AbbVie Uses Patents To Ambush Gilead

November 13, 2014

By Mark Terry, BioSpace.com Breaking News Staff

In a story by Seeking Alpha that underscores the complexities of biotech and drug patents, especially concerning drug combinations, Chicago-based AbbVie and Foster City, Calif.-based Gilead Sciences, Inc. are trading lawsuits over a drug combination marketed as Harvoni.

Gilead, which has a powerful portfolio of hepatitis C virus (HCV) treatments, particularly blockbuster drug Sovaldi, recently began marketing Harvoni, a combination of ledipasvir and sofosbuvir. Sovaldi was approved in December 2013 and had $9 billion in sales by September 2014.

What is particularly complicated here is that AbbVie has five U.S. patents for the use of sofosbuvir and ledipasvir. Gilead does not have patents for the two drugs used in the Harvoni combination, although the company did file an application in September 2011, a month before AbbVie’s first application.

AbbVie’s patent strategy was based on the use of a novel computer model that predicted effective combination therapies. The argument was that their computer model let them “conduct virtual clinical trials to test combinations of drugs for treating HCV.” So, they argue, it was this computer modeling that predicted the best combination.

The U.S. Patent and Trademark Office (PTO) apparently bought the argument and granted AbbVie expedited review and issued the first of two patents before Gilead could act. Gilead, on the other hand, filed a “method of use” patent a month before AbbVie’s applications.

In a November 10-Q filing, Gilead wrote, “We own published and pending patent applications directed to the use of combinations for the treatment of HCV, and, specifically, to combinations of sofosbuvir and ledipasvir.”

Gilead filed a lawsuit in December 2013. In what is, for a legal document, a moderately entertaining read, Gilead says, “This case involves a scheme by two large pharmaceutical companies, Defendants Abbott Laboratories (“Abbott”) and AbbVie, Inc. (“AbbVie”), to attempt to eliminate competition and dominate the market of drugs to treat the hepatitis C virus, known as ‘HCV.’ To execute their scheme, the defendants falsely and knowingly represented to the United States Patent and Trademark Office (“PTO”) that they invented highly valuable methods of treating HCV that were, in fact, invented by plaintiffs Gilead Sciences, Inc. Gilead Pharmasset LLC, Gilead Sciences limited, and their predecessor Pharmasset, Inc. (collectively “Gilead”) and others.”

AbbVie counter filed on February 18, 2014 and again in March for patent infringement, stating, “The [Gilead] complaint slanders AbbVie’s HCV drugs, its corporate integrity, and the integrity of its scientists and its attorneys, and overall seeks to disparage AbbVie’s scientific reputation. Indeed, it makes numerous statements that it would not be permitted to make outside a privileged litigation pleading without incurring liability for slander or reprisal from FDA.”

It is likely that the litigation will go on for several years.