Laporte (MJ, San Francisco)

Defendant Novartis Pharmaceuticals Corporation (“Novartis”) alleged that Plaintiff Plexxikon Inc.’s (“Plexxikon’s”) asserted patent claims are invalid for lack of enablement.  When one skilled in the art can practice the claimed invention only after undue experimentation, the claimed invention is invalid for lack of enablement.  One indication of undue experimentation is failed attempts to practice the invention.[1]

Plexxikon’s own expert, in a bid to argue that the claimed invention was enabled, directed that two compounds be synthesized:

(Figures from Plexxikon expert’s rebuttal report.[2])

However, Plexxikon’s expert then testified in deposition that he had considered “at least half a dozen” different synthetic routes for making one of the compounds, but had not disclosed them or the 33 reactions (some unsuccessful) in his rebuttal expert report.[3]  Stating that “[i]t is not in any way professional practice to write up experimentals on reactions which did not work,” Plexxikon’s expert confirmed that he did not disclose the failed synthetic routes or unsuccessful reactions in his report[4] but that he had considered the rejected synthetic routes in making the second compound[5].


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The BRAF gene helps human cells produce enzymes for cellular metabolism and growth.  Mutated BRAF genes contribute to the proliferation of cancer cells.  In 2005, Plaintiff Plexxicon Inc. began making compounds that reduce the growth of cancer cells that have the mutated BRAF gene.[1]  The core compound, vemurafenib, was tested in patients with metastatic melanoma with results such as those illustrated in the before-and-after picture shown at right.[2]  Vemurafenib, sold under the brand name Zelboraf®, was approved in 99 countries and enjoyed worldwide sales of over $1.5 billion by 2017.[3]  Plexxicon received U.S. Patent No. 9,469,640 for the compound’s core molecular structure.

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