GlaxoSmithKline’s heart drug Coreg has been around a good long while, but it still pumps out more revenue for the U.K. drug company to keep fighting patent battles for the drug. Teva now finds itself on the losing end of one of those fights in another carve-out patent battle.
A federal jury in Delaware has awarded GSK $235 million in a suit in which it found that Teva had infringed GSK’s drug by marketing its generic as a treatment for chronic heart failure, as well as high blood pressure, Reuters reports.
The award included $234.1 million in lost profits and said GSK deserved an additional $1.4 million in royalties. Teva told the news service that it's considering whether to appeal but still has pending an “equitable defenses” filing that could reduce the award.
Coreg, which generated $131 million for GSK last year, has been around since about 1995. It is approved for treating a number of conditions, including congestive heart failure. Teva’s generic when approved had a so-called carve-out for CHF, which essentially allows copies of a drug to launch for particular uses while one or more indication is still covered by a method-of-use patent.
GSK contended that Teva induced healthcare providers to infringe that patent by marketing its drug for congestive heart failure as well as its approved uses, and the jury agreed.
Carve-outs where the FDA approves a generic only for particular indications have complicated patent protections for drugmakers. Last year, Pfizer lost a closely watched carve-out case in the U.K. for its $5.1 billion blockbuster med Lyrica that is not unlike the GSK case in the U.S.
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The drug was initially approved for treating seizures but in time was prescribed most often for pain treatment. Pfizer had sued Actavis, now owned by Teva, for its generic, which was approved for use in epilepsy but which had a carve-out for pain. Pfizer contended the generic would encroach on the patented pain use as physicians prescribed the med off-label. The company sued for patent infringement on the grounds of “inevitable” off-label use of those generics.
A lower U.K. court ruling in favor of Actavis was upheld by an appeals court last year. Pfizer indicated at the time that it might continue its fight before the U.K. Supreme Court.
AstraZeneca attempted to stave off additional generic competition to statin Crestor in a case in which it argued the FDA shouldn’t be able to do carve-outs for Crestor generics to treat high cholesterol because it would lead to infringement of an orphan drug designation it won in May 2016 to treat children with a rare condition, homozygous familial hypercholesterolemia (HoFH). A judge turned down its request for a restraining order and the generics were unleashed.