Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Hoffmann-La Roche, Inc v. Roxane

May 11, 2011


The opinion of the court was delivered by: F Alk, U.S.M.J.


Before the Court is Defendant‟s motion to compel the production of documents Plaintiff claims are privileged. [CM/ECF No. 49.] The motion is opposed. No oral argument was heard. Fed. R. Civ. P. 78(b). Based upon the following, Defendant‟s motion is granted.


This is a Hatch-Waxman patent case. Plaintiff, Hoffmann-La Roche, Inc. ("Roche"), is alleged to own United States Patent No. 5,472,949 ("the "949 patent"). The "949 patent covers the drug capecitabine, which is used to treat breast and colon cancer. Roche manufactures its capecitabine drug under the trade name Xeloda®. Defendant Roxane Laboratories, Inc. ("Roxane") filed an Abbreviated New Drug Application with the FDA to market and sell a generic version of Xeloda®.

The issue to be decided is whether twenty-one (21) documents ("the Disputed Documents") are protected by the attorney-client privilege. The Disputed Documents are owned and were produced in this case by a non-party, Chugai Pharmaceuticals, Inc. ("Chugai"), who has never claimed they are privileged. Nevertheless, Roche has opposed their production on attorney-client privilege grounds. Roxane has objected to Roche‟s standing to assert the privilege, and has also sought production of the documents under various theories, including that they do not qualify as privileged communications, and that any privilege has been waived.

This Court holds that Roche lacks standing to assert attorney-client privilege over the Disputed Documents; that Roche has failed to establish that certain of the Disputed Documents are privileged; and that, whatever privilege may have existed has been waived.


A. The Relevant Parties

Capecitabine was allegedly discovered in the early 1990s by scientists employed by Nippon Roche K.K., a Japanese company ("Nippon Roche"). At that time, Nippon Roche was a wholly owned subsidiary of a large Swiss conglomerate, Roche Holding Ltd. ("Roche Holding"). (Pl‟s Br. 3; Declaration of Irene E. Hudson, Esq. ("Hudson Decl.") Ex. 5.) The plaintiff in this case, Hoffmann La-Roche, Inc., is a New Jersey company that is also a wholly owned subsidiary of Roche Holding. (Id.) A third subsidiary under Roche Holding‟s umbrella is F. Hoffmann-La Roche, Ltd., a Swiss company ("Roche Basel"). The application for the "949 patent apparently came to be through a collaboration between the three then-subsidiaries of Roche Holding; i.e., Plaintiff Roche, Roche Basel, and Nippon Roche.

In 2001, Nippon Roche merged with another Japanese company, Chugai, in a transaction described as an "alliance." (Declaration of Darryl H. Steensma, Esq., ("Steensma Decl.") Ex. 2.) Following the merger, Nippon Roche ceased to exist, and Chugai became the sole surviving entity. Chugai is not wholly owned by Roche Holding or any other Roche entity, although an additional Roche Holding subsidiary does own a percentage of the company. (Hudson Decl., Ex. 5.)

B. History of the Disputed Documents

The Disputed Documents have been the subject of prior proceedings before this Court, and some procedural history helps place the motion in context.

The 21 Disputed Documents belong to Chugai, the non-party entity that survived the merger with Nippon Roche. Since the merger in 2001, the documents have been stored in Chugai‟s facilities in Japan. (Steensma Decl., Ex. 3 at 6.) Indeed, in discovery, Roche has repeatedly emphasized that the companies are separate, and that Chugai‟s documents and are not within Roche‟s control. (See Steensma Decl., Ex. 4 ("Plaintiff Hoffmann La-Roche Inc. has zero ownership interest in Chugai, and therefore, cannot compel Chugai to produce documents."); id, Ex. 5 ("Plaintiff Hoffmann La Roche, Inc. restates that it has no ownership interest in Chugai and cannot compel Chugai to produce its documents." (emphases added)); id., Ex. 7 ("Roche has no control over the named inventors . . . and, therefore, Roche cannot compel the inventors to appear for deposition.").)

Substantively, the Disputed Documents were all created between 1992 and 1995. Roche claims they relate to the preparation and prosecution of the "949 patent application filed with the United States Patent and Trademark Office (USPTO). Roche contends that the "attorney," for purposes of applying the attorney-client privilege to these documents, is Robert A. Silverman, Esq., an in-house patent attorney at Roche.

In June 2010, Chugai voluntarily produced the Disputed Documents in discovery in this case. They were provided to Roche as an intermediary, who accepted the documents and transferred them, en masse and without a privilege review, to Roxane. (See Steensma Decl., Ex. 8; Def.‟s Br. 4.) Prior to production, Chugai alone collected the documents; Roche played no role, did not review the documents, and did not claim any were privileged before delivering them to Roxane. (Id.) Thus, beginning in June 2010, Roxane had unfettered access to the Disputed Documents.

On September 20, 2010, Teva Pharmaceuticals, Inc., a defendant in another capecitabine ANDA case that has been consolidated with this one for discovery purposes, Roche v. Teva, 09-5283 (WJM), noticed that certain documents, the eventual Disputed Documents, appeared on a privilege log provided to Teva but had in fact been produced to Roxane. (Def.‟s Br. 4; Steensma Decl., Ex. 9.) Teva notified Roche of the discrepancy, but Roche did not contact Roxane nor did it seek a return of the documents at that time. (Def.‟s Br. 4.)

On November 23, 2010, five months after the Disputed Documents were produced to Roxane and two months after the discrepancy was raised by Teva, Roche sent correspondence to Roxane asking whether certain allegedly privileged documents had been included in the Chugai production. (Steensma Decl., Ex. 12.) Roche‟s letter was not specific and conveyed that it was unsure what documents had even been produced; indeed, Roche simply provided Roxane with a log of approximately 100 documents and asked it to determine precisely what documents on that list had been received, and to return or destroy any that were produced pursuant to a provision contained in the Discovery Confidentiality Order entered in this case. (Id.)

On December 30, 2010, Roxane filed a letter and exhibits totaling 120 pages, seeking an order permitting use of the allegedly privileged Disputed Documents and challenging Roche‟s ability to claim privilege over non-party Chugai‟s documents. (Steensma Decl., Ex. 13; CM/ECF No. 34.)

Roche responded on January 20, 2011, stating that it had withdrawn its privilege claims as to approximately 80 of the 100 documents. Roche also provided a new and amplified privilege log that included, for the first time, a U.S. licensed attorney, Robert Silverman, Esq., as an author or recipient of various communications. Based on the new privilege log, Roche continued to maintain its privilege claim over the 21 Disputed Documents. (Steensma Decl., Ex. 6.)

Roxane submitted a second 100 page submission on January 31, 2011, objecting to the new privilege log and continuing to claim that Roche lacked standing to assert privilege, that the documents were not privileged at all, and that any privilege had been waived. (Steensma Decl., Ex. 14; CM/ECF No. 41.)

The next day, February 1, 2011, the Court held a conference in an effort to resolve the dispute.*fn1 This Court questioned whether Roche had standing to assert the privilege, given its continued insistence that it had no control over the documents, and also opined that it seemed doubtful that the documents, based on the descriptions in the privilege logs, would ultimately be held protected. (See Tr. at 18:22-19:17.) However, in light of the inconsistent, complicated and prolix letter submissions, the Court denied Roxane‟s application without prejudice to renewing the request in a formal way.*fn2 The Court also temporarily enforced the "claw-back" provision in the Discovery Confidentiality Order, effectively taking the Disputed Documents out of Roxane‟s control, solely to preclude use of the Disputed Documents in Japan. (Tr. at 18:11-21.)

On March 8, 2011, Roxane filed a formal brief supported by a dense appendix renewing its request for formal production of the Disputed Documents. Roche responded on March 25, 2011, with a brief, as well as declaration prepared by renowned, retained expert Professor of Law Stephen A. Saltzburg.*fn3 On May 4, 2011, the Disputed Documents were submitted for in camera review.


Roxane advances a panoply of arguments as to why the Disputed Documents should be produced: (1) Roche lacks standing to assert privilege over Chugai‟s documents; (2) Roche waived any privilege when the documents where left in Chugai‟s control following the merger in 2001; (3) Chugai waived any privilege it may have had over the documents by producing them to Roche and/or Roxane; (4) Roche has not established that the actual documents are privileged communications; (5) Roche waived any privilege through their tardy and ineffective attempts to rectify the inadvertent disclosure to Roxane; (6) ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.