Navigating Protective Order and Prosecution Bar Issues in BPCIA Litigation
Protective orders preventing litigation counsel from participating in the prosecution of litigation-related patents are commonplace. The Biologics Price Competition and Innovation Act (“BPCIA”), for example, provides a default protective order for the pre-litigation exchange of confidential information between the brand company and biosimilar applicant “provided that such attorneys [with access to the confidential information] do not engage, formally or informally, in patent prosecution relevant or related to the reference product.” 42 U.S.C. § 262(l)(1)(B).
Prosecution bars are intended to prevent the use of confidential information obtained for litigation to strategically amend patent claims. Versata Software, Inc. v. Callidus Software Inc., 2014 U.S. Dist. LEXIS 40469 (D. Del. Mar. 12, 2014) (“[T]he Federal Circuit has recognized that ‘strategically amending or surrendering claim scope during prosecution’ can implicate competitive decision-making…thus giving rise to a risk of inadvertent use of confidential information learned in litigation.”). These restrictions, however, could prejudice brand companies in light of the increasing trend among generic and biosimilar applicants to file IPR proceedings on the same patents that are at issue in litigation. Particularly where litigation counsel for the biosimilar applicant is leading both the litigation and the IPR attacks on the branded product patents, the brand company may be at a severe disadvantage if its litigation counsel is not permitted to defend patents involving the same issues and prior art raised in litigation.
The Federal Circuit recognized the potential problems associated with prosecution bars in In re Deutsche Bank Trust Co. Ams., 605 F.3d 1373, 1381 (Fed. Cir. 2010), and counseled courts to address these competing concerns. The Court explained that “denying access to [a party's] outside counsel on the ground that they also prosecute patents for [that party] is the type of generalization counseled against….The facts, not the category must inform the result.” 605 F.3d at 1379 (internal citation omitted).
In keeping with the Federal Circuit’s decision in Deutsche Bank, district courts in recent cases have been liberal in allowing trial counsel to be involved in IPR proceedings, post-grant proceedings, and reexaminations. See, e.g., Endo Pharmaceuticals Inc. v. Amneal Pharms Inc., et al., No. 1:12-cv-08115-TPG-GWG (S.D.N.Y. Aug. 13, 2014) at *25 (“Amneal’s protective order, which states that Dechert may not become ‘involved in prosecution of patent applications,’ does not bar Dechert from participating in the inter partes review proceedings.”); Accord Affinity Labs of Tex., LLC v. Samsung Elecs. Co., 2013 U.S. Dist. LEXIS 188485 (E.D. Tex.Nov. 18, 2013) (similarly limiting prosecution bar to permit litigation counsel to participate in post-grant proceedings); John v. Lattice Semiconductor Corporation, No. C 12-04384 PSG (N.D. Cal. May 7, 2013) at *6-7 (permitting plaintiff’s counsel to participate in re-examination proceedings “where, as here, reexamination or review proceedings are really nothing more than an extension of the litigation in the district court….[I]f the PTO and district court are just two fronts in the same battle, allowing a limited role for a patentee's litigation counsel while prohibiting counsel from crafting or amending claims is reasonable.”); Grobler v. Apple Inc., 2013 U.S. Dist. LEXIS 65048 (N.D. Cal. May 7, 2013), at *5 (“a limited rather than complete bar on litigation counsel's reexamination and review activities…strikes the right balance.”); EPL Holdings, LLC v. Apple Inc., 2013 U.S. Dist. LEXIS 71301, 9-10 (N.D. Cal. May 20, 2013), at *9-10 (“The Court concludes that [ ] litigation counsel…may participate in third-party initiated review proceedings so long as counsel is prohibited from assisting in any crafting or amendment of patent claims.”).
Exercising care in negotiating protective orders is crucial to ensure the sound resolution of protective order issues. Moreover, to spare both parties and courts from burdensome motion practice, counsel representing brand companies should try to negotiate prosecution bars that permit litigation counsel to be involved in IPRs, PGRs and reexaminations. This is consistent with a recent decision by the Patent Trial and Appeal Board (“PTAB”) that held that an IPR “is a trial, adjudicatory in nature and constitutes litigation.” Google Inc. v. Jongerius Panoramic Techs., LLC, No. IPR2013-00191, Paper No. 50, at 4 (P.T.A.B. Feb. 13, 2014).