YEARBOOK YEARBOOK ANNUAIRE JAHRBUCH ANNUAIRE JAHRBUCH ANNUAIRE YEARBOOK 2016 / IV

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1 YEARBOOK 2016 / IV ANNUAIRE YEARBOOK JAHRBUCH 2015 AIPPI WORLD CONGRESS RIO DE JANEIRO OCTOBER 10, OCTOBER 14, 2015 ADDED MATTER: THE STANDARD FOR DETERMINING ADEQUATE SUPPORT FOR AMENDMENTS ASSOCIATION INTERNATIONALE POUR LA PROTECTION DE LA PROPRIETE INTELLECTUELLE INTERNATIONAL ASSOCIATION FOR THE PROTECTION OF INTELLECTUAL PROPERTY INTERNATIONALE VEREINIGUNG FÜR DEN SCHUTZ DES GEISTIGEN EIGENTUMS ANNUAIRE WORKING GUIDELINES, GROUP REPORTS, SUMMARY REPORTS, RESOLUTIONS ANNUAIRE YEARBOOK JAHRBUCH

2 ASSOCIATION INTERNATIONALE POUR LA PROTECTION DE LA PROPRIETE INTELLECTUELLE INTERNATIONAL ASSOCIATION FOR THE PROTECTION OF INTELLECTUAL PROPERTY INTERNATIONALE VEREINIGUNG FÜR DEN SCHUTZ DES GEISTIGEN EIGENTUMS YEARBOOK 2016 / IV 2016 AIPPI WORLD CONGRESS MILAN SEPTEMBER 16, SEPTEMBER 20, 2016 ADDED MATTER: THE STANDARD FOR DETERMINING ADEQUATE SUPPORT FOR AMENDMENTS WORKING GUIDELINES, GROUP REPORTS, SUMMARY REPORTS, RESOLUTIONS 1

3 2016 AIPPI WORLD CONGRESS MILAN SEPTEMBER 16, SEPTEMBER 20, 2016 THE QUESTIONS ON THE AGENDA WORKING GUIDELINES GROUP REPORTS SUMMARY REPORTS RESOLUTIONS The reports and the summaries from the National and Regional Groups are normally reproduced without alteration in content, style and spelling. Dans le cas normal, les rapports et les résumés des Groupes nationaux et régionaux sont publiés sans corrections du contenu, du style et de l orthographie. Die Berichte und Zusammenfassungen der Landes- und Regionalgruppen werden im Normalfall ohne Korrekturen von Inhalt, Stil und Orthographie wiedergegeben. AIPPI General Secretariat AIPPI, Zurich 2017 Edited in the name of AIPPI by the AIPPI General Secretariat, Zurich (Switzerland) 2

4 Linking and making available on the Internet Création de liens et mise à disposition sur Internet Verlinkung und Zugänglichmachung im Internet La creación de enlaces y la puesta a disposición en Internet Requirements for protection of designs Conditions pour la protection des dessins et modèles Voraussetzungen für den Schutz von Designs Requisitos para la protección de los diseños Security Interests over Intellectual Property Sûretés sur les droits de propriété intellectuelle Sicherungsrechte an Rechten des Geistigen Eigentums Garantías reales sobre los derechos de la Propiedad Industrial e intelectual Added matter: the standard for determining adequate support for amendments Eléments ajoutés : les critères de détermination d un support suffisant des modifications Hinzugefügte Gegenstände: Der Beurteilungsmaßstab für hinreichende Stützung von Änderungen Materia añadida: los criterios para determinar el soporte adecuado de las modificaciones 3

5 Study Guidelines by Sarah MATHESON, Reporter General John OSHA and Anne Marie VERSCHUUR, Deputy Reporters General Ari LAAKKONEN, Yusuke INUI and Ralph NACK Assistants to the Reporter General 2016 Study Question (Patents) Added matter: the standard for determining adequate support for amendments Introduction 1) This Study Question concerns the role and effects of impermissible added matter in relation to amendments to patents. 2) The term patent as used in these Study Guidelines refers to a granted patent or an application for a patent, or both, as the context requires. Where it is necessary to distinguish between the two, these Study Guidelines refer to granted patents and patent applications. 3) The term impermissible added matter as used in these Study Guidelines refers to a proposed amendment to a patent that is impermissible because it lacks support (often referred to as basis ) in the application as filed. This includes added matter as referred to in Article 123(2) of the European Patent Convention. 4) The term amendment as used in these Study Guidelines refers to any amendment of, deletion from or addition to a patent specification, including to the description, figures or claims. 5) The primary objective of this Study Question is to define impermissible added matter. It is concerned with examining the support (or basis) for making amendments having regard to the patent application as filed. This Study Question is not concerned as such with: a) extensions of the scope of protection caused by an amendment where the amendment does not otherwise comprise impermissible added matter, e.g. where a claim is added for a combination A+B taught in the specification, making the patent broader that an old claim A+B+C; or b) insufficiency where there is no impermissible added matter, e.g. adding a claim for an embodiment disclosed in the application as filed, but without full instructions being provided in the specification for putting that embodiment into full effect. 6) In addition, a number of other questions arise, described below. Previous work of AIPPI 7) AIPPI has previously considered added matter in the following contexts. a) The Resolution on Q69 Sufficient description of the invention (Munich, 1978) addressed added matter but was mainly focussed on the issue of sufficiency. AIPPI resolved that: 4

6 i. The description shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art; and ii. Article II, paragraph 4: In addition to the correction of purely immaterial faults, the description of the invention may be amended in the course of the grant procedure, under the control of the examiner, and on the essential condition that this modification adds no new inventive matter to the description. b) The Resolution on Q189 Amendment of patent claims after grant (Gothenburg, 2006) addressed requirements for amending patents after grant, especially from the point of view of the scope of protection of the patent. AIPPI resolved that: 2) Patent claim amendment after grant must not extend the scope of protection of the claims as granted; 3) Patent claim amendment after grant must always have support in the original specification, drawings or claims, and in particular there should be no possibility of adding new subject matter; (emphasis added)... 5) It should be possible to amend patent claims after grant by introducing any subject matter from the specification, claims or drawings into the claims, provided this does not extend the original scope of protection of the claims as granted; Paragraph 3 of Resolution Q189 is highly relevant in the context of this Study Question, and makes it clear that new subject matter should not be added when amending the claims of a granted patent. However, Resolution Q189 does not address the amendment of patent applications. c) The Resolution on Q193 Divisional, Continuation and Continuation in Part Patent Applications (Singapore, 2007) addressed rules for basing divisional applications on matter disclosed or not disclosed in the parent application. AIPPI resolved that: 4) In a divisional application, it should be possible to claim subject matter that was unclaimed, but was disclosed in the parent application. 5) If matter not disclosed in the parent application as filed is included in a divisional application, the divisional application should not be invalid provided that the added matter is deleted prior to grant. (emphasis added) Paragraph 5 of the Resolution on Q193 assumes that the test for impermissible added matter is whether that matter is not disclosed in the relevant application as filed, and also explains that an appropriate corrective action is to delete that impermissible added matter prior to grant. d) The Resolution on Q209 Selection inventions (Buenos Aires, 2009) resolved in paragraph 13 that the impact of late submission of data (i.e. after filing the application) be studied further. 8) It is clear from the Resolution on Q189 that AIPPI has resolved that patent claim amendment after grant should always have support in the original specification, drawings or claims, and in particular there should be no possibility of adding new subject matter. 9) However, AIPPI has not yet squarely addressed the definition of impermissible added matter, the impact of impermissible added matter on amendments to both granted patents and patent applications, the extent to which the analysis depends on the construction of the patent by the skilled person, and relevant date(s) for the construction of the application as filed. It is not the intention of this Study Question to disturb prior Resolutions, but to simply refine the definition 5

7 of impermissible added matter, and to explore methods of remedying impermissible added matter problems. Discussion Impermissible added matter and scope of this Study Question 10) The Agreement on Trade-related aspects of Intellectual Property Rights (TRIPs) does not mandate a support requirement as part of the basic substantive rules relating to patents. However, TRIPs does mandate some disclosure requirements: Article 29 Conditions on Patent Applicants 1. Members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is claimed, at the priority date of the application. 11) If a claim, sought to be introduced by way of amendment, has no basis in the description then it is obviously not described sufficiently clearly and completely. 12) In the United States, 35 USC 132 stipulates: No amendment shall introduce new matter into the disclosure of the invention. 13) In Europe, Article 123(2) of the European Patent Convention (EPC) requires: The European patent application or European patent may not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filed. 14) Article 123(2) has been interpreted in the case law of the EPO s Technical Boards of Appeal such that amendments are permitted within the limits of what the skilled person would derive directly and unambiguously, using common general knowledge from the application as filed (the so called gold standard ; G 2/10; G 3/89; G 11/91 and T 248/12). This is also reflected in the EPO s Guidelines for Examination H, IV ) Moreover, the general principle from the Guidelines following case G 1/93 is: The underlying idea of Art. 123(2) EPC is that an applicant is not allowed to improve his position by adding subject-matter not disclosed in the application as filed, which would give him an unwarranted advantage and could be damaging to the legal security of third parties relying on the content of the original application (see G 1/93). An amendment should be regarded as introducing subject-matter which extends beyond the content of the application as filed, and therefore unallowable, if the overall change in the content of the application (whether by way of addition, alteration or excision) results in the skilled person being presented with information which is not directly and unambiguously derivable from that previously presented by the application, even when account is taken of matter which is implicit to a person skilled in the art. (Guidelines H-IV, 2). 16) Further, in the situation where features are removed from a disclosed embodiment so as to produce a generalisation of originally disclosed subject matter, EPO case law has established that the following questions should be posed in order to determine whether such a generalisation is allowable: 6

8 (1) are the features explained as essential in the disclosure; (2) are the features, as such, indispensable for the function of the invention in the light of the technical problem the invention serves to solve; and (3) does the removal require any real modification of other features to compensate for the change? 17) From a practical perspective, the nature of patent prosecution and judicial processes has tended to influence the manner and way in which added matter is assessed. Whilst courts in some countries have access to expert evidence which assists the court in understanding what the skilled person would have gleaned from the application as filed, in other countries the court may not have access to such evidence and might instead itself need to construe the application as filed or under the guidance of technical judges. 18) Similarly, patent offices will typically not have access to expert evidence to guide them on the meaning of the application as filed. 19) The EPO s direct and unambiguous requirement has, in particular, become a vexed issue in that it hints at a more literal approach than that set out in Article 123(2) of the EPC, and the principles established in G 1/93. Recently, some decisions of the Board of Appeal have taken a softer line and, moreover, a 2014 revision to the Guidelines for Examination introduced some wording which appeared to soften the strict assessment: When assessing the conformity of the amended claims to the requirements of Art. 123(2), the focus should be placed on what is really disclosed to the skilled person by the documents as filed as directed to a technical audience. In particular, the examiner should avoid disproportionally focusing on the structure of the claims as filed to the detriment of the subject-matter that the skilled person would directly and unambiguously derive from the application as a whole. (Guidelines H-IV, 2.2) This still leaves open the question of what is directly and unambiguously derivable from the application as filed by the skilled person. On an analytical level, this question is about what the patent application as a whole teaches the skilled person. Of course, the scope of a granted patent (and in some situations and in some countries, the scope of a patent application) is highly relevant to issues such as infringement, novelty and obviousness. 20) These issues are further complicated by the nature of the analysis in determining scope and teaching. In some countries, construing the scope of the patent claims is a matter of law and therefore not directly determined with the assistance of expert evidence, while the teaching of the patent application as filed is guided much more by expert evidence. In other countries, there is no difference between the nature of the analysis when determining scope and teaching. 21) If the teaching is narrower than the claim scope, then the patent can be bad for insufficiency if it does not enable the invention to be practised to its full claimed scope. As noted above, this Study Question does not directly address sufficiency, but simply the permissibility of a later increase in the teaching of the patent, potentially with a commensurate broadening in scope, if that increase in teaching was by way of an amendment to a claim. 22) However, if the scope of the patent has been broadened by amendment, e.g. by deletion of a limitation in the claim, thereby broadening the claim, but there is no increment in the teaching, that broadening is not due to impermissible added matter. This Study Question is not directed specifically to extensions of scope if such extension is not due to impermissible added matter. 7

9 23) If the scope of the patent has been narrowed by amendment, e.g. by adding claim integers, the additional information taught by those claim integers may be impermissible added matter. 24) The teaching of the patent application as filed might be said to be: a) the literal disclosure of the patent application as filed; b) the literal disclosure of the patent application as filed, supplemented with all matter that can be directly and unambiguously derived from the patent application as filed; c) the patent application as filed, unchanged, read with the common general knowledge of the skilled person; d) the application as filed incorporating all uninventive routine workshop variations (or nonmaterial changes) of the application as filed; e) the application as filed and anything which was obvious to the skilled person from the application as filed; or f) something else. 25) Another way of looking at this question is to ask what the skilled person would do, when the application as filed is placed in front of them and they are asked to implement the invention in accordance with it. When the skilled person has an objective in mind and is implementing the invention, what might or could be obvious to the skilled person from the application as filed may be less relevant if it is not directly related to the objective in mind. 26) A highly relevant consideration is what approach would promote greater certainty for both patentees and third parties, especially as many patent portfolios have an international dimension with families of patents in more than one country or region. That question is the primary issue addressed in this Study Question. 27) Further issues that arise are: a) what, if any role does the skilled person play in analysing impermissible added matter? b) what should be the relevant date of knowledge for the notional skilled person in evaluating the permissibility of an amendment? c) should the definition of impermissible added matter depend on when an amendment is made (for example, before versus after grant)? d) should the definition of impermissible added matter prohibit the addition of claims per se (as opposed to adding or removing limitations to claims)? e) should the definition of impermissible added matter be the same when applied by a patent office as when applied by a court? f) how can impermissible added matter be remedied? Questions I. Current law and practice You are invited to submit a Report addressing the questions below. Please refer to the Protocol for the preparation of Reports. You are reminded that a reference to patent in the following questions refers to both a granted patent and an application for a patent. 8

10 If your answer differs depending on the distinction between a granted patent and an application for a patent, please answer the questions for each, as applicable. 1) Under your Group s current law, are amendments to the description and/or figures of a patent possible? 2) Under your Group s current law, are amendments to the claims of a patent possible? 3) Further to your answers to questions 1) and 2), please indicate: a) the standard for determining whether such amendments are permissible and indicate whether this standard exists in statutes, regulations, patent office guidelines, and/or in case law. b) whether there are the differences between the substantive standards for amendments under 1) and 2) above. If so, what? 4) To the extent your answer to question 3) depends on timing (e.g. after filing but before examination, after allowance but before grant, and after grant), please explain how the standard changes and during which time periods. 5) Further to your answer to question 3), if impermissible added matter is a ground for refusing an amendment, please explain how impermissible added matter is defined. 6) In any assessment of impermissible added matter under your Group s current law, please explain: a) how the patent application as filed is interpreted; b) if interpreted as the notional skilled person would understand the patent application as filed, what is the relevant date of knowledge of the notional skilled person? 7) If an amendment that was made to a patent application prior to grant is later reviewed by your patent office or a court in a post-grant proceeding and determined to contain impermissible added matter, is there a mechanism for the patentee to remedy the defect, for example by removing portions of the amendment found to be impermissible? II. Policy considerations and possible improvements to your current law 8) How does your Group s current law strike a balance between allowing a patent applicant to make appropriate amendments during the examination process and preventing the applicant from adding impermissible matter? 9) Are there aspects of these laws that could be improved? 10) Does your Group s current law allow amendments post grant? If so, how does your Group s current law strike a balance between allowing a patentee to make appropriate amendments to a granted patent (such as amendments necessary to sustain its validity) and preventing the patentee adding impermissible matter? 11) Are there aspects of these laws that could be improved? 12) If your Group s current law uses, at least in part, the notional person skilled in the art to determine the permissibility of amendments, is this approach effective? Are there aspects of this that could be improved? 9

11 III. Proposals for harmonisation 13) Is harmonisation of the definition of impermissible added matter desirable? If, please respond to the following questions without regard to your Group s current law. Even if no, please address the following questions to the extent your Group considers your Group s laws could be improved. 14) If, please propose a definition of impermissible added matter that you believe is appropriate. 15) Should this definition depend on when an amendment is made (for example, after filing but before examination, after allowance but before grant, and after grant)? If, please explain. 16) Should rules against impermissible added matter prohibit the addition of claims per se, as opposed to adding limitations to claims? 17) Should rules against impermissible added matter prohibit the removal of claims per se, as opposed to removing limitations from claims? 18) Should the definition of impermissible added matter be the same when applied by a patent office as when applied by a court? 19) If your proposed definition refers to the notional skilled person, what should be the relevant date of knowledge for the notional skilled person in evaluating the permissibility of an amendment? 20) If the deletion of impermissible added matter by amendment would result in an impermissible extension of scope, how should the impermissible added matter defect be remedied in these circumstances? 21) Please comment on any additional issues concerning any aspect of impermissible added matter you consider relevant to this Study Question. 10

12 Argentina Report 2016 Study Question (Patents) in the name of the Argentina Group by Alicia ÁLVAREZ, Eduardo MCCALLUM, Gastón RICHELET and Ignacio SÁNCHEZ ECHAGÜE Questions Added matter: the standard for determining adequate support for amendments The Groups are invited to answer the following questions under their national laws. I.) Current law and practice You are reminded that a reference to patent in the following questions refers to both a granted patent and an application for a patent. If your answer differs depending on the distinction between a granted patent and an application for a patent, please answer the questions for each, as applicable. 1) Under your Group's current law, are amendments to the description and/or figures of a patent possible? Yes. 2) Under your Group's current law, are amendments to the claims of a patent possible? Yes. 3) Further to your answers to questions 1) and 2), please indicate: a) the standard for determining whether such amendments are permissible and indicate whether this standard exists in statutes, regulations, patent office guidelines, and/or in case law. Section 19 of the Regulating Decree No. 260/96 (to the Argentine Patent Law No. 24,481) states: As from the date of filing of the patent application and for NINETY (90) days afterwards, applicant may add supplements, corrections, and amendments, provided that they do not imply an extension of the object thereof. After said term, only the elimination of deficiencies found by the examiner shall be authorized. The new embodiments that might be added shall be complementary for a better understanding of the invention. No right can derive from supplements, corrections or amendments which imply an extension of the original application. In practice, the Argentine PTO accepts amendments to the claims at any time during prosecution. It should also be borne in mind that a decision in re Pfizer (2012) allowed amendments, during prosecution, to the claims and specification as long as they are obvious to the subject matter originally disclosed. b) whether there are the differences between the substantive standards for amendments under 1) and 2) above. If so, what? Yes. The provisions for amending the description and drawings are more restrictive than those related to claims. 11

13 4) To the extent your answer to question 3) depends on timing (e.g. after filing but before examination, after allowance but before grant, and after grant), please explain how the standard changes and during which time periods. N/A 5) Further to your answer to question 3), if impermissible added matter is a ground for re- fusing an amendment, please explain how impermissible added matter is defined. According to section 19 of Regulatory Decree No. 260/96, impermissible added matter is that which extends the scope of the subject matter. 6) In any assessment of impermissible added matter under your Group's current law, please explain: a) how the patent application as filed is interpreted; By persons of ordinary skill in the art and available common knowledge. b) if interpreted as the notional skilled person would understand the patent application as filed, what is the relevant date of knowledge of the notional skilled person? Date of filing the application or, if pertinent, the priority date. 7) If an amendment that was made to a patent application prior to grant is later reviewed by your patent office or a court in a post-grant proceeding and determined to contain impermissible added matter, is there a mechanism for the patentee to remedy the de- fect, for example by removing portions of the amendment found to be impermissible? no There are no provisions on this respect. It should also be borne in mind that there is no postgrant procedure in Argentina. Thus, should an amendment were found to be illegal, then the claim or the patent would be revoked. II.) 8) Policy considerations and possible improvements to your current law How does your Group's current law strike a balance between allowing a patent applicant to make appropriate amendments during the examination process and preventing the applicant from adding impermissible matter? An amendment is deemed appropriate if the overall disclosure as changed is derivable from the application as filed (including matter in priority documents) by persons of ordinary skill in the art. 9) Are there aspects of these laws that could be improved? Yes, we consider that it would be advisable to expressly state that amendments to both the specification and claims are permissible as long as they do not include new non-obvious matter. 12

14 10) Does your Group s current law allow amendments post grant? If so, how does your Group's current law strike a balance between allowing a patentee to make appropriate amendments to a granted patent (such as amendments necessary to sustain its validity) and preventing the patentee adding impermissible matter? No. 11) Are there aspects of these laws that could be improved? Yes, we consider that it would be advisable to expressly state that amendments to the specification and claims are permissible as long as they do not include new non-obvious matter. 12) If your Group's current law uses, at least in part, the notional person skilled in the art to determine the permissibility of amendments, is this approach effective? Are there as- pects of this that could be improved? We know of no substantial problems heretofore with this approach. III.) 13) Proposals for harmonisation Is harmonisation of the definition of impermissible added matter desirable? If, please respond to the following questions without regard to your Group s current law. Even if no, please address the following questions to the extent your Group considers your Group s laws could be improved. 14) If, please propose a definition of impermissible added matter that you believe is ap- propriate. Subject-matter non-obvious from the original specification or claims. 15) Should this definition depend on when an amendment is made (for example, after filing but before examination, after allowance but before grant, and after grant)? no 16) Should rules against impermissible added matter prohibit the addition of claims per se, as opposed to adding limitations to claims? No. 17) Should rules against impermissible added matter prohibit the removal of claims per se, as opposed to removing limitations from claims? no 18) Should the definition of impermissible added matter be the same when applied by a patent office as when applied by a court? 13

15 19) If your proposed definition refers to the notional skilled person, what should be the rele- vant date of knowledge for the notional skilled person in evaluating the permissibility of an amendment? Date of filing the application or, if pertinent, the priority date. 20) If the deletion of impermissible added matter by amendment would result in an imper- missible extension of scope, how should the impermissible added matter defect be remedied in these circumstances? The examiner should reject the amendment via an official action. Applicant may comply deleting or else amending the added matter to comply with the examiner s grounds, or may traverse the latter, for the examiner to reconsider. 21) Please comment on any additional issues concerning any aspect of impermissible added matter you consider relevant to this Study Question. Please indicate which industry sector views are included in part III. Proposals for harmoniza- tion of this form: Summary No discrimination of any industry sector. 14

16 Questions Australia Report 2016 Study Question (Patents) in the name of the Australia Group by Clare CUNLIFFE Added matter: the standard for determining adequate support for amendments The Groups are invited to answer the following questions under their national laws. I.) Current law and practice You are reminded that a reference to patent in the following questions refers to both a granted patent and an application for a patent. If your answer differs depending on the distinction between a granted patent and an application for a patent, please answer the questions for each, as applicable. 1) Under your Group's current law, are amendments to the description and/or figures of a patent possible? Yes. A patent specification and figures can be amended in the Patent Office if no litigation is on foot, under s 104 of the Patents Act 1990 (Cth) (Patents Act) or in the Court if litigation is on foot, under s 105 of the Patents Act (It should be noted that it is desirable to amend under s 104 where possible, since the court has a discretion as to whether to allow amendments under s 105, even if those amendments are otherwise permissible under the Patents Act, as set out further below). However, some amendments will not be allowable (s 102 of the Patents Act). The limitations on amendment will depend on the legislative regime applicable to the patent: For complete patent applications filed before 15 April 2013 for which examination had been requested before 15 April 2013, and for innovation patents granted before 15 April 2013 for which examination had been requested before 15 April 2013 (Pre Raising the Bar Patents): amendments are not allowable if the amended specification would claim matter not in substance disclosed in the specification as filed. amendments which convert divisional applications for innovation patents (similar to utility patents) into standard patents are not allowable; and amendments which seek to remove lawful grounds of objection to the validity of the patent in circumstances where the patentee had not furnished prior art searches for corresponding applications to the Patent Office are not allowable. Further, amendments after: the acceptance of a standard patent or the examination of an innovation patent are not allowable if a claim of the amended specification would not in substance fall within the scope of the unamended claims; or the specification would not comply with the old fair basis and sufficiency requirements (it should be noted that these requirements have been replaced in the Post Raising thr Bar Regime by support and enablement requirements, which are intended to be more onerous, although they have not yet been tested). Section 102 does not prevent amendments for the purpose of correcting a clerical error or obvious mistake. (It should be noted that many Australian patents are still under the Pre Raising the Bar Regime) 15

17 For complete standard patent applications filed on or after 15 April 2013, standard patent applications for which examination had not been requested before 15 April 2013, innovation patents granted after 15 April 2013 or innovation patents for which examination had not been requested for before 15 April 2013 (Post Raising the Bar Patents), a different regime applies.for these patents: amendments are not allowable if the amendment would result in the specification claiming or disclosing matter which extends beyond that disclosed in the complete specification as filed and other prescribed documents (Prescribed documents is defined to include an abstract that was filed with the complete specification; a missing part or element of a complete specification that was incorporated into the specification, in accordance with the regulations or the PCT; or an amendment that has been made to the complete specification after filing, for the purpose of correcting a clerical error or obvious mistake or complying with the deposit requirements applicable to micro-organisms). Amendments which convert divisional applications for innovation patents into standard patents are not allowable; and Amendments after acceptance of a standard patent or the examination of an innovation patent are not allowable if a claim of the amended specification would not in substance fall within the scope of the claims of the specification before amendment; or the specification would not comply with the new enablement and support requirements (the new enablement and support requirements are intended to be consistent with the standards applied in European jurisprudence, although the requirements have not yet been tested by Australian courts). The regulations place some further restrictions on amendments which: would convert standard patent applications into innovation patent applications and vice versa or would convert an accepted complete application into a divisional patent, or would convert an application into a divisional application after the time for filing a divisional, or would amend a patent request after grant, or would mean that the micro-organism deposit requirements are not met, or are made before an opponent can be heard, or would amend an innovation patent before grant, or would result in an innovation patent claiming excluded subject matter, or are made by the Patent Office while proceedings are on foot in relation to the Patent (including appeals from oppositions). Section 102 does not prevent amendments for the purpose of correcting a clerical error or obvious mistake. For the sake of brevity, the remainder of this response only deals with Post Raising the Bar patents, unless it is necessary to refer to the Pre Raising the Bar regime to explain the changes to the law. Any questions about the operation of the pre-raising the Bar regime, which worked quite differently, should be directed to the author. 2) Under your Group's current law, are amendments to the claims of a patent possible? Yes, subject to the limits set out above. Most relevantly for Post Raising the Bar Patents, amendments are not allowable if: the amended specification would claim or disclose matter that extends beyond that disclosed in the complete specification as filed and prescribed documents, or for standard patents which have been accepted or innovation patents which have been examined, a claim of the amended specification would not in substance fall within the scope of the unamended claims, or the amended specification would not comply with the new enablement and support requirements. The Court will also have a discretion as to whether to allow amendments if amendments are made during the course of litigation under s

18 3) Further to your answers to questions 1) and 2), please indicate: a) the standard for determining whether such amendments are permissible and indicate whether this standard exists in statutes, regulations, patent office guidelines, and/or in case law. Prior to 15 April 2013, the position was that an invention need only be fully described (disclosed) at the date of grant. This was the result of a decision of the Full Federal Court, in Pfizer Overseas Pharmaceuticals v Eli Lilly and Company [2005] FCAFC 224, that a filed specification could disclose a claimed invention in substance without necessarily satisfying the requirements under s 40 for the invention to be described fully, including the best method known to the applicant, at the time of filing, for performing the invention. This meant that it was possible for a patentee to file an inadequate description that could be subsequently remedied by amendment in order to meet the full description requirements before the date of grant. The legislature considered that this was problematic because: it meant that a patentee could gain protection for the period before it had adequately met its obligation to provide the public with a complete disclosure of the invention; and it created uncertainty for the public and competitors in the period between publication of the patent specification and grant, because the public and competitors may not be able to determine their freedom to operate. Accordingly, although the new sections have not yet been tested, the intention of the amendments is that an applicant will not be able to amend a Post Raising the Bar patent to remedy inadequate disclosure, so that a patent cannot be amended to disclose new matter. Amendments which affect claim scope Amendments will have the effect that a claim of the amended specification would not in substance fall within the scope of the unamended claims if a proposed new claim would extend the patent monopoly in the sense that it would make something an infringement which was not an infringement already: AMP Incorporated v Commissioner of Patents (1974) AOJP at page 322 (High Court). Such amendments are not allowed after acceptance/examination. This test is applicable to both Pre Raising the Bar Patents and Post Raising the Bar Patents. b) whether there are the differences between the substantive standards for amendments under 1) and 2) above. If so, what? There are no differences between the substantive standards for amendment to a specification and amendments to claims, although particular considerations apply to amendments which affect claim scope after acceptance (in the case of standard patents) or examination (in the case of innovation patents). Amendments which affect claim scope so that matter which was not previously claimed is claimed are prohibited. It should be noted that these considerations apply whether the amendment which affects claim scope is to the specification (for example, by changing the definitions of terms subsequently used in the claims which change the claim scope, or by adding or removing limitations to the description) or to the claims. 4) To the extent your answer to question 3) depends on timing (e.g. after filing but before examination, after allowance but before grant, and after grant), please explain how the standard changes and during which time periods. As set out above, after acceptance of a standard patent or examination of an innovation patent it is not possible to amend the patent in a way which would make something an infringement which was not an infringement already. 17

19 5) Further to your answer to question 3), if impermissible added matter is a ground for re- fusing an amendment, please explain how impermissible added matter is defined. For Post Raising the Bar Patents, impermissible added matter is matter which means that the specification claims or discloses matter that extends beyond that disclosed in the complete specification as filed (and prescribed documents), or (after acceptance/examination), matter which means that a claim of the amended specification would not in substance fall within the scope of the unamended claims, or the amended specification would not comply with the new enablement and support requirements. The case law provides that in identifying added matter, the Patent Office or the Court should engage in a two stage process: 1. identifying the precise nature of the proposed amendment - what is it that is changed?this requires a comparison between the specification before amendment and after amendment, and enables the identification of what matter results from the amendment. 2. Determining whether that matter is disclosed by the specification as filed (See RGC Mineral Sands Limited v Wimmera Industrial Minerals Pty Ltd (1998) 89 FCR 458). As noted above, it may be the case that the scope of the claims is affected by a change to the specification. 6) In any assessment of impermissible added matter under your Group's current law, please explain: a) how the patent application as filed is interpreted; In order to ascertain the invention described and claimed, it is necessary to refer to the specification as a whole: Welch Perrin & Co Pty Ltd v Worrel [1961] HCA 91; (1961) 106 CLR 588 at p 610 per Dixon CJ, Kitto and Windeyer JJ. The complete specification, which includes both the body and the claims (see Kimberley-Clark Australia Pty Limited v Arico Trading International Pty Limited and Others [2001] HCA 8; (2001) 207 CLR 1 at [14], per Gleeson CJ, McHugh, Gummow, Hayne and Callinan JJ), must be construed in the light of the common knowledge in the art before the priority date and must not be read in the abstract. The Court must place itself in the position of some person acquainted with the surrounding circumstances as to the state of the art and manufacture at the relevant time (being the priority date): Kimberley-Clark Australia Pty Limited v Arico Trading International Pty Limited and Others at [24], per Gleeson CJ, McHugh, Gummow, Hayne and Callinan JJ. Because the patent instrument is not a document operating inter partes, but rather a public instrument, it must define the monopoly in such a way that it is not reasonably capable of being misunderstood. Even though the specification must be read as a whole, it is necessarily made up of parts which have different functions. It is not legitimate to narrow or expand the boundaries of the monopoly, as defined by the claims, by adding to the language of the claims, glosses drawn from other parts of the specification. Further, if the language of a claim is clear, it is not to be rendered obscure simply because obscurities can be found in particular sentences in parts of the specification: Welch Perrin v Worrel at p 610, Dixon CJ, Kitto and Windeyer JJ. A proper analysis of the specification may show that references to a particular embodiment are by way of illustration and explanation of the invention rather than a definition of it : Welch Perrin v Worrel at p 612, Dixon CJ, Kitto and Windeyer JJ. 18

20 The rational starting point is not to simply turn to the language of the claims and seek to attribute meaning to those words in the abstract. The body of the specification and the claims must be read together as a whole in an attempt to identify the invention and determine whether the meaning of the words used in the claim (that is, the construction of the claim in question) is truly plain and unambiguous. If, having examined the description of the invention in the body of the specification and the definition of the claims, an expression used in the claims is not clear, it is then permissible to return to the body of the specification to either define or clarify the meaning of words used in the claim (see Interlego A.G. v Toltoys Pty Ltd, p 479 per Barwick CJ and Mason J) without infringing the rule that clear and unambiguous words in the claim cannot be varied or qualified by reference to the body of the specification. See also, to the same effect, Kimberley-Clark Australia Pty Limited v Arico Trading International Pty Limited and Others at [15], per Gleeson CJ, McHugh, Gummow, Hayne and Callinan JJ. (Principles taken from Artcraft Urban Group Pty Ltd v Streetworx Pty Ltd [2016] FCAFC 29 at [72] to [79] per Greenwood J, Rares J generally concurring at [142]). Two specific observations should be made in relation to best method and sufficiency (now enablement): First, best method and sufficiency under the Pre Raising the Bar regime require the patentee to disclose the best method known to the patentee at the filing date of the patent (not the priority date): Pfizer Overseas Pharmaceuticals v Eli Lilly and Company [2005] FCAFC 224 (31 October 2005) at [375].This probably also applies to enablement and support under the Post Raising the Bar regime (although there is no case law on the issue yet). Second, recent case law suggests that a rigorous standard applies to the best method requirement, so that the requirement to disclose best method is not satisfied simply because there is sufficiency of description (or enablement, under the law applicable to Post Raising the Bar Patents).There is a residual requirement to identify the best method of performing the invention. See Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27. b) if interpreted as the notional skilled person would understand the patent application as filed, what is the relevant date of knowledge of the notional skilled person? Patents are to be construed in light of common general knowledge at the priority date. See Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8 at [24]. 7) If an amendment that was made to a patent application prior to grant is later reviewed by your patent office or a court in a post-grant proceeding and determined to contain impermissible added matter, is there a mechanism for the patentee to remedy the de- fect, for example by removing portions of the amendment found to be impermissible? If a patent has been amended in a way which is impermissible, the claim will lose its priority date: s 114 of the Patents Act. Although it is theoretically possible to amend at a later stage to remove the objectionable matter, where there is litigation on foot and an application is made under s 105 (whether for before Pre and Raising the Bar patents), the Court has a discretion as to whether to allow the amendment. In recent years this discretion has been exercised against the patentee where the Court forms the view that the patentee s conduct is disentitling (for example, because the patentee should have been aware that the claims were invalid at an earlier point). 19

21 There may also be a limitation on a patentee s right to recover damages where a complete specification is amended after becoming open to public inspection and where the court is not satisfied that the specification without the amendment was framed in good faith and with reasonable skill and knowledge (s 115 of the Patents Act 1990 (Cth). II.) 8) Policy considerations and possible improvements to your current law How does your Group's current law strike a balance between allowing a patent applicant to make appropriate amendments during the examination process and preventing the applicant from adding impermissible matter? As set out above, there are two regimes which are currently in place under Australian law. The previous regime (applicable to Pre Raising the Bar Patents) allowed the patentee to make amendments to add matter during the examination process and after grant, provided that the added matter does not have the effect of: claiming matter that was not disclosed in the application as filed; or claiming matter after acceptance/examination which was not previously claimed. This regime (which is still applicable to many Australian patents) took a liberal approach to amendment, on the basis that there is a strong public interest that inventive genius should be encouraged (Ethyl Corporation s Patent [1972] RPC 169). As set out above, the exercise of the Court s discretion under s 105 places some limitations on a patentee s power to amend where a court considers that a patentee had acted in an unreasonable way (such as delaying in making amendments). However, the legislature was concerned that the law was too liberal and allowed patentees to remedy inadequate disclosure at a later date. In light of that concern, the regime applicable to Post Raising the Bar Patents was introduced. Broadly speaking, this regime, which has not yet been tested by the Courts, does not allow patentees to add matter that would have the effect of disclosing matter that extends beyond that disclosed at filing. 9) Are there aspects of these laws that could be improved? no The view of the Australian legislature was that the Pre Raising the Bar regime needed to be improved to ensure that patentees could not supplement inadequate disclosure at a later stage. This is reflected in the (as yet untested) Post Raising the Bar regime. The Post Raising the Bar regime also replaced the requirements of sufficiency and fair basis with those of enablement and support, to make Australian law more consistent with European law. It should be noted that Australia has particular requirements in relation to the disclosure of best method. These requirements are not satisfied merely because the sufficiency requirements (under the old law) are met: see Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27. These requirements are onerous and somewhat subjective (they are assessed by reference to the particular invention claimed), and they apply even where a patentee does not know that alternative methods produce a worse result. Following the Raising the Bar amendments, which prohibit the introduction of matter not disclosed in the specification as filed, it will be impossible to amend a patent to address a failure to comply with best method, which may result in some unfairness to patentees who do not appreciate the nature of the Australian best method requirement. In light of the recent decisions on the best method requirement, the Intellectual Property Law section of the Law Council of Australia recently recommended that the requirement be abolished. 20