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UK Government to Expand Bolar Exemption so that Trials of New Drugs will not Infringe Patent Rights

Date: 14 November 2012

The UK Government has this week published its response to the public consultation for the introduction into UK patent law of a research and Bolar exemption for innovative drugs.


At the present time, the UK only allows for an exemption to the regulatory tests required for approval of generic drugs. This exemption merely allows generic drug companies to obtain the necessary regulatory approval to launch their product prior to the expiration of patent protecting the original drug. The narrow scope of this exemption therefore makes the UK less attractive than other jurisdiction for conducting clinical and field trials into innovative drugs. US patent law, for example, has a much more extensive exemption in the form of the Hatch-Waxman exemption of 35 USC § 271(e)(1).


The UK Government consultation proposed a number of possible amendments to Section 60(5) of the Patents Act 1977, which would create an exemption from patent infringement for clinical and field trials using innovative drugs. The majority of respondents indicated that it was highly favourable to amend the patents act to expand the existing exemption to further exempt from infringement activities involved in:


  • preparing or running clinical or field trials;
  • involving innovative drugs; and
  • for the purpose of gaining regulatory approval in any country.


Many also indicated that this exemption should extend to the studies required for the drugs' health technology assessment.


In response to this consultation, the government has accepted the need for a change to the Patents Act such that it includes all of the above-mentioned proposals. This change will make the UK a more attractive jurisdiction in which to conduct drugs trials.


We believe this amendment will most likely be considered by Parliament at the same time as it considers the ratification of the Unitary Patent which is expected in 2014.

Wednesday, November 14, 2012

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