Drugs Companies Clap Back at Congress…Then Get Sued

After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately.  As we explained in September 2023, then again in November 2023, the FTC has intervened in the matter and asked 10 drug companies (really 8 given common ownerships of some of the relevant companies) to delist about 100 patents from the Orange Book that mainly cover the device constituent of a drug/device combination product.  On the heels of those FTC letters, Senator Warren and Representative Jayapal sent letters to the CEOs of those 8 companies urging them to remove the “sham patent claims improperly included” in the Orange Book, claiming that these companies have been “taking advantage of a loophole that delays generic competition.”

These companies have clapped back.  In their responses, each company emphasized that none of the patents listed were “sham patents” and that FTC never challenged the legitimacy of the patents.  While the letter from Congress suggested nefarious motives for listing these patents, each company pointed out that it was required to list all relevant patents and that FDA repeatedly had refused respond to questions about the proper listing of these types of patents. As Abbvie wrote: “While your letter refers to ‘sham’ patents and concerns about ‘abusing the patent system,’ the FTC’s letter makes no assertions that these patents were ill-gotten or are otherwise illegitimate.  Rather, the FTC questioned whether these patents meet the statutory and regulatory criteria for listing in the Orange Book.  In fact, federal law and regulation appear to require AbbVie to list these patents.”  No matter how Congress and FTC frame it, it is FDA that’s to blame for the listing confusion when it has had more than 20 years to respond to questions about whether these types of patents should have been listable in the first place.  And FDA still hasn’t said a thing!

Despite the continued lack of clarity about the propriety of listing device component patents in the Orange Book, 3 companies agreed to remove the patents cited by FTC while 5 others refused to delist.   Amneal delisted the requested patents, as well as two other patents, but pointed out that all of these patents were listed “[i]n a good faith effort to comply with the statutory requirement [to list relevant patents] given the regulatory guidance at the time . . . .”  Kaleo also delisted, but not without noting that “the decision to list each of these patents was proper, consistent, and required by the applicable statutes, regulations, and FDA’s guidance available at the time of listing.”  GSK and Glaxo Group, while defending their decision to list the relevant patents, delisted, citing to the “recent shift in policy, and the existence of potentially applicable case law in recent years, regarding the application of Orange Book listing criteria to patents covering drug-device combinations.”

Taking the opposite approach, AstraZeneca, Boehringer Ingelheim, Abbvie, Mylan/Viatris, and Teva all refused to delist the patents referenced by FTC and Congress.  Each made similar points as the 3 that did delist: patents that claim the finished dosage form must be listed in the Orange Book, and the referenced patents claim the finished dosage form.  Several even try to rewrite the anticompetitive narrative that Congress is painting by reminding Congress that the Orange Book listing of patents is intended to benefit both the brand and the generic by providing notice of such patents and providing an opportunity to address the patents prior to launch (at which point treble damages could be awarded).  Failing to list the patents, as AstraZeneca points out, “may expose the reference drug sponsor to legal risks,” as “at least one generic applicant has argued that a failure to do so constitutes a violation of the antitrust laws by depriving the applicant of information that would have affected its decision whether to develop a generic product.”

Both Congress and FTC seem to have spun this tale that the named drug companies have been intentionally abusing the Orange Book patent listing requirements by including device patents in the Orange Book, but it’s really important to note that until FTC took the unusual step of requesting delisting in Fall 2023, FDA not only had provided no guidance on whether device patents are listable but also refused to address the question when asked by industry on several occasions.  And, in fact, FDA muddied the waters itself when it stated in the 2003 implementing regulation preamble that “patents claiming devices or containers that are ‘integral’ to a drug product or require prior FDA approval should be submitted and listed” and noting that patents claiming a finished dosage form of a product, which include “metered aerosols, capsules, metered sprays, gels, and pre-filled drug delivery systems,” should be listed.  It’s difficult to conclude from these statements, as FTC and Congress appear to have, that device patents categorically shouldn’t be listed in the Orange Book.

FTC’s and Congress’s activities seem to have triggered litigation.  On March 6, 2024, the first antitrust suit arising from these letters was filed by the Massachusetts Laborers’ Health and Welfare Fund in the District Court of Massachusetts against Boehringer Ingelheim.  That Complaint alleges that “Boehringer improperly submitted 23 device patents to the Orange Book as claiming Combivent Respimat” and another 16 “as claiming Spiriva Respimat” citing specifically to FTC’s and Congress’s inquiries.  We expect that this is just the first of many antitrust cases to come—with AstraZeneca, Abbvie, Mylan/Viatris, and Teva all likely to be on the front lines.