Dr. Elizabeth O'Day
Section 101 of US Patent Law Needs Reform (or we will all lose)
To detect fetal abnormalities, mothers used to have to undergo an invasive and potentially dangerous amniocentesis procedure where a needle is inserted into the uterus to extract a sample of amniotic fluid. This has a risk of causing miscarriages. Now those same abnormalities can be screened through a simple blood test. Scientists at Oxford invented and patented this technology. The diagnostic company Sequenom bought an exclusive license to the patent for +$14M, and the company funded the additional development to make this breakthrough technology available for expectant mothers. The basis of intellectual property is that in exchange for creating something useful, like the Sequenom test, society gives the inventor the exclusive right to profit from the invention for a limited time, after which it goes into to the public domain and belongs to society. Accordingly, when other companies mimicked their technology for commercial sale, Sequenom looked for their IP to be upheld. This was not what followed—rather the Federal Court dismissed the original patent citing Section 101 of US patent law (Ariosa Diagnostics, Inc v. Sequenom, Inc, 2015).
Similar stories have unfolded for numerous diagnostic companies/patents (Table 1), often leading to significant economic losses for the original inventor. These battle losses have made some investors completely shun diagnostics, slowing innovation. And the real loser will be the public—you and me, as incredible, potential life altering technologies risk not even being developed.
What is Section 101 and why does it exist?
Section 101 of the US Patent Act defines patentable inventions. It states "Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title” (35 U.S.C. § 101). However, this classification is limited by the following clause, “Laws of nature, natural phenomena, and abstract ideas are not patentable” (Ibid). A major goal of this clause is to prohibit the patentability and thus ownership of products of nature and math. This is valid. We cannot allow a person nor a company to be able to patent a gene, protein, or metabolite that occurs naturally nor an equation.
But where does this clause leave precision medicine? Precision medicine is driven by biomarkers (genes, proteins and metabolites) and algorithms that identify an individual’s disease susceptibility, prognosis and response to specific treatments. Once discovered, rigorously validated, and commercialized, these biomarker inventions stand to benefit all of society, and IP protection would be expected to follow. Unfortunately, under Section 101, these biomarkers are not patent eligible.
How can we reform Section 101?
The shortcomings of Section 101 have led many to advocate for reform. A bi-partisan effort led by Sens. Chris Coons (D-Del.) and Thom Tillis (R-N.C.) and Reps. Doug Collins (R-Ga.), Hank Johnson (D-Ga.) and Steve Stivers (R-Ohio) has created an opportunity to reset IP norms for biomarkers. Clarity on what is and is not patentable should be clearly stated. The inventors of a particular biomarker/algorithm driven diagnostic tool deserve recognition and financial remuneration. However, patents must not be too broad that new improved methods cannot be developed. Reasonable models for licensing could enable the original patent holder to benefit while still allowing new innovation to foster. Further, there are likely, “carve out” opportunities that would prevent patenting bona fide products of nature, but provide protection for novel means of detecting, quantifying and correlating those products with a particular phenotype.
IP attorney, Karl Bozicevic frames the problem “The pendulum has swung so far away from the original intent of Section 101 that we are now in danger of depriving the public life saving products.”
Over the past year, I served on the World Economic Forum's Global Precision Medicine Council, leading a task force focusing on Access and Fair Pricing. We released a Vision Statement for advancing precision medicine globally, wherein included in the recommendations is innovating intellectual property protection regimes for biomarkers to incentivize investment in foundational new diagnostics.
Therapeutic companies require on average $2.9B and 12 years to bring a new drug to patients (DiMasi, 2016). In exchange for this investment, drug developers often receive 20-year patent protection on the new treatment, which typically brings billions back to the company. Despite a less than a 10% success rate of most drugs, this a return that investors are eager to make and has led to some breakthrough therapies (BIO, 2016).
Biomarkers and algorithms have the potential to make an even bigger impact in precision medicine. We have the omic technologies (genomic, proteomic, metabolomic, etc) and analytical tools needed to uncover biomarkers that could dramatically enhance our ability to detect and treat disease. Let’s reform Section 101 so that these breakthrough products have the opportunity to reach the people that need them.
Table 1. Examples of Biomarkers/Diagnostic Patents Contested Under Section 101
Ariosa Diagnostics, Inc v. Sequenom, Inc, 788 F.3d 1371 (2015)
Biotechnology Innovation Organization (2016). Clinical Development Success Rates 2006-2015
Dimasi, Joseph A., et al. “Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs.” Journal of Health Economics, vol. 47, 12 Feb. 2016, pp. 20–33.
United States Patent Law 35 U.S.C. § 101 (1952)