Hanmi loses first trial in patent dispute over Galvus

The Intellectual Property Trial And Appeal Board, decided on a “dismissal” request for a judgment on the scope of the passive rights

Galvus

Novartis won the patent dispute between Hanmi and Novartis over the DPP-4 inhibitor-based diabetes treatment agent Galvus (Vildagliptin).

 

The Intellectual Property Trial And Appeal Board made a decision to dismiss the passive right scope verification trial requested by Hanmi on the 1st.

 

Hanmi has filed a total of eight trials for Galvus patent, but the Board has dismissed it.

 

On the same day, Korea United Pharm also lost.

 

It is expected that the trial will have a significant impact on Novartis' application to the Seoul Central District Court for a prohibition of sales disposition, a lawsuit for patent infringement claim, and a lawsuit to cancel an item license.

 

◆Hanmi's new strategy, Patent challenge by dividing indications In July 2018, Hanmi filed a judgment against Novartis to confirm the passive scope of rights for Galvus and Galvusmet's material patents.

 

In the following year, Hanmi applied for permission of Vildagle, salt-changing generic for Galvus.

 

Hanmi applied for a product license except one of the five indications of the original drug, Galvus.

 

It was Hanmi's new patent avoidance strategy.

 

Hanmi unveiled the logic that Novartis' patent is limited to only 3 out of 1-5 indications applied to Galvus.

 

The indication is said that it is used dual oral therapy in combination with Metformin, Sulfonylurea, thiazolidinedione in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy.

 

Galvus

In other words, Hanmi asserted that since the validity of Galvus’ patent right only affects the indication #3 and not the rest of indication #1, #2, #4, and #5, Vildagle also does not infringe patent of Galvus.

 

Novartis refuted this.

 

In fact, the claims of Hanmi made an unreasonable demand because indications were included in the same scope (type II DMtreatment).

 

The MFDS approved the application for Hanmi in January this year.

 

In April, insurance benefits were decided.

 

However, Hanmi has not yet released the product.

 

As the Intellectual Property Trial And Appeal Board decided to take Novartis side on the 1st, the challenge of Hanmi has been put on hold.

 

Vildagle's release schedule has been postponed indefinitely.

 

◆Dutasteride was applied, but why is it not Vildagliptin This patent dispute is of great interest in the industry.

 

It is because expectations are raising whether the challenge of Hanmi will be a new path to generic's patent evasion strategy.

 

It is said that Hanmi got a hint from patent dispute of Dutasteride in 2015.

 

Patent dispute of Dutasteride was similar to Galvus, but proceeded with another issue.

 

At that time, Generic company claimed that the patent for the substance was extended because original company's Dutasteride (Brand name: Avodart) was limited to the permission for prostate hyperplasia.

 

In other words, it was argued that the patent right has no effect in the case of 'hair loss', another indication of Dutasteride.

 

Based on these claims, the MFDS approved it because Generic company applied only one indication for hair loss.

 

The generic company won the patent dispute.

 

The Intellectual Property Trial And Appeal Board judged that the effective right of Dutasteride patent was limited to prostate hyperplasia and did not affect hair loss.

 

Generic succeeded in launching a hair loss indication and before the patent expired.

 

◆Pharmaceutical industry expects new patent avoidance strategy The Judge's decision has not been released.

 

However, in the industry, it is persuasive to argue that the case of Dutasteride and Galvus is different.

 

In the case of the Dutasteride dispute, the indications of prostatic hyperplasia and hair loss are markedly different, whereas the Galvus dispute is virtually the same indication and cannot be regarded as the same case.

 

Generic companies was expecting the result.

 

A domestic patent official said, "It is true that we thought about whether to challenge patent evasion in the same way as Hanmi, but the possibility of success did not seem so high, so we were waiting for the result of this dispute." He added that there is no plan to file a referee with this strategy, the Intellectual Property Trial And Appeal Board did not accept the claim that it should judge the identity of medical use based on the individual indication.

 

Another official in the pharmaceutical industry said, "If Hanmi leads the case with an appeal, it is unlikely that the trial will be overturned."

The trial is expected to have a significant impact on other lawsuits between Novartis and Hanmi.

 

Three related lawsuits are in progress.

 

Novartis has filed a lawsuit against the Seoul Central District Court for infringement and prohibition of sale and filed a lawsuit against the Seoul Administrative Court to cancel the item permission, which is the main lawsuit of the provisional injunction.

 

Three cases are currently pending.

 

If the court accepts the provisional disposition, it is expected that Vildagle will not be available for the time being.