Fist instance ruling for 5 out of 7 Jardiance unlisted patent disputes

Generic companies win another patent victory in an invalidation trial related to the Jardiance use patent, which is set to expire in 2034

Five out of seven unlisted patents are closing at the first-instance trials…remaining are use patent‧formulation patent

The focus of dispute has moved to the Patent Court…Boehringer Ingelheim‧generic companies have each filed an appeal

Product photo of Jardiance

The dispute surrounding the unlisted patents for the SGLT-2 inhibitor diabetes treatment 'Jardiance (empagliflozin)' is nearing its end.

As generic companies have recently succeeded in invalidating another unlisted method-of-use patent, first-instance decisions have been closed for five of the seven complexly unlisted patents. A resolution for the remaining two patents is also expected in the near future.

Consequently, the focus in this dispute is projected to shift to the Patent Court. Both the original drug company and generic companies have already appealed a first-instance decision each after contesting the initial rulings.

Invalidating use patent set to expire in 2034…5 out of 7 unlisted patents received a first instance ruling

According to pharmaceutical industry sources on June 26, the Intellectual Property Trial and Appeal Board (IPTAB) issued a favorable ruling on June 25 in an invalidation trial petitioned against Boehringer Ingelheim by Genewone Sciences, Chong Kun Dang, Korea Prime Pharm, Boryung, Huons, and Hanmi Pharm regarding a Jardiance use patent (10-2138213).

This patent is set to expire in April 2034 and is not listed in the Ministry of Food and Drug Safety (MFDS) Patent List. It covers the treatment and prevention of diabetes or prediabetes using empagliflozin in patients with renal disease.

Generic companies petitioned for an invalidity trial against Boehringer Ingelheim in January 2024 and secured a first-instance victory after 2.5 years.

With this ruling, disputes over five out of the seven unlisted Jardiance patents received a first-instance ruling. Between 2023 and 2024, generic companies targeted these seven unlisted Jardiance patents by filing invalidation trials or passive scope confirmation trials.

At the time, pharmaceutical companies had to individually identify and respond to patents that were not listed in the official patent registry. Although overcoming unlisted patents is not a prerequisite for obtaining generic marketing authorization, the presence of these patents posed a significant risk of patent infringement liability and subsequent damages claims upon product launch.

Notably, analysis suggests that the existence of these unlisted patents continues to pose a risk for generic manufacturers, even as generic versions were launched concurrently following the expiration of the Jardiance substance patent in October last year.

The remaining unlisted formulation patent and use patent are expected to receive ruling soon

Jardiance has two listed patents and seven unlisted patents. Generic companies successfully avoided one of the listed patents in 2019. The other listed patent was the substance patent, which expired in October last year. The remaining unlisted patents include ▲three use patents for empagliflozin monotherapy ▲one use patent and one formulation patent for empagliflozin+metformin combination ▲one use patent for empagliflozin+linagliptin combination ▲one use patent for empagliflozin+linagliptin+metformin triple combination therapy.

Among these, a conclusion was reached first regarding a Jardiance use patent (10-2318207) expiring in April 2034. Generic companies won the first instance in November last year, and Boehringer Ingelheim has appealed the decision.

In February of this year, the original drug company emerged victorious in the composition and use patent dispute (expiring in August 2028) for Esgliteo (empagliflozin+linagliptin). IPTAB issued a ruling dismissing the generic companies' arguments regarding the passive scope confirmation and invalidation. Dissatisfied with the outcome, three generic manufacturers chose to appeal to the Patent Court.

In April, generic companies won a dispute over the use patent (expiring in November 2027) for Jardiance Duo (empagliflozin + metformin). Following this, generic manufacturers have now also secured a favorable first-instance ruling in the Jardiance use patent dispute. Separately, the use patent dispute concerning the empagliflozin+linagliptin+metformin triple combination therapy was concluded when Genewone Sciences voluntarily withdrew its trial petition.

The remaining patents include unlisted formulation patent expiring in October 2030 and another concerning a use patent expiring in April 2034.

The pharmaceutical industry anticipates that first-instance decisions for both remaining disputes will be made within the second half of this year. In this regard, IPTAB designated administrative patent judges to formulate patent cases in May. On the first of this month, judges were also assigned to the use patent case. Given that rulings are typically issued within 4 to 6 months of judge designation, a decision this year is highly probable.

Once the remaining two trials are completed, the dispute is expected to narrow and shift into a legal battle over a few core patents in the Patent Court.

Boehringer Ingelheim has already appealed to the Patent Court against the favorable decision that generic companies secured for the Jardiance use patent (10-2318207). Conversely, the domestic generic alliance that lost the Esgliteo patent (10-1491554) dispute due to a dismissal ruling has also filed an appeal, indicating an upcoming higher-court battle. Meanwhile, Boehringer Ingelheim has not yet decided whether to appeal its June 25 first-instance defeat in the other Jardiance use patent case.