1 of 2 patent suits filed this year proceed to the 2nd round

Novartis files an appeal after generic companies win first trial of patent suits for Entresto

Boryung succeeds in preserving Dukarb patent... companies that lost respond with a two-track strategy

Patent dispute for ‘Galvus’ continues... Novartis counters suit by filing a trial for the ‘active confirmation of the scope of rights'

It seems that the patent disputes in the pharma and bio industry will continue on in the long term.

 

Among the 20 major rulings made during the first trial, 11, over 50% are being retried in a second trial by the Patent Court of Korea.

 

Both the winning and losing parties of the patent suit that had been filed against Boryung Pharmaceutical’s fixed-dose combination for hypertension, ‘Dukarb (fimasartan and amlodipine),’ opted to continue their dispute in a second trial.

 

In the case of the patent dispute over Novartis’s heart failure treatment ‘Entresto (valsartan+sacubitril),’ the original company appealed after the generic drug companies won the first trial.

 

In the case of the dispute over the DPP-4 inhibitor class antidiabetic ‘Galvus (vildagliptin),’ the agenda is being fiercely tried again from square one after the Supreme Court's ruling of remand after reversal, and Novartis is also further countering by filing a trial for the active confirmation of the scope of rights.

 

◆Generics companies win first trial on Entresto...

 

Novartis appeals According to industry sources on the 23rd, 21 major trial rulings and judgments have been made this year for patents in the industry.

 

The number excludes cases where the company voluntarily withdrew its suit after requesting judgment.

 

20 of the cases received a ruling from the Intellectual Property Trial and Appeal Board (first trial), and 1 received a ruling from the Patent Court of Korea (second trial).

 

Of the 20 cases that received a ruling in the first trial, 11 cases chose to continue on to the second trial.

 

This means that more than half of the parties of major disputes did not accept the decision of the first trial.

 

Pic of Entresto

Entresto’s patent dispute is one representative example.

 

The dispute was sparked after its generic companies simultaneously filed suits to invalidate and confirm the passive scope of rights on Entresto’s 6 patents.

 

Starting with Elyson Pharm, 13 companies challenged ▲1 use·composition patent ▲ 1 salt·hydrate patent (un-listed in the patent register) ▲1 use patent ▲1 crystalline form patent ▲2 substance patents for Entresto.

 

The first trial was concluded in favor of the generic companies.

 

Generic companies succeeded in challenging 1 use·substance patent, 1 crystalline form patent, and 2 substance patents.

 

The remaining trials for the use patent and salt·hydrate patent have not been concluded yet.

 

The company of the original drug, Novartis, decided to continue on the fight to the second trial for the crystalline form patent and the use·composition patent in March and July of this year.

 

The company has given up the trials for its other 2 substance patents.

 

Entresto has no drug substance patent, and the role is replaced by the use·composition patent and crystalline form patent.

 

Therefore, Novartis plans to focus its defense strategy around these two patents.

 

◆Both the winning and loser parties appeal to ruling for Dukarb...

 

long-term dispute inevitable

Pic of Dukarb

Two conflicting rulings were made in the first trial for Boryung’s Dukarb patent.

 

Among 40 generic companies that challenged Dukarb’s patent, 2 won against Boryung, while the others lost.

 

29 of the companies filed a new trial on the same patent at the same time.

 

If the first trial they attempted was made to avoid the patent by confirming the passive scope of rights, the companies added a patent invalidation strategy after losing the first trial.

 

From the generic company’s perspective, whether it receives a winning decision from the Patent Court of Korea or a new ruling from the Intellectual Property Trial and Appeal Board, the company will be eligible to release its generic early.

 

This is why companies that challenge the patent are mobilizing all available strategies.

 

Boryung Pharmaceutical also filed a lawsuit against the two pharmaceutical companies that won against the company in the first trial to annul the trial decision.

 

As a result, the Dukarb patent dispute, which began in March last year, is expected to be prolonged to even after the substance patent for Kanarb expires in February next year.

 

◆Galvus dispute to continue to the end...Novartis files active confirmation of the scope of rights # i3 The patent dispute around Galvus was also inconclusive this year.

 

The analysis is that the conflict has been prolonged for more than 5 years due to the sharp differences in the position of the two parties.

 

The situation had also intensified with Novartis' counteract, filing a trial for the active confirmation of the scope of rights.

 

The conflict began in 2017 when Ahn-Gook Pharmaceuticals and Hanmi Pharmaceuticals claimed part of the term extended for the substance patent of Galvus invalid.

 

The generic companies won the first trial.

 

In the second trial, the court overruled the first court’s decision and ruled in favor of the original company.

 

In the third trial, the Supreme court questioned the qualifications of the original company that filed the appeal and remanded it back to the first trial.

 

With the remandment, the dispute resumed in the first instance court.

 

Unlike in the previous first trial, the Intellectual Property Trial and Appeal Board ruled in favor of the original company, and generic companies appealed once again.

 

Currently, Ahn-Gook Pharmaceuticals and Hanmi Pharmaceuticals are waiting for the second trial ruling.

 

Apart from the dispute, Novartis had filed a trial for the active confirmation of the scope of rights against Kyongbo Pharmaceutical, Ahn-Gook Pharmaceuticals, and Korea United Pharm.

 

The active confirmation of the scope of rights is filed by the original companies to protect their patent rights from generic companies.

 

The suit is rarely filed in the domestic pharmaceutical and bio-industry.

 

Kyongbo and the others have already released their generic versions after they won the first trial.

 

The substance patent for Galvus expired in March of this year.

 

However still, Novartis plans to see the dispute to the end and be recognized for the generic companies’ patent infringement.

 

If Novartis wins, it will be possible to claim damages due to patent infringement.

 

All companies that released Galvus generics will be subject to claims for damages.

 

Also, Roche and Alvogen Korea received mixed results over the 3 use patents for Avastin.

 

Alvogen Korea won 2 trials and Roche succeeded in defending 1 claim.

 

Both companies decided to appeal and take the dispute to the second trial.

 

However, Roche withdrew the lawsuit it had filed for cancellation of the trial decision in September and plans to focus on the case appealed by Alvogen Korea.

 

In the patent dispute over Monterizine Cap, Hanmi Pharmaceuticals filed an appeal for the cacellation of the trial decision against 20 pharmaceutical companies after losing the first trial.