Bonviva generics dodge a bullet from patent dispute

Generics launched in 2012, patent infringement suit filed after the original owner changed

Losing the case to result in sales ban and damage compensation, but the generics win the first trial

The generic makers won the patent dispute over an antiarthritis Bonviva (ibandronate) and now they are finally free from the risk of sales ban and damage compensation.

 

According to the pharmaceutical industry source on Mar.

 

23, the Intellectual Property Trial and Appeal Board issued a trial decision that the dosage regimen patent for Bonviva was invalid.

 

South Korean companies launched Bonviva generics in 2012.

 

Sales continued for several years without special patent disputes.

 

Roche owned the dosage regimen patent for the original Bonviva, but did not file a patent lawsuit at the time of the generic launch.

 

At the time, the Patent Court and the Supreme Court did not recognize the dosage regimen patent.

 

As for the original maker, a patent dispute meant nothing when the company was bound to lose it.

 

However, in 2015, the table has turned.

 

The Supreme Court abolished the precedent of the Baraclude (entecavir) patent dispute, and fully recognized the dosage regimen patent.

 

Bonviva’s dosage regimen patent, initially affected by the precedent, gained its validity.

 

Regardless, Roche did not file a patent dispute immediately.

 

The company did not intend to overturn the decision that it concluded that there were no problems at the time of release.

 

But a problem arose when Bonviva's patent rights were transferred from Roche to a British pharmaceutical company Atnas Pharma in 2018.

 

More assertive Atnas Pharma took a sharp turn on the matter and filed patent infringement suit against Bonviva generic makers in South Korea.

 

At the same time, they claimed for a colossus compensation for the damage.

 

The companies then were struck with the crisis.

 

Although they have been selling Bonviva generics for years without any problems, they were faced with sales ban and also cough up the revenue earned so far.

 

Accordingly, 10 generic companies such as Theragen Etex, Korea Arlico Pharm, Wooridul Pharmaceutical, ChoA Pharmaceutical, Korea Kolmar, Huvist, and Dongkwang Pharmaceutical, which sold Bonviva generics, decided to respond together.

 

A trial was filed to nullify the Bonviva dosage regimen patent.

 

Considering the gravity of issue, the Intellectual Property Trial and Appeal Board allocated the case to the Special Joint Trial Board.

 

Generally, a patent trial is handled by three judges, but the Special Joint Trial is conducted by five judges.

 

Ultimately, the Intellectual Property Trial and Appeal Board decided to invalidate the case.

 

South Korean companies are now relieved.

 

As of now, there is a high possibility that Atnas Pharma, holding the patent right, would request for an appeal.

 

Patent Attorney Park Jong-hyuk of Park Jong-hyuk Patent Law Firm said, “After the Supreme Court recognized the dosage regimen patent in 2015, the method of judging non-obviousness in dosage regimen patent was somewhat formed through the tadalafil case.

 

He emphasized, “The Intellectual Property Trial and Appeal Board conducted an elaborate trial for a long term through a Special Joint Trial Board, and determined requirement of a dosage regimen patent, necessity of test data, improper description and non-obviousness.

 

The latest decision would be used as a standard to other similar cases related dosage regimen patent.” A pharmaceutical market research firm UBIST reported Bonviva's outpatient prescription last year was 2.9 billion won.

 

In South Korea, Handok is in charge of sales.

 

Adding the prescription volume of Bonviva Plus (5.4 billion won), which combined with cholecalciferol, Bonviva makes about 8.3 billion won per year.

 

Currently, 93 Bonviva generics have been approved for marketing in South Korea.

 

These drugs combined generate about 10.3 billion won.