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Wednesday, 14 May 2014

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...

13 comments:

Wouter Pors said...

In The Netherlands, no change of national law is needed in relation to Unitary Patents or traditional patents that are not opted out. Under Article 120 of the Dutch Constitution, treaties such as the UPC Agreement take priority over national law. Thus, Article 24 UPC Agreement is automatically fulfilled.
The question however is what happens to traditional European Patents that are opted out. Industry representatives and the Dutch group of AIPPI took the position that it is desirable to apply Article 25 - 28 UPC Agreement to such patents and amend the Dutch Patent Act accordingly. The government is taking this into consideration. There has been no request to change the criteria for infringement of national patents; those are a separate system.

Wouter Pors,
Bird & Bird

Anonymous said...

If my contract synthesis laboratory manufactures and sells patented pharmaceuticals to third parties (not authorised by the patentee) for the purpose of conducting clinical trials, is this exempt from infringement? I am selling the product to increase my wealth and I have no interest in patients or research for any purpose.

Darren Smyth said...

Dear Wouter

Thank you very much for the information from the Netherlands.

I question (as indeed I did in my earlier post linked above) how having different criteria for national and European patents (unitary or not) can comply with Arts 2(2) and 64 EPC, which specify that the effects must be the same. So this approach puzzles me.

I am also not sure how, if the UPC Agreement is implemented by direct effect of the treaty rather than change as such to the national law, there exists a "law applied to European patents with unitary effect in the participating Member State whose national law is applicable" to apply Article 5(3) of the Unitary Patent Regulation. Is it simply the wording of Articles 25 to 28 of the Agreement in the form they appear in the Agreement?

Finally, some commentators have argued that the law of infringement of the UPC Agreement (i.e. Articles 25 to 28) applies even to opted out European patents - you can opt out of the jurisdiction of the Unified Patent Court, but not the substantive law of the Agreement. Given the definition of "patent" in the Agreement, and the wording of the opt out provision in Article 83(3), I cannot see why this view is wrong, and I rather think it may be correct.

Best wishes

Darren

Darren Smyth said...

To Anon at 23:24, I don't think it is possible to be certain about this from the statutory wording only, and (typical lawyer answer I fear) I think it would depend on the details of the surrounding circumstances. But my best guess is that in principle the activity you describe would NOT be exempt from patent infringement.
Best wishes
Darren

Anonymous said...

That was always my belief, Darren, even under the current 'Bolar' exemption. I know commentators have tried to argue that such activities should be covered (even construed to do so) by the current legislation, although in my view the acts are clearly not exempted by the Act. An esteemed member (former) of Mr Pors firm has researched and commentated much on this subject. The UKIPO even provided guidleines on the scope of the exemption, although I don't believe theis point was covered, such guidleines also being clearly without legal basis or in any way binding (may as well have been made by Mr Read of Pfizer).

Anonymous said...

The question whether the Bolar excemption extends to manufacturers of the drug was referred to the CJEU by the Düsseldorf Court of Appeal.

Specifically, it was asked whether and under what conditions the supply of patent protected substances by a third party to a generic company, which intends to use the substance for obtaining a marketing authorization, is covered by the Bolar exemption.

Darren Smyth said...

Thank you anon at 11:35 - that is jolly interesting. Do you have any further information, such as case reference?

Anonymous said...

Dear Darren,
the Information can be found e.g. on the IPKat:
http://ipkitten.blogspot.de/2014/02/astellas-pharma-your-chance-to-comment.html
Regards

Darren Smyth said...

Thank you anon at 13:08 - as you see I don't remember everything posted by my fellow IPKat team members.

Darren

Anonymous said...

I am not sure if it is relevant but the Swedish Government official report (SOU) investigation on the impact of UPR on Swedish law concluded that there might be minor deviations between Swedish law and UPCA. Hence, Art. 25-30 are to be incorporated in Swedish law (http://www.regeringen.se/sb/d/108/a/236374). The impact is however limited to UPR (when UPC decide on infringement of unitary patents). Traditional European patents and national patents are outside the scope of the changes. I am not sure about the Bolar exemption though. /Jonas

Tim said...

I am wondering for some time whether a unitary patent is a validation or not, precisely for the reason that is subject to different rules as a national patent. If only the renewal fees are different, but also the Bolar Exemption, and other aspects of the legal definition of infringing act, e.g. cross border indirect infringement. In addition the translation for the unitary patent has to be filed in 1 month from the mention of the grant, A65(1) EPC sets a minimum of three months for filing the translations. It seems to make more sense to think of it as a kind of "extension agreement" patent. Small detail is the implementation of the ban on a double validated "bundle patent" and EP patent, the EPC does not seem to allow Contracting States to close off the validation, not even under the pretext that a unitary patent exists.

Darren Smyth said...

Hi Tim,

An interesting thought. If, as I think, you mean ban on a double validated EP "bundle patent" and unitary patent (Article 4(2) of the regulation), I am also very interested to see what emerges from this, as the details will be very interesting.

I have previously wondered whether countries that currently prohibit a national patent and an EP for the name invention will necessary implement an identical prohibition on a national patent and a unitary patent.

As to what the unitary patent is, I am not sure. I am not sure that all the possible differences will fully come to pass - I still think that Art 2(2) and Art 64 EPC have to be taken account of as well. Once we have a range of ratifications perhaps we can tell.

Best wishes

Darren

Anonymous said...

I don't see why the legislators have not tackled the issue of whether the new exemption applies to research tool patents. When it says 'done in or for the purpose of a medicinal produce assessment' does it include infringements that could have been easily avoided? For example infringements that could have been done with non-infringing technology?

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