Credit: Net DoktorFirst-of-Its-Kind Parkinson’s Patch at Center of Fight Over FDA Approval of Generic Version
New Jersey-based pharmaceutical company UCB has sued to protect its patents for a Parkinson’s drug after an India-based company attempted to file an FDA application to create a generic version.
December 26, 2024 at 01:55 PM
3 minute read
New Jersey-based pharmaceutical company UCB has sued to protect its patents for a Parkinson’s drug after an India-based company attempted to file an application to the U.S. Food and Drug Administration to create a generic version.
Takeaway: The lawsuit is an abbreviated new drug application, or ANDA, case, which is a highly active practice in New Jersey and elsewhere. Some claims focus on the timing of a new drug application, but this case includes allegations about access to information, and claims that the defendant company barred the plaintiff's in-house attorneys from accessing the application.
Court: U.S. District Court for the District of New Jersey
Case Type: Patent Infringement
Industry: Pharmaceutical
Lawyers: William C. Baton of Saul Ewing for the plaintiffs; counsel has yet to make an appearance for the defendants.
Liability: UCB created Neupro, a transdermal patch, the first FDA-approved treatment containing the synthetic dopamine agonist rotigotine. The drug is used to treat Parkinson’s disease and restless legs syndrome. In its eight-count complaint, UCB alleged patent infringement and asked for a declaratory judgment on four separate patents covering Neupro.
UCB alleged that it first received a notice letter from Aurobindo regarding the patent on Neupro last month. UCB filed suit against Aurobindo on Dec. 23 for submitting an abbreviated new drug application to the FDA before the four patents covering Neupro expired. If the FDA approves the generic application, UCB alleged, the defendants will directly infringe on its patents for Neupro.
UCB alleged that the notice letters sent by Aurobindo failed to include a required statement of the legal basis for why it believes at least one of the patents is invalid. And it claimed that the defendant did not allow any of UCB’s in-house attorneys to access Aurobindo’s abbreviated new drug application. Instead, UCB alleged that Aurobindo imposed unreasonable restrictions on access to information, including limiting access to a single scientific expert.
Damages: UCB alleged that it would suffer irreparable harm if Aurobindo is not enjoined from infringing on its patents. The plaintiff also claimed that a permanent injunction is in the public interest and sought an order putting Aurobindo’s application to create a generic version of the drug on hold until after UCB’s patents expired. The plaintiff sought damages, costs and fees, among other claims.
What the lawyers are saying: Plaintiff’s counsel did not immediately respond to requests for comment. Aurobindo has yet to retain counsel on the matter, according to the docket. The communications team for the company did not return a message seeking comment.
Radar scan: This case is part of a steady stream of cases targeting pharmaceutical companies over their purported efforts to receive FDA approval to manufacture generic versions of drugs.
Caption: UCB v. Aurobindo Pharma
Date filed: Dec. 23, 2024
Judge: U.S. District Judge Claire C. Cecchi
Read the complaint here.
This complaint was first surfaced by Law.com Radar, ALM's source for immediate alerting on just-filed cases in state and federal courts. Law.com Radar now offers state court coverage nationwide. Sign up today and be among the first to know about new suits in your region, practice area or client sector.
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