USA Law and Practice Contributed by: Rob Cerwinski, Michael Johnson, Heather M Schneider and Michael B Cottler, Gemini Law LLP
286. A patent holder does not have to sue as soon as a patent issues or infringement is expected, although if the patent holder waits too long, the defence of lach ‑ es may come into play. Laches cannot bar a claim for damages if it is brought within the time period set by 35 USC 286. SCA Hygiene Prods Aktiebolag v First Quality Baby Prods , LLC, 137 S. Ct. 954, 121 USP.Q. 2d 1873 (2017). Parties in patent proceedings are notified of the action by service. Service is governed by FRCP 4 and 5, as well as local rules of the district in which the case is filed. Under FRCP 4 (m), a defendant must be served within 90 days after the complaint is filed, and the remainder of the deadlines in the case do not run until service is effected. A party can waive formal service in return for an automatic extension of the deadline to answer the complaint. FRCP 4 (d). The usual time to a final decision varies greatly by district and the nature of the case. The median time to trial can range from just over a year in some of the faster “rocket dockets” (E.D. Va.) to three to four years in other district courts. 1.6 Requirements to Bring Infringement Action Patent infringement suits can only be based on granted patents, not pending patent applications or allowed applications soon to grant. For a plaintiff to file a patent infringement suit, it must have standing, as discussed in 1.1 Claimants/Plaintiffs to an Action . Absent the specialised regulatory frameworks govern ‑ ing small molecules and biologics, the filing of a regu ‑ latory file would not constitute patent infringement. See 35 USC 271 (a) (infringing acts include making, using, offering to sell, selling, or importing a patented invention within the United States without authority to do so). The Hatch-Waxman Act and BPCIA enable plaintiffs to bring infringement actions at certain points in the ANDA or aBLA regulatory process even if the applicant has not yet committed an act that would traditionally constitute patent infringement. The filing of an ANDA or aBLA in these contexts qualifies as an “artificial” act of infringement under 35 USC 271 (e).
Under the Hatch-Waxman Act, to file suit based on an ANDA filing, the plaintiff must have received notice of a Paragraph IV certification from the ANDA filer, asserting that one or more patents listed in the FDA’s Approved Drug Products with Therapeutic Equiva ‑ lence Evaluations (the “Orange Book”) are invalid, unenforceable, and/or not infringed. The only patents that can be listed in the Orange Book are those that claim the drug substance (or active ingredient), the drug product (or the drug formulation), or an approved method of treatment using the drug substance or product. Patents for processes, packaging, metabo ‑ lites, intermediates, or devices that do not otherwise claim the active ingredient cannot be listed. Courts may allow patentees to assert non-listed Orange Book patents once a litigation has commenced, but those patents cannot be the basis for automatic stays of FDA approval. Under the BPCIA, to file suit based on an aBLA filing, at least one of the following acts must have occurred: (i) the aBLA filer provided an NCM (see 1.3 Preliminary Injunction Proceedings ), (ii) the parties completed the patent dance, or (iii) the aBLA filer opted out of the patent dance. There are no limits to the types of patents that can form the basis of a BPCIA patent infringement action. In fact, the vast majority of pat ‑ ents asserted in BPCIA cases are process patents. Generally, to maintain an action for patent infringe ‑ ment based on a process patent, the patentee must show that the process is performed in the United States under 35 USC 271 (a) or that the product of the patented process is sold in, or imported into, the United States under 35 USC 271 (g) unless the prod ‑ uct of the patented process was “materially changed” prior to importation or becomes a “trivial and nones ‑ sential component” of the product being imported. 1.7 Pre-Action Discovery/Disclosure There is generally no pre-action discovery for patent infringement cases in the United States except for pre-action information exchanges in Hatch-Waxman and BPCIA cases. Under the Hatch-Waxman Act, if the ANDA filer is relying on non-infringement posi ‑ tions in its Notice Letter, it must include an Offer of Confidential Access to produce at least relevant por ‑ tions of the ANDA. If the parties agree on the terms
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