In the US, skinny labelling was introduced to help generics manufacturers avoid patent walls, or ‘thickets’, set up by originator manufacturers. In essence, a patent wall can be created every time a drug is approved for a new indication (such as a new disease) or a new use (such as in paediatric patients). This can add another 20 years to a patent lifetime and block generics market entry. However, as approved by US congress, skinny labelling allows generics manufacturers to market a product following approval for the unpatented uses of the drug only. This enables the generics company to avoid waiting until existing patents expire and negates the need for them to attempt to invalidate patents in court.

Until now this has been a success. However, Teva has lost the battle against GSK over the skinny labeling of Coreg, used to treat patients with congestive heart failure (CHF) and other cardiovascular disorders. Teva has been requested to pay over US$20 million in damages due to patent infringement.

In 2007, Teva launched their generic version of Coreg with a skinny label that included two indications but did not include the treatment for CHF indication as this was still under patent. The CHF indication was later reissued for GSK and in 2011, the US Food and Drug Administration requested that Teva amend its label to include the patented CHF indication. Now, despite GSK initially losing the case in 2019, the US Federal Circuit has found Teva liable for inducing others, mainly physicians, to commit patent infringement by prescribing the generic form of the drug for indications not on its label (between 2008 and 2011).

It is thought that this case will have immediate ill effects for patients taking generic versions of carvedilol who may now have to switch to the more expensive brand-name version. It also has the potential to threaten other skinny labelled products on the market, and those that may seek approval in the future.

Related articles
Lawsuits and US$450 million payout for price fixing and delayed generics entry

FDA voices concerns around drug patents and competition

European court of Justice backs UK in pay-for-delay fine against GSK

UK accuses GSK of delaying generics

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.