Back in June, the United States Food and Drug Administration (FDA), “as part of an Agency-wide effort to modernize the Orange Book,” published a request for comments relating to patent listing. Apparently prompting this request was FDA’s recognition that New Drug Application Sponsors have “submitted patents for listing in the Orange Book, including certain types of device-related patents and REMS-related patents, for which there may be uncertainty regarding whether these are in fact the type of patents that must be submitted.”

Accordingly, FDA has sought comments relating to:

1. “the listing of patents that claim a device constituent part of a combination product approved under section 505 of the FD&C Act (e.g., a drug delivery device);

2. the listing of patents that claim a device whose use is referenced in approved drug labeling;

3. the listing of patents associated with an established Risk Evaluation and Mitigation Strategies (REMS); and

4. the listing of patents associated with digital applications (e.g., clinical decision support software, software as a medical device).”

In fact, FDA posed fourteen specific questions.

Comments were due on August 31^st.  Unsurprisingly, many of the usual suspects weighed in: the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Innovation Organization (BIO), the Intellectual Property Owners Association (IPO), the Knowledge Ecology International (KEI), Mylan, Teva, Sanofi, and Novo Nordisk.

The lines drawn were also largely as expected. Mylan, for instance, sought to limit the patents listed, asking FDA (1) to “not accept or list patents that claim one or more elements of a REMS” and (2)  to “accept device patents for listing only if the device component claimed in the patent: (a) is integral to the drug’s safety and effectiveness, (b) is available only as a single entity with the drug component; and (c) is reviewed and approved as part of the same NDA.”

PhRMA, meanwhile, took a more expansive approach, asking FDA to clarify that patents claiming the device constituent of a drug-device combination product approved as an NDA are subject to Orange Book listing requirements. PhRMA also urged that, consistent with the FDA’s “ministerial role in patent listing matters,” patents relating to REMS programs should not be excluded from listing. Finally, PhRMA recommended that “FDA consider patent listing policy issues for digital health technologies after further development of the regulatory framework for these products.”

The question regarding the listing of device patents has been murky at best. FDA has generally punted when asked about the listing of device patents, refusing multiple times to provide advisory opinions. See, for example, FDA’s response to Forest’s request regarding whether a patent that claims a drug delivery device “whose use is integral to the administration of the active ingredient and the approval of the NDA” should be listed in the Orange Book.^[1] Indeed, the First Circuit recently felt compelled to jump into the fray, holding in February that “Sanofi improperly submitted a patent [claiming the drive mechanism for an insulin injector pen] for listing in the Orange Book.” The First Circuit reversed the dismissal of the antitrust claim and remanded to the district court.^[2]

REMS programs in general have also garnered attention over recent years. Part of that attention has centered around listingin the Orange Book, a practice that at least one commentator, Michael Carrier, a distinguished Professor at Rutgers Law School, has vocally opposed for years.

FDA last updated its regulations regarding Orange Book listings in 2016 when it issued final regulations implementing the Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.^[3] But given the FDA’s new Drug Price Competition Action Plan, which specifically targets supposed “gaming” of FDA’s rules, including REMS, expect these comments to lead to rulemaking.

[1] See also, Request for Advisory Opinion by Novo Nordisk Inc., Docket No. FDA-2012-A-1169 (Nov. 26, 2012); Request for Advisory Opinion by AstraZeneca, Docket No. FDA-2007-A-0099 (June 21, 2007); Request for Advisory Opinion by AstraZeneca, Docket No. FDA-2006-A-0063 (Aug. 10, 2006); Request for Advisory Opinion by GlaxoSmithKline, Docket No. FDA-2011-A-0363 (Jan. 10, 2005).

[2] In re Lantus Direct Purchaser Antitrust Litig., 18-2086, 2020 WL 728628 (1st Cir. Feb. 13, 2020).

[3] “Abbreviated New Drug Applications and 505(b)(2) Applications; Final Rule,” 81 Fed. Reg. 69580 (October 6, 2016).