For the half-year to 30 June 2014, the IPKat's regular team is supplemented by contributions from guest bloggers Alberto Bellan, Darren Meale and Nadia Zegze.

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Sunday, 7 April 2013

Harmonisation by the back door - what will the Unified Patent Court Agreement do to the law of patent infringement?

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 UPC
There 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, or
(ii) any other act which is required for the purpose of the application of those paragraphs.
This 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.)

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,
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.
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).

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.

7 comments:

Meldrew said...

See also here for a more fundamental consequence for national law. The territorial scope of contributory infringement for national and opted out EP patents may need "adjustment".

Gibus said...

Thanks very much for this post which (unintentionally?) highlights some major issues surrounding the very legality of the UPC agreement.

The first issue is that this post demonstrates that UPC do affect common rules or alter their scope. As previously recalled, Art. 3.2 TFEU, this condition triggers EU exclusive competence in an international agreement. And as stated in Case C‑370/12 (ESM), CJUE considers this to apply to an international agreement concluded between Member States only (and without the EU being a party). Therefore, there is no doubt that UPC does not comply with EU exclusive competence.

The second issue is perfectly stressed in the title of this post: “Harmonisation by the back door”. Indeed UPC harmonises national laws. Worse, UPC harmonises some national laws that have been harmonised by some EU acts. There is a basis in the EU treaties to do this for the internal market: Art. 114 TFEU. Basing harmonisation on an international agreement, instead of Art 114 TFEU is an awkward way for Member States to circumvent the EU framework.

This is clearly not something that the CJEU will accept...

Emily Weal said...

A report from the European Scrutiny Commitee published in February confirms that an amendment to the UK Patents Act will be needed as part of the ratification process. It makes specific reference to acts constituting infringement (see paragraphs 8.11 to 8.14 here):

http://www.publications.parliament.uk/pa/cm201213/cmselect/cmeuleg/86-xxx/8610.htm

The report is pretty hazy on the details, but something is clearly underway already. It will be very interesting to see how much change is needed.

See here for a round-up of other recent rumours on progress of the unitary patent and the UPC:

http://wp.me/p2LC0X-ce

Russell said...

@Merpel/Darren I believe Sean Dennehey at the CIPA webcast indicated that the UK Patent’s Act would be changed though he did not indicate how.

@Meldrew . Thanks for the link to a very interesting topic. Two quick thoughts.

a.On a pedantic point I don’t think changes to national law on national patents are necessary for the Unitary Patent to have any desired effect in relation to infringement. Art 5 of the regulation (in contrast to Art 7) refers to national law on unitary patents (i.e. law that doesn’t yet exist and wont until the UPCA is ratified) not national law on national patents. Of course even with that interpretation countries might violate Arts 2(2) and 64 EPC if national law on national patents was out of step with the law on EPs.

b. Art 26 UPCA refers to “within the territory of the Contracting Member States in which that patent has effect” – it does not mention anything about equivalent patents. There is a decent argument to say that present national law is already aligned with this- its just that a national patent only ever had effect in one state. A Unitary patent or EP patent would then catch extra infringements over a national patent but only because their territories are larger and not because they have different rights or conditions per se to national patents. The words “effect of” in Art 2(2) EPC are a little harder to reconcile with such a situation.

@gibus “Worse, UPC harmonises some national laws that have been harmonised by some EU acts” Yes but I think they may only do so by reference to those EU Directives. Since interpretation of those directives is clearly under the jurisdiction of the CJEU why will they object?.

On the subject of UPCA provisions that haven’t got much attention does anyone have any thoughts on the new interoperability exemptions from infringement?

Anonymous said...

It wouldn't be the first time that legislation had had unintended consequences: legislators tend to concentrate on the big picture and leave others to sort out the detail, which is where the devil usually lives.

I still recall the unintended consequences on citability of pending EP applications against GB national applications that arose when the due date for paying EP designation fees was amended in the 1980's, meaning that an EP application whose due date had not expired could be a novelty citation if the due date had not passed, but would cease to be a novelty citation after the due date if the GB designation fee was not paid or the application withdrawn. (L'Oreal's Application: [1986] RPC 19).

Meldrew said...

@Russell
On the pedantic point, Article 5(3) of the Regulation indeed states that the scope of a unitary patent extends to that defined by the law applied to European patents with unitary effect. This means that the participating states have to introduce a definition into their national law. Of course, a unitary patent is a European patent. The effect of Arts 2(2) and 64 EPC is that the scope given to a European patent has to be the same as a national patent [not more, not less, but the same]. This gives no freedom to participating states to have any different scope of infringement for national or unitary patents.
Further, the Agreement in Article 26 extends not just to unitary patents but also to non-opted out European patents.
You state that Art 26 UPCA refers to “within the territory of the Contracting Member States in which that patent has effect” and does not mention anything about equivalent patents. Do you consider the different designation of a European patent to be equivalents? If not, why not?
Lastly consider the situation of a PCT application receiving an absolutely clear IPRP from the EPO such that a direct grant might be expected wherever you go to in Europe. Is it right that a different range of infringing acts should apply depending upon whether you:-
• Go for national patents in a few countries
• Go for a “bundle” European patent and opt out of the Unitary Patent Court
• Go for a “bundle” European patent and opt into the Unitary Patent Court
• Go for a unitary European patent and opt into the Unitary Patent Court
I can see the justice in the territorial scope being different – but not for the infringing acts being different – and there will be differences if national law is not appropriately amended.

Russell said...

Meldrew I agree. National law on national patents will have be amended in line with the UPCA to give the same rights and exemptions in regard to infringement.

My pedantic point might have been too subtle. Whilst countries will have to align infringement regarding national, EPs and Unitarys in order to comply with the UPCA and the EPC, what happens if they don’t do so or get it wrong?. If their law for infringement rights of national patents is out of line with EPs I think they will be in violation of the EPC but I don't think it will impact on how the will UPC consider infringement of Unitary Patents. For that the UPC will only look at the law on unitary patents and not national law on national patents.

Despite the wording of 5(3) I'm not even sure the UPCA will bother looking at the particular way nations implement law on unitary patents, just as the English Courts often no longer bother with the UK Act if they can go straight to the EPC. Whilst the method of ratification may vary between countries.(and in at least NL and FR I think international agreements are self-executing), ultimately I think if a country has ratified the UPCA then Arts 25 to 29 are part of their national law and there may be no need to look at national legislation.


“Do you consider the different designation of a European patent to be equivalents? If not, why not?”

I consider them to be part of the same patent. Consequently a right that refers to the territory of the patent could be described as the same right in regard to both a national, an EP or a Unitary but still have different effects depending on what the territory of the patent is. If section 60(2) UK act was changed so that “in the United Kingdom” became “in the territory in which that patent has effect” it would make absolutely no difference to national UK patents but would arguable be compatible with both Art 26 UPCA and Art 64 EPC.

Art 2(2) EPC is more problematic because it suggests the EFFECT in any contracting state should be the same as a national patent. If providing an essential mean in France for putting the invention into effect in the UK infringes an EP validated in GB and FR but doesn’t infringe a national UK patent or national French patent then the effect in those states would not appear to be the same.

However I’m not sure whether your clever suggestion of amending 60(2) to refer to equivalents solves the issue:
1/ Art 2(2) refer to the effect of a national patent not the effect of national patent which is accompanied by equivalents.
2/ The UPCA doesn’t extend Art 26 if there is an equivalent national patent in a UPCA country as well as an EP patent.
3/ Equivalents will be hard to define.

My guess would be that either the word “effect” will be glossed over as vague or the EPC will be amended.

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