RICHARD A. LLORET, Magistrate Judge.
Plaintiffs (collectively, "AbbVie") have filed a request (which I call a motion in this Memorandum) to compel a more complete response to their Interrogatory No. 21,
Boehringer argues that the BPCIA has a "carefully calibrated scheme" that provides for notice of launch plans 180 days in advance of launch. Doc. No. 243 at 2 ("Def. Opp.") (citing to Sandoz Inc. v. Amgen Inc., 137 S.Ct. 1664, 1670-71 (2017)). Early disclosure of launch plans will, on Boehringer's account, disrupt this statutory scheme. Id. (citing to Allergan, Inc. v. Teva Pharm. USA, Inc., No. 15-1455, 2017 WL 3676745 at *2 (E.D. Tex. Aug. 25, 2017) and Otsuka Pharm. Co. v. Torrent Pharm. Ltd., Inc., 99 F.Supp.3d 461, 471-72 (D.N.J. 2015)). Boehringer also argues that early disclosure of its launch plans would not be relevant to its unclean hands defense. Def. Opp. at 3-4.
I will address the BPCIA argument first, then the more conventional arguments about relevance and proportionality.
The language of the BPCIA does not expressly prevent or limit discovery in a biosimilar case, once litigation begins. Boehringer's argument is that the structure of the BPCIA provides for an echeloned dispute resolution process, the last phase of which is triggered by notice of an applicant's intent to commercially market a biosimilar drug covered by the statute.
Boehringer reads too much into the statute. The BPCIA's sequenced litigation process is designed to channel patent disputes involving biosimilar drugs into several successive stages: pre-litigation disclosure and negotiation; phase I litigation, which tests infringement claims for representative patents
The 180-day notice requirement is not designed to cloak launch plans with a broad ranging privilege against disclosure before the notice is filed. It is designed to avoid a preliminary injunction proceeding unless one is needed, that is, because a commercial launch is planned in six months. It is also designed to provide a reasonable period of 180 days within which to resolve the preliminary injunction, rather than the usual highly compressed time schedule forced on the parties and court by a commercial launch. Nothing in the statute says that otherwise relevant and discoverable launch plans may be withheld because the 180-day time clock has not been triggered.
The cases cited to by Boehringer hold that the Hatch-Waxman Act does not require a party to give early notice of its intent to launch, and that it is not good policy for a judge to impose such a requirement on a party. See Allergan, Inc. v. Teva Pharm. USA, Inc., No. 15-1455, 2017 WL 3676745 at *2 (E.D. Tex. Aug. 25, 2017); Otsuka Pharm. Co. v. Torrent Pharm. Ltd., Inc., 99 F.Supp.3d 461, 471-72 (D.N.J. 2015). The BPCIA, unlike Hatch-Waxman, does require advance notice of launch plans for those proceeding under the BPCIA. But requiring Boehringer to answer discovery about its launch plans is not the same as issuing an order compelling advanced notice of intent to launch under the BPCIA, with all its consequences. Boehringer would not be bound by the disclosure of contingent plans,
AbbVie explains that if the discovery reveals that Boehringer has largely or completely disregarded or discounted the "patent thicket" in formulating its launch plans, this would tend to undermine Boehringer's argument that the "patent thicket" has harmed Boehringer by slowing down the launch of Boehringer's biosimilar product. Boehringer insists that its launch plans are irrelevant to its unclean hands defense and explains that the "patent thicket" has harmed Boehringer and the public in different ways.
"A determination of relevance implicates substantive patent law. Therefore, we look to Federal Circuit law rather than regional circuit law in discussing relevance." Micro Motion, Inc. v. Kane Steel Co., Inc., 894 F.2d 1318, 1326 n.8 (Fed. Cir. 1990) (citing to Truswal Sys. Corp. v. Hydro-Air Eng'g, Inc., 813 F.2d 1207, 1211-12 (Fed. Cir. 1987)). "Unclean hands" is a defense to a cause of action for infringement. See Aptix Corp. v. Quickturn Design Systems, Inc., 269 F.3d 1369, 1380 (Fed. Cir. 2001) (citing to Keystone Driller Co. v. General Excavator Co., 290 U.S. 240, 243-44 (1933)). A patent holder's "unclean hands" may bar it from receiving equitable relief. See Gilead Sciences, Inc. v. Merck & Co., Inc., 888 F.3d 1231, 1240 (Fed. Cir. `). The defense requires that "`misconduct' of a party seeking relief `has immediate and necessary relation to the equity that he seeks in respect of the matter in litigation[.]'" Id. at 1239 (quoting from Keystone, 290 U.S. at 245). The misconduct must "in some measure affect the equitable relations between the parties in respect of something brought before the court." Id. Wide-ranging misconduct may invalidate an entire group of related patents. See Consolidated Aluminum Corp. v. Foseco Intern. Ltd., 910 F.2d 804, 809 (Fed. Cir. 1990).
In some patent contexts, the Federal Circuit has required an explicit causal connection between the alleged misconduct underlying a claim of unclean hands and prejudice to the party asserting unclean hands. See Serdarevic v. Advanced Medical Optics, Inc., 532 F.3d 1352, 1361 (Fed. Cir. 2008) ("a plaintiff relying on the unclean hands doctrine to defeat a defense of laches must show not only that the defendant engaged in misconduct, but moreover that the defendant's misconduct was responsible for the plaintiff's delay . . ."). Other circuit courts require proof that the wrongful conduct comprising "unclean hands" actually has injured the party claiming the defense. See Mitchell Bros. Film Group v. Cinema Adult Theater, 604 F.2d 852, 863 (5
I will assume that Boehringer need not prove that AbbVie's alleged "unclean hands" caused actual injury to Boehringer's business. That is not the end of the relevance inquiry, however.
Evidence is relevant if it tends to make a fact of consequence to the litigation more (or less) probable. Fed. R. Evid. 401. "The Rule's basic standard of relevance thus is a liberal one." Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 587 (1993). Relevance is "a relation between an item of evidence and a matter properly provable in the case," See Sprint/United Management Co. v. Mendelsohn, 552 U.S. 379, 387-88 (2008) (quoting from the Advisory Committee Notes to Fed. R. Evid. 401).
If harm to Boehringer is not a formal element of the "unclean hands" defense, Boehringer may still establish that AbbVie's "patent thicket"
Boehringer's response to Interrogatory No. 20 says that "AbbVie has engaged in a multifaceted, illegal scheme to prevent the sale of adalimumab in competition against Humira[,]®" and that "AbbVie's intensive desire to create a patent thicket encouraged and fostered an unconscionable pattern of withholding and/or misrepresenting information to the U.S. Patent and Trademark Office . . ." IA at 5. Boehringer also says that "AbbVie's program was successful in creating a thicket that AbbVie has exploited to delay competition of an FDA-approved adalimumab biosimilar" and that "AbbVie's misconduct . . . harms the public, including the Defendants, and renders its assertion of its patents violative of principles of equity." Id. at 5-6.
Boehringer says that AbbVie generated "a vast portfolio of dubious, overlapping patents years after the launch of Humira®" which were "designed to prevent an adalimumab biosimilar . . ." Id. at 7. All this was "part of a larger scheme to thwart adalimumab competition." Id. at 10. After identifying a wide variety of alleged misrepresentations and material omissions in connection with adalimumab related patent applications, Boehringer contends that "AbbVie's business strategy has been to leverage its thicket of dubious and overlapping patents to delay biosimilar competition." Id. at 30. Boehringer goes on to contend that "AbbVie has an ulterior motive for using the BPCIA process and patent litigation to delay Defendants' entry onto the market, and thus obtain an unfair advantage over competitors to maintain its `dominant position' in the marketplace." Id. at 33.
Though I agree with Boehringer that commercial injury to Boehringer is not a prerequisite to establishing an unclean hands defense, Boehringer's account of the motive for, and consequences of, AbbVie's alleged misconduct put the issue front and center. The degree to which the "patent thicket" delayed Boehringer's launch may have a legitimate impact on a fact-finder's assessment of whether AbbVie has unclean hands. At least, that is the import of Boehringer's explication of its unclean hands defense in its answer to Interrogatory 20. Certainly, the harm or intended harm to Boehringer may weigh in the decision whether to apply the doctrine of unclean hands. The weight given to the "patent thicket" by Boehringer when making its launch plans is thus a fact of consequence to the defense of "unclean hands," in large measure because Boehringer has made it so. Fed. R. Civ. Pro. 26(b)(1); Fed. R. Evid. 401(a) and (b). In short, if Boehringer argues — as it does — that the purpose and effect of the "patent thicket" was to delay competition and damage competitors, and seeks to prove this purpose and effect, it cannot refuse to quantify the delay and the damage. That would be unfair.
Relevance is not a daunting hurdle, and AbbVie's theory clears it.
As with most discovery disputes, a determination of relevance is not dispositive. Of more significance is the question of whether the discovery is proportionate to its burdens, under Federal Rule of Civil Procedure 26(b)(1), in light of the considerations listed in the rule. I make the following findings, guided by Rule 26(b)(1)'s considerations:
AbbVie argues that if Boehringer is making its biosimilar in quantities that indicate it is stockpiling for a commercial launch, this would be an act of infringement. Pl. Mot. at 4. Not necessarily. Likely at issue is the "safe harbor" provision of 35 U.S.C. § 271(e)(1), under which Boehringer may make an allegedly infringing product "solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products." 35 U.S.C. § 271(e)(1). If the evidence at trial indicates that
Boehringer's biosimilar drug infringed, and that some of its batches were made for commercial delivery, and not for developing information as part of the approval process, AbbVie has a point.
Boehringer says AbbVie's theory has lain unattended for much of the case and is make-weight. Def. Opp. 5-7. Boehringer also points out that it has supplied lots of detailed information about all the batches of biosimilar drug it has manufactured. Id. Boehringer has a point. AbbVie does not make a convincing case that additional stockpiling discovery is needed or will matter to the disposition of infringement issues in this case. I find that additional discovery on the subject is of minimal value and disproportionately burdensome. I will deny the motion to compel an answer about stockpiling.
I will grant AbbVie's motion in part and deny it in part and direct the parties to engage in limited discovery on the subject. An Order will be entered consistent with this Memorandum.
See U. S. Dist. Ct. Rules E.D.Tex., Rule CV-26(d), Provisions Governing Discovery; Duty of Disclosure. This definition is well-known to experienced patent counsel.