Purdue Allowed To Pursue Generic OxyContin Patent Claims Against KVK

Orange County – A New York federal judge on Friday declined to dismiss Purdue Pharmaceuticals LP’s patent infringement action against KVK Tech Inc. over its role in preparing a generic version of the blockbuster painkiller OxyContin for the market, rejecting KVK’s claims that it was not responsible for the abbreviated new drug application.

Purdue sued KVK and Varam Inc. after Varam submitted an ANDA to the U.S. Food and Drug Administration to manufacture and market a generic oxycodone hydrochloride extended release tablet product.

KVK researches, develops, makes and sells generic pharmaceuticals, including a generic immediate release oxycodone pill, while Varam is a sole proprietorship owned by Frank Nekoranik created expressly to own the rights to the extended release oxycodone ANDA at issue in the case.

KVK gave Varam the rights to its “draft” ANDA for the extended release oxcycodone product with the stipulation that if the FDA approved the application, Varam would pay KVK $1 million. Varam has no other business activity aside from pursuing the FDA’s approval of the ANDA.

In its motion to dismiss, KVK contended that only one entity can technically submit an ANDA for purposes of liability, and that the single entity must be the named applicant.

It is undisputed, though, that KVK and its employees performed all of the work necessary to submit the ANDA except for Nekoranik’s review, approval and signature, according to Judge Sidney H. Stein.

“KVK has been more than actively involved in the submission; it has taken every relevant action except the final formalities,” the judge said.

To find that Varam but not KVK had submitted the ANDA “would be to elevate form over substance,” he said.

KVK has researched and developed the product, produced the samples, prepared the ANDA on Varam’s behalf, and subsequently communicated about the ANDA with the FDA as Varam’s official agent, the judge said. Moreover, although KVK is neither Varam’s parent nor the owner of the ANDA, it holds a direct stake in the ANDA’s success, he noted.

Nekoranik admits he cannot understand the content of the ANDA, and his only role in its submission has been to periodically review and sign papers based on KVK’s recommendation, according to Judge Stein.