Patent Eligibility of Bioinformatics InnovationsJune 9, 2018

Bioinformatics has increasingly become of interest in the last decade. Bioinformatics generally refers to the use of computational methods used to compile, analyze, visualize effects, and predict trends or outcomes for oftentimes large data sets. Bioinformatics tools can be applied to gene regulation, immunology, drug repositioning, drug identification, and virtually any other application where a large data set is involved. In 2017, the bioinformatics market was valued at about $1.2 billion, and with a CAGR of 20.3% (between 2017 and 2025), the market is expected to reach $117 billion by 2025.

This market value does not easily translate to a corresponding increase in patent applications or patentability. In 2014, the Supreme Court in Alice Corp. v. CLS Bank Int’l held that computer-implemented inventions untransformed by human ingenuity are not patent-eligible subject matter. The ruling in this case put a significant dampener on the patentability of software, algorithms, and computational methods involving a generic computer. The number of bioinformatics patent applications has dramatically decreased since 2014, and the length of prosecution (i.e. the time to patent allowance) has increased. However, given the growing market value of bioinformatics innovations, it is a mistake to assume a lack of patentability and refrain from filing patent applications. Alice does not mean that all inventions involving bioinformatics tools (and relatedly all software, algorithms, and other computational tools) are per se unpatentable. Rather, research must be conducted in mind of the existing legal standards and patent applications must be carefully drafted such that the resulting innovation does not suffer from three key “pitfalls”.

Pitfall 1: No Transformation

To be patent eligible subject matter, the innovation must first qualify as a process, machine, manufacture or composition of matter. The innovation cannot be merely an abstract idea, law of nature, or natural phenomenon. While most bioinformatics inventions satisfy the first requirement, they often fail the second, as computational methods are considered to be abstract ideas. However, not all is lost: the bioinformatics invention is still patentable where the invention recites additional elements that amount to significantly more than the abstract idea (or natural phenomenon or law of nature) itself. This “transformation” requires a show of ingenuity, modification of existing concepts, a new application, etc., to make the invention patentable. Another way of circumventing the problem entirely is to find a way of incorporating an abstract bioinformatics invention into a concrete system. If the invention can be tied to something concrete and tangible, this obviates the need to pass the transformation test (as the innovation is not merely an abstract idea).

Pitfall 2: Indefiniteness

Bioinformatics inventions often require the use of terms that have no clearly established meaning (e.g. “efficacy value”) are facially relative (e.g. “smaller”) or are capable of multiple, inconsistent or confusing interpretations (e.g. “array”). This occurs usually because the terms are relative and/or specific to the particular context of the innovation and the experimental methods used. However, the Patent Office requires that all terms, particularly terms used in patent claims, be clearly defined. As a result, special care must be taken in bioinformatics applications to ensure that the written specification clearly defines all relevant terms.

Pitfall 3: No Enablement

The Patent Office requires that all applications be enabling, that is, one skilled in the art must be enabled to make and use the invention disclosed by the patent application without undue experimentation. At its simplest, the enablement requirement is met by disclosing in detail the experimental methods and bioinformatics tools used to arrive at the invention. However, bioinformatics applications tend to be highly cross-disciplinary, involving computational methods, functional validation through in vivo models, and possibly clinical trials. Disclosing every single step taken throughout the course of lengthy experimentation can be unduly burdensome. If a method or protocol is well-known, it is sometimes sufficient to reference and only briefly describe the protocol (e.g. by name and ASTM reference number). However, the requirement for transformation requires deviation and improvement upon existing computational and experimental methods. This means the inventive, “transformative” methods and procedures must carefully and specifically be described in order to be enabling. Especially where enabling requires the disclosure of a large amount of data, e.g. extended protocols, lengthy gene sequence listings, etc., care must be taken to fully disclose the invention.

With the expanding bioinformatics market, innovators and corporations should not be discouraged by the unique challenges to patentability posed by bioinformatics innovations. With proper planning and careful patent application drafting, new developments in bioinformatics can be protected under U.S. patent law.

Sarah M. Luth is an Associate Attorney in the Chemical/Biotech Patent Practice Group at McKee, Voorhees & Sease, PLC. For additional information please visit www.ipmvs.com or contact Sarah directly via email at sarah.luth@ipmvs.com .