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Tuesday, Dec 6, 2022
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Court’s Ruling Could Hamper Biotech Funding

The biotechnology industry is reeling after the U.S. Supreme Court unanimously ruled that two medical-testing patents held by San Diego-based Prometheus Laboratories Inc. were invalid.

At issue in the landmark case, Mayo Collaborative Services v. Prometheus, were patents protecting research Prometheus had conducted to develop a diagnostic test that helps doctors screen patients’ blood to determine the proper drug-dosing levels for therapies treating autoimmune diseases.

Justice Stephen Breyer sided with patient advocacy groups, saying the test did little more than observe laws of nature. Patents on so-called “natural phenomena” would potentially “inhibit the development of more refined treatment recommendations,” he said.

But life sciences industry representatives disagree; they say the ruling will hurt innovation because diagnostic companies will be less likely to spend on research and development if they aren’t able to protect their findings.

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Biotechnology lawyer Michael J. Shuster, a partner in the intellectual property group of Fenwick & West LLC in San Francisco, said he’s concerned that last week’s ruling will drive investment dollars away from an industry that’s already having a tough time attracting capital.

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