With great fanfare (and a seeming exercise of appropriate diligence), Senators Thom Tillis (R-NC) and Chris Coons (D-DE), chair and ranking member of the Intellectual Property Subcommittee of the Senate Judiciary committee, over the past few weeks have held a series of public hearings on the subject of legislative intervention to reform patent eligibility law rendered somewhat askew by several recent Supreme Court decisions (and, to be fair, how those decisions have been expansively, if not slavishly, implemented by the U.S. Patent and Trademark Office and the inferior courts, including the Federal Circuit).
On June 24, 2019, the Senators posted a synopsis of their recent efforts, entitled "What We Learned at Patent Reform Hearings." This synopsis is generally informative but particularly with regard to the Senators' understanding and commitment (at least for now) to solving the problems caused to the life sciences industry by the Court's decisions in Mayo v. Prometheus (as interpreted by CLS Bank v. Alice) and AMP v. Myriad Genetics.
Their missive begins with the almost requisite encomiums to innovation and entrepreneurship, and the contributions of the patent system to U.S. success in these endeavors. The Senators certainly "get it" with regard to the problem, saying that "[o]ver time, courts have clouded the [patent eligibility] line to exclude critical medical advances like life-saving precision medicine and diagnostics. Recent decisions have also made it difficult to predict whether exciting and important technologies like artificial intelligence make the cut." And they are careful (in these fraught days) to be sure to mention that their efforts have been "thorough, thoughtful, bipartisan and bicameral legislating." But the need is clear: "the U.S. patent system with regard to patent eligibility is broken and desperately needs to be repaired" because "[t]he U.S. Supreme Court has confused and narrowed Section 101 of the Patent Act to the point that investors are reluctant to pursue the innovations that propel our country forward." A more succinct and damning indictment by one branch of government of another is (fortunately) rare and even more significant because (in large part) it is true (although again, to be fair, the Supreme Court undoubtedly did not intend the consequences of its rather Delphic pronouncements on patent subject matter eligibility). These Senators' position that Congress needs to step in is further justified, according to their statement, that there have been "over 40 [actually, 42]" denials of petitions for certiorari on patent eligibility issues, indicating the Supreme Court's refusal to address the issue and as a result the lower courts and USPTO are and have been unable to ignore this precedent (but, until recently, it is at least arguable whether they have tried particularly hard to do so).
And what of the concerns of the life sciences industry? It is gratifying for those laboring in these particularly patent-infertile fields that the Senators understand how the life sciences have been specifically hard-hit by the current climate. The statement cites the Ariosa v. Sequenom case, not only because of the groundbreaking nature of the technology (and its beneficial effects on women no longer needing to be subjected to invasive procedures to obtain important diagnostic information about their babies), but because those individuals charged with stewarding U.S. patent law, embodied in Judge Richard Linn's "concurring" opinion in Ariosa, have said that there is discernably "no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible."
The Senators attest that they have considered the testimony of the naysayers, who are concerned that the current system "provides a mechanism to terminate baseless patent infringement lawsuits quickly and efficiently," but while acknowledging them (and the need for taking steps to mitigate these problems), the Senators understand that courts cannot be permitted to "destabilize" the patent system in an effort to correct issues like "deterring nuisance litigation." They are also careful to rebut the allegation that their proposal would "permit patenting of scientific research per se, mere abstract ideas and nontechnical methods of doing business," specifying that "our patent system was never intended to protect artistic creations, methods of investing, or items found in nature" (although the latter category would do with a bit of clarification and limitation as to its scope).
The Senators are also careful to state that by abrogating the "judicial exceptions" in prior case law they do not intend to reverse the individual outcomes of these cases; some, they say, were decided correctly while others excluded inventions that should have been deemed eligible for patenting. But they recognize that the issue is one of proper application of patent law to questions of prosecution, validity, and infringement, and that the Supreme Court's calculus has "collapsed" in error the more nuanced (yet well-defined) requirements for patentability into Section 101. In view of the propensity for many of the "naysayers" to be representatives of the electrical, mechanical, and "high technology" arts, the Senators wisely cite as an example of the errors occasioned by recent precedent invalidation of claims to a "network charging station for electric vehicles," subject matter having much less emotional impact than, for example, gene patenting. And Senators Tillis and Coons characterize as "admissions" concessions from high-tech representatives and legal academics that the law was being improperly applied to life sciences inventions.
Turning to the ACLU and their fellow travellers, the Senators address their concerns (which are to preserve their signal, albeit Pyrrhic, victory over gene patents):
Other witnesses, including the American Civil Liberties Union, expressed concerns about the patenting of human genes. As we stated at the hearing, it is not our intent to allow such patents, and several witnesses, including the Association of American Universities and the Intellectual Property Owners Association, disagreed that our proposal would enable that result.
Testimony at the hearings further clarified that — because the entire human genome has been mapped for many years — these concerns are misplaced. That said, we want to be very clear on this point, and we welcome proposals to clarify our proposed legislation.
So what do the Senators see as the aim of their legislation with regard to life sciences inventions? It includes at least this:
We do want to incentivize research and development into the exciting prospects of individualized diagnostics and precision medicine, which is tied to genetics. We are working hard to ensure the protections that will enable our innovators to bring these products to market while safeguarding research into the next generation of medical advances.
For example, we are considering a provision that would exempt research and experimentation from infringement liability. This type of exception is common around the world. It would allow basic research to continue unimpeded by patents, which are designed to control commercialization, not stifle research. We will be reviewing any additional suggestions we receive that would promote research without discouraging product development.
The latter idea is one that has been suggested before, and has the advantage of taking some of the force from the argument (always more as a possibility than reality; see "Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate") that basic research would be negatively impacted by permitting life sciences inventions to be patented.
Finally in the "lessons we have learned" section, the Senators mention that the alternative to fixing the patent subject matter eligibility pickle recent events have conspired to create will be to cloud inventions important to human health and diagnostics in trade secrecy -- a real risk with real consequences.
The Senators then set out the next steps: clarifying in statutory language exclusion of human genes, and identifying the meaning of the "field of technology" requirement, so that "critical advances like artificial intelligence and medical diagnostics qualify, but not economic transactions or social interactions."
How these efforts go forward are important to track, because the Senators state that "[w]e will also consider ideas for reinforcing Section 112 of the Patent Act, which should operate to prevent inventors from claiming all possible solutions to a problem while also serving to protect inventors against those seeking to profit on trivial modifications." There is much possible mischief in that statement, but these Senators are due the benefit of the doubt (and time) to fully flesh out how they intend to use Section 112 to address issues that have arisen (and have been imperfectly addressed) under Section 101.
