Daewoong succeeds in Entresto's unregistered patent

Overcame 5 patents for generic companies

A generic company succeeded in invalidating the unregistered patent of Novartis' heart failure treatment 'Entresto'.

 

This patent was one of the hurdles that must be overcome for the early release of generics.

 

As such, it is analyzed that generic companies are one step closer to the release of generic for Entresto.

 

According to the pharmaceutical industry on the 23rd, the Intellectual Property Trial and Appeals Board made a ruling on the invalidation of the Entresto salt/hydrate patent recently filed by Daewoong Pharmaceutical against Novartis.

 

This patent is not listed in the Ministry of Food and Drug Safety patent catalog.

 

However, from the perspective of generic companies, it was a patent that must be overcome in order to release later drugs early.

 

Novartis obtained approval for the crystalline form of sacubitril/valsartan, the main ingredient of Entresto, as '2.5 hydrates'.

 

In the patent catalog, only 2.5 hydrates, which are directly related, are listed.

 

Generic companies supplied crystalline raw materials as 'trihydrate' and 'tetrahydrate' instead of 2.5 hydrates.

 

The problem is that Novartis did not register it in the patent catalog, but separately registered the trihydrate patent with the Korean Intellectual Property Office.

 

From the perspective of a generic company, the unregistered patent trihydrate patent must be avoided or invalidated in order to release a trihydrate-based generic.

 

In response, Daewoong Pharmaceutical filed an invalidation trial on this unregistered patent in April 2021.

 

Afterwards, Erison Pharmaceuticals and Hanmi Pharmaceuticals joined by requesting the same judgment.

 

The Intellectual Property Tribunal sided with Daewoong Pharmaceutical.

 

It is expected that the same result will come out in the judgment of Hanmi Pharmaceutical and Erison Pharmaceutical, which has not yet been concluded.

 

As a result, generic companies have succeeded in overcoming 5 out of 6 patents related to Entresto.

 

The remaining patent that has not yet been overcome is 'Use Patent 2' related to heart failure, which preserves the ejection fraction, which Novartis registered after generic companies applied for product approval.

 

Since Novartis registered the patent a step later, it does not have a big impact on the early release of generics by patent challengers.

 

Generic companies have already applied for Entresto generic product approval since April of last year.

 

In addition, in December of last year, Novartis' request for an injunction to ban the sale of generics was also rejected by the court.

 

The remaining risk factor is the second trial of the patent dispute with Novartis.

 

Novartis appealed to the Patent Court in December 2021 after a first-instance defeat for the crystalline patent.

 

Then, in July of last year, after losing in the first trial related to patents, the case was similarly brought to the second trial.

 

No conclusion has been reached yet.

 

If generic companies win the second trial following the first trial, the timing of the release of Entresto's generics is expected to accelerate.

 

According to UBIST, a pharmaceutical market research institute, Entresto's outpatient prescription performance last year was 40.6 billion won.

 

Since its launch in 2017, Entresto's prescription performance has soared from 6.3 billion won in 2018 to 15 billion won in 2019, 23.5 billion won in 2020, and 32.3 billion won in 2021.