## United States Court of Appeals for the Federal Circuit

2009-1018 IOVATE HEALTH SCIENCES, INC. and UNIVERSITY OF FLORIDA RE SEARCH FOUNDATION, INC., Plaintiffs-Appellants,

v. BIO-ENGINEERED SUPPLEMENTS & NUTRITION, INC. (doing business as BSN, Inc.), Defendant-Appellee, and MEDICAL RESEARCH INSTITUTE, Defendant-Appellee.

Charles A. Weiss , Kenyon & Kenyon LLP, of New York, New York, argued for plaintiffs-appellants. Wi th him on the brief were Elizabeth A. Gardner and Cynthia Lambert Hardman

. Philip D. Segrest, Jr. , Husch Blackwell Sanders Welsh & Katz, of Chicago, Illinois, argued for defendant-appellee Bio-Engi neered Supplements & Nutrition, Inc. With him on the brief was Joseph E. Cwik . Of counsel on the brief was Jonathan J. Krit , Amin Talati, LLC, of Chicago, Illinois. Robert P. Latham , Jackson Walker L.L.P., of Da llas, Texas, argued for defendantappellee Medical Research Institute. With him on the brief was David T. Moran . Of counsel were Sara K. Borrelli and Alan B. Daughtry

. Appealed from: United States District C ourt for the Eastern District of Texas Judge Ron Clark

## United States Court of Appeals for the Federal Circuit

2009-1018

IOVATE HEALTH SCIENCES, INC. and UNIVERSITY OF FLORIDA RE SEARCH FOUNDATION, INC., Plaintiffs-Appellants,

v. BIO-ENGINEERED SUPPLEMEN TS & NUTRITION, INC. (doing business as BSN, Inc.), Defendant-Appellee, and

MEDICAL RESEARCH INSTITUTE, Defendant-Appellee.

Appeal from the United St ates District Court for the Eastern District of Texas in Case No. 9:07-CV-46, Judge Ron Clark.

____________________________

DECIDED: November 19, 2009

____________________________ Before MAYER, LOURIE, and PROST, Circuit Judges

. Opinion for the court filed by Circuit Judge LOURIE, in which Circuit Judges MAYER and PROST join. Concurring opinion filed by Circuit Judge MAYER. LOURIE, Circuit Judge

. Iovate Health Sciences, In c. (“Iovate”) and the University of Florida Research Foundation, Inc. (the “Foundatio n”) appeal from the summary judgment order of the United States District Court for th e Eastern District of Texas hold ing claims 1, 2, 5, 7, 8,9, and 18 of U.S. Patent 6,100,287 (“the ’287 patent”) inva lid as anticipated under 35 U.S.C. § 102(b). Iovate Health Sciences, Inc. v. Bio-Engineered Supplements & Nutrition, Inc. , No. 9:07-CV-46 (E.D. Tex. Aug. 27, 2008) (“Summary Judgment Order”). Because the invention claimed in the ’287 patent was disclosed in a printed publication before the critical date, we affirm the distri ct court’s decision. BACKGROUND The Foundation is the assi gnee and Iovate the exclus ive licensee of the ’287 patent, which 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 reco very from fatigue. Claim 1 reads as follows: 1. A method for enhancing muscle perfo rmance or recovery from fatigue wherein said method comprises admin istering a composition comprising a ketoacid and an amino acid wherein said amino acid is cationic or dibasic. Claims 2, 5, 7, and 8 all depend, directly or indirectly, from claim 1 and further define the composition: claim 2 requi res that the composition fu rther comprise a compound selected from glutamate, glut amine, or glycine; claim 5 r equires that the composition contain alpha-ketoisocaproic acid, or a sa lt thereof; claim 7 requires that the composition contain arginine; and claim 8 requi res that the amino acid and ketoacid be conjugated. Dependent claim 9 limits claim 1 to oral administration, and claim 18 limits claim 1 to use on a human. The ’287 pat ent was filed on November 13, 1998, and claims priority from a provisional application filed on November 13, 1997.In March 2007, Iovate brought suit in the Eastern District of Texas against BioEngineered Supplements & Nutrition, Inc. , d/b/a BSN, Inc. and Medical Research Institute (collectively, “BSN”), claiming in fringement of the ’287 patent by certain of

2009-1018 2BSN’s nutritional products. Th e allegedly infringing produc ts contain arginine alpha keto-glutarate and are advertised to, inter alia , enhance muscle strength or resistance to muscle fatigue. 1 The district court construed “enhancing muscle performance” to mean “increasing the ability of muscl e to maintain required or ex pected force or power output” and construed enhancing “recovery from fatigue” to mean “increasing muscle performance after muscle performance has been decreased by exercise.” BSN then moved for summary judgment of invalidity, asserting that the ’287 patent was anticipated or rendered obv ious by a number of amin o acid/ketoacid dietary supplements advertised in certain fitness periodicals. On August 27, 2008, the district court gr anted BSN’s motion, holding claims 1, 2, 5, 7, 8, 9, and 18 in valid under § 102(b) as anticipated by advertisements for TwinLab ®
Mass Fuel and Weider’s VICTORY TM Professional Prot ein published in Flex magazine before the November 13, 1996, critical date. 2 Each ad includes a list of ingredients, directions for administering the dietary s upplement orally to humans, and marketing claims and testimonials from bodybuilders extolling the vi rtues of the product. The Mass Fuel ad appeared in the June 1995 issue of Flex and describes a supplement that contains ornithine alpha-keto glutarate, keto-isocaproat e, glutamine, and alphaketoglutarates and that is designed to “ help promote muscle protein synthesis and

1 Flamma SpA initially joined Iovate as a plaintiff but was dismissed from the suit on October 4, 2007, after selling to Iova te all of its right, title, and interest in a second asserted patent, U.S. Patent 5,973,199 (“the ’199 patent ”), which claims certain hydrosoluble creatine salts. After the district court de nied BSN’s motion for summary judgment that the ’199 patent is invalid for obviousness, the parties stipulated that the ’199 patent is not invalid, is not unenforc eable, and is infringed by BSN’s products.

2 The district court denied summary judgment with respect to claims 10 and 12 of the ’287 patent. The parties stipul ated to a dismissal of those claims.

2009-1018 3growth”; “build[] thick, dense muscle mass”; and accelerate muscle recovery when taken mixed with water after weight-training. The ad urges athletes to look for the product at “fine health food stores” and gyms or to write for a free catal og, and it offers a free training video with purchase. The Prof essional Protein ad appeared the next year in the June 1996 issue of Flex . This ad describes a supplem ent that contains arginine aspartate, ornithine-alpha-ket oglutarate, alpha-ketoisocapr oic acid, and glutamine and that is taken with water before and after trai ning to increase muscle strength, size, and mass; to help muscles recuperate faster after exercise; and to “decrease[] the breakdown of muscle proteins” to “provide[] greater potentia l for post-workout recovery.” The ad also describes how the product is made, including the four steps used to isolate the protein components from milk whey; lists a price of $24.99; states that the product is available at GNC and other heal th food stores or by phone; instructs the user on the amount to take; and offers a manufacturer’s rebate of $5.00 for maili ng in a coupon with proof of purchase bef ore July 31, 1996. The district court held that the ads est ablished a public use and offer for sale under § 102(b), as they show an actual pr oduct and state that it is available for purchase in health food stores, gyms, or by ca talog. The court determined that the ads disclose all of the limitations of the asse rted claims, including each of the claimed chemical components as well as the stated function of oral adm inistration to a human to speed muscle recovery. And the court hel d that, assuming they needed to be, the ads were enabled under § 102(b) becaus e a person of skill in the art would, combining his or her knowledge with the ads’ suggestions, consider them to be enabled despite their failure to give precise amounts for each c hemical component contained in the product.

2009-1018 4On September 24, 2008, the district c ourt entered a consent judgment and order of dismissal disposing of al l the parties’ claims and count erclaims. Iovate timely appealed the district court’s grant of summa ry judgment of invalidity. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1). DISCUSSION We review the district cour t’s grant of summary judgment de novo under the same standards applied by the district court. Enzo Biochem, Inc. v. Gen-Probe, Inc. , 424 F.3d 1276, 1280 (Fed. Cir. 2 005). Summary judgment is ap propriate if there are no genuine issues of material fact and the moving party is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(c) . Patents enjoy a presumption of validity, 35 U.S.C. § 282 (2006), and a party seeking to invalidate a pat ent must overcome this presumption by facts supported by clear and convincing evidence. Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc. , 246 F.3d 1368, 1374 (Fed. Cir. 2001). While the district court’s decision and the parties’ ar guments discuss three of the grounds listed in § 102(b)— printed publication, pu blic use, and on sale —we need affirm the dist rict court’s decision on only a single ground, and we conclude that the Professional Protein advertisement clearly constitutes an antic ipatory printed publication. 3 Section 102(b) provides t hat “[a] person shall be enti tled to a patent unless . . . the invention was . . . described in a printed pub lication in this or a foreign country . . . more than one year prior to the date of the appl ication for patent in the United States.” 35 U.S.C. § 102(b). To qualif y as a printed publication, the Professional Protein ad

3 Because it is undisputed that the Mass Fuel ad does not disclose a composition containing arginine as required by dependent clai m 7, we rely solely on the Professional Protein ad.

2009-1018 5must have been disseminated or otherwise m ade accessible to persons interested and ordinarily skilled in the subject matter to which the ads relate prior to the critical date. Kyocera Wireless Corp. v. Int’l Trade Comm'n , 545 F.3d 1340, 1350 (Fed. Cir. 2008). Here the parties do not dispute that the Professional Protein ad was published in Flex and that the magazine was accessible to thos e interested in the art of nutritional supplements prior to November 13, 1996. To be anticipatory, the ad must also describe, either expressly or inherently, each and every cl aim 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).
A. Disclosure of Each and Every Claim Limitation On appeal, Iovate argues that there are genui ne issues of material fact regarding whether the Flex ads disclose all the limitations of the asserted ’287 patent claims and, specifically, whether the Professional Protein ad discloses an effective method of “enhancing muscle performance or recovery from fatigue.” 4 Iovate points to the testimony of its expert, Dr . Ivy, who opined that the Mass Fuel ad’s disclosure of “promot[ing] muscle synthesis and growth” is not synonymous with “enhancing muscle performance” and that the Pr ofessional Protein ad’s general concepts of muscle “recuperation” and “post-workout recovery ” do not address the claim term enhancing “recovery from fatigue” as construed to mean “increasing muscle performance after muscle performance has been decreased by exerci se” but rather as recovery from one

4 Iovate also argues that there are genuine issues of material fact regarding whether the advertisements meet the “conjugated” limitation of depe ndent claim 8. Because Iovate admitted that the listed ingr edient ornithine-alpha- ketoglutarate is an amino acid conjugated with a ketoacid in its opposition to BSN’s motion for summary judgment of invalidity, we decline to address this argument on appeal.

2009-1018 6workout to the next. Furthermo re, according to Dr. Ivy, those skilled in the art do not ordinarily rely on advertisements in muscle magazines to prove the effectiveness of a nutritional supplement because of the lack of scientific testi ng and the existence of false advertising in the industry. BSN responds that the claim preamble is either non-limiting or expresses only the purpose for which the composition is tak en, not a functional or effective result. Specifically, BSN points to the fact t hat the claims (1) recite a “method for ” rather than a “method of enhancing muscle performance or recovery from fatigue”; (2 ) are not limited to “an effective amount” or any particular r ange, amount, or concentr ation of ingredients; and (3) do not include a step in which the in tended effect is either measured or achieved. Furthermore, BSN contends, there is no genuine issue of material fact that both prior art supplements were advertised fo r exactly the same purpose as claimed in the ’287 patent. We agree with BSN that t he Professional Protein ad discloses each and every limitation of the claims asserted by Iovate. There is no dispute that the Professional Protein ad discloses a composition comp rising a cationic or dibasic amino acid (ornithine) and a ketoacid (alp ha-ketoglutarate) as well as the additional limitations found in claims 2 (glutamine), 5 (alpha-ketois ocaproic acid), 7 (arginine), 8 (conjugated amino acid and ketoacid, here ornithine-alpha-ketoglutarate), 9 (administered orally), and 18 (used on a human). It is also undisput ed that the ad discloses the administration of the nutritional supplement for the pur pose of enhancing muscle performance or recovery from fatigue (by building muscl e strength, promoting muscle growth, and achieving faster recuperation and post-workout recovery).

2009-1018 7To avoid anticipation, Iovate relies on c onclusory 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 t hat those skilled in the art of nutritional supplements used t he term “enhancing muscle performance”—and thus “increasing the ability of muscle to ma intain required or expected force or power output”—to exclude increasing muscle str ength. Such an argument borders on the frivolous. In fact, both the patent specific ation and Iovate’s infringement allegations refer to muscle strength as a proxy for this term. Specifically , the specification describes the invention as directed to “me thods and compositions for enhancing muscle performance . . . [and m]ore specifically . . . a unique metabolic intervention to improve athletic dynamic muscle strength and muscle work.” ’287 Pa tent col.5 l.66–col.6 l.3 (emphasis added). And Iovate repeatedly includes BSN’s advertising claims of enhancing muscle strength to suppor t its allegations of infri ngement by BSN’s products. See Bristol-Myers , 246 F.3d at 1378 (“[I]t is axiomatic that that which would literally infringe if later anticipates if earlier.”). Moreover, although only one of the stated purposes needs to be disclosed for anticipation, we also can discern no error in the district court’s finding that the Professional Protein ad’s statement s regarding faster post-exercise muscle recuperation and reco very are synonymous with “increasing muscle performance after muscle perfo rmance has been decreased by exercise,” especially given the absence of any time limit for recovery in the claims. Iovate also seeks to avoid anticipation by reading an effe ctiveness requirement into the preamble, which, it argues, the ads fail to disclo se. But the ’287 patent claims do not restrict the administration of the clai med amino acid and ketoacid composition to

2009-1018 8any specific dosage or amount, or even an “effe ctive amount.” The cl aims also do not require any further measurement or de termination of any result achieved by administering the claimed composition. Thus, the ad’ s disclosure of a certain composition taken for a certain purpose su ffices for the purpose of anticipation. BristolMyers , 246 F.3d at 1378; see also Gleave , 560 F.3d at 1336 (“[W]here the claims themselves do not require a particular acti vity, we have no call to require something more from the anticipating refe rence.”). But even if the cl aims did require an effective amount, the Professional Protein ad instructs t he reader that “active athletes need up to 2.0 g protein per 1 kg of body weight daily ” and that Professional Protein should be taken once, two to three hours before and once about one hour after exercise. And, according to the users quoted in the ad, “I re ly on Professional Protein as I strive to increase strength and size” and “I take [Professional Pr otein] one hour before my workout, and it . . . helps me recuperate faster from my workouts.” Thus, regardless of any questions about false advertising, the ad teaches that taking a supplement containing the claimed ingr edients as advertised is effective for increasing muscle performance and recovery after exercise. As su ch, we find that the Professional Protein ad discloses each and every claim lim itation as a matter of law. B. Enablement We next consider whether the Professiona l Protein ad enabled one of skill in the art to practice an embodiment of the claimed invention in June of 1996. Iovate argues that the district court erroneously focused on whether a person of or dinary skill in the art could have made the advertis ed supplements rather than the claimed invention. Furthermore, Iovate contends, the record lacks any evidence that the ad taught a skilled

2009-1018 9artisan how to make a composition effe ctive for enhancing muscle performance or recovery from fatigue because the ads lack any guidance on appropriate ingredient dosages. BSN responds that because the claims are not directed to any particular concentrations, ratios, or percentages, one of sk ill in the art could practice the invention by buying the individual ingred ients, or more simply the product itself, and administering them as directed by the ad for the purposes re cited. BSN argues in the alternative that determining the relative amounts and dosages of the disclosed compounds would not amount to undue experimentation. We agree with BSN that all one of ordinary skill in t he art would need to do to practice an embodiment of the invention is to mix together the known ingred ients listed in the ad and administer the composition as t aught by the ad. We have already rejected Iovate’s argument that the claims require administering an effective amount of the claimed composition. But even if the claims did require an effective amount, one of skill in the art would have been able to dete rmine such an amount based on the ad and the knowledge in the art at the ti me. Again, the ad teaches the amount of protein an active athlete needs per day per kil ogram of body weight and that Professi onal Protein should be taken once before and once after exercise. In addition, the ’287 patent specification lists numerous pre-1996 publicati ons that teach acceptable clinical dosages of the two claimed components. ’287 Patent col.8 ll.21-53. It also lists pre-1996 publications that teach the effects of the co mponents’ administrat ion on humans, including, for example, (1) a dietary intervention with analogs of ket oacids and diabasic amino acids that aids patients with eroding muscle mass, id. col.2 ll.50-58; and (2) ketoacid/amino acid

2009-1018 102009-1018 11 complexes that, inter alia , improve muscle trauma recovery time and alter muscle protein synthesis following exercise, id. col.2 l.65–col.3 l.10. Thus, contrary to Iovate’s assertions, the district court correctly conc luded, as do we, that a person of skill in the art, combining his or her knowledge of t he art with the advertisement’s suggestions, would have considered the adv ertisement to be enabled. See Bristol-Myers , 246 F.3d at 1379. Because no reasonable fact-finder co uld conclude other than that the Professional Protein ad discl oses each limitation of the claimed method in an enabling manner, it qualifies as a prin ted publication that invali dates the asserted claims. CONCLUSION The Professional Protein advertisement constitutes an anticipatory printed publication under § 102(b) that in validates the asserted claims of the ’287 patent. We therefore affirm the district court’s grant of summary judg ment in favor of BSN.
AFFIRMED

### UNITED STATES COURT OF APPEAL S FOR THE FEDERAL CIRCUIT

2009-1018

IOVATE HEALTH SCIENCES, INC. and UNIVERSITY OF FLORIDA RE SEARCH FOUNDATION, INC., Plaintiffs-Appellants,

v.

BIO-ENGINEERED SUPPLEMENTS & NUTRITION, INC. (doing business as BSN, Inc), Defendant-Appellee, and MEDICAL RESEARCH INSTITUTE, Defendant-Appellee.

Appeal from the United States District C ourt for the Eastern District of Texas in Case No. 9:07-CV-46, Judge Ron Clark.

MAYER, Circuit Judge , concurring. I join the opinion of the court. I also bel ieve the products were on sale more than one year before the critical date as contemplated by 35 U.S.C. § 102(b).