The industry of lab-engineered meats, milks, gelatin, and other alternatives to animal-based foods is rapidly expanding. These innovative products aim to closely mimic their animal-derived counterparts; however, achieving identicality with naturally occurring items 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 ruled that the breast cancer genes BRCA1 and BRCA2 were not eligible for patent protection because they were “not distinguishable from” naturally occurring genetic DNA. Following this, the 2014 Alice decision, which deemed certain software-based inventions unpatentable, established a two-step test for patent eligibility that the U.S. Patent and Trademark Office (USPTO) continues to apply.
In addition to these Supreme Court rulings, lower courts and the USPTO Patent Trial and Appeal Board (PTAB) have begun to invalidate numerous previously patented inventions under the new standards. For instance, between the Alice decision and June 2015, over 70% of patents challenged in federal courts based on this new criterion were ultimately ruled invalid. The U.S. Patent Office adopted a similar approach, rigorously analyzing and rejecting applications under 35 U.S.C. § 101, which governs patent eligibility. The number of rejections of biological, genetic, and organic chemistry inventions under § 101 doubled after the Alice case.
However, in the past year, there has been a shift in this trend. The Federal Circuit, the appellate court just below the Supreme Court that reviews patent appeals, has made several rulings that support patent eligibility. In response to these decisions, the USPTO has issued memoranda to its patent examiners, interpreting Federal Circuit rulings and guiding them on patent eligibility rejections. These memoranda suggest that the USPTO is inclined to allow more patents. For example, the Berkheimer memo released on April 19, 2018, indicated that examiners could no longer reject claims as “well-understood, routine, and conventional” without providing written justification for each element and their combination. 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, a method for determining a patient’s suitability for a medication based on a genetic test was upheld as patentable.
In September, USPTO Director Andrei Iancu remarked, “We have gotten ourselves into a rut when it comes to Section 101 analysis,” proposing a new approach that could alleviate many subject matter eligibility challenges. Iancu pointed out that the primary issue in patent eligibility revolves around “abstract idea” inventions, which are typically associated with software. This concern is less prevalent with engineered foods, as patents for these products generally pertain to specific, tangible food items or the processes and machines used in their production. Therefore, the USPTO’s focus on addressing “abstract idea” inventions may reduce scrutiny on patent eligibility for engineered food innovations.
As a result, there is cause for optimism among those creating innovative food and beverage products facing patent eligibility challenges. As the USPTO continues to provide guidance on Section 101 issues, new opportunities may arise for inventors to protect their creations. It is plausible that the USPTO could consider claims that explicitly denote them as “non-naturally occurring” versions of food or that specifically exclude natural food variants to be patent eligible. While there is no certainty that the USPTO will address natural products directly, the recent memoranda and statements from the director suggest that inventors with Section 101 challenges should contemplate filing applications to have pending claims in place when and if the USPTO aligns with the current trend regarding other aspects of patent eligibility.
Moreover, companies might explore a variety of patent claims that could effectively sidestep eligibility issues altogether. For instance, patents could be granted for products made through specific processes, the methods employed in creating the product, or the applications of the product itself. Additionally, the entire system utilized for producing the engineered food should be assessed for patentability. If a new calcium citrate reaction process, innovative growth medium, or novel machine was employed in developing the product, patents may be awarded for any of these ancillary innovations.