Brand-name drug company Allergan has prevailed against five generic drug makers in one of the first Eastern District of Texas interpretations of the Hatch-Waxman Act, the federal law governing the procedure for bringing generic drugs to market.
The Federal Circuit has ruled in favor of Allergan in a suit over eyelash enhancers, finding that California’s far-reaching unfair competition law does not limit claims of economic losses to parties with direct business dealings.
Allergan has agreed to pay $600 million in criminal and civil penalties and plead guilty to one misdemeanor count of “misbranding” its drug Botox as part of a global settlement with the federal government over off-label uses of the drug. As part of the plea deal, Allergan agreed to drop its First Amendment legal action against the government, which critics said threatened the entire federal regulation of pharmaceuticals.
An Oklahoma jury has found the maker of Botox negligent and awarded $15 million to a doctor who says she suffered botulism after using the anti-wrinkle drug.
The glaucoma drug Alphagan P is responsible for about $240 million in annual revenue for the pharmaceutical company Allergan. So it’s no surprise that when Apotex and Exela Pharmsci told the Food and Drug Administration that they wanted to make generic versions of the drug, Allergan and its lawyers at Fish & Richardson filed patent infringement suits to stop them.