On 12 March 2016 the United Kingdom published secondary legislation1 (“the Order”) to amend existing primary legislation so as to give effect to the Unified Patent Court (UPC) Agreement and the EU legislation on the Unitary Patent2. This is in the form of a Statutory Instrument (SI), which will come into force on the date of entry into force of the UPC Agreement. The Order is one of two SIs required to enable the UK to ratify the UPC Agreement, with another SI required to reflect the UPC Protocol on Privileges and Immunities. That SI is being drafted following approval of the Protocol by the Preparatory Committee in February 2016.
The Order will amend the Patents Act 1977 to extend certain provisions to encompass not only national patents and ‘classical’ European patents as currently granted by the EPO and that have effect in the UK (EP (UK) Patents) but also European patents with unitary effect (Unitary Patents). The Order will also introduce into UK patent law two new exceptions to infringement (which are included in the UPC Agreement). This commentary focuses on the ramifications of these changes, and highlights the likelihood of some variation in national implementation of the Unitary Patent and UPC system.
Exclusion of jurisdiction of the UK courts
The Order ensures that the UPC will have exclusive jurisdiction for actions within Article 32 of the UPC Agreement in relation to Unitary Patents and supplementary protection certificates where the basic patent is a Unitary Patent. Article 32 covers all the main patent actions, e.g. actions for infringement, revocation and declarations of non-infringement. For EP (UK) Patents the Order provides that the UK courts will continue to have jurisdiction to hear cases during the transitional period under Article 83 of the UPC Agreement. For EP (UK) Patents that have been opted out under Article 83 of the UPC Agreement, the UK courts will have exclusive jurisdiction, whereas for EP (UK) Patents that have not been opted out, the UK courts will have shared jurisdiction with the UPC subject to the application of the Recast Brussels Regulation3 on concurrent proceedings. The Order also ensures that following expiry of the transitional period under Article 83, the UPC shall assume exclusive jurisdiction for actions within Article 32 of the UPC Agreement for all EP (UK) Patents that have not been opted out as well as for supplementary protection certificates for which the basic patent is such an EP (UK) Patent.
On infringement under sections 60(1) to 60(3) of the Patents Act 1977, the existing territorial provisions on acts said to constitute infringement will remain unchanged for national patents and EP (UK) Patents. For example, the sale of a product will only infringe a national patent or an EP (UK) Patent if it takes place in the UK, and likewise the use or offer for use of a process will only infringe if this takes place in the UK (section 60(1) of the Act). The same will be true of the dual territorial requirement for contributory infringement under section 60(2) of the Act, which requires that both the supply of means relating to an essential element of the invention, and the putting into effect of the invention, must take place in the UK. However, for Unitary Patents the territories in question in all cases will be extended to the contracting member states in which the Unitary Patent has effect.
The exemption from infringement for acts done on accidently or transiently visiting ships, aircraft and other vehicles in section 60(5)(d)-(f) of the Act will also be modified to extend the relevant territory for Unitary Patents to the contracting member states in which the Unitary Patent has effect rather than just the UK as for EP (UK) Patents and national patents.
Two new exemptions
Article 5(3) of EU Regulation No 1257/2012 (“the Unitary Patent Regulation”) states that for Unitary Patents the acts against which the Unitary Patent provides protection and the applicable limitations (i.e. the scope of protection and available defences or exemptions) shall be those applied to Unitary Patents in the participating member state whose national law shall apply to that patent under Article 7 of the Regulation. As a result, all participating member states are required to implement the infringement provisions in the UPC Agreement (Articles 25 to 29). In the UK this requires the introduction into UK patent law of two new exemptions to infringement, in relation to plant breeders’ use of patented biological material and interoperability of computer software, set out in Articles 27(c) and 27(k) of the UPC Agreement. The plant breeders exemption (new section 60(5)(j) of the Patents Act 1977) will permit limited use of patented biological material so long as it is for the breeding, or discovering and developing of, another plant variety. However, on the wording of the exemption as set out in Article 27(c) of the UPC Agreement, this will not extend to the commercialisation of such new plant varieties. The exemption shall apply to all patents having effect in the UK, i.e. not only to Unitary Patents and EP (UK) Patents (as required to implement the UPC Agreement) but also to national patents.
The interoperability exemption (new section 60(5)(k) of the Patents Act 1977) is based on provisions in Directive 2009/42/EC (which relates to the legal protection of copyright in computer programs) regarding decompilation and interoperability. Articles 5 and 6 of this Directive, which have already been implemented into UK copyright law, allow users of computer programs to perform certain acts without infringing copyright. These include observing, studying and testing the program, or decompiling it to gain access to the underlying code, in order to understand the functionality of the program or to make an independently created program interoperable, so long as these acts are necessary or indispensable for the stated purpose. Article 27(k) of the UPC Agreement extends these exceptions to patents, even though only some computer-implemented inventions are patentable. Although the purpose appears to be to ensure that any patent protection that is obtained is subsidiary to the copyright framework, including the exceptions in copyright law, it is unclear exactly how this novel exemption to patent infringement should operate. In the response to the UK IPO consultation on the text of the draft Order, a number of consultees had concerns about how the exemption would be interpreted by the courts, as the exemption to patent infringement does not currently exist in the UK or other European countries. As a result, the UK government has created a ‘safe haven’ for national patents, which will not be the subject of this exemption, and so the interoperability exemption will apply to EP (UK) Patents and Unitary Patents only, notwithstanding that section 77(1) of the Patents Act 1977 and section 2 of the European Patent Convention state that EP (UK) Patents shall have the same effect as national patents. The UK government is considering how to provide users with greater certainty about the interpretation of the exemption and has indicated that, following a review of the exemption in practice, it may be extended to national patents.
Clinical trials exemption
The Order will not amend the UK’s clinical trial exemptions. Article 27(d) of the UPC Agreement exempts from infringement acts allowed pursuant to Article 13(6) of Directive 2001/82/EC or Article 10(6) of Directive 2001/83/EC, i.e. studies and trials in relation to the regulatory approval of generic human and veterinary medicinal products (sometimes referred to as a narrow ‘Bolar-type’ exemption). Such an exemption was introduced into UK patent law4 when implementing those Directives. However, following concern that clinical trials for the purposes of obtaining regulatory approval for originator products were potentially not exempted from patent infringement in the UK under either this exemption or the experimental use exemption5, the UK introduced a further exemption for anything done for the purposes of a ‘medicinal product assessment’. This is defined in section 60(6E) of the Patents Act 1977 as any testing or other activity undertaken with a view to providing data for the purpose of: (i) obtaining or varying any marketing authorisation to sell a medicinal product; as well as (ii) enabling a government or public body to carry out an assessment of suitability of a human medicinal product for the purpose of determining whether to use it in the provision of health care. This would include cost-benefit analyses done by health technology assessment (HTA) bodies such as NICE in the UK and G-BA in Germany. This was done by expressly extending the experimental use exemption to such activities. Although this wider exemption is not present in the UPC Agreement the UK government did not seek to amend the Patents Act in this respect, and the wider exemption will be applied to Unitary Patents when the Order comes into effect.
In addition to being absent from the UPC Agreement, the wider exemption is not present in the patent law of some UPC contracting states countries (these having only implemented the Bolar-type exemption in national legislation in a narrow manner as the UK had initially done). Therefore, it is likely that at least in relation to this exemption to patent infringement, there may not be complete harmonisation across UPC contracting states. As mentioned above, Article 5(3) of the Unitary Patent Regulation provides that the scope of protection applied to Unitary Patents is that applied to Unitary Patents in the participating member state whose national law shall apply to that patent under Article 7 of the Regulation (where the applicant for the Unitary Patent has his residence or principal place of business on the date of filing of the application for the Unitary Patent). However, Article 5(2) of the Regulation states that the scope of the rights and limitations for a Unitary Patent shall be uniform in all participating member states in which the patent has effect, Given that the various national implementations of Articles 25 to 29 of the UPC Agreement may not be identical, as seen in relation to the clinical trials exemption, there is a real risk that the law on infringement to be applied to Unitary Patents by the UPC will depend on the test in Article 7 of the Regulation. In light of this possibility, the UPC could well ignore Article 5(3) and thus national implementation, and apply the UPC Agreement directly.
Compulsory licences and Crown Use
The UK national provisions on compulsory licences and Crown use will also be extended to Unitary Patents. In brief, compulsory licences can be granted where there has been an abuse of the monopoly by the patent proprietor (sections 48 to 54 of the Patents Act 1977). The UK Crown use provisions allow the use by the Government of patented inventions in return for payment of compensation to the proprietor, although the compensated use is not strictly a licence but an exception to infringement (see sections 55 to 59 of the Patents Act 1977). The Government may also give authority for a third party to make use of the invention on behalf of the Government under Crown use.
Although neither compulsory licences nor Crown use are common nowadays, these provisions are not provided for in the UPC Agreement or EU legislation on the Unitary Patent, other than to state that compulsory licences should be governed by national law (Recital 10 of the Unitary Patent Regulation)). This is therefore another area where there is unlikely to be full harmonisation across the UPC contracting states in relation to Unitary Patents.
Under the current UK law, there is a prohibition on double patenting as between EP (UK) Patents and national patents. Under the present section 73 of the Patents Act 1977 the UK Intellectual Property Office “shall” revoke a national patent following grant of an EP (UK) Patent if the two patents have been granted for the same invention (and where the patents have been filed for by the same applicant and claim the same priority date), although only once the period for opposition at the EPO has expired or following final disposal of the opposition. The UK position is in contrast, for example, to the current position in some other EPC contracting states, which allow double patenting as between a European patent and a national patent.
The Unitary Patent Regulation does not expressly address the issue of double patenting. Indeed, Recital 26 suggests double patenting was never even contemplated.
In the UK, the Order will extend the power under section 73 of the Patents Act 1977 on like terms so as to prohibit double patenting as between a Unitary Patent and a national patent. However, whilst Germany has not yet passed its equivalent amendments to national law so as to implement the UPC Agreement and EU legislation on the Unitary Patent, the current proposal would allow double patenting in Germany as between a European patent that has not been opted out of the UPC under Article 83 of the UPC Agreement and a national patent, as well as between a Unitary Patent and a national patent.
Users of the new system will need to be alive to the fact that the rules on double patenting may not be uniform across the UPC contracting states and therefore may wish to consider applying for additional national protection as a fallback in those countries where double patenting will be allowed.
1 The Patents (European Patent with Unitary Effect and Unified Patent Court) Order 2016 (SI 2016/388)
2 Regulation (EU) No 1257/2012 and Regulation (EU) No 1260/2012
3 Regulation (EU) No 1215/2012
4 Section 60(5)(i) of the Patents Act 1977
5 Section 60(5)(b) of the Patents Act 1977