with Paulina Firozi
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.
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.
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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AHH, OOF and OUCH
AHH: Following the implementation of the Affordable Care Act, there was a reduction in racial disparities in cancer care, according to new research.
Black adults in the United States where Medicaid has expanded under the health-care law are receiving treatment at about the same time as white patients in terms of cancer care.That’s compared with before the ACA, when black patients with advanced cancer diagnoses were 4.8 percent less likely to begin cancer treatment within 30 days of a diagnosis, our Post colleague Laurie McGinley reports.
The research also found ovarian cancer is being diagnosed earlier, and more women are beginning treatment for such cancer within a month. “Health policy experts who were not involved in the studies said the findings are consistent with previous data showing that the ACA is associated with improved access to health insurance and medical care,” Laurie writes.
OOF: Democratic lawmakers in Illinois passed a measure to expand and enshrine access to abortion. The state Senate passed a sweeping abortion rights bill at almost midnight on Friday, sending it to the desk of Democratic Gov. J.B. Pritzker who has expressed support for the measure. .
The Reproductive Health Act repeals the Illinois Abortion Law of 1975, getting rid of provisions that call for spousal consent, waiting periods, or restrictions for facilities that perform abortions and criminal penalties for doctors who perform the procedure, the Chicago Tribune’s Jamie Munks reports. It establishes the “fundamental right” for women to get an abortion and adds that a “fertilized egg, embryo or fetus does not have independent rights.”
Pritzker signaled he would sign the measure:
In Illinois, we trust women to make the most personal and fundamental decisions of their lives - and now, that will be the law of the land, even as it’s under threat in other states.
— Governor JB Pritzker (@GovPritzker) June 1, 2019
— Meanwhile in Missouri, a judge ruled Friday to allow the state’s last remaining abortion clinic to continue to provide the procedure. The judge granted a request from Planned Parenthood for a temporary restraining order, which prevented the clinic’s license from expiring.
But the battle over abortion services in Missouri is far from over — there will be another court hearing Tuesday.
“Had the license from the state’s Department of Health and Senior Services expired as scheduled on Friday, Missouri would have been the first state since 1974 left without a licensed abortion clinic, leaving some women to travel hundreds of miles and across state borders for access to the procedure,” our Post colleague Reis Thebault reports. “The end of abortion services at the health center would mark a milestone in the state-by-state battle over abortion rights, one that has intensified in 2019 as conservative lawmakers across the country have pushed increasingly strict bans on the procedure."
OUCH: Health care is poised again to be a top issue ahead of the 2020 election year. In a recent Wall Street Journal-NBC News poll, Americans pointed to the issue as a top one for the federal government to tackle as a bigger priority than the economy, immigration, national security and other issues.
And in another recent survey, Gallup found financial concerns related to health care worried American families more so than wages, college expenses, housing and taxes, the Wall Street Journal’s Stephanie Armour reports.
“As such, health care presents an opportunity for both major parties heading into the 2020 presidential election,” she writes. “Half of Americans say they would support paying more in taxes to assure that all Americans have health care, according to a WSJ/NBC News poll … And yet, health care also poses risks for the nation’s elected officials.”
Another obstacle, as surveys have found, is that many Americans are happy with their health coverage, which makes it difficult for those pushing disruptive health policies.
HEALTH ON THE HILL
— At the first-ever public hearing on CBD, the acting head of the Food and Drug Administration made one thing clear: there are still many questions left about cannabidiol. Even as the popular product is already being sold in the form of pills, drinks and things like skin lotions, acting FDA commissioner Norman “Ned” Sharpless said it’s not clear how CBD will interact with other drugs, or how much is safe to consume or what the effect is for children or pregnant women.
“During the 10 hours of testimony that followed, hemp growers, start-up businesses, academic researchers and consumer advocates argued about how FDA should regulate the already booming CBD industry. Some demanded strict oversight. Others — especially companies with millions at stake — lobbied for looser regulation,” our Post colleague William Wan reports. “Without clearly defined regulations, no one knows for sure how much CBD is in products available on the market, or how safely the chemical compound is being manufactured and incorporated into them.”
Also left unclear is how the agency will regulate the CBD industry and when it will determine how it will do so.
MEDICAL MISSIVES
— Acting White House chief of staff Mick Mulvaney said it was too soon to discuss gun policies after 12 people were killed during a shooting in a city government building in Virginia Beach on Friday.
Mulvaney was asked during an interview with NBC's Chuck Todd whether the president believes the federal government has a role in preventing mass shootings.
“We have too many of these shootings, and every time the first thing we talk about is politics,” Mulvaney said on NBC's “Meet the Press” on Sunday. “The mourning period hasn't even stopped yet, let alone the healing process. So, let's not get too deep into politics too soon. Let's think about the families.”
“Let’s talk about policy and the policy is enforcement, and what we’re already doing,” he said, pointing to the banning of bump stocks among other policies. “There are things the government can do and there are things this government is doing but we're never going to protect everybody against everybody who is deranged and insane … You're never going to make everything perfectly safe, but we are doing a lot better on enforcement.”
— In the hours after 17 people were killed at a high school in Parkland, Fla. in 2018, Ed Stack, the chief executive of Dick’s Sporting Goods, considered getting his stores out of the gun business entirely, our Post colleague Rachel Siegel reports.
“Ultimately, he and the company's president, Lauren Hobart, decided against going that far,” she writes, adding Stack has continued to push for change on this issue. The stores have pulled assault-style weapons from stories and banned banning high-capacity magazines and “bump stocks." The stores also announced they would no longer sell firearms to people under 21.
And although some efforts largely haven’t gained momentum, Stack has brought the issue to Washington as well. ‘In meetings with Democrats and Republicans in the House and Senate, Stack has drilled down on what he sees as holes in nationwide gun laws,” Rachel writes. “He’s urged legislators to require universal background checks that include relevant mental-health information and previous run-ins with the law. And he’s pushed for closing the private sale and gun show loophole that waives the necessity of background checks.”
— And here are a few more good reads:
STATE SCAN
REPRODUCTIVE WARS
AGENCY ALERT
INDUSTRY RX
DAYBOOK
Coming Up
- The Senate Judiciary Subcommittee on Intellectual Property holds a hearing on patent eligibility on Tuesday.
- House Energy and Commerce Subcommittee on Health holds a hearing on “Investing in America’s Health Care” on Tuesday.
- The House Veterans Affairs Subcommittee on Economic Opportunity holds a hearing on “Evaluating the Effectiveness of VA Vocational Rehabilitation and Employment programs” on Tuesday.
- The Senate Judiciary Subcommittee on Intellectual Property holds a hearing on patent eligibility on Wednesday.
- The Senate Veterans Affairs Committee is scheduled to hold a meeting on pending nominations on Wednesday.
- Axios hosts an event on health care and drug pricing with Sens. Chuck Grassley (R-Iowa) and Debbie Stabenow (D-Mich.) and former FDA commissioner Scott Gottlieb on Wednesday.
SUGAR RUSH
Last Week Tonight with John Oliver: