On Tuesday in the Western District of North Carolina, Rubicon Research Private Ltd. filed a complaint against Kartha Pharmaceuticals and a company official, alleging that the defendants violated state and federal laws meant to protect trade secrets through their purported plans to manufacture and sell a generic drug product made by Rubicon.
The defendants have been consultants to Polish third-party pharmaceutical ingredient manufacturer and supplier Zakłady Farmaceutyczne Polpharma SA — which supplies ingredients to Rubicon and other pharmaceutical companies — since 2013, the complaint said.
Separately, North Carolina-based Kartha had been authorized by the Food and Drug Administration (FDA) to be Polpharma’s United States proxy, giving the defendants “access to extensive amounts of confidential and trade secret information belonging to Rubicon,” according to the complaint, particularly the “technical specifications” of the active ingredient in Rubicon’s generic multiple sclerosis pain management drug, baclofen, in 5 mg strength, given that Polpharma and Rubicon collaborated on the drug.
“The information concerning Rubicon’s 5 mg dose is particularly valuable because Rubicon was the first applicant—generic or branded—to receive FDA approval to sell baclofen in a 5 mg strength,” the complaint claimed. “Indeed, until April 2020, Rubicon was the only company approved to sell baclofen 5 mg, and Rubicon has become the market leader in the sales and distribution of this product.”
In October 2019, Rubicon, Polpharma, and the defendants held a meeting where they discussed information such as baclofen’s raw material supply, its market insights, regulatory pathways for FDA approval, marketing strategy, and product pricing. According to Rubicon, at the same time, the defendants were working to seek FDA approval to sell 5, 10, and 20 mg strengths of baclofen, but both the plaintiff and Polpharma were unaware of the defendants’ plan, the complaint claimed.
“With intimate knowledge of Rubicon’s trade secrets regarding the development, validation, regulatory approval, market introduction and commercial potential of baclofen products, Defendants prepared and filed an application to manufacture baclofen products that was quickly approved by the FDA in March 2021, despite the fact that this was Defendants’ first approval from the FDA to sell any drug product,” according to the complaint.
Rubicon claimed it had “no choice but to bring this action” in order to prevent the defendants from “unfairly competing and improperly usurping Rubicon’s significant investment” in its baclofen products.
The plaintiff alleged that the defendants’ actions are in violation of the federal Defend Trade Secrets Act, the North Carolina Trade Secrets Protection Act, and the North Carolina Unfair and Deceptive Trade Practices Act and constituted unfair competition, breach of fiduciary duty, and unjust enrichment.
Rubicon is requesting an injunction to bar the defendants from continuing their alleged conduct and punitive, treble, and exemplary damages, among other relief. Rubicon is represented by Rayburn Cooper & Durham P.A. and Blank Rome LLP.
