Novartis loses 2nd trial for its Entresto patent

bringing the entry of generics nearer

Patent Court of Korea rules in favor of generic companies…companies succeed in overcoming composition and use of patents

If generic companies win the other 2 suits... green light will be lit for generic entry

The second trial over Novartis’s heart failure treatment ‘Entresto (valsartan+ sacubitril) again ended with the victory of the Korean generic companies.

 

If the companies succeed in winning the remaining 2 suits, the companies will be one step closer to the early release of their generics.

 

Generic companies win first and second trials on Entresto’s composition and use patent According to industry sources on the 10th, the Patent Court of Korea ruled against the plaintiff (Novartis) in the second patent invalidation trial that Novartis filed against 10 generic companies, including Hanmi Pharmaceutical, on the 9th.

 

The patent was a composition/use patent that was set to expire in July 2027.

 

In April 2021, 10 companies including Hanmi Pharmaceutical filed an invalidation trial on the patent.

 

In July of the following year, the Property Trial and Appeal Board (1st trial) ruled the claims valid.

 

After losing the 1st trial, Novartis filed an appeal to the Patent Court of Korea to cancel the trial decision.

 

However, the 2nd trial court also ruled in favor of the generic companies.

 

As a result, the generic companies are now one step closer to the early release of their Entresto generics.

 

If companies win the remaining 2 disputes awaiting 2nd trial rulings, they will be eligible for early release of their generics.

 

However, if Novartis again appeals to the second trial decision and decides to take the matters to the Supreme Court, the dispute can be prolonged with the lingering burden of early release of generics.

 

Generic companies can become one step closer to the early release of Entresto generics if they win the other 2 remaining trials A total of 3, including the ruling made on the 9th, are being tried in the 2nd trial.

 

One is over a crystalline patent that expires in September 2027 and the other is over a salt/hydrate patent that expires in November 2026.

 

In the case of the crystalline patent, Elyson Pharm and other companies filed trials to confirm the passive scope of rights on the patent in January 2021, starting the dispute.

 

The generic companies triumphed in the 1st trial.

 

The Intellectual Property Trial and Appeal Board ruled in favor of generic companies in December 2021, and Novartis, which appealed, filed a lawsuit with the Patent Court of Korea to cancel the decision.

 

Currently, the generic companies and Novartis are awaiting the 2nd trial ruling.

 

The Patent Court of Korea has designated the 21st of next month as the hearing date.

 

The generic companies also won the 1st trial for Entresto’s salt/hydrate patent, and the companies are awaiting its 2nd trial ruling.

 

Daewoong Pharmaceuticals had first filed a suit to invalidate the patent in April 2021.

 

In March this year, the Intellectual Property Trial and Appeal Board ruled in favor of the generic companies, issuing a decision of partial valid and partial dismissal ruling.

 

Novartis appealed the ruling and dragged the case to the second trial.

 

The companies had also challenged Entresto’s 2 composition patents and 1 use patent.

 

The generic companies also won those disputes, however, Novartis did not file an appeal after losing the 1st trials, finalizing the trial decisions.

 

Quarterly prescriptions of Entresto

Faced with the imminent entry of its generics, Entresto has been rapidly increasing its prescription performance.

 

According to the market research institution UBIST, Entresto generated KRW 14.8 billion in outpatient prescriptions in Q3.

 

This is a 36% YoY increase compared to KRW 10.9 billion in Q3 last year.

 

Although 6 years have passed since its release in Q4 2017, the drug is still showing high growth.

 

Its performance rose by over 30% every quarter YoY.

 

Its sales exceeded KRW 5 billion in Q1 2020 and expanded to more than KRW 10 billion in Q2 2022.

 

If the current trend continues, its quarterly sales are expected to exceed KRW 15 billion in Q4 this year.