The European Patent Office (EPO) has released several Insight Reports since 2019 to inform about the latest important patent trends. Two of the ten Insight Reports released up to now relate to the biotechnology sector, which describe future and emerging technologies that are considered as groundbreaking in the medical sector. The present article focuses on the latest biotechnological Insight Report on mRNA-based vaccines, which is a particularly growing field of mRNA technologies.
What has been amended?
The amendments concern, inter alia, Rules 126(2), 127(2) and 131(2) EPC, which deal with service by postal services and by electronic means as well as the calculation of time limits triggered by the service of a document. (https://www.epo.org/en/legal/official-journal/2023/03/a29.html)
A Technical Board of Appeal of the EPO has referred questions to the EPO’s Enlarged Board of Appeal regarding the definition of the state of the art in relation to a commercially available product (link).
The referring Board asks whether the commercial availability of a product and partial information about its composition (e.g. datasheets) can be state of the art, even when the composition or internal structure cannot be analysed or reproduced. This is critical for the referring case, as the possibility to use such a product in the inventive step assessment is decisive. The last question considers what threshold is required for the “undue burden” criterion in r.1.4 of G 1/92.
Since January 19, 2022, the Unified Patent System in Europa has been ramped up. On this day, EU Member Austria has ratified the Unified Patent Court Agreement (UPCA). Now enough EU Members are on board for the new system and the execution of the “Protocol to the Agreement on a Unified Patent Court on provisional application (PPA)” has started. The implementation of the PPA will lead to the gradual launch of the system, for example, judges are elected and appointed. The new system will start on 1 June 2023.
Currently, the new European Unified Patent System is being implemented, which is planned to start on April 1, 2023. The introduction of the Unified Patent System will have an impact on all European patents, including “old” European patents that have already been granted and are in force. Please find below more information on the new Unified Patent System.
After the start of the European Unified Patent System, an applicant of a European patent application can choose between the following options after grant:
- European Unitary Patent which will be uniformly in force in (currently) 17 EU states, including Germany, France, and Italy. In Fig. 1 below, these are the EU states marked in blue.
- Classic European Patent, which will be validated in one or more of the 39 member states (including Montenegro as of October 1, 2022) of the European Patent Organization, as before. In Fig. 1, these are all states marked in blue and green.
- Mixture of the European Unitary Patent, which will be in force in 17 EU states (see Fig. 1 in blue), and the Classic European Patent, which will be validated in one or more of the remaining 22 member states of the European Patent Organization (see Fig. 1 in green).
The new Unified Patent System provides for a Unified Patent Court. Patent infringement proceedings or nullity proceedings relating to a Unitary Patent can be conducted centrally via this court. The Unified Patent Court is responsible for European Unitary Patents and for classic European Patents and thus also for “old” European Patents which are still in force. However, in the case of a classical European Patent, during a transitional period of between 7 and 14 years after the start of the Unified Patent System, the national courts in the countries where the classic European Patent is validated will have jurisdiction in addition to the Unified Patent Court as before. In other words, for example, patent infringement proceedings in the case of a Unitary Patent will take place centrally before the Unified Patent Court, whereas in the case of a classic European Patent, a choice can be made between the Unified Patent Court and the national courts.
A patentee of a classic European Patent has the possibility – during the transitional period mentioned above – to exclude the jurisdiction of the Unified Patent Court. For this purpose, it is necessary to file a so-called “opt-out-request” for the classic European Patent. After the exclusion of the Unified Patent Court due to an opt-out-request, the national courts will continue to have exclusive jurisdiction for the classic European Patent.
Fig. 2 below shows the different possibilities.
An opt-out-request can already be filed 3 months before the start of the Unified Patent system in the so-called “sunrise period”. It is currently planned that the sunrise period starts on January 1, 2023. The question as whether an opt-out-request should be filed for a classic European Patent depends on the individual case. An opt-out-request is only possible as long as no action is pending before the Unified Patent Court.
Patentees and applicants of classic European Patents should take the following steps with regard to the new Unified Patent System:
- A patent proprietor of a classic European Patent should be aware in advance – i.e. preferably before the start of the sunrise period – whether an opt-out-request is necessary. If so, this should be filed during the sunrise period.
- If a classic European Patent has several patentees, they must jointly decide on a possible opt-out-request. They should therefore reach an agreement – preferably in writing – regarding a possible opt-out-request.
If you have any questions about the new Unified Patent System – for example, about the steps mentioned above – we will be pleased to answer them personally.
You can also find more information on the new Unified Patent System in our whitepaper or directly download the pdf.
Since January 19, 2022, the Unified Patent System in Europa has been ramped up. On this day EU Member Austria has ratified the Unified Patent Court Agreement (UPCA). Now enough EU Members are on board for the new system and the execution of the “Protocol to the Agreement on a Unified Patent Court on provisional application (PPA)” has started. The implementation of the PPA will lead to the gradual launch of the system, for example, judges are elected and appointed. At the moment, Germany is acting as a “Gatekeeper”. As soon as the system is ready, Germany will file its ratification certificate and 3-4 months later (according to Art. 89(1) UPCA) the Unified Patent System will start.
The introduction of the Unified Patent System has an impact on all European patents, also on “old” European patents which are already granted and in force. Patentees and applicants of European patents and applications should be aware of the implications and respond as needed. This white paper is intended to provide a basic overview of the European Unified Patent System and to support the patentees and applicants in possible steps.
You can download a pdf version of this whitepaper in the following languages: english, japanese
The EPO and the China National Intellectual Property Administration (CNIPA) have agreed on a two-year pilot program last year that would allow Patent Cooperation Treaty (PCT) applicants filing a PCT application at the CNIPA to choose the EPO as their International Searching Authority (ISA). This agreement was signed on November 12, 2020, at their joint conference in Suzhou, China. Due to the outbreak of the new coronavirus, it had not been determined when the program will start until the middle of October 2020.
The Start of the program is in December 2020
Recently, the EPO finally announced that this pilot program will start on December 1, 2020. The pilot program will be open to nationals and residents of the People’s Republic of China filing with CNIPA or the International Bureau (IB) of the World IP Office (WIPO). Further, there is a limit participation in the program to 2,500 patent applications for the first 12 months and 3,000 for the next 12 months.
Benefits for Chinese applicants
For Chinese applicants, this program will offer an additional option to optimize their international patent strategy, especially when considering protection in Europe. As a result, Chinese applicants interested in accelerating the prosecution of their applications will, by selecting the EPO as their ISA, gain up to one year by entering into the European phase earlier and getting direct examination of their files, without the need for a supplementary European search. For more detailed questions about the pilot program, please use the following link:
WINTER BRANDL Partnerschaft mbB, Tianhao Miao (Chinese Manager, German, European and Chinese Patent Attorney) and Michael Schueller (Partner, German and European Patent Attorney)
Transitional provisions – applicability of Article 13(1) RPBA 2020 to cases where the summons to oral proceedings was notified before the entry into force of the RPBA 2020. (Catchword of the Board)
BoA, Decision of January 20, 2020 – T 1386/18; Article 13(1) RPBA 2020
The appellant filed requests with the BoA before the revised RPBA 2020 was into force
The appellant (applicant) lodged an appeal within the prescribed period and in the prescribed form against the decision of the examining division to refuse the European patent application No. 10840300.7.
- In 2018 the appellant filed his statement of grounds of appeal.
- In 2019 to prepare the oral proceedings, the BoA communicated its preliminary assessment.
- In 2019 the appellant filed a response.
- On January 20, 2020, the oral proceedings took place.
The revised RPBA 2020 is in force from January 1, 2020. Therefore, the written submissions of the appellant mentioned above have been filed before the RPBA 2020 came into force. The oral proceeding was held after the RPBA 2020 came into force.
The BoA notes in its decision the transitional provisions of the RPBA 2020
In its decision, the BoA noted that the RPBA 2020 applies, except for “new” Articles 12(4) to (6) and 13(2) RPBA 2020. Instead of which the “old” Articles 12(4) and 13 RPBA 2007 remain applicable.
This is laid down in the transitional provisions according to Article 25 RPBA 2020. “New” Articles 12(4) to (6) RPBA 2020 refer to the first stage (filing stage) of the appeal, see Fig. 1 below.
“New” Article 12(4) RPBA 2020 defines that a request, fact, objection, argument, and/ or evidence on which the decision under appeal was/were not based is considered as an amendment. Any such amendment may be admitted only at the discretion of the Board. Nevertheless, if the party demonstrates that the request, fact, objection, argument, and evidence was/ were admissibly raised and maintained in the proceedings leading to the decision under appeal, then it is not considered as an amendment. Compared to this, the “old” Article 12(4) RPBA 2007 –here applicable – has less stringent limitations on amendments at the first stage.
“New” Article 13(2) RPBA 2020 refers to the third stage of the appeal, see Fig. 1 above. This Article imposes the most stringent limitations on appeal submissions which are made at an advanced stage of the proceedings. Advanced stage means after the expiry of a period set by the board of appeal in communication under Rule 100(2) EPC or, where no such communication is issued, after notification of a summons to oral proceedings. In contrast, the “old” Article 13 RPBA 2007 – here applicable – has less stringent limitations.
BoA considers “new” Article 13(1) RPBA 2020 applicable
In the present decision, the BoA clarified, that the “new” Article 13(1) RPBA 2020 applies to the present proceedings because this Article is not excluded by the transitional provisions defined in Article 25 RPBA 2020. “New” Article 13(1) RPBA 2020 refers to the second stage of the appeal – see Fig. 1 above – and to amendments before notification of a summons or before the expiry of a time-limit of a communication. “New” Article 13(1) RPBA 2020 defines the conditions under which a party may amend its appeal case after the initial stage of the proceedings and before the period set in a communication under Rule 100(2) EPC has expired or before a summons to oral proceedings has been notified. The party must provide reasons as to why the amendment is submitted at this stage of the appeal proceedings. Its admittance is subject to the Board’s discretion alone.
Other Boards of Appeal have different views regarding the application/ interpretation of “new” Article 13(1) RPBA 2020
According to a further recent decision T 0032/16 of a different BoA, when compared, the revised wording in “new” Article 13(1) RPBA 2020 is more detailed in listing out the requirements on the party making an amendment to its appeal case and the criteria to be used by the Board when exercising its discretion. The difference however merely reflects much of the case law developed under “old” Article 13(1) RPBA 2007. Therefore, according to T 0032/16 no contradiction can be found in the wording of “new” Article 13(1) RPBA 2020 compared to “old” Article 13 RPBA 2007.
In a further recent BoA decision, T 0989/15 the Board saw no reason to apply the criteria of “new” Article 13(1) RPBA 2020 in addition.
- If the first stage took place before RPBA 2020 came into force then the “old” Article 12(4) RPBA 2007 for the first stage applies instead of “new” Articles 12(4) to (6) RPBA 2020. Therefore, for such cases, there are less stringent limitations on amendments at the first stage of the appeal proceeding.
- Where the summons to oral proceedings or a communication of the Board under Rule 100(2) EPC has been notified before the date of the entry into force (1 January 2020) “old” Article 13 RPBA 2007 instead of “new” Article 13(2) RPBA 2020 for the third stage applies. Hence, for such cases, there are less stringent limitations on amendments at the third stage of the appeal proceeding.
- Further, the “new” Article 13(1) RPBA 2020 for the second stage applies according to T 1386/18, irrespective of the fact that the summons to oral proceedings was notified before 1 January 2020. But according to T 0032/16 this “new” Article 13(1) RPBA 2020 is not stricter compared to the “old” Article 13(1) RPBA 2007 in combination with the developed case law which is good News.
Reasons for the decision
- Revised Rules of Procedure of the Boards of Appeal (RPBA 2020) – Transitional provisions
The present proceedings are governed by the revised version of the Rules of Procedure which came into force on 1 January 2020 (Articles 24 and 25(1) RPBA 2020), except for Articles 12(4) to (6) and 13(2) RPBA 2020 instead of which Articles 12(4) and 13 RPBA 2007 remain applicable (Article 25(2) and (3) RPBA 2020). The general applicability of the RPBA 2020 to the present proceedings includes Article 13(1) RPBA 2020, irrespective of the fact that the summons to oral proceedings was notified before 1 January 2020 (cf. T 2227/15, T 32/16 and T 634/16, none of them published in the OJ EPO)
Winter, Brandl – Partnerschaft mbB, Patent Attorney Michael Schüller
- a) 既に付与された欧州特許の欧州特許出願と同日に出願されたか、または
- b) 既に付与された欧州特許の欧州特許出願の先の出願または分割出願（EPC 第 76 条（1））であるか、または
- c) 既に付与された欧州特許の欧州特許出願と同じ優先権（EPC 第 88 条）を主張するものか。
1. A European patent application can be refused under Articles 97(2) and 125 EPC if it claims the same subject-matter as a European patent which has been granted to the same applicant and does not form part of the state of the art pursuant to Article 54(2) and (3) EPC. 2. The application can be refused on that legal basis, irrespective of whether it
a) was filed on the same date as, or
b) is an earlier application or a divisional application (Article 76(1) EPC) in respect of, or
c) claims the same priority (Article 88 EPC) as
the European patent application leading to the European patent already granted. (Headnotes of the Enlarged Board of Appeal (EBoA)) EBoA of the EPO, Decision of 22. June 2021 – G4/19 – Double Patenting
The appellant claimed priority of a granted EP Patent having the same subject matter
The appellant is the applicant of the European patent application-in-suit. The Examining Division of the European Patent Office (EPO) refused the application-in-suit. The refusal was based on the principle of the prohibition on double patenting. The application-in-suit claimed priority of a granted European patent, see figure below. The subject matter of the application-in-suit and the granted European patent comprised the same subject matter and are owned by the same applicant. Against the refusal of the Examining Division, the applicant of the application-in-suit filed an appeal.
The Board of Appeal (BoA) referred questions to the Enlarged Board of Appeal (EBoA)
In the appeal proceedings the BoA referred the following questions to the EBoA: “1. Can a European patent application be refused under Article 97(2) EPC if it claims the same subject-matter as a European patent which was granted to the same applicant and does not form part of the state of the art pursuant to Article 54(2) and (3) EPC? 2.1 If the answer to the first question is yes, what are the conditions for such a refusal, and are different conditions to be applied depending on whether the European patent application under examination was filed
- a) on the same date as, or
- b) as a European divisional application (Article 76(1) EPC) in respect of, or
- c) claiming the priority (Article 88 EPC) in respect of a European patent application on the basis of which a European patent was granted to the same applicant?
2.2 In particular, in the last of these cases, does an applicant have a legitimate interest in the grant of a patent on the (subsequent) European patent application in view of the fact that the filing date and not the priority date is the relevant date for calculating the term of the European patent under Article 63(1) EPC?”
EBoA gives an interpretation of the referred questions
- The essence of question 1 is according to EBoA, whether there is any legal basis under the EPC for refusing an application on the ground of “double patenting”. The term “double patenting” is interpreted in the narrow sense, where two or more EP applications are involved (and not a national patent).
- The definition of the “same subject-matter” or “the same applicant” is not the subject of the present referral.
- Further, the referred question 1 is restricted to substantive examination proceedings before the Examining division. Therefore, the referral does not extend to the question of whether and how the prohibition might be applicable in opposition proceedings.
- It is the EBoA’s understanding that in current Office practice an objection of double patenting is only raised if there are overlapping and still valid designations in both the granted patent and the application concerned.
- The essence of question 2.1 is as follows: if there is a legal basis in the EPC for the prohibition on double patenting, are all three of the possible constellations in which double patenting may arise to be treated in the same manner? Common to these constellations is that the granted patent and the application both have the same effective date.
Decision of the EBoA in regard to Question 1
For its decision, the EBoA concludes that Art. 125 EPC (https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar125.html) serves as a legal basis for the decision. Art. 125 EPC defines in the case of the absence of procedural provisions in the EPC, that the EPO shall take into account the principles of procedural law generally recognized in the Contracting States. To find out whether there is such a principle, the EBoA inter alia considers the preparatory documents of the Convention (= “travaux préparatoires”). Especially based on these documents the EBoA inferred that the prohibition on double patenting is such a principle generally recognized in the Contracting States according to Art. 125 EPC. As a consequence, the EPO is empowered and duty-bound based on Art. 125 EPC to apply the principle of the prohibition of double patenting. Therefore, the EBoA answered Question 1 in the affirmative. As a result, a European patent application can be refused if it claims the same subject-matter as a European patent that has been granted to the same applicant and does not form part of the state of the art pursuant to Article 54(2) and (3) EPC.
Decision of the EBoA in regard to Question 2.1 and 2.2
Questions 2.1 and 2.2 refer to certain conditions for a refusal based on double patenting. The EBoA derived the answer on Questions 2.1 and 2.2 mainly from the preparatory documents of the Convention again. The answer is pointed out in Headnote 2 above.
Overview of the different constellations in regard to the prohibition of double patenting based on the present decision of the EBoA
Below the different constellations according to the headnotes of the present decision are shown. Common to these constellations is that the granted EP patent and the EP application both have the same effective date.
- The EP patent application was filed on the same filing date as the EP patent application leading to the EP patent already granted (headnote 2a):
- The EP application is an earlier application in respect of the EP application leading to the European patent already granted (headnote 2b):
- The EP application is a divisional application (Article 76(1) EPC) in respect of the EP patent application leading to the EP patent already granted (headnote 2b):
- The EP application claims the same priority (Article 88 EPC) as the EP application leading to the EP patent already granted (headnote 2c):
- The EP application claims the same subject-matter as a EP patent which has been granted to the same applicant and does not form part of the state of the art pursuant to Article 54(2) and (3) EPC (headnote 1):
Consequences for practice
An applicant can have the legitimate interest to have a second EP patent application granted for the same subject matter. E. g. an interest can be the longer term of protection available to an applicant as a result of claiming an internal priority. Nevertheless, according to the present decision of the EBoA a European patent application can be refused based on the prohibition of double patenting irrespective of whether there is a legitimate interest of the applicant. To overcome the prohibition of double patenting, the applicant could amend one or more of the applications in such a manner that the subject-matters of the claims of the applications are not identical. For example, the applicant could adapt the applications such that the subject matters are partially overlapping. In such a case no objection regarding double patenting should be raised (see also the decision of the BoA T 877/06). A further strategy could be that the applicant in a first step tries to get an EP patent application with a narrower subject matter/scope of protection granted. Then, in a second step, the applicant could try to get an EP patent application with a broader subject matter/scope of protection granted. Thus, the applicant would already have a narrower EP patent and can then possibly try to obtain another EP patent with a broader scope of protection more freely and flexibly. This approach is especially beneficial for important inventions. To overcome the prohibition of double patenting in general the applicant could follow the proposals in the Guidelines for Examination G-IV-5.4 https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_iv_5_4.htm): withdraw overlapping designations, or choose which one of those applications is to proceed to grant.
Enlarged Board of Appeal Decision G4/19: http://documents.epo.org/projects/babylon/eponet.nsf/0/9D699BFBD3CC2C11C12586FC00338610/$FILE/G_4_19_decision_of_the_Enlarged_Board_of_Appeal_of_22_June_2021_en.pdf
WINTER BRANDL Partnerschaft mbB, Munich, German and European Patent Attorney Michael Schüller
The German legal media JUVE has announced that the German Federal Constitutional Court (Bundesverfassungsgericht) has received two new constitutional complaints (Case ID: 2 BvR 2216/20 and 2 BvR 2217/20) against the draft legislation enabling Germany to ratify the Unified Patent Court (UPC) Agreement and its Protocol on Provisional Application1).
The law approving the UPC Agreement was approved by the German federal council (Bundesrat) on 18 December 2020 and was awaiting the certification (signature) by the President of the Federal Republic of Germany in order to enter into force.
The identity of the complainants as well as the grounds for the constitutional complaints are currently unknown.
Further, it is not yet clear whether the constitutional complaints are admissible and whether Federal Constitutional Court will ask the President to halt the certifying process, as was the case with the previous constitutional complaint of 20172).
The ratification process of the UPC Agreement in Germany until now can be summarized as follows:
March 2017: German parliament (Bundestag) passes the German UPC legislation3).
March 2017: First constitutional complaint is raised4).
June 2017: German federal council (Bundesrat) approved the German UPC legislation5).
June 2017: Federal Constitutional Court asks the President to halt the certifying process2).
March 2020: Federal Constitutional Court decides that the German UPC legislation is void, since it has not been approved by the German parliament (Bundestag) with the required two-thirds majority although it amends the Constitution in substantive terms6).
November 2020: German parliament (Bundestag) passes the German UPC legislation with the required two-thirds majority7).
December 2020: German federal council (Bundesrat) approved the German UPC legislation8).
December 2020: Second Constitutional complaints are raised1). ← Now
(Prediction) XX 2021: Federal Constitutional Court asks the President to halt the certifying process?
(Prediction) XX 2023: Federal Constitutional Court decides that the German UPC legislation is void, since the unrestricted primacy of European law as stipulated in Article 20 of the UPC Agreement violates the German basic law9)?
(Prediction) XX 2023: Germany gives us to ratify the UPC Agreement?