Novartis Takes Aim at Bay-Area Biotech with Dana-Farber Roots in Legal Battle Over Potential Lung Cancer Drugs

12/2/10

The proverbial 800-pound gorilla has spoken. Novartis Institutes of BioMedical Research, the Cambridge, MA-based R&D unit of Swiss drug giant Novartis, has asserted itself in a lawsuit concerning rights to potentially game-changing drugs for lung cancer discovered at Dana-Farber Cancer Institute in Boston.

Novartis filed a counterclaim on November 19 in U.S. District Court in Boston against Millbrae, CA-based biotech startup Gatekeeper Pharmaceuticals, according to court records. The counterclaim asks the court for a declaratory judgment that would, among other things, give Novartis and not Gatekeeper rights to an experimental drug called WZ4002 and related compounds discovered at Dana-Farber.

Novartis does not comment on ongoing litigation, an attorney for the company at the law firm WilmerHale said this week.

A point of contention in this case—which Dana-Farber initiated on September 21—is whether the compounds in question were discovered as part of a January 2005 collaborative research agreement between Dana-Farber and Novartis. Novartis said in its counterclaim that they were. Dana-Farber scientists Michael Eck and Nathanael Gray, the filing says, “received approval and funding for, and ultimately directed ‘Funded Research Projects’ under the Novartis CRA during the time period relevant to the WZ4002 invention. The Funded Research Projects directed by Drs. Eck and Gray were specifically aimed at developing compounds, like [WZ4002], that modulate EGFR and drug-resistant mutations thereof.”

EGFR, or epidermal growth factor receptor, is a protein that plays a role in the growth of cancer cells. Gatekeeper and Novartis are hungry for control of the disputed compounds in part because they have been shown in lab tests, published in the journal Nature in December 2009, to be effective against forms of non-small cell lung cancer with a specific EGFR mutation that makes the tumors resistant to existing treatments. Though lung cancer is the number one cancer killer of Americans and treatments for the disease are a multibillion-dollar market, there are currently no drugs that target the disease in the same way as the Dana-Farber compounds.

Dana-Farber has asked the court for relief from its obligations under a June 2009 option deal with Gatekeeper, which was co-founded in March 2009 by Dana-Farber’s Gray and others. The option agreement granted rights to develop WZ4002 and related compounds to Gatekeeper under certain conditions. But Dana-Farber says in its lawsuit that it informed Gatekeeper in August that Novartis has rights to the compounds—even though the cancer institute had decided before it granted the option to Gatekeeper last year that the compounds weren’t discovered through research funded by Novartis. In fact, three previous investigations of this question had concluded that Novartis did not fund the discovery of the compounds, according to an October 18 motion filed in the case on behalf of John Chant, the president of Gatekeeper.

John Mirick, an attorney for Gatekeeper, did not return a call about this case on Tuesday. Court records do not show any hearing dates set for this case.

Though it’s unclear when this complex case will be resolved, it isn’t slowing down other drug developers in pursuit of similar drugs. Last month I wrote about efforts at Waltham, MA-based Avila Therapeutics to develop compounds with attributes similar to those of the molecules involved in the Dana-Farber lawsuit. Avila, whose research in this area is being funded by Boulder, CO-based Clovis Oncology, aims to get a compound from this effort ready for clinical trials by late next year or early 2012, Avila CEO Katrine Bosley said last month.

On Tuesday, Xconomy ran a guest post by Scott Forrest, the director of business development at The Scripps Research Institute in La Jolla, CA, about how to avoid some of the pitfalls of broad collaborations like the one between Dana-Farber and Novartis. Scripps actually counts Novartis among its corporate partners.

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