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.

Otsuka Pharmaceutical Co., Ltd. v. Apotex Corp.

September 12, 2008


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




This matter comes before the Court upon Motion by Defendant Apotex Inc. ("Apotex") for a Protective Order Preventing the deposition of Apotex's Chief Executive Officer Dr. Barry Sherman ("Dr. Sherman") [dkt. entry no. 138], returnable September 2, 2008. Plaintiff Otsuka Pharmaceutical Co., Ltd. ("Otsuka") opposed the motion on August 21, 2008. [dkt. entry no. 143]. Defendant filed a reply brief on August 28, 2008. [dkt. entry no. 150]. The issue is whether Dr. Sherman must appear for a deposition. The Court heard oral argument on September 11, 2008. For the reasons stated herein, Defendant's Motion is denied.


Otsuka alleges that Apotex committed patent infringement with respect to U.S. Patent No. 5,006,528. "[T]he alleged act of infringement is the technical act of Apotex's filing an abbreviated new drug application (ANDA) with the Food and Drug Administration (FDA) to manufacture and sell a generic version of Otsuka's aripiprazole drug product." (Def.'s Br. at 2.) This motion specifically addresses whether Dr. Sherman must submit to a deposition.

On March 10, 2008, Otsuka served a Rule 30(b)(6) notice seeking Apotex's corporate testimony on a number of topics. (Pl.'s Opp'n Br. at 9.) Apotex produced the President of Apotex Corp. and Apotex's Director of Regulatory Affairs, both of whom respectively disclosed that Dr. Sherman heads the product selection team, which in turns selects the drug products that Apotex will develop as generics, which is most likely what occurred with aripiprazole and that Dr. Sherman determines whether to make a paragpraph IV certification, and did so with respect to aripiprazole. (See Pl.'s Opp'n Br. Ex. 4 and Ex. 5.)

On August 11, 2008, Apotex filed the present Motion for a Protective Order to prevent the deposition of Dr. Sherman [dkt. entry no. 138]. The Motion was opposed on August 21, 2008 [143]. Subsequently, Apotex filed a reply brief on August 28, 2008 [dkt. entry no. 150].

A. Defendant's Arguments in Support of the Motion for a Protective Order

Defendant makes three arguments why the Motion for a Protective Order should be granted. Specifically, Defendant argues that (1) Dr. Sherman's deposition is not necessary for Otsuka to develop its infringement case; (2) Dr. Sherman's deposition is not necessary for Otsuka to defend agaisnt Apotex's allegations of patent invalidity and unenforceability; and (3) other courts routinely prohibit or severely restrict the scope of depositions of the other side's chief executive officers, unless they have unique, highly relevant knowledge that cannot be obtained through other witnesses. (Def.'s Br. at 2, 4 and 9.)

Defendant argues that the Federal Circuit has held that the paper ANDA record controls the infringement analysis. The Federal Circuit has stated that

Because drug manufacturers are bound by strict statutory provisions to sell only those products that comport with the ANDA's description of the drug, an ANDA specification defining a proposed generic drug in a manner that directly addresses the issue of infringement will control the infringement inquiry.

See Def.'s Br. at 3 (citing Abbott Labs. v. TorPharm, Inc., 300 F.3d 1367, 1373 (Fed. Cir. 2002)). Upon this backdrop, Defendant also contends that "Apotex already has produced its ANDA to Otsuka [and] [a]ll relevant and necessary information pertaining to Apotex's proposed generic product is contained therein" (Def.'s Br. at 3.) Defendant claims that "Otsuka has not alleged willful infringement [and], even if it did, case law firmly establishes that the mere filing of an ANDA, which is all that Apotex did here, is not sufficient to support a willfulness claim. Therefore, Apotex's motivation for filing its ANDA is not relevant to infringement nor relevant in order to depose Dr. Sherman on this subject." (Def.'s Br. at 4, citing Glaxo Group Ltd. v. Apotex, Inc., 376 F.3d 1339, 1350-51 (Fed. Cir. 2004)).

Defendant argues that Dr. Sherman has no unique or discoverable information that is relevant to Apotex's allegations that Otsuka's patent is invalid and unenforceable. (Def.'s Br. at 4.) Defendant represents that "Dr. Sherman will not testify at trial in support of Apotex's invalidity and unenforceability defense, and Otsuka can discover the bases of those defense from Apotex's experts and from contention interrogatory responses." Id. Defendant recognizes that there are four underlying factual determinations for obviousness with the fourth being objective indicia of nonobviousness. See Def.'s Br. at 5; Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369, 1377 (Fed. Cir. 2006). Defendant contends that "Otsuka is likely to assert that Dr. Sherman has knowledge pertaining to objective indicia of obviousness, including the alleged copying and alleged commercial success of Otsuka's ariprazole product." Id. Upon that assumption, Defendant argues that "a showing of copying is only equivocal evidence of non-obviousness in the absence of a more compelling objective indicia of other secondary considerations." (Def.'s. Br. at 6) (citing Ecolochem, Inc. v. Southern California Edison Co., 227 F.3d 1361, 1380 (Fed. Cir. 2000)). Defendant concedes that "even if copying evidence were somehow relevant to this case, Apotex's ANDA sets forth what Apotex did in developing its generic aripiprazole product; [therefore,] Dr. Sherman's deposition is not necessary to determine the makeup of Apotex's contemplated generic product." (Pl.'s. Br. at 7.) Defendant argues that commercial success is not relevant to this case and states that "[t]he Federal Circuit has stated on several occasions that commercial success is not probative of nonobviousness unless there is a nexus between the commercial success and the thing patented." Id. (See also Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371 (Fed. Cir. 2005); Merck & Co. v. Teva Pharm., 395 F.3d 136, 1376-77 (Fed. Cir. 2005)). Defendant ...

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.