Are nutritional supplements eligible for patent protection? NATURAL v. CREATIVE

A patent is a set of exclusive rights granted to the inventor of a new invention. A patent allows the owner of the patent to exclude others from making, selling, using or importing the invention within the boundaries of the country that granted the patent. If someone other than the patent owner attempts to exercise one of these exclusive rights, that can constitute patent infringement. A patent owner can file a lawsuit to stop patent infringement with an injunction and get monetary damages for patent infringement which has occured.

In the United States patents are granted by the United States Patent and Trademark Office. An inventor begins the process of obtaining a patent by filing a patent application with the United States Patent and Trademark Office. The process of reviewing a patent application is known as patent prosecution. In patent prosecution a patent application will be reviewed by an examining attorney at the United States Patent and Trademark Office. If the invention described in the patent application meets all the requirements for patentability, the inventor will be granted a patent.

The first hurdle that an invention must pass in patent prosecution is subject matter eligibility. Patents can only be granted to certain types of inventions. 35 U.S.C § 101 states that an inventor who invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent. The courts have interpreted this statute to mean that patent protection does not extend to the patent ineligible concepts of laws of nature, natural phenomena, or abstract ideas.

In the context of chemicals and pharmaceuticals, determining whether an invention is eligible subject matter depends on how the claims of the patent are written. A patent which claims a chemical compound, with no explanation of how to use the chemical compound would not be eligible for patent protection because chemicals are natural phenomena. However, a patent which claims the use of a chemical compound to serve a purpose, along with a description of the best way to produce results can be granted patent protection because a new use for a chemical compound is eligible for patent protection. Claims that describe the use of a chemical compound, along with dosage instructions, and expected results, elevate a discovery of a natural phenomenon to a treatment. A treatment is eligible subject matter for patent protection.

A case which illustrates how a court will determine if a patent on a chemical compound satisfies the eligible subject matter requirement is NATURAL ALTERNATIVES INTL, INC., v. CREATIVE COMPOUNDS, LLC, 2018-1295 (C.A.F.C. 2019). The plaintiff in this case owns a number of patents that relate to dietary supplements which contain the chemical compound beta-alanine. Distilled to its simplest explanation, the plaintiff’s patents explain how to administer beta-alanine so that athletes can build muscle faster.

The defendant sells products to build muscle, which contain beta-alanine. The plaintiff sued the defendant for patent infringement. The defendant moved for summary judgement on the grounds that the claims of the plaintiff’s patents were directed to patent ineligible subject matter under 35 U.S.C. § 101 and lacked an inventive concept sufficient to render them patent eligible. The district court granted judgment in favor of the defendant. The plaintiff appealed that decision to the Court of Appeal for the Federal Circuit.

The Federal Circuit reversed the district courts grant of summary judgement. The Federal Circuit held that the patents are eligible subject matter because the patents describe a method of treatment involving a chemical compound. The claims of the patents not only disclose the discovery of a chemical compound’s effect on a human, they require that an infringer actually administer the dosage form claimed in the manner claimed, altering the athlete’s physiology to provide the described benefits.

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