The Off-patent Drugs Bill is set to have its second reading debate on 6 November 2015.
The Bill is discussed in a previous post and has now been published together with the explanatory notes and a briefing paper.
Section 3 of the Bill provides for regulations which may specify “further requirements” that would need to be met before a licence is sought for an off-patent drug in a new indication.
Drug companies often maximise the patent lifetime for a given drug by filing additional patent applications for new uses and new formulations. The resulting protection may extend well beyond the (generally 20 year) term of the original “master” patent for the drug. If there is no requirement to search for other rights, the Bill could result in the Secretary of State for Health being granted a marketing authorisation for a new use on expiry of the original master patent, while remaining unaware of a further later patent covering the new use. If this occurred, any company seeking to develop the drug and bring it to market for the new use would be vulnerable to a claim of infringement of the later patent.
It will be interesting to see if the further requirements set out in section 3 of the Bill include searching for further patent rights which cover the new indication, prior to seeking the licence, to reduce the risk of such an infringement.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.