[Ip-health] Wall Street Journal: U.S. Supreme Court to Review Patents on Human Genes

Thirukumaran Balasubramaniam thiru at keionline.org
Wed Dec 5 02:44:50 PST 2012

	• LAW
	• Updated November 30, 2012, 5:10 p.m. ET

U.S. Supreme Court to Review Patents on Human Genes

WASHINGTON—The Supreme Court said Friday it would decide whether isolated human genes can be patented, a long-disputed legal question with broad implications for biotechnology companies and medical researchers.

The justices will consider a challenge to patents held by Myriad Genetics Inc. on two genes that can signal if a woman faces greater risk of developing breast cancer or ovarian cancer. Myriad's patents allow the company to be the exclusive U.S. commercial provider of genetic screenings for the diseases.

Patients, cancer organizations, medical groups and geneticists, all represented by the American Civil Liberties Union, are challenging the company's right to the patents. They won a trial court ruling in 2010, but a federal appeals court has twice sided with the Salt Lake City-based company.

The appeals court said isolated human genes are eligible for patent protection because the process of extracting and isolating a gene from the human body makes the gene chemically distinct from the DNA that exists naturally. In general, products of nature can't be patented.

The Supreme Court's decision to take up the case caused Myriad's shares to drop 3.8% to $28.72 in 4 p.m. composite tradingFriday. The decision comes on the heels of a March ruling in which the high court tightened rules on medical-testing patents. That ruling, which sparked concerns in the biotech industry, threw out two Prometheus Laboratories patents on a test to help doctors set drug dosages for patients with Crohn's disease. The court said the patents impermissibly sought to lay claim to laws of nature.

In a petition to the Supreme Court, Myriad's opponents said the company's breast-cancer-gene patents "have allowed it to dictate the cost of genetic testing, stopped other laboratories from creating and offering new and improved testing procedures, and made it impossible to obtain second opinions that could better inform patients of their cancer risk."

Myriad told the Supreme Court that isolating the genes responsible for breast and ovarian cancer was a "momentous advancement" that required "significant skill, insight and invention on the part of Myriad's inventors."

The company said the U.S. Patent and Trademark Office has allowed patents on DNA molecules for 30 years, with biotech firms relying on that patent protection to make major investments in scientific advancements.

Oral arguments in the Myriad case will likely take place in March, with a decision expected by the end of June.

The Supreme Court took another case Friday with implications for the pharmaceutical industry, saying it would review a $21 million judgment won by a New Hampshire woman who said she was harmed by taking a generic anti-inflammatory drug. The case could further limit liability suits against generic drug companies following a 2011 Supreme Court decision that shielded generic makers from suits alleging inadequate labeling.

Meanwhile the court took no action on gay marriage, putting off until at least the following week a decision on whether to hear cases testing the rights of same-sex couples.

Write to Brent Kendall at brent.kendall at dowjones.com


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)

thiru at keionline.org

Tel: +41 22 791 6727
Mobile: +41 76 508 0997

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