Recent Updates on Subject Matter Eligibility in the Life Sciences

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Recent case law further clarifying patent subject matter eligibility under § 101 provides useful guidance for addressing claim rejections and, ultimately, securing robust patent claims in the life sciences.  As the currently-published § 101 guidelines used by the USPTO do not utilize these recent clarifications, an understanding of the recent clarifications can be helpful to patent applicants.  The following provides a backdrop to the evolution of the law under § 101 and its application in the life sciences area, and an overview of the recent clarifying trends.

To be eligible for a patent, an invention must be directed to patentable subject matter in accordance with § 101.  Patentable subject matter under § 101 includes “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof….” In other words, an invention must be directed to a process, a machine, an article of manufacture, or a composition of matter.  For many years, § 101 was largely ignored as it was not applied to the majority of patent applications by the USPTO and/or by courts.  In recent years, the United States Supreme Court (“Supreme Court”) has reviewed its limit on § 101 patent-eligibility and further defined and/or clarified a number of judicially recognized exceptions that are not patent eligible, including laws of nature, physical phenomena, and abstract ideas. See Bilski v. Kappos, 130 S. Ct. 3218 (2010).  Following Bilski, the Supreme Court and lower courts have provided additional details for the eligibility analysis under Bilski.

On June 13th 2013, the Supreme Court in Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107, ruled that (1) isolated genomic DNA (gDNA) is not patent-eligible under § 101 and (2) complementary DNA (cDNA) is.  Following recent patent decisions such as Mayo v. Prometheus, 132 S. Ct. 1289 (2012), the Court struck down patent claims on gDNA as having been merely “isolated” from the body— meaning, removed and separated from its natural environment in the cell.  It upheld claims directed to cDNA as being “synthetically created DNA…which contains the same protein-coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins.”  Said differently, cDNA was chemically different than what occurred in natural DNA.

In Alice Corp. V. CLS Bank International, 134 Ct. 2347 (2014), the Supreme Court clarified the two-part test for compliance with § 101 that was previously established in Mayo.  The (clarified) two-part test includes determining whether the claims contain an otherwise patent ineligible concept, and if so, determining whether the patent claim embodies an “inventive concept.”

The Court of Appeals for the Federal Circuit (“Federal Circuit”) has issued a number of decisions further clarifying § 101 in light of the Mayo, Myriad, and Alice decisions.  In Ariosa v. Sequenom, 788 F.3d 1371 (2015), the Federal Circuit applied the two-part test of Mayo/Alice and affirmed the claims were invalid under §101. The claim at issue had two simple steps: (1) amplifying paternally inherited DNA from a plasma sample taken from a pregnant female, and (2) detecting the presence of DNA.  The technology for amplifying and detecting DNA was known at the time of invention, but the presence of fetal DNA in plasma from a pregnant female was alleged to be unknown. The Federal Circuit held that the claims were directed to a law of nature, and the testing and determination steps were well known in the art at the time of invention and thus not an “inventive concept.”

Following Sequenom, the Federal Circuit in Enfish, LLC v. Microsoft Corp, 822 F.3d 1327 (2016) explained that the common “directed-to” practice of invalidating claims that lower courts were applying based on the Mayo/Alice inquiry is wrong, and that the character of the claimed invention as a whole (including all parts of the claim) must be used to conduct this inquiry. Thus, the Court implied/explained in pertinent part that a claim can be patent eligible if the known procedures as a whole are not unduly preempting or too obvious when considering the advancement of the invention.  In other words, if the combination of known parts is considered as a whole, then it is not so easy to isolate and argue that the claim is “directed to” a patent-ineligible concept as has happened in so many invalidity decisions.

While Enfish was directed to software, the statute, the case law and the applicable patent-eligibility test for the analysis are common with closely-linked analysis and preemption concerns directed to any patent ineligible subject matter, such as laws of nature.  For example, the Federal Circuit in Rapid Litig. Mgt. v. CellzDirect, Inc, No. 2015-1570 (July 5, 2016) upheld patent claims directed to ways of preserving main liver tissue (hepatocyte cells) by using multiple freeze-thaw cycles.  Applying the Mayo/Alice test, the Federal Circuit clarified and distinguished the patent claims from Mayo, Alice, and Sequenom, explaining that the claims were “not directed to a patent ineligible concept” (i.e., the ability of hepatocyte cells to survive multiple freezes), but to a new and useful laboratory technique for preserving hepatocytes.  Specifically, the Federal Circuit indicated that the “inventors certainly discovered the cells’ ability to survive, but that is not where they stopped, nor is it what is patented.”  The Federal Circuit further indicated that while pre-emption is not the test for determining patentability, the claims at issue did not lock up the law of nature in its entirety.

In contrast to CellzDirect, the Federal Circuit in The Cleveland Clinic Foundation, Cleveland Heartlab, Inc., v. True Health Diagnostics, LLC No. 2016-1766 (June 16, 2017) invalidated claims directed to detecting a risk of cardiovascular disease by testing for myeloperoxidase (MPO) in bodily samples.  The district court found that the claims were directed to a law of nature under Alice step one because the claims were directed to “the correlation between MPO in the blood and the risk of [cardiovascular disease].”  Moreover, the district court found that looking at the claims as a whole, the steps in combination “simply instruct a user to apply a natural law, i.e., that an increase in MPO mass or MPO activity in a blood sample correlates to an increase in [cardiovascular disease] risk.”  In applying the Alice framework, and distinguishing the claims from CellzDirect, the court held that the claims were ineligible because they were directed to the natural existence of MPO in a bodily sample rather than to a new and useful laboratory technique for detecting this relationship.  Importantly, the court noted that a related patent, which claimed a method of treating a patient with a determined risk of cardiovascular disease based on detected MPO levels, was not challenged under § 101. Thus, consistent with the above-mentioned cases, the invalidated claims appeared to preempt the natural law itself (e.g., the correlation of MPO and cardiovascular disease) instead of a narrow laboratory technique and/or application of the natural law in treating patients.

Presently, the USPTO is lagging in applying the above-analysis to pending applications, which may be due to the fact that a revised § 101 guideline has not yet been issued.  Many patent practitioners anticipate a revised § 101 guideline to be issued shortly, based at least in part on a July 25th 2017 report published by the USPTO titled “Patent Eligible Subject Matter: Report on Views and Recommendations From the Public.” The report summarized public comments on the impact of the Supreme Court’s recent § 101 jurisprudence, as gathered during two roundtable discussions held in the latter part of 2016.  Much of the report focuses on two technology areas believed to be especially affected by recent law, life sciences and computer-related technologies, and includes comment that the legislature is the appropriate body to recalibrate the proper scope of patent eligibility.

Until revised § 101 guidelines are issued, or legislative action is taken to clarify the scope of patent eligibility in the life sciences, Applicants may avoid issue under § 101 through careful drafting.  The recent trends in Supreme Court and Federal Circuit decisions emphasize the importance of crafting claims and the relevant description in a manner that does not raise concerns of preemption.  The issue of patent claims preempting technological advancements has long been considered an issue under § 101. This follows because if the claimed invention is directed to an abstract invention, the abstraction creates overbreadth and thus would cover all such technological advancements under that abstraction.

We invite you to contact us for more information and other assistance in addressing issues relating to patent applications, patent infringement and patents in general.


© Crawford Maunu PLLC.  All rights reserved. This material is for informational purposes only and should not be construed as legal advice. Communication of this material is not intended to establish an attorney-client relationship. Legal advice should be sought from legal counsel.