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Your 2011-12 Guide to Key U.S. Supreme Court Cases

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Drug safety tests

The court will hear arguments Dec. 7 in a closely watched biomedical patent case, Mayo Collaborative Services v. Prometheus Laboratories.

Prometheus developed a method to analyze blood tests to determine how a patient is reacting to certain amounts of a drug. They hold two patents, and when Mayo, a for-profit division of the Mayo Clinic, developed a test that also measured a patient's reaction to dose levels, Prometheus filed a patent infringement suit.

Mayo claims that no patent should cover a doctor's observations on how a patient reacts to certain dosages of medicine, which they describe as a "natural phenomenon," and patenting the process would stifle normal medical practice.

"No one may seek or get a patent based on a law of nature, so if an apple fell on your head and you wanted to patent a law of gravity, you are out of luck," said attorney Miguel A. Estrada, a former assistant to the solicitor general who argued the case previously before the court.

This is the Supreme Court's second crack at the issues, after remanding the case back to federal circuit court. AARP is among groups that have weighed in on the case, urging the court to rule that the tests are not patentable.

Marsha Mercer is a freelance writer who covers public policy issues. She is based in Virginia.

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