The U.S. Federal Trade Commission (FTC) is challenging more than 100 patents related to asthma inhalers and other drug products due to concerns they are preventing “lower-cost generic alternatives” from competing in the marketplace, harming consumer choices.
The patents are listed in the U.S. Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book,” according to a Nov. 7 press release by the FTC. “The Orange Book is a list of drug products approved by the FDA as safe and effective. When a brand pharmaceutical company lists a patent in the Orange Book, it may lead to a statutory stay that generally blocks the introduction of competing drug products for 30 months, including lower-cost generic alternatives.”
“Listing patents in the Orange Book may negatively affect competitive conditions if listings are improper, as defined by law,” it said.
The FTC has sent letters to 10 companies that hold more than 100 disputed patents listed in the Orange Book.
Patents in question are related to asthma and other inhaler devices, Restasis multidose bottles used in boosting tear production, and epinephrine autoinjectors, commonly known as EpiPens that are used for dealing with severe allergic reactions.
“Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition,” said FTC Chair Lina M. Khan.
“The FTC’s action today identifies over 100 patents that we believe are improperly listed … We will continue to use all our tools to protect Americans from illegal business tactics that are hiking the cost of drugs and drug products.”
The 10 firms who received the letters are: AbbVie, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Impax Laboratories, Kaleo, Teva Branded Pharmaceutical, Norton Limited, Mylan Specialty, GlaxoSmithKline, and Glaxo Group.
When the listing of a specific drug product or substance in the Orange Book is disputed in accordance with the FDA’s regulations, the agency will send the statement of dispute to the New Drug Application (NDA) holder. In this case, the FTC has disputed over 100 patents from 10 companies. As such, the FDA will send the dispute statements to these firms.
The companies will then have 30 days to take either of the following actions—withdraw the listings, amend the listings, or certify under penalty of perjury that the listings comply with the necessary rules.
Improper Orange Book Listings
The FTC action comes after the agency issued a policy statement last month regarding the “improper listing of patents” in the Orange Book by drug manufacturers.“The goal of this policy statement is to put market participants on notice that the FTC intends to scrutinize improper Orange Book listings to determine whether these constitute unfair methods of competition in violation of Section 5 of the Federal Trade Commission Act,” it said.
In the statement, the agency warned companies who have products improperly listed in the Orange Book to remove them from the FDA list. Failure to do so “may result in legal liability under the FTC Act.”
The FTC press release pointed out that FDA regulations allow interested parties to dispute the accuracy or relevance of patents listed in the Orange Book.
Even though the commission is using the FDA’s dispute process to deal with the matter, the FTC made it clear to the 10 companies that it “retains the right to take any further action as needed in the public interest, which includes investigating the manufacturers’ conduct as a violation of FTC laws.”
- Teva: 35 patents covering three products—ProAir HFA, ProAir DigiHaler, and QVAR 40. Teva is the world’s largest manufacturer of generic drugs.
- Norton Limited: Seven patents covering QVAR RediHaler
- Mylan Specialty: Eight patents covering two products: EPIPEN and EPIPEN JR.
- Kaleo: Eight patents covering AUVI-Q
- Impax: Two patents related to Adrenaclick
- GlaxoSmithKline: 10 patents covering two items: Arnuity Ellipta and Ventolin HFA
- Glaxo Group: Four patents of two products: Advair HFA and Flovent HFA
- Boehringer Ingelheim: 22 patents covering four products: Atrovent HFA, Combivent Respimat, Spiriva, and Spiriva Respimat
- Astrazeneca: 10 patents on Symbicort
- AbbVie: Four patents related to Restasis Multidose
Discussing the FTC action, law firm Cooley asked pharmaceutical firms to be “extra cautious” to ensure their product listing in the Orange Book is on a “good faith basis,” according to a Nov. 21 post.
Intentionally listing a product in the Orange Book without adhering to regulations could result in “significant antitrust exposure,” it said.
“Such action is likely to attract antitrust counterclaims from the generic applicant—in addition to potential FTC scrutiny and class actions on behalf of purchasers—that may be difficult to defend.”
However, “FTC enforcement is much less likely to succeed in the absence of evidence that a particular listing was made in bad faith, and that the listing caused or is likely to cause generics to delay or forego entry.”
Under such circumstances, the likelihood of private claims is also on the lower side “since conduct that does not actually impact generic entry would not result in antitrust injury and damages,” the law firm noted.
