Pharmas succeed in additionally avoiding Entresto patent

Intellectual Property Trial and Appeal Board rule that the claims are established on two of Entresto’s substance patents

Generic companies avoid 3 of the 5 patents protecting Entresto… use patent will be key

Domestic pharmaceutical companies have succeeded in additionally avoiding the patent of Novartis’s heart failure treatment ‘Entresto.’ According to industry sources on the 2nd, the Intellectual Property Trial and Appeal Board recently ruled that the claims were established in the trial to confirm the passive scope of rights on Entresto’s substance patent (10-1700062) that Hanmi Pharmaceuticals filed against Novartis.

 

In May last year, 10 companies in addition to Hanmi Pharmaceutical – Chong Kun Dang, YooYoung Pharmaceutical, Hana Pharm, Hanlim Pharm, Ahn-Gook Pharmaceutical, Genuone Sciences, GenuPharma, Samjin Pharm, Yuyu Pharm, Elyson Pharm – filed the same claims on this patent that is set to expire in 2028.

 

Among these, the decision on Hanmi Pharmaceutical’s trial was the first to be made, and the results of other companies are also expected to be released soon.

 

The Intellectual Property Trial and Appeal Board had also ruled in favor of the generic companies in a trial to confirm the passive scope of rights filed on Entresto’s another substance patent(10-1589317) that is set to expire in 2029 that Hanmi Pharmaceutical and Daewoong Pharmaceuticals had filed.

 

The 10 companies – Chong Kun Dang, YooYoung Pharmaceutical, Hana Pharm, Hanlim Pharm, Ahn-Gook Pharmaceutical, Genuone Sciences, GenuPharma, Samjin Pharm, Yuyu Pharm, and Elyson Pharm – are also challenging the patent, results of which are expected to come out soon.

 

Generic companies have also succeeded in avoiding Entresto’s crystalline patent.

 

At the time, 13 domestic companies including Hanmi Pharmaceuticals and Chong Kun Dang succeeded in avoiding this patent that is set to expire in 2027.

 

Currently, the issue is being tried at the Patent Court of Korea after Novartis’ appeal.

 

Entresto is protected with a total of 5 (including 1 non-listed) patents.

 

The patents are ▲salt and hydrates 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, and another ▲composition patent set to expire in January 2029.

 

Among the 5 patents, generic companies have now overcome 3 patents, the ▲crystalline patent set to expire in September 2027, ▲the composition patent set to expire in November 2028, and another ▲composition patent set to expire in January 2029.

 

Only two patents, ▲the salt and hydrates patent that expires in November 2026 and the ▲use patent that expires in July 2027 are now left to be challenged.

 

If the generic companies succeed in overcoming the remaining patents, they will qualify for early generic release.

 

Entresto's PMS already expired in April.

 

The key is likely to be the use patent that is set to expire in July 2027.

 

Entresto is a combination drug of valsartan and sacubitril and has no separate substance patent.

 

Therefore, the two patents on the ingredients act as substance patents.

 

Entresto is Novartis’ heart failure treatment that was launched in October 2017 in Korea.

 

According to the market research institution UBIST, outpatient prescription sales of Entresto have been rapidly increasing in size after recording ₩6.3 billion in 2018.

 

Its sales recorded ₩32.3 billion last year.