Patent dispute over Entresto's patents continue

which posts sales of KRW 40 billion a year

Three second trials in progress... prolonged dispute

Novartis files appeal after losing 1st trial for its salt·hydrate patent

Is defending its crystalline form patent and use patent in 2nd trial... results to be known next month

Pic of Entresto

The patent dispute over ‘Entresto (sacubitril/valsartan),’ a chronic heart failure treatment with an annual prescription of more than KRW 40 billion, has been ongoing for over 2 years now.

 

Novartis, the company that owns the original drug, is actively pursuing a defense strategy against generic companies' patent challenges.

 

Novartis appealed after losing the 1st trial, and three cases are being tried in the second trial.

 

Some of the results are expected to be pronounced next month.

 

According to industry sources on the 8th, Novartis filed a trial revocation litigation against Hanmi Pharm and Elyson Pharm regarding Entresto’s salt·hydrate patent (10-1549318).

 

After losing to generic companies in the Intellectual Property Trial and Appeal Board (1st trial), the company filed an appeal to the Patent Court of Korea against the ruling.

 

Due to Novartis' appeal, the number of patent disputes in the second trial increased to 3.

 

In addition to the salt and hydrate patents, Novartis and generic companies are in dispute in the Patent Court of Korea the crystalline form patent (10-1432821) and composition/use patent (10-0984939) of Entresto.

 

Entresto is protected by 6 patents: ▲salt and hydrate patent that expires in November 2026, ▲use patent that expires in July 2027, ▲crystalline patent set to expire in September 2027, ▲composition patent set to expire in November 2028 (10-1700062), ▲another composition patent set to expire in January 2029 (10-1589317), and ▲a use patent set to expire in 2033 (10-2159601).

 

Among the 6 patents, generic companies have succeeded in nullifying or avoiding 2 patents.

 

The results of the two were finalized after the generic companies won the first trial and Novartis did not file an appeal.

 

In the case of the use patent that expires in 2033, the patent was listed after generic companies applied for marketing authorization of their generics.

 

The generic companies have also succeeded in winning against Novartis in the first trial for the other 3 patents as well.

 

However, Novartis chose to appeal and proceed to the Patent Court of Korea for all 3 cases.

 

The Patent Court of Korea announced that it will make a ruling on the crystalline patent on the 14th of next month.

 

This means that the outline of the second trial rulings regarding the Entresto patent dispute will be revealed next month.

 

After this ruling, the other 2 rulings are expected to be made until next year.

 

If the party that loses the 2nd trial decides to go on to the Supreme Court, the Entresto patent dispute is likely to be prolonged to more than 4 years.

 

Since 2021, generic companies have been filing trials against Entresto's patents.

 

Starting with Elyson Pharm, about 10 companies including Hanmi Pharm, Chong Kun Dang, and Daewoong Pharmaceutical jumped into the dispute.

 

Meanwhile, according to the market research institute UBIST, Entresto's outpatient prescriptions amounted to KRW 42.5 billion last year.

 

Entresto has shown rapid growth in the market, increasing prescription sales by nearly KRW 10 billion every year.

 

Its prescription performance, which recorded KRW 5.5 billion in 2018, increased to KRW 14.3 billion in 2019, KRW 22.4 billion in 2020, then to KRW 32.4 billion in 2021.