Trial Looms Over Breast Cancer Drug Herceptin

(CN) - A federal judge has refused to grant judgment to either the University of Pennsylvania or Genentech pharmaceuticals as a trial looms over a patent dispute regarding 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."

Both parties moved for summary judgment which U.S. District Judge Lucy Koh denied in an order Monday.

In denying Genentech's motion for summary adjudication, Judge Koh rejected the argument that the dispute could be resolved by claim construction and agreed with the U-Penn trustees that there is a factual question about infringement.

"While claim construction involves determining the scope of the claim terms as a matter of law, it is decidedly not the task of the court to determine whether every accused product falls within the 'scope' of the terms once the terms are construed," the judge wrote.

"A court may not, 'under the rubric of claim construction,' give a claim whatever additional precision or specificity is necessary to facilitate a comparison between the claim and the accused product,"

"Rather, after the court has defined the claim with whatever specificity and precision is warranted by the language of the claim and the evidence bearing on the proper construction, the task of determining whether the construed claim reads on the accused product is for the finder of fact,'" the judge continued, quoting a Federal Circuit Court precedent.

The main factual dispute in the case involves whether isolated tumor cells have the ability for uncontrolled growth; Genentech claims they do, while the U-Penn trustees claim they do not.

Because of this dispute, Judge Koh declined to grant Genentech judgment on the claim and also denied U-Penn's motion for judgment that it does not infringe.

That same factual dispute precludes the court from making a finding that Herceptin stops isolated tumor cells from becoming cancer cells, because it presumes that the isolated cells are not already cancer cells, Judge Koh found. A pretrial conference is scheduled for May 30. The trial is set to begin June 11.

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