On 24th June 2015, the UK Parliament began another attempt to make potentially significant new treatments more available to patients, and improve efficiency within the NHS.
An existing drug may be shown to have additional therapeutic benefit beyond its existing purpose. However, once the drug comes off patent, the manufacturer has reduced financial incentive to seek authorisation for the drug to be used for the new purpose (because they no longer have a monopoly). Doctors can prescribe drugs “off-label”, for a medical use for which the drug is not authorised, but there is a perception that prescription of a drug for a new use is more likely if that use is authorised. A Bill in the previous Parliament had proposed that the Secretary of State for Health would be able to obtain a marketing authorisation for a new use of an existing drug that was “off-patent”, that is, not covered by a patent, to encourage this new treatment.
The previous Bill was led by an MP who stood down from Parliament in May 2015, but there is now a new Private Member’s Bill sponsored by Nick Thomas-Symonds MP. The first reading of the so-called “Off-Patent Drugs Bill 2015-16” took place in the House of Commons on 24th June 2015. There was no debate on first reading: the debate at the second reading debate is expected to be on 6th November 2015. The new Bill is being prepared for publication, but seems likely to be similar to the previous one. It appears there will remain a risk of patent infringement for companies interested in taking advantage of the proposed system.
As is well known, 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. The Secretary of State for Health might feasibly apply for, and be granted, marketing authorisation for a new use on expiry of the original master patent, while 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 therefore remain vital for a company who intends bringing a drug to market to ensure they are not prevented from doing so by patent rights.
We look forward to seeing the wording of the new Bill, and how it fares on its way through Parliament.
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 before any action in reliance on it.