before the critical date under § 102(b).

Summary authored by Jin Zhang, Esq.