Entresto’s 2nd patent suit ruling postponed to November

Patent Court of Korea 1st Division postpones the sentencing date...from September 11 to November 9

Argument closed... Ruling of the other 2nd trials expected at the end of this year

The rulings for the 2nd trial surrounding the chronic heart failure treatment ‘Entresto (sacubitril/valsartan)’ have been postponed to November 9.

 

The drug has been posting annual prescriptions of more than KRW 40 billion annually.

 


 According to industry sources on the 11th, the Patent Court of Korea 1st Division recently postponed the decision date for the 2nd trial on Entresto’s crystalline patent to November 9.

 


 With the argument now concluded, the court originally planned to pronounce judgment on the 14th of this month but decided to postpone the decision for two more months.

 

The exact reason why the judgment was postponed remains unknown.

 


 As a result, the outline of the second trial of the Entresto patent dispute is expected to come out after the end of this year.

 


 Three Entresto patent disputes are currently being tried at the Patent Court.

 

In addition to the crystalline patent (10-1432821), whose judgment has been postponed, disputes over the composition/use patent (10-0984939) and the salt/hydrate patent (10-1549318) have not yet been resolved.

 

The ruling surrounding the crystalline patent is expected to come first, followed by the other 2 rulings.

 


 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 generic companies that challenged the 3 patents plan to succeed in overcoming the remaining patents and qualify for early release.

 

Entresto's PMS already expired in April, so the companies may release their generic versions early as long as they overcome the remaining patents.  
 However, if generic companies lose or win the second trial but Novartis appeals to the Supreme Court, the release of their generic will be further delayed.

 

There is the possibility that the Entresto patent dispute will be prolonged for more than four 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.

 


 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.

 


 By the first half of this year, its cumulative sales reached KRW 27.2 billion, heralding annual sales of KRW 50 billion this year.

 

The sales have surged after its indication was extended from heart failure with reduced ejection fraction (HFrEF) to heart failure with preserved ejection fraction (HFpEF)  
 Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that combines the angiotensin receptor blocker (ARB) valsartan and neprilysin inhibitor sacubitril.

 

The drug may be used as an alternative to an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme (ACE) inhibitor in patients with left ventricular (LV) dysfunction in combination with other heart failure treatments.