“Navigating Patent Eligibility Challenges in the Growing Lab-Engineered Food Industry”
The industry for lab-engineered meats, milks, gelatin, and other alternatives to animal-based foods is experiencing significant growth. These innovative products aim to closely resemble their natural counterparts, but achieving identicality can create challenges regarding patent eligibility. Over the past five years, the Supreme Court has tightened the criteria for what constitutes a patentable invention. In the landmark Myriad case of 2013, the Court deemed the breast cancer genes BRCA1 and BRCA2 unpatentable because they were “not distinguishable from” natural genetic DNA. The 2014 Alice case further established a two-step test for patent eligibility that the U.S. Patent and Trademark Office (USPTO) continues to apply today, ruling certain software-based inventions as unpatentable.
In addition to these Supreme Court rulings, lower courts and the USPTO’s Patent Trial and Appeal Board (PTAB) began to invalidate numerous previously granted patents under new guidelines. For instance, from the Alice decision to June 2015, over 70% of patents challenged in federal courts for ineligibility under this standard were ultimately deemed invalid. Consequently, the U.S. Patent Office began a stringent examination of applications under 35 U.S.C. § 101, which governs patent eligibility, leading to a doubling of rejections for biological, genetic, and organic chemistry inventions post-Alice.
However, in the past year, there has been a shift in the judicial landscape. The Federal Circuit, the appellate court below the Supreme Court that handles patent appeals, has issued several rulings favoring patent eligibility. Following these decisions, the USPTO provided guidance to its patent examiners through memoranda interpreting these rulings. These documents signify the USPTO’s willingness to approve more patents. For instance, the Berkheimer memo, released on April 19, 2018, stipulated that examiners could not reject claims as “well-understood, routine, and conventional” without written justification for each element’s status. The Vanda memo, issued on June 7, 2018, outlined a pathway to patent eligibility for claims related to diagnostic testing by specifying a particular application of the tests. In the Vanda case, claims related to a method for determining a patient’s eligibility for a medication based on a genetic test were upheld as patentable.
In September, USPTO Director Andrei Iancu remarked, “We have gotten ourselves into a rut when it comes to Section 101 analysis,” suggesting a new approach that could resolve many subject matter eligibility issues. Iancu noted that the primary challenge in patent eligibility often revolves around “abstract idea” inventions, commonly associated with software. However, this issue is not typically relevant to engineered foods, which are generally focused on tangible food products or the processes and machinery involved in their production. Therefore, the USPTO’s emphasis on addressing “abstract idea” inventions might ease the scrutiny surrounding patent eligibility for engineered food inventions.
This presents a glimmer of hope for innovators in the food and beverage sector who are grappling with patent eligibility challenges. As the USPTO continues to refine its guidance on Section 101 issues, more opportunities may arise for inventors to protect their creations. It is conceivable that the USPTO might view claims that explicitly describe products as “non-naturally occurring” or that exclude natural versions of food as patent eligible. While there are no guarantees that the USPTO will directly address natural products, the recent memoranda and statements from the director suggest that inventors facing Section 101 issues should consider filing applications to ensure their claims are pending if the USPTO aligns its approach with current trends in patent eligibility.
Moreover, companies can explore various patent claims that may bypass eligibility concerns entirely. For example, patents can focus on the product when produced through a specific process, the method of production, or the application of the product. Additionally, the entire system for creating engineered food should be evaluated for patentability. If a new processing technique, growth medium, or machinery was utilized to develop a product, patents could potentially be granted for any of these ancillary inventions. In this context, innovations such as calcium citrate, part of nature’s bounty, may also find new avenues for patent protection as the industry evolves.
