Plans to extend patent infringement exemption for drugs testing approved

The Regulatory Reform Committee (RRC) recommended that the UK parliament approve the draft Legislative Reform (Patents) Order. The provisions would amend existing UK patent laws and could help make the UK a more attractive place for conducting clinical trials, according to the RRC's report.

"Stakeholders have told us that the risk of infringement proceedings for UK-based trials is greater than for trials run in EU countries with broader infringement provisions," the Intellectual Property Office (IPO) said in giving evidence to the committee, according to the report. "They have indicated that when this risk is significant, they may decide to locate a trial abroad. Thus, legal action may be avoided, due to the location of the trial."

The draft Order would amend UK patent legislation to ensure that activities which are carried out for the purposes of obtaining regulatory approval, or health technology assessment are exempt from patent infringement.

Under the Legislative Reform (Patents) Order, "anything done in or for the purposes of a medicinal product assessment which would otherwise constitute an infringement of a patent for an invention is to be regarded as done for experimental purposes relating to the subject-matter of the invention".

Under the Patents Act any act "done for experimental purposes" relating to the subject-matter of an invention is exempt from being classed as an act of patent infringement.

The definition of 'medicinal product assessment' under the proposed amendments includes testing undertaken with a view to providing data for the purpose of "obtaining or varying an authorisation to sell or supply, or offer to sell or supply, a medicinal product".

It also permits drugs research testing to be carried out without infringing patents where the testing is to enable public health care providers "to carry out an assessment of suitability of a medicinal product for human use for the purpose of determining whether to use it, or recommend its use, in the provision of health care".

"The proposed changes to patent law should mean that the boundaries of the exemption will be more clearly drawn and it should be clearer whether or not certain activities in drug development fall within the exemption," said  life sciences expert Helen Cline of Pinsent Masons, the law firm behind Out-Law.com. "The changes will bring the UK legislation into line with other European Union countries such as Germany which exempt all clinical or field trial work with medicines from patent infringement."

"The proposed changes to UK patent law do not clarify whether the benefit of the exemption extends to a third party manufacturer which supplies a patent-protected substance to a drug company for use in trials for the purpose of generating data to be used to support of a marketing authorisation application," said Cline. "Clarification on this was expected from the CJEU following a referral from the Düsseldorf Court of Appeal in December 2013 in a case involving  Polypharma S.A. and Astellas Pharma Inc. However, the reference was withdrawn in May"

The exemption, if introduced as drafted, would apply to testing of human and animal drugs.

Some human and animal drug testing is already exempt from patent infringement under UK law, but the proposals seek to extend this exemption further.