Engineered natural products, like lab-grown meat and synthetic milks, are on the cutting edge of food science. Companies in this field often aim to make a product that is indiscernible from the real thing: a beef steak grown from cells in a petri dish that looks and tastes like a steak or milk cultured in a beaker that looks and tastes like dairy milk. But making a product identical to something found in nature can raise issues regarding the patentability of that product.
For example, the Supreme Court held in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) that naturally occurring products are unpatentable. And the Federal Circuit has stated that claims to products that are “not distinguishable from” their natural counterparts are not patent eligible, regardless of how they were made. See In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig., 774 F.3d 755 (Fed. Cir. 2014).
In view of such cases, companies making man-made alternative products to naturally occurring products must consider their patent strategies carefully. The first consideration is whether the product is completely indistinguishable from the naturally occurring product. In Myriad, only claims directed to the naturally occurring genomic DNA were unpatentable. Claims directed to the cDNA—a sequence representing the portions of the DNA that are translated into proteins—were patentable because they were distinguishable from what occurs naturally. Thus, valuable non-naturally occurring products similar to, but not identical to, naturally occurring products can still be patented.
Moreover, even if the end product is identical to the naturally occurring option, companies can pursue other types of patent claims. For example, patents may cover the product when it is made by a particular process, the method of making the product, or the use of the product. In addition, the entire system for creating the engineered food should also be considered for patentability. If a new processing technique, new growth medium, or new machine was used to develop the product, a patent could be granted for any of these ancillary inventions.
It is important to consider patent eligibility issues early in the patenting process to avoid problems later on. The initial patent application should contain a full disclosure of the invention to support all the potential claim types that might be pursued. For example, an application to an engineered milk should not only disclose the composition of the final milk product, but also a description of the process by which the product was obtained so patent protection for that process may be sought. Moreover, given the uphill battle that some patent applications may face, serious consideration to other intellectual property options—including trade secret protection—should be analyzed before pursuing a patent.
As the industry matures, uncertainty in the patent eligibility of engineered foods should dissipate. Until then, careful thought must be given to the protection of these inventions.
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