Federal Appeals Court Sides with Roche in HIV Test Kit Patent Spat with Stanford

The US Court of Appeals for the Federal Circuit last week ruled in favor of Roche in a longstanding patent-infringement dispute with Stanford University regarding ownership of PCR-based test kits for measuring HIV viral load.

Stanford did not have standing to file suit because, the court determined, Roche owned the patents at issue.

A lower court, the US District Court for the Northern District of California, was instructed to dismiss the suit. The district court had ruled in 2008 that the patents were invalid, but did not agree with Roche’s claims of ownership. According to the appeals court, the district should not have addressed the patents’ validity because Stanford didn’t own the IP to begin with.

This was considered, by many, to be a complete victory for Roche.

Stanford first sued Roche in 2005, seeking more than $200 million for the alleged infringement of three patents assigned to Stanford — US Nos. 5,968,730; 6,503,705; and 7,129,041. The three patents descend from a common parent application and share the same title: “Polymerase Chain Reaction Assays for Monitoring Antiviral Therapy and Making Therapeutic Decisions in the Treatment of Acquired Immunodeficiency Syndrome.”

The test was developed, and is currently used, to measure the viral load of HIV in a person’s blood, by measuring the amount of HIV RNA present in the bloodstream. The original description of the use of the PCR to measure HIV RNA was published in the Journal of Infectious Disease in 1991.

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