Drug Wars Continue Despite Registry Patent Listing Crackdown

No company happened to be hit harder by the US Federal Trade Commission’s crackdown when it came to patents listed on the federal registry of approved drugs than Teva Pharmaceutical Industries Ltd., the Israeli drugmaker, and the fact that a few companies have responded as aggressively.

It is well to be noted that the FTC went on to warn eight companies to pull dozens of not properly listed entries from the US Food and Drug Administration’s Orange Book registry. Their objective happens to be to accelerate approval when it comes to cheaper versions pertaining to branded drugs, such as asthma inhalers as well as epinephrine autoinjectors.

Three companies have gone on to pull most or all of the FTC-targeted listings. However, Teva, whose listings comprised almost 40% of the FTC’s 110 targets, did not deter.

It is well to be noted that the FDA’s Orange Book goes on to help the generic-drug makers gauge which brand-name drugs can be substituted with safe as well as effective generic choices. However, the makers of generics have been for a long concerned with the number as well as the nature of the patents that the brand-drug makers submit when it comes to inclusion. They argue that some of the patents may be irrelevant or strategically listed so as to create hurdles as far as competition is concerned.

Rather than complying with federal warnings targeting the questionable Orange Book listings, Teva went on to fire-off one of the first disputes, thereby asserting patents that the FTC had marked for delisting. Though Teva’s legal strategy goes on to flout the spirit of FTC’s challenges, the company happens to be risking more than the actual cost of litigation, all thanks to US patent law, remarked Arti Rai, who is an intellectual property professor at Duke Law School.

It is well to be noted that the Israeli company on February 16, 2024, went on to sue Cipla Ltd., which happens to be an Indian generic- drug maker, thereby looking to block its proposed copy of Teva’s Qvar RediHaler for in a way allegedly infringing 12 patents for asthma treatment. Seven of the patents happen to be among the FTC’s targets.

Central to Teva’s strategy happens to be an aspect of the Hatch-Waxman Act that is meant to accelerate access as far as affordable drugs are concerned while still going ahead and rewarding innovation. In this kind of pharma peace treaty, generics happen to get shortcut to market by way of making usage in terms of brand research, while the branded drugs score an unusual bonus, which is a 30-month stay pertaining to the FDA approval of generic competition, while the courts go on to consider the infringement claims.

Teva happens to be doing just that.

By way of submitting patents for listing in Orange Book, like two in the first three months of 2023, Teva went on to respond to Cipla’s Jan. 4 notice letter by way of suing within a 45-day window that goes on to trigger the FDA delay. That effectively went ahead and blocked approval of Cipla’s generic until July 4, 2026, unless Cipla goes on to prevail before then.

According to Rai, in other words, it is equal to a 30-month preliminary injunction with no need to prove, as one ordinarily would, that one’s case has merit. In spite of the FDA’s warning, what Teva happens to be doing is the sort of thing that any aggressive litigator might as well do given the structure of Hatch-Waxman scheme.

Counterclaims to the Orange Book

Though the FTC is most unlikely to sue companies that happen to ignore its warning letters, the agency will want to go ahead and pressurize the brand-drug makers, remarked Chad Landmon, who happens to chair the intellectual property as well as FDA practices at Axinn, Veltrop & Harkrider LLP. It is well to be noted that some of that pressure may as well manifest as patent-delisting counterclaims from the generic-drug makers when it comes to infringement suits, as the FTC has gone on to make these so prominent within its warning letters, he added.

Notably, a unit of Alvogen Group Inc. went on to file one such counterclaim in October 2024 while seeking to produce a copy of a treatment in terms of chronic obstructive pulmonary disease- COPD.

It is worth noting that Boehringer Ingelheim International GmbH went on to sue in July 2023 to block Alvogen’s version when it comes to Boehringer’s top selling Spiriva HandiHaler. Alvogen in October of the same year requested the delisting of Boehringer’s US Patent No. 9,010,323. The filing cited the FTC’s Sept. 14 policy statement, however, which came weeks before its November warning letters.

The same day, apparently, the FTC sent Boehringer its warning letter, and the German drugmaker asked the court not to accept Alvogen’s request. A case-status teleconference is all set for April 23.

Boehringer was hit with a lawsuit by the Laborers’ Health Benefits Fund, thereby alleging drugmakers wrongfully listed patents when it comes to inhalers in Orange Book to stifle generic competition as well as maintain inflated prices, thereby causing overcharges of numerous millions, if not billions, of dollars.

Apparently, Boehringer announced next morning it would cap out-of-pocket expenses at $35 for eligible patients across all the company’s inhalers starting June 1. The company, when asked about the move, which happened to be in response to the lawsuit, said that the conversations pertaining to prescription drug prices go on, and they have indeed listened.

The statement coming from Boehringer said that it is important to come forward with solutions now that will be advantageous to patients, while they will also continue to go ahead and work with policymakers and other stakeholders on broader system reform.

Notably, Alvogen’s counterclaim looks forward to the delisting of a patent that covers an inhaler as well as its sieve. The patent, which is set to expire in April 2030, is one of two included within the FTC’s Orange Book-removal list for Boehringer. However, there have been no enhancements to inhaler efficacy or compliance in the last 40 years, in spite of the countless design changes, as per the proposed class-action suit against Boehringer.

Taking into account the steps

Not all the recipients when it comes to the warning letters have ignored the FTC’s overtures.

Just like Teva as well as Boehringer, GlaxoSmithKline Plc too had patent listings for four products in the FTC’s crosshairs. By mid-December 2023, though, GSK had gone on to agree to pull Orange Book listings that were related to three of them. All this left the asthma inhaler Arnuity Ellipta as the only GSK product, which is still among the FTC’s targets.

It is well to be noted that prior to the FTC’s historic November actions, as per the agency, an average of 10 patents had gone on to be challenged every year since 2017, as per the FDA’s database.

The FTC spokesperson went on to remark to Bloomberg that they strongly encourage manufacturers to follow law and to also voluntarily de-list the patents that are not able to meet the listing criteria, which are established by the applicable statutory as well as regulatory scheme. The fact is that not only is the FTC considering forthcoming steps under its authorities, but there may also be certain legal consequences from parties outside the FTC.