Latest news: a few milestones have been reached

Latest news and milestones from the UPC

Where did the UPC stand at the end of 2018?

In December 2018 the Unified Patent Court Preparatory Committee published a statement summarizing last year’s major events for the Court. It listed notably Latvia and the UK’s ratifications of the UPC Agreement, as well as the progress of the technical and operational preparations.

On a less positive note, the statement also mentioned the fact that the German constitutional case was still pending.

Since the begining of 2019, a few milestones have since been reached:

  • Milestone 1: In January, Austria signed the UPC Protocol on Provisional Application (PPA). The PPA allows some provisions of the UPC Agreement to come into force early. This protocol will allow final preparations to take place, such as the recruitment of judges, and ensure that the UPC can start smoothly. Under Article 3, the PPA will come into force the day after France, Germany, the UK and 10 other countries ratify, or inform the depositary that they have parliamentary approval to ratify the Agreement and have consented to be bound by the PPA. So far France, the UK and nine other countries (Belgium, Bulgaria, Denmark, Estonia, Finland, Italy, Luxembourg, the Netherlands and Sweden) have already done so.  Germany signed the PPA on 1 October 2015 but must now ratify it. However, Germany’s ratifications of the PPA and UPC Agreement, is on hold due to the constitutional complaint pending before the German Constitutional Court.
  • Milestone 2: In February, in Italy, the Parliament has amended its legislation (legislative decree n°18 dated 19th February 2019) to make it compatible with the Unitary Patent Regulation (EU 1257/2012) and the UPC Agreement. The Italian Industrial Property Code now recognises the unitary patent and introduces new exceptions to infringement (Article 27(c), (f), (g), (h) and (k) UPC Agreement), such as the “plant breeders’ exemption” (“The rights conferred by a patent shall not extend to any of the following: (…) c) the use of biological material for the purpose of breeding, or discovering and developing other plant varieties and the “interoperability exemption”) and the interoperability exemption (” The rights conferred by a patent shall not extend to any of the following: (…) k) the acts and the use of the obtained information as allowed under Articles 5 and 6 of Directive 2009/24/EC1 , in particular, by its provisions on decompilation and interoperability“) .
  • Milestone 3: In Germany, the constitutional review of the law enabling the country to take part in the UPC is still ongoing. The German Federal Constitutional Court has however listed the constitutional Complaint with the cases it will rule on in 2019. Moreover, in February 2019 the four committees of the German Parliament voted against a motion to repeal the UPC legislation. The motion will now return to the Bundestag for a definitive vote, which should a priori reject it.
  • Milestone 4: In March, the EPLIT published a short survey regarding the dress code for representatives before the UPC. The survey asked three questions: ” Should representatives wear uniform robes in oral proceedings before the UPC?” “Why should or shouldn’t they wear uniform robes in oral proceedings before the UPC?” and “If they should, which colour should the robe be?” Indeed, the draft Code of Conduct adopted by the Preparatory Committee mentions a dress code (“Finally, we note that once decided for the judges, some provision on the dress code for Representatives should be added to avoid possible discrimination.”). This is because in some participating member states, representatives already wear a robe, such as in France, Germany the Netherlands or the UK. The EPLIT states that apparently a blue robe has been proposed, and annouced the results of the survey at the EPLIT’s annual meeting. The results have not yet been published.

Despite some progress, the UPC’s start of operation is still very uncertain.

Indeed, although the UPC’s entry into force was announced for 2019, the uncertainty created by Brexit as well as by the German constitutional challenge has considerably slowed down the process. One can now hope that there is a better visibility over the UPC’s future once the EU and the UK agree on a Brexit deal.

How to get Unitary Patent protection?

The Steps to get a unitary patent protection?

This is a two steps procedure:

1/ First apply for a EP patent with the EPO
The filing procedure , examination and grant formalities are similar in any way to those of a regular EP patent.
Any person may file a patent application, in any language, provided that a translation into one of the three official languages of the EPO (french, german or english) is filed within two months of the date of filing. The language of the translation will be the language of the proceedings. The patent is published in the language of the proceedings and the claims are translated into the two other official languages.

2/Then, upon grant of the EP patent: the request for the unitary effect

Unitary patent protection will only be available for EP patent granted on or after the date of entry into force of the UPC Agreement (A. 18(6) of Reg. (EU) N° 1257/2012, and having the same set of claims in respect of all the participating Member States.

The patent proprietor shall apply with the EPO for  the unitary protection within one month from the publication of the mention of grant of the EP patent in the European Patent Bulletin . The request shall be filed in the language of proceedings of the EP patent (A.9(g) of Reg. (EU) 1257/2012).
The unitary effect will be indicated in the Register for unitary patent protection, administered by the EPO.

The EPO is currently developing machine translations of patent specifications into all of the official languages of the Union. Therefore, no further translations of the EP patent will be required from the patent proprietor after the end of the transitional period of 6 years (up to 12 years), except in the event of a dispute.
During the transitional period, if the patent is in english, the specification must be translated into any other official language of the Union; if however the patent is in french or german, it shall be translated into english.

The EPO will also administer a compensation scheme for the reimbursement of translation costs for some applicants filing the EP application in one of the official languages of the Union that is not an official language of the EPO. Applicants eligible for the compensation scheme include SMEs, non-profit organisations, universities, individual having their residence or principal place of business within a Member State.


Renewals in respect of the years following the year in which the mention of the grant is published in the European Bulletin will have to be paid with the EPO. There will be a 6 months period for late payment of the renewal and corresponding additional fees.
Can software be patented under the new rules? Will the rules governing patent ability for software change?

No. The unitary patent package will not change the rules on granting a patent, but only the geographic extent of the legal protection that a patent affords, once it has been granted.


(G) Fees

The fees for the Unitary Patent are yet to be decided. The criteria for setting the fees can be found at Article 12 of the Unitary Patent regulation. The process will need to take into account administration costs, the size of the market and the level of fees paid for current European bundle patents.

According to the European Parliament, today, a European patent issued by EPO providing protection in the 27 EU Member States can cost up to €36,000, including up to €23,000 in translation fees alone. According to the European Commission, the new unitary patent will cost a minimum of €4,725, when the new rules are fully implemented, up to a maximum of €6,425. The costs for translation will range from €680 to €2,380.


How are trade secrets protected under the UPC Agreement?

TRADE SECRETS under the UPC Agreement

How are trade secrets protected at national level within the EU?

The protection of trade secrets is an essential guarantee for the protection of intellectual property. However, until recently, EU Member States offered very different levels of protection for confidential information. Directive EU 2016/943 adopted in June 2016 thus aimed at harmonizing national legislations.

Indeed, as highlighted by the directive, “there is a higher risk for businesses in Member States with comparatively lower levels of protection, due to the fact that trade secrets may be stolen or otherwise unlawfully acquired more easily. This leads to inefficient allocation of capital to growth-enhancing innovation within the internal market because of the higher expenditure on protective measures to compensate for the insufficient legal protection in some Member States. It also favours the activity of unfair competitors who, subsequent to the unlawful acquisition of trade secrets, could spread goods resulting from such acquisition across the internal market. Differences in legislative regimes also facilitate the importation of goods from third countries into the Union through entry points with weaker protection, when the design, production or marketing of those goods rely on stolen or otherwise unlawfully acquired trade secrets. On the whole, such differences hinder the proper functioning of the internal market.”
All industries should thus benefit from the homogenization of trade secrets at EU level .

Although, while the directive transposition deadline was set for 6th June 2018, EU Member States have actually implemented it at different paces. Companies have however already seized the opportunity to rely on it. In France for example, the Paris Court of Appeal held on 9th October 2018 the first French decision relying on the transposition of the directive (see the decision below). In this case LGE had asked the Court to order Conversant Wireless to present confidential evidence, who opposed it. The Paris Court of Appeal granted LGE‘s request, considering that the confidentiality conditions provided by article L. 153-1 of the French Code of commerce, which transposes EU directive 2016/943, would adequately protect the trade secrets contained in the confidential evidence at stake.

The protection of trade secrets and confidential information is a problem that will similarly arise before the UPC.

How will trade secrets be protected by the UPC?

The UPC Agreement provides for different measures to protect confidential information, at articles 45, 52, 58, 59 and 60.

Article 45 allows the UPC to arrange for private proceedings, and article 52 provides that the UPC may, with the agreement of the parties, dispense with the oral hearing. Article 58 grants the Court the power to order the prohibition or restriction of the collection and use of evidence, while articles 59 and 60 subject the Court’s power to present and preserve evidence as well as inspect premises, subject to the protection of confidential information.

However, the UPC Agreement also contains provisions that may be more challenging for the protection of trade secrets.

Article 10 for example states that the register shall be public (though article 45 provides for private proceedings) . Article 80 adds that the Court may, at the request of the applicant, order the display or publication of the decision.

But what about Non-Disclosure Agreements?

The UPC Agreement does not say anything about Non-Disclosure Agreements. The UPC Rules of Procedure on the other hand specify when the parties can request such agreements.

Hence, when the UPC must give an order “to produce evidence” (Rule n°190), “on the application for preserving evidence” (Rule n°196), or “for inspection” (Rule n°199), measures to preserve the confidentiality of the information at stake can be granted by the Court. Such measures restrict the disclosure of the information “to certain named persons only and be subject to appropriate terms of non-disclosure“.

Rule n°190 for example states: “Where a party has presented reasonably available and plausible evidence in support of its claims and has, in substantiating those claims, specified evidence which lies in the control of the other party or a third party, the Court may on a reasoned request by the party specifying such evidence, order that other party or third party to produce such evidence. For the protection of confidential information the Court may order that the evidence be disclosed to certain named persons only and be subject to appropriate terms of non-disclosure. (Emphasis added)

Rule n°105, 115, 197 and 262 also provide for the Court to adapt respectively the interview conference, oral hearing, order to preserve evience and public access to the register. These guarantee that the information is kept “to the extent necessary, confidential in the interests of one or both parties or third parties or in the general interests of justice or public order“.

Rule n°105 for example provides:

” 1. The interim conference should, where practicable, be held by telephone conference or by video conference. 2. On request by a party, subject to paragraph 1 and the approval of the judge-rapporteur, the interim conference may be held in Court. If the interim conference is held in Court, it shall be open to the public unless the Court decides to make it, to the extent necessary, confidential in the interests of one or both parties or third parties or in the general interests of justice or public order. “

The UPC Agreement and the UPC Rules of Procedure thus, in a similar way than EU member states, transpose the EU directive 2016/943. The UPC Agreement is thus drafted to guarantee that trade secrets are not stolen or otherwise unlawfully acquired. Nonetheless, it will now be for the UPC to apply its discretion and decide consistently when to use the measures provided for in the UPC Agreement and in the UPC Rules of Procedure.

How to opt-out a patent / withdraw an opt-out / correct an opt-out?

Opt-out: How to opt-out a patent?

§. Who can lodge the applications to opt-out / withdraw an opt-out / correct an opt-out and how?

  • According to the Rule of Procedure 5 of the Unified Patent Court: the patent proprietor or a person mandated by her are the only persons allowed to opt-out, withdraw and correct an opt-out. In case of multiple patent proprietors, the opt-out must be lodged by or on behalf of all proprietors.


  • Opt-out on behalf of the sole patent proprietor:  If the authorised user is a representative before the UPC, as defined in article 48 of the UPC Agreement, a mandate authorising the opt-out is not required. If the user is not such a representative, a mandate from the proprietor – and, if applicable, holder of Supplementary Protection Certificates- must also be lodged. This mandate must specifically authorise the opt-out. The mandate can be delivered to any person or private company. It must include the patent number, the patent holder’s name and her signature. The UPC published a template mandate which can be found below.


  • Opt-out on behalf of multiple proprietors:
    • The opt-out may be lodged on behalf of a proprietor by a registered user of the CMS. The user must be authorised to lodge the opt-out by all proprietors. She must declare in the opt-out that each proprietor is entitled to be registered as proprietor pursuant to Rule of Procedure 8.5.
    • If the authorised user is a representative before the UPC, in accordance with article 48 of the UPC Agreement, a mandate authorising the opt-out is not required. If the user is not such a representative a mandate from all proprietors and holders of SPCs must also be lodged specifically authorising the opt-out in question.

The mandate template for lodging an application is available on the UPC Case Management System and can be found below:

§. What if Supplementary Protection Certificates (SPCs) have been granted in respect of the patent being opted-out?

If at the date of the opt-out one or more SPCs have been granted in respect of the patent that is being opted-out, the following details of the SPCs must be included in the opt-out:
the name, postal and, where applicable, electronic addresses of each proprietor and of the holder of any supplementary protection certificate based on the European patent in question ;
details of any supplementary protection certificate granted based on the patent concerned, including the number.
Each holder of an SPC, if different from the proprietor of the patent, must lodge or authorise the opt-out in addition to the proprietor of the patent. Such a patent must be opted out even if expired.
The opt-out will be effective in respect of any further SPC granted after the registration of this opt-out.

§. What are the different procedures?

1. Opt-out procedure:

The opt-out procedure must be completed online by logging into the UPC Case Management System. This is a 9 steps process:

Opt-out process

All opt-out requests will appear on the EPO Register. All European patents opted out will be published on the UPC website.

It is not possible to opt out a European patent with unitary effect. Therefore if the application for opting-out a European patent with unitary effect is granted, the opt-out is deemed to be withdrawn from the date of grant. It is also not possible to opt out any patent/SPC which is the subject of an existing or prior action before the UPC.


2. Correction of the opt-out procedure:

Following the lodging of the correction of the opt-out, the correction date will be recorded in the opt-out register. An email will be sent with details of the corrected registration. The correction will be available to the public.

3. Withdrawal of the opt-out:

A patent which has been the subject of a withdrawal may not thereafter be opted out again.

Following the lodging of the withdrawal of the opt-out, the relevant European Patent published application number will be removed from the opt-out register. An email will be sent to the patent proprietor with details of the withdrawal. These details will be available to the public.
4. Correction of the withdrawal of the opt-out:
As it is not possible to correct the patent number in the original withdrawal, a new application to withdraw an opt-out must be lodged with the correct number. A correction of a withdrawal of an opt-out must be lodged in respect of each patent where the withdrawal data was incorrect. Following the lodging of the correction of the opt-out withdrawal the date of correction will be recorded in the opt-out register. An email will be sent to the patent proprietor with details of the corrected registration of the withdrawal. These details will be available to the public.

§. When will the opt-out take effect?

An opt-out lodged before the date of entry into force of the UPC Agreement will be treated as lodged on the date of entry into force.
Following the lodging of the opt-out the relevant European Patent published application number will be recorded in the opt-out register. An email will be sent to the patent proprietor with details of the registration. These details will be available to the public.
All corrections and withdrawals will take effect respectively from the date of correction and date of withdrawal.

§. How much will it cost to opt-out?

The Preparatory Committee confirmed that there will be no fee for the opt-in nor opt-out procedure.

§. The Templates

Template opt-out mandate

Opt-out template

OPt-out template 2

Representative, you shall…What is the proposal for the UPC’s code of conduct saying?

After much debate about the UPC Code of Conduct and the publication of a letter by the Council of Bars and Law societies of Europe (see our post here) highlighting the potential tensions between national codes of conduct and the UPC code of conduct, its proposal has been made public by the Preparatory Committee on the Unified Patent Court’s website.

As explained in its preamble, the code of conduct has been drafted by a working group comprising the EPLAW, EPLIT and epi which “undertook a comparative study of existing professional laws to identify the needs as well as the limitations for regulations within the Code of Conduct”.

The proposed code of conduct has therefore been divided into four articles covering issues related to its field of application, the representatives’ general conduct, witnesses and experts, and change of representation.

Regarding its field of application and in view of the potential conflict between national laws, the UPC rules of procedure and the code of conduct itself, the proposal makes clear in its first article that its scope is limited to the scope required by the rules of procedure. The code of conduct cannot therefore be in contradiction with national laws. On the other hand, in case a conflict arises between the code of conduct and the rules of procedure, the latter will prevail.

The second article lists the principles that must guide the Representatives’s general conduct, who shall:

  • act respectfully, courteously and competently. Representatives’ competency is further defined in the notes as the necessity for representatives to “inform themselves sufficiently about the new system and applicable law to prepare their cases correspondingly”.
  • have due regard for the fair conduct of proceedings, exercise his or her right in good faith, not abuse the Court process, be reasonably accommodating and flexible.
  • not contact a judge about a specific case without the participation or prior consent of the other party’s Representative.
  • serve the interests of their clients in an unbiased manner without regard to his or her personal feelings or interests.
  • ensure the appropriate demeanour of anyone accompanying him or her.
  • not misrepresent cases or facts before the Court (knowingly or where the inaccuracy could easily have been discovered).
  • in case he or she becomes aware that they have misled the court, inform the Court with the consent of their client. If the Representatives’ client refuses to give consent, representatives shall cease to represent that client.
  • not disclose any document that is subject to privilege without the consent of his or her client.

The third article looks specifically at the Representatives’ legal obligations in respect of witnesses and party  experts. The code of conduct states that representatives shall ensure that:

  • witnesses are fully informed about their obligation to tell the truth and of their liability under the applicable national law in the event of any breach of this obligation.
  • experts are fully informed of their obligation to assist the court impartially, being independent and objective and not advocating for any party.
  • the substance of evidence of a witness or expert solely reflect the witness’ or expert’s respective recollection or opinion.
  • reasonable compensation for the work of witnesses and experts is arranged if necessary.

Finally, in case of a change of representation, the former representative shall be responsible of the notification of the change to the Registry without undue delay.

This code of conduct raises however a few questions. For instance,  which national law will be applicable to witnesses? Will it be the witness’ own national law or will it be the national law of the country where it is trialled? One can also wonder whether, independently of which law is applicable, this will create an uneven playing field  in the event of a breach by a witness of her obligations as both options suggest that witnesses would not all be subject to the same national law. Similarly the extent to which a representative will have to “inform” a witness of its liability is uncertain. In fact, does the code of conduct mean that a representative has to advise witnesses on their liability under applicable national laws or does it mean that representatives simply have to alert witnesses? More questions could of course be raised on this code of conduct, for example on the very broad terms used to describe the general conduct of representatives, which may appear particularly vague in comparison with some of the national codes of conduct.

However, as indicated by the Preparatory Committee, further work is expected this month (June 2016) before the draft is tabled again at the meeting of the Committee planned for 30th June…

Supplementary Protection Certificates, European Patents, and Unitary Patents: How is it going to work after the entry into force of the UPC?

Supplementary Protection Certificates ensure the recovery of high investments necessary over a long development period to bring a successful innovative product to the market. SPCs in particular are critical for the agrochemical, pharmaceutical and medical devices industries which rely heavily on industrial protection through patents and SPCs. Existing SPCs complement national or European patents to ensure an extra period – up to five years – of protection for patent holders, to offset the time required to obtain marketing authorisation for their patented products.

The entry into force of the UPC will however bring major changes to SPCs as well as European Patents.  This post therefore looks at the provisions in the UPCA and the Rules of Procedure which deal with SPCs; the impact of these provisions on SPCs, European Patents and Unitary Patents; the issues raised by these changes; and finally the project of a unitary SPC.

I. The provisions concerning the SPC in the Unified Patent Court Agreement (UPCA) and the Rules of Procedure: 

A.  The UPCA:

  • Article 2 (h)Supplementary protection certificate” means a supplementary protection certificate granted under Regulation (EC) No 469/20091 or under Regulation (EC) No 1610/962


  • Article 3This Agreement shall apply to (b) supplementary protection certificate issued for a product protected by a patent


  • Article 30  “A supplementary protection certificate shall confer the same rights as conferred by the patent and shall be subject to the same limitations and the same obligations


  • Article 32The Court shall have exclusive competence in respect of:(a) actions for actual or threatened infringements of patents and supplementary protection certificates and related defences, including counterclaims concerning licences; (b) actions for declarations of non-infringement of patents and supplementary protection certificates; (d) actions for revocation of patents and for declaration of invalidity of supplementary protection certificates; (e) counterclaims for revocation of patents and for declaration of invalidity of supplementary protection certificates”.


  • Article 83(1) During a transitional period of seven years after the date of entry into force of this Agreement, an action for infringement or for revocation of a European patent or an action for infringement or for declaration of invalidity of a supplementary protection certificate issued for a product protected by a European patent may still be brought before national courts or other competent national authorities. (2) An action pending before a national court at the end of the transitional period shall not be affected by the expiry of this period. (3) Unless an action has already been brought before the Court, a proprietor of or an applicant for a European patent granted or applied for prior to the end of the transitional period under paragraph 1 and, where applicable, paragraph 5, as well as a holder of a supplementary protection certificate issued for a product protected by a European patent, shall have the possibility to opt out from the exclusive competence of the Court. To this end they shall notify their opt-out to the Registry by the latest one month before expiry of the transitional period. The opt-out shall take effect upon its entry into the register. (4) Unless an action has already been brought before a national court, proprietors of or applicants for European patents or holders of supplementary protection certificates issued for a product protected by a European patent who made use of the opt-out in accordance with paragraph 3 shall be entitled to withdraw their opt-out at any moment. In this event they shall notify the Registry accordingly. The withdrawal of the opt-out shall take effect upon its entry into the register. (5) Five years after the entry into force of this Agreement, the Administrative Committee shall carry out a broad consultation with the users of the patent system and a survey on the number of European patents and supplementary protection certificates issued for products protected by European patents with respect to which actions for infringement or for revocation or declaration of invalidity are still brought before the national courts pursuant to paragraph 1, the reasons for this and the implications thereof. On the basis of this consultation and an opinion of the Court, the Administrative Committee may decide to prolong the transitional period by up to seven years.


B. The Rules of Procedure:

  • Rule 2:” 1. Subject to paragraph 2, in these Rules with the exception of Rule 5 the expression “patent” and “proprietor” shall whenever appropriate include, respectively, a supplementary protection certificate as defined in Article 2(h) of the Agreement and granted in respect of the patent and the holder of such certificate. 2. References in these Rules to the language in which the patent was granted shall mean that language and not the language in which a supplementary protection certificate in respect of the patent was granted.


  • Rule 5: “Rule 5 – Lodging of an Application to opt out and withdrawal of an opt-out 1. The proprietor of a European patent (including a European patent that has expired) or the applicant for a published application for a European patent (hereinafter in this Rule 5 an “application”) who wishes to opt out that patent or application from the exclusive competence of the Court in accordance with Article 83(3) of the Agreement shall lodge an Application (hereinafter in this Rule 5 an “Application to opt out”) with the Registry. (a) Where the patent or application is owned by two or more proprietors or applicants, all proprietors or applicants shall lodge the Application to opt out. Where the person lodging an Application to opt out is not recorded as the proprietor or applicant in the registers referred to in Rule 8.5(a) and (b), respectively, the person shall lodge a declaration pursuant to paragraph 3(e). (b) The Application to opt out shall be made in respect of all of the Contracting Member States for which the European patent has been granted or which have been designated in the application. 2. An Application to opt out or an Application to withdraw an opt-out pursuant to paragraph 8 (hereinafter in this Rule 5 an “Application to withdraw”) shall extend to any supplementary protection certificate based on the European patent. (a) Where any such supplementary protection certificate has been granted at the date of lodging the Application to opt out or the Application to withdraw, the holder of the supplementary protection certificate shall, if different from the proprietor of the patent, lodge the Application to opt out or the Application to withdraw together with the proprietor. (b) Where any such supplementary protection certificate is granted subsequent to lodging the Application to opt out, the opt-out shall take effect automatically on grant of said supplementary protection certificate. (c) Paragraphs 7 and 9 shall apply mutatis mutandis. For the purposes of paragraphs 7 and 9, reference to actions (i) in respect of a European patent shall apply to all supplementary protection certificates based on that European patent, and (ii) in respect of a supplementary protection certificate shall apply to the European patent on which such supplementary protection certificate is based and (iii) in respect of a supplementary protection certificate shall apply to all other supplementary protection certificates based on the same European patent. (d) For the avoidance of doubt, it is not possible to opt out supplementary protection certificates, whether granted by the authorities of a Contracting Member State or otherwise, based on a European patent with unitary effect. 3. The Application to opt out shall contain: – 22 – (a) the name of the proprietor or applicant for the European patent or application and of the holder of any supplementary protection certificate based on the European patent in question, and all relevant postal and, where applicable, electronic addresses; (b) where such proprietor, applicant or holder have appointed a representative, the name and postal address and electronic address for service of the representative; (c) details of the patent and/or application including the number; (d) details of any supplementary protection certificate granted based on the patent concerned, including the number; and (e) for the purposes of paragraph 1(a), a Declaration of proprietorship that the person lodging the Application to opt out is the proprietor or applicant pursuant to Rule 8.5 and entitled to lodge the Application to opt out. 4. Rule 8 shall not apply to Applications to opt out and to Applications to withdraw made pursuant to this Rule 5. Where a representative is appointed, such a representative may include professional representatives and legal practitioners as defined in Article 134 EPC in addition to those referred to in Article 48 of the Agreement. 5. The applicant for an opt-out shall pay the fixed fee in accordance with Part 6. The Application to opt out shall not be entered in the register until the fixed fee has been paid. One fixed fee shall be payable in respect of each European patent or application for which an Application to opt out has been filed, including any supplementary protection certificate based on said patent or application. 6. Subject to paragraph 5 the Registrar shall as soon as practicable enter the Application to opt out in the register. Subject to paragraph 7, the opt-out which meets the requirements laid down in this Rule shall be regarded as effective from the date of entry in the register. If the requirements are missing or incorrectly recorded, a correction may be lodged with the Registry. The date of entry of the correction shall be noted in the register. The opt-out shall be effective from the date of correction. 7. In the event that an action has been commenced before the Court in respect of a patent and/or an application contained in an Application to opt out prior to the date of entry of the Application to opt out in the register or prior to the date of correction pursuant to paragraph 6, the Application to opt out shall be ineffective in respect of the patent and/or application in question, irrespective of whether the action is pending or has been concluded. 8. A proprietor of a patent or an application the subject of an opt-out pursuant to this Rule may lodge an Application to withdraw in respect of the patent or application, but not in respect of different Contracting Member States for which the European patent has been granted or which have been designated in the application. The Application to withdraw shall contain the particulars in accordance with paragraph 3 and shall be accompanied by the fixed fee in accordance with Part 6; paragraph 5 shall apply mutatis mutandis. Subject to the receipt of the fixed fee the Registrar shall as soon as practicable enter the Application to withdraw in the register and the withdrawal shall be regarded as effective from the date of entry in the register. Paragraphs 1(a) and 6 shall apply mutatis mutandis. 9. In the event that an action has been commenced before a court of a Contracting Member State in a matter over which the Court also has jurisdiction pursuant to Article 32 of the Agreement in respect of a patent or application contained in an Application to withdraw, prior – 23 – to the entry of the Application to withdraw in the register or any time before the date pursuant to paragraph 6, the Application to withdraw shall be ineffective in respect of the patent or application in question, irrespective of whether the action is pending or has been concluded. 10. Where an application for a European patent subject to an opt-out pursuant to this Rule proceeds to grant as a European patent with unitary effect, the proprietor shall notify the Registry. The opt-out shall be deemed to have been withdrawn in respect of the Contracting Member States covered by the European patent with unitary effect at the date of the registration of the unitary effect and the Registrar shall as soon as practicable enter the withdrawal in the register in respect of such Contracting Member States. No fee shall be payable pursuant to paragraph 8. 11. A patent or application the subject of an Application to withdraw which has been entered on the register may not thereafter be the subject of a further Application to opt out. 12. The Registrar shall as soon as practicable notify the European Patent Office and the national patent office of any Contracting Member States concerned of the entries in the register pursuant to paragraphs 6 and 8. 13. Applications accepted by the Registry before the entry into force of the Agreement shall be treated as entered on the register on the date of entry into force of the Agreement. Relation with Agreement: Article 83(3) and (4)



II. So how is it going to work?

A.  SPCs granted on top of European Patents:

As with European Patents (EP) themselves, SPCs referencing the European Patent as the basic patent will, under Article 3 of the UPC agreement, be subject to the UPC’s exclusive jurisdiction. Under article 83 UPCA, it will however be possible during the transitional period (currently 7 renewable years) to opt out of the UPC’s exclusive jurisdiction European Patents and their corresponding SPC.

 During the transitional period:

(i) SPCs granted on top of European Patents which are opted-out: 

  • If an EP has been opted out, and an SPC granted subsequently, the SPC is automatically opted out, and this opt out lasts for the whole life of the SPC. 
  • If an SPC has been granted before an application to opt out an EP is filed, the proprietor(s) of both the EP and (if different) the SPC must register the opt out.  In order for an opt out to be valid, all relevant proprietors must, in fact, participate in the opting out process.  In the 18th Draft Rules of Procedure, Rule 8.4 has been amended, and the proprietor is now defined as “the person shown in the Register for unitary patent protection as the proprietor shall be treated as such”.
  • If the EP has expired, and only the SPC remains in force at the time of the opt-out, the SPC proprietors and the expired EP proprietors will both need to register the opt-out.

Consequences of the Opt-out: if an SPC and its underlying EP are opted out, only national litigation in relation to those rights will be possible.

(ii). SPCs granted on top of European Patents which are not opted-out:

Under Article 83(1), if the European patent has not been opted-out, the patent and its corresponding SPC will be prima facie under the exclusive jurisdiction of the UPC. However actions for infringement or revocation may still be brought before national courts.


 After the transitional period:

(i) At the end of the transitional regime, the UPC will be the sole court to be competent in case of litigation concerning:

  • All European Patents not opted-out
  • All SPCs granted on top of European Patents not opted-out

(ii) National Jurisdictions will be competent in case of litigation concerning:

  • All European Patents opted-out
  • All SPCs granted on top of European Patents opted-out


B. SPCs granted on top of European Patent with unitary effect (or Unitary Patent):

European patents with unitary effect will not have the possibility to be opted-out. They will be under the exclusive jurisdiction of the UPC during and after the transitional period. This will therefore also be true for their corresponding SPCs.

However, despite being based on Unitary Patents, valid in 25 Member states, SPCs will not have the same territorial scope as Unitary Patents. Instead, the same system which exists at present for SPCs based on national or European Patents will apply, and individual national applications will have to be made.
III. Uncertainties: 

 There are quite a few grey areas concerning the interaction between the Unitary Patent, national patents and SPCs, notably:

  • For European Patents (opted-out or not), it is uncertain whether the corresponding SPCs, which are national titles, can benefit from Art. 34 UPCA, which states that the decisions of the Court shall cover the territory of those contracting Member States for which the European patent has effect, and be applied by the patentee in all 25 Member States.

The European Commission, despite declaring that the articulacy between the unitary patent and the current EU rules on SPCs is a “key challenge to get the end game right ” in its “Staff working document” on a “Single market strategy for Europe”, identifies further issues:

  • The Commission first fears that if SPC users wish to benefit from the unitary patent this “will require multiple administrative procedures in multiple jurisdictions, limiting the full benefits of a unitary system.
  • The Commission also highlights the problem of  the”patent research exemption” and “Bolar exemption” which are applied by Member States differently. This exemption could lead with the entry into force of the Unitary Patent and UPC to forum shopping. In fact “on the one hand, some Member States do not allow the supply of active pharmaceutical ingredients (APIs) to EU-based generic manufacturers for the purpose of seeking marketing authorisation. On the other hand, in a number of Member States, it is not certain whether testing in the EU by originators and biosimilars can benefit from these exemptions for the purpose of seeking marketing authorisation in the EU and in non-EU countries, or for meeting emerging regulatory requirements such as those related to health technology assessment“.

The European Commission thus announced to be working on a project of Unitary SPC, and on the coherence between the upcoming unitary patent and current EU rules on SPC -in the absent of a unitary SPC title.



IV. Towards a Unitary SPC? 

The European Commission considers that applying the unitary patent system to SPCs would help optimising the legal framework for industry sectors whose products are subject to regulated market authorisations, and which currently “presents several features not fit for purpose in today’s global economy and in the light of new regulatory requirements“.  The European Commission therefore calls for a Unitary SPC to  “enhance the value, transparency and legal certainty of the protection of medicines and plant protection products; and provide a one stop shop for the granting of SPCs in Europe, and give enhanced certainty to European health authorities, to patients and to generic companies on the status of a regulated product’s IP protection.

The European Commission’s project is supported notably by the European Crop Protection Association (ECPA), European Federation of Pharmaceutical Industries and Associations (EFPIA) and the International Federation of Animal Health (IFAH). These three organisations published in 2015 a letter in support of a Unitary SPC being granted on the basis of European Patent with unitary effect which they see as “a logical continuation of the Member States’ decision and agreement to create a European Patent with unitary effect“. In this letter the ECPA, EFPIA and the IFAH point out that it will be necessary to designate a body responsible for granting the Unitary SPC for the 25 Member States participating to the enhanced cooperation mechanism.

The Unitary SPC might however be a project for which a political compromise is quickly reached, following the positive valuation for the UPC of a gain of 0.25 % GDP in EU -“which represents the possible net productivity impact resulting from the reduction of validation and maintenance fees in the Member States for patents granted by the European Patent Office”- and a reduction of up to 80% in the cost in administrative costs.

How is it going to work? A new update on the UPC Case Management System:

Brexit and the German constitutional challenge

On Monday 25/01/2016 was organised in Paris a presentation on the UPC Case Management System with the UPC IT Team. The UPC Case Management System is the platform that will allow the submission of actions and their documents before the UPC, the communication with Judges and Clerks, and the free access by the public to all cases and decisions.

This system is therefore central to the UPC and can already be accessed here. Users are encouraged to leave feedbacks to help shape the system, even if as indicated by the IT Team in its weekly newsletter, no further changes will take place until after March 2016, and all feedbacks “will be logged and put in the backlog for future development which will take place in April 2016“.

Below are the main points developed in this presentation which should clarify the major elements of the UPC Case Management System.

IT and Security:

The Case Management System (CMS) will be available from any device. It will require users to register on the UPC CMS. Registered users will need their email address, their password, and a code sent by text to the user’s phone to log in.

Users will have to register twice: first for the trial version of the UPC CMS (you can do so here) and then to the real version of the UPC Case Management System. (See Registration for more info)

The EU STORK system may be used, although not initially. The aim of the STORK project is “to establish a European eID that will allow citizens to establish new e-relations across borders just be presenting their national eID”. This system would allow users to get connected to the UPC CMS with their national login.

Data is stored in Munich, Germany, by a company which is a Deutch Telecomm subsidiary. Two penetration attempts have been simulated and failed. Twenty attacks have already been recorded.

The IT management will be handed over to the permanent IT Team in Luxembourg in March 2016 .

There will be the possibility to connect law firms’ IT system with the UPC CMS  -to obtain alerts for example. There will also be the possibility to synchronise the Court calendar with firms’ calendars.

The Court’s diary and the case history will be publicly accessible. Once on the UPC CMS, the cases will be freely available to be viewed by the public (see confidentiality section for more info).

Arbitration Centre:

The Arbitration Centre will use the same CMS. The Arbitration Centre CMS will however be independent from the UPC. It won’t therefore be possible for the UPC to access the Arbitration Centre CMS.


Internal users: Clerks, Judges, Administrators will be registered by the system administration.

External actors: The parties (claimant and defendant) and third parties (witness and experts) will need to apply for registration before being able to access the system.

At the moment the creation of groups is not possible but it will be allowed soon. All users will need to register individually, then one user will become an Administrator and will be able to create a group of representatives. It won’t be possible to have more than one administrator.


The IT Team built the UPC CMS around the Rules of Procedure. Therefore, if the Rules do not provide for a specific provision, the IT Team cannot create it in the IT system. By the end of February/Beginning of March the rules of procedure will be finalised and the IT Team will be able to finalise the UPC CMS.

Cases are included within a process of a pre-determined actions: Infringement, Declaration of non-Infringement, Revocation, Compensation for licences, Action against decision of the EPO.

Each action is organised around a system of logically interconnected sub-processes, for example: submit a statement of claim, raise a preliminary objection.

All actions, undertaken at any stage, of the process are recorded and will be the object of an email to the user, confirming that that specific action has been carried out by the user.

Timers are also available for each task. They will ensure that every action is accomplished within the procedural time limit.


Every action is built around documents: forms (which will be pre-filed to save time), pleadings, exhibits, orders, applications.

Documents will be stored on the CMS. It is not possible at the moment to create a draft document and keep working on the system but it is possible to create a draft case, which will only become public and available to the court once it is submitted. It will therefore be possible for an external user to update documents until submission.

If the document is submitted by an external user, it can be rejected or validated by a Court member. If rejected, the external user can submit a request of amendment.

In case of a group of representatives, all members will be able to submit documents.


Request for confidentiality can be obtained for confidential documents. It is however not automatic and can be challenged. The documents included in the request for confidentiality will be notified to the judge for an evaluation of the documents’ confidential nature.

If the documents are not deemed confidential they will be available to the public. The submitting party can however withdraw these documents. If they are deemed confidential, the party who submitted them must provide a redacted version, which will be available to the public.

It will be possible to create a confidentiality club, which may include the defendants and/or any chosen third party.


CMS will send electronic receipts to confirm that the documents have been received and that an action has been performed for the case. The UPC however still has to provide the details of these emails.

The Participants to the Paris’ workshop asked the IT team to have the possibility to attach to the case the communication with the Judge. The IT Team responded favourably to this request.

Audio (Interim Conference) and Video (Final Hearing) record of court sessions will be available on the CMS.


A patent can be opted-out by filling a form on the CMS. It requires the patent number. Once the patent number is entered, the information will be extracted from the EPO registers, and will be used for the automatic filling-in of the opt-out form.

The EPO’s information might not be up to date, so it will be important to check the pre-filled form and amend any incorrect information. In fact, if some details are missing or are incorrect the opt-out is ineffective until corrected (Rule 5.6).

Once the information is amended on the UPC CMS, it will become public. The EPO will therefore have an opportunity to amend its register. At the moment, there is however no partnership between the EPO and the UPC. It is therefore uncertain whether the EPO’s registers will be updated.

There will be a different opt-out form for the SPCs.

It is presently only possible to opt-out patents one by one. However the IT Team is looking at an option, which would enable patent owners to opt-out baskets of patents (not more than 30).

Claimants will be able to file a claim even if the patent has been opted-out, to prevent a legitimate action to be stopped by a fraudulent opt-out. In fact when submitting a claim for a patent, which is identified as opted-out by the CMS, its opt-out will be flagged and the CMS will identify the cases in which this patent has appeared. If there is a disagreement as to whether the patent has actually been opted-out (for example the claimant could argue that it has not been opted-out by the patent proprietor but by someone else) it will be to the court to decide whether the patent was opted-out.

The method of payment is not yet scheduled as the fees are not determined yet. If there is a fee it will be payable online.

The Opt-out will be ready by March. No exact date however for the public to start opting-out.


The patent proprietor is the person shown in the relevant register. Rule 8.5 however makes clear that this presumption can be rebutted by the actual proprietor by showing that there are entitled to be recorded as proprietor in each country where the patent has been validated, even if  in fact not registered.

Therefore, if the claimant is not the proprietor, they will be required to submit a declaration of proprietorship following Rule 5.3(e), to prove that they can legitimately pursue the case or the opt-out. This document won’t however be checked by UPC officials.  Thus, if a problem arises the validity of the opt-out will have to be challenged before the court.


The fees will be decided in February by the Preparatory Committee. The IT Team will then design a user-friendly fee platform to allow users to pay online. No other form of payment will be possible. The assessment of the fee should be based on “fair royalties” as the Preparatory Committee intends to have simple fee guidelines.


Where a Member State nominates a language of proceedings both under Article 49(1) and Article 49(2) UPCA, the claimant may choose the language of proceedings subject to:

-Rule 14.2(b)-the “Belgian exemption” which applies when there is only one local exception;

-Rule 14.2(c)-the judge rapporteur may in the interests of the panel of judges order that the decision may be given in the Article 49(1) language together with a certified translation.

Concerning the CMS, the IT Team is now waiting for it to be finalised to start the translations that will enable claimants to have access to the CMS in English, French or German.

Is the UK’s participation to the UPC any more certain after the Brexit deal?

Brexit deal and UK participation to the UPC

The UK government and the European Union  signed the Brexit deal on 25th November 2018. Although the UK parliament still needs to approve the deal, the “Political Declaration setting out the Framework for the Future Relationship between the European Union and the United Kingdom” calls regarding intellectual  property for “the protection and enforcement of intellectual property rights to stimulate innovation, creativity and economic activity“. It also urges the parties to “establish a mechanism for cooperation and exchange of information on intellectual property issues of mutual interest, such as respective approaches and processes regarding trademarks, designs and patents“.

However, the agreement itself does not contain any provision regarding patents. This means that although the UK has ratified the UPC agreement and published statements confirming its commitment to the UPC, the UK’s participation to the UPC after Brexit is still very uncertain. This uncertainty has indeed been hotly debated (see Brexit IP Guidance, An Inquiry onto the effect of Brexit on the UPC, More on Brexit from the AIPPIUK IPO update on Brexit,  The Patents Order 2016)  since the Brexit vote, but recently the debate has reached a peak with the publication of a long study (182 pages) published by the Max Planck Institute, which has attracted many criticisms.

What does the Max Planck Institute article say about the UK participation to the UPC?

The article published by the Max Planck Institute  argues strongly against the UK’s participation to the UPC. Its authors, Hanns Ullrich and Matthias Lamping, declare that:

  • Opening the UPCA to accession by third countries would render the Agreement incompatible with the Treaties.
  • It would entail a threat to the autonomy and effectiveness of EU law and, ultimately, to the EU’s control over the conditions of innovation and its legal protection within the Internal Market.
  • (…) it is not the safeguards incorporated into the UPCA in the aftermath of Opinion 1/09301 that ensure the compatibility of the UPC’s judicial system with the Treaties but rather the limitation of contracting parties to EU Member States, because that is what makes those safeguards applicable as a matter of Union law, regardless of whether they are incorporated into the UPCA or not.
  • (…) what is needed is the development of a flexible arrangement on the protection and enforcement of patents that properly fits into the framework of the future UK–EU relationship, adequately caters to both sides’ interests in a patent policy and practice of their own and is well balanced so as to be generally acceptable rather than primarily desirable for some particular stakeholders. As regards the European Union’s own system of patent protection, every effort should be undertaken to complete it in respect of both its substance and adhesion by all Member States with a view to make it a true success of genuine economic and sociopolitical integration. The authors argue therefore that the UK’s participation to the UPC could geopardize this new dynamic.
  • While the UK intends to explore staying on board, the EU might draw a different conclusion from Brexit. As it stands, opening the UPCA to accession by third countries would render the Agreement incompatible with the Treaties.

The researchers also question what the UK would gain by participating to the UPC as the UK would have “to delegate  jurisdiction over its patents to the UPC” and  “accept that all cases brought before the court are decided in the light of the “letter and spirit of the Treaties””. Indeed, acording to Ulrich and Lamping, for it to participate the UK would have to agree with the fact that “the EU could amend the UPCA anytime through the “backdoor”of secondary Union law” and that the “UK would have to accept that the EU is in full control of post-grant patent law”. The UK had however adopted a very different position throughout the Brexit negotiations. This may thus compromise the UK’s participation to the UPC.


How was the article received?

The Max Planck Institute article was widely criticised, most notably by the fictional lawyer from How to Kill a Mocking Bird,  Atticus Finch. The anonymous writer behind that pseudonym formulated the following remonstrances :

  • (T)he studies overlook some important precedents in EU law and policy which results in parts of the studies being based on wrong assumptions. In fact “extension of EU instruments to third countries is something quite frequent ” and “the problems the authors see with such an extension can easily be solved as other examples of extensions of EU instruments to third countries show”.
  • The authors also do not seem to fully recognize the economic needs of European and of UK companies as “(w)hen stating that the mere loss of an option for business to get patent protection in the UK (by means of a Unitary Patent) does not negatively affect businesses they do not seem to fully acknowledge that this will render patent protection more complex and costly for all companies who need patent protection in the UK”
  • It is further somewhat astonishing that the authors argue an extension of the Unitary Patent to the UK is not in the UK’s own interest since the UK allegedly needs policy space with respect to framing its patent law.
  • (T)he authors do not put forward any new arguments regarding the alleged incompatibility of the UK’s participation with Union law and with Opinion 1/09 of the CJEU.” Moreover, “(p)arts of the arguments against the UK participation are based on the wrong assumption that the UK could block any alignment of the UPC Agreement with Union law, which is not the case”.

Other professionals defended a similar position, such as A. Ohly and R. Streinz (“Can the UK stay in the UPC system after Brexit?”, GRUR Intl. 2017, 1) R. Gordon and T. Pascoe (“Re The effect of “Brexit” on the Unitary Patent Regulation and the Unified Patent Court Agreement”)  and M. Leistner and P. Simon (“Auswirkungen des Brexit auf das europäische Patentsystem”, GRUR Intl. 2017, 825).

W. Tilmann, for example,  in the German Association for the Protection of Intellectual Property magazine rebunks the Max Planck study in terms similar to those of Atticus Finch:

  • He highlights the fact that although the authors argue against the UK’s participation to the UPCA they do not “give more details on possible improvements of the unitary patent and the UPCA which would be possible to realise without the UK participating” to support their views. Tilmann notes for example that while the UPC is often said to be missing “prior use right, protection of published patent applications, novelty depriving prior rights and compulsory licences“, it is doubtful that their provisions by Member States “liberated from the UK’s participation” would “offset the loss of UK’s participation and make the horizon for inventors and industry on the continent look brighter”.
  • Tilmann also criticises the lack of information regarding the legal effect of a Brexit agreement that would not contain “any rule on the UK remaining as a contracting State of the UPCA” and argues that the authors’ answer that “the UPCA would automatically change from a common court of Member States to an “ordinary” international court” is not satisfying.
  • In the second part of its article Tilmann looks at the question of the entitlement of the UPC to refer question to the CJEU after the Transition Period. He notes that the end of the Transition Period will give rise to a special situation “characterized by the UPC being supported by 24 CMS, fully integrated into the relationship between the CJEU and the national courts, and one contracting State having been a CMS when it pledged to respect Union law (…) and all obligations out of the Agreement as if it were a CMS.” This for him shows that the UPC is well integrated in the “CJEU-national courts system” and contradicts the Max Plank Institute research fellows’ theory that “the UPC will not be able to refer Union law questions to the CJEU once the UK has left the Union by Brexit.
  • Finally, in the third part of the article, Tilmann rebutes the “second major argument of the authors against the UK’s participation in the UPCA”  according to which“the UK would have a veto power against further amendments (…) of the UPCA (...) The Brexit would put the UK in a stronger position than at present.” Tilmann however notes that the UK will have no power regarding Union law as “with the exception of horizontal effect of not implemented all Union law is immediately to be applied by the UPC without a change of the UPCA being necessary“.  Tilmann also rebates the argument put forward by Ullrich and Lamping regarding the fact the “UK could have a veto power against a change of the UPCA following a change of Union law, not only from the position of the UK (after Brexit) as a contracting State but also from Art.87(3) UPCA (declaration not to be bound by a change of the UPCA law by the Administrative Committee)” as “this provision does not apply in the case of a change of Union law” which therefore leaves the UK without any veto power regarding Union law.


Has the UPC commented yet on the UK’s participation?

On 19th December 2018 the UPC published a short statement which reads: “2018 has been a year of mixed highs and lows. This year has seen two more Signatory States ratify the Unified Patent Court Agreement, namely Latvia and the UK which means there are now 16 ratifications in total of the Agreement, well over the number required. We still await the outcome of the complaint pending before the Constitutional Court in Germany before the project can move into the next phase, the period of provisional application.

The UPC also highlighted its progress regarding the technical and operational preparations which are “allowing for the project to move at pace in the event of a positive outcome from the German Constitutional Court”.  In addition, the UPC Chairman holds regular meetings with the Executive Group and the operational team  to review the status of the project. Similarly the recruitment of judges is going on and “(t)hose that have applied for judicial positions in the Unified Patent Court are being contacted separately”.

Therefore, although the UPC is silent on the UK’s participation it seems nevertheless to put all its focus on its coming into function and on the growing number of ratifications.

What does a no-deal Brexit mean for the UPC? The UK Government IP Guidance

Brexit deal and UK participation to the UPC

Need any guidance for your IP after Brexit?

Brexit will take place on 29th March 2019. The date is fixed and is not dependant on any agreement between the UK and the EU.  The risk of a “no-deal Brexit” has spurred the publication of governmental guidelines for businesses. This week the UK government notably published  a “Patents if there is no brexit deal” Guidance, which looks specifically at the issues of patents and supplementary protection certificates and those of the Unified Patent Court and the Unitary Patent.

Regarding patents and supplementary protection certificates:

So what still needs to be done for the UPC to come into operation?

Ratification of the UPC Agreement:

Germany must ratifiy the UPC Agreement. The German constitutional court however needs to decide whether the ratifying German legislation is compatible with the German constitution. According to Mooney the decision should be rendered before the end of 2018.

Case management system:

The electronic case management system is still in working progress.  This system is key to the functioning of the Court, which will be a paperless court. However as explained by Mooney, the tailoring of the case management system to the UPC Rules of Procedure is sensitive. Indeed, there are more than 300 rules of procedure which must now be fitted in a binary computer system.

Could there be a Unitary Supplementary Protection Certificate?

Supplementary Protection Certificate

A Unitary Supplementary Protection Certificate to complement the Unitary Patent?

A few countries have recently geared up for the ratification of the UPC Agreement. Although the date of its entry into force is yet unknown it is hoped that the Unified Patent Court will start its operation before the UK leaves the EU. This means that the Unitary Patent may also become available before March 2019. Indeed, EU Regulations No 1257/2012 and No 1260/2012 entered into force on 20 January 2013 will apply from the date of entry into force of the UPC Agreement. However, the issue of the Unitary Supplementary Protection Certificate still has to be resolved.

In 2015, the EU Commission announced that as part of the Single Market Strategy,  an initiative of the European Commission’s plan to unlock the full potential of the Single Market,  the Commission would ‘consult, consider and propose further measures, as appropriate, to improve the patent system in Europe, notably for pharmaceutical and other industries whose products are subject to regulated market authorisations’. The Strategy thus aimed at exploring a recalibration of certain aspects of patent and supplementary protection certificate protection. According to the EU Commission, this could comprise the following three elements: (1) the creation of a European Supplementary Protection Certificate title, (2) an update of the scope of EU patent research exemptions, and (3) the introduction of an SPC manufacturing waiver.

The promised consultation process finally took place between 12 October 2017 to 4 January 2018 and a total of 231 replies were provided. Its outcomes are summarised in the “Summary of the replies to the public consultation on Supplementary Protection Certificates and patent research exemption for sectors whose products are subject to regulated market authorisations

It transpires from it that a very large majority of the respondents across all categories favour the creation of a unitary Supplementary Protection Certificate”, extending unitary patents when such patent rights expire.

Regarding the benefits of a unitary Supplementary Protection Certificate the participants declared the following:

 (I)t could boost the value of investments, that it would reduce red tape relating to registration and to litigation, that it would provide uniform protection across the Union as well as legal certainty, that it would reduce maintenance costs, that it would offer a specialised court, and that it would make licensing easier. A large majority of generics/biosimilars (‘G/B’) manufacturers, including SMEs, share these views.

One Member State considered that it would also simplify and enhance the efficiency of the SPC application process.

Opinions diverge regarding the practicalities for implementing such a new title. While some respondents favour the grant of that title by a virtual office composed of national experts working on behalf of an EU agency, others prefer either to entrust the EPO with this task, or to set up a new EU agency to do so.

Amongst SMEs manufacturing G/Bs, half of them favour the grant of unitary SPCs by a new EU agency, while the other half favour the EPO for this purpose.”

Concerning the languages to be used for a unitary Supplementary Protection Certificate:

(A) clear majority favoured the EPO language regime (English, French, German), which is the regime that is applicable to the EU unitary patent. However, SMEs manufacturing generics and biosimilars prefer the five language regime of the EUIPO (English, French, German, Italian and Spanish), whilst one of these favours the EPO regime.

Respondents also mostly considered that national marketing authorisations should be able to be used (in addition to EU marketing authorisations) as a basis for getting a unitary SPC, even though the latter would then not be enforceable in those Member States where no marketing authorisation would have been granted (through mutual recognition or decentralisation procedure).