Video Now Available: “Gene Patenting, the Supreme Court’s Myriad Decision, and the Future of Biotechnology”

In case you missed it live on Monday evening, video from the Petrie-Flom Center’s event “Gene Patenting, the Supreme Court’s Myriad Decision, and the Future of Biotechnology” (co-sponsored by the Broad Institute) is now available here.

09/27/13 UPDATE: Our intern Fatima Mirza also wrote up this summary:

At this event, a distinguished panel of law and biotechnology experts convened to discuss the landmark Supreme Court Myriad decision and its implications on the future of scientific innovation and development.

The discourse began with an introduction of the high-profile case that extended beyond simply the scientific, political, or legal spheres.

“A broad coalition of people came to file this case,” said Tania Simoncelli, former Science Advisor to the ACLU. “Everyone from clinical geneticists, genetic counselors, individual women who could not access testing, the American Medical Association, the American Association of Human Genetics, and the March of Dimes were involved.”

In order to provide context for the case, Glenn Cohen, Professor at Harvard Law School and Faculty Co-Director of the Petrie-Flom Center, offered a brief history of biotechnology and patent law.  He highlighted developments from as early as 1911 when adrenaline, a naturally occurring compound, could be patented and distributed commercially based on the principle of purification. Emphasizing paradigm shifts in a rapidly advancing society, Cohen further outlined the role of the Patent and Trademark Office. “At the heart of patent law is whether we will have a pro-innovation or anti-innovation effects,” said Cohen.

Continue reading

Art Caplan on the Myriad Decision: Patenting natural DNA never made sense

Bill of Health contributor Art Caplan weighed in on the Supreme Court’s decision in the Myriad case with an opinion piece at NBC:

“The Supreme Court has finally done what should have been done years ago — declared that genes which naturally exist in all of us cannot be patented.  For years Myriad Genetics, the company that sells the genetic tests used by Angelina Jolie and thousands of other women to assess their risk of breast cancer and ovarian cancer, has held back the development of better tests and access for many women to testing by invoking their patent claims on key genes. Now the Supreme Court has rightly said that kind of patent is not valid.

“Patenting a naturally existing gene never made any sense. Sure, it takes work to figure out what genes do, but the rewards for that are publications, tenure, professional honors and even a Nobel Prize — not a patent. Patents should be given not for discovery, but for inventions: What genes can you change; what test kit can you build; what program can you run to screen genetic risks?

“The implications of the decision could be far broader than Myriad, whose stock price went up after the ruling. Many companies have taken out patents on genes not only those found in humans but in animals, microbes and plants.  All of these are now in question — which may cause some reevaluation of the worth of some companies who have been touting their ownership of genes to Wall Street.”

You can read the full piece here: Patenting natural DNA never made sense.

Sebelius v. Auburn Regional Medical Center: Hospitals Allege Medicare Intentionally Underpaid Providers–And Got Away With It

By Katie Booth

In the Supreme Court’s recent decision in Auburn Regional Medical Center, the Court held that a suit against HHS by eighteen hospitals alleging intentional underpayment of Medicare reimbursements was barred by a 180-day internal agency deadline for appeals of reimbursement decisions. The rub is that the hospitals only found out about the underpayments, which allegedly occurred from 1987 to 1994, in March of 2006. These underpayments affected thousands of hospitals and added up to billions of dollars. Yet under Auburn, since the hospitals did not sue within 180 days of the underpayment (or even within an extended three-year window for “good cause”), they cannot recover. The Court in Auburn rejected the hospitals’ argument that equitable tolling should apply, finding instead that “the presumption in favor of equitable tolling does not apply to administrative appeals of the kind here at issue.”

The Auburn decision raises important questions about the ability of the federal government to intentionally underpay healthcare providers. In oral argument, the lawyer for the hospitals characterized HHS’s actions as “intentional concealment . . . [and] misconduct by the Secretary, that caused the statute of limitations time to be missed.” While there are good reasons not to disturb decades-old reimbursement decisions, it is sobering that the federal government can intentionally conceal underpayments and—if it conceals the underpayment for only 180 days—never have to reimburse the injured party. This situation presents a striking contrast “to 42 CFR § 405.1885(b)(3) (2012), which permits reopening of an intermediary’s reimbursement determination ‘at any time if it is established that such determination . . . was procured by fraud or similar fault of any party to the determination.’” In other words, HHS can reopen reimbursement decisions if a provider intentionally conceals important information, but not vice versa.

Continue reading