Discovery Rulings in Abbvie v. BI Adalimumab Litigation

Magistrate Judge Lloret of the District of Delaware recently issued two discovery rulings in the ongoing AbbVie v. Boehringer Ingelheim (“BI”) litigation.

Grant of BI’s Motion To Compel Production Of Pre-litigation Disclosures and Settlement Agreements

In an opinion issued on April 11, 2019, the court granted BI’s motion to compel production of pre-litigation “patent dance” disclosures from the AbbVie v. Amgen suit, and settlement agreements between AbbVie and other biosimilar applicants.  The AbbVie v. Amgen litigation involved seven of the eight patents asserted against BI. During the litigation, Amgen and Abbvie engaged in disclosures pursuant to BPCIA including Amgen producing confidential information about its proposed biosimilar under § 262 (l)(1)(B)(i), (l)(2), and disclosures regarding the parties invalidity and infringement assertions (“3B” and “3C” disclosures).  Amgen and AbbVie later settled.

In evaluating whether the 3B and 3C disclosures from the AbbVie v. Amgen case are discoverable in the suit against BI, Judge Lloret looked to the language of the statute.  In particular, he noted that information disclosed pursuant to § 262 (l)(1)(B)(i), (l)(2) “are to be kept confidential and used by the reference product sponsor only for the purpose intended under the statute.”  Opinion at 2 (citing 42 U.S.C. § 262 (l)(1)(C) and (D)).  Judge Lloret also noted that while “[t]he BPCIA has much to say about the confidentiality of the biosimilar applicant’s (Amgen) information disclosed under 42 U.S.C. § 262(l)(1) [it] does not provide for separate or additional confidentiality for the contentions required under § 262(l)(3)(B) and (C).”  He found that the 3B and 3C disclosures constitute “statements by a party that may be used against the party, provided they are relevant.”  Opinion at 3 (citing Fed. R. Evid. 801(d)(2)(A)).  Finally Judge Lloret found that the 3B and 3C disclosures were relevant given the overlapping patents at issue in the Amgen case and the BI case.  Id.  After noting that Amgen had consented to the production of these documents subject to court order and maintenance of confidentiality, the court ordered that they must be produced subject to the confidentiality provisions of the protective order. Opinion at 4.

BI also sought production of the settlement agreements AbbVie entered with Amgen, Samsung Bioepis, and Mylan related to their adalimumab biosimilar products.  The court held these agreements were “likely to be relevant to [BI’s] invalidity and unenforceability defenses, are easily identifiable and producible without undue burden, are within the control of AbbVie and not accessible to [BI], and are routinely produced in patent litigation, with adequate confidentiality protections.”  Opinion at 4-5.  The court found that the settlement agreements “may be relevant” to whether the patents in suit had a nexus to Humira’s commercial success, and may be relevant BI’s unclean hands defense.  Given that BI “has made enough of a showing” to warrant discovery, the court ordered the settlement agreements must be produced on an outside counsel eyes only basis.  Id. at 6-7.  Finally, the court rejected as ”unworkable” AbbVie’s request that a separate set of attorneys may only access the materials.  Opinion at 7-8.

Denial of AbbVie’s Motion For More Complete Responses On Interrogatories

In an order on April 15, 2019, Judge Lloret denied AbbVie’s motion for more complete responses to interrogatories on BI’s basis for its safe harbor defense and when BI first became aware of the patents-in-suit.  BI had explained that it would assert the safe harbor defense only to the extent that AbbVie asserted that the manufacture and clinical use of the biosimilar is an act of infringement. In essence, BI stated that it would not assert the safe harbor unless AbbVie argued “actual infringement based on [BI’s] conduct relating to its aBLA.”  Order at 1.  The court found that the probative value of the interrogatory was “remote” and not likely material to resolution of the litigation, which is triggered by the “artificial infringement” provided by filing a biosimilar application with the FDA.  Because the “potential value of the discovery is outweighed by its burdensomeness,” the Court denied the motion for a more complete response. Id. at 2.

As to the interrogatory seeking information regarding when BI first became aware of the patents-in-suit, AbbVie argued that such information is relevant to showing inducement of infringement and to copying or design around.  The court disagreed on both points.  First, the Court noted that “a theory of inducement does not make sense in the first phase of a case involving ‘artificial infringement’ under the BPCIA.”  Order at 2.  Because the BPCIA “encourages” biosimilar applicants to take the steps that trigger “artificial infringement” (i.e., an aBLA filing), the Court held that AbbVie’s inducement theory did not support compelling the discovery at this time.  The Court also noted that BI had not given notice of intent to commercially market its product. Id.  As to copying or design around, the Court held that the development of the biosimilar predated the issuance of the patents in suit, rendering evidence of copying or designing around the patents “remote.”  Id. at 3.  Accordingly, the court held that the discovery sought was disproportionately burdensome in view of its potential value in the case and denied AbbVie’s request.