“Opponents of the 101 amendment have been referring to ‘human genes’ or ‘genes’ in a sloppy, unscientific manner without indicating whether they are talking about human genes in the body or isolated gene segments outside of the body. The distinction is critical…and confusion causes anti-patent hysteria. Sadly, confused anti-patent hysteria seems to be the goal, and how the opponents of thoughtful reform are poised to fight.”
Last week, all eyes were on the first two days of historic Senate Judiciary IP Subcommittee Hearings, led by Senator Thom Tillis (R-NC), Chair of the Subcommittee, and Senator Chris Coons (D-DE), Ranking Member of the Subcommittee. The purpose of the hearing was simple: to determine a fix for the disaster foisted upon the industry by the patent eligibility jurisprudence of the Supreme Court of the United States.
The testimony of the first 30 witnesses has already been summarized, so there is no need for me to dive into the particulars of who said what here. Suffice it to say that the Subcommittee heard a range of opinions—some better supported than others.
One issue that begs discussion is the extraordinary confusion over what the Supreme Court actually ruled in AMP v. Myriad during the two days of testimony. Indeed, at times it was difficult to determine whether there was simply confusion on the part of some witnesses, or an attempt to conflate and mislead the Subcommittee. With that in mind, a review of what the Supreme Court actually held seems to be in order.
Justice Thomas summarized the Court’s decision by saying:
[W]e hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.
Further, with respect to cDNA, Justice Thomas also explained:
[T]he lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature” and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.
Myriad is often misquoted as saying that cDNA is patent eligible per se, but that obviously is not what the Court ruled. In fact, cDNA is patent eligible only so long as it is distinguishable from DNA. That may seem sound, but cDNA is only ever man-made. This more than anything else explains the depth of the Supreme Court’s lack of understanding of the science, and the issues.
Creating the Crisis
The Supreme Court’s decision in Myriad seriously undermines the continued relevance of the Chakrabarty decision, given that something (i.e., cDNA) created in a lab by man may not be patent eligible. The very foundation of the Chakrabarty decision mandated a finding of patent eligibility when a person had engaged in activity to alter something. Clearly, a composite cDNA is created by man and is precisely the type of innovation the Constitution and laws of Congress envision being patent eligible. But the very fabric of the Chakrabarty ruling was shredded, overruled in fact, despite the Supreme Court continuing to say that it remains good law.
Of course, the fact that the Supreme Court overrules case after case without explicitly acknowledging that it has done so has created, at least in part, the patent eligibility crisis. It is also why the actual ruling in Myriad must be defined with great care. To wit:
- Human genes and DNA in the body have NEVER been patent eligible because they are not man-made and are not new. The Myriad decision did not change that. Opponents of the 101 amendment have been referring to “human genes” or “genes” in a sloppy, unscientific manner without indicating whether they are talking about human genes in the body or isolated gene segments outside of the body. The distinction is critical when discussing Myriad and matters of patent eligibility, and confusion causes anti-patent hysteria. Sadly, confused anti-patent hysteria seems to be the goal, and how the opponents of thoughtful reform are poised to fight. If they cannot win on the merits or science they will scare the public.
- The Myriad decision addressed whether isolated gene segments outside the body are patent eligible, and the holding is inconsistent with the language of 101 because an isolated material outside the body is due to human intervention and is thus man-made.
- The Supreme Court’s ruling in Myriad is based on the Court’s judicial exceptions to the statute, not the language of the statute as passed by Congress. Earlier this year in Henry Schein, Inc. v. Archer & White Sales, Inc., the current Supreme Court ruled 9-0 that there can be no judicial exceptions to a statute. Although not interpreting the Patent Act, such a declarative statement has to apply equally to all legislation if it applies to one Act of Congress.
- The Myriad decision threw out the baby with the bathwater, because it was interpreted to hold that all isolated natural materials are not patent eligible subject matter. These materials have played an essential part in the creation of medicines, such as antibiotics, anticancer agents, and in personal diagnostics. The downstream effect of Myriad has been devastating in all of these categories. As Sherry Knowles said in her testimony on June 4, research on isolated natural materials to cure diseases, including cancer, has come to a dead stop in the U.S.
- The Supreme Court in its Myriad decision stated that certain universities were not able to provide BRCA1/BRCA2 testing because of the Myriad However, there was NO evidence in the case that these universities had independently discovered the BRCA genes, their relationship to breast cancer, or developed the product and got FDA approval, i.e., carried out the “extensive effort” to create the invention and product. The universities wanted to tag team on inventions they did not create. Indeed, the Myriad case is a perfect example of a well-known and documented phenomena relating to the Supreme Court using facts not in the record to decide cases, which is antithetical to U.S. jurisprudence. Indeed, according to the NY Times, the Justices on the Supreme Court are “are quite receptive to this dodgy data” contained in amicus briefs.
- The Myriad Court thus made a fundamental error by skipping from the need to motivate basic research to later market accessibility, which was a theme on the second day of testimony when Senator Richard Blumenthal (D-CT) talked about his Affordable Prescriptions for Patients Act. This discussion has to unlink motivation to invent from prices and distribution, which are apples and oranges. Simply stated, as I have previously explained, drug prices in the U.S. are high not because of patents, but because foreign governments restrict access to markets, which force U.S. consumers to pay for R&D of drugs while patients around the globe do not contribute. See The Price of Price Controls. Of course, there will be nothing to price if nothing is invented because of insufficient motivation. Witness Bob Armitage and Senator Tillis ably emphasized this on the first day of testimony.
- Because of the human genome project and other publications, the human genome is now public. Therefore, there is diminishing value, if at all, in researching or getting a patent on isolated non-disease based naturally occurring gene segments out of the body. The only isolated gene segments of remaining interest are those linked to diseases, which we better be providing motivation to track down for all of our sakes. Any debate about isolated natural healthy genes is arguing to a quickly emptying, if not emptied, room. However, the downstream fallout of the decision is not going away.
The Supreme Court has now refused 43 petitions seeking further clarification and guidance on patent eligibility since Alice v. CLS Bank, with the Court most recently refusing Villena v. Iancu. While there are some who want to stop sensible reform based on scare tactics and misinformation, the truth is the Supreme Court has made a mess of patent eligibility law and is continually refusing to clean it up. Congress must act, and the time is now.
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