The CAFC ruling on a patent claiming isolated form in the ChromaDex Case

The CAFC ruling on a patent claiming isolated form in the ChromaDex Case

The ChromaDex v. Elysium ruling by the Court of Appeals for the Federal Circuit (CAFC) was a landmark decision in biotechnology. The ruling had implications for patents related to isolated forms of Vitamin B3, popularly referred to as “niacin” or “nicotinic acid.” In this blog post, we’ll take a closer look at the ruling and what it could mean for the future of patents related to this vitamin.

The case centered around ChromaDex’s patent for an isolated form of nicotinamide riboside, a novel vitamin supplement ingredient with various health benefits. The U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a district court’s finding that ChromaDex’s isolated form of nicotinamide riboside (NR) is not patent eligible under 35 U.S.C. 101. As per the US patent act, 35 U.S.C. 101 indicates that patents are to be granted on “any new and useful process, machine, manufacture, or composition of matter.” This means that an invention that does not fall under one of these four categories (i.e., is not a process, the machine, manufacture, or composition of matter) will not be eligible for patent protection. While most inventions fall within one of these categories, some do not.

The patent covers a composition containing isolated NR that results in increased biosynthesis of the coenzyme nicotinamide adenine dinucleotide (NAD+) upon oral administration. In 2018, ChromaDex Corporation filed a patent infringement case against Elysium Health, Inc. regarding the latter’s use of a patent owned by Dartmouth College to sell dietary supplements.

What is the status of Chromadex’s Vitamin B3 patent?

ChromaDex’s Vitamin B3 patent was held to be invalid for lack of patentability under Section 101 of the Patent Act. The court’s decision was largely based on the “isolation” theory of patent infringement. The court found that ChromaDex’s claimed invention was not “isolated” from prior uses or disclosures of Nicotinamide riboside (NR). Nicotinamide riboside (NR) is a form of vitamin B3 that is naturally present in cow’s milk.  The court also held that the claimed invention was merely the natural result of a natural process and was not patentable under Section 101 of the Patent Act. U.S. Patent No. 8,197,807 is titled “Nicotinamide riboside kinase compositions and methods for using the same.”. The invention covers a composition containing isolated NR that results in increased biosynthesis of the coenzyme nicotinamide adenine dinucleotide (NAD+) upon oral administration.

What does this mean for the future of CAFC Cases?

This case is noteworthy as it marks the first time that the CAFC has considered the “isolation” theory of patent infringement in a case involving Vitamin B3. This case could also be used to shape future decisions in CAFC cases as the court considers the “isolation” theory of patent infringement. Companies should be conscious that the CAFC is eager to consider the “isolation” theory of patent infringement when evaluating the validity of claimed inventions under Section 101 of the Patent Act.

What is the final say?

The CAFC’s decision in the ChromaDex case serves as an important reminder of the importance of ensuring that claimed inventions meet the requirements for patentability under Section 101 of the Patent Act. ChromaDex’s patent was found to be invalid for lack of patentability under Section 101 based on the “isolation” theory of patent infringement. Going forward, companies should be aware that the CAFC will consider the “isolation” theory when evaluating cases involving Vitamin B3. Additionally, companies should ensure that claimed inventions meet the requirements for patentability under Section 101 of the Patent Act to avoid similar results.

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