When will the Zyprexa lawsuit for damages be concluded?

Still fierce legal battles

Early Generic Release may be difficult when domestic companies lose

Zyprexa

Interest is focused on whether the lawsuit for Zyprexa (Olanzapine) could be completed within this year.

 

The range of compensation for patent infringement is determined according to the decision of the Supreme Court.

 

If the Supreme Court sided with the original company Lilly Korea, it would be an obstacle to the early release of generics by domestic companies.

 

  ◆ Fourth year pending in Supreme Court According to the pharmaceutical industry and legal circles on the 7th, the lawsuit for damages between Lilly Korea and Hanmi filed in the Supreme Court on October 31, 2016 has been in progress on the 1438th day.

 

Myungin’s damage claim, also 944 days have passed since it was filed on March 9, 2018.

 

It seems that the proceedings of the lawsuit have been slow since the conclusion has not been reached for the fourth year, but the legal dispute is still going on very fiercely.

 

Even if it is limited to the Hanmi case, there are more than 30 data submitted by the plaintiff and the defendant.

 

Even just before this Chuseok holiday, the two sides are in a tight confrontation, submitting reference materials and answers.

 

The Supreme Court also appears to be cautious about the decision.

 

The opinions of interest groups and civic groups were received to understand the impact of the judgment.

 

Opinions were submitted by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, the KRPIA, and the Pharmaceutical Association for a Healthy Society.

 

◆ Generic release after overcoming patents, Supreme Court's ruling overturned by 'patent infringement'

The lawsuit is very complicated.

 

The initiation was a request for a patent invalidation trial.

 

In 2008, a trial was filed stating that Zyprexa's patent was invalid.

 

The first and second trials interpreted the patent as invalid.

 

Based on this ruling, Hanmi and Myungin launched generics called 'Olanza' and 'Neurozapine' in 2011.

 

The situation got complicated as the Supreme Court overturned the ruling.

 

Hanmi and Myungin overcame their patents and then infringed suddenly their patents.

 

After the Supreme Court ruling, Lilly fought back.

 

Each filed a lawsuit for damages against Hanmi and Myungin.

 

In both cases, it was ruled to compensate the patentee for damages.

 

Hanmi and Myungin accepted the judgment.

 

The profits from selling generics were paid to Lilly as damages.

 

◆Mixed judgment by the second trial court Usually, a lawsuit for damages due to patent infringement is concluded in this way.

 

However, Lilly Korea, not the patent holder (Lilly's headquarters), filed a lawsuit.

 

Lilly Korea said that the drug price of Zyprexa was lowered with the release of generics, so the two companies should be compensated for the damages.

 

In the first trial, Lilly Korea won.

 

The court ruled in favor of some of the plaintiffs.

 

However, the judgment was changed at the second trial.

 

The two courts made different judgments on the case with the same contents, different from the defendant, Hanmi and Myungin.

 

The second trial court on Hanmi did not accept Lilly Korea's claim.

 

The Seoul High Court interpreted that Hanmi had no 'illegal intentions' because the subject of the drug price cut was the MOHW.

 

On the other hand, the second trial court related to Myungin sided with Lilly Korea.

 

The Patent Court judged that Myungin launched a generic by infringing the patent, knowing well that the drug price of Zyprexa would be lowered, causing damage to Lilly Korea.

 

Accordingly, Lilly Korea and Myungin, who lost in the two cases, each filed appeals.

 

It was October 2016.

 

Four years later, the Supreme Court is struggling with this.

 

◆When Lilly wins,'strategy for early release of generics after overcoming patents' virtually lost The Supreme Court's ruling is expected to have a considerable impact on the domestic pharmaceutical industry.

 

If the Supreme Court decides on the side of Lilly Korea, the strategy of 'early release of generics after overcoming patents' is expected to lose power.

 

This is because the burden of generic companies for patent challenges becomes very large.

 

In the event that a generic company is finally judged for infringement of a patent, it must compensate for damages from drug price cuts in addition to the sales revenue of the generic.

 

There is a possibility that astronomical compensation will be charged depending on the sales volume of the original drug and the period of early generic release.

 

It is pointed out that the generics are released only after the patent dispute is completely ended, and at this time,'early release' becomes impossible.

 

This is because if the original company attempts a 'delay strategy' that leads the patent dispute to the Supreme Court, the release of the generic is delayed and the patent may expire while a dispute is in progress depending on circumstances.

 

◆Does the Supreme Court to conclude this year? As a result, the attention of the pharmaceutical industry and the legal profession is drawn to the Supreme Court, but it is likely that it is difficult to predict what kind of judgment the Supreme Court will make for the time being.

 

One legal official said, “Unlike the first and second trials, the Supreme Court does not make public arguments except in special cases.

 

Most of the schedule and progress of the hearing are kept secret.

 

For this reason, it is difficult for the parties to know when the final judgment will be made.” Another legal official was rumored that the sentence was imminent last year, but in the end, the two sides are still in a firm position, and officials expect that the sentence will be postponed again to next year as the Supreme Court struggles.

 

An official from a pharmaceutical industry said that the cost of the lawsuit itself is ₩1.5 billion for Hanmi and ₩27 million for Myungin, which is not a heavy burden on the company.

 

However, as the Supreme Court decision will determine the direction of the early generic release strategy in the future, it is expected that there will be little impact.