Small Company Contests Big Pharma’s Patent Challenge

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"Patents should stimulate innovation and contribute to technological progress. We feel that by patenting the use of a well-understood composition with a common ingredient like lidocaine, they are using the patent system to stifle competition and choice.”

This month, Prollenium Medical Technologies, Inc. filed its answer and counterclaims to a lawsuit by Allergan (C.A. No. 19-126-CFC, filed in the United States District Court for the District of Delaware). Allergan alleges that Prollenium’s hyaluronic acid (HA) dermal filler, Revanesse Versa+, infringes upon several patents it holds, relating to its injectable gel fillers.

The patents in question cover formulations for and methods of manufacturing HA dermal fillers that include lidocaine. Lidocaine is an anesthetic drug that was discovered in 1946 and is widely used for pain treatment in procedures as varied as dental surgery, mole removal, cataract correction, biopsies and nerve blocks. It is included on the World Health Organization’s List of Essential Medicines. For over fifteen years, it’s been used to add comfort to treatments in the medical aesthetic industry.

In its answer and counterclaim, Prollenium Medical Technologies contests the claims and contends that the patents to which they refer – patents on HA compositions cross-linked with butanediol diglycidyl ether (BDDE) and containing lidocaine – are invalid because they claim what was already well known in the art. In its counterclaim Prollenium also alleges that, “Allergan’s patents for cross-linked HA dermal fillers containing Lidocaine, are unenforceable because they are founded on misstatements made to the United States Patent Office, about information that were material to the patentability of the claims.”

“In our opinion, they are using the US patent office as a tool to limit patient and provider choice, and to keep drug costs high. In filing baseless patents, then suing smaller manufacturers to try to enforce them, we believe, they are endeavoring to ensure that they have sole rights to leverage a commonly used, elemental ingredient that eases patient discomfort,” said Khasha Ighanian, President of Prollenium.

“Patents should stimulate innovation and contribute to technological progress. We feel that by patenting the use of a well-understood composition with a common ingredient like lidocaine, they are using the patent system to stifle competition and choice,” said Ario Khoshbin, Prollenium CEO and Founder.

He continued, “We include lidocaine in our product because we believe that patient wellness and comfort can be and should be available to patients and providers as a standard, not a luxury.”

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