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AbbVie Inc. v. Boehringer Ingelheim International GMBH,

United States District Court, D. Delaware

May 23, 2018




         AbbVie[1] has moved under Fed. R. Civ. Pro. 26(b)(2)(C) for a protective order[2]staying responses to eight third-party subpoenas issued by Boehringer.[3] Doc. No. 69 (“AV Mot.”). Boehringer has responded. Doc. No. 76 (“BI Res.”). AbbVie filed a reply. Doc. No. 84 (“AV Rep.”).

         The third party subpoenas seek information related to three clinical studies related to adalimumab, known as HUMIRA, the drug at the center of this case. The three studies are the ARMADA study, which concerned rheumatoid arthritis (number DE009), a continuation of the ARMADA study (number DE009X), and the ATLAS study, which concerned ankylosing spondylitis (number M03-607). AbbVie Mot. at 4. AbbVie argues that these subpoenas are duplicative of information already requested from AbbVie, are unduly burdensome, and seek irrelevant information. Id. AbbVie also claims that the subpoenas jeopardize AbbVie's “key relationships” with customers and clinical investigators. Id. Boehringer disputes AbbVie's contentions. BI Mem. at 6-9.

         Rule 26(c) places the burden of persuasion on the party seeking the protective order. . . [T]he party seeking the protective order must show good cause by demonstrating a particular need for protection. Broad allegations of harm, unsubstantiated by specific examples or articulated reasoning, do not satisfy the Rule 26(c) test.

         Cipollone v. Liggett Grp., Inc., 785 F.2d 1108, 1121 (3d Cir. 1986). “Good cause is established on a showing that disclosure will work a clearly defined and serious injury to the party seeking closure.[4] The injury must be shown with specificity.” Pansy v. Borough of Stroudsburg, 23 F.3d 772, 786 (3d Cir. 1994) (internal quotation and citation omitted).

         Four factors guide the evaluation of good cause: “relevance, need, confidentiality and harm.” Mannington Mills, Inc. v. Armstrong World Industries, Inc., 206 F.R.D. 525, 529 (D.Del. 2002) (citing to Micro Motion, Inc. v. Kane Steel Co., Inc., 894 F.2d 1318, 1323 (Fed. Cir. 1990). “[E]ven if the information sought is relevant, discovery is not allowed where no need is shown, or where compliance is unduly burdensome, or where the potential harm caused by production outweighs the benefit.” Id.

         1. Relevance

         Relevance is a forgiving standard, even when evaluating evidence to be admitted at trial. Fed.R.Evid. 401. During discovery the question is whether the information sought is “relevant to any party's claim or defense and proportional to the needs of the case . . .” Fed. R. Civ. Pro. 26(b)(1). Boehringer explains that the clinical trial documents it seeks from third parties may be relevant to its public use defense. BI Res. at 6-7; see 35 U.S.C. § 102(b) (2000). The documents are also directed to obtaining documents AbbVie is unlikely to have, and to check the completeness of the discovery produced by AbbVie. Id. at 7-9.

         The public use defense is available if an “invention was . . . in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States.” Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1379 (Fed. Cir. 2005) (quoting 35 U.S.C. § 102(b)) (emphasis omitted). Boehringer's theory of relevance is that details about the use of the drug during the clinical trial process may establish the defense. How the clinical trials were conducted - “the nature of the activity that occurred in public; public access to the use; confidentiality obligations imposed on members of the public who observed the use; and commercial exploitation” - may bear on a public use defense. Id. at 1380 (citing to Allied Colloids, Inc. v. Am. Cyanamid Co., 64 F.3d 1570, 1574 (Fed.Cir. 1995)).

         AbbVie argues that the “proper focus of any public use inquiry was on the party in control of the clinical trials, ” not the patients. AV Rep. at 2 (citing Dey, L.P. v. Sunovion Pharmaceuticals, Inc., 715 F.3d 1351, 1358 (Fed. Cir. 2013)). AbbVie overstates the holding in Dey. The Federal Circuit held only that patient “clinical trial at-home use of the formulation of Batch 3501A without an affirmative confidentiality obligation” did not doom Dey's patents. Id. at 59. The decision did not hold that communications with patients were categorically irrelevant. Instead, it held only that the district court could not “discount the relevance of the study participants' limited knowledge of Batch 3501A's formulation or . . . sidestep disputed factual questions about the nature of the allegedly public use[, ]” because “a reasonable jury could conclude that if members of the public are not informed of, and cannot readily discern, the claimed features of the invention in the allegedly invalidating prior art, the public has not been put in possession of those features.” Id. This is a far cry from holding that communications between health care providers and participants in a clinical study are irrelevant.

         Boehringer's theory of relevance is not make-weight. Details of the clinical testing process and protocols, and communications with patients, are reasonably calculated to produce relevant evidence concerning a public use defense. See Fed. R. Civ. Pro. 26(b)(1) (“Parties may obtain discovery regarding any nonprivileged matter that is relevant to any party's claim or defense and proportional to the needs of the case . . . [i]nformation within this scope of discovery need not be admissible in evidence to be discoverable.”).

         2. Need

         “Need is enhanced when information is uniquely available from the party from whom it is sought. The corollary is that need is diminished when the information is available elsewhere.” Avago Technologies U.S., Inc. v. IPtronics Inc., 309 F.R.D. 294, 299-300 (E.D.Pa., 2015) (quoting American Standard Inc. v. Pfizer Inc., 828 F.2d 734, 743 (Fed. Cir. 1987)). Need is especially salient when a subpoena to third parties covers information available from a litigant. AbbVie contends that the clinical trial information is available from AbbVie, and has been requested by Boehringer. AV Mot. at 1. A review of the subpoenas, compared to Boehringer's requests for production, reveal that there is considerable overlap, although not exact congruence. Id. at 2-3.

         Boehringer argues that the discovery seeks information related to patent invalidity - their “public use” defense. BI Res. at 7-8. Boehringer points out that the subpoenas seek information that AbbVie has refused to produce, and that some of the information is unlikely to be in AbbVie's possession. Id. at 8. The ...

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