Battle Begins Over Legislation To Expand What Inventions May Be Patented

BIO, PhRMA, AAM, former PTO Commissioners to testify at two-day Senate hearing on draft bill to revise Section 101 of Patent Act; ACLU coalition says legislation will allow patenting of human genes.

What may be one of the fiercest fights over US patent law in recent years is about to formally kick off. At issue is draft legislation to revise Section 101 of the Patent Act governing what subject matter is eligible to be patented.

The Senate Judiciary Committee's Subcommittee on Intellectual Property is holding hearings on 4 and 5 June to address the state of patent eligibility. It will address the proposed measure, which would favor eligibility for inventions that have previously been excluded under the law, such as medical diagnostics.

The witnesses will include representatives of the Biotechnology Innovation Organization and Pharmaceutical Research and Manufacturers of America, which have advocated for the proposed change, and the Association for Accessible Medicines, which opposes it.

On June 3, the American Civil Liberties Union and more than 100 other groups sent a letter to the bill's sponsors opposing the legislation, arguing that it would overrule Supreme Court precedent forbidding the patenting of human genes.

Biopharma patent owners have been pushing for legislation to amend Section 101 of the Patent Act. Last year, the American Intellectual Property Law Association and the Intellectual Property Owners Association adopted a joint proposal to limit when a claimed invention would be patent ineligible. At a hearing in March, Subcommittee Chairman Thom Tillis, R-NC, said he intended to have a draft bill made public by early summer. (Also see "Bill To Revise US Subject Matter Patent Eligibility Standard Expected By 'Early Summer'" - Pink Sheet, 13 Mar, 2019.)

Tillis released a "framework" for the bill in April, which included a list of exclusive categories of subject matter which alone would not be eligible for patent protection. On 22 May, Tillis, ranking member of the subcommittee Chris Coons, D-DE; ranking member of the House Judiciary Committee Doug Collins, R-GA; chair of the House Judiciary Subcommittee on IP and the Courts Hank Johnson, D-GA; and Rep. Steve Stivers, R-OH, issued a one-page draft text of the bill.

The draft states that patent eligibility "shall be determined only while considering the claimed invention as a whole, without discounting or disregarding any claim limitation."

"A conservative approach to patentable subject matter would focus narrowly on identified problems in the medical diagnostics business, rendering significant new medical discoveries patentable when they have a practical application but otherwise leaving the law unchanged." – Mark Lemley

 

It specifies that provisions of Section 101 "shall be construed in favor of eligibility." The proposed bill would eliminate the three judicial exceptions the Supreme Court has held are categories of inventions that are not patent eligible.

"No implicit or other judicially created exceptions to subject matter eligibility, including 'abstract ideas,' 'laws of nature,' or 'natural phenomena,' shall be used to determine patent eligibility under section 101, and all cases establishing or interpreting those exceptions to eligibility are hereby abrogated," the draft states.

Drug Pricing And Patent Thickets

AIPLA has said recent Supreme Court decisions, including its 2012 Mayo Collaborative Services v. Prometheus Laboratories Inc. ruling, its 2013 decision in Association for Molecular Pathology v. Myriad Genetics Inc., and its 2014 decision in Alice Corp. Pty. Ltd. V. CLS Bank International have distorted patent eligibility requirements. At a hearing in March, US Patent and Trademark Office Director Andrei Iancu acknowledged that it is difficult to find medical diagnostics patent eligible.

AAM expressed concern about the bill's impact on drug pricing. The proposed revisions to Section 101 of the Patent Act "would allow brand-name drug companies to raise drug prices even more by adding basic mental processes, the facts of life, and laws of nature to their patent arsenals," the association said. "Critically, the Supreme Court has held such patents to be ineligible for monopoly protection for 150 years. Now is not the time to arm brand-name drug companies with even more weapons to hold off pharmaceutical price competition."

The ACLU said the proposed bill is an attempt to overturn the Supreme Court's Myriad Genetics decision, which held that isolated DNA is a product of nature and thus cannot be patented. The ACLU filed suit against Myriad on behalf of medical organizations, researchers and breast cancer and women's health groups. (Also see "Biotech Industry Fears Fallout From Supreme Court’s Myriad Ruling; PTO Offers Guidance" - Pink Sheet, 17 Jun, 2013.)

During a press call on 3 June, Kate Ruane, ACLU senior legislative counsel, said Tillis and Coons had convened closed door round table discussions on how to reform the Patent Act which, like the upcoming hearings, did not include patient advocates or representatives from the broader scientific community.

Harold Varmus, professor at Weill Cornell Medicine and former director of the National Institutes of Health and NIH's National Cancer Institute, also spoke on the call saying the proposed legislation would dramatically broaden the terrain of what is patentable.

"The new legislation would almost certainly lead to thickets of patents on genes and other natural products," he said. "This would result in a quagmire of patent claims and legal impediments to the normal scientific exchange, and that resulting quagmire would impair the vitality of basic research in the US."

Bill Could Focus On Medical Diagnostics, Lemley Suggests

Two former commissioners of the US Patent and Trademark Office, Q. Todd Dickinson and David Kappos, will testify on the first day of hearings, as will former Eli Lilly & Co. General Counsel Robert Armitage and Stanford University School of Law professor Mark Lemley. BIO, PhRMA, and AAM will be testifying on the second day, along with representatives of the AIPLA, IPO, and the Association of American Universities and Council on Government Relations.

In his prepared testimony, Lemley says the Tillis-Coons bill is too broad and suggests that a bill could be crafted that addresses the Federal Circuit's inconsistent and uncertain application of Section 101.

"The Tillis-Coons bill makes dramatic changes to the law of patentable subject matter, overturning not just a decade's worth of Supreme Court precedent but nearly eliminating nearly two hundred years of doctrine," he said.

Lemley said the current 101 rules are bad for life sciences but might be good for software innovation. "A conservative approach to patentable subject matter would focus narrowly on identified problems in the medical diagnostics business, rendering significant new medical discoveries patentable when they have a practical application but otherwise leaving the law unchanged," he stated.

The subcommittee plans to hold a third hearing on the topic on 11 June, but the Judiciary Committee has not yet put it on the calendar.