The European Patent Convention ("EPC 2000") comes into force on 13th December 2007 introducing significant changes to the European patent system and the text of the original EPC 1973. These changes will have an impact on substantive patent law, the application procedure, amendments and appeals. The Patents Act 2004 implements the changes to the UK patent regime occasioned by the EPC 2000 via SI 2007 No.3396 (C.1440) The Patents Act 2004 (Commencement No.4 and Transitional Provisions) Order 2007, which will come into force on 13th December, along with the EPC 2000 itself.
The patenting of known compounds for use in novel second and further medical uses has been simplified.
Equivalents – the protocol on the interpretation of Art. 69 has been amended such that due account is to be taken of elements that are equivalent to those specified in the claims.
"Novelty only" prior art – prior filed but unpublished European patent applications are now part of the state of the art for novelty assessment, no matter which states they designate.
Post-grant amendment – EPC 2000 introduced a new mechanism whereby a granted patent can be amended or revoked by the proprietor centrally at the EPO.
"Petition" for review by the Enlarged Board of Appeal of Boards of Appeal decisions introduced in certain exceptional circumstances involving fundamental procedural improprieties.
Changes to applications procedure for European patents
Stakeholders should be aware of how the changes to the European patent system may affect the granting and enforcement of European patents. Many of the changes are complex and technical and, given the importance of value attaching to patents, it is inevitable that some of the questions arising out of the scope of these amendments will need to be clarified by the EPO and the national courts.
HIGHLIGHTED CHANGES TO UK AND EUROPEAN PATENT SYSTEMS
The EPC has been updated for a number of reasons. In particular, account had to be taken of developments in international law, including the TRIPS agreement and the Patent Law Treaty 2000. For example, the EPC 2000 clarifies the fact that, in accordance with the requirements of TRIPS, patents can now be granted for any inventions in all fields of technology provided they are new and comprise an inventive step.
Methods of medical treatment
Methods of treatment or diagnosis for humans and animals will remain unpatentable under EPC 2000. However, new Article 53(c) does away with the old legal fiction (under Article 52(4)) that such methods are incapable of industrial application and therefore are not patentable, and makes it clear that such inventions are excluded for public policy reasons.
Article 54(5) – new uses of known compounds
The patenting of known compounds for use in novel second and further medical uses has been simplified. The EPC 2000 removes the need to phrase claims for second medical use in the "Swiss" form i.e. "Use of compound X for the manufacture of a medicament for treating disease Y1. New Article 54(5) clarifies that a substance or composition, forming part of the state of the art, that is the subject of a first medical use claim, will not be precluded from patentability in relation to a specific new therapeutic use. In theory, the Swiss form claim can now be replaced with a simpler form of claim, for example "substance X for use in treatment of disease Y". It may be advisable however, to employ both forms of claim, pending the outcome of proceedings concerning these new forms of claim and determining their exact scope.
The transitional provisions2 state that Article 54(5) will apply to applications pending when EPC 2000 enters into force and applications filed on or after entry into force. New section 4A(4) of the amended Patents Act 1977 will implement these changes.
Equivalents to be considered in relation to scope of patents
In some jurisdictions (including the United States) claim protection can be extended to cover embodiments that do not fall within the literal scope of the claims, but which are "equivalent" to that which is claimed. This permits a court to find a party liable for patent infringement where the infringing product or process does not fall within the literal scope of a patent's claims, but nevertheless performs the substantially same function, in substantially the same way, to achieve substantially the same result.
The EPC 2000 now formally recognises that equivalents should be a consideration when addressing the scope of patent claims.
The scope of claims under current European practice is governed by Article 69 which states protection shall be determined by the terms of the claims as interpreted in conjunction with the description and drawings. The Protocol on the interpretation of Article 69 ("the "Protocol") attempts to strike a balance between a literal interpretation of a claim and using the claim only as a guideline, seeking to achieve a position between these extremes which combines a fair protection for the patentee with a reasonable degree of certainty for third parties. The EPC 2000 adds a new Article 2 to the Protocol, which reads "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".
It remains to be seen how national courts will interpret and apply this new addition to the Protocol. There is no formal doctrine of equivalents under English law that allows the extension of claim scope, a position recently reasserted by the House of Lords in Amgen v TKT3. In that case, Lord Hoffmann gave an indication as to how the English courts may interpret new Article 2 of the Protocol:
"Although article 69 prevents equivalence from extending protection outside the claims, there is no reason why it cannot be an important part of the background of facts known to the skilled man which would affect what he understood the claims to mean. That is no more than common sense. It is also expressly provided by the new article 2 added to the Protocol by EPC 2000".
It appears, therefore that the new "equivalents" wording will have little if any impact on claim interpretation in the courts of England and Wales. It is interesting to note that the EPO also regards this change as cosmetic. The Explanatory Remarks4 make it clear that the new Article 2 of the Protocol is purely clarificatory and editorial. Nevertheless, it is too early to say if the new Protocol will affect the interpretation of claims under European practice.
The new Protocol will apply to all patents, whether granted before or after implementation, and to applications pending at the date of implementation.
"Novelty only" prior art
Under Article 54(3), a prior filed unpublished European patent application can be considered as part of the state of the art, but for the purposes of assessing novelty only. Under the EPC 1973, Article 54(3) references were considered state of the art only to the extent that the designated states for each application overlap (Article 54(4)). This can lead to the unsatisfactory position that different claims are granted for different designated states.
EPC 2000 removes Article 54(4), meaning an Article 54(3) reference will now be relevant to the novelty of a subsequently filed European patent, no matter which states are designated.
Under the transitional provisions, patents granted pre-implementation, and applications pending at the time of implementation shall continue to be governed by current Article 54(4), meaning that novelty will only be destroyed where both applications designate the same states.
The EPC 2000 introduces a new mechanism whereby, upon request of the patent proprietor, a granted patent can be amended or revoked centrally at the EPO. Currently, a granted European patent can only be amended outside of the opposition procedure by applying separately to the patent office or courts of each designated state, a costly and complicated exercise.
New Article 105a(1) provides that, upon request of the proprietor, a European patent may be revoked or limited by the EPO by amendment to the claims. In fact, a request can be made to amend the claims, description and/or drawings (Rule 92(2)(d)). Such requests cannot, however, be made whilst there are opposition proceedings in respect of the patent (Article 105a(2)). Likewise, any limitation proceedings will cease if an opposition is filed with the EPO (Rule 93 (2)).
Any decision to limit or revoke the European patent takes effect in all designated states from the date on which the mention of the decision is published in the European Patent Bulletin (Article 105b(3)).
The new revocation and limitation procedures apply to all granted European patents.
This new amendment route may allow patentees to bypass more rigorous national procedures. For example, in the UK there is no amendment as of right. Section 75 of the UK Patents Act 1977 provides that, on a patent amendment application in revocation or infringement proceedings the court or comptroller may allow the amendment. Thus, even if the proposed amendment does not add matter or extend the claim scope, the Court has discretion on whether to give leave to appeal. The new Patents Act provisions do not appear to have removed the Court's discretion to allow amendment. New ss. 27(6) and 75(6) introduced by the Patents Act provide that when a request for amendment is made in infringement or revocation proceedings, or there is a request to amend after grant, the court or the comptroller when exercising its discretion shall have regard to any relevant principles applicable under the European Patent Convention. It will be interesting to see how the courts and comptroller exercise their discretion in light of the provisions of the EPC which essentially provide for amendment as of right.
The Patents Act 2004 introduces into the Patents Act 1977 a new section 63(4) which allows the court or comptroller to request that the proprietor of a partially invalid UK designated European patent limit the patent to the court/comptroller's satisfaction at the EPO before granting relief for infringement of that patent. In relation to revocation, the Patents Act 2004 introduces into the Patents Act 1977 a new sub section (72(4A)) allowing the court or comptroller to revoke a partially invalid UK designated European patent unless the proprietor limited its patent to the court/comptroller's satisfaction at the EPO.
This is an important change. A party to English litigation is likely to be required to limit its European patent post grant if it appears that the patent is partially valid. Accordingly, litigation in England may now have an important substantive impact on not just the UK designated European patent but also on all other equivalent patents in other designated territories.
Review by the enlarged board of appeal
The EPC 2000 introduces the possibility of a "petition for review" in respect of decisions made by Boards of Appeal to the Enlarged Board of Appeal ("EBA"), albeit only in certain exceptional circumstances involving fundamental procedural improprieties. The limited grounds for appeal include circumstances where one or more members of the Board of Appeal should not have been involved in a decision for reasons of having an interest in that decision or having previous involvement in the matter. Also, a petition for appeal to the EBA can be made if there is a fundamental violation of Article 113 concerning the right to be heard and the basis of decisions. Finally, the EBA can be petitioned if there is any other fundamental procedural defect under the Rules in the appeals proceedings or a criminal act under the Rules had an impact on the Board of Appeal's decision.
There will also be a number of changes to the procedure for making a European patent application. For example, an application will no longer be required to be filed in one of the official languages of the EPO provided that a translation in one of the official languages is submitted within one month. Furthermore, all contracting states will be deemed to be designated in the request for the grant of a European patent and the designation of any State can be withdrawn prior to grant of the patent. This is in contrast to the present position whereby States must be individually designated.