By Jason Rantanen
This past spring, Senators Tillis (R-NC) and Coons (D-DE), ranking members of the Senate Judiciary Committee, together with Representative Collins, Johnson and Stivers, released draft bill text for bipartisan patent legislation focusing especially on Section 101 (read here). The Senate Judiciary Subcommittee on Intellectual Property conducted hearings on patent eligibility and disclosure requirements in June, and there was a sense that a proposed bill would drop before the August recess. With the Senate recess beginning on Saturday, that is looking unlikely. More likely we will see something in a few weeks, once Congress reconvenes.
There’s still a day and a half to go, however, and two recent letters to the Senate Judiciary Subcommittee on Intellectual Property have presented opposing viewpoints on the central issue being addressed by the proposed legislation: patent-eligible subject matter.
Letter from medical, health and civil rights organizations:
The first, signed by over 200 organizations, including the ACLU, Mayo Clinic Laboratories and Women’s March, begins:
We, the undersigned civil rights, medical, scientific, patient advocacy, and women’s health organizations, write to express our opposition to the recent proposal to amend Section 101 of the Patent Act. The draft legislation if enacted would authorize patenting products and laws of nature, abstract ideas, and other general fields of knowledge. Most troublingly, the legislation would permit patenting of human genes and naturally-occurring associations between genes and diseases. Allowing these patents will prevent the discovery of novel treatments for diseases including cancer, muscular dystrophy, Alzheimer’s disease, heart disease, and other rare and common diseases. It would also create barriers to patients’ access to potentially lifesaving genomic tests, eliminate access to confirmatory testing and dramatically increase the cost of tests that have benefited from innovation that led to reduced costs of DNA sequencing technology. Further, it will stymie competition for developing and improving diagnostic and medical tests, and increase the cost and hinder advancement of targeted therapeutics involving genomic markers. That means higher costs for patients, payers, and the healthcare system overall.
It further asserts that:
The draft legislation released by your offices not only rewrites Section 101 of the Patent Act, it states explicitly that any judicially created exception to patent-eligibility will be abrogated, thereby overturning the Mayo, Myriad, and Alice decisions. If enacted, this threatens to take us back to a time of greater uncertainty regarding patent eligibility. The draft goes further than that, as well. Beyond explicitly abrogating judicial precedent holding that genes, isolated from the genome, are not patentable, the legislation also would define the concept of what is useful to mean “any invention or discovery that provides specific and practical utility in any field of technology through human intervention.” This language essentially adopts the argument for patenting isolated genes that the Supreme Court rejected in Myriad. Myriad argued for, and the PTO granted,15 the patents on the BRCA1 and BRCA2 genes because the DNA was “isolated” from the cell through an act of human intervention. Isolation is required for scientific work with DNA, and permitting patents on isolated DNA resulted in the issuance of patents covering an estimated 20% of the human genome.16 Defining “useful” to include essentially any invention or discovery that was developed through human intervention reinvigorates the argument that human genes are patent-eligible.
Read the whole letter here: ACLU Letter
Law Professor Response Letter
A letter in response, signed by a group of 24 law professors, former government officials, and scholars (some of whom testified at the June hearings) opens with:
As law professors, former government officials, and scholars, we write to express our support for the congressional effort at reforming patent eligibility doctrine. As Congress considers legislation to bring balance back to the patent system in promoting the high-tech and biopharmaceutical inventions that drive the U.S. innovation economy, it is imperative that its deliberations are based on accurate statements of the law and of the real-world performance of the U.S. patent system.
The letter takes direct aim at the health and civil rights’ organizations’ letter:
We are deeply concerned about misapprehensions of law and misleading rhetoric in a recent letter to Congress submitted by the American Civil Liberties Union (ACLU) and other medical and policy organizations that oppose this legislative reform effort. Their claim, for instance, that the “draft legislation if enacted would authorize patenting products and laws of nature, abstract ideas, and other general fields of knowledge” is a profoundly mistaken and inaccurate statement. Rather, the proposed amendments preclude “implicit or judicially created exceptions to subject matter eligibility,” and do not eliminate constitutional and statutory bars to patenting laws of nature, abstract ideas, and general fields of knowledge.
Read the full letter here: Law professor response letter
Stay tuned for a third perspective, offered by Syracuse University College of Law professor Shubha Ghosh.