COVID-19 Research: Will the Results be Patent Eligible?

May 21, 2020 | James T. Nikolai

Medical researchers across the country are racing to develop accurate and efficient tests to determine whether a person has been infected by COVID-19 and whether people who have survived COVID-19 infection are immune from further infections.  The entire world’s economy and the lives of millions depend on this research. 

The U.S. Patent System was designed to “To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”  U.S. Constitution, Article I, Section 8, Clause 8.  But will those who make crucial discoveries concerning COVID-19 be able to patent their discoveries and inventions?  A 2012 decision of the U.S Supreme Court provides significant guidance related to this question.

In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012), the Supreme Court considered patents covering processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level is too low or too high.  Thiopurine drugs are used in the treatment of autoimmune diseases, such as Crohn’s disease and ulcerative colitis. When a patient ingests a thiopurine compound, the body metabolizes the drug, causing metabolites to form in his bloodstream.  Because the way in which people metabolize thiopurine compounds varies, the same dose of a thiopurine drug affects different people differently, and it has been difficult for doctors to determine whether for a particular patient a given dose is too high, risking harmful side effects, or too low, and so likely ineffective. 

Prometheus discovered that metabolite concentrations beyond a certain level indicate that the dosage is likely too high for the patient, while metabolite concentrations lower than a certain level indicate that the dosage is likely too low to be effective.  Prometheus then proceeded to secure a patent covering various methods of testing based on this discovery.  When Mayo was sued for infringement, it challenged the patents asserting that they covered a law of nature, subject matter that is not patent eligible.

Ultimately, the case ended up in the U.S. Supreme Court.  The Court stated, “’Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.’  Gottschalk v. Benson, 409 U.S. 63, 67, 93 S.Ct. 253, 34 L.Ed.2d 273 (1972).  And monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it.”

The Court continued, “The Court has recognized, however, that too broad an interpretation of this exclusionary principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.”

The Court then went on to discuss what is required to transform an unpatentable law of nature into a patent-eligible application of such a law.  The question that must be asked, according to the Court, is “do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?”  In analyzing this question, one must consider whether “additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.”  To be patentable, the claim must do more than “inform a relevant audience about certain laws of nature,” identify “additional steps [that] consist of well-understood, routine, conventional activity already engaged in by the scientific community” particularly when “those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.”

So, what likely is patentable?  A claimed invention that not only recites a law of nature but also several unconventional steps that confine the claims to a particular useful application of the principle. 

For example, the use of conventional well-known techniques to isolate and quantify COVID-19 antibodies in a person’s blood, saliva or the like is likely not patentable.  However, a novel test strip or solution that reacts to the presence of such antibodies may be patentable.  Likewise, standard, conventional vaccination techniques using either a low load of active COVID-19 virus, dead COVID-19 virus, or antibodies from another source likely would not be patentable.  However, novel processes used to isolate the ingredients of such vaccinations for more effective administration, or the invention of a novel drug that safely and effectively stops the virus in its tracks may very well be patentable.

In the end, the issue is complex.  The principles for addressing such issues must be understood and applied whether one is seeking patent protection for a cure for COVID-19 or for any other invention involving chemical, physical, or biological laws of nature. The experienced practitioners of the DeWitt’s intellectual property team are well-positioned to assist.