Generic companies win 1st trial on unlisted Jardiance patent

IPTAB upholds generic companies' request for invalidation trial

First result among 7 non-listed patent disputes for Jardiance

Generic drugmakers have scored the first victory in Korea’s ongoing disputes over unlisted patents related to the SGLT-2 inhibitor class diabetes treatment Jardiance (empagliflozin).

 

Industry observers expect this decision to set the tone for similar disputes surrounding Jardiance's unregistered patents that are pending.

 

According to industry sources on the 15th, the Intellectual Property Trial and Appeal Board (IPTAB) ruled in favor of four Korean generics companies, including Chong Kun Dang, Genuone Science, Korea Prime Pharm, and Huons, in an invalidation trial they filed against Boehringer Ingelheim’s unlisted use patent for Jardiance.

 

This is effectively the first conclusion made regarding the disputes surrounding Jardiance's non-listed patents.

 

Since January last year, Chong Kun Dang and the other companies have filed successive invalidation trials against the patent for ‘Therapeutic Uses of Empagliflozin (Patent No.

 

10-2318207)’.

 

This patent pertains to the treatment and prevention of cardiovascular diseases in diabetic patients using empagliflozin.

 

It expires in April 2034.

 

A total of 7 unregistered patent disputes related to Jardiance are currently ongoing.

 

Generic companies have filed successive trials against unlisted Jardiance-related patents since August 2023.

 

All related patents pertain to the uses of empagliflozin or empagliflozin+linagliptin.

 

Specifically: ▲1 patent expiring November 2027 (10-1463724) ▲1 patent expiring August 2028 (10-1491554) ▲1 patent expiring in February 2030 (10-1694136) ▲1 patent expiring in October 2030 (10-1737142) ▲Three patents expiring in April 2034 (10-1725469/10-2318207/10-2309654), etc.

 

The patent that expires in November 2028 has drawn the most challenges.

 

13 companies, including Chong Kun Dang, Hanmi Pharm, PharmGen Science, DongKoo Bio&Pharma, Daehan Nupharm, Dongwha Pharm, Youngpoong Pharm, Withus Pharmaceutical, JW Pharmaceutical, Medica Korea, Boryung, Aprogen Biologics, and Korea Pharma filed invalidation trials, while Aju Pharm has filed a passive scope confirmation request.

 

For the 2028 combination-use patent (empagliflozin + linagliptin), 9 companies, including Genuone Sciences, Boryung, Dongkook Pharmaceutical, Medica Korea, Aprogen Biologics, Korea Prime Pharm, Daewha Pharm, GC Biopharma, and Aju Holdings, have each filed for invalidation trials and passive scope confirmation trials.

 

In addition, Hana Pharm and Aju Pharm filed avoidance trials for the 2030 empagliflozin + metformin related use and formulation patent, while Genuone Sciences filed an invalidation trial for the 2030 triple-combination patent (empagliflozin + linagliptin + metformin).

 

However, Genuone Science voluntarily withdrew this trial.

 

For the 3 patents expiring in April 2034, companies including Chong Kun Dang, Genuone Science, Korea Prime Pharm, Huons, and Cosmax Pharma are currently challenging them for invalidation or seeking to circumvent them.

 

With this first trial decision regarding Jardiance's non-registered patents issued, the industry anticipates that similar pending cases will follow with first-instance conclusions.

 

Indeed, in most cases, examiners have been assigned to panels for deliberation.

 

If generic companies prevail in multiple disputes over non-listed patents, they could significantly reduce their patent risks.

 

Non-listed patents are those registered with the Korean Intellectual Property Office but not included in the Ministry of Food and Drug Safety's Green list.

 

Since they are not listed, they have no impact on generic product approvals.

 

However, product launch is a different matter.

 

The original drug’s company can claim infringement of unregistered patents.

 

If the Patent Trial and Appeal Board or the Patent Court finds the generic company in infringement of the patent, the original drug’s company can then seek a preliminary injunction to halt product sales and claim damages for patent infringement.

 

From the generic company's perspective, overcoming all unregistered patents is necessary to fully eliminate patent risk.