Yungjin won patent dispute on Abilify after 6 years

The Supreme Court dismissed Otsuka's appeal

Yungjin alone challenged

Yungjin won the patent dispute between Otsuka and Yungjin over Abilify (Aripiprazole), a treatment for schizophrenia and bipolar disorder, in six years.

 

This added Abilify's indication for bipolar disorder.

 

Yungjin, which won the dispute, relieved the burden of compensation for damages caused by patent infringement.

 

◆Generic release as an indication for schizophrenia after product patent expiration On the 29th, the Supreme Court reaffirmed the court's decision in the Abilify patent invalidation lawsuit between Otsuka and Yungjin and dismissed the appeal.

 

It has been six years since the conflict began.

 

In 2014, when Abilify's product patents expired, domestic companies entered the generic market one after another.

 

There are five indications of Abilify: schizophrenia, bipolar disorder, major depressive disorder, autism disorder, and Tourette syndrome.

 

Among them, only the indication for schizophrenia was applied due to the expiration of the product patent.

 

Indications for bipolar disorder and major depressive disorder have been expanded as Otsuka's use patent (expired in 2022) was listed.

 

Considering that Abilify is used for both schizophrenia and bipolar disorder, it was beneficial to launch it in both indications.

 

In March 2015, Yungjin filed a trial claiming that the use patent for bipolar disorder was invalidated.

 

However, the Intellectual Property Trial and Appeal Board took the side of the original company Otsuka in October 2016.

 

Otsuka pushed generic companies in all directions by requesting a trial to verify the scope of their rights and sending out certification of contents.

 

Eventually, generic companies sold only as schizophrenia, excluding bipolar disorder, as an indication.

 

◆Yungjin, including indications for bipolar disorder

However, Yungjin was an exception.

 

Yungjin continued fighting against the defeat of the first trial.

 

It filed a lawsuit with the Patent Court of Korea to cancel the trial decision.

 

The Patent Court of Korea overturned the first trial decision.

 

In July 2017, on the side of Yungjin, he ruled that the patent for use with bipolar disorder was invalid.

 

Otsuka objected.

 

Through an appeal, the case was taken to the Supreme Court.

 

A fierce legal dispute ensued in the Supreme Court.

 

The conclusion came out after 3 years.

 

As with the second trial, a ruling was handed over to Yungjin's side.

 

The ruling included Abilify's indications for bipolar disorder, allowing Yungjin as well as other generics to add indications for bipolar disorder to schizophrenia.

 

It can be added immediately after the trial for reversal of revocation in the Patent Court is concluded with a final judgment.

 

Yungjin escaped the crisis of large-scale counterindemnity.

 

If the Supreme Court ruled in favor of Otsuka, it was because Yungjin had to hand over a significant portion of the sales revenue of generics over the past five years to Otsuka.

 

An official from Yungjin said, "Yungjin had a dispute alone.

 

It was defeated in the first trial, but under the judgment that the logic of invalidity was certain, the second trial was enforced and finally won." He predicted that "Otsuka is also in the process of action against infringement of patent, apart from this lawsuit.

 

It is currently in the process of winning the first trial and in the patent court.

 

In line with this Supreme Court decision, the action against infringement of patent will also be finalized." Patent Attorney Park Jong-hyuk, who represented Yungjin, said, "Unlike composition patents and formulation patents, it is not easy to obtain an invalidation judgment.

 

The Supreme Court recently sided with the patentee, but it means that a ruling to invalidate the use patent was made.” He explained "Bipolar disorder is a recurrent disease of two opposing conditions, mania and depression.

 

It is the judgment of the Supreme Court that if there are no experimental data that clearly show the therapeutic effect of both diseases, it is invalid as a description." According to UBIST, a pharmaceutical market research institute, the amount of Aripiprazole's outpatient prescription last year was ₩25.3 billion.

 

Among them, the generic prescription amount is ₩1.3 billion.

 

However, considering that the prescription of Aripiprazole is 40% to 50% for schizophrenia, 30% to 40% for bipolar disorder, and 20% to 30% for the rest of major depressive disorders, the addition of indications for bipolar disorder will increase the prescription performance of generic companies.

 

It is expected to work positively.