In the first part of this series posted last week, I discussed the majority and concurring opinions in Athena v. Mayo decided by the Federal Circuit Court on July 3, 2019. In part 2 of the series, I will review the four dissenting opinions for this case.
In the first dissent, Judge Moore (joined by Judges O’Malley, Wallach, and Stoll) provided a thorough and detailed discussion of the medical diagnostic industry and its importance to the healthcare industry, including patients, providers, and research & development (R&D) companies. She notes that despite the significance of these inventions, since the 2012 Supreme Court Mayo decision, the Federal Circuit has never found one of these patents to be eligible for protection. There is a presumption against eligibility for medical diagnostic inventions. However, in Judge Moore's opinion, the Court has extended the Mayo rationale too far to effectively exclude all diagnostics from patents. She also notes that patient diagnosis is the foundation of medicine and submits that diagnostic techniques and kits are precisely the type of innovation the patent system exists to promote, because they are critical to treating illnesses and saving lives. The long time and high cost (10 years, $100 million) often required to develop and test new diagnostic techniques, economically necessitates the need for strong patent protection. In the absence of patent protection to recover these costs, there is little incentive to invest in such endeavors, to the detriment of patients. Judge Moore concludes that based on the simple math, it is bad for the health of the American people and the health of the American economy that diagnostic inventions are not eligible for patent protection. And, jurisprudence has ignored the explicit instruction from Congress in § 101 that a discovery can be patentable. But her only hope lies with her Court or Congress to fix this eligibility problem.
The second dissent (Judges Newman and Wallach) also notes the critical role of patents in developing new diagnostic procedures, which are admittedly expensive, but provide substantial public benefit. As stated by Judge Newman, "The patent system provides the economic foundation for the cycle of experimental study, clinical evaluation and proof, and implementation in commerce." She notes the legislative history of the 1952 Patent Act, which confirmed that Congress intended patentable subject matter to include "anything under the sun that is made by man." The legislative intent of the patent system is to provide an incentive to advance useful technologies by enabling inventors to benefit economically. The current law is a disincentive to the development of new diagnostic methods. When an entire industry and various scholars criticize this situation, judicial attention is warranted.
The third dissent (Judges Stoll and Wallach) acknowledged that the Federal Circuit has established a bright line rule of ineligibility for diagnostic inventions, based on an over-reaching and flawed test for eligibility which undermines the constitutional rationale for the patent system, that is, promoting the progress of science and useful arts. This is not only a patent issue, but an issue of human health.
In the fourth and last dissent, Judge O'Malley states that the Federal Circuit has applied the Mayo Supreme Court decision too broadly. He explains that the Supreme Court requires an "inventive concept" under § 101, even though Congress removed this concept in the 1952 Patent Act. Therefore, he encourages Congress to clarify what it said 67 years ago when Congress eliminated the "invention" requirement which was unworkable then and is not workable now.