Kolon TissueGene has failed to obtain a patent for Korea’s 29th novel drug , a cell gene therapy for osteoarthritis treatment, in Europe.

Invossa

The three patents of Invossa that the company sought were “gene therapy using transforming growth factor (TGF)-β,” “mixed-cell gene therapy,” and “cartilage regeneration using chondrocyte and TGF-β.”

The European Patent Office (EPO) gave the nod for the patent on “mixed-cell gene therapy” last year in Europe except for six countries, 14 years after the company applied for the patent registration on March 28, 2003. However, the EPO refused to approve the other two patents, apparently due to unmet conditions under the European patent law, officials said.

The EPO told Korea Biomedical Review via email that it repeatedly requested Kolon TissueGene to send a revised patent application form, as the patent application for “cartilage regeneration using chondrocyte and TGF-β” did not comply with Article 52 of the European Patent Convention.

“Although claims 1-20 (by TissueGene for patents in Europe) are directed to a method of treatment of the human/animal body, the search has been carried out and based on the alleged effects of the compound/composition,” the EPO said.

As the patent applications submitted by Kolon TissueGene have been repeatedly rejected, the EPO has requested verbal explanations. However, the Korean firm notified EPO through a patent attorney that it would discontinue the application and the patent registration procedure ended as of April 8, 2011. The process for the gene therapy using TGF-β ended in 2007.

Kolon TissueGene has yet to obtain a sales license for Invossa in Europe. Even if it wins approval in the future, the company might struggle to keep its sales rights protected in case generic drugs appear, sources said.

“The approval procedure takes place at the European Medicines Agency (EMA). So, winning approval without a patent could be no problem,” said an official in charge of patent affairs at a pharmaceutical company. “But if copy drugs come out in the market, having no patent could hurt the business (of Kolon TissueGene).”

Most of Korea’s 30 novel drugs, including those whose patents expired, have their substance patents registered not only in Korea but the U.S. and Europe.

Among the holders of locally developed new medicines, those who have a registered patent in Europe include JW Pharmaceutical, Daewoong Pharmaceutical, Dong-A ST, Boryung Pharmaceutical, Bukwang Pharm, Yuhan Corp., Ildong Pharmaceutical, Il-yang Pharmaceutical, Chong Kun Dang, and CrystalGenomics.

Samsung Pharm’s pancreatic cancer treatment Riavax, which won approval in 2015, and CJ Healthcare’s reflux esophagitis treatment K-Cab, the 30th novel drug in Korea, are in the patent registration procedure in Europe, after registering the patent in Korea and the U.S.

Not every local novel drug was successful in winning a patent from the EPO.

Donghwa Pharmaceutical’s chronic obstructive pulmonary disease therapy Zabolante has a patent only in Korea and China, and liver cancer treatment Milican, only in Korea.

However, Kolon TissueGene’s failure to register Invossa’s patent was a rare case, industry officials said.

“It takes only five or six years to get a European patent. I wonder why it took 14 years to register a patent after the 2003 application and why the claim was refused in eight years,” an official at a drug company said.

Another official said he did not know if the delay of the patent decision on Invossa was the company’s fault or an administrative issue. “The company will at least have to come up with a strategy to protect the sales rights (of Invossa or it could be in trouble,” he said.

Kolon TissueGene said the company decided to stop the patent registration because it consumed too much administrative time. It added that the company would protect the rights of Invossa with the registered patent.

“The patent on ‘cartilage regeneration using chondrocyte and TGF-β’ aims to protect the patent on Invossa. The two other patents are important but the already-registered patent on ‘mixed-cell gene therapy’ can protect the technology for Invossa,” an official at Kolon TissueGene said. “It took excessive time in the administrative procedure to register the two other patents in Europe. So, we decided to discontinue it because there was no benefit.”

hwz@docdocdoc.co.kr

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