Boehringer withdraws 1 lawsuit over unlisted Trajenta patent

Has voluntarily withdrawn patent invalidation lawsuit over 'combination of linagliptin and sulfonylurea'

Boehringer Ingelheim continues dispute following launch of Trajenta generics

"Will Boehringer Ingelheim withdraw the remaining disputes over unlisted patents?'…pharmaceutical companies focus on this matter

Product photo of Trajenta

Boehringer Ingelheim has voluntarily withdrawn one of its ongoing patent disputes involving unlisted Trajenta (linagliptin) patents.

 

Attention is focused on whether this withdrawal will lead to the conclusion of other ongoing disputes, as Boehringer Ingelheim has been pursuing unlisted patent challenges even after the launch of Trajenta generics.

 

According to the pharmaceutical industry, on October 21 Boehringer Ingelheim voluntarily withdrew a lawsuit seeking to cancel a patent invalidation ruling against 16 companies, including Genuone Sciences, on October 20.

 

The patent was registered under the name "Treatment of Diabetes in Patients with Insufficient Glycemic Control Despite Therapy with Oral or Non-oral Agents for Diabetes." It involves the combination of linagliptin and sulfonylurea (SU).

 

This patent was one of the unlisted Trajenta-related patents.

 

Boehringer Ingelheim filed this patent in January 2020, and it was registered with the Korean Intellectual Property Office in April 2022.

 

However, it was not listed in the Ministry of Food and Drug Safety (MFDS) patent registry.

 

Generic companies, anticipating the launch of Trajenta generics in June 2023, challenged this unlisted patent to alleviate patent risk.

 

Companies that filed the invalidation trial included Genuone Sciences, Kukje Pharm, Kyungbo Pharmaceutical, KyungDong Pharm, DongKoo Bio & Pharma, Dongwha Pharm, Daewon Pharm, Boryung, Shinil Pharm, Aju Holdings, Alvogen Korea, Ildong Pharmaceutical, Jeil Pharmaceutical, Korea Prime Pharm, Korea Huons, and Hanlim Pharm.

 

The substance patent for Trajenta expired while the dispute was ongoing.

 

Twenty-nine companies launched their generics when substance patent expired in May of last year.

 

However, Trajenta's unlisted patents continue to pose a risk to generic companies.

 

If generic companies lose unlisted patent disputes, their generic sales could be deemed patent infringement.

 

In such a scenario, Boehringer Ingelheim could file for preliminary injunctions to halt sales and pursue damages through lawsuits.

 

In May of this year, the Intellectual Property Trial and Appeal Board ruled in favor of the generic companies.

 

Boehringer Ingelheim subsequently appealed to the Patent Court.

 

However, it voluntarily withdrew the lawsuit approximately five months later.

 

This concluded one of the multiple lawsuits surrounding Trajenta's unlisted patents.

 

The pharmaceutical industry's attention is now focused on whether the remaining disputes over Trajenta's unlisted patents will also be resolved.

 

Boehringer Ingelheim has registered over 10 unlisted Trajenta patents, in addition to the linagliptin-sulfonylurea combination patent.

 

Generic companies have filed circumvention and invalidation trials against each of these patents, and the disputes are ongoing.

 

If Boehringer Ingelheim voluntarily withdraws the remaining unlisted patent lawsuits, the patent risks surrounding Trajenta generics are mostly expected to be resolved.