Jim Boyle Sep. 11, 2014, 2:52pm


The makers of a testosterone replacement drug have been accused by the Federal Trade Commission of unlawfully preventing generic pharmaceuticals from getting a similar, cheaper product into the market, costing potential consumers hundreds of millions of dollars in lost savings.

In a lawsuit filed Monday at the U.S. District Court for the Eastern District of Pennsylvania, the FTC says that representatives from AbbVie Inc. intentionally filed patent infringement suits they knew to be shams against two generic companies, Perrigo Company and Teva Pharmaceuticals, which is located in Horsham, Pa.

The infringement suits triggered a 30-month delay before the Food and Drug Administration could complete the approval process for the generic drug, the suit says. Teva has also been accused of accepting an unlawful agreement with AbbVie to delay the release of the competitive alternative drug in exchange for a deal where AbbVie would supply Teva with the generic version of Tricor, a cholesterol medication.

According to the suit, AbbVie's initial patent for its AndroGel testosterone drug was too broad because it sought to include any penetration enhancer, an inactive component of the drug that facilitates the delivery of the medication's active ingredient. The company re-filed, narrowing the patent to just one enhancer, isopropyl myristate (IPM). Once AndroGel hit the market, it has earned an average revenue of $1 billion in sales per year.

Perrigo and Teva began developing their generic alternatives using different enhancers to avoid patent infringement. AbbVie filed the sham suits anyway, the FTC says, as part of a strategy to delay the generic drugs from competing against AndroGel.

In fact, the FTC says, AbbVie argued in its original patent application that similar drugs using different enhancers than IPM would not be as effective and could not be demonstrated as substantially equivalent.

The complaint says that Teva decided it would be more profitable to reach a deal with AbbVie. The FTC says that the monopolized sales of AndroGel afforded AbbVie the ability to compensate Teva for keeping its alternative out of the market a little longer with access to its Tricor generic drug.

The federal case ID is 2:14-cv-05151-RK.

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