The Health 202: The Supreme Court banned patenting genes. But Congress might change that.

Media Article 9 Jul 2019


The justices of the U.S. Supreme Court

The Supreme Court has ruled unanimously that genes can’t be patented. But a bipartisan group of lawmakers is trying to change that with legislation pushed by biopharmaceutical companies and patent lawyers.

Three hearings are scheduled this week and next before the Senate Judiciary Committee’s intellectual property subcommittee, where its members will consider draft legislation from Sens. Chris Coons (D-Del.) and Thom Tillis (R-N.C.) loosening rules around what types of things can and can’t be patented.

The measure is drawing scrutiny from patient and civil rights groups, who say it would reopen a door repeatedly closed by the Supreme Court to companies that have previously claimed exclusive rights to parts of the genetic code — and the very act of diagnosing diseases such as breast cancer and Crohn’s disease. The court has said companies can’t patent natural phenomena or observations about it — a situation that some say could hamper scientific research and hurt patient access to medical care.

“Our patent system is really about encouraging innovation, but when you allow patents on basic things in nature, you’re blocking all the follow-up innovation we want to see,” said Sandra Park, senior staff attorney with the ACLU’s Women’s Rights Project.

Sen. Thom Tillis (R-N.C.) REUTERS/Aaron P. Bernstein

The draft from Coons and Tillis — also sponsored by Reps. Doug Collins (R-Ga.), Hank Johnson (D-Ga.) and Steve Stivers (R-Ohio) in the House — essentially erases a precedent the Supreme Court laid out in three unanimous rulings between 2012 and 2014 in which the justices said patents can’t be granted for “products of nature,” “laws of nature” or “abstract ideas.”

The highest-profile of those cases involved a company named Myriad Genetics, which claimed to own genes called BRCA1 and BRCA2. Myriad initially held a lucrative monopoly on diagnostic tests for mutations in those genes, which are tied to a higher risk of breast and ovarian cancer in women. When other companies started offering tests to analyze the two genes, Myriad sued, arguing its patents were being infringed on. But all nine of the justices disagreed.

“Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes ‘new . . . composition[s] of matter,’” Justice Clarence Thomas wrote in the court’s opinion.

In another case, the Mayo Clinic challenged a patent held by Prometheus Laboratories for how to determine the proper dosage of drugs that treat gastrointestinal and other autoimmune diseases. The procedure — which merely involved administering the drug and testing its level in the bloodstream — wasn’t an invention but simply an observation, the court ruled.

It would be one thing if these companies were trying to protect their patent rights to a specific test they themselves had developed. But that’s not what they were doing. They were trying to claim the exclusive ability to carry out the testing at all. It would be like if an insulin manufacturer claimed a patent for the mere act of measuring blood glucose levels to determine insulin dosing — a crucial part of diabetes management.

Sen. Chris Coons (D-Del.) (Andrew Harnik/EPA-EFE)

These questions probably will get a spirited debate this week, as Judiciary Committee members consider the ramifications of the changes to patent law being sought by Coons and Tillis. The legislators argue the Supreme Court decisions weakened intellectual property rights and say the patent limits could discourage the biopharmaceutical industry from developing new tests and cures.

“The United States is the most innovative country on the planet,” Coons said in a statement. “Strengthening our intellectual property laws to encourage and reward research and innovation is critical to our leadership in developing cutting-edge technologies.”

The draft bill explicitly erases the boundaries laid out by the Supreme Court, stating that “no …. judicially created exceptions to subject matter eligibility, including ‘abstract ideas,’ ‘laws of nature,’ or ‘natural phenomena,’ shall be used to determine patent eligibility.”

The Trump administration appears on board with the Coons-Tills bill. Andrei Iancu, director of the U.S. Patent and Trademark Office, praised the measure in a May 22 keynote address at a dinner hosted by the Eagle Forum Education & Legal Defense Fund. The event was sponsored by the Pharmaceutical Research and Manufacturers of America, among others.

“I and the subject matter experts at the USPTO stand ready to help with any legislative efforts,” Iancu said. “If the United States is to maintain our technological edge in an increasingly competitive global environment, the American patent system must move beyond the confusion of the past several years when it comes to this most fundamental issue in the patient system.”

Myriad was among the stakeholders invited to roundtable discussions hosted by Coons and Tillis as they were drafting their legislation. So were representatives from the American Intellectual Property Law Association, the American Bar Association and the Biotechnology Innovation Organization, which represents biotech companies.

These groups also argue that patent laws need overhauling to protect innovation. But reversing the Supreme Court’s three limits would undoubtedly lead to more patent litigation, as it would massively broaden the field of things that could be patented.

Tahir Amin, co-founder of the group Initiative for Medicines, Access and Knowledge, said he doesn’t buy the arguments for “cleaning up” patent law.

“Behind the attempt to clean it up, I think it’s an opportunity to push a pro-patent agenda,” Amin said.

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