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].

Continue Reading When Expert’s Failed Experiments are “Facts or Data” to be Produced, Not Protected Communications

Pharmaceutical Hatch-Waxman litigation proceeds under a unique framework.  In this case, Hatch-Waxman declaratory judgment (“DJ”) defendants Gilead Sciences, Inc. (“Gilead”) and Astellas Pharma US, Inc. (“Astellas Pharma”) sought to dismiss Astellas Pharma for lack of personal jurisdiction and improper venue, and to dismiss pursuant to Federal Rule of Civil Procedure 19 non-joined and “necessary party” Astellas US LLC (“Astellas LLC’), the exclusive licensee.[1]  DJ plaintiff Apotex Inc. (“Apotex”) did not contest dismissing Astellas Pharma, nor seriously contest lack of personal jurisdiction or improper venue of Astellas LLC.  Instead, Apotex sought to apply the plain language of the Hatch-Waxman Act and its specific provisions regarding Hatch-Waxman DJ actions to prevent dismissal under Rule 19 for failure to join a required party.[2]  Thus, the dispute centered on whether Rule 19 of the Federal Rules of Civil Procedure (“FRCP”) applied to Hatch-Waxman DJ actions and, if so, whether Astellas LLC was a required party necessitating dismissal.

Continue Reading Failure to Join Hatch-Waxman Exclusive Licensee Required Dismissal

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.

Continue Reading HIGHLY CONFIDENTIAL-AEO Designation Ruled Adequate Protection for Non-Parties