The Galvus patent dispute continues

Original developer may abuse irrelevant clinical studies to prolong patent period, depending on result of the 1st trial

After the Supreme Court’s dismissal, the legal battle will again resume at the Intellectual Property Trial and Appeal Board

Although the Supreme Court had made its ruling on the ‘Galvus (vildagliptin)’ patent dispute, it seems that the fierce battle is yet far from being over.

 

The case will now again be dealt by Intellectual Property Trial and Appeal Board, and depending on its result, there remains the possibility that the original developer may abuse irrelevant follow-up clinical trials that were conducted abroad to extend its drug’s patent duration.

 

◆The battle continues… will be again dealt at IPTAB On October 28th, the Supreme Court dismissed Novartis’ appeal against Hanmi Pharmaceutical and Ahngook Pharmaceutical over the Galvus patent dispute.

 

The written judgment showed that the court ‘found no profit in appeal for Novartis.’ As Novartis had already won the second trial and achieved its purpose, the court decided that there was no need to file an appeal in the first place.

 

Even if Novartis was dissatisfied with the judgment from the 2nd trial, the court decided that appealing this to the Supreme Court was procedurally right.

 

As a result, the case will again be dealt by IPTAB.

 

The industry expects a decision will be made early next year, which will finally conclude the 4-year patent dispute over Galvus’s patent term.

 

◆Novartis extends substance patent duration by 2 years, of which Ahngook claims187 days invalid On the surface, the Supreme Court’s ruling is in favor of the generic companies, as the court dismissed Novartis’ appeal against the 2nd trial ruling.

 

However, the key point of the case lies elsewhere.

 

Domestic pharmaceutical companies are raising the concern that the original developer may abuse irrelevant follow-up clinical trials that were conducted abroad to extend its drug’s substant patent duration, depending on the ruling that will be made by IPTAB.

 

The key issue in the 4-year long dispute was how much of the ‘extended patent duration’ of a drug’s substance patent should be considered invalid.

 

Patent rights are usually protected for 20 years from the filing date.

 

For pharmaceutical products, the time taken for clinical trials and for regulatory approval is added onto the term as companies cannot release their product immediately after applying for a patent.

 

Depending on how much of this period is recognized, patent protection for a drug can be extended to last 21 years or even 22 years.

 

Novartis had succeeded in extending Galvus’ substance patent for 2 years, 2months, and 23 days (813 days).

 

With the extension, the patent, which was to originally expire on December 9, 2019, was extended to expire on March 4, 2022.

 

◆Mixed rulings at the 1st and 2nd trial regarding the ‘132 days’ extended for overseas clinical trials of Galvus Ahn-Gook Pharmaceutical claimed that ‘187 days’ of the extended term for Galvus’s substance patent was invalid.

 

Ahn-Gook claimed that Novartis did not do its due care during the ‘132 days,’ from the completion of the bridging trial on Koreans to the submission of API report, and the ’55 days’ from receiving the MFDS’ notice to supplement its data to the data submission, rendering the 187 days invalid.

 

The court ruled in favor of Ahn-Gook Pharmaceutical in the first trial.

 

The Patent Court of Korea accepted Ahn-Gook’s claim and ruled all of the 187 days invalid.

 

With the ruling, the substance patent expiry date of Galvus was shortened to August 30th, 2021.

 

In the second trial, the IPTAB partially accepted Novartis’ claim and ruled only 55 days of the 187 days invalid, making the substance patent expiry date of Galvus January 9th, 2022.

 

Acceptance of Novartis’ claims on the 132 days that the company conducted clinical trials overseas was what made the difference between the rulings The claim, which was not accepted at the 1st trial, was then accepted at the 2nd.

 

In other words, the overseas trial that was deemed irrelevant to the drug’s domestic approval in the 1st trial was deemed necessary in the 2nd trial.

 

◆Dispute continues for no real benefit on either side Novartis, discontent with the 132-day extension recognized at the 2nd trial, appealed to the Supreme Court to receive acceptance for the remaining 55 days.

 

However, the Supreme Court returned the case to IPTAB.

 

Right now, how hard the two parties will continue to fight this battle remains unclear as both parties - the original developer and generic companies – have little to earn from the continued battle.

 

On Novartis’ part, it is now difficult to implement a strategy to delay the entry of latecomer drugs through litigations, as its substance patent is likely to expire while the case is reassigned to IPTAB and again reviewed.

 

Novartis can always file a claim for damages after winning the dispute and being recognized for patent infringement.

 

However, even so, the period of infringement will only be around 2 months, and not be very profitable.

 

The cost of litigation may be greater than the profit earned from the suit for damages.

 

Also, on the generic companies’ part, the companies have already succeeded in moving up the release of their latecomer drugs by 2 months and have no need to actively continue the dispute.

 

◆Original developers may ‘abuse’ the system to extend the duration of their substance patent The issue arises when the IPTAB follows the existing ruling of its higher court, the Patent Court of Korea.

 

If the companies do not actively engage in the legal dispute, the IPTAB will highly likely follow the existing ruling made by the Patent Court.

 

If the dispute ends this way, Novartis’ claim of ‘132 days of follow-up trial overseas’ will also be recognized for the extension.

 

This has been raising concern among domestic pharmaceutical companies that it may be abused as a basis for original developers in extending their substance patents in the future.

 

Until now, no period for overseas follow-up trials was accepted for extension of substance patents.

 

Until now, the Korean Intellectual Property Office and the Ministry of Food and Drug Safety both had deemed follow-up trials that were only conducted overseas irrelevant, unlike global trials that include Koreans or bridging studies on Koreans.

 

The Patent Act stipulates that the patent duration may be extended to 5 years at most.

 

If overseas follow-up trials are included in the term of patent duration, original developers may abuse the system to extend their patent’s duration to the maximum 5 years.

 

In other words, the concern is that the existing substance patent duration of ‘20+2 years’ may be prolonged to ‘20+5 years.’