In an important decision for the personal care and ingredients industries, the U.S. Court of Appeals for the Federal Circuit recently vacated a district court decision that held patent claims invalid as being directed to non-patent eligible subject matter in Natural Alternatives Int'l v. Creative Compounds, LLC (Case No. 18-295).
Natural Alternatives sued Creative Compounds for infringement of six patents covering: (a) various forms of the amino acid beta-alanine; (b) methods of treatment as muscle-building dietary supplements; and (c) uses of beta-alanine in manufacturing the supplements.
The District Court dismissed the lawsuit, holding that the claims were invalid since they were directed to a natural ingredient.
The Federal Circuit reversed, cautioning against taking the law-of-nature prohibition too far, since, "[w]e live in the natural world, and all inventions are constrained by the laws of nature..." Here, the statute and earlier cases "do not stand for the proposition that any combination of ineligible subject matter is itself ineligible." The court noted that, "[a] claim to a manufacture or composition of matter made from a natural product is not directed to the natural product where it has different characteristics and "the potential for significant utility." (quoting Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980)).
The court provided useful guidelines in determining patent eligibility of natural ingredients. Regarding the method of treatment claims, "homeostasis is overcome" in a way that leads to "specific physiological benefits." That is, "[t]he claims ... require that an infringer actually administer the dosage form claimed in the manner claimed, altering the athlete's physiology to provide the described benefits. These are treatment claims and as such they are patent eligible."
Although beta-alanine is a natural product, the court reasoned that, "the Product Claims ... incorporate natural products, but they have different characteristics and can be used in a manner that beta-alanine as it appears in nature cannot." There were "sufficient factual allegations" that "when combined the beta-alanine and glycine have effects that are greater than the sum of the parts." Thus, the product claims were not "directed to" a natural product.
It was helpful that the claims were directed to muscle-building supplements - that is, their goal was altering the body's operation away from a natural state - whereas most drug treatments are just in pursuit of a natural state.
Bottom Line: Natural ingredients can be protected by patents; laws of nature cannot. Think about your innovations in a broad and narrow manner, collect sufficient data and ensure the patent application is well constructed.
|Braginsky, Philip Partner and Co-Chair of Intellectual Property Group and Pharmaceutical and Biologics Practice and China Practice||Partner and Co-Chair of Intellectual Property Group and Pharmaceutical and Biologics Practice and China Practice||212.216.8065|
|Lin, Rachel J. Counsel||Counsel||212.216.1152|