USA Trends and Developments Contributed by: Ed Haug, Andrew Wasson and Wan Chieh (Jenny) Lee, Haug Partners LLP
product (formulation and composition) patents are properly listable, while methods of manufac - ture and process patents are not properly lista - ble. Then, after prompting from the FTC in 2002, the FDA further determined that polymorph and product-by-process patents are properly lista - ble, but patents claiming packaging, metabolites and intermediates are not. While the FDA was able to describe several bas - kets of properly listable patents, it soon found that the line between “packaging” and some types of complex pharmaceutical products was harder to draw. For example, industry urged the FDA to clarify whether patents claiming device components of drug–device combination prod - ucts like pre-filled syringes and metred dose inhalers were properly listable. Proponents of listability of device patents for these complex products contended that devices were not pack - aging – rather they were integral to the approved dosage form. Responding to these comments in 2003, the FDA declined to categorically exclude patents covering devices. Rather, pointing to the Orange Book appendix that lists approved dos - age forms, such as metred aerosols and pre- filled drug delivery systems, the FDA found that the key factor was whether the patent claims the finished dosage form. But the FDA’s 2003 comments were largely its last words on the issue. Seeking additional clar - ity, a number of innovators asked the FDA to provide advisory opinions about whether cer - tain categories of device patents were listable. In particular, among other related issues, inno - vators asked the FDA to clarify whether it was necessary for a patent to specifically claim or mention the active ingredient in the drug prod - uct. The FDA has not responded, however, and has not otherwise provided guidance to industry on this issue.
While the Agency has remained silent, the issue of whether patents are properly listed in the Orange Book more recently has started falling in the lap of courts. In 2020, the issue of whether a patent claiming “a drive mechanism in a drug delivery device” was properly listed for Sanofi’s Lanus (insulin glargine) SoloSTAR product was determined by the First Circuit in the context of an antitrust litigation (In re Lantus Direct Pur - chaser Antitrust Litig., 950 F.3d 1 (1st Cir 2020)). In the Lantus case, antitrust plaintiffs contend - ed that the alleged improper listing of the drive mechanism patent was anticompetitive conduct. The district court dismissed the complaint, but the First Circuit reversed the dismissal, finding that the patent-at-issue did not meet the listing criteria. The First Circuit commented that the patent did not claim, let alone mention, Lantus SoloSTAR or insulin glargine. Consistent with the FDA’s 2003 comments, the First Circuit distin - guished between a component in a device (like a drive mechanism) and the finished product itself (for example, the injector pen). Notwithstanding the FDA’s silence, the Federal Trade Commission has again turned up the heat on innovators, starting with its September 2023 policy statement. In the FTC’s policy statement, it announced that it would scrutinise improper Orange Book listings and warned that improper listing could give rise to civil and criminal liabil - ity. But critically, the FTC did not articulate the standards for proper listing in its policy state - ment. Soon thereafter, the FTC issued two sets of challenges (November 2023 and April 2024) identifying specific innovators, products and patents that the FTC alleged were improperly listed. Simultaneously with these challenges, the FTC also initiated the FDA’s patent information dispute pathway for the patents. In response to the FTC’s challenges, some innovators voluntar - ily delisted the challenged patents.
363 CHAMBERS.COM
Powered by FlippingBook