Victory in 7 out of 13 Trials – Ongoing Appeals Crucial
Strategic Advantage Seen in Anticipation of Original Manufacturer’s Legal Actions
In June, the launch of a generic version of the diabetes treatment 'Trajenta' was met with ongoing 바카라 프로 disputes, presenting significant challenges. South Korean pharmaceutical companies, however, are currently gaining the upper hand, particularly in the initial 바카라 프로 trials.
Korean United Pharmaceuticals and Korea Biochem Pharm recently secured favorable rulings in the 바카라 프로 trial concerning the 'DPP IV Inhibitor Formulations' 바카라 프로', which validates their claims. This 바카라 프로, related to Boehringer Ingelheim's 'Trajenta' (linagliptin) and its combination with metformin, 'Trajenta Duo,' is set to expire on April 30, 2027.
The ongoing 바카라 프로 trials are divided into two categories: invalidation trials aimed at nullifying the 바카라 프로 and passive scope confirmation trials to avoid infringement. Daewon Pharmaceutical was the first to file an invalidation trial last July, while Korean United Pharmaceuticals and Korea Biochem Pharm initiated passive scope confirmation trials. Although Aprogen Pharma and Ilhwa received favorable rulings on June 17, the delayed decision was due to procedural aspects.
Despite the product’s launch, the ongoing disputes over Trajenta highlight continued efforts to challenge non-registered 바카라 프로s. Currently, 13 disputes related to non-registered 바카라 프로s for Trajenta (including Trajenta Duo) are ongoing. These disputes involve formulations, manufacturing methods, and usage, divided into various "evergreening" strategies. Companies are actively identifying and challenging these non-registered 바카라 프로s, leading to a series of legal battles.
One confirmed victory involves a formulation 바카라 프로 set to expire in April 2027, originally challenged by Shinil Pharmaceutical. Though Shinil eventually withdrew its case, it had already secured a favorable ruling. Additionally, Genuone Science achieved the first victory in the non-registered 바카라 프로 disputes concerning another formulation 바카라 프로 expiring in 2027.
While lawsuits involving two manufacturing method 바카라 프로s and three usage 바카라 프로s remain ongoing, recent victories mark a turning point. The number of successfully challenged 바카라 프로s now exceeds those still pending.
Pharmaceutical companies are persistently challenging 바카라 프로s even post-launch, driven by the potential to reduce future liabilities, such as damage claims, by invalidating or circumventing 바카라 프로s.
In late May, Boehringer Ingelheim issued a formal notice, asserting that generic developers were infringing on its 바카라 프로s and warning of injunctions and damage claims if generics were brought to market. Despite this, 19 companies received approval to market 127 generic products, with some eligible for launch as early as June 9.
Under the current 바카라 프로 linkage system, generic companies cannot be challenged merely for selling their products. However, the issue arises because some 바카라 프로s were not registered on the Green List, creating uncertainty about potential legal actions multinational companies might pursue if the generics show significant market performance.
As South Korean companies continue to navigate and overcome these 바카라 프로s, industry speculation suggests they could gain a strategic advantage in future litigation if more 바카라 프로s are invalidated or circumvented. With the number of overcome 바카라 프로s now exceeding those still in contention, interest is growing in how far these 바카라 프로 disputes will extend between domestic pharmaceutical companies and the original 바카라 프로 holders.