Local companies in panic over ‘Eliquis’ patent suit result

Supreme court reversed and remanded the first and second trial and ruled in favor of BMS

Discontinued sale of generics and full-fledged lawsuit for damages deemed inevitable

Price cut of Eliquis will also be pushed back…current price ceiling may be maintained

The winner and loser of the long patent suit were reversed in the end.

 

After losing the first and second trial, BMS finally got the upper hand in the fight with the generic manufacturers with a favorable ruling by the supreme court.

 

On the other side, the generic companies are in hot water due to the unexpected result.

 

In addition to immediately discontinuing the sale of its generics, the companies are expecting a massive damages claim will be filed by the original drug’s company.

 

The ruling will also affect the price cut that was previously ordered for Eliquis.

 

If the ruling is finalized, the price cut disposition will be pushed back to the patent expiry date.

 

◆Case remanded to Patent Court… Attention on whether the final ruling sides with the Supreme Court's decision On the 8th, the Supreme Court’s Special 3rd Division reversed and remanded the original ruling of the patent invalidation suit in the appeal filed by BMS against Navipharm, Huons, Intron Biotechnology, and Alvogen Korea.

 

The lawsuit is linked to multiple other suits filed by BMS including the patent infringement suit as well as the administrative suit filed in objection to the disposition to reduce the ceiling price of Eliquis.

 

Considering the gravity of the issue, the Supreme Court rendered an en banc decision.

 

The Supreme Court’s ruling is not final.

 

As the Supreme Court reversed the original judgment, the case will once again be tried by the Patent Court.

 

However, as most trials for remanded cases follow the higher court’s decision, which would be the Supreme Court’s decision in this case, expectations are leaning towards BMS’s victory.

 

◆Patent infringement suit to pace up… generic sales highly likely to be discontinued

With the victory, BMS expects to be able to achieve three goals.

 

First is the discontinued sale of generics.

 

The prescription of Eliquis has been dwindling with the release of its generics.

 

According to U-BIST, outpatient prescription sales of Eliquis had increased annually from 19.5 billion won in 2016 to 49 billion won in 2019.

 

However, its sales dropped 3% to 47.7 billion won last year.

 

On the other hand, prescription sales of generics of Eliquis have been rapidly increasing, from 1.2 billion won accrued from July to December in 2019 to the 8.3 billion won last year.

 

The numbers suggest that the release of generics had some effect in reducing Eliquis prescriptions.

 

BMS also plans to speed up the patent infringement suits filed against each generic company.

 

Around 10 relevant suits are currently in progress.

 

The cases were waiting for the Supreme Court's judgment on this case to determine whether the generic drugs infringed upon BMS Korea's patent right.

 

If BMs wins the patent infringement suit, BMS will also be able to enjoy reflective benefits from the discontinuation of its generics.

 

◆ Full-fledged claim for damages deemed inevitable.…calculation of the compensation amount is key BMS's second purpose is to file claims for damages against the generic companies.

 

The Supreme Court's ruling recognized the validity of the drug substance patent.

 

If the court recognizes the patent infringement of the generic companies in subsequent infringement lawsuits, BMS will meet all the requirements to claim compensation for damages.

 

Eliquis generics that were released since June 2019 include ▲Chong Kun Dang’s ‘Liquisia’ ▲Samjin Pharm’s ‘Elxaban’ ▲Yuhan Corp’s ‘Yuhan Apixaban’ ▲Hanmi Pharm’s ‘Apixban’ ▲Aju Pharm’s ‘Eliban’, and ▲Yooyoung Pharm’s ‘Yupix.’ Last year, prescription sales of Liquisia were 2.6 billion won, and 1.1 billion won for Yuhan Apixaban.

 

The key lies in the reinforced standards used for the calculation of compensation for damages since last December.

 

Last year, the National Assembly passed an amendment to the Patent Act that would strengthen the standards used to calculate damages caused by patent infringement.

 

Previously, the compensation was calculated by multiplying the 'range of production capacity' by the 'profit per unit.' However, the newly amended act that took effect in December last year adds an amount calculated by multiplying the 'amount exceeding range of the production capacity' by the 'reasonable royalty.' For instance, under the previous law, if the patent holder's production capacity was 100 but the infringer sold 1000, the patent holder was unable to receive compensation for the 900 that exceeds the patent holder's production capacity.

 

However, the amended act allows for the company to receive compensation for the exceeding 900 products as well.

 

At first sight, the prescription amount of the original Eliquis overwhelms the amount of generics prescribed.

 

However, experts believe the result may differ depending on how 'production capacity' is interpreted.

 

Nevertheless, faced with potential claims for damages by BMS, generic companies are now moving to voluntarily discontinue sales of their generic products.

 

An unnamed official of one company that sells a generic of Eliquis stated, "After the ruling, we are considering whether we should voluntarily stop selling our product." ◆Price cut disposition for Eliquis may be suspended until September 2024 The third is to nullify the drug price cut disposition.

 

In July 2019, the government had notified BMS that it would lower the price ceiling of Eliquis by 30% with the reason being the release of its generics.

 

However, BMS had filed a suit with the Administrative Court to suspend the price cut as the final ruling has not been made on its substance patent suit.

 

BMS's request was to suspend the execution of the price cut disposition until the Supreme Court's ruling.

 

The court accepted the company's request, therefore Eliquis is currently being sold at the same price, at 1,185 won per tablet.

 

With the Supreme Court's ruling adding support, the government's justification to execute price cuts based on the introduction of generics will not be able to stand.

 

The substance patent of Eliquis will expire on September 9th, 2024.

 

If the Patent Court ruling is in line with the Supreme Court ruling, the launch of Elquis's generics will be postponed to September 2024.

 

Also, in that case, it is highly likely that the price of Eliquis will be lowered in October 2024.