An elegant way to have different defences to patent infringement under the UPC? UK IPO may have found one...
The IPKat is grateful to Bernie McDonald of GJE, who pointed the Kat to this subject matter and has posted an excellent commentary here, and also to Tim Belcher, new colleague at EIP, for writing assistance with this piece.
As previously noted by this Kat, to ratify the UPC Agreement, member states will have to amend their national law to define infringement in a manner consistent with the treaty (see here). As pointed out in that post, the scope of the “Bolar” exemption codified in Article 27(k)(l) of the UPC Agreement gives rise to some concerns about how this exemption will be harmonised, since current national laws have implemented “corresponding” exemptions in different ways, and some of these seem incompatible with the Agreement wording.
Some countries (such as the UK) use the same “narrow” implementation as used in the UPC, excluding only trials for obtaining marketing authorisation for generics:
[Section 60(5)(i) UKPA77]
(5) An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if - (i) 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.
In contrast, some countries (such as Germany) implement the exemption in a broad manner (which for simplicity, this moggy will refer to as “Bolar+” in this post). The “Bolar+” wording exempts from infringement studies and trials in relation to obtaining any marketing authorization, not simply generics, thereby facilitating research and obtaining marketing approval in relation to innovative drugs and treatments. There are a number of online articles explaining the different scope of the Bolar-type exemption in different countries including Germany, for example this useful piece from Taylor Wessing.
Following a consultation on the topic (the outcome of which is published here [pdf report]), the UKIPO announced that the Government decided to implement the “broad” implementation of the Bolar exemptions favoured by other countries, by amendment to the Patents Act. Many observers, including this Kat, thought this was nugatory; since it appeared that any change to the “Bolar” wording would have to be reversed on ratifying the UPC to implement its “narrow” definition.
However, the proposed legislative changes (you can see the full draft Statutory Instrument here) do not alter the wording of s.60(5) of the Patents Act; the wording of this subsection broadly matches and is entirely consistent with the wording of Article 27 UPC.
Instead, the proposed change is to codify clinical trials as work done for experimental purposes under subsection (5)(b) of the Act:
(5) 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.
New subsection (6D) in section 60 of the Act, would provide that “[f]or 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.” Further subsections (6E) to (6G) provide definitions to interpret the scope of this exclusion.
In leaving subsection 60(5) of the Act unchanged, the UK Act contains equivalent wording to Article 27 UPC. The UPC does not codify the meaning of “experimental purposes” – further definition in the UK Act is therefore on the face of it not inconsistent with the UPC.
This moggy is thus intrigued as to whether these new subsections, pendant on subsection 60(5) UKPA, could be used to implement a definition of infringement that is both consistent with the UPC and different from that in other states (where there are no corresponding provisions that this Kat knows of). The current “Bolar+” wording used in Germany does not seem consistent with the UPC wording and this Kat supposes that it must be narrowed [although Merpel would welcome any thoughts on this from a German specialist practitioner]; has the UKIPO found wording that will allow a similar provision to be installed whilst maintaining consistency with the UPC and allowing its ratification? “Cat-like cunning” Merpel says.
If the proposed legislative changes in the UK were found to be not in conflict with the UPC Agreement, perhaps countries currently using the “Bolar+” wording could implement similar provisions. However, presumably not all member states will necessarily do so.
According to Article 5(3) of the Unitary Patent Regulation, infringement of a Unitary patent will be governed by the national law of the state in which the proprietor has its residence, principal place of business or place of business (or, if none of these exist within a participating EU member state, then German law). As has been pointed out by the IPKat here, this means the law relating "to European patents with unitary effect" (not the pre-existing law), and so this Kat thought up until now that this could only mean a new law, harmonised by the ratification procedure in each participating member state (which would be interpreted only by the judgments of the UPC in the future). But this ruse of statutory drafting, with internal redefinition of existing terms, means that he is now not so sure. Could differing national laws on unitary patent infringement then lead to a situation in which clinical trials would not infringe, for example, a unitary patent owned by a UK company, but which would infringe a unitary patent owned by a company based in another member state? “Humdinger” notes Merpel.
Such a scenario could lead to the undesirable situation in which companies set up unitary patent-holding subsidiaries in states which do not implement such a legislative tool, thereby restricting the scope for clinical trials in all states. Forum shopping in this manner will not appease those skeptical about the UPC.
As usual when endeavouring to interpret freshly minted legislation, the IPKat welcomes comments and other views on the topic. Over to you, dear readers...
As previously noted by this Kat, to ratify the UPC Agreement, member states will have to amend their national law to define infringement in a manner consistent with the treaty (see here). As pointed out in that post, the scope of the “Bolar” exemption codified in Article 27(k)(l) of the UPC Agreement gives rise to some concerns about how this exemption will be harmonised, since current national laws have implemented “corresponding” exemptions in different ways, and some of these seem incompatible with the Agreement wording.
Some countries (such as the UK) use the same “narrow” implementation as used in the UPC, excluding only trials for obtaining marketing authorisation for generics:
[Section 60(5)(i) UKPA77]
(5) An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if - (i) 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.
In contrast, some countries (such as Germany) implement the exemption in a broad manner (which for simplicity, this moggy will refer to as “Bolar+” in this post). The “Bolar+” wording exempts from infringement studies and trials in relation to obtaining any marketing authorization, not simply generics, thereby facilitating research and obtaining marketing approval in relation to innovative drugs and treatments. There are a number of online articles explaining the different scope of the Bolar-type exemption in different countries including Germany, for example this useful piece from Taylor Wessing.
Following a consultation on the topic (the outcome of which is published here [pdf report]), the UKIPO announced that the Government decided to implement the “broad” implementation of the Bolar exemptions favoured by other countries, by amendment to the Patents Act. Many observers, including this Kat, thought this was nugatory; since it appeared that any change to the “Bolar” wording would have to be reversed on ratifying the UPC to implement its “narrow” definition.
However, the proposed legislative changes (you can see the full draft Statutory Instrument here) do not alter the wording of s.60(5) of the Patents Act; the wording of this subsection broadly matches and is entirely consistent with the wording of Article 27 UPC.
Instead, the proposed change is to codify clinical trials as work done for experimental purposes under subsection (5)(b) of the Act:
(5) 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.
New subsection (6D) in section 60 of the Act, would provide that “[f]or 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.” Further subsections (6E) to (6G) provide definitions to interpret the scope of this exclusion.
In leaving subsection 60(5) of the Act unchanged, the UK Act contains equivalent wording to Article 27 UPC. The UPC does not codify the meaning of “experimental purposes” – further definition in the UK Act is therefore on the face of it not inconsistent with the UPC.
This moggy is thus intrigued as to whether these new subsections, pendant on subsection 60(5) UKPA, could be used to implement a definition of infringement that is both consistent with the UPC and different from that in other states (where there are no corresponding provisions that this Kat knows of). The current “Bolar+” wording used in Germany does not seem consistent with the UPC wording and this Kat supposes that it must be narrowed [although Merpel would welcome any thoughts on this from a German specialist practitioner]; has the UKIPO found wording that will allow a similar provision to be installed whilst maintaining consistency with the UPC and allowing its ratification? “Cat-like cunning” Merpel says.
If the proposed legislative changes in the UK were found to be not in conflict with the UPC Agreement, perhaps countries currently using the “Bolar+” wording could implement similar provisions. However, presumably not all member states will necessarily do so.
According to Article 5(3) of the Unitary Patent Regulation, infringement of a Unitary patent will be governed by the national law of the state in which the proprietor has its residence, principal place of business or place of business (or, if none of these exist within a participating EU member state, then German law). As has been pointed out by the IPKat here, this means the law relating "to European patents with unitary effect" (not the pre-existing law), and so this Kat thought up until now that this could only mean a new law, harmonised by the ratification procedure in each participating member state (which would be interpreted only by the judgments of the UPC in the future). But this ruse of statutory drafting, with internal redefinition of existing terms, means that he is now not so sure. Could differing national laws on unitary patent infringement then lead to a situation in which clinical trials would not infringe, for example, a unitary patent owned by a UK company, but which would infringe a unitary patent owned by a company based in another member state? “Humdinger” notes Merpel.Such a scenario could lead to the undesirable situation in which companies set up unitary patent-holding subsidiaries in states which do not implement such a legislative tool, thereby restricting the scope for clinical trials in all states. Forum shopping in this manner will not appease those skeptical about the UPC.
As usual when endeavouring to interpret freshly minted legislation, the IPKat welcomes comments and other views on the topic. Over to you, dear readers...
