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

NEW YORK (GenomeWeb News) – 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.

On Sept. 30, the appeals court ruled that Stanford did not have standing to file suit against Roche because it didn't own the patents at issue. The court determined that Roche owned the patents and instructed a lower court to dismiss the suit.

The lower court, the US District Court for the Northern District of California, had ruled in 2008 that the patents were invalid, but did not agree with Roche's claims of ownership.

Last week's ruling, which found that the lower court should not have addressed the patents' validity because Stanford didn't own the IP in the first place, "is a complete victory for Roche," Adrian Pruetz, an El Segundo, Calif.-based attorney who represented Roche in the case, told GenomeWeb Daily News.

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 technology covered by the patents was developed in the late 1980s and early 1990s by researchers at Stanford and Cetus, which Roche acquired in 1991.

The crux of the case is a series of agreements signed by Stanford researcher Mark Holodniy, one of the inventors on the patents, who collaborated with Cetus on the development of the test kits. Holodniy had signed a "Copyright and Patent Agreement" with Stanford that required him to assign his inventions to the university, but then later signed a "Visitor's Confidentiality Agreement" with Cetus that compelled him to assign to the company any inventions that resulted from the collaboration.

When the case was tried in the Northern District of California, "we claimed that Stanford had no standing to sue Roche because it didn't own all the rights — that Roche had an ownership interest in these patents, because it had basically Mark Holodniy's interest, the [interest] that was signed to Cetus," Pruetz told GWDN.

"But the district court didn't agree with us. Instead, the district court agreed with us on other arguments we made that the patents weren't valid because this whole protocol that was developed at Cetus was actually published more than a year before the patents were filed." The protocol, which described the use of PCR to measure HIV RNA, was published in the Journal of Infectious Disease in 1991.

Stanford appealed the district court's ruling that the patents were invalid, while Roche cross-appealed in order to assert its ownership of the patents.

The appeals court ultimately decided that Roche owned the patents, vacated the district court's judgment of invalidity, and instructed the district court to dismiss the suit.

"Stanford cannot establish ownership of Holodniy's interest and lacks standing to assert its claims of infringement against Roche," the ruling states. "Thus, the district court lacked jurisdiction over Stanford's infringement claim and should not have addressed the validity of the patents."

Pruetz said that Stanford could ask the Federal Circuit's full court to rehear the case, or it could petition the US Supreme Court, "but they haven't said that they're going to do any of those things."

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