The relationship between insufficiency and clarity Clear or unclear?

The relationship between insufficiency and clarity Clear or unclear? Christof Keussen 24.10.2014 www.glawe.de 1 24.10.2014 Legal Sources in EP and DE Art. 83 EPC: The European patent application shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. Art. 84 EPC: The claims shall define the matter for which protection is sought. They shall be clear and concise and be supported by the description. Sec. 34(3) German Patent Act: An application shall contain: 3. one or more claims defining the subject for which protection is sought; www.glawe.de 2 1

The EP approach: Different types of insufficient disclosure Type 1: Impossibility of carrying out the invention (classical lack of sufficiency) Type 2: At least one way of carrying out the invention is disclosed, but no concept fit for generalization over the entire claim width (T409/90; T 435/91) A third type increasingly appeared over the last years: Type 3: Ambiguity of the patent claim 24.10.2014 www.glawe.de 3 Insufficiency due to ill-defined claim limits T 464/05 3.4 the skilled person is faced with a situation in which, at least for some samples, he is not be able to determine whether these samples are in accordance with the claimed invention or not. Therefore, the invention cannot be reproduced over the whole area claimed. 3.5 It must thus be concluded that the patent in suit does not disclose the invention in accordance with claim 1 of the auxiliary request in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art (Article 83 EPC). 24.10.2014 www.glawe.de 4 2

T 805/93 Insufficiency due to ill-defined claim limits 4. results in uncertainty as to the exact limits of the scope of Claim 1. Therefore, the viscosity cannot be considered to be clearly indicated and the matter for which protection is sought cannot be deemed defined, so that Claim 1 does not comply with Article 84 EPC. 5. For the same reason, the skilled person would be left in considerable doubt as to which compounds to select when choosing the reactive components in order to obtain the reaction product falling within the terms of the claimed adhesive. Therefore, the disclosure of the application in suit does not enable him to carry out the claimed subject-matter on a general basis, so that the requirements of Article 83 EPC are also not met. 24.10.2014 www.glawe.de 5 Inside or Outside the Claim Test The cited decisions led to the development of the Inside or Outside the Claim Test. Thereafter the skilled person has to be able to determine whether each conceivable embodiment is within or outside the scope of the claim. Otherwise there is not just lack of clarity but also lack of sufficient disclosure. Considerable risk for patent claims defining the invention using measurable quantities (parameters). Parameters in patent claims are often important in order to obtain an appropriate scope of protection. 24.10.2014 www.glawe.de 6 3

T 1405/05 No enablement in a gray zone Claim was directed to a range for a length of a fiber The term length of a fiber was not defined, an interpretation in two different ways was possible For one of these interpretations neither fibers nor their fabrication were disclosed Patent claims in the broadest reasonable interpretation did include a variant that could not be carried out Enabling disclosure under Art. 83 EPC denied 24.10.2014 www.glawe.de 7 Gray zone penetrates the entire scope of the claim T 541/09 Claimed MW (molecular weight) range: 220.000 300.000 Measurement inaccuracy of MW roughly 20% due to insufficiently disclosed measurement method Measurement inaccuracy of the lower limit approx. 44.000, upper limit approx. 60.000 Determination of MW not reliable in the entire scope of the claim Compliance with the claimed MW range is described as essential in order to solve the technical problem in the patent Result: No enabling disclosure 24.10.2014 www.glawe.de 8 4

Gray zone is overlapping with the state of the art T 1404/08 The definition of a claim limit is unclear, which leads to a problem under Art. 84 EPC, no ground for opposition Several possible interpretations of the ill-defined feature all applicable If a state of the art exists, that discloses at least one of the possible claim interpretations, this results in a lack of novelty Application of this principle to the evaluation of inventive step is possible, smallest possible gap between the state of the art and a possible claim interpretation is critical for the determination of inventive step. 24.10.2014 www.glawe.de 9 No technical effect in the gray zone T 939/92: Inventive step is acknowledged only if the relevant technical effect is present over the whole area claimed Application of this principle to unclear claims: All possible interpretations of the claim are applicable For each possible interpretation of the claim there must be a technical effect that solves the objective technical problem If for at least one of the possible claim interpretations no technical effect can be shown, no inventive step will be acknowledged 24.10.2014 www.glawe.de 10 5

Summary Ambiguity in the claim will lead to insufficiency if: The gray zone penetrates the entire scope of the claims No enablement in the gray zone Ambiguity in the claim will lead to lack of novelty/inventive step if: The gray zone overlaps with prior art (or comes close) No technical effect in the gray zone 24.10.2014 www.glawe.de 11 The DE approach to clarity not entirely clear Clarity in infringement proceedings BGH X ZR 95/05 Straßenbaumaschine Infringement claim must not be rejected due to lack of patent claim clarity Clarity in revocation proceedings BGH X ZR 72/08 kosmetisches Sonnenschutzmittel III Lack of clarity no ground for revocation BGH - Xa ZR 54/06 Proxyserversystem Claim amendments of European patents in national revocation proceedings must be compliant with Art. 84 EPC 24.10.2014 www.glawe.de 12 6

The DE approach to clarity not entirely clear Clarity in examination proceedings BPatG 21W (pat) 13/10 of 22 May 2014 Claims have to define the claimed subject matter in a clear and unambiguous manner (Sec. 34(3) No 3 Patent Act) BPatG 11W (pat) 32/13 of 15 December 2014 Sec. 34(3) No 3 Patent Act is no legal basis for rejecting unclear claims in examination, no provision similar to Art. 84 EPC in the German Patent Act BGH X ZB 8/12 - Dipeptidyl-Peptidase-Inhibitoren Unclarity no ground for revocation, avoidable unclarities must be addressed in examination proceedings 24.10.2014 www.glawe.de 13 Thank you Questions? keussen@glawe.de 21.04.2015 www.glawe.de 14 7

Crystal clear? Clarity Questions in Prosecution/Opposition Proceedings The views expressed in the presentation are the personal views of the author and are not necessarily shared by any other members of the boards of appeal. The authentic texts of the decisions of the boards and the EPC provisions cited are accessible under www.epo.org Marco Alvazzi Delfrate Technically qualified member, Board 3.2.08 27 February 2015 Substantive aspects Article 84 EPC - Claims The claims shall define the matter for which protection is sought. They shall be clear and concise and be supported by the description. But what is the definition of clear? 2 1

Substantive aspects Why there is no clarity test? T 68/85 (27.11.1986): synergistic agent for selective weed control. Examining Division: the ratio range of the active ingredients was to be specified. Board: feature must be defined - in the objectively most precise form - without unjustifiably limiting the scope of the invention or unacceptably restricting protection. 3 Substantive aspects The term substantially T 971/10 (25.08.2011): a gas-liquid contacting tray which comprises a tray plate with substantially circular circumference... T 637/01 (10.12.2003): a vehicle with inductive pick-up means capable of deriving power from a magnetic field and decoupling means to substantially completely disengage the inductive pick-up means from the magnetic field. Examining Division: substantially rendered the claim unclear. Examining Division: substantially rendered the claim unclear. Board: lack of clarity. Board: no lack of clarity! 4 2

Substantive aspects The term substantially T 971/10 : Meaning of technical terms in claims neither absolute nor theoretical but what is generally accepted in the technical field. In the field of gas-liquid contacting apparatuses a circular shape never means perfectly circular. Substantially in combination with circular deviations from the circular shape larger than the usual tolerances. No explanation of what the deviations might be impossible to determine the extent of protection. 5 Substantive aspects The term substantially T 637/01: The person skilled in the art understands that to substantially completely disengage does not imply 100% disengagement but prevents resonant current from flowing. In the context of the invention, to substantially completely disengage the inductive pick-up means do therefore, in combination with the other features sufficiently clearly define the matter for which protection is sought. 6 3

Substantive aspects Description to be taken into account? T 500/01 (12.11.2003): A patent is a legal document may be its own dictionary and determine how to interpret a specific word. Not necessary if the patent does not depart from the normal meaning of the word in the technical field. If different meaning is intended, the description may give this word a special, overriding meaning by explicit definition. 7 Substantive aspects Description to be taken into account? T 1271/05 (27.11.2007): Distinction between various terms in the description: no impact on the interpretation of the claim if the distinction is not clear from the wording of the claim alone. Exception to this principle: may exist if the description provides unambiguous definitions of certain terms and makes clear that the definitions apply throughout the complete application. 8 4

Substantive aspects How is clarity examined elsewhere? US Supreme Court in NAUTILUS, INC. v. BIOSIG INSTRUMENTS, INC. (2 June 2014). Federal Circuit: a patent satisfies the definiteness requirement if the claim is amenable to construction and not insolubly ambiguous. Supreme Court: A patent is invalid for indefiniteness if its claims, read in light of the patent s specification and prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention. 9 Substantive procedural aspects 10 5

Procedural aspects Examination phase Article 84 is comprised in Part III- Chapter I of the EPC Filing and requirements of the European patent application. Clarity always to be examined for all claims. 11 Procedural aspects The patent as granted Clarity not among the grounds of opposition in Article 100 EPC. No opposition based on lack of clarity. Clarity plays no role in filing an opposition? 12 6

Procedural aspects The patent as granted T 18/08 (17.08.2010): catheter with solution of a therapeutic agent in a concentration of at least 75% of the limit solubility of the therapeutic agent in the solvent. Board: to carry out the invention measurement of the relative concentration of therapeutic agent in the solution. Limit solubility not a common term known to the person skilled in the art and not defined in the description. Patent revoked on the basis of Article 100(b). 13 Procedural aspects The patent as granted No hidden Article 84 objection! T 608/07 (27.04.2009): not enough if ambiguity effect only at edges of the claims but does not permeate whole claim. T 2403/11 (30.04.2014): four-step approach (problem solved; relevance of parameter; ambiguity of parameter; link ambiguity-relevance for problem solution). 14 7

Procedural aspects Amended patent Article 101 (3) EPC: if the patent is amended the patent and the invention to which it relates must meet the requirements of the EPC. Examination completely re-opened if patent amended? 15 Procedural aspects Amended patent G 9/91 (31.03.1993): In case of amendments of the claims or other parts of a patent in the course of opposition or appeal proceedings, such amendments are to be fully examined as to their compatibility with the requirements of the EPC. T 301/87 (16.02.1989): Absurd if making a minor amendment could enable objections outside Article 100 EPC with no connection with the amendment itself. No objections based upon Article 84 EPC, if such objections do not arise out of the amendments made. 16 8

Procedural aspects Amended patent Objection arise out of amendments? Independent claim amended by inserting feature(s) from the description Clarity to be examined. Independent claim amended by inserting feature(s) from the dependent claims Clarity to be examined? 17 Procedural aspects Combination of granted claims T 301/87 (16.02.1989), T 367/96 (03.12.1997), T 381/02 (26.08.2004), T 1855/07 (07.09.2010),...: Substantial amendments to be assessed for their compliance with the EPC, but in principle no examination of clarity where a dependent claim as granted is inserted literally into the claim under scrutiny. Clarity not a ground of opposition and the dependent claims already present in granted patent. 18 9

Procedural aspects Combination of granted claims T 472/88 (10.10.1990), T681/00 (26.03.2003): amendment brings into notice an ambiguity that may have existed all along. T 1440/08 (05.08.2010): amendment gave rise to a contradiction in the amended claim. T 1459/05 (21.02.2008): not all the dependent claims sistematically examined. Board empowered to examine clarity in that case, otherwise examination of novelty and inventive step would be hampered. All exceptions not questioning the principle that generally clarity of combination of granted claims should not be examined. 19 Procedural aspects Combination of granted claims T 459/09 (13.12.2012): Clarity of an amended independent claim should, in principle, be examined, even if amendment consists in a mere literal combination of claims of the patent as granted. An amendment consisting of the incorporation of a technically meaningful feature in an independent claim is of a substantial nature irrespective of the kind of amendment performed. T 409/10 (08.10.2013): T459/09 is established jurisprudence of the Boards of Appeal. 20 10

Procedural aspects Combination of granted claims T 373/12 (02. 04.2014): Claim 1 as granted: a prosthetic medical device with a liner comprising a layer of protective and lubricious coating. Claim 1 of auxiliary request 1: combination of granted claims 1 and 3. Dependent claim 3 as granted: liner coated over substantially all of its surface area. Auxiliary request 1 objected for lack of clarity or request of referral to Enlarged Board of Appeal. 21 Procedural aspects Referral G3/14 (T373/12) Combination of granted independent claim with (features from) granted dependent claims 1. Clarity always to be examined? 22 11

Procedural aspects Referral G3/14 (T373/12) Combination of granted independent claim with (features from) granted dependent claims 1. Clarity always to be examined? 2. All the features or only inserted features? 23 Procedural aspects Referral G3/14 (T373/12) Combination of granted independent claim with (features from) granted dependent claims 1. Clarity always to be examined? 2. All the features or only inserted features? 3. Never to be examined? 24 12

Clarity and Sufficiency a UK perspective Iain Purvis QC Legislative Provisions in the UK Insufficiency objection defined by s14(3) of 1977 Patents Act in terms which mirror Article 83 EPC clear enough and complete enough for the invention to be performed by a person skilled in the art Lack of clarity objection defined by s14(5) in terms which mirror Article 84. In particular s14(5)(b) requirement that the claims be clear and concise Section 72 sets out grounds on which Patent may be revoked, mirroring Article 138. So s72(c) allows revocation for insufficiency. All these provisions to be construed as near as practicable to have the same effect as the corresponding provisions of the EPC s130(7). 1

Old law in UK prior to 1978 S32(1)(i) of Patents Act 1949 allowed patent to be revoked for ambiguity First case under 1977 Act Genentech s Patent [1989] RPC 147 and 553 First instance Judge held that ambiguity still an objection to validity under inherent power of the Court. Court of Appeal disagreed. No power to revoke on grounds not expressly conferred by statute. So no objection of ambiguity post grant? This was widely believed. 2

See Milliken v Walk Off Mats [1996] FSR 292 and Scanvaegt v Pelcombe [1998] FSR 786 where it was said that a truly ambiguous claim was not invalid but simply could not be infringed! The law changed after the House of Lords decision in Kirin Amgen v Hoechst Marion Roussel [2004] UKHL 46 Claim 19 was to repo products having a higher molecular weight by SDS PAGE from erythropoietin isolated from urinary sources. 3

Problem: not all uepos had the same molecular weight, irrespective of source and method of isolation. So the scope of the claim was inherently unclear: Simply to use the first uepo which came to hand would turn the claim into a lottery. On the other hand, it would be burdensome to have to work one s way through several specimens of uepo and even then the result would be inconclusive because non constant that some untried specimen did not have a different molecular weight. All the skilled man can do is try to guess which uepo the patentee had in mind and if the specification does not tell him, then it is insufficient Adopted in later cases: SmithKline Beecham v Apotex Europe [2004] EWCA Civ 1568 The meaning of the words solvate and anhydrate are truly ambiguous One just does not know what the patentee meant at all and thus [the claims are] insufficient on the principles laid down by Lord Hoffmann in Kirin Amgen The Courts draw the distinction between: (a) Words in a claim which simply have a fuzzy boundary this can be resolved by the Court so no ambiguity and no insufficiency; and (a) Words which one cannot define at all 4

In reality, this distinction is easier to state in words than to apply! The vast majority of cases of potential ambiguity are resolved by construction. Ambiguities at the edge of the claim are generally ignored. See Zipher v Markem [2009] FSR 1 at 374: It will normally be necessary for the problem to permeate the whole claim. Dealing With Clarity Objections on Amendment The party applying to amend in revocation proceedings is obliged to comply with s14(5) in the same way as if he was making an application for a patent. See Horne Engineering v Reliance [2000] FSR 90 at 111 However, the Courts will not revisit questions of clarity arising out of matter which was already in the claim prior to amendment. See Chiron (No.5) [1994] FSR 258 5

Thus: mere deletion amendments to existing subsidiary claims will not be subject to s14(5) examination, unless: (i) (possibly) fraud or the like on the Patent Office is alleged see Chiron at 266; or (ii) The existence of the subsidiary claim played a part in the construction of the main claim and therefore its deletion would obscure the scope of that main claim, resolving a potential ambiguity see Plastics SA [1970] RPC 22. These decisions were all taken on the basis of the discretion which the Courts had to disallow applications to amend. However, the position is considered not to have changed in the light of the removal of that discretion and/or the 2004 Act. 6

The impact of the EU Enforcement Directive on Dutch IP litigation London, October 5, 2009 Clarity and Sufficiency A Dutch perspective Munich, February 27, 2015 Ricardo Dijkstra Vondst Advocaten Jacob Obrechtstraat 56 1071 KN Amsterdam The Netherlands t: + 31 20 504 20 00 f: + 31 20 504 20 10 e: ricardo.dijkstra@vondst-law.com Grounds for invalidity DPA 1910 Section 51(1)(a) Dutch Patent Act 1910 (before 1 December 1987): A patent shall be invalidated insofar as: a. [ ], if a European patent is concerned, the patent should not have been granted according to sections 52-57 of the European Patent Convention. No reference to section 83 EPC, also not to 138 EPC October 2009, Otto Swens, Vondst Advocaten 1

The impact of the EU Enforcement Directive on Dutch IP litigation London, October 5, 2009 Parliamentary history 51 DPA Netherlands Patent Office and only grant a patent for sufficiently disclosed inventions. Therefore, there is no need to introduce insufficient disclosure as invalidity ground in the Dutch Patent Act. Amendment 51 DPA Amendment Act 29 May 1987 (in force 1 December 1987) amended Section 51(1)(a) Dutch Patent Act 1910: A patent shall be invalidated insofar as: a. [ ], if a European patent is concerned, the patent should not have been granted according to sections 52-57 of the European Patent Convention; b. the patent specification does not contain a description of the invention that [ ] is sufficiently clear and complete to allow a person skilled in the art to perform the invention; October 2009, Otto Swens, Vondst Advocaten 2

The impact of the EU Enforcement Directive on Dutch IP litigation London, October 5, 2009 Supreme Court, Navcom / Philips, 2005 Section 57 EPC: An invention shall be considered as susceptible of industrial application if it can be made or used in any kind of industry, including agriculture. Section 83 EPC: The European patent application shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. Does section 83 EPC further elaborate on section 57 EPC and was the amendment of the Dutch Patent Act therefore unnecessary? Supreme Court, Navcom / Philips, 2005 Section 51(1) Dutch Patent Act refers to section 52-57 EPC and not to section 138 EPC. Section 138 EPC leaves room to the member states to deviate from 138 EPC. The legislator explicitly chose to refer to section 52-57 EPC. Supreme Court quashed the decision of the Court of Appeal that used the criterion of insufficient disclosure for lack of industrial susceptibility. October 2009, Otto Swens, Vondst Advocaten 3

The impact of the EU Enforcement Directive on Dutch IP litigation London, October 5, 2009 Supreme Court, Navcom / Philips, 2005 Dissatisfactory outcome, but legal certainty, legal methodology and legal history should prevail. Other options: use insufficient disclosure in order to interpret the patent for an argument based on lack of inventive step. use insufficient disclosure in order to limit the scope of protection. District Court, Novartis / J&J, 2009 Claim 1 attempts to define the invention by a result (maintain corneal health and wearer comfort) and therefore unclear. Lack of clarity (84 EPC) not a ground for invalidity (EPO Guidelines, C, III-8, par 4.10, now: F, Chapter IV, par. 4.10). J&J did not show insufficiency (83 EPC). Person skilled in the art will recognize the error in the formula used in the description and apply the correct formula. October 2009, Otto Swens, Vondst Advocaten 4

The impact of the EU Enforcement Directive on Dutch IP litigation London, October 5, 2009 District Court, Novozymes / DSM, 2010 Novozymes argues that the arguments of DSM regarding insufficiency are in fact clarity objections under section 84 EPC. District Court refers to Guidelines: It should be noted that, although an objection of lack of support is an objection under Art. 84, it can often, as in the above examples, also be considered as an objection of insufficient disclosure of the invention under Art. 83 [ ], the objection being that the disclosure is insufficient to enable the skilled person to carry out the "invention" over the whole of the broad field claimed (although sufficient in respect of a narrow "invention ). District Court, Novozymes / DSM, 2010 The District Court finds that section 83 EPC requires that the patent specification describes the invention sufficiently clear and complete that the invention can be performed without undue burden throughout the entire area of the claim. The patent specification and common general knowledge has to enable the person skilled in the art to reproduce at least a substantial part of the embodiments of the invention. District Court does not allow free beer claims: Novozymes tries to protect something that everyone would want (free beer), without clearly disclosing how the person skilled in the art could reach such desirable results. October 2009, Otto Swens, Vondst Advocaten 5

The impact of the EU Enforcement Directive on Dutch IP litigation London, October 5, 2009 District Court, Bayer / Abbott, 2010 An invention may be described in functional terms, but this should be omitted if it is not necessary and not in accordance with the contribution to the state of the art. The interest of third parties is a viewpoint to be taken into account. In all cases, the sufficiency requirement entails that the invention can be performed without undue burden throughout the entire area of the claim. The District Court notes that this is not the case if the technology to perform the invention throughout the entire area of the claim is not available. Insufficiency: Bayer claims more than it technically made available. District Court, PPG / Rhodia, 2013 The desired product characteristics in the method claim dependent on a lot of parameters in the fabrication process and small changes can lead to great changes in product characteristics. High demands on the description of the method. Claimed range of the parameters in claim 1, the description and the examples too broad. 5 out of 6 experiments did not result in the claimed products with the advantageous characteristics. Claim 1 invalid based on insufficient disclosure. October 2009, Otto Swens, Vondst Advocaten 6

The impact of the EU Enforcement Directive on Dutch IP litigation London, October 5, 2009 District Court, Permavoid / HTW, 2015 HTW argues that the invention is insufficiently disclosed, because it is unclear for the person skilled in the art what a feature ( direct ) in the claim means. Lack of clarity as such does not necessarily lead to insufficiency. HTW did not show that a person skilled in the art could not perform the claimed invention. Lack of clarity (section 84 EPC) not a ground for invalidity. A matter of interpretation Supreme Court, Navcom / Philips, 2005 (find other ways) Use lack of clarity for: Subject matter not patentable (52 57 EPC) Insufficient disclosure Added subject matter Extension of protection Scope of protection October 2009, Otto Swens, Vondst Advocaten 7

The impact of the EU Enforcement Directive on Dutch IP litigation London, October 5, 2009 A matter of interpretation Lack of clarity for the average person skilled in the art works in principle to the detriment of the patentee. (Supreme Court, Ciba Geigy / Ote Optics, 1995; Supreme Court, Lely / Delaval, 2007; Supreme Court, Medinol / Abbott, 2014) There are no facts, only interpretations (Friedrich Nietzsche) Any questions? Ricardo Dijkstra Vondst Advocaten Jacob Obrechtstraat 56 1071 KN Amsterdam The Netherlands t: + 31 20 504 20 00 f: + 31 20 504 20 10 e: ricardo.dijkstra@vondst-law.com October 2009, Otto Swens, Vondst Advocaten 8