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...