Teva Eyes High Court as Drug-Patent Listings Face Scrutiny (1)

The Federal Circuit’s refusal to reconsider its ruling forcing Teva to delist asthma-inhaler patents from the FDA’s Orange Book tees up a pharmaceutical-industry push for the Supreme Court to weigh in and resolve questions over what qualifies as a drug.

Teva Pharmaceutical Industries Ltd. told the US Court of Appeals for the Federal Circuit March 4 it will ask the justices to review the issue. The same day, the appeals court, with exclusive jurisdiction over patent cases, denied Teva’s petition to reconsider a December ruling affirming an order that the company must delist five patents covering its ProAir HFA asthma inhaler from the US Food and Drug Administration’s registry of approved drugs because they don’t cover the treatment’s active ingredient, albuterol sulfate.

The Federal Circuit on March 7 denied Teva’s request to continue pausing the enforcement of the district court’s order in favor of Amneal Pharmaceuticals Inc. and the intervenor Federal Trade Commission pending Supreme Court review. The appeals court rejected Teva’s argument that without a continued stay, it will “indisputably lose several of the statutory rights” that protect its patents.

The Orange Book lets drugmakers automatically delay generic rivals for 30 months if they sue alleging infringement of listed patents, and the FTC says some listings abuse the system by including ineligible patents, such as those covering inhalers that aren’t drug-specific. If the Supreme Court declines review and Teva is forced to delist its patents, the ruling could spur more challenges, especially to drug-device patents.

Teva called its since-denied motion “highly time-sensitive” because it must submit requests by March 17 that the FDA delist the patents. That will cause irreparabe injury “even if it were able to re-list its patents after that date,” Teva said.

Mark Lemley of Stanford University said Teva’s case is unlikely to sway the justices.

“The decision is entirely consistent with prior law, so there is no circuit split, and it seems pretty clearly correct,” Lemley said. “But it is worth noting that Teva stands to make enormous amounts of money if it can delay the mandate for another several months.”

Teva didn’t respond to requests for comment.

Industry Amici

The Federal Circuit’s March order didn’t address arguments from the parties or amici who filed briefs backing Teva’s bid for reconsideration.

Sanofi and AstraZeneca Plc filed separate amicus briefs arguing rehearing would clarify the standards for listing patents in the registry. Industry groups Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization also jointly filed a brief arguing for rehearing or a revised opinion “expressly limited to device-related patents.”

Teva’s forthcoming high court petition will be “likely supported by even more amici,” said Kevin E. Noonan, a partner at McDonnell Boehnen Hulbert & Berghoff LLP with more than 30 years of experience in drug-patent cases for both branded- and generic-drugmakers. He declined to speculate on what the high court will do.

PhRMA and AstraZeneca spokespersons declined to comment beyond their respective briefs. BIO and Sanofi didn’t respond to requests for comments.

Amneal also has its supporters in the dispute. A group of 14 law and medical professors filed an amicus brief supporting Amneal’s response against rehearing, arguing the ruling would help remove improperly listed patents and accelerate generic competition that could reduce drug prices.

William B. Feldman, a physician and faculty member at Harvard Medical School and Brigham and Women’s Hospital, was one of three signatories who guided the research, drafting, and editing of the brief. He called the denial of Teva’s rehearing bid “a win for patients.”

“These improperly listed device-only patents increase the barriers for generic entry,” he said, “The ruling has potential implications for a wide range of products, from inhalers and injector pens to transdermal patches and other drug-device combinations. But Teva’s ‘sky is falling’ argument just doesn’t hold up to empirical scrutiny.”

Broader Impact

The case “concerns a narrow set of points” within the generic-drug approval system, including drug-device patents, language used in patent claims, and the dilatory benefits for brand drug companies—especially the automatic 30-month stay associated with litigation over Orange Book-listed patents, according to Robin Feldman, a professor at the University of California College of the Law, San Francisco.

“The Teva case concerns one technique in a chessboard of moves drug companies have used to protect their territory and ensure higher returns for their drugs,” she said. “The flurry of briefs suggests an effort to ensure that when courts close off one move, the decision language does not reach into other moves.”

Noonan downplayed the case’s impact on broader Orange Book-listing questions, calling it “ultimately a statutory-construction case.”

“There are ways to do the listings that could pass muster, and we will likely see that happening,” he said.

For example, he said, Teva or other drugmakers could submit delisted patents for reissuance to cover methods of treatment rather than only devices. If they’re granted by the US Patent and Trademark Office, he said, they could relist them in the Orange Book.

Benjamin Dach, a partner at Weiss & Arons said the Federal Circuit drew a “bright orange line” between drug-agnostic patents and drug-specific ones. He said he doesn’t expect a different result at the high court.

Other companies likely will join the Supreme Court fray, Noonan said, if they’re concerned about “the mischief that could be made” by the Federal Circuit’s “broad language that could be used to challenge many drug-device delivery patents now listed in the Orange Book.” By attempting to draw a line about listing mechanical devices in the patent registry, he said, the court might’ve created broader rules that could make it harder for drug companies to protect their innovations.

“I know why they did it,” he said, “but this is where sometimes, when you want too much, it can come back and cause trouble for you.”

The case is Teva Branded Pharm. Products R&D Inc. v. Amneal Pharms. of NY LLC, Fed. Cir., No. 24-1936.