Old precedent: generics prevail in rosuvastatin litigation
New precedent: brands victorious in key case
Comment
A recent Federal Circuit ruling has opened what had been considered a closed door for litigation over pharmaceutical method-of-treatment (MOT) patents brought under the Hatch-Waxman Act. While the ruling's implications differ for branded pharmaceutical makers and generic producers, one thing seems likely: MOT litigation is poised to take off. How did the situation reach this point? As is typical with litigation, it goes back a few years and requires some explaining.
Old precedent: generics prevail in rosuvastatin litigation
In the late 2000s, branded pharmaceutical maker AstraZeneca sued several generic producers for infringement of AstraZeneca's patents on rosuvastatin, a blockbuster drug for reducing cholesterol. AstraZeneca filed two sets of suits, one alleging that the generics infringed a patent directed to the rosuvastatin compound that would expire in 2016, and a second wave alleging infringement of MOT patents directed to using rosuvastatin to treat specific disorders, which would expire as late as 2021.
The District of Delaware dismissed the second-wave suits because the generics had submitted "skinny" product labels that properly omitted the patented methods of use. The Federal Circuit affirmed, essentially holding that generic producers could not be liable for infringement of MOT patents as long as generic product labels did not reference the treatment specified in the relevant MOT patent. This was the first time in decades of Hatch-Waxman litigation that the Federal Circuit so unambiguously established the grounds for infringement in a way that favoured generics. The number and frequency of MOT claims declined accordingly.
New precedent: brands victorious in key case
It did not take long for the legal tide to turn, however. In 2021's GlaxoSmithKline v Teva, the Federal Circuit expanded the grounds for infringement of MOT patents to allow branded companies to rely on proper skinny labels as well as evidence beyond the labels, delivering a huge victory to the brands.
GlaxoSmithKline claimed that Teva's carvedilol generic had infringed the MOT patent for GSK's Coreg drug to treat congestive heart failure (CHF), even though Teva's skinny label did not seek approval to treat CHF. A split Federal Circuit panel agreed, holding that the District of Delaware had failed to properly consider expert testimony regarding the skinny label, press releases and other promotional materials that the panel found showed that Teva had marketed carvedilol as a CHF treatment.
Against this evidentiary backdrop, the Court noted that doctors could have reasonably interpreted information on the skinny label to suggest that carvedilol could be used to treat CHF, and restored GSK's original award of $235 million in damages. Teva asked the Federal Circuit to rehear the appeal en banc, prompting amicus briefs from the Association for Accessible Medicines, other generic producers, a group of law professors and former Representative Henry Waxman, co-author of Hatch-Waxman. The Federal Circuit has denied the request, with some strongly worded dissents.
The litigation landscape for MOT patents has changed because of the GlaxoSmithKline decision. Branded pharma companies will very likely bring more MOT infringement cases as they reassess the vulnerability of generic competitors. In addition to more MOT cases, the scope and cost of MOT litigation could rise significantly as branded companies increase the number of treatments and patents for existing drugs.
Given the questions the decision raises about Hatch-Waxman's clarity – not to mention the potentially billions of dollars at stake – the issue may well go to the Supreme Court.
For further information on this topic please contact Laura Lydigsen at Crowell & Moring LLP by telephone (+1 202 624 2500) or email ([email protected]). The Crowell & Moring LLP website can be accessed at www.crowell.com.