Biosimilars Patent Litigation Faces Normal Discovery Dispute

By George Khoury, Esq. on August 24, 2017 | Last updated on March 21, 2019

Although some litigation attorneys might claim that patent law may as well be Greek to them, when it comes to the rules governing discovery disputes in patent cases over Biosimilars, the attorneys for Amgen are learning a hard lesson: the Federal Rules of Civil Procedure apply as they would for any other case.

The case, Amgen v. Hospira, centers around Hospira attempting to patent a biosimilar to Amgen's EPOGEN, a drug that is used to increase the production of red blood cells in order to treat various medical conditions. Amgen filed an infringement action after Hospira allegedly failed to comply with the requirements under the Biologics Price Competition and Innovation Act, which allows biosimilars to be approved, but only if they've complied with several regulations designed to safeguard the public, and the original inventor of the product that the biosimilar is based upon.

Amgen Appeal Isn't Appealing

Amgen sought review on a few different bases after a motion to compel was denied. The court explained that it did not really have jurisdiction to grant the relief Amgen sought.

First off, the court explained that under the Collateral Order Doctrine, the denial of their discovery motion, to compel certain evidence from Hospira, was not a final order from which an appeal could be taken. The appellate court explained that while sometimes discoveries orders can be subject to an interlocutory appeal, this was not one of those times.

Additionally, the court explained that this was not an appropriate time to use the writ of mandamus, which is generally reserved for when there is not adequate procedure to allow an appellate court to do what is right, just and fair. Here, the court explained that there were several avenues for Amgen to follow, many of which, Amgen failed to utilize, and thereby failed to show a clear and indisputable right to relief (which is required for a writ of mandamus to issue).

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