In Iovate Health Sciences, Inc. vs. Bio-Engineered Supplements & Nutrition, Inc., 92 USPQ2d 1672 (Fed. Cir. 2009), Iovate is the exclusive licensee of U.S. Patent No. 6,100,287 (the ‘287 patent). The ‘287 patent is assigned to the University of Florida Research Foundation, Inc. The ‘287 patent was filed on Nov. 13, 1998 and claims priority from a provisional application filed on Nov. 13, 1997. The invention is directed to using nutritional supplements containing a ketoacid and either a cationic amino acid or a dibasic amino acid to improve muscle performance or recovery from fatigue.
Claims 2, 5, 7 and 8 of the ‘287 patent disclose various features defining the composition recited in claim 1, which recites “A method for enhancing muscle performance or recovery from fatigue wherein said method comprises administering a composition comprising a ketoacid and an amino acid wherein said amino acid is cationic or dibasic.” Additionally, claim 9 recites orally administering the composition, and claim 18 recites using the composition on humans.
Iovate sued BSN for the infringement of the ‘287 patent in March 2007 in the Eastern District of Texas. The allegedly infringing products contain arginine alpha keto-glutarate and are advertised as enhancing muscle strength or resistance to muscle fatigue. With respect to the recitations of claim 1 of the ‘287 patent, the District Court interpreted “enhancing muscle performance” to mean “increasing the ability of muscle to maintain required or expected force or power output,” and interpreted “recovery from fatigue” to mean “increasing muscle performance after muscle performance has been decreased by exercise.” BSN moved for summary judgment, asserting that the ‘287 patent was invalid because it was anticipated or rendered obvious by numerous amino acid and ketoacid nutritional supplements advertised in fitness periodicals.
The District Court granted BSN’s motion for summary judgment and found claims 1, 2, 5, 7, 8, 9 and 18 to be invalid under 35 U.S.C. §102(b) because they were anticipated by ads for TwinLab Mass Fuel and Weider’s VICTORY Professional Protein, as published in Flex magazine before the critical date of Nov. 13, 1996. The ads each included a list of respective ingredients and directions on how to orally administer the supplements to a human. Additionally, the ads described the supplements as generally accelerating muscle recovery, helping to increase muscle growth and helping muscles recuperate after exercise. The Professional Protein ad listed a price for the supplement and stated that the product was available at health food or nutritional stores. As such, the District Court held that the ads established public use and an offer for sale of the product under 35 U.S.C. §102(b). Furthermore, the District Court held that the ads disclosed all the limitations of the claims at issue and that the ads were enabling because a person of skill in the art would consider the disclosures in the ads in combination with the person of skill’s knowledge to be enabled.
The U.S. Court of Appeals for the Federal Circuit Court reviewed the District Court’s grant of summary judgment de novo. The Federal Circuit Court stated that, although the District Court and the involved parties discussed three factors listed under 35 U.S.C. 102(b), including printed publication, public use and on sale, the Federal Circuit Court would need to only affirm the District Court’s ruling as per one factor, and held that the Professional Protein advertisement clearly constitutes an anticipatory printed publication. With respect to the 35 U.S.C. §102(b) requirement of a printed publication, the involved parties did not dispute that the Professional Protein advertisement appeared in the Flex Magazine before the critical date of Nov. 13, 1996. In arriving at the holding, the Federal Circuit Court discussed two primary issues: a) the disclosure of each and every claim limitation; and b) enablement. The Federal Circuit Court stated that, to be anticipatory, the advertisement must “describe, either expressly or inherently, each and every claim limitation and enable one of skill in the art to practice an embodiment of the claimed invention without undue experimentation. In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009).”
In appealing, Iovate argued that there are genuine issues of material fact as per whether the Flex Magazine ads disclose all the limitations of the claims at issue, and specifically, as per the ads disclosing an effective method of “enhancing muscle performance or recovery from fatigue,” as claim 1 recites. Iovate relied upon the testimony of Dr. Ivy, their expert, who stated that the ads’ disclosures are not synonymous with and/or do not address limitations of claim 1 recited in the preamble. Additionally, Iovate relied upon Dr. Ivy’s opinion that those skilled in the art do not rely upon ads appearing in muscle magazines as per the effectiveness of advertised supplements because of false advertising and a lack of scientific testing in the industry.
BSN responded to Iovate’s argument by asserting that the preamble is either non-limiting or only recites the purpose for which the composition is taken, and thus, “enhancing muscle performance or recovery from fatigue” is not a functional or effective result. The Federal Circuit Court noted that BSN argued that the claims (1) recite “a method for” rather than “a method of”; (2) do not recite limiting amounts, concentrations or ranges; and (3) do not recite a step to measure an effect or result. Furthermore, BSN argued that there was no genuine issue of material fact as per the advertised supplements having the same purpose as claimed in the ‘287 patent.
The Federal Circuit Court stated that they “agree with BSN that the Professional Protein ad discloses each and every limitation of the claims asserted by Iovate,” and stated that it was undisputed that the ad disclosed the limitations of the claims as per the composition and the purpose of the administration of the supplement. The Federal Circuit Court went on to state that “[t]o avoid anticipation, Iovate relies on conclusory expert testimony and attempts to increase the specificity of the language used in the claims’ preamble. But even assuming that the preamble limits the claims, there is no evidence that those skilled in the art of nutritional supplements used the term “enhancing muscle performance” –and thus “increasing the ability of muscle to maintain required or expected force or power output” –to exclude increasing muscle strength. Such an argument borders on the frivolous.” In fact, the Federal Circuit Court noted that the specification of the ‘287 patent discussed improving muscle strength and that Iovate previously asserted that BSN’s ads’ claims of enhancing muscle strength support Iovate’s allegations that BSN products infringed on the ‘287 patent.
A per Iovate’s argument, which reads an effectiveness requirement into the preamble, the Federal Circuit Court noted that the ‘287 patent claims do not restrict elements of the composition to specific dosages, ranges, or even an “effective amount.” Thus, the Federal Circuit Court found that, with respect to the ‘287 patent claims, “the ad’s disclosure of a certain composition taken for a certain purpose suffices for the purpose of anticipation.” In summary, the Federal Circuit Court found that the Professional Protein ads disclose each and every claim limitation as a matter of law because the ads disclose that taking a supplement having the advertised ingredients is effective for increasing muscle performance and recovery after exercise.
With respect to enablement, Iovate argued that the District Court was incorrect to focus on whether a person of ordinary skill in the art could have made the advertised supplements rather than the invention of the ‘287 patent, and furthermore, that the record lacks evidence as per the ad teaching a person of skill in the art how to make a composition that is effective for enhancing muscle performance or recovery from fatigue. BSN argued that because the claims of the ‘287 patent did not recite concentration levels, ratios or percentages, one of skill in the art could practice the invention by buying the listed ingredients or the product itself and administer them as directed in the ad. Alternatively, BSN argued that determining relative amounts and doses was not undue experimentation.
The Federal Circuit Court agreed with BSN and stated that “all one of ordinary skill in the art would need to do to practice an embodiment of the invention is to mix together the known ingredients listed in the ad and administer the composition as taught by the ad. We have already rejected Iovate’s argument that the claims require administering an effective amount of the claimed composition.” The Federal Circuit Court went on to state that “even if the claims did require an effective amount, one of skill in the art would have been able to determine such an amount based on the ad and the knowledge in the art at the time,” because the ad teaches how much protein an active athlete needs per day per kilogram of body weight. Furthermore, the Federal Circuit Court noted that the ‘287 patent specification lists publications dating from before 1996 which teach clinical dosages of the components claimed in the ‘287 patent.
In summary, the Federal Circuit Court found that the Professional Protein ads constitute an anticipatory printed publication under 35 U.S.C. §102(b) and upheld the District Court’s grant of summary judgment because “no reasonable fact-finder could conclude other than that the Professional Protein ad discloses each limitation of the claimed method in an enabling manner.” Thus, the Federal Circuit Court affirmed the District Court’s decision that the asserted claims of the ‘287 patent were invalid.