Hanmi and SK win the final round of Xarelto patent dispute

The Supreme Court rules in favor of the generic companies on Bayer’s Xarelto composition patent

No more barrier left for early generic release in October 2021

South Korean pharmaceutical companies won the patent dispute on Bayer’s non-Vitamin K antagonist oral anticoagulants (NOAC) Xarelto (rivaroxaban).

 

As a result, Hanmi Pharmaceutical and SK Chemicals have overcome the last obstacle to prepare an early launch of rivaroxaban generic in next October.

 

On Dec.

 

24, the Supreme Court ruled in favor of Hanmi Pharmaceutical and SK Chemicals for the third ruling on the negative confirmation scope in Xarelto’s composition patent.

 

Besides the latest case, Hanmi has also won the patent nullification case as well.

 

The patent dispute started from March 2015, when the two companies filed a negative scope confirmation on Bayer’s original tablet.

 

The two Korean companies won the first ruling, and they earned the preferential sales rights after they received the item approval in 2016.

 

However, Bayer disagreeing with the ruling filed an appeal to the Patent Court.

 

But the second ruling remained unchanged from the first.

 

The multinational company then filed the last appeal.

 

The case initiated from November 2016 at the Supreme Court was concluded four years after, bringing good news to the generic companies.

 

Bayer requested for trials for correction, while arguing the case, to lessen the claim but the company also lost the patent nullification case as well.

 

The final ruling was the last step towards the early generic release for Hanmi and SK.

 

The two companies’ generic may be marketed from October 2021 with preferential sales rights lasting until July 3, 2022.

 

A pharmaceutical market research firm UBIST found Xarelto has generated total 50.8 billion won for the outpatient prescription.

 

As of the third quarter this year, 37.6 billion won worth of the drug was prescribed.

 

Now the industry’s interest is shifting towards Chong Kun Dang, who started taking legal action to evade Xarelto’s substance patent.

 

If Chong Kun Dang succeeds in evading the substance patent to be expired in October 2021, the company would be able to launch its generic even before Hanmi and SK.