Iovate Health Sciences, Inc. v. Bio-Engineered Supplements & Nutrition, Inc.

United States Court of Appeals for the Federal Circuit
2009-1018

IOVATE HEALTH SCIENCES, INC.
and UNIVERSITY OF FLORIDA RESEARCH 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. With 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-Engineered 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 Dallas, Texas, argued for defendant-
appellee 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 Court 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 RESEARCH 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 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, Inc. (“Iovate”) and the University of Florida Research

Foundation, Inc. (the “Foundation”) appeal from the summary judgment order of the

United States District Court for the Eastern District of Texas holding claims 1, 2, 5, 7, 8,
9, and 18 of U.S. Patent 6,100,287 (“the ’287 patent”) invalid 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 district court’s decision.

BACKGROUND

The Foundation is the assignee and Iovate the exclusive 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 recovery from fatigue. Claim 1 reads as

follows:

1. 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.

Claims 2, 5, 7, and 8 all depend, directly or indirectly, from claim 1 and further define the

composition: claim 2 requires that the composition further comprise a compound

selected from glutamate, glutamine, or glycine; claim 5 requires that the composition

contain alpha-ketoisocaproic acid, or a salt thereof; claim 7 requires that the

composition contain arginine; and claim 8 requires 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 patent 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 Bio-

Engineered Supplements & Nutrition, Inc., d/b/a BSN, Inc. and Medical Research

Institute (collectively, “BSN”), claiming infringement of the ’287 patent by certain of

2009-1018 2
BSN’s nutritional products. The allegedly infringing products 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 muscle to maintain required or expected 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 obvious by a number of amino acid/ketoacid dietary

supplements advertised in certain fitness periodicals.

On August 27, 2008, the district court granted BSN’s motion, holding claims 1, 2,

5, 7, 8, 9, and 18 invalid under § 102(b) as anticipated by advertisements for TwinLab®

Mass Fuel and Weider’s VICTORYTM Professional Protein published in Flex magazine

before the November 13, 1996, critical date. 2 Each ad includes 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

Mass Fuel ad appeared in the June 1995 issue of Flex and describes a supplement that

contains ornithine alpha-ketoglutarate, keto-isocaproate, glutamine, and alpha-

ketoglutarates 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 Iovate 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 denied 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 unenforceable, 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 stipulated to a dismissal of those claims.

2009-1018 3
growth”; “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 catalog, and it offers a

free training video with purchase. The Professional Protein ad appeared the next year

in the June 1996 issue of Flex. This ad describes a supplement that contains arginine

aspartate, ornithine-alpha-ketoglutarate, alpha-ketoisocaproic acid, and glutamine and

that is taken with water before and after training 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 potential 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 health food stores or by phone; instructs the user on the

amount to take; and offers a manufacturer’s rebate of $5.00 for mailing in a coupon with

proof of purchase before July 31, 1996.

The district court held that the ads established a public use and offer for sale

under § 102(b), as they show an actual product and state that it is available for

purchase in health food stores, gyms, or by catalog. The court determined that the ads

disclose all of the limitations of the asserted claims, including each of the claimed

chemical components as well as the stated function of oral administration to a human to

speed muscle recovery. And the court held that, assuming they needed to be, the ads

were enabled under § 102(b) because 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 chemical component contained in the product.

2009-1018 4
 On September 24, 2008, the district court entered a consent judgment and order

of dismissal disposing of all the parties’ claims and counterclaims. Iovate timely

appealed the district court’s grant of summary judgment of invalidity. We have

jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).

DISCUSSION

We review the district court’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. 2005). Summary judgment is appropriate 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 patent 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’ arguments discuss three of the grounds listed in § 102(b)—

printed publication, public use, and on sale—we need affirm the district court’s decision

on only a single ground, and we conclude that the Professional Protein advertisement

clearly constitutes an anticipatory printed publication. 3

Section 102(b) provides that “[a] person shall be entitled to a patent unless . . .

the invention was . . . described in a printed publication in this or a foreign country . . .

more than one year prior to the date of the application for patent in the United States.”

35 U.S.C. § 102(b). To qualify 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 claim 7, we rely solely on the
Professional Protein ad.

2009-1018 5
must have been disseminated or otherwise made 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 those 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 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).

A. Disclosure of Each and Every Claim Limitation

On appeal, Iovate argues that there are genuine 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 Professional 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 exercise” 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 dependent claim 8.
Because Iovate admitted that the listed ingredient 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 6
workout to the next. Furthermore, 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 testing 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 taken, not a functional or effective result.

Specifically, BSN points to the fact that 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 range, amount, or concentration of ingredients;

and (3) do not include a step in which the intended effect is either measured or

achieved. Furthermore, BSN contends, there is no genuine issue of material fact that

both prior art supplements were advertised for exactly the same purpose as claimed in

the ’287 patent.

We agree with BSN that the 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 comprising a cationic or dibasic amino acid

(ornithine) and a ketoacid (alpha-ketoglutarate) as well as the additional limitations

found in claims 2 (glutamine), 5 (alpha-ketoisocaproic 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 undisputed that the ad discloses the administration

of the nutritional supplement for the purpose of enhancing muscle performance or

recovery from fatigue (by building muscle strength, promoting muscle growth, and

achieving faster recuperation and post-workout recovery).

2009-1018 7
 To 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, both the patent specification and Iovate’s infringement allegations

refer to muscle strength as a proxy for this term. Specifically, the specification

describes the invention as directed to “methods and compositions for enhancing muscle

performance . . . [and m]ore specifically . . . a unique metabolic intervention to improve

athletic dynamic muscle strength and muscle work.” ’287 Patent col.5 l.66–col.6 l.3

(emphasis added). And Iovate repeatedly includes BSN’s advertising claims of

enhancing muscle strength to support its allegations of infringement 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 statements regarding faster

post-exercise muscle recuperation and recovery are 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 seeks to avoid anticipation by reading an effectiveness requirement

into the preamble, which, it argues, the ads fail to disclose. But the ’287 patent claims

do not restrict the administration of the claimed amino acid and ketoacid composition to

2009-1018 8
any specific dosage or amount, or even an “effective amount.” The claims also do not

require any further measurement or determination of any result achieved by

administering the claimed composition. Thus, the ad’s disclosure of a certain

composition taken for a certain purpose suffices for the purpose of anticipation. Bristol-

Myers, 246 F.3d at 1378; see also Gleave, 560 F.3d at 1336 (“[W]here the claims

themselves do not require a particular activity, we have no call to require something

more from the anticipating reference.”). But even if the claims did require an effective

amount, the Professional Protein ad instructs the 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 rely on Professional Protein as I strive to

increase strength and size” and “I take [Professional Protein] 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 ingredients as advertised is effective for increasing muscle

performance and recovery after exercise. As such, we find that the Professional Protein

ad discloses each and every claim limitation as a matter of law.

B. Enablement

We next consider whether the Professional 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 ordinary skill in the art

could have made the advertised supplements rather than the claimed invention.

Furthermore, Iovate contends, the record lacks any evidence that the ad taught a skilled

2009-1018 9
artisan how to make a composition effective 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 skill in the art could practice the invention

by buying the individual ingredients, or more simply the product itself, and administering

them as directed by the ad for the purposes recited. 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 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. But 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. Again, the ad teaches 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 ’287 patent specification

lists numerous pre-1996 publications 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 components’ administration on humans, including, for example,

(1) a dietary intervention with analogs of ketoacids and diabasic amino acids that aids

patients with eroding muscle mass, id. col.2 ll.50-58; and (2) ketoacid/amino acid

2009-1018 10
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 concluded, as do we, 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 enabled. See Bristol-Myers, 246 F.3d

at 1379.

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, it qualifies as a printed publication that invalidates the asserted claims.

CONCLUSION

The Professional Protein advertisement constitutes an anticipatory printed

publication under § 102(b) that invalidates the asserted claims of the ’287 patent. We

therefore affirm the district court’s grant of summary judgment in favor of BSN.

AFFIRMED

2009-1018 11
 UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT

2009-1018

IOVATE HEALTH SCIENCES, INC.
and UNIVERSITY OF FLORIDA RESEARCH 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 Court 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 believe the products were on sale more than

one year before the critical date as contemplated by 35 U.S.C. § 102(b).