Is the Sky Really Falling?: Myriad and Its Impact on Therapeutic Development


In 2013, the Supreme Court held in Association for Molecular Pathology v. Myriad Genetics that isolated products of nature are not patentable subject matter. Researchers believe that many pharmaceutical advances reside in natural products, so commentators worry that if products of nature cannot be patented, then promising innovation in this area will not be pursued. Because of these fears, Congress has recently focused on reforming the patent eligibility statute to abrogate the Court’s recent limiting case law. But even after congressional hearings and public comment periods, there is still little rigorous evidence of how Myriad has affected innovation. This Note seeks to fill this gap by contributing new evidence to the debate, paying particular attention to therapeutics derived from natural products.

The evidence of affected innovation post-Myriad is presented through a review of lower court decisions that handle natural therapeutics under a Myriad standard, analysis of Department of Commerce, Patent and Trademark Office (USPTO) Patent Trial and Appeal Board (PTAB) decisions addressing the same category of inventions, and first-hand stories of deterred innovation due to Myriad-related concerns. Included in these stories is the case of Mambalgin-1, a snake toxin that possesses painkilling attributes with little-to-no negative side effects. The case of Mambalgin-1 answers the call by intellectual property academics for more evidence of discontinued projects due to patent eligibility concerns.

In short, with regard to therapeutics, Myriad has made a drop in the ocean in lower courts, a splash at the USPTO, and waves at biotechnology companies where encouraging natural therapeutics have been discovered, yet remain commercially unpursued. This does not mean, however, that Myriad has been an inherently negative development; Myriad has positively influenced privacy and bodily autonomy, collaborative research, and access to quality healthcare. But in their assessment of patentable subject matter jurisprudence, Congress must balance both the strengths and weaknesses of Myriad, in order to honor the concerns that led to Myriad’s holding while simultaneously spurring innovation. In order to do so, non-patent incentives, such as longer periods of regulatory exclusivity, increased grants and direct funding, and tax credits for natural therapeutics should be pursued as the government seeks impactful reform that will ensure that the sky does not fall on future therapeutic innovation.


Stanford University Stanford, California
  • Taylor Beardall, Is the Sky Really Falling?: Myriad and Its Impact on Therapeutic Development, 34 Stan. L. & Pol'y Rev. 311 (2023).
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