Tag: Gene Patenting

concept illustration of genes in DNA.

A Response to ‘Another Legislative Attempt to Revive Gene Patenting’

The Petrie-Flom Center Staff 1 Comment

By Emily Michiko Morris

Professor Jorge Contreras’ commentary on the Patent Eligibility Restoration Act of 2022 objects to Senator Thom Tillis’ recently introduced bill. Specifically, he argues that proposed inclusion of isolated and purified human genes and other naturally occurring substances as patent eligible subject matter is unnecessary and would both stymie research and obstruct access to medicine. But the truth is these criticisms rely mostly on narrative and anecdote rather than rigorous empirical evidence. (Professor Contreras has written an article acknowledging the many narratives behind the gene patenting debate: see Narratives of Gene Patenting, 43 Fla. St. U. L. Rev. 1133 (2016)).

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BETHESDA, MD - JUNE 29, 2019: NIH NATIONAL INSTITUTES OF HEALTH sign emblem seal on gateway center entrance building at NIH campus. The NIH is the US's medical research agency.

Will NIH Learn from Myriad when Settling Its mRNA Inventorship Dispute with Moderna?

Jorge Contreras 7 Comments

By Jorge L. Contreras

The National Institutes of Health (NIH) is currently embroiled in a dispute over the ownership of patent rights to Moderna’s flagship mRNA COVID-19 vaccine (mRNA-1273).

The NIH, which funded much of Moderna’s research on the COVID-19 vaccine, should be assertive in exerting control over the results of this taxpayer-funded research. Failing to do so would be a missed opportunity for the public sector to have a say in the distribution and pricing of this critical medical technology.

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Concept illustration of DNA and genes.

The Civil Rights Challenge to Gene Patenting

Jorge Contreras 1 Comment

By Jorge L. Contreras

In 2009, the American Civil Liberties Union (ACLU) launched a unique lawsuit against Myriad Genetics, challenging fifteen claims of seven patents covering various aspects of the BRCA1/2 genes and their use in diagnosing risk for breast and ovarian cancer. In mounting this case, the ACLU assembled a coalition of lawyers, scientists, counselors, patients and advocates in an unprecedented challenge not only to one company’s patents, but the entire practice of gene patenting in America. And, against the odds, they won. In 2013, the U.S. Supreme Court ruled in Association for Molecular Pathology v. Myriad Genetics that naturally occurring DNA sequences are not patentable, a ruling that has had repercussions throughout the scientific community and the biotechnology industry.

In The Genome Defense: Inside the Epic Legal Battle to Determine Who Owns Your DNA (New York: Hachette/Algonquin, 2021), I describe the long road that led to this unlikely Supreme Court victory. It began in 2003 when the ACLU hired its first science advisor, a Berkeley-based cellist and non-profit organizer named Tania Simoncelli. At the ACLU, Simoncelli’s job was to identify science-related issues that the ACLU could do something about, from DNA fingerprinting to functional MRI brain imaging. A couple of years into the role, Simoncelli mentioned gene patenting to Chris Hansen, a veteran ACLU litigator who had been involved in cases covering mental health to school desegregation to online porn. At first, Hansen didn’t believe her. How could a company patent something inside the human body? But Simoncelli persisted, showing him articles and statistics demonstrating that, by 2005, more than 20% of the human genome was covered by patents. The realization led to Hansen’s oft-quoted exclamation, “Who can we sue?”

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A stethoscope tied around a pile of cash, with a pill bottle nearby. The pill bottle has cash and pills inside.

What Ever Happened to NIH’s “Fair Pricing” Clause?

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By Jorge L. Contreras

In the midst of the COVID-19 pandemic, calls have been made for “fair” and “reasonable” pricing of the vaccines and therapeutics that will eventually be approved to address the virus. A range of proposals in this regard have been made by members of Congress, the Trump Administration, various states, academics and civil society.

Amid this current debate, it is worth remembering the brief period from 1989 to 1995 when the U.S. National Institutes of Health (NIH) did impose reasonable pricing constraints on drugs that were developed as part of cooperative R&D agreements (“CRADAs”) between federal agencies and private industry.

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

The Petrie-Flom Center Staff Leave a comment

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.

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