Seven Korean pharmaceuticals successfully invalidated the composition-of-matter patent for Eliquis, a novel anticoagulant (NOAC), Wednesday. Developer Bristol-Myers Squibb (BMS) said Friday it would file an appeal and “respond aggressively.”

The Intellectual Property Tribunal invalidated the first and second claim of the patent called “Lactam-Containing Compounds and Derivatives thereof asFactor Xa Inhibitors” for the firms. The seven domestic companies are Dong-A ST, Daewoong Pharmaceutical, Huons, Alvogen Korea, Intron Biotechnology, Navipharm, and Aju Pharm, according to the Korea Intellectual Property Rights Information System (KIPRIS).

Seven pharmaceutical firms successfully have invalidated an Eliquis patent of Bristol Myers Squibb Korea, which vows to appeal the decision.

Industry experts are now speculating whether the patent invalidation will open the door for domestic drugmakers to launch their developments on the market. Inist Bio Pharmaceutical, Hutecs, Jinyang Pharm, and Samjin Pharm got approvals for their therapies in January under the condition that the related patent expires. An industry official predicted that Intron Biotechnology, Huons, and Alvogen Korea would get approvals this month.

“Although it will differ by company, sales of the generics may start as early as in Q3 of this year,” the industry official stated.

But Kang Jong-hee, a director at BMS Korea stated Bristol-Myers Squibb would file an appeal, adding that it will use “all tools and methods” to protect intellectual property rights aggressively.

“Although the filing for invalidating the composition-of-matter patent was received on Feb. 28, it is difficult to view it as invalid if an appeal proceeds at the tribunal. BMS intends to appeal,” Kang said.

“We will use all methods to protect our intellectual property rights,” she added.

The Korean pharmaceuticals now seem to be preparing for the second round of the patent fight, with an official from one of the seven companies expecting a ruling in favor of generic developers.

“The patent invalidation in the first round most likely doesn’t signify the end since patent trials last three rounds. The original company will probably file an appeal,” the official said. “But because the trial is based on the same content as the first round, we believe we will get a beneficial result until the third and final round.”

Meanwhile, domestic pharmaceuticals also invalidated Boehringer Ingelheim’s Pradaxa patent last year, opening the way for the launch of generics and adding to the competition in the NOAC market.

yjc@docdocdoc.co.kr

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