USA Law and Practice Contributed by: Jim Hurst, Jeanna Wacker, Sam Kwon and Ashley Ross, Kirkland & Ellis
decisions take on average four months in the District of Delaware, 2.7 months in the Northern District of California, and 3.7 months in the East - ern District of Texas. When an injunction is requested also depends on the type of action. Given that the “irrepara - ble harm” factor considers the immediacy of the harm, PIs in ANDA actions are often filed after the expiration of the 30-month stay and approval of the accused product if there is evidence of potential imminent launch by the generic chal - lenger. aBLA applicants must provide notice to the sponsor 180 days before commercial market - ing begins, but this notice may be provided after filing an aBLA — even before the applicant receives FDA approval to license its biosimilar (Sandoz Inc v Amgen Inc, 137 S Ct 1664, 1677 (2017)). However, this notice alone may not be sufficient to establish “immediacy” in harm. See Genentech, Inc v Amgen Inc, 2019 WL 3290167 at *2–3 (D Del 18 July 2019). Unlike Hatch-Waxman actions, BPCIA actions involve different phases. The first phase ensues if the biosimilar applicant initiates the “patent dance” – ie, a statutory system established to facilitate information exchange between the applicant and patent owner before an action starts (42 USC Section 262(l)(2)). During the patent dance, parties identify which patents will be litigated as part of the first phase and which patents will be subject to dispute in the second phase in accordance with 42 USC Section 262(l) (3). The second phase starts after the reference product sponsor (RPS) receives the 180-day notice; at this point, the RPS can seek a PI to prohibit the manufacture or sale of the biosimi - lar (42 USC Section 262(l)(8)(B)). The RPS may assert any patents identified in the patent dance.
However, if a PI is not granted at this time, the biosimilar can launch during litigation. Protective letters are not filed in the US. 1.4 Structure of Main Proceedings on Infringement/Validity In the US, infringement and validity proceedings are generally not bifurcated, and they tend to be handled together. Sometimes, the issue of dam - ages may be handled separately – either upon application or by sua sponte order of a court. It is possible to file patent actions while the Pat - ent Office is conducting IPR. It is also possible to file for an IPR during the pendency of district court proceedings on patents. The cancellation of patents by IPR will render moot the parallel district court action (Dragon Intell Prop, LLC v Dish Network LLC, 956 F.3d 1358, 1361 (Fed Cir 2020)). As a result, district court cases are often – although not always – stayed if there is a parallel IPR proceeding. 1.5 Timing for Main Proceedings on Infringement/Validity In 2017, the Supreme Court made it more dif - ficult to maintain a laches defence in patent infringement cases (SCA Hygiene Prods Aktie - bolag v First Quality Baby Prods, LLC, 137 S Ct 954 (2017)). However, pursuant to 35 USC Sec - tion 286, a patentee may generally only reach back six years prior to the filing of the complaint for infringement damages. Parties in patent proceedings are notified of the action by service. Service is governed by Fed - eral Rules of Civil Procedure (FRCP) 4 and 5, as well as local rules of the district in which the case is filed.
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