The use of prosecution history in post-grant patent proceedings

Question Q229 National Group: Denmark/Dänemark/Danemark Title: The use of prosecution history in post-grant patent proceedings Contributors: Ulla KLINGE, Peter-Ulrik PLESNER, Mikkel VITTRUP, Jakob KRAG NIELSEN, Nicolai LINDGREEN, Martin GANTZHORN, Holm SCHWARZE & Ejvind CHRISTIANSEN Reporter within Working Committee: Ejvind CHRISTIANSEN Date: 7 May 2012 Questions The Groups are invited to answer the following questions under their national laws. 1) What types of post-grant proceedings are available in your jurisdiction? Are post-grant proceedings available both at a patent office and at a court? In Denmark post-grant proceedings in respect of the validity of a patent are available both in the form of administrative proceedings at the Danish Patent and Trademark office and in the form of judicial proceedings at the courts. At the patent office, post-grant opposition proceedings as well as post-grant, inter partes re-examination proceedings are available to third parties who wish to challenge the validity of a Danish national patent or the Danish part of a European patent. These proceedings are similar to opposition proceedings at the European patent office. However, re-examination proceedings may be initiated even after expiry of the opposition period. Furthermore, ex parte re-examination proceedings are available to the proprietor of a Danish patent or Danish part of a European patent. These ex-parte re-examination proceedings are similar to limitation proceedings before the European Patent Office. However, during ex parte re-examination proceedings, the Danish Patent and Trademark office also examines the patent as regards novelty and inventive step. Finally, for European patents validated in Denmark, the central opposition and limitation proceedings at the European Patent office are available. As regards judicial proceedings, invalidity actions may also be initiated by third parties at the Danish courts. Validity is often also raised as a counterclaim in infringement proceedings. Finally, decisions by the Danish Patent and Trademark office in the above administrative proceedings are open to appeal, first before an administrative appeal board and ultimately at the courts. 1

2) In your country or region, may the prosecution history be taken into account for purposes of interpreting claim scope during post-grant proceedings? In Denmark the answer to the question is: Yes. The file history can be and is very often used in infringement proceedings. In AIPPI Q 175 concerning the role of equivalence and prosecution history in defining the scope of patent protection the Danish Group wrote: "In several cases, the court has referred to this correspondence in its decisions. The correspondence can be used to narrow or confirm the scope of protection but not to broaden the scope of protection." The legal basis for this answer is a White Paper from 1964 by a joint Danish, Finnish, Norwegian and Swedish governmental committee. The governmental committee proposed new Patents Acts to be enacted in each of the Nordic countries. The acts entered into force on 1 January 1968 and had the same wording in all the four Nordic countries. The acts contained as Article 39 a new rule with the same wording as the later Article 69 EPC This was a new rule in Nordic Patent Law and it was based on the then existing draft for a European Community Patent. When the new act was proposed to Parliament the responsible minister stated that this rule was in accordance with Danish caselaw. At the same time, all documents in the patent application file, including correspondence between the applicant and the Patent Office ( the prosecution history ), were made available for public inspection. The following was stated in the White Paper: "If the applicant in a letter to the patent authority or in connection with oral proceedings before it, for example for the purpose of pointing out differences in relation to novelty impediments stated, has interpreted expressions used in the claims restrictively, it is reasonable that such restrictive interpretation also be taken into account in later proceedings." It is important to understand that under Danish law preparatory works such as theseare used by the courts when they interpret the statute law. Under the former Danish Patents Act, the prosecution history could only be produced after a court order which was generally always granted. In several cases the Danish courts had referred to statements by the applicant to the Patent Office when determining the scope of protection. This practice was upheld after the new act and the following was, for instance, stated in a High Court decision from 1990 (Ugeskrift for Retsvaesen, 1992, page 704): "Based on the text of the patent claim compared with the patent description and the correspondence with the Patent Office, it is held that it is characteristic of the plaintiff's invention that [ ]". In 1978 the Danish Patents Act was amended in order to enable Denmark to join the EPC. At that time it was presumed that Danish caselaw was in accordance with Article 69 EPC and the corresponding Protocol. 2

There have not been sufficient Danish decisions to be able to set up detailed rules on how the prosecution history can be used when interpreting the claims. The Danish group expects the courts to take a pragmatic view on the prosecution history based on the facts of the individual case in accordance with the Danish principle of free evaluation of evidence. The principle of free evaluation of evidence is generally used by the courts in the absence of any specific evidentiary rules in statute. A few principles may, however, be deduced. The patentee cannot use the prosecution history to broaden the scope of protection. A statement from the patentee to overcome an objection to novelty or inventive step can be used to narrow the scope of protection to, for instance, the literal wording of the claim. In relation to amendments to the claims made by the applicant we have in Denmark what can be described as a flexible approach. This can be demonstrated by the Danish case concerning Atorvastatin ( Lipitor ) in which the prefix (±) was added by the applicant during the proceedings. The prefix (±) is the indication for a racemate of a chemical compound having an optically active centre giving rise to the presence of so-called enantiomers, which frequently have different pharmacological properties. Atorvastatin is the active enantiomer of the racemate. The High Court stated as follows: "The prefix (±) was added by the defendant [ ], but the patent agent's letter of [ ] does not include any firm basis for assuming that the defendant by this has intended to limit the patent to comprise only the racemate and not also the enantiomers of which the racemate consists." The court decided that the claim covered Atorvastatin in spite of the prefix. The decision was appealed to the Supreme Court, but the appeal was later withdrawn. The Norwegian professor, Are Stenvik, summarises the legal situation in Norway as follows: ". it should be decisive how a third party has had reason to understand the amendment. If the amendment is such that a third party is left with the impression that it has been made to exclude certain variations from the scope of the patent, the third party should generally be able to assume that such variations can be exploited freely. If, on the other hand, the amendment is just a result of the applicant's general efforts to obtain a precise, appropriate or formally correct definition of the invention, a third party does not have the same reason to assume that the variations that fall outside the amended patent claim may be exploited freely." (Are Stenvik, "Patentrettens beskyttelsesomfang", 2001.) (Emphasis added) The Danish group believes that the above statement also reflects the present state of Danish case law. If the answer to question 2 is yes, please answer the following questions: a) Please explain the types of prosecution history that may be considered. For example: i. Does applicable prosecution history include amendments, arguments, or both? 3

Both amendments and arguments, positions taken, and interpretations made, during prosecution may be invoked in later proceedings, and can influence the scope of protection of a patent. For example, in a recent case (Eastern High Court, 10 th department, B-2106-99, Hedegaard vs. Hardi International), the patentee had pointed out during prosecution, in order to overcome the prior art, that the apparatus according to claim 1 was characterised in being based on a conventional apparatus in the relevant technical area, as opposed to being based on a different design known from a particular prior art document. As the defendant's apparatus was mainly based on the construction known from the prior art document, defendant was held not to infringe the patent, neither by literal infringement nor by way of equivalence. In another recent case (Maritime and Commercial Court, T-5-08, Power Stow vs. RASN et al.), the patent claims were the result of prolonged correspondence with the patent authority, and the claims were in important aspects the result of clarification and delimitation towards the prior art. The court observed that the parts of the patent claim that had been amended during prosecution must be interpreted restrictively, as they had been restricted to avoid conflict with the prior art. The patent was held not to be infringed, as the features of the claim that were new, compared with the prior art, were not present in the allegedly infringing apparatus. ii. Could applicable prosecution history include a limiting interpretation that is implied through the applicant s arguments, or would it include only explicit definitional statements? There is no authority in Danish case-law on this point. However, the Danish Group believes that if, for example, the patent authority has - expressly or implicitly - stated assumptions, on which the patent is granted, and the patentee has accepted such assumptions, this may be taken into consideration in subsequent proceedings. Presumably, this also applies if the patentee can be seen to have accepted the patent authority's assumptions or understanding of the patent by not protesting against the assumptions or understanding of the patent authority. The Danish group adopts the statement above by Professor Are Stenvik that it is decisive how a third party would understand the applicant s arguments. iii. Does applicable prosecution history include only amendments to the claims, or does it also include amendments to any aspect of the disclosure? Applicable prosecution history could include amendments to the description, as well as amendments to the claims. However, the circumstances surrounding the amendments are in both cases relevant in determining whether the amendments should influence the scope of protection of the claims (see below iv). iv. Does it matter if the amendments and/or arguments are made to overcome prior art versus being made to address sufficiency or some other formal requirement? The decisive factor is probably what impression the amendment/argument would give a third party as to whether the amendment was made to limit the scope of the patent (to exclude subject matter) or not. Amendments that are made to delimit the invention towards the prior art will often be understood to 4

be necessary and to have been made to limit the scope of protection in order to obtain a valid claim, cf. the decision in Power Stow vs. RASN et al. cited in (i) above. It may be less clear when amendments are made for other purposes than delimiting the claims towards the prior art. However, amendments made, for example, to limit the claims to a scope that is supported by the description, or which are made because a previous amendment implied adding matter not disclosed in the original application, will probably often be understood to have been made with the purpose of excluding subject matter from the claim, but this may not always be the case. Amendments made to ensure unity or clarity, or similar "formal" requirements should, on the other hand, probably not result in a restriction of the scope of the remaining claim. v. Does it matter if the prosecution history has the effect of broadening the interpretation of the claim, versus narrowing it? Under Danish patent law, the prosecution history may be invoked to clarify, including narrowing, the interpretation of the claims. In the interest of potential infringers legal position, the prosecution history may as such not be used to broaden the interpretation of the claims. Such clarifying interpretation can be relied on by defendants in infringement proceedings as well as by patent proprietors in proceedings concerning the validity of a patent. b) Does the applicability of prosecution history depend on when the prosecution history occurred? For example, does it matter if a particular statement by an applicant was made during initial examination as opposed to during a later invalidity proceeding? No case law supports that this distinction is of relevance to the applicability of the prosecution history. Thus whereas case law exists to the applicability of the prosecution history relating to a statement made during the examination process, no case law exists to the applicability of the prosecution history relating to a statement made after grant. Thus while such statements put forward in any postgrant invalidity proceedings may be asserted depending on the actual circumstances it is considered that they may not carry the same weight as any pre-grant statements. (In the response to this question prosecution history is understood as any statement made anywhere in the preceding proceedings, not only during the examination process as set forth in Discussion, point 5) above.). c) Does the applicability of prosecution history depend on the type of post grant proceeding, or on the authority before which the proceeding is held? For example, would prosecution history be more applicable in an infringement action at court than in a post-grant patent office invalidity proceeding? No. The National Group is not aware of any case law which makes a distinction between different types of proceedings in the applicability of the prosecution history. d) Is the applicability of prosecution history limited to infringement proceedings where equivalents are an issue? No. The prosecution history may e.g. also be applied in connection with claim interpretation where e.g. the meaning of a term in a claim might reasonably be interpreted in light of what the applicant has explained during examination. This may occur for instance in a case where a (deliberate) renunciation of a species among a genus recited in the claim has taken place. It is considered, however, 5

that the applicability of prosecution history is most relevant in proceedings where equivalents are an issue. e) Could prosecution history from a corresponding foreign application be considered in a post-grant proceeding in your jurisdiction? If so, under what circumstances? The principle of free evaluation of evidence may allow for prosecution history from a corresponding foreign application to be asserted in post-grant proceedings. The consequences of such line of argumentation for the court is, however, unclear. f) Is the use of prosecution history authorized by statute or by case law in your jurisdiction? The use of prosecution history is authorized by the 1964 White Paper and construed/interpreted in practice by use of well-established case law (see the answer to question 2(a) above). g) Explain the policy reasons for considering prosecution history during the claim interpretation process. Although not stated in the 1964 White Paper (or discussed in case law), the Danish Group believes that the reasons for considering prosecution history relate to public policy rationales. The main rationale is that the patent holder should not be able to argue around citations during prosecution, and then during post-grant proceedings disregard such argumentation (to broaden the scope of the patent). This rationale is supported by case law (See the answer to question 2(a) above). If the answer to question 2 is no, please answer the following questions: h) Is the disallowance of use of prosecution history mandated by statute or by case law in your jurisdiction? i) Explain the policy reasons for not considering prosecution history during the claim interpretation process. 3) Assuming that at least some countries will consider foreign prosecution history as part of claim interpretation in their jurisdictions, does this have implications for how you would handle prosecution of a patent application in your country? Is this problematic? Many Danish applicants are particularly cautious in respect of their actions and argumentation during the prosecution of Danish and European patent applications which have counterparts in jurisdictions where there is a likelihood that these jurisdictions may consider foreign prosecution history as a more doctrinarian part of claim interpretation in their jurisdiction as opposed to the free evaluation of evidence in a fact-based manner as applied by the Danish Courts. As applicants may refrain from presenting arguments they otherwise would find appropriate, such behaviour inherently involves the risk of prolonging the Danish and European proceedings, increased costs, and ultimately the risk of a less favourable outcome of the Danish or European proceedings. 4) In your country or region, may a patent be invalidated in post-grant proceedings on the basis of the same prior art which was taken into account by the examiner of the patent office during prosecution of the patent? If so, may the patent be invalidated on the basis of the same prior art and the same argument used by the examiner or may the same prior art only be used if it is shown that there is a new question based on some other teaching or aspect of that prior art? 6

In Denmark the answer to the question is: Yes. During a Danish court case on the merits, the court may perform a full review of the validity of the patent, including the facts and legal arguments that have already been assessed by the Danish or European Patent Office. The fact that the burden of proof lies with the party claiming invalidity implies, however, that the original administrative assessment carries some presumption for being correct. Proposals for harmonization The Groups are invited to put forward proposals for the adoption of harmonized rules in relation to the use of prosecution history in post-grant proceedings. More specifically, the Groups are invited to answer the following questions without regard to their national laws: 1) Is harmonization of the applicability of prosecution history in post-grant proceedings desirable? The Danish Group is of the opinion that it would be desirable, if a harmonization could be reached. This would create an improved legal certainty for patent proprietors and third parties and reduce the risk of different national courts reaching different decisions with regard to validity and infringement of patents having essentially the same claims and faced with essentially the same prior art and essentially the same arguably infringing object. 2) Is it possible to find a standard for the use of prosecution history that would be universally acceptable? Yes, the Danish Group is of the opinion that based on the principles agreed to in earlier resolutions Q142 and Q175 and in view of the practice of the EPO with regard to the very limited allowable discussions of the pertinent prior art by amendment of the patent description it should be possible to agree on some general principles as a minimum standard. This might possibly be coupled with a recommendation that the national courts should adopt the principle of free evaluation of evidence allowing the parties to argue on the basis of the prosecution history but decide each individual case on its facts rather than in a doctrinarian manner.. 3) Please propose a standard you would consider to be broadly acceptable for a) the types of prosecution history that should be considered, if any; and b) the type of proceeding and circumstances in which it should be considered. By way of introduction, the Danish Group is of the opinion that it should always be the claims that form the starting point for the evaluation of the validity and infringement of a patent. The claims should be clear and concise and supported by the description and if necessary - their wording should be interpreted by a skilled person who might seek guidance from the description and drawings. The Danish Group is also of the opinion that it should be possible to generally agree that as a matter of principle or public policy - it is not fair that an applicant during examination should be allowed to argue a narrow interpretation of an element in a claim to overcome the prior art and secure allowance of the patent and then later argue a broad interpretation of the same element in support of a charge of infringement. While indeed some examiners might insist that the narrow interpretation should be reflected in the claims and/or in the specification, the examination standards differ between countries and even between examiners in the same country. Especially the 7

permissible discussion of the prior art by amendment of the description varies considerably between countries. There is also a trend that for reasons of economy, examination backlog etc,- the natural requirement for a strict conformity between the allowable claims and the description is observed less meticulously than before.since the claims are the basis for any evaluation possible discrepancies relied on by any of the parties will have to be sorted out, the most straightforward way being by an inspection and evaluation of the prosecution history. Nowadays, in the opinion of the Danish group, a patent document can only seldom be read in isolation. With the commendable on-line access offered by many patent authorities the inspection of the prosecution history is much easier for a third party than some years ago. The patent authorities should be encouraged to increase the on-line access to the prosecution histories. European patents specifically mention on their front page if there is important technical information in the file. A similar procedure should be adopted by other patent authorities. Most countries list the prior art cited etc. It would seem improper if this kind of information could not be used in later court proceedings. The Danish Group does not support any of the prevailing extremes, viz that there is a rebuttable presumption that anything the applicant has told the patent office can be held against him vs that unless something from the prosecution history is explicitly reflected in the granted patent, it is irrelevant. However, the Danish group finds that there are indeed situations where elements from the prosecution history can be of importance when seeking to find the right balance between a fair protection for the patentee and a reasonable legal certainty for third parties, i.e predictability. The Danish group proposes that the following principles are adopted in the AIPPI resolution: a) The parties to a patent litigation should be allowed to rely on elements from the prosecution history which however should be evaluated by the court on their merits as any other facts of the case. The courts should apply the principle of free evaluation of evidence. b) It should be decisive how a third party has had reason to understand a given argument or a given amendment of a claim. c) If the argument or amendment is such that a third party is left with the impression that it has been made to exclude certain variations from the scope of the patent, the third party should generally be able to assume that such variations can be exploited freely. d) If, on the other hand, the argument or amendment is just a result of the applicant's general efforts to obtain a precise, appropriate or formally correct definition of the invention, a third party does not have the same reason to assume that the variations that fall outside the amended patent claim may be exploited freely. Summary In Denmark the prosecution history may be considered in court proceedings relating to infringement and invalidity of a patent as a part of the overall evidence of the case under the principle of free evaluation of evidence applied by the Danish Courts This finds support in the preparatory works from 1964 by a joint Nordic governmental Committee. 8

The committee found that if an applicant during prosecution had interpreted expressions used in the claims restrictively, it was reasonable that such restrictive interpretation should also be taken into account in later proceedings. This public policy consideration has since been applied fairly consistently by the Danish High courts and has resulted in a restrictive interpretation of certain elements of a claim, in particular if the claim had been amended in order to distinguish over the prior art. The Danish Group is of the opinion that it should be decisive how a third party would interpret a given statement and/or amendment by the applicant in its proper context. The Danish Group is in favor of a harmonization along these lines. Zusammenfassung In Dänemark können die Erteilungsakten in Gerichtsverfahren bezüglich Verletzung und Ungültigkeit eines Patents als Teil der gesamten Beweisführung in der Sache unter dem von den dänischen Gerichten verwendeten Grundsatz der freien Beweiswürdigung in Erwägung gezogen werden. Dies findet in der Vorbereitungsarbeit von 1964 durch einen gemeinsamen nordischen Staatsausschuss Unterstützung. Der Ausschuss war der Auffassung, dass sofern ein Anmelder während der gerichtlichen Verfolgung die in den Ansprüchen verwendeten Ausdrücke einschränkend interpretiert hätte, wäre es angemessen, eine solche einschränkende Interpretation auch in nachfolgenden Gerichtsverfahren in Betracht zu ziehen. Diese Berücksichtigung des ordre public wird seitdem ziemlich konsistent von den dänischen Landgerichten verwendet und hat eine einschränkende Interpretation von gewissen Teilen eines Anspruchs zur Folge gehabt. Besonders wenn der Anspruch geändert worden ist, um vom Stand der Technik unterscheiden zu können. Die dänische Gruppe ist der Ansicht, dass es maßgebend sein sollte, wie ein Dritter eine gegebene Erklärung und/oder Änderung durch den Anmelder im richtigen Zusammenhang interpretieren würde. Die dänische Gruppe ist für eine Harmonisierung in diesem Sinne. Résumé Au Danemark, l histoire de la poursuite judicaire peut être considérée dans les procédures des tribunaux portant sur la contrefaçon et la nullité d un brevet comme faisant partie de l ensemble des pièces justificatives de l affaire selon le principe de «la libre appréciation des preuves» appliqué par les cours d appel danoises. A l appui de ce principe viennent les travaux préparatoires de 1964 faits par un Comité gouvernemental et mixte des pays nordiques. Le Comité estimait que dans le cas où un demandeur lors de la poursuite aurait interprété de manière restrictive des termes utilisés dans les revendications, on pouvait raisonnablement présumer qu une telle interprétation restrictive devait également être prise en compte dans les procédures suivantes. Dès lors, cette considération de «l ordre public» a été appliquée d une manière assez consistante par les cours d appel danoises et a abouti à une interprétation restrictive de certains éléments d une revendication, en particulier si la revendication a été modifiée afin de la distinguer de l état de la technique antérieure. Selon l avis du Groupe danois, la façon d interprétation par un tiers d une déclaration et/ou d une modification faite par le demandeur dans son propre contexte devrait être décisive. Le Groupe danois est en faveur d une harmonisation selon ces lignes. 9