Congress: Getting Serious About Patentability
By Mike Waring
July 17, 2019
Since January, the United States Senate’s Judiciary Committee has shifted its focus to one of the most important questions facing innovation – what is, or is not, “patentable?”
Over a series of roundtables and three legislative hearings, the Intellectual Property Subcommittee, led by Chairman Thom Tillis (R-NC), and ranking member Chris Coons (D-DE), have looked at a series of court cases that have made securing patents more difficult, particularly for discoveries such as medical diagnostics.
In recent years, federal courts have expanded the ability of Section 101 - which states that whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent and is subject to the conditions and requirements of this title - to negate the patentability of a number of innovations, especially in the life sciences space.
How? By determining that these discoveries are part of “nature,” the courts have ruled that such inventions are not patentable. This has also caused problems for patent examiners at the United States Patent and Trademark Office. Many pro-patent groups believe that Section 101 is being used too powerfully to reject inventions, and that other sections of patent law should take precedence in determining if a discovery meets the test of patentability.
AUTM has provided expert advice from its Legal Task Force to the other higher education associations in DC as this issue has progressed. It now appears that legislation could be moving forward soon.
Patents are a key incentive for investors once a discovery leaves the laboratory and heads toward commercialization. Without patentability for many diagnostic tests, patients and doctors may miss out on life-saving or health-improving treatments. Patient access to new diagnostic tests must be at the forefront, but if that access trumps the ability to create new life-saving tests, no one benefits. Expect to hear more about this issue in the coming months as the Committee considers legislation.
Mike Waring, is the Chair of AUTM’s Advocacy and Alliances portfolio and the Executive Director of Federal Relations for the University of Michigan.