AndroGel

The makers of the testosterone therapy AndroGel could not have prevailed on patent infringement actions they filed against a generic drug maker over the medication, a federal judge has ruled. The decision is a win for the Federal Trade Commission, which is contending that the drugmakers only filed the patent actions to delay a generic form of the drug from entering the market.

U.S. District Judge Harvey Bartle of the Eastern District of Pennsylvania on Sept. 15 granted the FTC summary judgment on one of two prongs needed to establish that the defendants, AbbVie and Besins Healthcare, engaged in monopolistic conduct by filing the allegedly sham patent lawsuit against Teva and Perrigo Co. Specifically, he determined the patent lawsuits were “without question objectively baseless.”

“AbbVie and Besins could not realistically have expected success on the merits of this issue or have had a reasonable belief that they had a chance to prevail,” Bartle said. “The FTC is entitled to partial summary judgment on the objective baselessness element of the sham litigation prong of their illegal monopolization claim. To the extent that the defendants move for summary judgment on objective baselessness, their motion will be denied.”

The second prong that the FTC will need to prove in order to succeed on its claims involves showing that the underlying patent lawsuits were intended to be used in an anti-competitive manner by interfering with a competitor’s business interests. Bartle noted that this question was not before the court.

As part of Bartle’s 33-page opinion he also denied the defendants’ bid to have the case dismissed, finding that an issue of fact existed as to whether AbbVie and Besins exercised monopoly power in the market.

According to Bartle, the FTC’s action stemmed from lawsuits AbbVie and Besins filed in 2011 against generic drug makers Teva and Perrigo Co., which, at the time, were both seeking approval from the U.S. Food and Drug Administration to put a generic version of the testosterone therapy, often referred to as a “low T” drug, on the market. Filing the patent lawsuits, Bartle noted, automatically triggered a 30-month stay of the FDA approval process.

Arguments about the baselessness of the lawsuit hinged on the process that AbbVie and Besins underwent in litigating the patent for the testosterone gel, which used the chemical isopropyl myristate as part of the gel’s “penetration enhancer.”

AbbVie and Besins had first sought a broad patent covering several different penetration enhancer chemicals, but the companies later narrowed the patent in a way that excluded the penetration enhancers that Teva and Perrigo used in their products.

According to Barley, because AbbVie and Besins surrendered their claims to the use of these chemicals, they could not reasonably later file patent infringement suits against Teva and Perrigo over their use of those chemicals.

“Prosecution history estoppel without question prevents the defendant from claiming that the doctrine of equivalents encompasses the penetration enhancers that they abandoned during the application process,” Bartle said. “The defendants clearly surrendered broader language for narrower language. There is no plausible argument to overcome the presumption in favor of the application of prosecution history estoppel.”

Adam Lawton of Munger, Tolles & Olson represented AbbVie, and Gregory Neppl of Foley & Lardner represented Besins Healthcare. Lawton did not return a call for comment. Neppl and a spokeswoman with the FTC both declined to comment.