Pharmaceutical Companies Sued Over Generic Parkinson’s Medication

A host of pharmaceutical companies are under suit over allegations of patent infringement after they all filed Abbreviated New Drug Applications (ANDAs) with the FDA requesting permission to manufacture a medication for Parkinson’s Disease (PD). Newron Pharmaceuticals S.p.A., Zambon S.p.A., and MDD US Operations, LLC are suing Aurobindo Pharma Limited, Aurobindo Pharma USA Inc., MSN Laboratories Private Limited, Optimus Pharma PVT LTD, Prinston Pharmaceutical, Inc., RK Pharma Inc., and Zenara Pharma Private Limited and demanding a trial by jury over the supposed infringement of three separate patents.

PD is a disease of the nervous system that results in gradual muscular degeneration, affecting older adults most heavily. Newron, the plaintiff, is a biopharmaceutical company that works to develop “novel therapies for patients with diseases of the central and peripheral nervous system.” They have created a patent-protected supplemental medication for PD that is taken with its primary medication, Levodopa or L-dopa. The medication is called XADAGO and serves to control some of the L-dopa side effects that are known to elicit both “on” and “off” episodes. The medication seeks to prolong the “on” episodes. XADAGO is FDA-approved and is covered by three separate patents.

Since the approval of XADAGO by the FDA, each of the defendants has filed an ANDA with the FDA requesting approval for tablets containing safinamide mesylate. This is the principal component of XADAGO, meaning the new tablets by the defendants would be a generic version of the medication. The defendants are seeking approval by the FDA to “engage in the commercial manufacture, use, importation, offer for sale, and/or sale,” of their products prior to the expiration of the patents protecting XADAGO. They maintain that the patents are invalid and unenforceable.

The plaintiff contended that any new product created by the defendants would be marketed with labeling nearly identical to the labeling of XADAGO, and therefore it would infringe on the aforementioned patents. They are charging each pharmaceutical company (Aurobindo, MSN, Optimus, Prinston, RK Pharma, and Zenara) with patent infringement on three separate patents. The plaintiff is seeking for the defendants to be permanently enjoined from manufacturing the medication, as well as a declaration by the court that manufacturing the product would constitute patent infringement. They further demand a trial by jury.

The plaintiff is represented by Fish & Richardson.