Lab-engineered meats, milks, gelatin and other replacements for animal-based foods is a growing industry. The purpose of these innovative products is to be as similar as possible to their animal-based counterparts, but being identical to naturally occurring products can pose a problem to patent eligibility.
In the last five years, the Supreme Court has started tightening the requirements for patent eligible inventions. In the Myriad case in 2013, the Supreme Court found the breast cancer genes BRCA1 and BRCA2 ineligible for patent protection because they were “not distinguishable from” natural genetic DNA. In 2014, the Alice case, which found certain software-based inventions unpatentable, laid the basis for the two-step test for patent eligibility that the U.S. Patent and Trademark Office (USPTO) still uses today.
In addition to those Supreme Court decisions, the lower courts and the USPTO’s Patent Trial and Appeal Board (PTAB) also began finding numerous previously patented inventions unpatentable under the new guidance. For example, between the Alice decision and June 2015, over 70% of patents challenged in federal courts as ineligible under this new standard were ultimately found invalid.
The U.S. Patent Office followed suit, strictly analyzing and rejecting applications under 35 U.S.C. §101, the statute that governs patent eligibility. The number of rejections under §101 for biological, genetic, and organic chemistry inventions doubled after Alice.
But in the last year, the tide has been turning. The Federal Circuit, the appellate court one step below the Supreme Court that handles all patent appeals, has issued several decisions that have gone the other way, upholding patent eligibility. Based on these decisions, the USPTO has issued memoranda to its patent examiners. These memoranda interpret federal circuit decisions and provide guidance to the patent examiners on issuing patent eligibility rejections. Each of these memoranda indicate that the USPTO is interested in allowing more patents.
For example, the Berkheimer memo, issued April 19, 2018, instructed that examiners could no longer reject claims as being “well-understood, routine, and conventional” without providing written support as to why each individual element and the combination of elements was “well-understood, routine, and conventional.”
The Vanda memo, issued June 7, 2018, provided a path to patent eligibility for claims involving diagnostic testing by reciting a specific application of the testing. For example, in the Vanda case, claims to a method for determining whether a patient was a candidate for a medicine based on a genetic test and then administering the medicine to the patient if the test showed they were a good candidate were upheld as patentable.
And in September, USPTO Director Andrei Iancu stated, “We have gotten ourselves into a rut when it comes to Section 101 analysis,” and proposed a new approach that could eliminate many subject matter eligibility issues. Iancu indicated that the biggest problem in patent eligibility was “abstract idea” inventions, which are usually considered software-based inventions.
“Abstract ideas” are not often an issue with engineered foods. Patents for engineered foods are normally directed to concrete and tangible food products, or processes or machines used in making the food. So, the USPTO’s focus on combating “abstract idea” inventions may ease patent eligibility scrutiny on engineered food inventions.
Thus, there are reasons to be hopeful for those with innovative food and beverage inventions facing patent eligibility issues. As the USPTO continues to issue guidance on Section 101 issues, further avenues may be available for inventors to protect their inventions. It is entirely possible that the USPTO may consider claims that explicitly state that they are “non-naturally occurring” versions of food or that exclude natural versions of the food to be patent eligible.
So, although there is no guarantee that the USPTO will address natural products directly, given the recent memoranda and director statements, inventors of products with Section 101 issues should consider filing applications so that they have claims pending when and if the USPTO follows the current trend for other aspects of patent eligibility.
And, as always, companies can pursue a variety of patent claims that may circumvent eligibility issues altogether. 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 might be granted for any of these ancillary inventions.
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