In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November 7, 2023, challenges to more than 100 patent listings by brand drug manufacturers in the Food and Drug Administration’s (FDA) Orange Book. The challenges implicate 62 unique patents and 18 FDA-approved products. In letters sent by the FTC to certain brand drug manufacturers, specific patents directed to drug delivery devices are alleged to be improperly or inaccurately listed in the Orange Book.[1] Under FDA’s regulatory dispute process, recipients of the letters have 30 days to confirm the correctness of the patent information or withdraw or amend the patent information.[2] In a recent interview, a senior FTC official stated that “[t]he lists we identified in those letters weren’t exhaustive” and promised that the FTC is “continuing to review a wide array of patent listings.”[3]

The November 7 letters follow a policy announcement from November 2022, in which the FTC articulated a new, more expansive view of its enforcement authority under Section 5 of the FTC Act.[4] At the time, the FTC stated that it would pursue more “rigorous enforcement” against unfair methods of competition across a broader range of conduct. (For more examples and analysis of the FTC’s new stance on Section 5 across a range of industries, see these prior MoFo Client Alerts.)[5]

The FTC began to wade into Orange Book patents with a Statement Concerning Brand Drug Manufacturers’ Improper Listing of Patents in the Orange Book (“September Policy Statement”) issued on September 14, 2023.[6] In the September Policy Statement, the FTC expressed concerns about the potential anticompetitive effects of improper Orange Book patent listings. The FTC further stated that it intended to take action against companies and individuals that improperly list patents in the Orange Book that do not meet the statutory listing criteria.

The September Policy Statement indicates that improper listing may be deemed an “improper means” of competition, citing recent decisions from the First Circuit and the Second Circuit. In In re Lantus Direct Purchaser Antitrust Litig., the First Circuit found a device patent covering an injector pen drive mechanism was improperly listed in the Orange Book because the patent did not claim insulin glargine, the drug in Lantus’s Solostar product.[7] In United Food & Com. Workers Local 1776 v. Takeda Pharm. Co., the Second Circuit found a combination patent did not meet the “Listing Requirement” under 21 U.S.C. § 355(b)(1) and was improperly listed in the Orange Book because a combination patent does not claim any of its component drug substances past their individual patent expiration dates.[8]

The listing of patents in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, known as the “Orange Book,” is a statutory mechanism under the Hatch-Waxman Act to put potential generic manufacturers on notice of patents that the brand drug manufacturer considers as covering the drug. Under 21 U.S.C. § 355, the brand manufacturers must submit for listing any patent that: (I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or (II) claims a method of using such drug for which approval is sought or has been granted in the application. FDA regulations further require that process patents, patents claiming packaging, patents claiming metabolites, and patents claiming intermediates must not be submitted to FDA.[9]

MoFo’s patent prosecution team independently reviewed the patents identified in the FTC letters and made the following findings:

• All are related to drug delivery devices, including liquid eye-drop dispensers, inhalers, and injectors.
• All are indicated in the Orange Book to cover a drug product.
• None of the patents have claims that recite the specific drug that is in the product, although a few of the patents include dependent claims that recite one or more classes of drugs.

Despite requests from stakeholders for clarity regarding drug-delivery device patents, FDA has provided no formal guidance on whether such patents can be listed in the Orange Book. Brand drug manufacturers have submitted numerous requests for Advisory Opinions from FDA explicitly asking for determinations that certain drug-delivery patents would be properly listed in the Orange Book and providing notifications to FDA that they would be listing these types of patents in the Orange Book.[10] These requests related to drug-delivery device patents were left pending for many years before FDA ultimately declined to offer clarity in June 2020, saying that the issue should be part of a broader review of the Orange Book.[11] When FDA denied the brand drug manufacturers’ requests, it issued a Federal Register notice “seeking comments on, among other things, the submission of patent information under section 505 of the FD&C Act[12] and the listing of such patent information in the Orange Book as it relates to 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).”[13]

Shortly after publication of the Federal Register notice, President Trump signed the Orange Book Transparency Act (OBTA) of 2020 (Pub. L. 116-290) into law in January 2021, pursuant to which FDA solicited public comments on, among other things, whether drug-delivery patents should be included in, or removed from, the Orange Book. In response to this directive, FDA reopened the comment period on its earlier request, receiving several comments focused on the drug-delivery device patent listing issue.[14] In a recent report to Congress, FDA stated that it “will create a multidisciplinary working group” to address these comments in line with the existing statutory requirements for patent listing in the FD&C Act.[15] To date, FDA has not published any further guidance on the appropriateness of listing drug-delivery device patents and has asserted for decades that it has a merely ministerial role in administering the Orange Book.

In contrast, these recent actions from FTC show it is willing to play a more assertive role in furtherance of the Biden administration’s priority to promote competition in the pharmaceutical industry and lower drug prices, consistent with the current FTC’s expansive view of its authority under Section 5 of the FTC Act.

We’ll be watching how FDA will respond now that the ball is in its court. Any company that wants to impact these proceedings should be coordinating with counsel quickly on how to have the biggest strategic impact.

[1] Letter from FTC to Abbvie Inc. re: Improper Orange Book-Listed Patents for Restasis Multidose (Nov. 7, 2023); Letter from FTC to AstraZeneca LP re: Improper Orange Book-Listed Patents for Symbicort (Nov. 7, 2023); Letter from FTC to Boehringer Ingelheim re: Improper Orange Book-Listed Patents for Atrovent HFA, Combivent Respimat, Spiriva, and Spiriva Respimat (Nov. 7, 2023); Letter from FTC to Glaxo Group Ltd. re: Improper Orange Book-Listed Patents for Advair HFA and Flovent HFA (Nov. 7, 2023); Letter from FTC to GlaxoSmithKline Intellectual Prop. Dev. Ltd. re: Improper Orange Book-Listed Patents for Arnuity Ellipta and Ventolin HFA (Nov. 7, 2023); Letter from FTC to Impax Laboratories LLC re: Improper Orange Book-Listed Patents for Adrenaclick (Nov. 7, 2023); Letter from FTC to Kaleo Inc. re: Improper Orange Book-Listed Patents for AUVI-Q (Nov. 7, 2023); Letter from FTC to Mylan Specialty LP re: Improper Orange Book-Listed Patents for EPIPEN and EPIPEN JR (Nov. 7, 2023); Letter from FTC to Norton (Waterford) Ltd. re: Improper Orange Book-Listed Patents for QVAR RediHaler (Nov. 7, 2023); Letter from FTC to Teva Branded Pharm. Products R&D, Inc. re: Improper Orange Book-Listed Patents for QVAR 40, ProAir HFA, ProAir DigiHaler (Nov. 7, 2023).

[2] 21 C.F.R. § 314.53(f)(1).

[3] Brenda Sandburg, FTC's Rahul Rao On Why Agency Targeted Drug-Device Orange Book Patents, pink sheet, Nov. 12, 2023.

[4] Policy Statement Regarding the Scope of Unfair Methods of Competition Under Section 5 of the Federal Trade Commission Act Commission File No. P221202.

[5] FTC Meeting Signals Aggressive and Novel Enforcement to Come; FTC Takes Unprecedented Enforcement Actions Against Non-Compete Restrictions.

[6] Federal Trade Commission, Statement Concerning Brand Drug Manufacturers’ Improper Listing of Patents in the Orange Book (Sept. 14, 2023), FTC Policy Statement Concerning Brand Drug Manufacturers' Improper Listing of Patents in Orange Book.

[7] In re Lantus Direct Purchaser Antitrust Litig., 950 F.3d 1, 7 (1st Cir. 2020).

[8] United Food & Com. Workers Local 1776 v. Takeda Pharm. Co., 11 F.4th 118, 134–136 (2d Cir. 2021).

[9] 21 C.F.R. § 314.53(b).

[10] GlaxoSmithKline Request for Advisory Opinion Concerning “Orange Book” Listing of Patents, Docket No. FDA-2005-A-0476 (Jan. 10, 2005); Ropes & Gray on behalf of AstraZeneca, Request for Advisory Opinion Concerning “Orange Book” Listing of Patents, Docket No. FDA-2006-A-0063 (Aug. 10, 2006); Ropes & Gray on behalf of AstraZeneca, Request for an Advisory Opinion–“Orange Book” Listings of Patents, Docket No. FDA-2007-A-0099 (June 21, 2007); Finnegan on behalf of Forest Laboratories, Inc., Request for Advisory Opinion Regarding Patents Listable in the Orange Book in connection with NDA No. 202-450, Docket No. FDA-2011-A-0363 (May 12, 2011); Novo Nordisk Inc., Request for Advisory Opinion, Docket No. FDA-2012-A-1169 (Nov. 26, 2012).

[11] FDA CDER Response to Request for Advisory Opinions re: Docket Nos. FDA-2005-A-0476, FDA-2006-A-0063, FDA-2007-A-0099, FDA-2011-A-0363, and FDA-2012-A-1169 (June 1, 2020).

[12] Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 355-355e).

[13] “Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments” (85 FR 33169, Docket No. FDA-2020-N-1127 (June 1, 2020)).

[14] Apotex Comment to Docket No. FDA-2020-N-1127 (Aug. 30, 2020); Novo Nordisk Comment to Docket No. FDA-2020-N-1127 (Aug. 31, 2020); PhRMA Comment to Docket No. FDA-2020-N-1127 (Aug. 31, 2020); Sanofi Comment on Docket No. FDA-2020-N-1127 (Aug. 31, 2020).

[15] FDA Report to Congress, The Listing of Patent Information in the Orange Book, (last accessed Nov. 9, 2023).

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