Genentech Must Give More Cancer Cell Data

SAN JOSE, Calif. (CN) - Drug manufacturer Genentech has not fully complied with a discovery demand by researchers as they fight over patent licensing for the breast cancer drug Herceptin, a federal judge ruled.

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

At this stage of the litigation, the parties are still embroiled in discovery. The U-Penn Trustees accused Genentech of shirking its obligation to produce responsive documents about Herceptin's effect on noncancerous cells that overexpress the HER2 protein.

Focusing on the minutiae of disputed cell categories and what qualifies as "overexpression," Genentech countered that the school is trying to obtain off-limits discovery.

U.S. District Judge Paul Grewal disagreed this week. Even if sought-after information falls outside the scope of discovery, Genentech cannot withhold discovery of all isolated tumor cell and cancer stem cell-related studies that are otherwise relevant, the ruling states.

To the extent that Genentech has performed relevant studies on isolated tumor cell and cancer stem cells that lack "malignant form and structure, the ability for uncontrolled growth, or the potential or ability to invade or metastasize," the university is entitled to discovery on those studies.

Genentech must also respond as to cells that "do not exhibit uncontrolled growth and invasiveness, but for which the ability to do so remains."

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