Boehringer wins 'Jardiance' generic trademark dispute

Boehringer Ingelheim argues for trademark nullification of Shinil Pharma's 'Jadiance'… the Intellectual Property Trial and Appeal rules 'acceptance'

Differs from previous trademark disputes…high similarity with the English name 'Jardiance'

Product photo of Jardiance

In a trademark dispute over the generic-name trademark for the SGLT-2 inhibitor diabetes treatment, 'Jardiance (empagliflozin),' the original manufacturer has won a ruling from the Intellectual Property Trial and Appeal Board (hereafter, the Board).

 

Analysis suggests that the Board's rare decision to rule in favor of the original company was based on the high similarity between the English brand name, 'Jardiance,' and the disputed generic trademark, 'Jadiance.' According to the pharmaceutical industry on the 4th, the Intellectual Property Trial and Appeal Board recently issued a ruling of 'acceptance' in the trademark nullification trial filed by Boehringer Ingelheim against Shinil Pharma.

 

The trademark in question is 'Jadiance,' which Shinil Pharma filed in March 2022.

 

Shinil Pharma applied for this trademark with a focus on generics for both Jardiance and Jardiance Duo.

 

The trademark was registered in August 2023.

 

Shinil Pharma subsequently received a priority marketing authorization for a Jardiance Duo generic under the name 'Jadiance Duo.' However, just two months after the 'Jadiance' trademark was registered, Boehringer Ingelheim filed a nullity action in October 2023.

 

The Board sided with the original manufacturer after approximately two years of deliberation.

 

With generics expected to launch simultaneously after the expiration of the Jardiance substance patent on the 23rd of this month, Shinil Pharma is now unable to launch its generic product under the name 'Jadiance Duo' due to the loss of the trademark dispute.

 

Shinil Pharma must either receive a reversal ruling through an appeal to the Patent Court or secure a new product approval under a different trademark to launch its generic.

 

In this regard, Shinil Pharma holds trademarks such as 'Januglia,' 'Janumetia,' 'Januxr,' and 'Empagl,' which are presumed to be for Jardiance and Jardiance Duo generics, and these are not subject to the current dispute.

 

The ruling is being called exceptional, given the Board's precedents.

 

While global pharmaceutical companies have brought numerous legal actions to protect the trademarks of their original drugs, the Board and the Supreme Court have generally been lenient toward generic companies.

 

More recently, in May, Novartis lost a trademark nullification trial it filed against Elyson Pharmaceutical, arguing that the generic name 'Entrelto' was too similar to its heart failure treatment, 'Entresto.' Similarly, Boehringer Ingelheim filed nullification trials in 2020 against Kwangdong Pharmaceutical's 'Dijenta' and Daewoong Pharmaceutical's 'Traceta' for being too similar to its diabetes treatment, 'Trajenta,' but those trials were also dismissed.

 

Even the trademark dispute between 'Gliatirin' and 'Gliatamin' was ultimately decided in favor of the generic company by the Supreme Court.

 

Meanwhile, the original company won the latest dispute, which is unlike past rulings and decisions.

 

In this regard, the pharmaceutical industry notes that the Board found a high degree of similarity between Jardiance's English brand name, 'Jardiance,' and Shinil Pharm's 'Jadiance.' The global product name is 'Jardiance.' Both the U.S.

 

FDA and the European Medicines Agency (EMA) approved the original empagliflozin-containing diabetes treatment under the product name 'Jardiance.' However, when Boehringer Ingelheim introduced the product in Korea, the company obtained product approval under the Korean spelling of "Jardiang" rather than the English pronunciation 'Jardiance.' Despite this, the approved English product name remains 'Jardiance,' identical to the global name.

 

The company's registration with the Ministry of Intellectual Property only includes the Korean name "Jardiang", not 'Jardiance.' In this context, it is also explained that Boehringer Ingelheim only filed a trademark nullification trial against Shinil Pharma's 'Jadiance.' It has been confirmed that Shinil Pharma's 'Jadiance' is the only case currently involved in a trademark dispute with Boehringer Ingelheim over Jardiance and Jardiance Duo.