USA Law and Practice Contributed by: Rob Cerwinski, Michael Johnson, Heather M Schneider and Michael B Cottler, Gemini Law LLP
6. Other IP Rights 6.1 Trade Marks
7.2 Appeal Court(s) Arbiter The Federal Circuit has nationwide and exclusive juris ‑ diction in a variety of subject areas, including patents, trade marks, and international trade. This means that the Federal Circuit handles all federal district court appeals regarding patent cases. The Federal Circuit also reviews certain administrative agency decisions, including those from the Patent Trial and Appeal Board (PTAB), the Trademark Trial and Appeal Board (TTAB) and the ITC. The Federal Circuit’s work begins after the Clerk’s Office dockets a new appeal or petition and assigns a docket number. The parties to the cases prepare and file written briefs to present their arguments. The appeal is then randomly assigned to a panel compris ‑ ing three randomly selected judges. There may be oral arguments, in which each side is typically allotted 15 minutes for argument. Parties may seek review of a Federal Circuit decision in the US Supreme Court. 7.3 Special Provisions US district courts generally have broad discretion to manage their docket. Many district courts have local rules, including specific patent rules that govern the parties’ infringement and invalidity contentions, initial document production, claim construction, and oth ‑ er issues. In New Jersey, for example, the rules are reversed in Hatch-Waxman cases so that the Para ‑ graph IV filer presents its contentions first. L Pat R 3.6. 8. Other Relevant Forums/Procedures 8.1 The UPC or Other Forums Aside from US district courts, the most popular forum for pharmaceutical disputes has been the PTAB, which has heard many IPR petitions on pharmaceuti ‑ cal patents. However, since the middle of 2025 the Acting Director and current Director of the USPTO have denied more petitions for discretionary reasons than in the past, particularly if the patent owner has “settled expectations” that its patent has been in existence long enough that it is not likely to be chal ‑ lenged. Some have argued that this “settled expecta ‑ tions” doctrine is not appropriate for Hatch-Waxman and BPCIA cases because a party has no incentive to
Trade mark disputes are not unheard of in the pharma ‑ ceutical industry. The core legal framework for trade mark disputes is the Lanham Act, but pharmaceutical product names are also regulated by the FDA. Phar ‑ maceutical companies often trade mark their prod ‑ uct names, logos, and trade dress, as well as non- functional aspects of product packaging and devices. Trade marks are occasionally asserted alongside pat ‑ ents. See Glaxo Group Limited, et al. v Transpire Bio Inc. , No. 25-cv-61939 (S.D. Fla. 25 September 2025). 6.2 Copyright Copyright claims are not common in pharmaceutical cases. The Second Circuit Court of Appeals held that an ANDA filer cannot be liable for copyright infringe ‑ ment related to the reference product label because the Hatch-Waxman Act requires generic drug produc ‑ ers to use the same labelling. See SmithKline Bee- cham Consumer Healthcare, LP v Watson Pharms, Inc , 211 F.3d 21, 23 (2d Cir. 2000)). 6.3 Trade Secrets Trade secrets allegations have been raised in the pharmaceutical industry, particularly where employ ‑ ees have moved from one company to a competitor. For example, Amgen sued Coherus alleging a “mas ‑ sive conspiracy” of former employees who tried to “steal Amgen’s trade secrets and siphon off its talent” related to Amgen’s Neulasta product. The case later settled. See Amgen Inc. et al. v Coherus Biosciences Inc. et al. , California Superior Court, County of Ventura (3 March 2017).
7. Appeal 7.1 Timeframe to Appeal Decision
In federal court litigation between private parties, an appeal must be filed within 30 days after entry of the order or judgment being appealed from. Fed R App Proc 4 (a)(1). A patent holder obtaining a preliminary injunction is required to provide a bond in case the decision is reversed on appeal. FRCP 65 (c).
268 CHAMBERS.COM
Powered by FlippingBook