USA Law and Practice Contributed by: Rob Cerwinski, Michael Johnson, Heather M Schneider and Michael B Cottler, Gemini Law LLP
In Hatch-Waxman and Biologics Price Competition and Innovation Act (BPCIA) litigations, patentees are required under 35 USC 271 (e)(2) to sue at least the party that submits the ANDA or aBLA, respectively, because it is the submission that can constitute an artificial act of infringement. In at least one litigation, however, a district court adopted an expansive defini ‑ tion of what it meant to submit an application and per ‑ mitted a patentee to bring infringement claims against a foreign parent company where the US subsidiary, not the parent, was the named sponsor of the aBLA. See AbbVie Inc. v Alvotech hf. , No 1:21-cv-02258, Doc. 51 (N.D. Ill. 23 August 2021). Referring to an ear ‑ lier Federal Circuit case, the district court stated that an entity “submits” a regulatory file where it “intends to benefit directly” from approval and “by participat ‑ ing in the manufacture, importation, distribution and/ or sale” of the drug product. Unless it impacts a patentee’s preference for venue, a patentee may also sue other affiliates/parties involved in the development, submission, and/or commerciali ‑ sation of the accused drug product. Often the paten ‑ tee will stipulate to dismissal of the dispensable par ‑ ties in exchange for an agreement that they will be bound by the outcome of the case and co-operate with discovery. Whether any other entities will be sued is fact-depend ‑ ent, but rare. In one instance, an insurance company was sued for inducing infringement of a method of treatment patent that had been allegedly carved out from the generic applicant’s product. Those infringe ‑ ment allegations survived a motion to dismiss. Amarin Pharma, Inc. v Hikma Pharms. USA Inc. , 578 F. Supp. 3d 642 (D. Del. 2022). Third parties who supply components of a drug prod ‑ uct or manufacturing services are less likely to be sued but may be the subject of subpoenas for discov ‑ ery. See In Re Subpoena to FujiFilm Irvine Scientific , Civil No 24-8830 (CPO/EAP) (ECF No 18). Distribu ‑ tors (apart from commercial partners) and doctors are rarely sued in typical Hatch-Waxman or BPCIA cases. 1.3 Preliminary Injunction Proceedings Preliminary injunctions (PIs) are available in life sci ‑ ences patent cases in district court. PIs are ordered
if a four-factor test is met, where the plaintiff must establish: • it is likely to succeed on the merits on a granted patent; • it is likely to suffer irreparable harm in the absence of relief; • the balance of equities tips in the plaintiff’s favour; and • an injunction is in the public interest. Winter v Natural Resources Defense Council , Inc, 555 U.S. 7 (2008). The Court may deny relief if the plaintiff fails to prove any one of the four factors, especially either of the first two. See, eg, Jack Guttman, Inc. v KopyKake Enters., Inc. , 302 F.3d 1352, 1356 (Fed. Cir. 2002). A PI, if granted, will enjoin allegedly infringing activi ‑ ties, eg, sales of the defendant’s products, until patent expiration or a district court decision on the merits. Ex parte preliminary injunctions are not available. The defendant always has an opportunity to oppose a request for a PI. A temporary restraining order (TRO) may also be avail ‑ able and can be requested ex parte. The standards for granting TROs and PIs are generally the same, but TROs are more limited in time, as they only last for a short, specified period and are a first-line, emergency relief that a patentee may seek if infringement/harm is imminent. Demonstrating irreparable harm entails showing a likelihood of substantial and immediate irreparable injury. Apple, Inc. v Samsung Elecs. Co. , 678 F.3d 1314, 1325 (Fed. Cir. 2012). In general, demonstrat ‑ ing irreparable harm is more straightforward where the defendant is directly taking, and the only party directly taking, market share away from the paten ‑ tee. See, eg, Abbott Labs. v Sandoz , 544 F.3d 1341, 1361-62 (Fed Cir 2008). Additionally, although there is no true deadline for seeking a PI, where a patentee fails to show urgency and delays seeking a PI once a launch is imminent or infringement is recently dis ‑ covered, that weighs in favour of denying the request for the PI. See, eg, Pfizer, Inc. v Teva Pharms. , USA, Inc. , 429 F.3d 1364, 1382 (Fed. Cir. 2005); Genentech,
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