Eliquis generics pull out from market after losing suit

How much the generic companies would pay for damages recieve attention

Chong Kun Dang’s Liquisia, Samjin Pharm’s Elxaban fully withdraws from market

Will the sluggish damage claim suits speed up after the Supreme Court ruling?

With major Eliquis (apixaban) generics products removed from the insurance benefit list after losing the patent suit, the Eliquis generics have now completely withdrawn from the market.

 

As a result, the only dispute left between the original and generic companies for Eliquis is the claims for damages, and a fierce legal battle is expected on the calculation of compensation for damages.

 

According to the pharmaceutical industry on the 23rd, 26 products (13 companies) of Eliquis generics were removed from the reimbursement list this month.

 

The drugs include Chong Kun Dang’s ‘Liquisia,’ Samjin Pharm’s ‘Elxaban,’ Yuhan Corp’s ‘Yuhan Apixaban,’ Hanmi Pharm’s ‘Apixban,’ and Jeil Pharmaceutical’s ‘Jerixaban.’ The other generics that were left on the reimbursement list were drugs that haven’t been sold after listing.

 

With the removal, the market withdrawal of Eliquis generics has been officially complete in 2 years since the generics were released in the market.

 

Chong Kun Dang and others had succeeded in targeting Eliquis’ substance patent in February 2018 (first trial), then succeeded in nullifying Eliquis’ composition patient, which led to the sequential release of its generics from June 2019.

 

However, the situation took a downturn with the Supreme Court ruling, which overturned the first and second trial and ruled in favor of the original company.

 

Companies that sold Eliquis generics voluntarily discontinued sales of their products to reduce the claims for damages from patent infringement.

 

With the exit of the generics, the only dispute left between the original and generic companies is the compensation suit filed by BMS against generic companies.

 

BMS filed a claim for damages against generic companies in 2019.

 

However, the progress of the damages suit was sluggish as the Supreme Court ruling remained.

 

And after the Supreme Court ruling came out in April, not many further pleadings were held due to the influence of the COVID-19 incident.

 

The pharmaceutical industry predicts that lawsuits for damages will speed up with the Supreme Court ruling.

 

And a fierce battle between the two sides is expected over how the specific amount for damages will be set.

 

In general, the amount of damages for patent infringement is set at 14.2% of actual sales sold for each generic, as the judiciary considers the operating profit of the industry to be around 14.2%.

 

However, the calculation becomes much more complex when damages are specifically calculated by category because the 'profit' made from patent infringement is considered the amount that should be compensated for damages.

 

For example, the cost of the raw material sand APIs is generally excluded from charges, because the ingredients would not have been purchased if not for the generics’ release.

 

Calculation of labor, sales, and promotion expenses is more complex.

 

This is the part where the two parties clash the most.

 

As each generic company invests different amounts in labor, sales, and promotion expenses, the original company is having the most trouble calculating this amount.

 

Also, some have mentioned that the original company is preparing new reasoning to increase the compensation that should be paid by generics companies.

 

Until recently, generic companies have earned a total of 12.7 billion won in 2 years by releasing Eliquis generics.

 

According to the pharmaceutical market research firm UBIST, Liquisia earned 4.1 billion won; Elxaban 2.4 billion won; Yuhan Apixaban 1.7 billion won; and Apixaban 1.1 billion won.

 

An industry official said, “Based on previous rulings, the generic companies will have to pay around 1.8 billion won in compensation for damages incurred, so each company will be paying less than 0.6 million won.

 

However, the companies may have to pay more under the new reasoning the original company is preparing.