Nutritional supplement claims fail to meet utility requirement, according to Judge Engelmayer

George D. Petito et al. v. Puritan’s Pride, Inc. et al.

Case Number: 1:13-cv-08040-PAE

U.S. Patent No. 6,645,948 (“Nutritional composition for the treatment of connective tissue”) claims a “nutritional composition for the treatment of connective tissue in mammals comprising: a therapeutically effective amount of [1] a glucosamine salt, [2] chondroitin sulfate, [3] collagen, and [4] sodium hyaluronate.” The claimed ingredients work together, according to the patent, to “synergistically act as the chondroprotective agent” and “effectively provide foundational support for the creation of new body tissue and cartilage growth, facilitate chondrocyte synthesis, protect and maintain healthy muscle and tissue, increase hyaluronic acid concentrations, and reduce inflammation.”

The defendants challenged the claims for lack of utility and a failure to meet the written description requirement, and the court granted summary judgment on these grounds.

Concerning utility, the court concluded that In re ´318 Patent Infringement Litig., 583 F.3d 1317 (Fed. Cir. 2009) and Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318 (Fed. Cir. 2005) “instruct that a medical patent whose utility is not immediately apparent to a person of ordinary skill in the art demands a measure of proof. Such proof typically requires experimental results but may, in the rare case, be accomplished by analytical reasoning.”

The court noted that the patent’s results were not supported by experimental results—“whether human, animal, or in vitro.” Further, the court said that the patentee “only halfheartedly” argued that the patent can be sustained either by analytical reasoning or by belief in the patent’s efficacy held by a person of ordinary skill in the art. Accordingly, Judge Engelmayer concluded that the claims failed to meet the utility requirement.

The court also noted that the defendants framed their principal argument as one of written description, but that “[t]he leading cases in this area, however, treat this issue as principally one of utility.” Accordingly, the court led with the analysis guided by In re ´318 Patent Infringement and Rasmusson. However, the court also noted that “where an invention fails the utility requirement, it often will fail the written description requirement,” citing Boston Scientific Corp. v. Johnson & Johnson, 647 F.3d 1353, 1362 (Fed. Cir. 2011). The court found the claims at issue also invalid for failure to meet the written description requirement.

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