September 17, 2009 7:19 PM

LITIGATION DAILY: Latham Scores Patent Win for Biotech Client over Treatment Method

Posted by Ross Todd

This story was originally published by The Am Law Litigation Daily.

Hear that sound? It's a collective sigh of relief from the biotech sector. In a closely watched case at the U.S Court of Appeals for the Federal Circuit, Latham & Watkins helped its client Prometheus Laboratories overturn a ruling concerning the patentability of the company's method to treat Crohn's disease and other inflammatory bowel conditions. The lower court's holding in favor of Mayo Collaborative Services and Mayo Clinic Rochester had raised the possibility that many diagnostic and treatment method patents might also be invalid. Here's the 22-page decision from the Federal Circuit.

Prometheus's patents cover tests that measure levels of metabolites produced after a person takes drugs used to treat Crohn’s disease and other conditions. These tests help doctors figure out how well a patient is responding to treatment and determine whether to modify drug dosage.

Mayo Collaborative Services and Mayo Clinic Rochester had used Prometheus's tests but in 2004 announced that they planned to use their own test internally, and sell it to other hospitals. Prometheus sued for infringement. The district court first held that Mayo infringed but later ruled Prometheus’s patents were invalid because they depend on observations of certain measurable metabolites in the patient that occur naturally. (Wilson Sonsini Goodrich & Rosati represented Prometheus at the district court level.) For a more thorough take on the case and its underlying issues, check out this post at The Prior Art blog written by our colleague Joe Mullin of IP Law & Business.

Judge Alan Lourie of the Federal Circuit wrote that Prometheus's patents "squarely fall within the realm of patentable subject matter because they ‘transform an article into a different state or thing,’ and this transformation is ‘central to the purpose of the claimed process.'" Wednesday's ruling reversed the lower court's decision and remanded the case for further proceedings.

Prometheus's appellate lawyer, Latham & Watkins's Richard Bress, said in a interview Thursday that the court focused on the question of "What did the applicant invent?"

"The court agreed with Prometheus's decision that what was invented here was a series of transformative steps," Bress said. Had the court ruled that the patent was invalid just because it dealt with natural, observable processes, it could have been disastrous for biotech, since those processes dominate the industry's work. The ruling, Bress says, preserves "crucial incentives for innovation in the medical diagnostic and treatment areas."

Mayo's outside counsel at Fish & Richardson forwarded a request for comment to Joseph Colaiano, the in-house legal counsel overseeing the case. Colaiano said the company plans to file a petition for cert with the Supreme Court. "This decision will prevent doctors from observing things that occur naturally" and incorporating their observations into effective treatment, Colaiano says. "We think this case to be less about innovation and more about the ability of patients to obtain high-quality care at a cost they can afford."

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