Prolonged Galvus patent dispute… results to come next year?

Supreme Court is contemplating on Novartis vs. Ahn-gook’s ‘invalidation of substance patent extension’ case

No early release benefit for generic companies if ruling comes after March 2022

The patent dispute surrounding Novartis’ anti-diabetic DPP-4 inhibitor ‘Galvus (vildagliptin)’ may be prolonged and not be concluded within this year.

 

With the substance patent of the said product to expire in March of next year, the benefits of early release will disappear for generic companies if the ruling comes after then.

 

However, generic companies plan to continue the legal dispute to the end in consideration of the impact this case will have on future pharmaceutical patent strategies set by the industry in general.

 

◆4 years of legal dispute over invalidation of the extended period for a substance patent deepens Supreme Court’s concerns

Pic of Galvus

1According to the pharmaceutical industry, the legal dispute between the original drugmaker Novartis and generic companies centered around Ahn-Gook Pharmaceutical is ongoing for 4 years now.

 

The case is currently pending in the Supreme Court.

 

In November last year, Novartis filed an appeal to the Supreme Court despite the partial win it received in the second trial.

 

The period for the dismissal of appeal to the Supreme Court had passed, and the Supreme Court will now officially review the legal dispute.

 

However, negative prospects on whether the Supreme Court will make a final decision soon are being raised, as the court will have to carefully examine this new type of legal dispute that had not existed in the past.

 

A legal official said, “Many legal suits to invalidate the extended period of substance patents for pharmaceuticals had been filed; however, the claims had never been recognized in the first or second trial.

 

The Galvus case was the first ruling by the court that accepted the invalidation claim to shorten the extended term of a patent.” “Due to these issues that require careful consideration, the Supreme Court seems to be seriously contemplating on the case.

 

Even the parties in dispute will not be able to predict the date of the Supreme Court's ruling, and there is a possibility that a final decision will not be reached within this year," he added.

 

◆Despite substance patent expiry in March 2022, generic companies are 'in for the whole fight' The key is whether the Supreme Court will make its ruling before March 4th of next year.

 

March 4th is the date when the substance patent for Galvus expires.

 

If the court’s ruling comes after May 4th, the generic companies will not be able to reap the benefits of overcoming Galvus’s patent or from the early release of its generic.

 

According to UBIST, Galvus and Galvusmet sold 8.1 billion and 36.4 billion won in outpatient prescriptions last year.

 

If the ruling comes after March, the generic companies will lose the opportunity to acquire the right to exclusive marketing approval of their generic in the prescription market that amounts to 40 billion won per year.

 

Despite the risks, the generic companies plan to fight the full battle, as the results of this legal dispute may set a new milestone for generic companies in establishing patent strategies for generics in the future.

 

If the generic companies succeed in invalidating even just one day of the extended patent term, this will may start a series of challenges on substance patents of original drugs, an area that had been considered impregnable.

 

◆187 days vs 55 days vs 0 days… What will the Supreme court’s judgment be?

The Supreme Court‘s ruling is expected to be one of the three – recognizing the ‘187 days invalid’ by accepting the ruling of the first trial; recognizing the ’55 days invalid’ by accepting the ruling of the second trial, or accepting Novartis’ claim and not recognizing any part of the term invalid.

 

The conflict began 4 years ago in July 2018 when Ahn-Gook Pharmaceutical requested a trial claiming that part of the term extended for the substance patent of Galvus is invalid.

 

Hanmi Pharmaceutical later joined in the fight.

 

Patent rights are usually protected for 20 years from the filing date.

 

For pharmaceutical products, the time taken for clinical trials and regulatory approval is added to the protection term.

 

Depending on the recognized period, patent protection for a drug can last 21 years or even 22 years.

 

The same applied to Novartis when applying for Galvus’s patent in Korea.

 

The company requested the patent term for Galvus to be extended to make up for the time spent on clinical trials and for the regulatory review by the Ministry of Food and Drugs Safety.

 

The Korean Intellectual Property Office accepted the request and extended the term by 2 years, 2 months, and 23 days (1068 days).

 

Ahn-Gook Pharmaceutical claimed that the 187 days of the extended term for Galvus’s substance patent was invalid.

 

IPTAB accepted Ahn-Gook claim and ruled the 187 days invalid.

 

Novartis appealed, and the case went to the hands of the Patent Court of Korea.

 

Intellectual Property Trial and Appeal Board had overturned the first instance judgment to take Novartis’ side.

 

However, the court ruled that only 55 of the 187 days are invalid.

 

As a result, Ahn-Gook did lose the suit but reaped the rewards.

 

As a result, Novartis once again appealed, and the case is not being reviewed by the Supreme Court.