PRACTICE GUIDANCE ON THE TRANSITION PERIOD IN THE WITHDRAWAL AGREEMENT - PATENTS

Published: 3 February 2020
CIPA has updated its Brexit advice to members, prepared by Alicia Instone, CIPA Vice-President and Chair of the Designs and Copyright Committee with help from Julia Florence, CIPA Immediate Past President. 
The UK IPO have issued new guidance on intellectual property during the transition period. To find out more, click here. 
NB: The Transition Period is currently set to end on 31 December 2020.

European (EPC) Patents

The UK’s exit from the EU will not result in any change (either during or after the Transition Period, currently set to end 31 December 2020) in relation to European (EPC) Patents before the European Patent Office (EPO). This is because the EPO is not an EU Institution and the EPC is not EU law. UK-based European Patent Attorneys can continue to act before the EPO and the UK can still be designated in an EPC filing. It is “business as usual”, and we must take every opportunity to reinforce this message internationally. 

In dealings with associates overseas, many of whom remain confused about the effects of Brexit, members may wish to utilise some of the international marketing materials collected in the members’ area of the CIPA website.

In addition, the EPO has made a statement which can be found in more detail in the following link and as set out below:

https://www.epo.org/law-practice/legal-texts/official-journal/information-epo/archive/20200129.html

The EPO has confirmed that the European Patent Organisation is an international organisation established on the basis of the European Patent Convention (EPC). It is independent of the EU and currently has 38 member states, of which 28 are also members of the EU (incl. the UK) and 10 are not. The UK's withdrawal from the EU will consequently have no impact on its status within the European Patent Organisation.

The EPO has also confirmed that the UK's status as a contracting state to the Agreement on the application of Article 65 of the Convention on the Grant of European Patents (London Agreement) will likewise remain unaffected by its withdrawal from the EU. Consequently, patent holders will remain exempt from filing any translations of European patents granted for the UK, after its withdrawal from the EU.

The EPO has also confirmed that the principles governing representation before the EPO will also remain unaffected by the UK's withdrawal from the EU.  In particular, UK European patent attorneys who have been entered on the list of professional representatives before the EPO in accordance with Article 134(2) EPC will remain fully entitled to represent their clients in proceedings before the EPO, including oral proceedings, without the need for a work permit, in either of the states in which proceedings established by the EPC may be conducted, i.e. Germany or the Netherlands. The UK's withdrawal will also have no implications for any future requests for entry of UK candidates on this list of professional representatives before the EPO.

Similarly, the EPO has confirmed that legal practitioners qualified and having their place of business in the UK who are entitled to act as professional representatives in patent matters there, such as barristers and solicitors, will still be able to represent parties in proceedings before the EPO (Article 134(8) EPC).

Finally, the EPO has confirmed that UK professional representatives will remain entitled pursuant to Article 134(6) EPC to establish a place of business in any contracting state to the EPC in which proceedings under the EPC may be conducted. They should bear in mind, however, that any regulations governing entry to and residence in the territory of a given EU member state, such as regulations on visa requirements, will apply.

UPC

The UKIPO has announced very recently (February 27) that the Government will no longer seek to participate in the Unitary Patent or Unified Patent Court system.
It is currently unclear whether the remaining members will wish to proceed without the UK.  This may depend on the outcome of the current challenge before the German Constitutional Court.   There were signs that this may be resolved by mid-2020, but this is not guaranteed.
If the court is to proceed the Life Sciences division will need to be relocated from London.

Under the present UPC Agreement any European Patent Attorney, with the requisite litigation qualification may act as a representative at the UPC.  Relevant UK qualifications include the following:

 

  • ·The Intellectual Property Litigation Certificate or a Higher Courts Litigation Certificate or Higher Courts Advocacy Certificate.
  • ·The Certificate or the MSc in Intellectual Property from Queen Mary, University of London.
  • ·The Nottingham Law School course “Intellectual Property Litigation and Advocacy”.

Thus as things presently stand, British-based European Patent Attorneys have the opportunity to obtain rights of audience before the UPC.

Supplementary Protection Certificates and Paediatric Extensions

Supplementary protection certificates (SPCs) are not granted as EU-wide rights, but rather as national rights. It was therefore not necessary for the UK and the EU to agree the creation of a comparable right to ensure continued protection of existing SPCs in the UK at the end of the Transition Period.

SPCs granted in the UK before the end of the Transition Period will not be affected; they will continue to exist and take effect at the end of the relevant patent term, remaining in force (subject to the usual criteria) for the duration originally granted.

Furthermore, Article 56 of the Withdrawal Agreement together with the Patent Regulations 2019 ensure there will be very little change in relation to pending and future SPC applications.

Thus, the current EU SPC Regulations (Regulations (EC) No 1610/96 and No 469/2009)  will continue to apply to any UK SPC applications pending during the Transition Period, including those filed in the UK between 1 February and the end of the Transition Period.

These EU regulations will also continue to apply to any UK SPC applications which are still pending at the end of the Transition Period.  Any SPC which is granted based on those applications will provide the same protection as existing SPCs.

Following the end of the Transition Period, i.e. from 1 Jan 2021 any new SPC applications in the UK will be dealt with under equivalent UK domestic law.  However, this will cause little change because the current EU regulation will be retained in domestic law, although certain references to EU directives and EU agencies will be replaced by UK equivalents. These changes will be implemented via the Patents (Amendment) (EU Exit) Regulations 2019.

Examples of such changes include replacing references to the EU medicines authorisation under Directive 2001/83/EC with the relevant UK authorisation and to the EU paediatric regulation with the corresponding UK Human medicines regulation. 

Paediatric Extensions

During the Transition Period pending applications for paediatric extension (to an SPC) will be dealt with under the current EU Regulation.   Therefore, it will still be necessary to provide evidence of corresponding authorisations in the EEA during this time.

Applications for paediatric extension which are still pending at the end of the Transition Period will also continue to be processed under the current EU Regulation.

After the end of the Transition Period paediatric extensions will continue to be available based on equivalent provisions in the UK Human Medicines Regulations. However, under the UK provisions it will not be necessary to provide evidence of corresponding authorisations in the EEA.

Practice Point: There will be no need to refile SPC applications. Because SPC applications are examined by the UKIPO and because the law and regulations governing them will not change (at least in the short-medium term) there will be essentially no change to the way we obtain SPCs. 

Practice Point: Members should be aware that some references to the European Economic Area (EEA) will be retained according to the Patent Regulations 2019. Under the current EU Regulation, when applying for an SPC, the details of the first marketing authorisation for the product in the relevant country must be provided along with the first marketing authorisation in the EU/EEA. In practice these are generally one and the same thing – a centralised EU marketing authorisation covering all member states. From the end of the Transition Period, it will be necessary to obtain a separate UK marketing authorisation. Under the UK SPC legislation it will be necessary to provide details of the relevant UK marketing authorisation as well as the earliest EEA marketing authorisation, if this predates the UK authorisation (Article 8 (a)(iv) and (v)). Under the new UK domestic SPC regulation the duration of the SPC will be based either on the first authorisation in the UK or any earlier authorisation in the EEA.

EU marketing authorisations, which have been granted before the end of the Transition Period, will be converted to equivalent UK marketing authorisations. The UKIPO may request information regarding the converted marketing authorisations.

Pending applications for EU marketing authorisation will need to be refiled at the UK MHRA.

Practice point: It is good practice when dealing with SPCs for members to ensure that they or their clients maintain good communication with those colleagues responsible for obtaining marketing authorisations, and this will be especially important as the above changes are implemented.

SPC Manufacturing Waiver

The SPC regulation was amended with effect from 1 July 2019, by virtue of the new Regulation (EC) 2019/933. This permits generic and biosimilar manufacturers in Europe to manufacture medicines protected by an SPC for export to countries where parallel protection does not exist. The waiver also permits stockpiling during six months prior to SPC expiry, to enable launch in Europe immediately on SPC expiry. The waiver will not apply to SPCs in force on 1 July 2019, but will apply to SPCs applied for after that date. For SPCs pending on 1 July 2019 the waiver will apply as from 2 July 2022.  At the end of the Transition Period, this new Regulation will be retained in UK domestic law, and as with other EU regulations it will be amended by means of an SI, to ensure it will function correctly.