EP 724.444 B1 protects the application of the drug finasteride for the treatment of androgenic alopecia. The symptoms of androgenic alopecia include hair loss in patches, usually in circular patterns. Both men and women suffer from this affection. EP 724.444 B1 expires in October 2014.

Merck Sharp & Dohme Corp (MSD) initiated infringement proceedings in 2012 against Mylan, since Mylan began to market its generic finasteride product in the Netherlands from the end of 2011.

Mylan did not deny the infringement, although it presented arguments that its generic product was not within the scope of the claims. However, the court held that these arguments were based on an incorrect interpretation of the claims and description of EP 724.444 B1, and therefore denied them.

Mylan also argued that EP 724.444 B1 was invalid on the grounds of:

  • unallowed added matter;
  • lack of enablement;
  • lack of novelty; and
  • lack of inventive step.

However, the District Court of The Hague rejected the suggested grounds for invalidity and held EP 724.444 B1, as granted by the European Patent Office, to be valid.

The court also decided that although EP 724.444 B1 was due to expire soon, there was no reason to allow Mylan’s infringing acts to continue. Therefore, the court ordered Mylan to:

  • stop its infringement at once;
  • recall its generic product from customers; and
  • pay MSD damages and the costs of the infringement action.

EP 724.444 B1 has been the subject of legal proceedings in various countries, with different outcomes:

  • In the United Kingdom, the Court of Appeal held the patent to be valid.
  • The German Federal Patent Court invalidated the patent for lack of novelty. On appeal, MSD and Mylan settled the case.
  • In France, EP 724.444 B1 was held invalid by the first-instance court; the case is now on appeal.
  • The Spanish first-instance court and the court of appeal invalidated EP 724.444 B1 for lack of inventive step.
  • In Italy, EP 724.444 B1 was held valid at first instance, and MSD and Mylan settled on appeal.

Henk de Boer

This article first appeared in IAM magazine. For further information please visit www.iam-magazine.com.