Two new weapons for defending Hatch-Waxman litigation


Mark Remus

Two new weapons for defending Hatch-Waxman litigation

MariuszSzczygiel /

Mark Remus of Brinks Gilson & Lione discusses two patent-related challenges for generic pharmaceutical companies and how they might be overcome.

The generic pharmaceutical market is as competitive today as ever. Generic companies compete with innovator companies to clear the legal pathway and they compete with each other to create, maintain or destroy exclusivity. They seek to accomplish all of these objectives with minimal legal spend. The following discussion addresses two particular challenges and potential ways to overcome them.

New life to an old defence

Induced infringement arises most often in the context of method of treatment claims. Induced infringement requires the patent owner to prove that the accused infringer will do something that causes others to infringe the patent-in-suit. Generic companies have long argued that they do nothing to encourage others to infringe the innovators’ patents because they do not administer medication to patients and neither, typically, do they market or advertise their products.

Hatch-Waxman litigation, generic drugs, patent challenges, Brinks Gilson & Lione, innovation, GSK, AstraZeneca, Teva, patent infringement, labelling, brand