Filewrapper®

Patent Judges Agree that Patent Eligibility Law Needs Fixing: Part 2

August 14, 2019
Post by Kirk M. Hartung

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.

Kirk Hartung is Chair of the Mechanical Patent Practice Group at McKee, Voorhees & Sease, PLC. For additional information, please visit www.ipmvs.com or contact Kirk directly via email at kirk.hartung@ipmvs.com.


Post Categories

Comments (0)
Post a Comment



Captcha Image
Return to the Filewrapper Blog

Search Posts

Purpose

The attorneys of McKee, Voorhees & Sease, P.L.C. designed this blog as an informational and educational resource about intellectual property law for our clients, other attorneys, and the public as a whole. Our goal is to provide cutting-edge information about recent developments in intellectual property law, including relevant case law updates, proposed legislation, and intellectual property law in the news.

Disclaimer

McKee, Voorhees & Sease, P.L.C. provides this blog for general informational purposes only. By using this blog, you agree that the information on this blog does not constitute legal or other professional advice and no attorney-client or other relationship is created between you and McKee, Voorhees & Sease, P.L.C. Do not consider this blog to be a substitute for obtaining legal advice from a qualified, licensed attorney. While we try to revise this blog on a regular basis, it may not reflect the most current legal developments. We consciously refrain from expressing opinions on this blog and instead, offer it as a form of information and education, however if there appears an expression of opinion, realize that those views are indicative of the individual and not of the firm as a whole.

Connect with MVS

Enter your name and email address to recieve the latest news and updates from us and our attorneys.

Subscribe to: MVS Newsletter

Subscribe to: Filewrapper® Blog Updates

  I have read and agree to the terms and conditions of McKee, Voorhees & Sease, P.L.C.