This moggy has been taking a few days off over the Easter period and has therefore not been blogging. Nor has he been reading many decisions or cases. He has, however, like probably the whole of the European patent profession, been thinking about the Unitary Patent. At the risk of further flogging the horse, he wants to follow on from this guest post from Nick Cunningham, and consider the law of infringement of the unitary patent, and the consequences for ratification of the Unified Patents Court Agreement (UPC).
It seems to this moggy that, in order to ratify the UPC, member states will have to:
1) Amend their national law to remove the national effect of European Patents with Unitary Effect, as required by Article 4(2) of the Regulation2) Amend their national law to define infringement in a manner consistent with Articles 25 to 28 of the UPCThere may be other amendments to national law required (dear readers – do please contribute any areas where you see that national law may need to be amended), but for the time being this moggy wants to concentrate on the second.
The UPC relates to European patents whether with or without unitary effect, ie to both unitary and “bundle” European patents. However, it does not relate to national patents. So the law on infringement according to the UPC must apply to all European patents. Furthermore, Article 2(2) of the EPC requires a European patent to have the same effect as a national patent, so it does not appear to be open to member states to have different law in relation to infringement for national patents.
Therefore, in order to ratify the UPC, member states must amend their national law of infringement, for all types of patent, to conform to the UPC.
So what will this involve?
What appears to the IPKat to be highly significant is the “Bolar” exemption which excludes from infringement certain activities relating to obtaining regulatory approval for pharmaceutical or veterinary products.
Section 60(i) of the UK Patents Act excludes from infringement:
(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, orThis attempts to define the acts themselves which are not to be considered patent infringement, as you can see by looking at the wording of Article 10 of the latter Directive as amended. (The wording is not reproduced here as it is easier to look at it in context via the link - the two directives are analogous for the present purposes but the former relates to veterinary products and the latter to pharmaceutical products for humans. Merpel advises to be sure to look at the amended versions of the Directives, not those as originally passed, as they have been substantially changed by subsequent legislation.)
(ii) any other act which is required for the purpose of the application of those paragraphs.
On the other hand, the UPC refers in Article 27 to the sections that create this exemption:
the acts allowed pursuant to Article 13(6) of Directive 2001/82/EC or Article 10(6) of Directive 2001/83/EC in respect of any patent covering the product within the meaning of either of those Directives.Now the meaning of these two might be considered to be the same, or at least close, since Article 10 (6) of Directive 2001/83/EC (as amended) states:
Conducting the necessary studies and trials with a view to the application of paragraphs 1, 2,Both the current UK Patents Act and the UPC represent a “narrow” implementation, excluding only trials for obtaining marketing authorisation by the abridged route for generics (i.e. authorisation for generic equivalents of already authorised products). However, when Directive 2004/27/EC amended the two earlier Directives and introduced the exemption from patent infringement, some countries such as Germnay implemented the exemption in a broad manner, exempting from infringement, for example, any activity related to obtaining marketing authorisation, whether via the abridged route or the normal route (requiring submission of a full dossier relating to safety and efficacy of the product - this procedure is pursuant to Article 8 of Directive 2001/83/EC as amended).
3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products.
It appears to the IPKat that countries ratifying the UPC will have to harmonise their Bolar exemption provisions to those set out in Article 27 of the UPC, but this fact does not seem to have been widely discussed. On the contrary, in fact, what has been announced by the UK IPO is that the UK Government is planning to change the exemption to the “broad” implementation preferred by certain other countries. But the broad implementation now seems incompatible with the UPC wording. If this is correct, then the “broad” implementation of the Bolar provision will be wiped out. But the IPKat has seen no retraction of the UK IPO's announcement, just over a month ago, of the intention to broaden the UK implementation of the Bolar exemption. Has he missed something? Are practitioners in other countries (particularly those with "broad" Bolar provisions such as Germany) discussing the possible loss of scope of their Bolar exemption?
The IPKat has noticed that there are some further differences in wording between the infringement provisions of the UPC and, for example the UK Patents Act. For example, in relation to indirect infringement and infringement by offering of a process, section 60 of the UK Act refers in paragraphs 1 and 2 to “when he/the third party knows or it is obvious to a reasonable person in the circumstances”, whereas the UPC in Articles 26 and 27 says “knows, or should have known”. This UPC wording does not come from the Community Patent Convention, as might have been supposed, which says “or it is obvious in the circumstances”. Presumably the UK section 60 will have to be amended, or a provision will have to be included in the Act to state that it should be interpreted consistently with the wording of the UPC. Perhaps not much will turn on this, but the IPKat wonders what the reason is. There are others, which a meticulous verbal comparison will reveal.
The IPKat has also been wondering how ratification in the UK will be achieved. As the UPC is not an EU agreement, but an international treaty, the usual procedure for implementing EU law by statutory instrument (under Section 2 of the European Communities Act) will not presumably be applicable. Will in fact a new Patents Act be required? Will that affect how long the ratification process takes? Merpel is itching to find out.