August 10, 2011

Source: ISB News Report
by Phillip Jones

Stanford University reportedly looked at Roche for more than $200 million in damages for infringing patents on a polymerase chain reaction method for measuring human immunodeficiency virus RNA in human blood samples. On June 6, 2011, the US Supreme Court told Stanford to look elsewhere.

In 1988, around the time that Dr. Mark Holodniy joined Stanford as a research fellow in the Department of Infectious Diseases, scientists in the department started collaborating with Cetus scientists on methods to test the effectiveness of new drugs to treat AIDS. Holodniy worked on a PCR technique for quantifying HIV levels in patient blood samples. Since he had limited experience with PCR, Holodniy’s supervisor arranged for him to continue his research at Cetus. For nine months, Holodniy worked with Cetus researchers and devised a PCR assay to measure HIV RNA in human plasma. He published his findings with Cetus co-authors. After he returned to Stanford, Holodniy collaborated with Stanford researchers to test the PCR assay on samples from patients undergoing antiretroviral drug therapy. Their results showed that levels of HIV RNA in human blood provided a marker of antiviral drug efficacy, and they filed a patent application that eventually matured into three patents.

After Roche purchased Cetus’ PCR business in December 1991—a package deal that included Cetus’ agreements with Stanford researchers—the company began to manufacture PCR kits for detection of HIV RNA. In May 1992, Stanford filed the PCR-HIV RNA patent application. Holodniy and the other inventors assigned their patent rights to Stanford. In April 2000, Stanford asserted its ownership of the HIV RNA assay and offered Roche an exclusive license to all related patents. Roche declined the offer, responding that it owned the patent rights. Following years of failed negotiations, Stanford filed a lawsuit against Roche in the Northern District of California on October 14, 2005.

The university alleged that Roche’s HIV PCR detection kits infringe its patents. Among other things, Roche declared that the company owns the patents through the acquisition of Cetus’ PCR assets. Roche pointed out that Holodniy had assigned his rights in Cetus’ Visitor’s Confidentiality Agreement, which he had signed before collaborating with Cetus scientists. Stanford replied that Holodniy had no rights to assign to Cetus, because the University’s HIV research had been federally-funded, which gave the university superior rights in the invention under the Bayh-Dole Act. The district court agreed with Stanford; the Bayh-Dole Act enables an inventor to obtain title to a federally-funded invention only if the government and the contracting party (i.e., Stanford University) declined to do so. That was not the case here: In 1995, Stanford had formally notified the government that it elected to retain title to the PCR-HIV inventions under the Bayh-Dole Act. Roche appealed the decision to the Court of Appeals for the Federal Circuit.

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Website: http://www.isb.vt.edu

Published: August 10, 2011