Never-ending patent dispute over Galvus

Proactive claim for judgment on the scope of rights against generic companies

Litigation related to the invalidation of material patent extension is still ongoing

In a patent dispute over Galvus, a DPP-4 inhibitor-type diabetes treatment, Novartis received a dismissal from the Intellectual Property Tribunal.

 

Apart from this trial decision, the Galvus patent dispute is expected to continue for some time.

 

This is because the dispute between Novartis and the generic company regarding the extension of the duration has not yet been resolved, even though the substance patent expired in March of last year.

 

According to the pharmaceutical industry on the 14th, the Intellectual Property Tribunal recently made a decision to dismiss Novartis in a trial to confirm the scope of its rights filed against a generic company.

 

A dismissal is a trial decision in the sense that the claim does not meet the appropriate requirements.

 

In January 2022, Novartis had previously requested a judgment to confirm the scope of its rights against Kyongbo Pharmaceuticals, United, Ahn-Gook, and Ahngook Newpharm.

 

It was a judgment requesting a judgment on whether they infringed on some of the Galvus material patent claims.

 

Generic companies released generics for Galvus one after another after the Supreme Court ruling in October 2021.

 

Novartis argued that the validity of the Galvus material patent is also valid as the Supreme Court issued a ruling on remand overturns, but the dispute was not finalized as the first trial appealed.

 

Accordingly, it was argued that the early release of generics by generic companies also has room for patent infringement.

 

While this trial was in progress, the Galvus material patent expired (March 4, 2022).

 

In the end, it is analyzed that the Intellectual Property Trial and Appeal Board made a decision to dismiss the trial, judging that the active trial for confirmation of the scope of rights requested by Novartis did not meet the appropriate requirements as a trial.

 

In 2017, Ahn-Gook and others requested a judgment against Novartis that part of the Galvus material patent duration was invalid.

 

In the first trial, the generic company won, and in the second trial, Novartis won.

 

The Intellectual Property Trial and Appeal Board determined that 187 days of Galvus material patents were invalid, and the Patent Court ruled that 55 days were invalid.

 

After the second trial, Novartis appealed.

 

However, the Supreme Court judged that Novartis, which won in the second trial, had no right to appeal, and remanded the case to the first trial.

 

In May of last year, the Intellectual Property Tribunal sided with Novartis.

 

This time, generic companies appealed.

 

The Patent Court opened its defense in January this year.

 

On the 20th of this month, the second defendant has been announced.

 

According to UBIST, a pharmaceutical market research institute, the combined prescription of Galvus and Galvusmet last year was 32.4 billion won.

 

It decreased by 30.7% compared to 46.6 billion won in 2021.

 

Generic products such as Kyongbo, Hanmi Pharm, and Ahn-Gook, which were released early last year, recorded a combined prescription record of 14.5 billion won.