Patent outlook after Forxiga withdrawal in Korea

Related to indications for heart failure and kidney disease

AZ has registered the method-of-use patent for heart failure…The patent for kidney disease has not been registered

Generic companies have to file a patent nullification in order to market the drug for heart failure treatment purpose

Forxiga

If ‘Forxiga (dapagliflozin)’, a SGLT-2 inhibitor class treatment for diabetes, is withdrawn from the Korean market, the question is whether companies can begin selling generics containing the same active ingredient for the treatment of heart failure.

 

The answer to the question is that selling Forxiga generics for the purpose of treating heart failure might be challenging.

 

This is because the ‘method-of-use patent' describing the treatment of heart failure has been registered, regardless of the withdrawal of Forxiga from the Korean market.

 

However, generic companies may have options available to treat kidney disease.

 

AstraZeneca has completed the filing of the method-of-use patent for treating heart failure with the patent office.

 

Yet, they must still complete the filing process for the method-of-use patent related to treating kidney disease.

 

Even though the method-of-use patent for heart failure has been registered and listed for reimbursement, Forxiga withdraws from the Korean market In March 2020, AstraZeneca filed the method-of-use patent for Forxiga, which described its use in treating heart failure.

 

The patent, titled ‘the use of dapagliflozin in treating heart failure with reduced ejection fraction,’ is set to expire in March 2040.

 

The company faced challenges before finally obtaining patent registration.

 

Following the initial patent filing, the company received a rejection letter from the patent office and subsequently faced two more rejection decisions.

 

AstraZeneca revised the patent statement three times before successfully registering the method-of-use patent with a description related to heart failure in February 2022.

 

In July of the same year, the patent was listed with the Ministry of Food and Drug Safety (MFDS).

 

Prior to this listing, in December 2020, the indication for 'the use of dapagliflozin in treating heart failure with reduced ejection fraction' was added to the MFDS approval list.

 

The expanded reimbursement will be applied to Forxiga.

 

On the 19th, the Ministry of Health and Welfare (MOHW) announced that the reimbursement for SGLT-2 inhibitors, including Forxiga and Jardiance, will be expanded to the treatment of chronic heart failure, starting next month on the 1st.

 

The issue is that AstraZeneca Korea decided to withdraw Forxiga from the Korean market between the time when the heart failure indication was added, and the reimbursement application was made.

 

In December of last year, AstraZeneca announced its decision to withdraw Forxiga from the Korean market by the first half of this year.

 

AstraZeneca explained it as a "portfolio restructuring decision." AstraZeneca has stated that the supply of Forxiga in Korea is secured enough until its withdrawal.

 

However, there is concern that patients with heart failure may face limited access to Forxiga, as they will need to discontinue its once the remaining stock is depleted.

 

Generic companies would need to challenge the 'method-of-use patent' related to the active ingredient to begin selling drugs for the treatment of heart failure The generic versions of Forxiga only have indications for type 2 diabetes because generic companies have not challenged the method-of-use patent.

 

When generic companies began extensive patent challenges after 2015, the method-of-use patent for heart failure had not been registered.

 

In technical terms, Forxiga generics cannot be marketed for the treatment of heart failure without nullifying the method-of-use patent.

 

After last year’s flood of generics, certain companies used promotional materials claiming their products as being effective in treating heart failure.

 

In response, the MFDS concluded in June last year that "promotion for the treatment of heart failure is a violation of the Pharmacist Act." As a result, companies that used such promotional materials faced a three-month suspension of advertising activities in August.

 

Due to these reasons, generic companies are in a situation where they need to file for nullification of the patent for the use of Forxiga to treat heart failure.

 

However, no generic companies have applied to nullify the patent for Forxiga for treating heart failure.

 

"Many pharmaceutical companies are closely monitoring the potential nullification of the patent through cancellation applications, given AstraZeneca's decision to withdraw Forxiga," a pharmaceutical industry staff has commented and added, "Once AstraZeneca's stance becomes clear, generic companies will likely determine whether to challenge the patent for heart failure." "The headquarters are responsible for managing the patent-related matters, and there are currently no plans for patent cancellation," AstraZeneca has stated.

 

AstraZeneca “undecided on canceling the patent”…Has not registered the kidney disease method-of-use patent The status of the patent for the treatment of kidney disease remains uncertain.

 

Although the indication for kidney disease treatment has been added to the MFDS’s regulatory approval, an official patent has not yet been registered.

 

AstraZeneca submitted a patent application titled 'the use of dapagliflozin in treating heart failure with reduced ejection fraction' in April 2021.

 

However, this patent has yet to be officially registered.

 

The Patent Office has rejected the patent registration twice, and in response, AstraZeneca has filed an appeal against the rejection decision.

 

If the patent for treating kidney disease is officially registered, generic companies may have the opportunity to challenge it through nullification proceedings and gain approval for the indication of kidney disease.

 

However, the current situation is complicated because there is no registered patent for kidney disease treatment, making initiating a challenge through invalidation proceedings impossible.

 

Generic companies may have two options.

 

One option is to wait until the kidney disease method-of-use patent is finally registered and then initiate a nullification proceeding, following a path similar to the heart failure method-of-use patent.

 

Another option is for generic companies to modify their generic approval by adding the kidney disease indication before it is officially registered.

 

If the kidney disease method-of-use patent is registered later, generic companies can address any potential patent infringement lawsuits that AstraZeneca might file in response.

 

Yet, it seems that no generic companies have applied for the addition of the indication for kidney disease at this time.

 

Additionally, AstraZeneca has stated that they are still undecided about whether they will complete the patent registration process for kidney disease, similar to the heart failure patent.