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].

Federal Rule of Civil Procedure 26(a)(2)(B)(ii) requires a testifying expert witness to disclose in a report “the facts and data considered by the witness in forming” his or her expert testimony.  Looking to the Advisory Committee’s Notes to the 2010 Amendment, Magistrate Judge Laporte emphasized that:

[T]he intention is that “facts or data” be interpreted broadly to require disclosure of any material considered by the expert, from whatever source, that contains factual ingredients.  The disclosure obligation extends to any facts or data ‘considered’ by the expert in forming the opinions to be expressed, not only those relied upon by the expert.[6]

While the Court agreed with Plexxikon that “[d]ocuments regarding methods [its expert] chose not to use are independently protected from disclosure to the extent they were prepared for and sent to counsel, [Plexxikon] has not shown here that [its expert] did so.”[7]  The Court noted that Plexxikon had not shown that any of the documentation for the failed synthetic routes or unsuccessful reactions were draft reports by for example, “assert[ing] that [the expert] intended to include these documents in his report, that they were actually included in earlier versions of his report, or that the documents represent summaries and conclusions that might reasonably be expected to be included in a draft report.”[8]

As a result, Plexxikon was ordered to produce the documents relating to the synthetic routes, and to produce its expert for a further deposition on these documents and others already produced from a contract research organization that ran the unsuccessful reactions under the expert’s direction.

 

Plexxikon Inc. v. Novartis Pharmaceuticals Corporation, Case No. 4:17-cv-04405-HSG (EDL), Dkt. 161 (N.D. Cal. May 3, 2019).


Endnotes:

[1]  Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1372-73 (Fed. Cir. 1999).

[2]  Plexxikon Inc. v. Novartis Pharmaceuticals Corporation, Case No. 4:17-cv-04405-HSG (EDL) (“Plexxikon”), Dkt. 158, Ex. B at ¶ 11 (N.D.Cal. Apr. 29, 2019).

[3]  Plexxikon, Dkt. 161 (“Order”) at 3-4 (N.D.Cal. May 3, 2019).

[4]  Id. at 4.

[5]  Id. at 5.

[6]  R. Civ. P. 26, Advisory Committee Notes to the 2010 Amendment.

[7]  Order at 5 (internal quotations omitted).

[8]  Id. at 6, citing Salazar v. Ryan, 2017 WL 2633522, at *2 (D.Ariz. June 19, 2017).