The IPO has issued a consultation on the research and Bolar exceptions to patent infringement in clinical and field trials. All responses should be received by 19 December 2012.

Background

The law in the UK on what constitutes an exception to patent infringement in clinical/field trials involving on-patent drugs is uncertain and less generous than in other Member States or the US. This has led to suggestions that the UK is losing clinical/field trials and upstream and downstream work (such as R&D and manufacturing) to other countries.

On 24 October 2012, the Intellectual Property Office (“IPO”) issued a formal consultation on the scope of the exceptions in the UK. The IPO clearly favours domestic legislative change to clarify the position, and asks for input on three legislative options and surrounding issues by 19 December 2012. The consultation can be found here: http://www.ipo.gov.uk/propolicy/ consult/consult-live/consult-2012-bolar.htm

Relevance

The IPO consultation reports that the current wording of the UK exceptions has led to uncertainty about what acts fall within the exceptions. In particular, the consultation reports that there is uncertainty about what clinical/field trials involving ‘on-patent’ drugs (innovative drugs which are protected by patents held by third parties) may be conducted without risk of patent infringement. The following areas have been identified by various stakeholders as areas in which the impact of the current uncertainty is most acute:

  •  clinical/field trials for combination drugs;
  •  clinical/field trials for obtaining marketing authorisations for biosimilar products through the non-generic route;
  •  acts done to collect data for marketing and/or use for public health procurement (e.g. as required by NICE); and
  •  supply of drugs to third parties (e.g. charitable institutions) wishing to perform such clinical/field trials themselves.

The IPO consultation suggests that patent holders only rarely seek to demand licence fees or injunctions to prevent use of on-patent drugs in such activities and that the ambiguous scope of the UK exceptions creates unacceptable uncertainty. This uncertainty may give rise to one or more of the following consequences:

  •  if the trial is to be conducted in the UK, the time and expense of:
    • freedom to operate searches;
    • activities to ‘clear the path’ such as (i) conducting revocation/invalidity and/or opposition proceedings; and/ or (ii) negotiating and entering into licence agreements;
    • negotiating warranties with CROs;
  •  conduct of the clinical trials in a country other than the UK with broader exceptions to infringement; and
  •  conduct of related workstreams such as R&D and manufacturing in a country other than the UK. (Once a manufacturing facility has been set up to manufacture product for the clinical trials, it is often easier to continue ongoing commercial manufacture at the same facility (especially in relation to biologics, the manufacture of which is notoriously difficult to transfer between facilities, let alone countries)).

The current UK exceptions

Experimental Use

The experimental use exception is set out in section 60(5)(b) of the Patents Act 1977:

An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if –

(b) it is done for experimental purposes relating to the subject-matter of the invention;”

The UK courts have interpreted the exception narrowly (e.g. Monsanto -v- Stauffer [1985] RPC 515 and Auchinloss -v- Agricultural & Veterinary Supplies Ltd [1999] RPC 397). In particular, trials carried out to demonstrate to a third party that a product works, or to amass information to satisfy a third party that it works as claimed, are not regarded as acts done for “experimental purposes” and therefore are not exempt from infringement.

Bolar

The Bolar exception (named after the US case Roche Products -v- Bolar Pharmaceutical 733F.2d 858 (Fed. Cir. 1984)) is set out in section 60(5)(i) of the Patents Act 1977:

An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if –

  1. it consists of –
    1. an act done in conducting a study, test or trial which is necessary for and is conducted with a view to the application of paragraphs 1 to 5 of article 13 of Directive 2001/82/EC or paragraphs 1 to 4 of article 10 of Directive 2001/83/EC [these paragraphs relate to veterinary and human generic drugs], or
    2. any other act which is required for the purpose of the application of those paragraphs.”

The exception is limited to acts done for the purposes of obtaining EU marketing approval of generic drugs via the abridged procedure.

International Context

Both the experimental use exception and the Bolar exception vary in scope across Europe and the US. This causes a problem for the life sciences sector as the sector operates globally.

In relation to the Bolar exception, the variation across Europe depends on how the relevant Directives (2004/27/EC and 2004/28/EC) have been implemented in each Member State. The key difference between Member States is whether the exception applies to trials to obtain marketing approvals:

  1. for any medicinal product or only for generic products; and
  2. in the EU only or in any country in the world.

In some Member States, such as Germany, the exception is wide and covers all studies and trials necessary to obtain marketing approval of any medicinal product in any country. Outside the EU, the exception is also wide in the US, where case law has interpreted the Hatch-Waxman Act to exempt from infringement all uses of compounds that reasonably relate to submission of information to the US government, under any law regulating the manufacture, use or distribution of drugs.

However, like the UK, Member States such as the Netherlands and Spain have a narrow exception which only covers acts done in relation to obtaining marketing approvals for generic products in the EU. This means that clinical/field trials using on-patent drugs to obtain marketing approval for an innovative drug do not fall within the exception in the UK.

The Proposals

In the consultation the IPO expresses a strong preference to provide the clarity the life sciences industry is seeking by legislative means (rather than by, for example, issuing guidance notes or encouraging industry agreements).

Three legislative options are given. All of them involve amending section 60(5) Patents Act 1977 to add a new exception to remove the risk of infringement when carrying out clinical/field trials when using innovative drugs. The scope of that exception varies as follows:

  1. Option 1: exemption applies to all activities required to secure regulatory approval to market innovative drugs in all countries.
  2. Option 2: exemption applies to all activities required to secure regulatory approval to market innovative drugs in the EU and EEA only.
  3. Option 3: exemption applies to all activities required to secure regulatory approval to market innovative drugs AND all activities necessary for health technology assessment e.g. data to support assessment by NICE.

One concern is that the scope of the acts which the IPO proposes to exempt from infringement are not sufficiently clear. The IPO clearly states (page 9) that the amendment will apply only to clinical/field trials and that the IPO is not seeking to exempt any other acts from infringement. However, the IPO also states that “it is envisaged that acts to secure regulatory approval will include acts done for submission to regulatory authorities such as the MHRA, EMA; and activities necessary to submit data for health technology assessment activity such as that undertaken by NICE”. This could certainly cover more than clinical/field trials and would seem to make Option 3 redundant as the IPO’s interpretation of activities required to secure regulatory data (already covered by Options 1 and 2) would seem to also cover the additional limb in Option 3.

The IPO acknowledges the attraction of amending the overarching EU legislation in order to provide a harmonised exception for clinical/field trials in the EU, but the length of time to achieve such an amendment and the risk of dissimilar implementation in Member States means that the IPO does not regard this option as viable.

However, something which we do regard as a problem, is the lack of a proposal to lobby for amendments to the Bolar provision in the draft Regulation creating the unitary patent (Article 8(c)). This merely replicates the provision in the current EU Directives, the implementation of which has created the current uncertainties.

Conclusion

The IPO’s proposal to clarify the existing law has been a long time coming. However, the scope of the new exception must be carefully drafted. It is important that the life sciences industry contributes to the IPO consultation to ensure that the proposed exception is fit-for-purpose, unambiguous and not overreaching, and that it re-instates the UK as an attractive venue for clinical/field trials and related workflows. It will also be important to monitor the scope of the Bolar provision in the Regulation creating the unitary patent.