Nivagen accuses India-based big pharma of ‘meddling’ in patent application
Sun Pharma’s Sezaby, used to treat infant seizures, infringes two patents says Nivagen | US firm accuses Indian rival of attempting to block patent from issuing.
US firm Nivagen this week claimed Sun Pharmaceuticals had infringed two of its patents through the sale of neonatal seizures drug Sezaby, also accusing the firm of “meddling” in its patent application process.
The California-based drugmaker filed its suit at the Eastern District of Texas federal court on Tuesday (January 23), claiming that as well as infringing its patents, Sun Pharma and its subsidiaries had tried to block one of them from being approved and were trying to establish a monopoly for the allegedly infringing product.
Nivagen said Sun Pharma’s Sezaby infringed two of its patents—US patent numbers 11,406,598 and 11,878,076, which relate to phenobarbital injections and methods of manufacturing phenobarbital injections.
Sezaby was approved by the US Food and Drug Administration (FDA) in 2022 for the treatment of neonatal seizures in term and pre-term infants, and contains an active ingredient of phenobarbital sodium.
‘Attempt to block’ patent
The complaint details an alleged attempt by Sun Pharma to “meddle” in the prosecution of the ‘598 patent, which was issued in August 2022.
Nivagen said an anonymous third party submitted ten prior art references to the Patent Office examiner, which it believed to be Sun Pharmaceuticals and/or its subsidiaries.
Sun wanted to block the ‘598 patent application from issuing because it infringed one or more of the claims, Nivagen claimed.
The defendants “acted individually or jointly to meddle with Nivagen’s patent application process”, it went on.
Allegations of ‘monopoly’ attempt
According to the lawsuit, Sezaby was developed by Sun Pharma Advanced Research Company (SPARC), which submitted the new drug application (NDA) for the product.
On its company website, SPARC says it demerged from Sun Pharmaceuticals in 2007. Nivagen’s complaint states that SPARC licenses the Sezaby rights to Sun, and that the firms had a “joint mutual interest in the future sales of Sezaby” in the US.
Nivagen alleged that in 2023, SPARC filed a citizen petition to the FDA requesting that it take enforcement action to remove all unapproved phenobarbital injectable products from the market.
Upon information and belief, Sezaby’s price would rise because of this “monopolistic position”, Nivagen said, with the defendants being “unjustly rewarded”.
SPARC was said to be pursuing its own US patent application for phenobarbital injections, with application number 17/715,491 issuing as US patent 11,857,683 on January 2 this year.
The complaint stated that Sun had notice of the ‘076 patent—issued on January 23 this year, the same day as the lawsuit was filed—as it was referenced in the ‘491 application.
This constituted “wilful infringement”, Nivagen claimed.
The pharmaceutical firm is asking the court for a judgment of infringement, damages, costs and injunctive relief including the removal of Sezaby from the market.
The case is Nivagen v Sun Pharmaceuticals, Sun Pharma Advanced Research Company and Sun Pharmaceutical Medicare.
Nivagen is represented by Gillam & Smith and Upadhye Tang.
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