Court ordered Teva to remove asthma patents from Orange Book

Amneal Pharmaceuticals wins after court rejects infringement claims | The decision orders Teva to remove patents relating to its respiratory drug from the FDA’s Orange Book | It paves the way for a general release of Amneal.

Teva pharmaceutical company five patents for a respiratory drug were ordered to be withdrawn from circulation US Food and Drug Administrationlist of patents (FDA), Orange Book.

A U.S. district court ruled in favor Amneal pharmaceutical companywhich was supported by US Federal Trade Commission (FTC) in a patent dispute with Teva.

The court found that Teva’s patents covered only parts of its inhaler technology, unlike ProAir HFA, and ordered them removed from the Orange Book, clearing the way for Amneal’s proposed generic drug.

Judgment, issued by United States District Court for the District of New Jerseyrevolves around Teva ProAir HFA (albuterol sulfate) Inhalation aerosol and allegations of patent infringement under the Hatch-Waxman Act.

Judge Stanley Cheslerin its June 10 decision, it also denied Teva’s attempt to dismiss Amneal’s claims that Teva violated state and federal antitrust laws.

The judgment follows FTC fight against “illegal tactics” by pharmaceutical manufacturers by challenging the “improper or inaccurate” listing of patents on the FDA’s Orange Book.

Focusing on more than 300 patent listings for 20 different brand-name products, the FTC sent warning letters to 10 pharmaceutical companies in April for filing so-called “junk” patent listings.

Background of the case

Teva, which has approved new drug application number 021457 for ProAir HFA, said last year that Amneal’s attempt to introduce a generic version of the product infringed several Teva patents.

These include US patent numbers: 8,132,712; 9,463,289; 9,808,587; 10,561,808; and 11,395,889.

Amneal filed an abbreviated new drug application (ANDA), arguing that its generic product does not infringe any valid claims of these patents.

In response, Teva filed a patent infringement lawsuit, while Amneal responded with 12 counterclaims.

Counterclaims included requests to strike patents from the Orange Book, as well as allegations of violations of the Sherman Act and the New Jersey Antitrust Act.

In a recent opinion, the court addressed two critical motions: Teva’s motion to dismiss Amneal’s antitrust counterclaims and Amneal’s motion for partial judgment on the pleadings.

Teva’s antitrust arguments

Teva moved to dismiss Amneal’s counterclaims based on alleged violations of antitrust law based on “improper entries in the Orange Book” and “sham litigation.”

Teva argued that antitrust law did not cover improper listings in the Orange Book and insisted that its patents be listed correctly.

She also argued that even if the listings were improper, antitrust law would not apply because the Trinko doctrine limits antitrust claims when a regulatory system already exists to address the issue.

However, Chesler found Teva’s arguments unconvincing.

He noted that the Orange Book inclusion act does not impose an obligation on NDA holders to behave in the same way as the network sharing obligations in the Trinko case under the Telecommunications Act.

Moreover, the court emphasized that the FDA’s role in listing products on the Orange Book is administrative in nature and does not include enforcing actions against anti-competitive behavior, unlike the regulatory system in Trinko.

The court also rejected Teva’s argument that the statute prevented antitrust claims based on improper listing. Chesler explained that the bill only limits stand-alone delisting lawsuits, not antitrust claims related to broader competitive conduct.

Court ruling: Teva’s application rejected, Amneal’s counterclaim

The court denied Teva’s motion to dismiss Amneal’s counterclaims and granted Amneal’s motion for partial judgment on the pleadings, allowing the case to proceed and further consideration and determination of Amneal’s counterclaims.

The court dismissed Amneal’s antitrust counterclaims with prejudice, barring them from being brought again in this case, but allowed separate antitrust claims to be brought outside this litigation.

With respect to the delisting counterclaims, the court denied Teva’s motion to dismiss and granted Amneal’s counterclaim for judgment on the pleadings, siding with Amneal.

Teva argued that the delisting requests misinterpreted the Listing Statutes. However, Amneal and the FTC argued that listing inhaler patents in the Orange Book was inappropriate and unauthorized.

The court emphasized two statutory requirements for including a patent in the Orange Book: the patent must relate to the drug for which the application has been submitted and it must relate to a medicinal substance or product.

The court found that the inhaler patents did not meet these requirements because they did not include a claim regarding albuterol sulfate or disclosure of the finished drug form.

As a result, the court ordered Teva to correct or delete the relevant Orange Book entries relating to these patents.

Teva is represented by Daryl Wiesen and Natasha Daughtrey from Goodwin Procter.

Amneal is represented by Rebecca Conroy of Stone Conroy; Steven Maddox and Jeremy Edwards z Prokopio.