PATENTS
Experimental use exemptions in the UK
There are many ways that experimental use exemptions provide life sciences products with essential relief from patent infringement, as Sophie Topham of Marks & Clerk explains.
There are three categories of experimental use exemptions from infringement, and we discuss each of these in this article. The original experimental use exemption is provided under section 60(5)(b) of the UK Patents Act (UKPA) 1977.
Section 60(1) of the UKPA provides that use in the UK of a product or process falling within the scope of the claims of a granted patent, without the consent of the proprietor, is an infringement of those claims. However, section 60 also provides that in certain circumstances—including, and of particular relevance to, the life sciences sector, experimental uses of the invention— permitted acts that would otherwise constitute an infringement.
The original experimental use exemption
Section 60(5)(b) of UKPA recites: “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.”
This has been held to mean that trials carried out in order to discover something unknown about the patented invention, to test a hypothesis about it, or to find out whether a patented invention which is known to work in specific conditions will work in different conditions, are “experiments” exempted from infringement (Monsanto v Stauffer Chemical [1985]).
This experimental use exemption covers experiments that have the purpose of discovering something new about the subject matter of the invention, and not to verify something already known. This exemption applies only to research which has a real and direct connection with the invention found in the claims of the patent (Smith Kline & French Laboratories v Evans Medical [1989]).
This exemption applies only to experiments relating to the subject matter of the invention and does not apply to experiments that merely use the patented process or product as a part of some other product or process. Exempted experiments are those into, or on, the patented invention and not those which merely use the patented invention.
It should also be noted that exempted experiments can have a commercial end in view and are not limited to experiments in a non-commercial setting, as long as they meet the criterion of being for finding out something new about the invention.
However, tests carried out in order to further commercial exploitation—eg, to obtain marketing authorisation—of the product in question are unlikely to be exempt from infringement (Monsanto v Stauffer Chemical [1985]).
Similarly, tests or trials which are intended to obtain information on the invention in order to satisfy a third party (eg, a customer), or which are for demonstrating to a third party that the invention works, are unlikely to fall within the exemption provided by section 60(5)(b).
In particular, in Corevalve v Edwards (2009) the judge held that, when the potential infringer had several purposes for carrying out the act in question, it is the “preponderant purposes” which matter in assessing whether the act is exempted from being an infringing act.
In that case, the act in question was done to further the commercialisation of the product, to generate revenue and to gain information about the product itself. However, the purpose of gaining information about the product was not considered to be the main purpose and the judge considered that the act in question would therefore not be exempted from infringing the patent.
There is little case law relating to the experimental use exemption, so it is not simple to predict which acts would fall under this exemption from infringement. However, examples of activities that might benefit from this exemption include tests to discover which amino acid residues of a patented protein are essential for its function, or how an enzyme’s activity can be optimised. Experiments aimed at discovering the mechanism of action of a drug might also be able to benefit from this experimental use exemption.
”Exempted experiments are those into, or on, the patented invention and not those which merely use the patented invention.”
Sophie Topham, Marks & Clerk
Late-stage clinical trials, particularly those aimed at obtaining regulatory approval, are unlikely to be able to benefit from this exemption from infringement, but clinical trials may benefit from other experimental use exemptions, as discussed below.
The original experimental use exemption provided for by section 60(5)(b) UKPA is relatively narrow, but UK researchers and research and development departments will be pleased to know that this exemption is not affected by the UK’s exit from the EU.
Bolar exemption
The Bolar exemption is provided for by section 60(5)(i) UKPA, which reads: An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if … it consists of
(i) 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; or
(ii) any other act which is required for the purpose of the application of those paragraphs… This sub-section provides an exemption for some clinical trials on medicinal products for human use and for trials on veterinary products.
However, it should be noted that this provision extends only to studies, tests, and trials that are required in order to take advantage of the abridged regulatory approval procedures available for generic and biosimilar medicines.
Thus, the exemption would apply where trials are required to show that the generic product is bioequivalent to an approved patented product (where this is required to obtain marketing authorisation), and to providing supplementary data for biosimilars.
The exemption does not extend to trials of new medicinal products that have not previously received a marketing authorisation, or of new indications for a previously authorised product.
While there has not, so far, been any case law on the implementation of the Bolar exemption, the UK Intellectual Property Office (IPO) issued a practice notice, which sets out a list of exemplary activities that the IPO considers are covered by the Bolar exemption. This list includes:
- The carrying out of chemical and biological synthetic processes suitable for the making, disposal or keeping of an active substance;
- The manufacture or the import of batches in quantities sufficient to provide material for preparing investigative batches of a medicinal product and to validate processes to the satisfaction of the competent authorities;
- The development of the final pharmaceutical composition and manufacturing processes for a medicinal product to be marketed;
- The making, disposal or keeping or import of medicinal product batches in quantities sufficient to conduct the necessary pre-clinical tests, clinical and bioavailability trials and stability studies of the medicinal product and to validate the processes to the satisfaction of the competent authorities; and
- The manufacture and supply to the competent authorities of samples of active substances, their precursors, intermediates or impurities and of finished product samples.
Although there is no case law on this experimental use exemption, the scope of the exemption is, in one respect, very narrow and covers only acts required and carried out for the purpose of an abridged regulatory approval.
On the other hand, within that context the exemption is broad and covers any acts required to take advantage 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 (ie, abridged regulatory approval).
However, although the IPO has provided some examples of acts which it considers would be exempted from being infringing acts (as discussed above), it should be borne in mind that the UK courts may not agree.
”There is little case law relating to the experimental use exemption, so it is not simple to predict which acts would fall under this exemption from infringement.”
While the Bolar exemption in the UK has its origins in an EU directive, the European Union (Withdrawal) Act 2018 provides, at section 2(1), that domestic law derived from EU law and which is in effect in the UK before December 31, 2020, will continue to have effect in domestic law. This means that the Bolar exemption will continue to apply in its domestic form.
One question that has not yet been considered by the courts is whether an application for abridged regulatory approval to the UK Medicines and Healthcare products Regulatory Agency will continue to be treated as an application under one of the two directives specified in the Bolar exemption, and whether the exemption will apply when abridged approval is being sought only in the UK.
However, this is unlikely to be of significance, as the expanded experimental use exemption would normally apply in such circumstances.
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.
Section 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:
a) obtaining or varying an authorisation to sell or supply, or offer to sell or supply, a medicinal product (whether in the UK or elsewhere);
b) complying with any regulatory requirement imposed (whether in the UK or elsewhere) in relation to such an authorisation;
c) enabling a government or public authority (whether in the UK or elsewhere), or a person (whether in the UK or elsewhere) with functions of:
(i) providing healthcare 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 healthcare,
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.
Section 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).
”Other European countries had incorporated broader Bolar exemptions into their domestic patent laws which were not limited only to generic and biosimilar medicines.”
Section 60(6G)
Nothing in subsections (6D)–(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 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 section 60(5)(i) Bolar exemption 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 section 60(5)(b).
Such regulatory authorities may be, eg, 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 applies where the patented drug is part of a combination of drugs. The IPO has 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).
While there has not yet been opportunity to test the interpretation of the exemptions provided by sections 60(6D)–(6F) in the courts, the IPO expects these provisions to exempt the following acts from being infringements:
a) Activities carried out to provide data to regulatory authorities;
b) Activities carried out to provide data to bodies carrying out health technology assessments,
c) Post-approval studies to comply with regulatory requirements;
d) Activities carried out to amend an authorisation for a medicine;
e) Activities done to obtain an authorisation for a new indication of an existing drug;
f) Any tests or studies required by regulatory bodies;
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 section 60[28]) is not used;
h) Activities related to health technology assessment of a generic or biosimilar product; and
i) Activities carried out to provide data for obtaining regulatory approval for a generic or biosimilar product in another country.
”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.”
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.
The SPC manufacturing waiver.
Although not strictly speaking an experimental use exemption, there is one further means by which the production of medicinal products is exempted from infringement: the Supplementary Protection Certificate (SPC) manufacturing waiver.
SPCs provide an extension to the period of exclusivity provided by a patent, of up to five years, for pharmaceutical products or plant protection products. They are intended to compensate the patent owner for the time required to obtain marketing authorisation for the product.
However, as of July 1, 2019, certain acts no longer infringe SPCs. It should be noted, however, that this exemption does not have retrospective effect; does not apply to SPCs in force on July 1, 2019; and from July 2, 2022 will apply to certificates applied for before July 1, 2019, that take effect on or after that date.
In particular, the SPC manufacturing waiver provides that the manufacture of generic or biosimilar versions of the SPC-protected drug within the EU is not an infringing act if the manufacture is done exclusively for exporting the product out of the EU. This exemption from infringement applies for the lifetime of the SPC.
The waiver also exempts from infringement the manufacture of an SPC-protected product where the product will be stored within the EU, but this stockpiling exemption applies only within the last six months of the term of the SPC in question. This exemption is aimed at enabling generic and biosimilar manufacturers to launch the generic/biosimilar product as soon as possible after the day of expiry of the SPC, in order to improve patient access to medicines.
The SPC manufacturing waiver is based upon an EU regulation, and there was, for a time, uncertainty as to whether the manufacturing waiver would continue in the UK after the Brexit transition period. However, the UK government decided to implement the manufacturing waiver in domestic law in largely the same form as it was introduced in July 2019, with only a change in the administrative requirements for benefiting from the exemption from infringement.
It should be noted that the SPC manufacturing waiver continues to apply where the SPC-protected product is being manufactured in the UK for exportation outside of the UK, Isle of Man and the EU, or where the SPC-protected products are stockpiled in the UK (in the last six months of life of the SPC) for selling in the UK, the Isle of Man or the EU once the SPC expires. However, for the purposes of the EU waiver, the UK is a third country, so companies can manufacture or stockpile under the EU waiver for export to the UK.
Summary
The various forms of experimental use exemptions provide exemption from patent infringement in the UK for experiments having the purpose of discovering something new about the invention, for tests required to obtain abridged marketing authorisation for a generic drug, and for tests required for obtaining marketing authorisation for medicinal products or for providing information for determining the suitability of the product for use in healthcare.
In addition, depending on the specific circumstances, the manufacture of a patented product within the UK may not infringe an SPC when the manufacture is exclusively for exporting the product outside of the UK, the Isle of Man and the EU, or, in the final six months of life of an SPC, when the product is stockpiled within the UK ahead of sales in the UK, the Isle of Man or the EU.
Brexit has impacted the availability of some of the exemptions from infringement, there is still a range of exemptions available for the life sciences industry.
Sophie Topham is an associate at Marks & Clerk. She can be contacted at: stopham@marks-clerk.com
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