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July 2017: Eve-of-Trial Settlement Victory in Hatch-Waxman Suit

July 2017

The firm recently secured a key settlement for an innovator pharmaceutical company, Gilead Sciences, Inc., in a Hatch-Waxman patent litigation against two generic competitors in the District of New Jersey. The settlement preserves patent protection on Gilead’s life-extending, $800 million/year cardiovascular drug, Letairis®.

Ambrisentan, the active ingredient in Letairis®, was originally discovered and researched as an herbicide. Further research showed that it has properties that could treat a disease of the heart and lungs known as “PAH” (pulmonary arterial hypertension), a rare disease that was previously considered a death sentence. Letairis® changed that—it provides not only life extension, but also a significant quality-of-life upgrade.

The case began in April 2015, when Watson Laboratories, Inc. sent a notice to Gilead that it had filed an application with the Food and Drug Administration to market a generic version of Letairis® prior to the expiration of the patent that covers the product. Another generic company, Sigmapharm Laboratories LLC, quickly followed Watson’s lead. Gilead’s patent claims various groups of compounds, including the active ingredient in Letairis®, ambrisentan. The generics stipulated to infringement of the patent, but argued that the patent was invalid for obviousness-type double patenting in view of an earlier patent that claimed much broader groups of compounds in the field of herbicides.

Quinn Emanuel quickly identified that the generics’ obviousness theory was based entirely on hindsight—starting with Gilead’s patent and working backwards to piece together the claimed inventions. Throughout discovery, the firm sought to expose the flaws in the generics’ misplaced theory, including that persons skilled in the art at the time would not have been able to narrow the vast genuses of compounds claimed in the herbicide patent to arrive at the narrow subset of compounds that would be useful for treating PAH. The firm obtained key admissions from the generics’ experts that persons skilled in the art at the time of invention would not have had reason to focus on the later-claimed compounds of Gilead’s patent, and that even if they did, they would not have reasonably expected that those compounds could effectively treat PAH.

With fact and expert discovery complete and the final Pretrial Order filed, trial was about to be scheduled. Before that could happen, however, our adversaries accepted Gilead’s long-standing settlement offer rather than facing us at trial. While the terms of the settlement are confidential, Gilead is thrilled with the result.