Press Release October 17, 2018

Alston & Bird Secures Hatch–Waxman Win for Mylan Pharmaceuticals

Alston & Bird won a complete victory in New Jersey federal court in a ruling that invalidated all patents asserted against Mylan Pharmaceuticals, Inc.

Mylan is seeking to market generic versions of Tradjenta® (linagliptin) and Jentadueto® (linagliptin/metformin), treatments for controlling blood sugar levels in patients with type 2 diabetes that generate more than $1.5 billion in annual U.S. sales.

In 2015, Boehringer Ingelheim Corporation brought a Hatch–Waxman suit against Mylan and other drug companies after they filed abbreviated new drug applications with the U.S. Food and Drug Administration seeking approval to sell low-cost generic versions of Tradjenta® and Jentadueto®. The suit alleged that Mylan and the other companies had infringed patents related to the two drugs.

Following a two-week bench trial, the U.S. District Court for the District of New Jersey found in favor of Mylan and another defendant, ruling that the two remaining patents-in-suit were invalid on grounds of both nonstatutory double patenting and obviousness.

Before trial, Mylan invalidated a third asserted patent for claiming unpatentable subject matter and dismissed a fourth patent from the case following a successful inter partes review petition.

Leading the trial team representing Mylan were Alston & Bird partner Thomas Parker and senior associate Chris McArdle, assisted by senior associate Stephen Yang, associate Charles Naggar, and paralegal Linda Sanchez of the firm’s Patent Litigation Team.

The case is Boehringer Ingelheim Pharms., Inc. v. HEC Pharm Co., No. 3:15-cv-05982, in the U.S. District Court for the District of New Jersey.

Media Contact
Alex Wolfe
Communications Director

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