The Orange Book is the new dispute: FTC demands removal of ‘incorrectly’ listed medical device patents :: Medtech Insight

The Federal Trade Commission (FTC) has challenged over a hundred medical device patents listed in the U.S. Food and Drug Administration’s Orange Book, claiming the improper listings would hinder competition and further drive up drug prices.

The Orange Book – officially the FDA’s “Approved Drugs with Therapeutic Equivalence Evaluations” – is the agency’s authoritative guide to approved prescription drugs.

The Orange Book not only publishes all FDA-approved drugs, but also contains a drug’s active ingredients, dosage forms, strengths, and approval dates, as well as information on therapeutic equivalence of generic drugs.

In addition, the book contains relevant patent information on the listed drugs.

But as Sara Koblitz, principal at the law firm Hyman, Phelps & McNamara, said Medtech InsightThe Orange Book also lists medical devices such as inhalers and injectors that administer medication. However, these device patents are not listed separately in the Orange Book, but as part of the patented medication.

“If the drug is used with the device, the device can be listed with the drug,” Koblitz said.

Patent protection

Koblitz further explained that the inclusion of device patents in the Orange Book gives companies the opportunity to enforce their patents before they are approved. This allows them to file a patent infringement suit against a potential competitor before the competitor’s product has been approved.

For example, as Koblitz noted in a recent post on the FDA Law Blog, in March, before its launch, Teva Pharmaceutical initiated a patent dispute against Amneal Pharmaceuticals for infringement of five of its Orange Book patents related to Teva’s combination product, ProAir HFA. ProAir HFA is the brand name of the drug albuterol sulfate, which is used in a metered dose inhaler.

“Incorrectly listed patents can significantly increase the prices Americans pay for drugs and pharmaceuticals while undermining fair and honest competition.” – Lina Khan

In response to Teva’s patent dispute, Amneal filed a counterclaim seeking a declaratory judgment that there was no patent infringement. It also asked the court to invalidate the five Teva patents and strike them from the Orange Book. Amneal also sought damages for “alleged anticompetitive conduct in violation of state and federal antitrust laws.”

Koblitz noted that the FTC filed an amicus curiae brief in that case arguing that Teva’s patents “did not claim” an FDA-approved drug.

SARA KOBLITZ

In her blog, Koblitz quotes the FTC’s view: “Device patents that do not mention a drug in their claims do not meet the statutory criteria for inclusion in the Orange Book, and a device patent that is incorrectly listed in the Orange Book must be delisted.”

Last month, the New Jersey District Court ruled that Teva’s patents were improperly listed and ordered their removal from the Orange Book.

In addition, the court ruled that Teva’s patents, which covered only the inhaler component of the drug ProAir HFA, were also not properly listed.

Koblitz quotes the court’s opinion: “The inhaler patents do not claim the medicinal product for which the applicant filed the application.”

As Koblitz later explained, this means that while the Court acknowledged that the definition of a drug is broad enough to include the device used to deliver it—in this case, the inhaler—the Court also found that the definition was too narrow to justify the inhaler patent claim without specifying the drug used with the inhaler.

In other words, because the FDA identified “albuterol sulfate HFA inhalation aerosol” as the drug in Teva’s New Drug Application (NDA) with the agency, albuterol sulfate must be claimed in the inhaler patent to be eligible for Orange Book listing.

Teva has appealed the ruling.

More aggressive attitude

In November 2023, the FTC sent letters to ten of the largest pharmaceutical companies, including Teva, challenging more than one hundred patents on branded asthma inhalers, epinephrine auto-injectors, and other combination products for being improperly or inaccurately listed in the Orange Book.

The FTC also informed the FDA that it disputes the validity of these patents.

“The FTC now believes that device patents that do not cover the specific drug delivered by the device should not be listed,” Koblitz said, noting that the FDA prefers not to address this issue and has been putting it off for some time.

“The FDA has never commented on this,” she added. “They have been asked since 2005 and have refused to answer. So everyone has listed their device patents and assumed they are essential to the use of the drug listed in the book.”

But while the FDA did not give a clear answer on the patent issue, the FTC now does.

Anti-competitive

As part of its more aggressive stance, Koblitz said the FTC ruled that it was anticompetitive for a company to claim a device patent that did not cover the specific drug associated with the device.

Announcing its actions against the ten pharmaceutical companies, FTC Chair Lina Khan said that improperly listed patents not only drove up prices but also undermined “fair and honest competition.”

“These patents are valid patents. Just because they don’t claim an active ingredient doesn’t mean there’s anything wrong with the patents themselves.” — Sara Koblitz

While some companies have complied with the FTC’s request to remove their patents from the Orange Book, others have refused to do so, Koblitz noted.

And of these companies, Koblitz said, Teva has taken the most determined stance in opposing the Commission. As recently reported in the WashingtonPostThe FTC has launched an investigation into the company because it refuses to delist several of its inhaler patents.

From Koblitz’s perspective, what is important for the device industry is the value the FTC places on device patents.

“These patents are portrayed as junk or bogus patents,” she said, adding that this terminology, which is gaining traction in Congress, is damaging the medical device industry.

“These patents are valid patents,” Koblitz added. “Just because they don’t claim an active ingredient doesn’t mean there’s anything wrong with the patents themselves.”

Regardless of how successful Teva is in its defense against the FTC or how the various court proceedings turn out, Koblitz is convinced that the Commission will not give up its pressure.

“The FTC has filed amicus curiae briefs in these very run-of-the-mill patent litigation cases that often arise in drug-device combination products, saying that the patents should never have been listed in the Orange Book in the first place,” Koblitz said. “They’re being extremely aggressive. So I don’t think that’s going to change any time soon.”

Medtech Insight has asked Teva for comment.