Champix, conclusion of patent disputes imminent

What are the issues and prospects?

"Solifenacin’s precedent should apply" vs "As a separate case"

Pfizer's possbility to win, acts as a milestone in future salt change strategy

Domestic company's economic incentives gradually diminish due to sharp decline in Champix’s sales

A patent dispute over the Champix(Vareniclin) marks the end.

 

The Patent Court has announced that it will issue a judgment on a patent dispute related to the Champix on the 20th , 4 days later.

 

The result of the Champix patent dispute attracted interest in that it could see the future of domestic salt-modifying drugs after the so-called ‘Solifenacin decision’ earlier this year The legal disputes between the two sides were so intense that the court would postpone the sentence four times.

 

The ruling, originally scheduled for February, was postponed for four months, from May to August to October to December.

 

The jurisdiction of the judiciary is also a matter of how deep.

 

The ruling of the patent court is expected to be applied as a definitive ruling.

 

This is because the Supreme Court's appeal is unlikely, as the expiration date of the material patent is almost imminent.

 

◆Patent Judge sided with generic company, Pfizer appeals In September 2016, more than 20 domestic companies, including Hanmi Pharmaceuticals, filed a patent dispute with Pfizer.

 

Domestic companies tried to speed up the launch of generics with the strategy of “avoiding patents with salt changes.” It is a strategy that avoids the extended duration of material patents by developing salt-changing generics and raising passive judgments on the scope of rights.

 

The Patent Judge, the first case of a patent dispute, raised the hands of domestic companies.

 

Based on this, domestic companies have launched salt-modifying drugs since last November.

 

Pfizer dissatisfied with the decision of the Judge.

 

The company filed a lawsuit with the Patent Court asking to cancel the decision.

 

The ruling on the lawsuit is sentenced on the 20th.

 

◆Interpretation over Supreme Court's decision to Solifenacin. During the second trial over Champix, a ruling was imposed elsewhere that would have a modest impact on the case.

 

It was a Solifenacin decision issued by the Supreme Court in January this year.

 

The Supreme Court sided with the original company, Astellas, in a salt-altering patent dispute between the original company and the generic company over Solifenacin, an overactive bladder treatment.

 

The key point of the ruling was that ‘the salt-modified product and the original product had substantially the same active ingredients, therapeutic effects, and uses, and those skilled in the art could easily change the salt’.

 

Interpretations were mixed with this ruling.

 

Pfizer and other originals interpreted the Supreme Court as setting a case for the salt change, which has been the main patent evasion strategy of domestic companies.

 

Of course, the case is expected to affect the results of the Champions suit.

 

On the other hand, some domestic companies draw a line that the case of Solifenacin salt-modifying drug and the Champix salt-modifying drug, which were previously lost, is quite different.

 

They explain that the 'substantial identity' that has been crucial in the Solifenacin decision is a separate part of the decision.

 

They also argues that there is a difference in the ease of realization of technology by trade technicians.

 

◆If a domestic company loses, 'Change salt patent avoidance' strategy useless

The patent court's decision will act as a measure of whether to avoid the patent of salt-modified products in the future.

 

If the patent court raises Pfizer's hand in accordance with the Supreme Court case, domestic companies will not be able to use the patent evasion strategy by changing the salt.

 

On the other hand, if the patent court raises the hands of domestic companies separately from the Soliphenacin case, the avoidance of salt-changing patents by domestic companies is likely to continue strategic vitality.

 

A legal personnel said, “At present, the patent court is expected to apply Solvenasin's judgment as a precedent and side with Pfizer, however, as domestic companies insist, there is some possibility of judging the Solifenacin case and the Champix case separately.

 

Either way, it will have a big impact on our strategy for avoiding salt modifications in the future”.

 

◆Material patent expires after 7 months, Less possibility of 3 trial appeals On the other hand, even if the patent court raises Pfizer's hand, there is a possibility that domestic companies are unlikely to lead the case to the Supreme Court.

 

This is because the champix material patent expiration is shortly until July 19 next year.

 

Given the time it takes to appeal after the Supreme Court appeals, it is likely that the avoidance of the extended patent duration, which was the original purpose of the patent dispute, has already been achieved.

 

In addition, as domestic sales of Champix have been plunging recently, domestic companies' economic incentives have weakened significantly.

 

According to drug research firm IQVIA, Champix's 3Q revenue was ₩5.7 billion, down 46% from ₩10.6 billion a year earlier.

 

It is a quarter compared to the peak season, ₩21.4 billion in the first quarter 2017.

 

An official in the pharmaceutical industry said, "With a huge drop in sales of successful successes, we know that many pharmaceutical companies have decided to stop the release of Champix salt-modifying drugs regardless of the Soliphenacin case."

Champix