The many discovery disputes between AbbVie and Boehringer Ingelheim (“BI”) over BI’s biosimilar of HUMIRA® (adalimumab) in the Delaware District Court are providing insight on the bounds of discovery in Biologics Price Competition and Innovation Act (“BPCIA”) litigation. Below, we discuss some of the key discovery motions and rulings in AbbVie v. Boehringer (1:17-cv-01065, D. Del.) and illustrate how they provide guidance to other BPCIA litigants.
I. BI’s Discovery Efforts
Over the past several months, BI has filed at least six motions to compel production of a broad range of documents, in addition to motions to enforce discovery orders. Despite AbbVie’s resistance, BI has succeeded, at least in part, in obtaining such discovery.
BI has sought extensive discovery in this litigation, including third-party discovery from physicians and medical centers who participated in clinical trials related to HUMIRA®. (Dkt. 69.) On May 9, 2018, AbbVie filed a motion for a protective order staying responses to these third-party subpoenas. (Id.) AbbVie claimed that BI’s subpoenas would cause undue burden and jeopardize AbbVie’s “key relationships” with these third party “customers.” (Id. at 4.) BI responded that the requested information was highly relevant to its public use defense, such as the potential disclosure of the claimed dosing regimens and confidentiality obligations that would affect whether a public disclosure occurred. (Dkt. 99 at 6-7 (redacted).) On May 23, 2018, Magistrate Judge Lloret denied AbbVie’s motion for protective order, holding that “[d]etails of the clinical testing process and protocols, and communications with patients, were reasonably calculated to produce relevant evidence concerning a public use defense.” (Dkt. 100 at 4.) The court also rejected AbbVie’s characterization of clinical researchers and doctors as “customers” and further stated that “[t]he risk of having to respond to discovery is or should be factored into the cost of doing clinical trials.” (Id. at 5-6.)
BI has also offensively sought to compel production from AbbVie, starting with three motions to compel filed on May 10, 2018. The first motion sought to compel production of AbbVie’s supply, distribution, and manufacturing agreements for adalimumab from 1996 to 2014. (Dkt. 70 (filed under seal); Dkt. 82 (redacted).) BI argued that the requested commercial agreements were relevant to an on-sale bar under 35 U.S.C. §102(b), and were neither burdensome nor expensive for AbbVie to produce. (Dkt. 82 at 4-5.) Because there was no dispute that HUMIRA® was on sale since January 2003, AbbVie argued in its opposition that agreements after 2003 were not relevant. (Dkt. 98 at 3 (redacted version).) On May 30, 2018, the court granted BI’s motion to compel and ordered AbbVie to produce both proposed and executed agreements from 1996 to 2003 (worldwide and the U.S.) and from 2003 to 2011 (U.S.). (Dkt. 110 at 3.) Specifically, the court held that because the patents-in-suit were filed as late as 2013, post-2003 agreements could be relevant because “that which was ‘on sale’ must match the contours of the patent it seeks to invalidate.” (Id. at 2.)
BI’s second motion to compel filed on May 10, 2018, sought discovery concerning BI’s affirmative defense of unclean hands. (Dkt. 71 (filed under seal); Dkt. 81 (redacted).) In its Answer, BI had alleged that AbbVie’s patents were unenforceable because of its anticompetitive conduct—the use of a “patent thicket” of “non-inventive or overlapping patents” to delay competition. (Dkt. 81 at 3.) AbbVie resisted discovery into this defense, arguing that BI failed to plead the unclean hands defense adequately in its answer, including the required “unconscionable and egregious misconduct” necessary to maintain such a defense and thus should not be entitled to discovery on this issue. (Dkt. 88 at 5 (redacted).) On June 4, 2018, the court granted BI’s motion to compel. (Dkt. 112.) The court held that unclean hands need not be based on fraudulent conduct and rejected AbbVie’s arguments regarding the merits of the defense, noting that “[a] discovery motion is not a good mechanism for litigating the substance of the defense.” (Dkt. 112 at 2, 4.) Subsequently, on October 17, 2018, BI filed a motion to enforce the court’s June 4th Order regarding unclean hands discovery. (Dkt. 233 (filed under seal); Dkt. 269 (redacted).) On February 8, 2019, the court granted BI’s motion (Dkt. 411; Dkt. 410), noting that AbbVie’s arguments against production were “unhelpful, to put it politely” and cautioned AbbVie not to “throw more wrenches in the gears” of this discovery. (Dkt. 410 at 7, 10.) Notably, Magistrate Judge Lloret ordered AbbVie to “engage in rapid and punctilious compliance with [his] Order.” (Id. at 9.)
BI’s third motion to compel filed on May 10, 2018, sought production of AbbVie’s research and development documents. (Dkt. 72 (filed under seal); Dkt. 83 (redacted).) BI contended that the requested documents were relevant to its invalidity and unclean hands defenses. (Dkt. 83 at 3-4.) BI also argued such documents were relevant to testing the credibility of AbbVie’s assertions regarding its conception and reduction to practice. (Id. at 4-5.) In its opposition, AbbVie took the position that BI’s request was unduly burdensome since almost every document at AbbVie related to adalimumab would fall into the categories of “research” or “development.” (Dkt. 77 at 4.) AbbVie also argued that, under the Delaware Default Standard for Discovery, BI failed to show “good cause” to seek documents outside the court’s default six-year limitation on discovery. (Id. at 5-6.) On June 7, 2018, the court granted BI’s motion only in part. (Dkt. 119.) The court ordered AbbVie to produce all research and development documents for the six-year period preceding filing of the complaint, as well as the research and development documents related to the asserted prior art or the conception and reduction to practice of the alleged inventions of the patents-in-suit for the time preceding the six-year period. (Dkt. 119 at 7.)
On July 20, 2018, BI filed an additional motion to compel, this time seeking production of pre-litigation BPCIA patent contention exchanges between AbbVie and Amgen (another adalimumab biosimilar manufacturer) and settlement agreements with other biosimilar manufacturers concerning adalimumab. (Dkt. 138.) Because the 3B and 3C statements exchanged under the BPCIA’s “patent dance” provisions “must contain descriptions of why AbbVie’s patents are invalid and/or unenforceable and include AbbVie’s responses to those positions,” BI argued that the requested documents directly related to the current litigation involving some of the same patents. (Id. at 3.) Further, BI argued that the requested portions of the 3B and 3C statements did not contain Amgen’s confidential information (such as Amgen’s noninfringement contentions), nor did they include negotiations between Amgen and AbbVie. (Id. at 4.) BI also alleged that the settlement agreements with other biosimilar manufacturers were relevant to commercial success and BI’s unclean hands defenses. (Id. at 5-6.) AbbVie opposed the discovery, contending that the 3B and 3C statements were pre-litigation confidential documents and Amgen’s pre-litigation positions were irrelevant to the present litigation, especially to the extent they involved patents not currently at issue. (Dkt. 145 at 2-3.) AbbVie also argued that BI “is a sophisticated party that is capable of developing its own invalidity positions without piggybacking on a third party’s work.” (Id. at 4.) In addition, AbbVie argued that the settlement agreements were highly sensitive documents and BI failed to make “a particularized and heightened showing of relevance” of these agreements. (Id. at 5.) On September 7, 2018, the court ordered AbbVie to produce the requested patent contention exchanges and the settlement agreements, holding that “[p]roduction of these documents will not be overly burdensome and there is sufficient reason to believe that the discovery will produce admissible and relevant evidence.” (Dkt. 207 at 2.) This is the first time we are aware of a court ordering production of patent dance exchanges.
II. AbbVie’s Discovery Efforts
BI has not been the only party aggressively seeking discovery. AbbVie has also filed at least four discovery motions, and the court is just beginning to rule on these motions.
On October 17, 2018, AbbVie filed a motion to compel a complete response to its interrogatory requesting information on BI’s decision, plan, or preparation to launch or not launch its biosimilar adalimumab product. (Dkt. 234 (filed under seal); Dkt. 246 (redacted).) BI took the position that it would “provide notice to AbbVie at least 180 days before the date of the first commercial marketing of its adalimumab product in the United States to the extent required by law.” (Id. at 2.) AbbVie argued that the requested information is relevant to BI’s purported “unclean hands” defense (including whether Boehringer is actually prevented from launching its product due to AbbVie’s alleged “unclean hands”), and whether BI “is stockpiling product that can be commercially sold,” which can constitute infringement in a BPCIA litigation. (Id. at 3-4.) On February 25, 2019, the court ruled that BI had to disclose information related to its launch in light of its unclean hands defense, and that such discovery did not “disrupt” the statutory scheme in the BPCIA that lays down the timing for notice of commercial marketing. The court also denied AbbVie’s request for additional discovery regarding potential stockpiling because it had “minimal value” and was “disproportionately burdensome.” (Dkt. 428.)
On December 28, 2018, AbbVie filed a motion to compel complete responses to AbbVie’s interrogatory requesting BI to describe its factual and legal bases for its safe harbor defense under 35 U.S.C. § 271(e)(1). (Dkt. 327 (filed under seal); Dkt. 351 (redacted).) In the same motion, AbbVie asked the Court to compel BI to answer an interrogatory asking when BI first learned of the patents-in-suit (or the applications leading to them). (Id.) In the opposition, BI argued that it would only assert its 35 U.S.C. § 271(e)(1) defense if AbbVie were to assert actual infringement based on BI’s aBLA. (Dkt. 349 at 4.) But BI asserted that because it has not given any notice of future commercial marketing (which is a requirement for asserting such an infringement contention), AbbVie is not entitled to the requested discovery in this first wave of BPCIA litigation. (Id.) BI claimed that such request was irrelevant to this case, where infringement is based on “an artificial act of infringement,” and was not proportional to the needs of the case as it “covers at least 34 ‘applications’ filed over 16 years.” (Id. at 3-5.) The court has not yet decided this motion.
Also on December 28, 2018, AbbVie filed a motion to compel deposition testimony (Dkt. 326 (filed under seal); Dkt. 350 (redacted).) AbbVie claimed that BI’s counsel improperly instructed deponents to not answer questions relating to the status of formulations and the launch and release of the accused product. (Id. at 1.) AbbVie argued that the information sought “is relevant to multiple claims and defenses” and that “the questions sought ‘very sensitive commercial information’ is no justification.” (Id. at 1-2.) BI countered that the formulations sought were the subject in a pending motion to limit discovery, and the future launch plans were the subject of another pending dispute. (Dkt. 356 at 2-3 (redacted).) BI also argued that AbbVie’s questions during 30(b)(6) depositions were overbroad and concerned patents that were not at issue. (Dkt. 356 at 4-5.) This motion is currently pending, although may be partially resolved by the court’s February 25, 2019 ruling ordering BI to disclose information relating to its launch. (Dkt. 428.)
On January 4, 2019, AbbVie filed a motion to enforce an earlier court order (Dkt. 207) requiring BI to produce documents concerning BI’s internal strategies and programs. (Dkt. 335 (filed under seal); Dkt. 346 (redacted).) For example, AbbVie asked the court to enforce its order to compel the production of documents related to BI’s “top selling” drug SPIRIVA®, which could impact the credibility of BI’s “unclean hands” defense, and the production of BI’s internal documents regarding risankizumab, because BI has allegedly made statements in prosecuting the risankizumab patents that directly contradict its invalidity position in the current case. (Dkt. 346 at 3, 5 (SPIRIVA® “was Boehringer’s top-selling product in 2017 with over EUR 2.8 billion in net sales” and risankizumab is an antibody.)) AbbVie alleged that BI’s production was insufficient as BI primarily only produced public information that did not address any internal business strategies nor scientific basis for its prosecution and litigation positions. (Id. at 2-3, 5.) This motion is currently pending.
The discovery disputes between BI and AbbVie illustrate the types of discovery that parties engaged in BPCIA litigation may seek, especially when fact-intensive issues such as “unclean hands” are at issue. The court’s rulings could influence other courts in a number of areas including, for example, the discovery of previous settlement agreements and 3B and 3C statements obtained during patent dances with other biosimilar manufacturers. In support of its rulings, the District of Delaware has frequently noted the “large” financial stakes and “abundant” resources of the parties, a situation that is common in other biosimilar litigation. (See, e.g., Dkt. 110 at 3; Dkt. 125 at 4.)
The discovery disputes between AbbVie and BI are still ongoing, and we will continue to monitor this case.
Authors: Qiuyi Wu, Jenny Shmuel, Tasha Francis
The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.
Jenny Shmuel, Ph.D., represents clients on a range of intellectual property matters, with an emphasis on medical device and pharmaceutical technologies. She has extensive experience in pre-suit diligence, case management, expert and fact discovery, and brief writing, and has examined and cross-examined witnesses at trial.
Over the last several...
Qiuyi (Autumn) Wu is a litigation associate in the Boston office of Fish & Richardson P.C. Her practice focuses on patent litigation across a wide range of technologies, primarily in the fields of biotechnology, life sciences, and mechanical arts. Autumn also has experience with Section 337 investigations at the International Trade...