Yungjin Pharm wins the 1st trial against Ofev

Indication including the clause 'excluding IPF' has been approved…MFDS acknowledges the 'exclusion clause' for the first time

Exclusion clause was a key to Yungjin Pharm's victory… will this become the new patent avoidance strategy?

Yungjin Pharm has won the usage patent dispute for Ofev (nintedanib), a treatment for idiopathic pulmonary fibrosis (IPF).

 

Based on the victory, Yungjin is one step closer to the early launch of its generic version of Ofev.

 

The pharmaceutical industry suggests this decision is significant beyond Yungjin Pharmaceutical's avoidance of Ofev's usage patent.

 

It may serve as a patent-avoidance strategy for generics.

 

Yungjin Pharm wins the first trial for Ofev's usage patent…brings closer to the early launch of generic According to the pharmaceutical industry on December 20, the Korean Intellectual Property Trial and Appeal Board (IPTAB) recently issued a decision of 'claim upheld' in a passive rights scope confirmation trial filed by Yungjin Pharm against Boehringer Ingelheim regarding the usage patent of 'Ofev Soft Cap.' In September, Yungjin Pharm filed claims for a passive rights scope confirmation trial against the usage patent of Ofev.

 

Following that, Cosmax Bio and Daewoong Pharmaceutical also filed claims for the same avoidance trials.

 

Among these companies, Yungjin Pharm was the first to win..

 

Product photo of Ofev

Ofev is protected by at least three patents: a substance patent expiring in January 2025, a usage patent expiring in September 2026, and a formulation patent expiring in June 2029.

 

Only the substance patent is listed in the Ministry of Food and Drug Safety's (MFDS) patent registry, while the usage·formulation patents are unlisted patents.

 

Having won the first trial for the usage patent, Yungjin Pharm is now closer to the early launching its generic version of Ofev.

 

On December 12, Yungjin Pharm received approval for its generic version of Ofev as 'Nintebro.' The generic can be launched after the substance patent expires on January 25.

 

The unlisted formulation patent remains to be solved but nullifying the substance patent is easier than the substance patent or usage patent.

 

Yungjin Pharm is expected to enter the KRW 5.7 billion (USD 4.3 million) nintedanib market with the sole generic version of Ofeb if it launches its product.

 

According to pharmaceutical market research firm IQVIA, Ofev's sales in 2023 totaled KRW 5.7 billion.

 

Despite not being covered by national health insurance, Ofev has steadily increased its sales, reporting KRW 1.8 billion in 2020, KRW 3.3 billion in 2021, KRW 5.6 billion in 2022, and KRW 5.7 billion last year.

 

A single clause in the generic's indication was the key to determining the patent dispute outcome The pharmaceutical industry closely examines the reasons behind Yungjin Pharm's victory in the usage-patent dispute.

 

This success is due to the company's innovative strategy to address the usage-patent conflict, setting it apart from traditional methods.

 

The key to the victory was the MFDS' acknowledgment of the 'exclusion clause.' Nintebro approval was the first time the MFDS has acknowledged 'excluding X.' Ofev is approved for the following indications: ▲Treatment of IPF ▲Delay of pulmonary function decline in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) ▲Treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype (excluding IPF).

 

For Nintebro, it is approved for the following indications: ▲Delay of pulmonary function decline in patients with SSc-ILD ▲Treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype, excluding IPF.

 

Boehringer Ingelheim

Yungjin Pharm

The analysis suggests a key element in the trial outcome in this usage-patent dispute was the 'excluding IPF' clause in Nintebro's second indication.

 

Yungjin Pharm strategically focused on the remaining indications of Ofev, deliberately excluding IPF to circumvent the drug's usage patent.

 

If the MFDS had not acknowledged the 'exclusion clause,' Yungjin Pharm's strategy may not have been successful.

 

Even if the company removed Ofev's first indication, IPF could be interpreted as being included within Ofev's third indication.

 

In other words, if Yungjin Pharm had not included the exclusion clause in the Nintebro indication, the company would have won the avoidance only if it had deleted Ofev's first and third indications.

 

However, the MFDS recognized the wording 'excluding IPF' for Nintebro's second indication, which Yungjin Pharm strategically emphasized during the patent dispute.

 

Ultimately, the Korean IPTAB accepted Yungjin Pharm's argument, ruling that Nintebro did not infringe on Ofev's usage patent.

 

MFDS has acknowledged the 'excluding X' clause for the first time…will this become the new patent avoidance strategy? Until now, the MFDS has not acknowledged phrases such as 'excluding X' in the indication section during the drug approval process.

 

Generic manufacturers have repeatedly requested MFDS to acknowledge such exclusion clause to circumvent originator companies' specific use patents.

 

However, until now, only the deletion of certain indications was permitted, which was a more passive approach.

 

In the Nintebro case, the MFDS broke from its traditional practices, approving an active approach that recognizes indications excluding certain conditions for the first time.

 

The pharmaceutical industry positively views this precedent as a new strategy for patent avoidance.

 

If generic manufacturers focus on obtaining approval for exclusionary language such as 'excluding X' during the regulatory process, they could secure a significant advantage in subsequent usage patent challenges.

 

"Previously, avoiding patent infringement was difficult if the 'active exclusion clause' was not included in the efficacy and effectiveness section of a generic," Park Jong Hyuk, Yungjin Pharm's patent attorney, said.

 

"The company received the ruling by including the exclusion clause in the efficacy and effectiveness section of the generic.

 

It will now open a new door for avoiding patient group-specific discovery," Park said.

 

Industry experts view that the recent ruling is expected to expand access to nintedanib for patients with rare pulmonary diseases in South Korea.

 

Ofev has not yet been listed for reimbursement under the national health insurance system, leaving patients to pay approximately KRW 3 million monthly for the medication.

 

The high cost has prompted a public petition for its inclusion in the reimbursement list.

 

Now, the generic version of Ofev can be launched earlier.

 

Patients will be able to access medication at a lower price.