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Protective Agreements Before and During BPCIA Litigation: Prosecution and Regulatory Bars

April 7, 2017

Protective Agreements Before and During BPCIA Litigation: Prosecution and Regulatory Bars

April 7, 2017

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Protective orders that regulate the disclosure and use of confidential information exchanged during patent litigations are commonplace.  However, the patent dispute resolution procedures under the Biologics Price Competition and Innovation Act (“BPCIA”), i.e., the patent dance, provide for exchange of confidential information between the biosimilar applicant and the reference product sponsor (“RPS”) before the parties engage in patent litigation.  In particular, the patent dance starts when the biosimilar applicant shares its biosimilar application and other information with the RPS.  42 U.S.C. § 262(l)(2).  To regulate the use and disclosure of such pre-litigation exchange of confidential information, the BPCIA provides a default protective order, § 262(l)(1), which remains in effect until a court enters a protective order in a patent infringement case between the BPCIA parties.  § 262(l)(1)(F).  As discussed below, the BPCIA default provisions leave room for significant negotiation regarding the scope of the protections that the parties wish to implement before and during litigation.

The Default Protections

Under the BPCIA, the RPS cannot use the biosimilar applicant’s confidential information for any purpose other than “determining, with respect to each patent [], whether a claim of patent infringement could reasonably be asserted” against the biosimilar applicant.  § 262(l)(1)(D).  The BPCIA also provides a “prosecution bar” that prevents the recipients of confidential information, i.e., one or more attorneys designated by the RPS as outside counsel, and one attorney who is in-house counsel for the RPS, from “engag[ing], formally or informally, in patent prosecution” relevant to the reference product.  § 262(l)(1)(B).  Prosecution bars are intended to prevent the use of confidential information obtained for litigation, or the BPICA patent dance, to strategically amend patent claims.

The BPCIA parties are free to negotiate a different protective order agreements covering additional individuals, information, and/or contingencies.  § 262(l)(1)(A).  In practice, the biosimilar applicant may want to introduce additional protections to the BPCIA default protective order, while the RPS may seek to narrow the scope of protection.  The sparsity of the BPCIA default protective order provides ample room for such negotiations.

Disputes over the scope of protections during the BPCIA litigation have already arisen in litigations pending in various district courts, proving that the parties often have very different approaches to confidentiality issues.  Familiarity with these various approaches enables BPCIA parties to engage in a more comprehensive negotiation over the scope of pre-litigation protections, minimizing the risk of undesired disclosure and future disputes.

Prosecution Bars

Prosecution bars have become an essential component of BPCIA pre-litigation protective agreements and protective orders in effect during litigation. Although the BPCIA implements a “prosecution bar,” parties may be able to negotiate the contours of the bar given the ambiguity surrounding the scope of “patent prosecution.”  For example, in Amgen Inc., et al. v. Sandoz Inc., et al., the parties disputed the scope of the prosecution bar to be incorporated in the protective order. Case No. 14-Civ-4741, ECF No. 48, at 5 (N.D. Cal.). The parties agreed “prosecution” included directly or indirectly drafting, amending, advising, or otherwise affecting the scope or maintenance of patent claims, including in an action defending a patent before a foreign or domestic agency.  Id.   The parties also agreed that “prosecution” did not include representing a party challenging a patent before a domestic or foreign agency, such as inter partes reexamination.  Id.  Amgen and Sandoz, however, disagreed as to whether “prosecution” included representing a party defending a patent before such an agency.

Under Sandoz’s proposal, which was adopted from the district court’s Model Order, “prosecution” did include representing a party defending a patent before a domestic or foreign agency.  Id. at 9.  Amgen, on the other hand, proposed that “prosecution” did not include a party defending a patent before a domestic or foreign agency, so long as that representation did not include the drafting or amendment of claims.  Id. at 5-6.  Amgen argued that the prosecution bar should be reciprocal in the sense that, if Sandoz’s counsel is permitted to participate in an inter partes reexamination proceeding challenging Amgen’s patents, Amgen’s counsel should be allowed to defend Amgen’s patents.  Id. at 6.  Sandoz responded that this reciprocity argument was based on a false assumption that Amgen and Sandoz have an equal ability to revise claims in such proceedings—yet a party “defending” a patent in an inter partes reexamination proceeding is allowed to amend patent claims and/or draft new claims, whereas a party challenging a patent in those proceedings cannot.  Id. at 9-10.  Sandoz also argued that Amgen’s proposal that its designated in-house counsel would refrain from participation in any claim drafting or amendments was unworkable in practice.  Id. at 10.  Amgen could not convince Sandoz, or the court, to deviate from the court’s Model Order, and thus, Sandoz’s proposal was adopted and included in the protective order entered by the court.  ECF. No. 60 ¶ 8.1.  While the court here sided with Sandoz, other courts, in the context of Hatch-Waxman litigation, have held that the prosecution bar did not include representing a party in a post-grant proceeding, either challenging or defending a patent.  See, e.g., Endo Pharma, Inc. v. Actavis Inc., Case No. 1:12-civ-08060, ECF No. 77 (S.D.N.Y. Aug. 13, 2014).  

The BPCIA parties can also negotiate the duration of the prosecution bar based on the circumstances of the case at hand.  For BPCIA protective orders, for example, the parties may agree that the prosecution bar would expire upon final disposition of the case, Amgen v. Sandoz, ECF No. 48, at 12 (Amgen’s proposal), one year after the final disposition of the case, AbbVie Inc., et. al. v. Amgen Inc., et al., Case No. 16-Civ-666, ECF No. 43 ¶ 37 (D. Del.) (protective order entered by the court), or two years after final disposition of the case.  Amgen v. Sandoz, ECF No. 60 ¶ 8.3 (protective order entered by the court).

Regulatory Bars

The BPCIA default protective order is silent with regard to whether recipients of confidential information are barred from substantive involvement in communications with the Food and Drug Administration (“FDA”), but a BPCIA party may wish to add an explicit regulatory bar to the pre-litigation protective agreement and/or to the protective order in effect during the litigation.  For example, in AbbVie v. Amgen, the parties disagreed whether the protective order in effect during the litigation should include an explicit regulatory bar.  Amgen, the biosimilar applicant, proposed that persons exposed to confidential information be barred from any substantive involvement in citizen petitions to the FDA involving adalimumab, the reference product.  ECF No. 36 ¶ 36.  Amgen argued that this regulatory bar was necessary to protect Amgen’s sensitive information because “unlike typical FDA submissions seeking approval to market products, a citizen petition can target a competitor’s product or seek to affect the FDA regulations concerning the competitor,” and that a person advising AbbVie on the timing or subjects of future citizen petitions cannot reasonably “compartmentalize” Amgen’s sensitive information.  ECF No. 38.

AbbVie opposed this regulatory bar as excessive, arguing the agreed-upon provisions of the order barred the use of confidential information for any purpose other than “this Litigation and future United States patent infringement litigation between the Parties,” and expressly prohibited using confidential information for purposes of “any petitioning, counseling, litigation, or other work involving the [FDA].”  ECF No. 36 ¶ 27.  Amgen’s argument did not prevail as its proposal was not adopted in the protective order entered by the court.  ECF No. 43.  It is worth noting that the same court declined to include a similar regulatory bar in the proposed protective order in a Hatch-Waxman litigation, finding that other provisions in the protective order governed the use of litigation-generated information in FDA correspondence.  See Cephalon Inc. v. Impax Laboratories Inc., Case No. 1:11-Civ-1152, ECF No. 105 (D. Del.); see also In re Impax Labs., Inc., 495 F. App’x 82, 84 (Fed. Cir. 2012) (denying petition for writ of mandamus to direct the district court to vacate its order declining to enter a protective order with an FDA bar).

The duration of a regulatory bar is another issue that the parties should consider.  The regulatory bar duration was a point of dispute between the parties in Amgen v. Sandoz. While negotiating the protective order covering the exchange of information during the litigation, the reference product sponsor, Amgen, proposed that the regulatory bar should expire upon final disposition of the case.  ECF No. 48, at 12.  Sandoz, on the other hand, proposed that the regulatory bar should expire one year after the final disposition of the case.  Id.  Sandoz’s proposal was adopted in the protective order entered by the court.  ECF No. 60 ¶ 8.3.


The sparse provisions of the BPCIA default protective order addressing the issues of prosecution and regulatory bars leave ample room for the parties to set the scope of the pre-litigation protective agreement and the protective order in effect during the litigation according to the circumstances of the case at hand.  Prosecution and regulatory bars should be considered in addition to other issues we have discussed previously, e.g., how many tiers of confidentiality should be designed and who may access confidential documents within each tier.  The BPCIA parties can navigate these negotiations using the Federal Circuit’s guidance—a party seeking to impose a bar has the burden to show the proposed bar reasonably reflects the risk presented by the disclosure of proprietary competitive information.  See In re Deutsche Bank Trust Co. Americas, 605 F.3d 1373, 1381 (Fed. Cir. 2010) (addressing prosecution bar).  Similarly, the party seeking an exemption from a bar must show that counsel’s participation in the barred activity does not and is not likely to implicate competitive decision-making related to the subject matter of the litigation, and that the potential injury to the moving party from restrictions imposed on its choice of counsel outweighs the potential injury to the opposing party caused by an inadvertent use of confidential information.  See id.  Therefore, the party proposing to expand or limit the scope of the BPCIA default protective order provisions, or a district court’s Model Order provisions, for protections in effect before and during litigation, should be ready to justify its position based on the unique facts of the case.    

Authors: Tasha Francis, Ph.D., Jenny Shmuel, Noorossadat Torabi, Ph.D.


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.

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Jenny Shmuel, Ph.D. | Principal

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...