Genentech Experts Can Testify About Patents

(CN) - A federal judge has refused to strike out portions of expert reports Genentech pharmaceuticals submitted in a patent dispute over the Herceptin breast cancer drug.

Herceptin (trastuzumab) is a popular dug used to treat a type of breast cancer in which cells overproduce copies of the HER2 protein. Because these proteins regulate cell growth, division and death, HER2-positive cancers are considered to be more aggressive and fast-growing, leading to a higher risk of recurrence and death in patients.

Genentech obtained Food and Drug Administration approval for Herceptin in the 1990s.

But the University of Pennsylvania claims that Genentech needs a license because Herceptin allegedly infringes on its 2004 patent for "Prevention of Tumors with Monoclonal Antibodies Against NEU."

Genentech asked a federal judge to rule that Herceptin does not infringe on the university's allegedly invalid patent.

Last year, the U-Penn Trustees showed that Genentech had shirked its obligation to produce responsive documents about Herceptin's effect on noncancerous cells that overexpress the HER2 protein.

The San Jose court rejected Genentech's claim that the school tried to obtain off-limits discovery by focusing on the minutiae of disputed cell categories and what qualifies as "overexpression."

Hot off the heels of that success, the U-Penn trustees urged the court to exclude portions of Genentech's expert reports that were not part of the company's original invalidity contentions.

Genentech's experts discussed a research group of mice that received low drug doses, but the trustees said this added theories to data that the court had previously rejected.

"Litigants should not be permitted to game this court's procedural system," according to a letter to the court authored by attorney Gary Frischling with Irell and Manella in Los Angeles. "Genentech chose not to disclose certain of its invalidity and/or inequitable conduct claims until the last minute."

"Such a tactical maneuver subverts the purpose of disclosure rules and pleading requirements," he added

But U.S. District Judge Paul Grewal denied the motion Thursday, finding insufficient grounds to strike the expert testimony at issue.

"Based on Genentech's representations to that effect, the court finds no attempt by Genentech to commit an 'end run' around the court's earlier order denying Genentech its motion to amend invalidity contentions," he wrote.

As long as the expert does not rely on that data as evidence of a lack of written description, Grewal said the report can stand.

Genentech has said it will rely only on disclosed clinical trials for direct evidence of obviousness, and the trustees "require too much" by arguing that certain clinical trials referenced in invalidity contentions went beyond their initial disclosures, Grewal said.

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