Kolon Life Science has lost its substance patent for Invossa-K, a cell gene therapy for osteoarthritis treatment developed by its subsidiary Kolon TissueGene, in six countries in Europe due to non-payment of due fees, sources said. The treatment is the 29th locally developed novel drug.

Kolon Life Science is likely to suffer a setback in the global business strategy for Invossa-K, although the company has been pushing to export the treatment to Hong Kong, Mongolia, Saudi Arabia, and the United Arab Emirates. The drugmaker had been successful in selling Invossa-K to leading general hospitals in Korea.

According to people familiar with the matter, Invossa-K lost its substance patent in Finland, Greece, Austria, Bulgaria, and Estonia on Oct. 31, 2017, and in Slovenia on May 31, 2018.

The European Patent Office cited “lapse in a contracting state announced via postgrant inform national office to EPO” as the reason for patent cancellation. To maintain the patent registration, the company was supposed to pay due fees. However, Kolon Life Science failed to do so, and the patent expired.

The expired patent was on “mixed-cell gene therapy,” a technology to mix transgenic cells with normal cartilage. The technology is one of the two essential substance patents of Invossa-K.

A patent is the only legal right to keep rivals from developing generic drugs. Therefore, if the patent expires, it will be possible for other pharmaceutical companies to make use of the once-patented technology to do other drug business such as making generic copies.

“In Europe, a pharmaceutical firm should obtain a patent from the European Patent Office, as well as register the patent in each country,” a patent expert working at a local drugmaker said. “To do so, the company has to pay fees to maintain the patent every year. However, in this case on Invossa-K, the company did not pay due fees to the six countries and lost its patent rights.”

He said Kolon Life Science might not be able to thwart rival companies’ use of the previously-patented technology for their business.

An official at Kolon Life Science said the company would maintain the patent in Europe, except for the six countries. “If we consider the size of the rest of the European market and trends, there will be no problem in our business in Europe,” he said.

Invossa-K’s patent in Korea, the U.S., and Japan does not have any problem, according to Kolon Life Science.

The drugmaker signed a deal in July to export Invossa-K to Hong Kong and Macau for 17 billion won ($15 million) and to Mongolia for 10 billion won. Recently, it signed another contract to sell 230 billion won worth of Invossa-K to China’s Hainan Province for five years.

hwz@docdocdoc.co.kr

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