Generic companies win 3 out 4 patent disputes

[2023 Pharma Patent Dispute Summary] Companies challenging patents win 3 out of 4 disputes

Generic companies won in the Supreme Court for Forxiga& Pazeo Eye Drops, but lost in Dukarb dispute

Original developers faced defeat in the 1st trial of the patent disputes involving Jublia, Recomid, and Monterizine

This year, out of 29 trial decision and verdict cases that arose as patent disputes, companies that filed a trial or lawsuit have won in 21 cases.

 

This translates to a win rate of approximately 76% for companies challenging patents.

 

Especially, excluding cases where the lawsuit or suit qualification was deemed ineligible, the dispute hadn’t commenced, or was dismissed, generic companies have won all the other disputes, except for the Dukarb dispute.

 

This year, patent challenging companies have won 22 out of 29 trial decision and verdict cases According to the pharmaceutical industry on the 26th, 29 cases of trial decisions and verdicts were made on patent disputes, excluding those cases with voluntary withdrawal of trial decisions or lawsuits.

 

The 21 patent dispute cases included trial decisions from the first trial at the Intellectual Property Trial and Appeal Board (IPTAB), 5 verdicts from the second trial at the Patent Court of Korea, 3 verdicts from the third trial at the Supreme Court of Korea.

 

Out of the 29 cases, 22 were won by companies that filed for the trial decisions or lawsuit.

 

In terms of pharmaceutical patents, of the 4 cases that reached final decisions or lawsuits, 3 of which (76%) ended in victory.

 

Excluding instances where cases were dismissed because the requirements for a patent trial claim were not met, or cases where the patent-holder deleted the related claim phrase after the trial has begun, generic companies have scored a major victory in all disputes, except for the Dukarb dispute.

 

When generic companies challenge a patent, they typically approach it with a fully developed abdication or invalidating plan; therefore, this approach is known to contribute to a high success rate in the first trial.

 

In other words, it’s relatively rare for companies challenging patents to lose in the first trial.

 

For these reasons, pharmaceutical companies are closely watching the first trial decision in the Dukarb’ dispute.

 

In Jaunary 2023, the IPTAB ruled in favor of the original-drug developer, dismissing the trial decision regarding Arlico pharm and others who filed a patent invalidation trial against Boryung Pharmaceutical’s combination drug patent related to Dukarb.

 

Boryung also secured a victory in the second trial.

 

In November, the patent court of Korea ruled against the plaintiffs in two cases of Dukarb patent disputes, favoring Boryung.

 

These cases are awaiting a final ruling by the Supreme Court, following an appeal by generic companies who lost in the second trials.

 

Boryung, having won both first and second trials, has been able to maintain the patent for Dukarb key dosages (30/5mg).

 

As a result, generic companies are unable to release generics of these key dosages onto the market.

 

Disputes involving Forxiga and Pazeo Eye Drops have finally concluded, with generic companies securing victory The two disputes involving SGLT-2 class diabetes treatments, Forxiga and Pazeo Eye Drops, have finally concluded with the Supreme Court ultimately ruling in favor of the generic companies that challenged patents.

 

In February 2023, the Supreme Court issued a final ruling on the patent dispute regarding Forxiga, concluding a patent dispute that spanned eight years.

 

The dispute comes after Kukje Pharma and other Korean companies filed a patent invalidation trial of the 2nd substance patent.

 

The generic companies won both the first and second trials.

 

AstraZeneca then appealed to the Supreme Court.

 

However, in February, the Supreme Court ultimately ruled in favor of the generic companies.

 

Following their victory in the lawsuit, generic companies could advance their plans by 9 months.

 

After the 1st substance patent voided on April 7th 2023, generics released their drugs onto the market.

 

In August, the Supreme Court delivered a final ruling on the patent dispute concerning Pazeo Eye Drops.

 

The generic companies secured an ultimate victory after a six-year-long patent dispute.

 

The dispute started on June 2017, when SamChunDang Pharm filed a patent invalidation trial against an active ingredient patent.

 

Then in the following year, Hanmi Pharm filed a patent invalidation trial in another active ingredient patent.

 

Having lost in the first trial, generic companies won all cases of the lawsuits.

 

Novartis then appealed to the court, but the generic companies ultimately won the cases.

 

Generic companies win patent disputes of Jublia, Recomid, and Monterizine The patent disputes concerning Jublia Topical Solution, Recomid SR Tab., Monterizine Cap., Ibrance Cap., Lenvima Cap., and Opsumit Tab.

 

reached decisions in the first trials.

 

In the patent dispute involving Jublia, seven companies, including Daewoong Therapeutics, gained victories in the first trial in November.

 

In a similar lawsuit, ten pharmaceutical companies, including, Jeil Pharm, are still awaiting a decision.

 

Yet, pharmaceutical companies anticipate that generic companies will likely win the cases, in line with previous trial decisions.

 

Companies like Mother’s Pharmaceutical have won patent dispute in the first trial related to Yuhan’s Recomid SR Tab.

 

in October.

 

Last year, when generic companies filed for patent lawsuits, the reimbursement status of Rebamipide ingredient, which includes Recomid SR Tab., was uncertain because those were included as candidates in the 2023 reimbursement re-evaluation review.

 

This year, however, Rebamipide successfully passed the reimbursement re-evaluation review.

 

Additionally, the companies that challenged patents have also won in related trials, thus increasing the likelihood of early releases of generics.

 

Companies like Han Wha Pharma achieved victory in trial decisions on four cases related to passive trials to confirm the scope of a right involving Hanmi Pharm’s Monterizine Cap.

 

active ingredient patent.

 

Although Hanmi Pharm, the original-drug developer, appealed to the patent court of Korea for two out of these four cases, the disputes ended with its withdrawal.

 

Companies like Shin Poong Pharmaceutical, Boryung Pharmaceutical, and Samjin Pharmaceutical have achieved victories in passive trial to confirm the scope of a right.

 

Shin Poong Pharmaceutical won against Pfizer's Ibrance active ingredient patent in October, Boryung Pharmaceutical Eisai's Lenvima active ingredient patent and salt and crystalline form patent in August, and Samjin Pharmaceutical won Actelion's Opsumit active ingredient patent in April.

 

Novartis faced defeat in passive trial to confirm the scope of a right involving Gabes ingredient patent filed against Kyongbo Pharmaceutical.

 

The Patent Court of Korea ruled against Novartis in April of this year.

 

Despite Novartis previously initiating patent litigation against generic companies, these efforts did not achieve the desired outcomes.

 

In January of the previous year, Novartis had filed a passive trial to confirm the scope of a right with the Patent Court of Korea to ascertain whether Kyongbo Pharmaceutical had infringed on the Gabes ingredient patent.