Generic companies win ‘Jardiance Duo’ unlisted patent 1st instance trial

14 companies invalidate Use Patent for empagliflozin + metformin

Generic companies also won invalidation trial for Jardiance monotherapy unlisted patent late last year

Original company won empagliflozin + linagliptin unlisted patent dispute

Product photo of Jardiance Tab

Fourteen pharmaceutical companies, including Chong Kun Dang, have won a favorable ruling in a patent dispute regarding unlisted patents for Jardiance Duo (empagliflozin + metformin).

Analysis suggests that following their victory in the unlisted patent dispute for the Jardiance monotherapy late last year, this subsequent win for the metformin combination therapy significantly mitigates patent risks for generic products.

According to pharmaceutical industry sources on the 29th, the Intellectual Property Trial and Appeal Board (IPTAB) issued a decision on the 28th in favor of the invalidation trial filed by Chong Kun Dang and others against Boehringer Ingelheim regarding the use patent for Jardiance Duo. In addition to Chong Kun Dang, generic companies participating in this trial include Genupharma, Pharmgen Science, Dongkoo Bio & Pharma, Daehan Nupharm, Dongwha Pharm, Young poong Pharmaceutical, Withus Pharmaceutical, JW Pharmaceutical, Medica Korea, Boryung, Aprogen Biologics, Korea Pharma, Hanmi Pharm, and Aju Pharm.

This patent is concerning the use patent for the combination therapy of empagliflozin and metformin, which is set to expire in November 2027. Notably, it was not listed in the Ministry of Food and Drug Safety’s (MFDS) patent Green List.

Boehringer Ingelheim has registered two listed patents and seven unlisted patents related to Jardiance with the Korean Intellectual Property Office. Generic manufacturers successfully bypassed one of the listed patents in 2019. Based on that ruling, companies challenging the patent obtained generic product licenses and launched their generics in October last year, around the time of the expiration of the substance patent.

However, the seven unlisted patents have been analyzed as potential obstacles to the sale of Jardiance generics. While they do not affect product authorization, selling products without overcoming unlisted patents carries the risk of patent infringement litigation.

Boehringer Ingelheim’s unlisted patents related to Jardiance include ▲three use patents for empagliflozin single-agent ▲one use patent and one formulation patent for empagliflozin + metformin ▲one use patent for empagliflozin + linagliptin ▲one use patent for the triple combination therapy of empagliflozin + linagliptin + metformin.

Korea's fourteen pharmaceutical companies, including Chong Kun Dang, Genupharma, Pharmgen Science, Dongkoo Bio & Pharma, Daehan Nupharm, Dongwha Pharm, Young poong Pharmaceutical, Withus Pharmaceutical, JW Pharmaceutical, Medica Korea, Boryung, Aprogen Biologics, Korea Pharma, Hanmi Pharm, and Aju Pharm have won a favorable ruling in a patent invalidation trial concerning unlisted patents for Jardiance Duo (empagliflozin + metformin).

Among these, generic companis, including Genuone Sciences, Chong Kun Dang, Korea Prime Pharm, Boryung, and Huons, successfully invalidated one of the use patents for the Jardiance monotherapy formulation in November last year. Boehringer Ingelheim has appealed to the Patent Court following this first-instance defeat.

With the sequential invalidation of the use patents for both the Jardiance monotherapy and the metformin combination product, industry analysts believe generic companies have resolved a substantial portion of the patent risks associated with product sales.

However, generic manufacturers have failed to overcome the unlisted use patent for Esglito (empagliflozin + linagliptin). Companies including Genuone Sciences, Boryung, Dongkook Pharm, Medica Korea, Aprogen Biologics, Korea Prime Pharm, Daehwa Pharm, GC Biopharma, and Aju Holdings filed invalidation and passive negative scope confirmation trials against the Esglito patent. These companies received dismissal rulings in February and March of this year, respectively.

Additionally, decisions regarding two cases of use patents for Jardiance and one case of formulation patent for Jardiance Duo is pending.