As many Japanese companies in the healthcare and veterinary fields may have experienced or be aware, obtaining regulatory approval to market a drug in Europe can be time-consuming and often challenging. One difficulty is country-specific legislation while another is uncertainty over the precise extent to which different European Union ("EU") countries permit companies to use third-party patented products in research and tests without infringing patent owners' rights. Such use may typically be required in clinical or field trials when a new drug needs to be compared to a third-party patented product for regulatory reasons, or when the drug to be tested is a combination of an existing third-party patented product and a new drug.
In the UK in particular, the generally accepted view is that there is currently only a limited exception from patent infringement in respect of clinical and field trials (as discussed below). However, as part of the UK government's attempts to make the UK a more favourable place for research and development, on 24 October 2012, the UK's Intellectual Property Office ("IPO")1 published a consultation2 on proposals to amend the UK Patents Act 1977 (the "Patents Act") to provide a broader exception to patent infringement for activities related to regulatory approval of pharmaceuticals. The aim is to eliminate the legal uncertainty for companies wishing to carry out clinical trials in the UK and to reduce the financial burden placed on them by the law as it currently stands, creating a more supportive environment for pharmaceutical research and development in the UK.3
In this newsletter, we explain the background to the consultation and the existing position in the UK in respect of the exemptions from patent infringement for certain clinical and field trials, and set out the current proposals for reform.
Following a commitment by the UK government to ensure that the intellectual property system supports the life science sector,4 the IPO ran an informal consultation in 20115 (the "informal consultation") to investigate whether UK patent legislation was having an impact on clinical6 and field trials7 in the UK. The responses8 indicated that the current wording of the so-called "Bolar" exemption and experimental use sections of the Patents Act9 does put some parties at risk of patent infringement when preparing and running clinical trials involving innovative drugs that are protected by patents held by third parties. One example is comparator trials, in which a new, innovative drug is tested for safety and efficacy against an existing drug that is protected by third-party patents. The infringement risk is caused by uncertainty as to what activities fall within the scope of the legislation. The UK government acknowledged, in November 2011, the evident need to amend UK patent law in this area.10
The Research Exception
Section 60(5)(b) of the Patents Act provides a defence to patent infringement for acts "done for experimental purposes relating to the subject matter of the invention" (often known as the "experimental use exemption" or, more commonly, as the "research exception").
Patent laws in most European countries include a research exception in line with international agreements;11 however, its interpretation varies from country to country. The English courts, for example, give it a narrow interpretation so that it:
- covers only trials carried out to discover something unknown, to test a hypothesis, or to find out whether something will work in specific conditions; and
- does not cover 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.12
This means that, on a strict interpretation, a company may not be able to benefit from the research exception when conducting trials to satisfy national or EU regulators (i.e. a third-party) that a new product is merely as safe and efficacious as an existing product (as opposed to trials to discover, for instance, a new feature of the product) and thus should be granted marketing approval.
The Bolar Exemption
The uncertainty relating to trials for obtaining a pharmaceutical marketing authorisation does not exist in the United States of America ("US"): a specific defence to patent infringement is available in the so-called "Bolar" exemption. It was introduced in the US through the Hatch-Waxman Act13 after the US Court of Appeals for the Federal Circuit refused to recognise such exemption in Roche Products v Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir.1984).
The EU followed this exemption in EU-level legislation,14 but in essence only expressly in relation to work for the purposes of obtaining marketing authorisations for generic drugs. A generic drug is a pharmaceutical product, usually intended to be interchangeable with an innovator product, which is manufactured without a licence from the innovator company and marketed after the expiry date of the patent or other exclusive rights.15
However, the scope of the Bolar exemption is not uniform in the EU. Whereas the UK implemented the Bolar exemption as set out in the EU Directives and no further,16 in most other EU countries, the Bolar exemption has been specifically extended to clinical and field trials using patented drugs so that the producer of a new, innovative drug is also protected from patent infringement claims made by a third-party in respect of the use of the third-party's patented drugs in such trials.
Germany is cited as a particularly industry-friendly regime, as its Bolar exemption covers all studies and trials necessary to obtain marketing approval of any medicinal product in any country, not just generics, and not just in the EU.
Proposed amendments to section 60(5) of the Patents Act
The UK Government recognizes the financial burden currently placed on pharmaceutical companies of the uncertainty of the current regime, and in particular of assessing or removing the risk of patent infringement before carrying out clinical and field trials in the UK. The risk of patent infringement gives rise to costs associated with the need to undertake legal analysis of the patent landscape and clearing the path by challenging the validity of existing patents before the Courts, or patent applications before patent offices, as indicated by evidence received during the informal consultation process.17
The UK Government has therefore put forward three proposed amendments to section 60(5) of the Patents Act to remove the risk of infringement when carrying out clinical and field trials18 using innovative drugs, as follows:
- change UK patent law to exempt from infringement all activities required to secure regulatory approval to market innovative drugs in all countries;
- change UK patent law to exempt from infringement all activities required to secure regulatory approval to market innovative drugs in the EU and European Economic Area only; or
- change UK patent law to exempt from infringement all activities required to secure regulatory approval to market innovative drugs and also all activities necessary for health technology assessment e.g. obtaining data to support assessment by the National Institute for Health and Clinical Excellence ("NICE").
The IPO envisages that acts to secure regulatory approval will include acts done for submission to regulatory authorities such as the Medicines and Healthcare Regulatory Authority (MHRA) or the European Medicines Agency (EMA), and activities necessary to submit data for health technology assessment activity such as that undertaken by NICE.
There are already many positive factors attracting pharmaceutical companies to the UK,19 including its traditional strength in medical research, stringent standards on the safety and price of medicines and pool of skilled labour. This has led to a number of pharmaceutical companies from Japan, China and India to open offices in the UK in recent years.20
At the same time, however, the UK share of clinical trials has fallen in the last decade,21 and removing the uncertainty and reducing the risk of infringement would make the UK a more desirable location to carry out clinical trials.
When the consultation was launched, the IPO's Chief Executive, Mr Sean Dennehey said: "Previous discussions with the pharmaceutical industry revealed a widespread appetite for change in the way UK patent law treats clinical or field trials… I look forward to receiving a wide response providing views and evidence enabling us to move in the direction which industry needs to succeed".22
The consultation is intended to offer interested parties an opportunity to shape the UK's patent infringement provisions. These bodies will include private sector pharmaceutical companies, charitable foundations, publicly-funded research institutions and clinical research organisations that undertake trials on behalf of clients, bodies involved in the organisation or performance of clinical or field trials, as well as owners of pharmaceutical patents. The IPO is also seeking more evidence of the costs and specific examples of the burdens that current legislation places on stakeholders. Japanese pharmaceutical companies doing business in the UK and Japanese pharmaceutical associations may wish to provide comments.
All responses to the consultation should be sent by 19 December 2012. Please let us know if you would like more details on how to comment or respond to the consultation. Subject to the outcome of consultation, the IPO is proposing that the changes be implemented 1 October 2013.