Takeaways from the USPTO Report on Subject Matter Eligibility

The PTO recently issued a report on two roundtables held to discuss patent eligible subject matter. Views on recent Supreme Court subject matter eligibility jurisprudence varied depending on the industry affected. The life sciences industry was strongly critical of the Mayo/Alice two-step framework. In particular, representatives from the life sciences industry asserted that “natural products and their derivatives form the basis for many biopharmaceutical innovations” and that “the act of isolating a natural product should be sufficient for patent subject matter eligibility, at least when isolation permits the product to be used or applied in a new or different way.”¹ One commentator cited a National Institutes of Health study which estimated that 75 percent of antibacterial drugs and 80 percent of anti-cancer drugs approved by the FDA between 1981 and 2010 would not be patent eligible.

The computer-related industry, in contrast, were more divided in their views of the recent Supreme Court decisions. Those in support stated that Alice addressed the problems of “abusive patent litigation driven by overly broad patents.”² However, others in the computer industry cited negative impacts on software innovation as well as uncertainty in their business practices.

The Report outlined three different recommendations by the public. Those generally supportive of the decisions saw no need for legislative intervention and recommended the judiciary to continue developing the eligibility case law.

Another recommendation from the public was to increase the consistency and clarity of eligibility issues by improving the application of the two-part eligibility test by the PTO. Several commentators pointed out that PTO examiners are currently not required to specifically rebut applicants’ arguments, and that the current guidelines issued by the PTO do not include enough examples of patent eligible subject matter, nor do they provide any guidance on how patent ineligible claims might be rewritten to claim patent eligible subject matter.

Finally, a majority of the commentators urged for legislative reform. Recommendations included replacing the Mayo/Alice two-part test with a technological or useful arts test, which would eliminate the “new” but maintain the “useful” requirement in § 101. Others recommended expressly defining exceptions for eligibility, for example, “claimed inventions that exist in nature independent of human intervention or exist only in the human mind.” ³ Another set of legislative proposals focused on relying on the other statutory conditions for patentability (i.e., the provisions of §§ 102, 103, and 112). Finally, some commentators proposed a legislative amendment which would create a research exemption from patent infringement, in order to encourage technological progress.

The Report did not provide any further guidance or future directions on subject matter eligibility; however, the steps to be taken – whether it be legislative reform or improved administrative measures – will undoubtedly have a significant impact across at least the life sciences and computer technologies.