K-CAB·Entresto awaiting the Supreme Court rulings

For the K-CAB patent dispute, HK inno.N·generic companies proceed to the Supreme Court

For the Entresto patent dispute, the Supreme Court ruling and the Intellectual Property Court of Korea ruling remain

Dukarb·Zemiglo patent disputes nearing end…will they reach conclusion this year?

Patent disputes involving blockbuster drugs, K-CAB (tegoprazan) and Entresto (valsartan/sacubitril), are reaching their final stages.

 

Observations suggest that the Supreme Court's final ruling could come as early as the second half of this year.

 

K-CAB's annual prescription sales amount to KRW 200 billion, while Entresto's are KRW 70 billion.

 

In other words, the patent barriers for these blockbuster drugs could be lifted, depending on the Supreme Court's decision.

 

K-CAB Crystal Form and Substance Patent Disputes Head to Supreme Court… Will KRW 200 Billion Patent Barrier Be Lifted?

Product photo of K-CAB

According to the pharmaceutical industry on July 2, HK inno.N and generic companies are awaiting the Supreme Court's ruling in their disputes over K-CAB's substance patent and crystal form patent.

 

For the crystal form patent, generic companies won both the first and second instances.

 

Approximately 80 companies filed declaratory judgment actions to circumvent K-CAB's crystal form patent and won in the first instance.

 

Generic companies continued their winning streak in the second trial following HK inno.N's appeal.

 

HK inno.N, having lost in the second trial, chose to appeal to the Supreme Court.

 

Cases were successively filed with the Supreme Court starting in March this year.

 

In May, a presiding Supreme Court Justice and the presiding panel were assigned.

 

The panel is currently reviewing the legal arguments for the appeal.

 

Industry observers predict that a Supreme Court ruling could come as early as this year.

 

In contrast, in the substance patent dispute, HK inno.N has consistently won.

 

The Intellectual Property Court of Korea has issued successive rulings in favor of HK inno.N since May this year.

 

Generic companies that lost in the second trials have submitted appeals to the Supreme Court.

 

In some appeals, the Supreme Court's final judgment has already been rendered.

 

In May, the Supreme Court dismissed the appeals filed by generic companies without deliberation, upholding the original judgment.

 

Dismissal without deliberation is a system in which the Supreme Court rejects an appeal without conducting a full review of the merits if it determines that there are no specific grounds, such as legal violations, in the original judgment.

 

However, an analysis suggests it is difficult to interpret this as HK inno.N having definitively secured victory in the substance patent dispute.

 

This is because if generic companies present arguments different from those of LitePharmTech and HLB Pharmaceutical, there remains a possibility for the Supreme Court to initiate a full review of the merits.

 

In such a case, some view that the final ruling could change.

 

The timing of the early launch for generics will be determined by the Supreme Court's final ruling on both the crystal form patent and substance patent disputes.

 

This means that the patent barrier for K-CAB, which has grown to an annual market size of KRW 200 billion, could be lifted as early as this year.

 

K-CAB's substance patent is set to expire in August 2031, and its crystal form patent is scheduled to expire in March 2036.

 

If the Supreme Court rules in favor of the generic companies in both the substance patent and crystal form patent disputes, generic companies could launch their products immediately.

 

In contrast, if, as in the first and second instances, generic companies win the crystal form patent dispute and HK inno.N wins the substance patent dispute, the generic launch date would be August 2031.

 

If the Supreme Court rules in favor of HK inno.N in both the crystal form patent and substance patent disputes, a generic launch would not be possible until 2036.

 

Entresto Patent Dispute Nearing Conclusion with One Case Each Pending in 2nd·3rd Trials...Crystal Form Patent Appeal is Key

Product photo of Entresto

The Entresto patent dispute is also heading towards its final stages.

 

Generic companies filed invalidation and declaratory judgment actions against six Entresto patents starting in January 2021.

 

Generic companies won all cases in the first trial.

 

After losing in the first trial, Novartis appealed three of the six patents.

 

Novartis lost the appeal related to the use patent.

 

Novartis subsequently appealed to the Supreme Court but received a dismissal without deliberation ruling in April last year.

 

With this, generic companies have overcome the use patent, which expires in July 2027.

 

Novartis also lost the appeal related to the crystal form patent and appealed to the Supreme Court.

 

In April this year, the deliberation period expired.

 

This means that, unlike the use patent dispute, a full review of the merits will proceed, and a ruling could potentially come within the year.

 

The appeal for the salt·hydrate patent is still pending in the second trial.

 

A hearing date has not yet been set.

 

Industry observers predict that once a ruling is issued for the crystal form patent appeal, a ruling of similar conclusion will follow.

 

If the crucial crystal form patent appeal ruling is handed down this year, the possibility of a generic early launch will further increase.

 

Entresto's crystal form patent is set to expire in September 2040.

 

The salt·hydrate patent is set to expire in November of next year.

 

Suppose the Supreme Court rules in favor of the generic companies in the crystal form patent appeal, as in the first and second instances.

 

In that case, the challenging companies can launch their products immediately.

 

Although the salt·hydrate patent dispute is still ongoing, the product launch becomes possible based on the victory in the first trial.

 

Once the salt/hydrate patent expires in November next year, related risks will also be resolved.

 

Dukarb Patent Dispute Nearing Conclusion...Will Zemiglo Dispute End in 2nd Trial? Patent disputes surrounding Boryung's hypertension combination drug Dukarb (fimasartan/amlodipine) and LG Chem's diabetes treatment Zemiglo (gemigliptin) are also nearing their conclusions.

 

In the case of Dukarb, a Supreme Court ruling was recently issued.

 

The Supreme Court remanded the Dukarb patent invalidation lawsuit appeal on the 26th of last month.

 

This overturned the second trial ruling and sided with the generic companies.

 

Following the Supreme Court's decision, the Dukarb patent dispute will be re-litigated at the original court, the Intellectual Property Court of Korea.

 

The pharmaceutical industry expects that since the Supreme Court found legal issues in the second trial's judgment, the Intellectual Property Court of Korea is highly likely to overturn its previous ruling and side with the generic companies.

 

Once the Intellectual Property Court of Korea issues ruling, the Dukarb patent dispute, which has lasted over four years, will effectively conclude.

 

If generic companies secure a final victory at the Intellectual Property Court of Korea, the launch of generics for Dukarb's core 30/5mg dosage product will become possible.

 

Dukarb was launched in four dosages: ▲30/5mg ▲30/10mg ▲60/5mg ▲60/10mg.

 

Among these, the 30/5mg dosage is reported to account for over 60% of Dukarb's total sales.

 

Furthermore, the combination composition patent, which is at the heart of the Dukarb dispute, applies only to this dosage.

 

Generic companies launched Dukarb generics after the expiration of the fimasartan single-agent (Kanarb) substance patent in February 2023.

 

However, generics for the 30/5mg dosage could not be launched due to the combination composition patent.

 

As a result, Dukarb generics have struggled to gain traction in the prescription market.

 

In Q1 this year, the combined prescription sales of Dukarb generics amounted to only KRW 700 million.

 

The Zemiglo patent dispute is nearing its second trial ruling.

 

The Intellectual Property Court of Korea has scheduled the verdict for the Zemiglo patent invalidation lawsuit for the 21st of next month.

 

Generic companies filed invalidation trials and declaratory judgment actions against the Zemiglo use patent starting in May 2023.

 

Generic companies prevailed in the first instance.

 

The Intellectual Property Trial and Appeal Board issued rulings in favor of the generic companies in April and September 2024, respectively.

 

LG Chem appealed.

 

Generic companies also won in the subsequent appeal.

 

The Intellectual Property Court of Korea sided with the generic companies in the appeal against the declaratory judgment ruling.

 

LG Chem decided not to appeal this ruling to the Supreme Court.

 

The appeal against the patent invalidation ruling is scheduled for a verdict next month.

 

Some in the industry predict that even if generic companies win in the second trial, LG Chem will likely forgo appealing to the Supreme Court.

 

This is because LG Chem had already lost and chose not to appeal the previous judgment related to the declaratory order.

 

This ruling could significantly accelerate the launch of Zemiglo generics.

 

The Zemiglo use patent, challenged by generic companies, expires in October 2039.

 

In addition to this patent, two other patents remain: a salt·hydrate patent that expires in October 2031 and a substance patent that expires in January 2030.