NAI Prevails in Federal Circuit Appeal on CarnoSyn® Patents
CARLSBAD, Calif., March 19, 2019 /PRNewswire/ — Natural Alternatives International, Inc. (“NAI”) (NASDAQ: NAII), a leading formulator, and marketer of customized nutritional supplements announced today that the U.S. Court of Appeals for the Federal Circuit has ruled in NAI’s favor, holding that its CarnoSyn® beta-alanine patents are “patent eligible” under existing law. The Court’s decision reverses a 2017 ruling by a California district court and revives important patent rights in NAI’s existing patent portfolio.
The Federal Circuit disagreed with the lower court, concluding a dietary supplement may be patented despite being based on a naturally occurring substance, and ordered the case to be remanded back to the lower court to move forward on NAI’s infringement claims against the original defendant.
Mark A. LeDoux, NAI’s CEO and Chairman of the Board, said that “NAI has always been confident that the Federal Circuit — which has particular expertise in patent law — would look at the body of science NAI put into the record, properly apply the law, and find NAI’s patents are valid. That is what the Federal Circuit did in issuing its fact-based and carefully reasoned decision. As it has consistently done, NAI will continue to vigorously enforce its intellectual property rights.”
He went on to say that “The Court’s decisive ruling is very significant to the dietary supplement industry, not just NAI.” LeDoux, who is also the Chairman of the Natural Products Association, said that “The Court’s ruling means members of the supplement industry can and should continue to avail themselves of U.S. patent laws as well as regulatory tools, such as NDIs, to protect their significant investments in clinical research, product development, substantiation and testing for innovative products and uses that benefit consumers every day.”
NAI’s CarnoSyn® beta-alanine is widely-recognized as a patented, high-quality ingredient of choice among companies wishing to use the safest ingredients in their products. NAI has invested millions of dollars over the years in its CarnoSyn® beta-alanine brand, including research, development, clinical trials, marketing, intellectual property protection and regulatory compliance. On February 19, 2019, NAI announced that it received New Dietary Ingredient (NDI) status from the Food and Drug Administration (FDA) for its CarnoSyn® beta-alanine ingredient at a total daily intake level of 6.4 grams per day. NAI received the FDA’s Acknowledgement Without Objection or AKL letter, and within its statutory 75-day evaluation period to respond. It has been assigned NDI report number 1103. CarnoSyn® is the only beta-alanine that has successfully obtained NDI status with the FDA.
NAI, headquartered in Carlsbad, California, is a leading formulator, manufacturer and marketer of nutritional supplements and provides strategic partnering services to its customers. NAI’s comprehensive partnership approach offers a wide range of innovative nutritional products and services to NAI’s clients including: scientific research, clinical studies, proprietary ingredients, customer-specific nutritional product formulation, product testing and evaluation, marketing management and support, packaging and delivery system design, regulatory review and international product registration assistance. For more information about NAI, please see its website at http://www.nai-online.com.
This press release contains forward-looking statements within the meaning of applicable securities laws that are not historical facts and information. These statements represent our intentions, expectations and beliefs concerning future events, including, among other things, our expectations and beliefs with respect to the outcome of pending litigation, the continued validity of our patents, and our ability to successfully develop, license and enforce our intellectual property rights. We wish to caution readers these statements involve risks and uncertainties that could cause actual results and outcomes for future periods to differ materially from any forward-looking statement or views expressed herein. NAI’s financial performance and the forward-looking statements contained herein are further qualified by other risks including those set forth from time to time in the documents filed by us with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
CONTACT – Kenneth Wolf, President and Chief Operating Officer, Natural Alternatives International, Inc., at 760-736-7700 or [email protected]
SOURCE Natural Alternatives International, Inc.