Report on the Diplomatic Conference for the Revision of the European Patent Convention. Munich, November 20-29, 2000

Transcription

1 REPORTS Report on the Diplomatic Conference for the Revision of the European Patent Convention Munich, November 20-29, 2000 By Ralph Nack (1) and Bruno Phélip (2) A. Background of the Diplomatic Conference In 1998, less than 30 years after the signing of the European Patent Convention (EPC), the Administrative Council of the European Patent Organization (EPO) initiated a major process of reform of the EPC. The intergovernmental conference in Paris (June 1999, see OJ EPO 1999, 545) requested the EPO to prepare a EPC revision conference according to Art. 172 EPC to be convened in the year After consultation with the interested circles and the Standing Advisory Committee (SACEPO), the Administrative Council of the EPO worked out a Basic Proposal which was made available to interested members of the public (document MR/ 2/ 00). The proposals for revision related to many different aspects of the EPC. According to the Basic Proposal, almost 100 articles of the Convention were subject to be either amended or deleted. Most of the changes are not very spectacular in themselves, but seen as a whole they are significant in both in practical and institutional terms. The aim of the revision was to subject the European patent system to cautious modernization, while maintaining the proven principles of substantive patent law and procedural law which underlie the 1973 EPC. Many different issues have been discussed in the interested circles with regard to this process of reform. However, it became clear at a very early stage of the preparatory consultations that not all of these issues could be considered in this part of the revision process: The schedule for preparing the Diplomatic Conference requested by the intergovernmental mandate was very tight. Therefore, the idea of a first and a second basket was born: The more difficult issues like biotech patents or the grace period were postponed to the second basket. In August 2000, the European Commission proposed a Council Regulation on the Community patent including a Common European patent court (COM [2000] 412 final). This issue had been discussed for many years, but came to the fore again only with the publication of the Commission s Green Paper on the Community patent and the European patent system in 1997 (COM [97] 314 final). According to the proposal, the unitary EU patent will, after grant, no longer be subject to the national law of the member states, but only to Community Law in the form of the Council Regulation. Therefore, the implementation of the EC Community Patent System in the EPC was postponed to the second basket. Regarding the problem of the costs of translating European patents, an optional protocol was concluded at the intergovernmental conference in London (October 2000) enabling member states to waive, wholly or in part, the requirement for translation of European patents into their official language. The protocol is subject to ratification and can only enter into force when it has been ratified by eight states, including the three for

2 which the EPO granted the largest number of European patents in B. The composition of the conference The Diplomatic Conference was chaired by Dr. Roland Grossenbacher, president of the Administrative Council. The conference consisted of the delegations of the contracting states, the delegation of the European Community, and observer delegations (states permitted to accede the EPC), WIPO, and invited non-governmental organizations like the AIPPI. Except for the Credentials Committee and the Drafting Committee, the conference always met in plenary sessions. C. The outcome of the Diplomatic Conference The Basic Proposal formed the basis for the discussions of the conference. Proposed amendments to this Basic Proposal required for their adoption a majority of two third of the votes cast by the Ordinary Member Delegations present. On the other hand, a three quarter majority of the votes cast by the Ordinary Member Delegations present was required for adoption of the entire Revision Act, Article 172 (1) and (2) EPC. The conference was very well prepared by the EPO. Not even the permanent demonstration of Greenpeace in front of the EPO building substantially disturbed the proceedings. Thanks to the excellent chairmanship of Dr. Grossenbacher, the negotiations were mainly successful. Only a few provisions of the Basic Proposal have been subject to amendments or deletions. The following issues are the most important elements of the revision: Computer programs have not been deleted from Article 52 (2) (c) EPC; the respective provision of the Basic Proposal was overruled by 16 of 20 votes. The patentability of a known pharmaceutical for a new specific use has been affirmed (2 nd medical use), Article 54 (4) and (5) rev. version. The doctrine of equivalents is now mentioned in Article 2 of the protocol on Article 69 EPC, but there is no definition of equivalence, and the file wrapper estoppel is not mentioned. The wording of Article 52 (1) has been brought in line with Article 27 (1) of the TRIPS-agreement. A petition for review of the Boards of Appeal decisions by the Enlarged Board of Appeals is now possible. The petition may only be filed on the grounds expressly named in the EPC and the Implementing Regulations. The central limitation procedure for European Patents has been adopted. Patent applications can be filed in any language (see the recently signed Patent Law Treaty); a translation into one of the official languages of the EPO will not be required until a later date in accordance with the Implementing Regulations. The separation of search and examination has been removed from the EPC. Both tasks can be performed by the same examiner located either in The Hague, Berlin or Munich (BEST-project). A protocol on the staff complement of the EPO at The Hague has been annexed to the EPC. The Administrative Council has been authorized to adapt the EPC to international treaties or Community Law, albeit with wide restrictions. The ministerial conference has been made a permanent institution of the EPC. Special agreements concerning European patent law between two or more

3 contracting states are now explicitly recognized. Many provisions have been transferred from the EPC to the Implementing Regulations. The new provisions will not enter into force immediately, as they first have to be ratified by the parliaments of the member states. Therefore, the revised convention will not have any legal effect for another four or five years. In the Conference Resolution, the Administrative Council is urged as a priority to make preparations for another Diplomatic Conference which will deal in particular, with the question of software and biotech patents as well as Community patents. D. The hot issues discussed at the Diplomatic Conference As mentioned above, only a few provisions of the Basic Proposal have been subject to amendments or deletions. However, there has been a controversial discussion on many issues. In the following, the most important proceedings of the conference are summarized in chronological order. I. Implementation procedure with regard to EC Law and international treaties, Article 33 (1) (b) and (5), Article 35 (3) The traditional way to implement EC Law and international treaties in the EPC is convening a Diplomatic Conference of the member states for the adoption of a revised convention, a very time consuming and expensive procedure. Therefore, the Administrative Council has been empowered to amend EPC provisions concerning patent law and procedural law by a unanimous vote of all member states. In order to ensure the sovereignty of the member states and the rights of the national legislative bodies in particular, each Contracting State has a period of 12 months from the time the decision is adopted in which to declare that it wishes not to be bound by the decision. However, these guarantees did not satisfy the Swedish delegation for constitutional reasons : Under the Swedish constitution, a three quarter majority in parliament is apparently required for the ratification of this provision. Therefore, Sweden proposed to postpone this matter to the second basket. This proposal was supported by some member states. Germany, Switzerland and most other member states opposed this proposal very strongly, however, arguing that the national sovereignty was not endangered as the national legislative bodies have one year to induce the Government to revoke their vote. However, as a mutual concession, all member states agreed to amend Article 33 as follows: International treaties cannot be implemented in the EPC before they enter into force of the respective treaty; EC Law cannot be implemented before it enters into force or before the expiry of the implementation period respectively. The German delegation agreed to this compromise with a bad grace and the Swiss delegation called it a self-castigation. II. Computer programs, Article 52 (2) (c)

4 In the first draft of the Basic Proposal (CA/100/00), it was stated that in any event, the deletion of computer programs from Article 52 (2) (c) EPC has met with broad consensus. Furthermore, this draft discussed the question whether the entire paragraph (2) should be deleted or transferred to the Implementing Regulations. In contrast, the wording of the final version of the Basic Proposal (MR/2/00) is much more restraint; it is merely stated that the committee on patent law and the Administrative Council have advocated the deletion of programs for computers from Article 52 (2) (c) EPC. The deletion of the entire paragraph (2) is no longer proposed. The Basic Proposal makes clear that broadening the scope of patentable subject matter was not intended by the deletion of computer programs: The deletion should merely reflect the current jurisprudence of the EPO s Boards of Appeal. At the Diplomatic Conference, France, Denmark, and Germany proposed to postpone the deletion of computer programs and all other EC member states except for Austria supported this proposal. The background of this initiative were the massive protests against software patents by a number of software developers. The delegations of the EC member states had met in Brussels on November (i.e. three days before the Diplomatic Conference) in order to agree on a common standpoint and to coordinate their voting with regard to computer programs. As the 15 EC member states represent a majority of two third of the votes cast by the Ordinary Member Delegations (which is needed for amendments of the Basic Proposal), there was no real discussion on this issue during the Diplomatic Conference. Apart from the Austrian delegation, all EC member states reasoned their voting by more or less identical statements: Further consideration with the interested circles is needed. The European Commission has recently launched a consultation within the member states with the purpose of having a thorough discussion of the issue and possibly establishing proper means for harmonization on this issue within the Community. The outcome of this initiative should be awaited before any further action on this matter is taken in relation to the EPC. A deletion of computer programs from Article 52 (2) might be misunderstood as broadening the scope of patentable subject matter. The Austrian delegation emphasized that their interested circles supported patenting of computer programs. Therefore, this delegation abstained. The Swiss delegation vehemently criticized the behavior of the EC member states: The postponement might be misunderstood as criticism of the current EPO practice concerning computer related inventions. In future, Article 52 (2) (c) might be a disadvantageous locational factor for Europe. The preparation of another Diplomatic Conference ( second basket ) is very time consuming. This will significantly delay the revision process. The other delegations were not impressed by the statements of the Swiss delegation. However, all delegation emphasized that the postponement is definitely not a criticism of the current EPO practice concerning computer related inventions. The delegations mandated the chairman Dr. Grossenbacher to make this clear at the final press conference. All non governmental organizations representing the users were in favour of the deletion

5 of the exclusion of computer programs per se from patentability. The AIPPI representative made a strong statement in referring to the resolution taken almost unanimously at the Executive Committee of Vienna. Finally, 18 member states supported the postponement. III. First and second medical use, Article 54 (4) and (5) EPC The exclusion of methods of treatments and diagnostic methods in Article 52 (4) EPC has been added as new paragraph (c) to the two exceptions to patentability which appear in Article 53 (a) and (b) EPC. The former provision was considered undesirable since these methods are excluded in the interest of public health and not for their lack of industrial applicability. According to current Article 54 (5) EPC (now Article 54 [4]), by way of compensation for the exclusion from patentability of medical methods under Article 53 (c) EPC, known substances or composition of matter are deemed to be new, provided they are used for the first time in such a medical method. Up till now, the EPO, following the case law of the Boards of Appeal (see e.g. T 128/ 82, Pyrrolidine derivatives/ Hoffmann-La-Roche, OJ EPO 1984, 164), has granted a broad claim for the first medical use, i.e. for a general therapeutic purpose, e.g. as a pharmaceutical substance, even if only a specific use of the substance is disclosed in the application. The Enlarged Board of Appeal was asked to decide whether any further medical use could receive patent protection under the EPC in spite of the wording of current Article 54 (5) EPC (now Article 54 [4]) which seemed to limit patentability to the first medical use. The Enlarged Board answered in the affirmative to this question and allowed the so-called Swiss type claim, i.e. a claim directed to the use of a substance or composition for the manufacture of a medicament for a specific new and inventive therapeutic application (see G 5/ 83, Second medical indication/ EISAI, OJ EPO 1985, 64). The national courts and appeal divisions of the patent offices of the contracting states have generally followed this decision. However, the French Cour de Cassation, the Dutch Octrooiraad and the UK High Court expressed doubts on the validity of Swiss type claims. Therefore, a new Article 54 (5) EPC was introduced which unambiguously permits purpose related product protection for each further new medical use of a substance or composition already known as a medicine. On the Diplomatic Conference, all delegations supported the introduction of this clarification. However, there has been a long discussion on two issues: Should the permissible scope of protection provided by a claim on the first or second medical use be prescribed by the EPC or should this continue to be a matter for case law? Does Article 54 (4) and (5) EPC prescribe or proscribe the scope of protection provided by a claim on the first or second medical use? In order to illuminate theses issues, the wording of the new Article 54 (4) and (5) is cited below: (4) Paragraph 2 and 3 shall not exclude the patentability of any substance or composition,

6 comprised in the state of the art, for use in a method referred to in Article 53 (c), provided that its use for any such method is not comprised in the state of the art. (5) Paragraph 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in any method referred to in Article 53 (c), provided that such use is not comprised in the state of the art. Austria, Greece, Germany, and other delegations took the view that the permissible scope of protection provided by a claim on the first or second medical use should continue to be a matter for case law. The Austrian delegation emphasized that the scope of protection is solely determined by the content of the disclosure and that this rule prohibits the introduction of any provision prescribing the scope of protection with regard to a particular case. On the other hand, Sweden, Switzerland, and a number of other delegations supported a prescription of the permissible scope of protection according to the status quo for the sake of legal certainty. Consequently, there has been no consensus whether Article 54 (4) and (5) EPC prescribes or proscribes the scope of protection provided by a claim on the first or second medical use: In the first draft of the Basic Proposal it is stated in the explanatory remarks that Article 54 (4) and (5) does neither prescribe nor proscribe the scope of protection. However, the final draft does not comment on this issue. The Swedish delegation took the view that the revised Article 54 (5) is intended to match as closely as possible to the scope of protection... provided by a Swiss type claim (see document MR/18/00). Many other delegations agreed on this point; especially the EPO made it clear that paragraph 4 if interpreted in the light of paragraph 5 prescribes a broad claim for the first medical use. For this reason, Portugal proposed to transfer paragraph 4 and 5 to Article 53 (c). Greece proposed to replace these provisions by a paragraph allegedly neutral with regard to the scope of protection. In addition, Belgium, Austria, Germany, and other delegations insisted that Article 54 governs exclusively the novelty requirement and therefore cannot prescribe the scope of protection in any respect. Finally, the Greek proposal did not find the required majority and the Diplomatic Conference adopted Article 54 (4) and (5) in the wording cited above. During the discussion, the AIPPI was in full support of the text revised as above indicated. IV. Central limitation procedure, Articles 105a to 105c EPC Under the extended limitation procedure set forth in the new Articles 105a to 105c EPC, a European patent may be limited or revoked ab initio at the request of the patent proprietor. Limitation or revocation may be requested at any time, although precedence must always be given to opposition proceedings. The central limitation procedure as such has been supported by all delegations; however, for constitutional reasons Sweden and Denmark proposed to postpone the introduction of this procedure to the second basket : According to these delegations, the Swedish and Danish constitutions require a 3/4 and 5/6 majority, respectively, for the ratification of these provisions. The other member states expressed their concerns about the situation in Denmark and

7 Sweden. However, they supported the introduction of the central limitation procedure in the first basked. The Dutch delegation emphasized that the initiative for the limitation procedure can solely be taken by the patent proprietor and not by the EPO; therefore, the introduction of the limitation procedure does not constitute a substantial transference of sovereign rights. The German and Swiss delegation pointed out that the central limitation procedure would be an appropriate means to solve cases like the one of the so-called Edinburgh-patent in a fast and cheap way: If a patent is not in line with regulations concerning biotechnological inventions, this kind of error can be removed by an action of the patent proprietor. Therefore, the limitation procedure was also seen as an answer to the criticism voiced by Greenpeace. The President of the EPO made it clear that there is no real constitutional problem but rather a political problem in Sweden. Germany added that the legal situation in Denmark and Sweden will not change in the near future. The observer delegations supported the introduction of the limitation procedure. The UNION pointed out that this procedure will be very helpful if a third party finds alleged new prior art and thereby tries to extort a free license from the patent proprietor. The AIPPI also expressed its favorable opinion on the central limitation procedure. Dr. Grossenbacher proposed an amendment allowing each contracting state to reserve the right that the limitation procedure shall have no effect in respect of that state. Many delegations rejected this proposal in order to secure the unity of the convention. Finally 11 states voted in favor of this amendment. Therefore, this amendment was dismissed and the Basic Proposal adopted. V. Petition for review by the Enlarged Board of Appeals, Article 112a EPC In order to make possible a limited judicial review of decisions of the boards of appeal, the Enlarged Board of Appeal was given the competence to decide on petitions for review. According to the Basic Proposal, a petition can be filed on two grounds: A fundamental procedural defect as defined in the Implementing Regulations occurred in the appeal proceedings, or a criminal act which may have had an impact on the decision. In contrast, France, Germany and other delegations preferred a non-exclusive list of fundamental procedural defects in Article 112a EPC in order to allow a flexible definition of that term by case law. The Netherlands, Sweden and Switzerland even proposed not to name any examples of fundamental procedural defects at all. On the other hand, Italy and other delegations proposed to introduce an exclusive list of fundamental procedural defects in the EPC in order to prevent a excessive extension of this mean of redress. Finally, Germany, France, and the EPO proposed as a compromise the introduction of an exclusive list of fundamental procedural defects defined partly in the convention, partly in the Implementing Regulations. This proposal was unanimously adopted. VI. Doctrine of equivalents, Protocol on Article 69 EPC

8 The discussion on this protocol was very controversial. The Basic Proposal provided to rename the present provision of the Protocol as Article 1 and to add two new Articles: Article 2 had the following wording: (1) For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of means which at the time of the alleged infringement are equivalents to the means specified in the claims. (2) A means shall generally be considered as being equivalent if it is obvious to a person skilled in the art that using such means achieves substantially the same result as that achieved through the means specified in the claim. Article 3 provided that for the purpose of determining the extent of protection, due account shall be taken of the so called file wrapper estoppel, i.e. statements limiting the extent of protection made by the applicant or the proprietor in the application, the patent, or during proceedings concerning the grant or validity of the patent. The UK strongly opposed the introduction of Articles 2 and 3 because this proposal would not attain the aim of harmonizing European patent law. A legal definition of equivalence cannot prevent different ways of interpreting this definition. Furthermore, the UK criticized that there is no European consensus concerning the critical date for determining the scope of protection. Additionally, Europe should keep in mind the negative experiences with the file wrapper estoppel made by the Americans. Several observer delegations emphasized that further considerations are needed and therefore the discussion should be postponed to the second basket. The AIPPI disagreed with the definition of equivalence given in the basic proposal but stated that the principle of equivalence must be kept as indicated in Article 2 (1) without precise reference to the date of appreciation of the equivalence. Switzerland took the position that this issue has been discussed for a very long time and further discussions would not improve the results. Therefore the Basic Proposal should be adopted. Germany also supported the Basic Proposal because it provided a harmonization of European patent law although the German patent law is already in line with the proposed provisions. Belgium took the view that a legal definition of equivalence would be very helpful as there is no legal definition of the term invention. The AIPPI replied that there is no definition of equivalence in the US law as well. Finally, Germany, the UK, and France proposed as compromise a new wording of Article 2 (see MR/PLD 6/00): For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims. No definition of equivalence is given. Germany pointed out that this proposal permits national courts to apply the doctrine of equivalence in a flexible and fair way.

9 The Swiss delegation asked why the word means had been replaced by elements. The UK answered that this wording derives from the Patent Law Treaty and fits better to chemical inventions. The CNIPA took the view that the word element is not as comprehensive as the word means. Finally, Article 2 (according to MR/ PLD 6/00, see above) was adopted by 16 votes. After this decision, Denmark proposed to remove Article 3 of the Protocol (file wrapper estoppel) from the Basic Proposal as well. The Danish delegation argued that the interested circles had demanded further considerations on this issue and that this need should be respected. No objections were raised and this proposal was adopted by (just) 14 votes. VII. Transitional Provisions The draft of the Revision Act did not contain precise transitional provisions. Article 7a was therefore added and discussed in depth. The AIPPI stressed that the revision should not have retroactive effect. On the basis of a paper drafted by the EPO, The German, British and Dutch delegations suggested an amended wording, which was adopted as follows: (1) The revised version of the Convention shall apply to all European parent applications filed after its entry into force,, as well as to all patents granted in respect of such applications. It shall not apply to European patents already granted at the time of its entry into force, or to European patent applications pending at that time, unless otherwise decided by the Administartive Council of the European Patent Organization. (2) The Administrative Council of the European Patent Organization shall take a decision under paragraph (1) no later than 20 June 2001 by a majority of three quaters of the Contracting States represented and voting. Such decision shall become an integral part part of this Revision Act. VIII. The Conference Resolution All governmental delegations agreed to discuss an conference resolution which would summarize the results of the Diplomatic Conference and give a general view for the future. A lengthy debate took place before the adoption of a text to be unanimously approved. Some delegations strongly desired that an agenda was fixed. In contrast, a basic proposal stemming from the EPO and supported by theaippi, did not contain any limit for preparing a new diplomatic conference. The resolution specifically refers to software and biotechnological inventions among the topics for further considerations: Proposals for further revision might in particular relate to software and such changes as are required to implement the Community Patent without delay, bearing in mind the declaration of the heads of state and government of the European Union made in Lisbon in March 2000.

10 E. Future Perspectives The conference has shown that European patent law remains a very important issue; however, there has been a shift concerning the leading players in this field: As Dr. Grossenbacher pointed out in his concluding remarks, the European Community is more and more controlling the further development of substantial European patent law. The EPO interprets its future role as providing mainly a procedural framework concerning patent prosecution. The schedule for the second basket has not been determined, although this second basked served as a kind of excuse for the postponement of very important issues like software and biotech patents and the community patent. This cast a shadow on the intention to continue the process of reform. However, the steps of this process of reform already taken at the Diplomatic Conference are very important and should be regarded as an example of impressive willingness to compromise. (1) German group of the AIPPI; Max Planck Institute, Munich. R.Nack@intellecprop.mpg.de (2) Reporter General of AIPPI [ Home ][ Contact ][ Top ]