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Court struggles with question of human gene patentability

Court struggles with question of human gene patentability

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WASHINGTON – Drawing a legal line to determine when human genetic material ceases to be a creation of nature and instead becomes a patentable product is not easy — even for the U.S. Supreme Court.

During oral arguments in Association of Molecular Pathology v. Myriad Genetics, Inc., the justices struggled with the question of whether the patents on two isolated human genes that indicate an increased risk for breast and ovarian cancer are valid.

The stakes in the case are high. The patent holder in the case, Myriad Genetics, and its supporters — including the American Bar Association — say that allowing patents on such materials encourages the crucial innovation necessary to better understand genetic indicators and leads to faster treatments and cures.

“What Myriad inventors created in this circumstance was a new molecule that had never before been known to the world,” agued Gregory A. Castanias, a partner in the Washington office of Jones Day, on behalf of his client Myriad Genetics.

But opponents say that genetic material is a product of nature never meant to be patented because it isn’t an invention. Such patents tie the hands of other researchers who don’t hold the patents, they argue.

“The patent system was designed to encourage innovation, not stifle scientific research and the free exchange of ideas, which is what these patents do,” said Christopher A. Hansen, Senior National Staff Counsel for the American Civil Liberties Union in New York, after arguing at the court on behalf of the group of doctors, researchers, health care organizations and cancer patients challenging Myriad’s patent.

The ruling could have major implications for the science and health care industries. Researchers increasingly rely on the patent system for just about every aspect of the process of discovering, isolating and engineering genetic materials in search of causes, cures and treatments for illnesses.

The justices expressed concern not only for keeping naturally-occurring material free for all to access, but also for encouraging new discoveries.

“I can bake a chocolate chip cookie using natural ingredients: salt, flour, eggs, butter,” said Justice Sonia M. Sotomayor. “But I can’t imagine getting a patent on the basic items of salt, flour and eggs, simply because I’ve created a new use or a new product.”

But conversely, Justice Elena Kagan asked, “Why shouldn’t we worry that Myriad or companies like it will just say: ‘Well, we’re not going to do this work anymore?’”

‘Decisions that were made by nature’

At oral arguments that were at times filled with the highly technical jargon of biophysicists and genetic engineers, Hansen argued that the genes at issue, even in isolated form, don’t rise to the level of patentability.

“What exactly did Myriad invent?” asked Hansen. “The answer is: nothing. … The genes themselves — where they start and stop, what they do, what they are made of, and what happens when they go wrong — are all decisions that were made by nature, not by Myriad.”

Justice Samuel A. Alito Jr. asked whether “the leaves of a plant that grows in the Amazon,” containing a substance with medicinal value, can be patented.

“If there is no alteration, if we simply pick the leaf off of the tree and swallow it and it has some additional value, then I think it is not patentable,” Hansen said.

Alito asked if the answer would be different if the substance on the leaf is “extracted and reduced to a concentrated form?”

“That may well be eligible, because you have now taken what was in nature and you’ve transformed it,” Hansen said.

“Then I’m not sure how you distinguish the isolated DNA here, because it has a different function,” Alito said. “Isolated DNA has a very different function from the DNA as it exists in nature.”

Kagan asked if patents encourage companies to innovate.

“If you assume that it takes a lot of work and takes a lot of investment to identify this gene, [without a patent,] what does Myriad get out of this deal?” Kagan asked.

Hansen said the patents have the opposite effect.

“Other labs were looking for [the] genes and they announced that they would not patent them if they were the first to find it,” Hansen said. By finding it first and patenting the gene, “Myriad shut all that testing down.”

Goal ‘to get closer to nature’

Castanias argued on Myriad’s behalf that the isolated genes are “fundamentally different from what is in the body,” and that this case exemplifies the problems with the common law doctrine excluding natural materials from patents.

“The ‘product of nature’ doctrine is troublesome for this reason: Modern medicine [is] trying to get to a point where what we are administering to individual patients is giving them the opportunity to mimic the actions of the body,” Castanias said. “The goal of medicine is to get closer to nature, rather than farther away.”

Justice Stephen G. Breyer was concerned about limiting potential discoveries.

“It’s important to keep products of nature free of the restrictions,” Breyer said. The rationale behind excluding patents on nature-based materials is to allow people to place ownership claims only “on the process, on the use of the thing, but not the thing itself.”

Castanias pointed out that the U.S. Patent and Trademark Office granted the patents under guidelines that have long been in place, and that interpretation should be given deference by the court.

The guidelines, adopted in 2001, “have been relied on now for 12 years, and they confirm a practice that has been in place much longer than that,” Castanias said.

Solicitor General Donald B. Verrilli Jr. advocated on the government’s behalf for an alternative approach: a test that balances the interests of “encouraging individual inventors and keeping the basic building blocks of innovation free for all to use.”

Applying that test, Verrilli argued: “Isolated DNA falls on the ineligible side of that divide because it is simply native DNA extracted from the body.”

A decision is expected later this term.


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