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.

Non-party GlaxoSmithKlein sold a portfolio of oncology drugs, including dabrafenib (Tafinlar®), for approximately $16 billion to Defendant Novartis Pharmaceuticals Corp. (“Novartis”).  Novartis received FDA approval to sell Tafinlar® in June 2017, and Plexxicon filed suit two months later claiming that Novartis’s Tafinlar® infringes the patented core compound found in Plexxicon’s Zelboraf®:

L:  Claim 1 of the asserted Plexxicon patent, embodied in vemurafenib (Zelboraf®).
R:  Formula of the accused Novartis product, dabrafenib (Tafinlar®).[4]

Because Tafinlar® had been part of the portfolio of oncology drugs acquired by Novartis from GlaxoSmithKlein, Plexxicon subpoenaed GSK for information relevant to Tafinlar®.   GlaxoSmithKlein produced documents containing redactions based upon relevance.  Plexxikon moved to compel GlaxoSmithKlein to re-produce the documents without the relevance redactions.  Although it is common practice in the Northern District of California to prohibit redactions for relevance, there may be circumstances in which redactions are appropriate when a document production is made by a non-party because “the Ninth Circuit has long held that nonparties subject to discovery requests deserve extra protection from the courts.”[5]  GlaxoSmithKline argued that the relevance redactions were necessary because the redacted information, while irrelevant to the underlying case itself, was “highly relevant and valuable to Plexxikon’s other research and development programs that compete with GlaxoSmithKline’s research and development programs.”[6]  Nevertheless, Magistrate Judge Laporte ordered GlaxoSmithKline to re-produce its documents without relevance redactions because any such concern would be ameliorated by producing unredacted copies of the documents with the  “HIGHLY CONFIDENTIAL – ATTORNEYS’ EYES ONLY” designation provided in the stipulated protective order and because GlaxoSmithKline previously produced documents in the litigation without relevance redactions.

Update:  After GlaxoSmithKlein produced the documents with relevance redactions, as ordered by Magistrate Judge Laporte, Plexxicon alleged in another discovery dispute letter that “one such redaction was a 2007 ‘Clinical Competitor Landscape’ analysis that prominently featured Plexxikon’s clinical candidate, PLX4032,” which appear to be responsive to Plexxicon’s request to GlaxoSmithKlein for “[a]ll documents, including lab notebooks, test results, and correspondence related to the testing and analysis of the PLX4032 and PLX6098 compounds…”[7]

 

Plexxikon Inc. v. Novartis Pharmaceuticals Corp., Case No. 4:17-cv-04405-HSG (EDL), Dkt. 125 (N.D. Cal. Feb. 1, 2019).


Endnotes:

[1]  Plexxikon Inc. v. Novartis Pharmaceuticals Corp., Case No. 4:17-cv-04405-HSG (EDL) (“Plexxikon”), Dkt. 1 (“Complaint”) at ¶ 8 (N.D. Cal. Aug. 3, 2017).

[2]  Id. at ¶ 12.

[3]  Id. at ¶ 15.

[4]  Id. at ¶¶ 20 and 21.

[5]  Plexxikon, Dkt. 125 (“Order”) at 2 (N.D. Cal. Feb. 1, 2019), quoting High Tech Medical Instrumentation, Inc. v. New Image Industries, Inc., 161 F.R.D. 86, 88 (N.D. Cal. 1995).

[6]  Id. (emphasis added).

[7]  Plexxicon, Dkt. 129 at 2 (N.D. Cal. Feb. 7. 2019).