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Roche, Promega, University of Pittsburgh


Roche, Promega Litigation Heats Up With Fresh Salvo Alleging Overcharging Scheme

Promega last week sued Roche for allegedly overcharging the US government and its agencies by requiring royalty payments for research using the Taq DNA polymerase. In its response one day later, Roche called Promega’s suit an “overcharging scheme” and a “[simple] litigation tactic,” and said it lacks merit.

“We reject all claims brought by Promega,” Heino von Prondzynski, head of Roche Diagnostics said in a statement. “Promega obviously tries to shift the focus away from their own unlawful behavior of selling unlicensed PCR products by trying to damage our reputation. We consider taking all steps available against this material reputation damage.”

Furthermore, Prondzynski said that Promega had recently tried to settle the suit. “If they believe they have such a strong case, it is more than difficult to understand why Promega called us two weeks ago to put this case on hold and to settle it outside of court,” he said.

In a press release issued last week, Promega said that it filed suit against Roche and “co-conspirators” under the US False Claims Act, alleging that Roche engaged in schemes involving royalty payments for the use of Taq “based upon a patent obtained by inequitable conduct.” The suit also alleges that Roche “anticompetitive[ly]” tied Taq sales “to other products” and employed “deceptive licensing practices” and “predatory threats of litigation.” Promega said it is suing for triple damages on behalf of US government researchers.

However, Roche’s statement, issued one day later, said the lawsuit “recycles allegations that have been litigated in a decade-long lawsuit between the two companies,” and that Promega’s characterization in its press release of a recent ruling in this underlying lawsuit was “misleading.”

This is the latest round of litigation between the two firms that stretches back to 1992, when Roche sued Promega for allegedly violating a license agreement and infringing Roche’s PCR and Taq enzymes patents.

According to court documents in the earlier case, Promega had a license to one patent for the Taq enzyme and to sell Taq reagents for applications other than PCR. Promega obtained the license to this patent, No. 4,889,818, from Cetus, the original holder of the patents to the Taq enzyme and PCR. In December 1991, Roche acquired all of Cetus’ Taq patents. Roche sued Promega the following year, alleging that Promega’s sale of “PCR optimized kits” to researchers violated the license agreement to the ‘818 patent and contributed to infringement on Roche’s patents.

In defending against this claim, Promega argued that the ‘818 patent was obtained through “inequitable conduct,” and was therefore unenforceable, the court documents show. In December 1999, the California US District Court ruled that the patent was unenforceable, holding that the applicants to the ‘818 patent did commit inequitable conduct based on eight misrepresentations and omissions of information about Taq. (This ruling rendered moot Roche’s claims for infringement or breach of the licensing agreement.) Roche then appealed the District Court’s decision on the unenforceability of this patent to the US Court of Appeals for the Federal Circuit.

In March, the Appeals Court issued a ruling that ensured the litigation would continue. While it found the applicants to the ‘818 patent had committed some of the inequitable conduct, it overturned the lower court’s finding as to some of the other inequitable conduct, and returned the case to the California District court for a further determination as to whether the patent is unenforceable based on these findings.

In July, Roche was denied a rehearing by a full panel of the appeals court’s judges, so the case returns to the lower court, and the issue about the enforceability of the ‘818 patent — as well as Roche’s underlying claim against Promega — remains in legal limbo.


Pitt Team Uses Mass Spectrometry to Find Protein Biomarkers Linked to ALS

Researchers from the University of Pittsburgh suggest that detecting protein abnormalities in the cerebrospinal fluid of patients with amyotrophic lateral sclerosis might enable physicians to more quickly diagnose and monitor drug efficacy in clinical trials.

The findings may lead to the first test for early-stage ALS, or Lou Gehrig’s disease, the researchers said.

“There are no known diagnostic biomarkers for ALS and no sensitive methods to determine whether a particular drug is working in an ALS patient, nor any way to best test drug combinations for effectiveness,” Robert Bowser, a researcher at the University of Pittsburgh School of Medicine, said during the 11th annual meeting of the International Alliance of ALS/MND Associations and 14th International Symposium on ALS/MND. “A panel of biomarkers would not only be useful in a more rapid diagnosis of ALS, but also would be a valuable tool to evaluate drug efficacy in clinical trials.”

To arrive at their results, Bowser and colleagues identified ALS-specific biomarkers after profiling proteins in cerebrospinal fluid from 25 patients with ALS and 35 controls. (Some controls had no neurologic symptoms, while others had neurological diseases, including four with peripheral neuropathies, one with myopathy, one with probable Alzheimer’s, one with demyelinating disorder, one with meningitis and one with autoimmune sensory motor axonopathy).

Using mass spectrometry, the researchers were able to identify biomarkers that diagnose ALS with “near 100 percent” specificity and sensitivity.

“Not only will a CSF-based test lead to faster diagnosis, it will permit physicians to monitor the patient during drug treatment and determine whether any of the protein abnormalities that have occurred in the patient have been reduced due to drug treatment,” said Bowser. “By monitoring the biomarkers, we will be able to directly monitor drug efficacy. By using data from multiple clinical trials, we can determine the best drug combination to offer ALS patients.”

— KL

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