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Policy

Gene Patents Ruled Invalid

Biotechnology: Industry says setback will not undermine multi-billion-dollar business

by Glenn Hess and Lisa Jarvis
April 5, 2010 | A version of this story appeared in Volume 88, Issue 14

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Credit: Shutterstock
A district court weighs in on whether genes are patentable.
Credit: Shutterstock
A district court weighs in on whether genes are patentable.

In a surprise ruling last week, a federal judge struck down patents covering two genes—BRCA1 and BRCA2—associated with breast and ovarian cancers. The patents are held by Salt Lake City-based medical diagnostics maker Myriad Genetics.

U.S. District Court for the Southern District of New York Judge Robert W. Sweet ruled that the patents were “improperly granted” because they involved a “law of nature” rather than an invention. Myriad argued that plucking out the genes relevant to predicting breast and ovarian cancers was a transformative process and therefore made the genes patentable.

Industry watchers were taken aback by the ruling. The decision “is contrary to our and likely most investor expectations,” Morgan Stanley analyst Marshall Urist said in a note to investors.

James C. Greenwood, president and CEO of the Biotechnology Industry Organization, a trade group representing 1,200 biotech companies, says the decision is “only a preliminary step in the legal process” and will not affect how the Patent & Trademark Office evaluates patent applications related to DNA-based inventions.

He also questions the court’s reasoning, arguing that preparations of isolated and purified DNA molecules “are patentable because they are fundamentally different from anything that occurs in nature.”

Myriad sells tests that predict the risk of getting a disease or help pinpoint what therapy will work best for a patient. The test at the heart of the case, BRACAnalysis, has been on the market since 1996 and, at $3,120 each, accounted for 67% of the company’s total sales in 2009.

Myriad said last month that its molecular diagnostics revenues were unlikely to be hit hard by an unfavorable verdict. The case only challenged a fraction of the claims on seven of the 23 patents Myriad owns on the BRCA genes, and the company has already said it will appeal the judgment.

On a broader scale, the decision that a gene isn’t patentable, if upheld, could be game changing for the industry, with potential impacts for medical researchers and patients. The American Civil Liberties Union (ACLU), which brought the case against Myriad, points out that the validity of patents on some 2,000 genes is now in question.

“There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas,” said ACLU staff attorney Chris Hansen in a statement.

The dispute provides the first major court ruling on the legality of patenting human genes for diagnosis, noted Robert Cook-Deegan, director of the Center for Genome Ethics, Law & Policy at Duke University’s Institute for Genome Sciences & Policy.

“This completely changes the game, at least for now,” Cook-Deegan said in a statement. “Judge Sweet reached a decision the opposite of prior cases. One big difference is that this case is about diagnostics, getting information about DNA in a person’s cells, and not about using DNA to make drugs.”

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