FTC’s Targeting of Orange Book Patents Won’t Impede Hatch-Waxman Litigation
By Brenda Sandburg June 21, 2024
The US Federal Trade Commission’s efforts to get pharmaceutical companies to delist device patents from the Food and Drug Administration’s Orange Book will not change the course of Hatch-Waxman litigation, at least in the near term, patent litigators say.
The FTC stepped into the arena of Orange Book patent listings with much fanfare, sending letters to pharmaceutical companies asserting that they had improperly listed device patents and indicating it would take enforcement action if the patents were not delisted. While FTC’s campaign has riled the pharmaceutical industry it is not expected to prevent innovators from claiming infringement of device patents pertaining to drug-device combination products.
The FTC issued a policy statement in September 2023 warning pharmaceutical companies that they could face legal action if they improperly list patents in FDA’s catalog of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.” The agency said improper listings may harm competition from less expensive generic alternatives and keep prices artificially high.
Two months later, the agency sent warning letters to eight drug manufacturers and their subsidiaries claiming they had improperly listed more than 100 patents for asthma and chronic pulmonary disease inhalers, epinephrine autoinjectors and Restasis multidose bottles.
On April 30, the FTC sent another round of letters, expanding the list of challenged patent listings to include those for injectable diabetes and weight loss drugs, including Novo Nordisk Inc.’s Victoza and Ozempic. In a press release, the FTC referred to them as “junk patent listings.” The challenged listings pertain to patents on devices or device components that do not claim the drug’s active ingredient.
‘A Lot Of Hoopla’
Irena Royzman, a partner at Orrick, Herrington & Sutcliffe, said that in her more than 20 years of working on HatchWaxman cases she has never litigated a device patent. While device patents may be involved in some cases, she said it is not a rampant issue impacting generics or Hatch-Waxman litigation.
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“I feel like this is a super minor issue because normally the patents that you see are patents to the active pharmaceutical ingredient, the small molecule, and patents to a formulation of that active pharmaceutical ingredient,”
Sanya Sukduang, a partner at Cooley LLP, said the FTC’s actions will not likely have much impact in the near term. “But as the FTC moves from what I’m calling the identification phase to an enforcement phase, it might have a broader impact on companies and what they deem listable in the Orange Book,”
The FTC utilized FDA’s patent listing dispute process, under which any interested person can dispute the accuracy of patent information in the Orange Book. While this was not an enforcement action, the FTC asserted that it retained the right to take further action, including investigating the improper listing as an unfair method of competition under Section 5 of the FTC Act. In response, several companies asked the FDA to delist their patents.
GlaxoSmithKline delisted four of five patents challenged by the FTC and Impax Laboratories, a subsidiary of Amneal Pharmaceuticals Inc., and Kaleo Inc. agreed to delist all of their challenged patents. AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc. and Teva Pharmaceuticals USA Inc. declined to do so, asserting that their
Senator Elizabeth Warren and Representative Pramila Jayapal sent letters to all of the companies in December asking them to delist the patents identified by the FTC and answer questions about them. The companies responded that they believed their patents were listed in accordance with statutory requirements, FDA regulations and case law.
Boehringer replied that current regulations require the holder of an approved new drug application to submit information for patents claiming the drug product, which includes the device that delivers the medicine to the patient. “As specified by FDA, the drug product is the finished dosage form,” the company stated. “Thus, importantly, the approved drug product for each of the BIPI inhaler products referenced in FTC’s letter includes the device that delivers the medicine to the patient.”
Faster Generic Entry?
Last year, the FTC submitted an amicus brief in Mylan Pharmaceutical Inc.’s suit against Sanofi alleging that Sanofi improperly listed patents related to injector pens that did not claim insulin glargine or Sanofi’s SoloSTAR product. The agency did not take a position on Mylan’s factual allegations but said such improper Orange Book listings can
And in March the FTC filed an amicus brief in Teva’s suit against Amneal claiming Amneal infringed five patents on Teva’s ProAir HFA inhaler. The FTC said the court should order Teva to delist the patents. The patents were among those the FTC cited as improperly listed in its letter to Teva. On June 10, New Jersey District Judge Stanley Chessler issued a ruling that the patents were improperly listed and ordered Teva to correct or delete the patent information
Sukduang said it is significant that the FTC has taken the first actionable steps over Orange Book patent listings. For years, companies have asked the FDA to provide guidance on whether drug delivery device patents that do not claim the active ingredient in the drug product can be listed but the FDA has declined to do so. The FDA says it plays only a “ministerial” role in listing patents in the Orange Book and will not review the correctness of patent information submitted by the branded drug manufacturer.
Industry is now waiting to see if the FTC will file lawsuits against companies for refusing to delist their patents. “If the FTC were to take enforcement action and a court were to determine what types of patents would be listable and not listable, particularly these device patents, then I think companies would just follow course and take those patents off the Orange Book,” Sukduang stated. “I think any court proceeding will help further define what listings might look like.”
Under the Hatch-Waxman Act amendments to the Food, Drug, and Cosmetic Act, a new drug application must include a list of patents that could “reasonably be asserted” against a person not licensed by the owner to engage in the manufacture, use or sale of the drug. After a drug is approved the patents are listed in the Orange Book.
If a generic drug applicant files a paragraph IV certification that a patent listed in the Orange Book is invalid, unenforceable or will not be infringed by the generic product, and the NDA holder brings an infringement lawsuit within 45 days, FDA cannot issue final approval of the ANDA for 30 months unless the patent expires or is judged to be invalid or not infringed before then.
The FTC contends that delisting patents will enable generic drugs to get on the market faster since they would not be subject to the 30-month stay of approval. However, Sukduang said he does not think this is realistic. “The companies that are listing device patents have other patents listed in the Orange Book so generic manufacturers are going to have to litigate those. There’s still a 30-month stay. And so I don’t really see this as expediting generic entry,” he said.
In addition, patents not listed in the Orange Book may still be subject to Hatch-Waxman litigation. For example, Royzman noted that while manufacturing process patents cannot be listed in the Orange Book they are often part of Hatch-Waxman lawsuits.
“A big part of the reason that I think these issues are overblown is because non-OB listed patents are routinely litigated as part of Hatch-Waxman litigation so as to resolve all relevant patent disputes,” Royzman said. “And it is possible to get TROs, preliminary and permanent injunctions based on those non-OB patents.”
Courts May Provide Clarity
The FTC first addressed the effect of Orange Book patent listings on competition as part of a 2002 study. It has filed several amicus briefs on improper Orange Book listings in private litigation, including a 2022 brief in Jazz Pharmaceuticals Inc.’s patent infringement suit against Avadel CNS Pharmaceuticals. The agency argued that Jazz improperly listed a patent on a system for distributing Xylem because the patent does not claim the drug or a method of using it. A district court concluded this as well and ordered Jazz to ask FDA to delist the patent.
ACI will be covering the FTC’s actions on Orange Book patent listings at the Paragraph IV Disputes Master Symposium in Chicago Oct. 15-16. For information about the meeting visit the
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