CKD to outrun SK and Hanmi with Xarelto patent challenge

SK and Hanmi won preferential sales right after evading formulation patent, launching after October next year

CKD could enter generic market faster than SK and Hanmi, if successfully wins the patent challenge

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Chong Kun Dang is now the sole contender to challenge Bayer’s non-Vitamin K antagonist oral anticoagulants (NOAC) Xarelto (rivaroxaban) substance patent.

 

As it overcame Xarelto’s formulation patent, Chong Kun Dang plans to enter the follow-on drug market faster than SK Chemicals and Hanmi Pharmaceutical, who won the preferential sales rights.

 

According to a pharmaceutical industry source on Dec.

 

18, the South Korean company has requested the Patent Court to provide a negative scope confirmation on Xarelto’s substance patent.

 

So far, Chong Kun Dang is the only one filed the suit.

 

Xarelto own three patents; a formulation patent expiring in 2024, an indication patent expiring I 2022, and a substance patent expiring in 2021.

 

A number of Korean companies have successfully evaded the formulation patent.

 

Bayer registered the indication patent, after the court ruled favorable for the Korean companies on evading the formulation patent.

 

In 2015, SK Chemicals and Hanmi Pharmaceutical jointly filed for the negative scope confirmation on Xarelto’s formulation patent and won the first and second cases.

 

Since then, Hanlim Pharm, GC Pharma, Samjin Pharm and Yungjin Pharm were also able to evade the patent.

 

Currently, Bayer’s appeal case is pending in the Supreme Court.

 

SK Chemicals and Hanmi Pharmaceutical that evaded the formulation patent, were the first ones to receive the preferential sales rights.

 

The two companies can sell the generic drugs exclusively for nine months from Oct.

 

3 next year, when the substance patent is expired.

 

And now, Chong Kun Dang is intercepting by challenging the substance patent.

 

If the company succeeds and overcomes the substance patent, Chong Kun Dang would be able to launch its product faster than SK Chemicals and Hanmi Pharmaceutical with the preferential sales rights.

 

However, the feasibility of the substance patent would be the deciding factor.

 

Unlike the formulation and indication patents, the substance patent challenge tends to be even more difficult.

 

In 2015, Daewoong Pharmaceutical filed a substance patent challenge on Xarelto to nullify the patent, the court has dismissed the case and there has never been another substance patent challenge.

 

At the moment, Chong Kun Dang has a generic named ‘Riroxia’ approved to market.

 

Both the tablet and capsule forms have been approved.

 

Capsule form option is only offered by Chong Kun Dang.

 

Even if Chong Kun Dang fails to challenge the substance patent but succeeds in evading formulation and indication patents, Riroxia in a capsule form can be sold regardless of the preferential sales right.

 

However, the company has not tapped on either formulation or indication patents, yet.

 

A pharmaceutical market research firm UBIST found Xarelto has raised 50.8 billion won last year for outpatient prescription.

 

Up until the last third quarter, the prescription volume of the drug reached 37.6 billion won.