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5 August 2021GenericsSophie Topham

UK experimental use exemptions: Part 3—the expanded exemption

In the third article of a four-part series on experimental use exemptions from infringement in the UK, we consider the expansion of the original experimental use exemption (Section 60(5)(b) UK Patents Act [UKPA] 1977) introduced by the Legislative Reform (Patents) Order 2014/1997.

Expanded experimental use exemption

Sections 60(6D)-(6G) UKPA 1977 were added to the UKPA in order to expand upon the original exemption provided by Section 60(5)(b) to broadly cover acts undertaken for the purpose of a “medicinal product assessment”. The new provisions came into force in October 2014.

S.60(6D)

For the purposes of subsection (5)(b), 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.

Section 60(6E)

In subsection (6D), “medicinal product assessment” means any testing, course of testing or other activity undertaken with a view to providing data for any of the following purposes:

  1. a) obtaining or varying an authorisation to sell or supply, or offer to sell or supply, a medicinal product (whether in the United Kingdom or elsewhere);
  2. b) complying with any regulatory requirement imposed (whether in the United Kingdom or elsewhere) in relation to such an authorisation;
  3. c) enabling a government or public authority (whether in the United Kingdom or elsewhere), or a person (whether in the United Kingdom or elsewhere) with functions of:

(i) providing health care on behalf of such a government or public authority, or

(ii) providing advice to, or on behalf of, such a government or public authority about the provision of health care,

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.

S.60(6F)

In subsection (6E) and this subsection “medicinal product” means a medicinal product for human use or a veterinary medicinal product; “medicinal product for human use” has the meaning given by article 1 of Directive 2001/83/EC(a); “veterinary medicinal product” has the meaning given by article 1 of Directive 2001/82/EC(b).

S.60(6G)

Nothing in subsections (6D) to (6F) is to be read as affecting the application of subsection (5)(b) in relation to any act of a kind not falling within subsection (6D).

These subsections were added because the original experimental use exemption (discussed in Part 1 of this three-part series of articles) was unlikely to cover all of the experiments and trials required for the purpose of obtaining regulatory approval for a medicinal product.

In particular, late-stage clinical trials were unlikely to be covered by the original exemption as their primary purpose is usually to generate additional evidence supporting the safety and efficacy of the drug, rather than to find out something new about the invention. In addition, the s.60(5)(i) Bolar exemption (discussed in Part 2 of this series of) only covers studies undertaken to support an abridged application for a generic medicine or biosimilar.

Other European countries had incorporated broader Bolar exemptions into their domestic patent laws which were not limited only to generic and biosimilar medicines. Consequently, there was concern that the UK was losing out on opportunities to carry out work in support of obtaining marketing authorisations for new drugs.

Sections 60(6D)-(6G) provide that the use of a patented invention (eg in clinical trials) with a view to providing data to a regulatory authority in support of an application for marketing authorisation, or complying with any regulatory requirement imposed on such an authorisation (eg any required post-authorisation safety studies), or for allowing a government/public body to decide whether a medicine should be used in healthcare, is deemed to be done for experimental purposes relating to the subject matter of the invention and is therefore not an infringing act as it falls within the experimental use exemption in s.60(5)(b).

Such regulatory authorities may be, for example, the Medicines and Healthcare products Regulatory Agency or the European Medicines Agency. An example of a body which assesses if a new drug should be used in the provision of healthcare is the National Institute for Health and Care Excellence.

Of note, such testing is exempted from infringement even if the testing is done for drug approval by a non-UK authority (see Section 60(6E)). In addition, this exemption also applies where the patented drug is part of a combination of drugs. The UK Intellectual Property Office (IPO) published guidance on the expanded exemption.

However, it should be noted that Section 60(6F) states that only products which fall within the scope of the Directive on the Community code relating to medicinal products for human use (2001/83/EC) or the Directive on the Community code relating to veterinary medicinal products (2001/82/EC) are exempted from infringement by Section 60(6D). The former is the main legislation regulating medicinal products in the EU, while the latter is the main legislation regulating veterinary medicines in the EU.

While there has not yet been opportunity to test the interpretation of the exemptions provided by Section 60(6D)-(6F) in the courts, the IPO expects these provisions to exempt the following acts from being infringements:

  1. a) Activities carried out to provide data to regulatory authorities;
  2. b) Activities carried out to provide data to bodies carrying out health technology assessments,
  3. c) Post-approval studies to comply with regulatory requirements;
  4. d) Activities carried out to amend an authorisation for a medicine;
  5. e) Activities done to obtain an authorisation for a new indication of an existing drug,
  6. f) Any tests or studies required by regulatory bodies;
  7. g) Activities carried out for the purposes of obtaining full authorisation of a generic drug or biosimilar, eg, where the abridged procedure exempted by the Bolar exception (see 60.28) is not used;
  8. h) Activities related to health technology assessment of a generic or biosimilar product; and
  9. i) Activities carried out to provide data for obtaining regulatory approval for a generic or biosimilar product in another country.

As with the Bolar exemption, there has been no case law in this area of law, and this is likely because the context in which the exemption applies is clearly defined, and its application within that context is very broad.

The life sciences industry will be pleased to know that this experimental use exemption from infringement is not affected by Brexit, as it is not based on EU law.

For more on this series, see  Part 1: the original and  Part 2—the Bolar exemption.

Sophie Topham is an associate at Marks & Clerk. She can be contacted at  stopham@marks-clerk.com

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Generics
22 July 2021   In the second of a four-part series, Sophie Topham of Marks & Clerk explains the rules around the exemption for studies, tests, and trials required for generic and biosimilar medicines.

More on this story

Europe
10 August 2021   In the final article of a four-part series, Sophie Topham of Marks & Clerk discusses the supplementary protection certificate manufacturing waiver.
Big Pharma
15 July 2021   In the first of a four-part series, Sophie Topham of Marks & Clerk explores how experimental use provides life sciences products with essential relief from patent infringement
Generics
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