On Monday, Merck KGaA and Merck Serono SA filed a complaint in the District of Delaware against Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd. for allegedly attempting to infringe upon their patents with a “bioequivalent” multiple sclerosis treatment.
Merck’s ‘903 and ‘947 patent are both entitled “Cladribine Regimen for Treating Multiple Sclerosis,” which have been used to produce 10 mg cladribine tablets known as Mavenclad, the complaint said. The patents are listed alongside this drug in the FDA’s “Orange Book” of approved drugs.
On June 13, Accord notified Merck that they were filing an Abbreviated New Drug Application (ANDA), and they supposedly told the FDA that their product “has the same active ingredient as MAVENCLAD®, has the same dosage forms and strengths as MAVENCLAD®, and is bioequivalent to MAVENCLAD®.” According to the complaint, Accord alleged that Merck’s patents were “invalid,” which would allow them to produce and sell their equivalent product.
The plaintiffs argued that they were entitled to declaratory judgment since the “making, using, offering to sell, selling, and/or importing the Accord ANDA Product, and inducement thereof” would contribute to the infringing of their patents and lead to irreparable harm. Merck further alleged that Accord “acted without a reasonable basis for believing that it would not be liable” for infringing upon Merck’s patents. The plaintiffs argued that Accord never established a reason why their patents would be invalid and are seeking to stop Accord from gaining FDA approval of their bioequivalent drug.
Merck is seeking a judgment that Accord infringed upon their patents, an order declaring that Accord’s ANDA cannot be submitted until Merck’s patent expires, declaratory relief enjoining Accord from continuing to manufacture, distribute and sell their infringing products, attorney’s fees and costs, and other relief.
Merck is represented by Morris, Nichols, Arsht & Tunnell LLP.
