NORCROSS, Ga., Sept. 6, 2017 /PRNewswire/ -- Today we
eviscerated (5) Natural Alternatives International, Inc. ("NAI";
NASDAQ: NAII) patents related to Beta-Alanine. NAI alleges to be a
leading formulator, manufacturer and marketer of customized
nutritional supplements. However, Hi-Tech had warned NAI that their
patent portfolio was bogus and they proceeded with filing a lawsuit
anyway. NAI had sued dozens of supplement manufacturers and raw
material importers over the past 5 years trying to intimidate them
into stopping selling beta alanine.
The five Beta Alanine patents, issued by the U.S. Patent
and Trademark Office is part of NAI's portfolio covering CarnoSyn®
beta-alanine. On September 16, 2016,
Plaintiff NAI filed a complaint against Hi-Tech. (16-cv-2343-Doc.
No. 1.) Subsequently, Plaintiff filed a first amended complaint
against Hi-Tech, alleging claims for: (1) breach of contract; (2)
patent infringement; and (3) violation of the Lanham Act § 32.
(16-cv-2343-Doc. No. 21, FAC 197-217.) In its claim for patent
infringement against Hi-Tech, Plaintiff alleges infringement of
U.S. Patent Nos. 5,965,596, 7,825,084, RE45,947, 8,993,610, and
8,470,865. However, in a ruling by the Honorable MARILYN L. HUFF
all 5 listed patents were invalidated.
The Supreme Court has "'long held that this provision contains
an important implicit exception[:] Laws of nature, natural
phenomena, and abstract ideas are not patentable.'" Ass'n for
Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107,
2116 (2013). The Supreme Court has devised a two-stage framework to
determine whether a claim falls outside the scope of section 101."
Affinity Labs of Texas, LLC v.
DIRECTV, LLC, 838 F.3d 1253, 1257 (Fed. Cir. 2016); see
Alice Corp. Pty. v. CLS Bank Int'l, 134 S. Ct. 2347, 2355
(2014). "The prescribed approach requires a court to determine (1)
whether the claim is directed to a patent-ineligible concept, i.e.,
a law of nature, a natural phenomenon, or an abstract idea, and if
so, (2) whether the elements of the claim, considered both
individually and as an ordered combination, add enough to transform
the nature of the claim into a patent-eligible application."
Thus, the five beta alanine patents acknowledges that
beta-alanine is a natural occurring phenomenon. Accordingly, claim
1 of '084 patent is directed to excluded subject matter –
specifically beta-alanine, a natural phenomenon – thereby
satisfying step one of the Alice inquiry. Here, the inventive
concept described in claim 1 of the '084 patent is placing a
specific dosage of beta-alanine into a human dietary supplement.
See '084 Patent at 22:26-29. The '084 patent acknowledges that
placing a natural substance into a dietary supplement to increase
the function of tissues is conventional activity. Because placing a
natural substance into a human dietary supplement to increase the
function of tissues when consumed is a conventional activity,
employing a dietary supplement to administer beta-alanine – a
natural phenomenon – to achieve a high level of carnosine synthesis
in a human – applying a natural law – is insufficient to render the
claims at issue patent eligible.
Additionally, Hi-Tech was awarded legal fees in 2017 from a
similar dispute with Thermolife.
Recently Hi-Tech finished driving a stake into the ground in our
relentless fight against patent trolls – we were awarded our legal
fees from the Third most litigious patent troll in America –
Thermolife International and Ron
Kramer" said Jared Wheat,
President of Hi-Tech Pharmaceuticals. To that end, Hi-Tech
Pharmaceuticals, Inc. ("Hi-Tech") moved for attorney fees against
Plaintiffs The Board of Trustees of the Leland Stanford Junior
University and ThermoLife International, LLC (collectively
"Plaintiffs") in accordance with the requirements set forth in
Federal Rule of Civil Procedure 54(d)(2)(B), Hi-Tech
Pharmaceuticals recovered $913,370.006 in attorney fees and $25,071.46 in expenses.
Beginning in March 2013,
Thermolife filed eighty-one related patent infringement lawsuits in
this Court, including the instant case regarding Hi-Tech
Pharmaceuticals. The company prevailed in its
argument that this case was "exceptional" due to the fact that
Plaintiffs (1) lacked a reasonable basis to allege infringement;
and (2) pursued a file-and-settle strategy typical of "patent
trolls" while simultaneously engaging in "questionable litigation
conduct." Hi-Tech also successfully argued that this case is
"exceptional" because of Plaintiffs' aggressive litigation tactics;
namely that Thermolife and Stanford
sued many defendants in order to extract nuisance-value
settlements, which is typical behavior for a "patent troll."
NAI tried to get creative and argue that the inventive concept
of the patents-in-suit is to "unnaturally over-supplement the
normal/natural level of beta-alanine in the diet of an individual
over time to force an override [in] the homeostatic nature of the
individual's muscle tissue to achieve an unnatural high level of
carnosine synthesis." But the Court ruled that even assuming NAI
was correct, this inventive concept would still be insufficient to
render the patents-in-suit subject matter eligible under § 101.
This inventive concept as described by NAI still only describes a
natural law: the relationship between beta-alanine in an
individual's diet with the carnosine synthesis that occurs in the
individual's tissue.
Hi-Tech hopes that after winning another high stakes patent case
that companies would simply leave Hi-Tech alone. In the past 5
years Hi-Tech has been part of invalidating the following
compounds: D-Aspartic acid, L-Citrulline, L-arginine, creatine
nitrate and beta alanine. In sum, the '084 patent, the '947 patent,
the '376 patent, the '596 patent, the '865 patent, and the '610
patent claim ineligible subject matter and, thus, are invalid under
35 U.S.C. § 101.16 Accordingly, the Court granted Hi-Tech' motions
for judgment on the pleadings, and the Court dismisses NAI's claims
for patent infringement with prejudice.
About Hi-Tech Pharmaceuticals
Hi-Tech Pharmaceuticals (https://www.hitechpharma.com/index.htm)
is a leading Sports Nutrition manufacturer. Since 1979,
Hi-Tech Pharmaceuticals, Inc. and its sister company, Hi-Tech
Nutraceuticals, LLC have been providing quality custom
manufacturing services to the pharmaceutical, dietary supplement
and beverage industries. Hi-Tech Pharmaceuticals is a cGMP
certified company that operates out of Four (4) US Production
facilities and (2) Warehouses, totally over 600,000 sq. ft. The two
Georgia based production
facilities are both located outside Atlanta in the
Norcross and Suwanee Advanced
Technology areas. Hi-Tech also has Two (2) facilities located
outside State College,
Pennsylvania. Hi-Tech holds a Drug Manufacturing License
issued by the State of Pennsylvania Food and Drug Branch and is
registered as a Food and Drug Establishment with the FDA in
Pennsylvania.
Hi-Tech is an extremely aggressive company that has been looking
to increase scale, revenue, market share, and competitive advantage
by being very active with mergers and acquisitions. Hi-Tech has
been able to increase its market share in the United States through the acquisition of
Florida-based Synergy Nutritional
Industries in 2005, and gained a larger market share when it
acquired Advanced Performance Supplements ("APS") in 2011. Hi-Tech
gained further industry dominance when it acquired Nittany
Pharmaceuticals in Pennsylvania
and ALR Industries in California
in 2012. Hi-Tech's recent strategy has been, and according to its
leaders will continue to be, growth through M&A activity. In
2015, Hi-Tech acquired Advanced Pharmaceuticals and Nutritionals,
FormuTech Nutrition, Innovative Laboratories, Sports One, LG
Sciences and iForce Nutrition. In 2016, Hi-Tech acquired the
majority interest in Prime Nutrition and Gaspari Nutrition. In
2017, Hi-Tech acquired Top Secret Nutrition and launched the
Nature's Essentials line of supplements. Hi-Tech also acquired one
of the industry's top sports nutrition websites
supplementwarehouse.com to showcase its brands of products.
Hi-Tech Pharmaceuticals has impressive capabilities to supply
the global demand of sports supplements, vitamins, and
pharmaceuticals. On an annual basis, Hi-Tech Pharmaceuticals can
manufacture 35 billion tablets and 10 billion capsules. Hi-Tech
Pharmaceuticals can also package 500 million bottles, 250 million
blister packs, and 150 million pacquettes
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SOURCE Hi-Tech Pharmaceuticals, Inc.