What Should be Patentable? – A Proposal for Determining the Existence of Statutory Subject Matter Under 35 U.S.C. Section 101

The recent Supreme Court decision in the Myriad case, like past decisions, did not announce a clear rule that can be extrapolated from the decision and applied in other technology areas. Consequently, the determination of what subject matter is patent-eligible continues to be unclear.  Patent law specifically identifies four broad categories of subject matter—process, machine, manufacture, or composition of matter—that are patent-eligible.  Although very few things fall outside these categories, the Supreme Court has engrafted some exceptions and limitations onto these statutory categories.  Patentable-eligible subject matter that is otherwise within these categories is deemed ineligible for patent protection if it is a “law of nature,” a “physical phenomenon,” or an “abstract idea.”  The precise meaning or scope of these exceptions and limitations are difficult to enunciate despite the numerous courts that have grappled with this issue. These exceptions and limitations can be viewed as labels that are attached after a judicial balance has been made between competing or conflicting underlying concepts. Justice Thomas recognized that balance in Myriad when he wrote, relying on both Mayo, and Chakrabarty, that “patent protection strikes a delicate balance between creating ‘incentives that lead to creation, invention, and discovery’ and ‘impeding the flow of information that might permit, indeed spur, invention.’”

This balance provides the underlying justification for viewing some discoveries as being so basic or fundamental that everyone should be free to utilize them. Nevertheless, it is imperative that a clear rule or test, based on this justification, is enunciated by the Supreme Court. Any resulting rule will be imperfect because it will potentially be over or under inclusive. Additionally, it will have disproportionate effects on different industries. But the importance of a uniform and predictable rule outweighs these deficiencies because it allows a business enterprise and courts to more easily make decisions. Recent Supreme Court patent decisions have generally rejected bright line tests in favor of a more-opened ended or flexible approach. Unfortunately, this provides limited guidance to lower courts and consequently the issue remains unsettled.

Early stage research often produces discoveries such as previously unknown mathematical relationships, fundamental concepts, physical forces, biological data, or correlations.  These discoveries are fundamental building blocks which are very valuable starting points for engaging in future research that will lead to new technological products and processes that have real world practical applications.  Such discoveries are denied patent protection because they are potentially too valuable.  Granting patent protection would ultimately impede future innovation based on these building blocks.  Hence, fundamental building blocks are labeled as a “law of nature,” a “physical phenomenon,” or an “abstract idea” to signify they are not patent-eligible subject matter.  Once the level of innovation and development moves further downstream on the innovation continuum, the subject matter becomes patent-eligible at some point. Divining this precise point has eluded courts. The variety of new technology and the multitude of ways patent claims are drafted make it impossible to create a single rule for ascertaining whether something is patent-eligible subject matter.

My proposal is that courts should use the following rules, gleaned from Supreme Court decisions, to determine if a patent claim covers patent eligible subject matter.

In addition to the machine-or-transformation test for process claims, the following alternative tests are proposed for both product and process claims.  Multiple tests are necessary because no single test will produce predictable and consistent results in light of the different types of subject matter that can be patented and the variation in how patent claims are drafted. Although failure to satisfy the machine-or-transformation test is not determinative, in light of Bilski, it is suggested that failure to satisfy one or more of the following proposed tests should render a claim unpatentable for failure to claim statutory subject matter under Patent Law section 101.

• The preemption test, which holds that a claim is not patent-eligible if it essentially preempts all meaningful use of a law of nature, natural phenomena, or an abstract idea in substantially all contexts.

• The insignificant limitation test helps to recognize inclusion of limitations in claims that appear to limit claim scope, but in fact do not provide any significant practical limitation on claim scope, and therefore, the claim should be determined to cover unpatentable subject matter.

• The equation test disallows a claim that amounts to no more than a disguised attempt to claim a formula, equation, or mathematical relationship.

• The human intervention test provides that a fundamental discovery of something, such as a new plant species, a new mineral, a new compound, or a new biological material, is patent-eligible if it is altered or modified so that it is in a non-naturally occurring state and has properties that are not exhibited in its naturally occurring form.

• Finally, the data comparison test negates patent eligibility if a claim merely covers the act of comparing data without more.

This essay is a based on the article “What Should be Patentable? – A Proposal for Determining the Existence of Statutory Subject Matter Under 35 U.S.C. Section 101”, 13 Wake Forest Journal of Business and Intellectual Property Law 145 (2013), available at:  http://lawprofessor.org/resources/pdf/articles/wake-forest-article.pdf and SSRN.