Once More with Feeling: Patent Eligible Subject Matter Part 2

For those fortunate enough to sit on the sidelines, there is the observation that many patents and patent applications have met their demise in the Federal Circuit because of patent ineligible subject matter. In my previous article I identified a large group of patents and patent applications which are foreseeably patent ineligible: that is, abstract ideas implemented by conventional computers. In this article I identify biomedical innovations that comprise patentable subject matter, while for other innovations no amount of application drafting expertise results in patent eligible subject matter.

Unlike computer related inventions comprising abstract ideas, for biomedical inventions the issue is generally whether the invention primarily comprises a (i) natural phenomenon, such as relationship between substances in a human body, or (ii) a natural law such as that for gravity.[1] The United States Supreme Court has held that naturally occurring subject matter is not patent eligible, in large part because private ownership would hinder medical innovation. Allowing patent eligibility would also prevent people from obtaining proper medical care because (i) their physician could not access the private owned natural medical subject matter, or (ii) it was prohibitively expensive to do so.

The Federal Circuit has held that diagnostic procedures which, without more only detect and quantify naturally occurring physiological events, are not patent eligible. However, the situation differs for medical treatment because these innovations (i) address a process which relies upon underlying natural human physiology, but (ii) sufficiently build upon naturally occurring events with new practical steps. For example, in Boehringer Ingelheim Pharmaceuticals et al. v. Mylan Pharmaceutical, Inc. et al.[2], the patent addressed treatment of diabetes mellitus with biochemical inhibitors metabolized by the liver instead of the kidneys. The Federal Circuit found the treatment was patent eligible, because it comprised a particular method with a specific biochemical inhibitor at quantified doses. Similarly, for a laboratory technique based upon naturally occurring cell free fetal DNA, the Federal Circuit held that the method of concentrating this fetal DNA, was patent eligible, although the natural correlation between DNA length and designation as fetal, was not.[3]

In sum, treatments and laboratory methods, but not diagnostic methods, are much more likely to be patent eligible if properly drafted. However, physicians and pharmaceutical companies should greatly appreciate these present criteria for biomedical subject matter eligibility and ‘weigh in’ to support its continued viability. Otherwise, if colleagues privately own patents for naturally occurring medical subject matter, physicians and other pharmaceutical companies could not (i) continue related research or (ii) diagnose their patents without high fees and permission of competitors.

© 2021 Adrienne B. Naumann. All rights reserved. Ms. Naumann does not sponsor or endorse the advertisements at adriennebnaumann@wordpress.com.

[1] Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012); Association for Molecular Pathology v. Myriad Genetics, 569 U. S. 576 (2013). In Mayo the Court held that a diagnostic method for detecting  thiopurine metabolite levels and toxicity of thiopurine was naturally occurring. Furthermore, there was nothing else to the claimed diagnosis method except observation and mental steps. According to Mayo, each patent subject matter eligibility requires a two-step inquiry:

  • Is a claim sentence as a whole directed to a natural event or natural law?
  • If so, is there an inventive concept within a claim sentence which transforms the naturally occurring event/law into patent eligible subject matter?

[2] 803 Fed. Appx. 397 (Fed. Cir. 2020) (non-precedential).

[3] Illumina, Inc. et al. v. Ariosa Diagnostics, Inc. et al., 952 F.3d 1367 (Fed. Cir. 2020) modified at 967 F.3d 1319,  petition for cert. dismissed, May 21, 2021.


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