European IP Law (Patents), Catania, May 29-30, 2013 Scope of Protection Prof. Dr. Martin Senftleben VU University Amsterdam Bird & Bird, The Hague Contents • Legal sources • Interpreting the claims • Equivalence • Infringement – exclusive rights – exceptions – prior use Legal sources European patent law European Patent Convention Community Patent Convention concluded in concluded in Munich, Luxemburg, October 5, 1973, December 15, 1975, revision: EPC 2000 not in force Art. 1 European Patent Convention (EPC) ‘A system of law, common to the Contracting States, for the grant of patents for invention, is established by this Convention.’ ... 38 Contracting States, 2 extension States Territorial reach of the EPC system European patents (art. 2 EPC) ‘Patents granted under this Convention shall be called European patents.’ ‘The European patent shall, in each of the Contracting States for which it is granted, have the effect of and be subject to the same conditions as a national patent granted by that State, unless this Convention provides otherwise.’ European and national phase centralized registration procedure at the result: bundle of national patents European Patent Office (EPO) (national phase) National phase and harmonization no full harmonization of substantive patent law (infringement criteria): Community Patent Convention had strong influence on national legislation, but never entered into force! result: bundle of national patents (national phase) Dream of a Community Patent EU registration procedure carried out by an EU Patent Office result: Community Patent = unitary patent right for the entire EU territory European Patent with Unitary Effect centralized registration procedure at the European Patent Office (EPO) result: patent governed by only one national law (but applicable national law differs from patent to patent) Interpreting the claims (EPC) Art. 69(1) EPC ‘The extent of the protection conferred by a European patent or a European patent application shall be determined by the claims. Nevertheless, the description and drawings shall be used to interpret the claims.’ Addressee of the patent specification • person skilled in the art • artificial, objective standard • (average) specialist – skilled technician rather than leading expert – has working experience in the relevant field – has standard knowledge – knows the specific, relevant state of the art Source material for interpretation • elements of the patent specification: – claims – description, drawings • different approaches to interpretation: – literal (wording of the claims) – teleological (core of the inventive idea) • in addition: application file? Aims underlying interpretation validity: infringement: narrow reading to shield the patent against prior art wide construction to obtain broad scope of protection Approaches in EPC countries • EPO allows consultation of application files • art. 69(1) EPC does not seem to preclude use for claim construction • rather reluctant: UK courts – nonetheless: if narrow meaning was given to a term to secure the patent grant, a later argument of wide interpretation unlikely to be accepted • more liberal approach in other countries – additional aid to clarify meaning of the claims – example: The Netherlands Dutch Hoge Raad, December 22, 2006, Dijkstra/Saier • at issue: strength of a bucket sealing mechanism • use application file in favour of patent owner: – possible, but: cautious approach required – only if claims remain unclear after careful study of description and drawings • use application file against patent owner: – no reason for restricting use of the file if this supports position of the defendant Protocol Concerning Art. 69 EPC • ‘Article 69 should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims.’ = literal interpretation (English tradition) Protocol Concerning Art. 69 EPC • ‘Nor should [Article 69] be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated.’ = teleological interpretation (German tradition) Protocol Concerning Art. 69 EPC ‘On the contrary, [Article 69] is to be interpreted as defining a position between these extremes which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties.’ literal (legal certainty) teleological (fair protection) ‘position between these extremes’ Dutch Hoge Raad, January 13, 1995, Ciba Geigy/Oté Optics • Ciba Geigy: – has European process patent for disinfecting and cleaning contact lenses – according to the claims, the process is based on a specific sodium chloride solution which is isotonic • Oté Optics: – markets a cleaning product for contact lenses with a different solution that is isotonic Dutch Hoge Raad, January 13, 1995, Ciba Geigy/Oté Optics • no strict, literal interpretation • core idea underlying the invention = starting point of the interpretation • but: additional test of legal certainty • third party interests may require correction of the interpretation • criterion: degree of novelty Equivalence Doctrine of equivalence the same function in the same way with the same results Impact in practice doctrine (+) doctrine (-) no need to specify more detailed each and every claims advisable to variant of the close potential invention in the loopholes for specification competitors Dutch Hoge Raad, October 31, 2003, Van Bentum/Kool • Van Bentum: – has a product patent concerning a truck for the transport of laden pallets – achieves optimal use of space by combining a movable lowest load floor with a fixed highest load floor • Kool: – markets a truck that has a movable highest load floor and a removable top Dutch Hoge Raad, October 31, 2003, Van Bentum/Kool Dutch Hoge Raad, October 31, 2003, Van Bentum/Kool • claims not drafted carefully • nonethelss: interpretation required that strikes a proper balance between fair protection for the patent owner and legal certainty for third parties • equivalent variant of the invention (+) Different approaches in EPC countries • ‘Epilady’ saga (1990-1993) • plaintiff – holds patent rights to ‘Epilady’, a gadget for removing body hair with a coiled spring • defendant – applies same inventive idea – but: uses a rubber tube instead of the coiled spring • DE and NL: infringement (+) • UK: infringement (-) UK approach: three questions • variant having material effect upon the way the invention works? – if yes, infringement (-) • if no: absence of material effect obvious at the date of patent publication? – if no, infringement (-) • if yes: claim indicating that strict compliance with the primary meaning of the terms essential to the invention? – if yes, infringement (-) UK approach: three questions • inherent problem: last question takes the court back to interpretation • critique led to departure from the test – Kirin-Amgen vs. Hoechst Marion Roussel, [2005] RPC (9), 169 – no mechanical application, in particular less helpful in case of complex chemical or biotechnological inventions – example: claim to a whole group of chemical compounds expected to have similar characteristics Protocol Concerning Art. 69 EPC, as amended under the EPC 2000 ‘For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims.’ = recognition of the doctrine of equivalence? • guarantee of a more uniform interpretation of patent claims in EPC countries? Exclusive rights (CPC) Art. 25(a) Community Patent Convention ‘A Community patent shall confer on its proprietor the right to prevent all third parties not having his consent: from making, offering, putting on the market or using a product which is the subject-matter of the patent, or importing or stocking the product for these purposes;…’ Art. 25(b) Community Patent Convention ‘from using a process which is the subjectmatter of the patent or, when the third party knows, or it is obvious in the circumstances, that the use of the process is prohibited without the consent of the proprietor of the patent, from offering the process for use within the territories of the Contracting States;…’ Art. 25(c) Community Patent Convention ‘from offering, putting on the market, using, or importing or stocking for these purposes the product obtained directly by a process which is the subject-matter of the patent.’ Overview direct infringement product patent process patent acts relating to the product use of the acts relating to (making, offering, process the product using etc.) directly obtained from the process Problem 1: identical product may be obtained with a different process process A process C process B process D Art. 34(1) of the TRIPS Agreement ‘…if the subject matter of a patent is a process for obtaining a product, the judicial authorities shall have the authority to order the defendant to prove that the process to obtain an identical product is different from the patented process. Therefore, Members shall provide, in at least one of the following circumstances, that any identical product when produced without the consent of the patent owner shall, in the absence of proof to the contrary,…’ Art. 34(1) of the TRIPS Agreement ‘…be deemed to have been obtained by the patented process: a. if the product obtained by the patented process is new; b. if there is a substantial likelihood that the identical product was made by the process and the owner of the patent has been unable through reasonable efforts to determine the process actually used.’ Art. 35 Community Patent Convention ‘If the subject-matter of a Community patent is a process for obtaining a new product, the same product when produced by any other party shall, in the absence of proof to the contrary, be deemed to have been obtained by the patented process.’ ‘In the adduction of proof to the contrary, the legitimate interests of the defendant in protecting his manufacturing and business secrets shall be taken into account.’ Problem 2: further products may be required to obtain the final product father mother son production of compact discs final Process patent infringement? (UK: Pioneer Electronics vs. Warner Music) A is holder of a UK process patent for the production of ‘father’ discs at a particular pressure. He wants to prevent B from importing final discs. father mother B uses the patented process in China to obtain father discs and carry out the further production steps. He offers the final discs in the UK. son production of compact discs final Indirect infringement Extending patent rights to preliminary acts direct infringement: rights against those who directly carry out prohibited acts indirect: rights against those who are essentially involved, in a preliminary way, in bringing about complete infringement Art. 26(1) Community Patent Convention ‘A Community patent shall also confer on its proprietor the right to prevent all third parties not having his consent from supplying or offering to supply […] a person, other than a party entitled to exploit the patented invention, with means, relating to an essential element of that invention, for putting it into effect...’ = supplying means for putting a patented invention into effect to someone not authorized to work the patent Art. 26(1) Community Patent Convention ‘…when the third party knows, or it is obvious in the circumstances, that these means are suitable and intended for putting that invention into effect.’ = supplier is treated as knowing what is obvious to a reasonable person in the circumstances Dutch Hoge Raad, October 31, 2003, Sara Lee/Intergro Dutch Hoge Raad, October 31, 2003, Sara Lee/Intergro • Sara Lee: – holder of a European patent relating to an ‘assembly for use in a coffee machine for preparing coffee, container and pouch of said assembly’. • Intergro: – offers pouches (coffee pads) on the market that can be used to prepare coffee in the way patented by Sara Lee. Dutch Hoge Raad, October 31, 2003, Sara Lee/Intergro • infringement (-) because the pouches are not an essential part of the patent ‘It does not follow from the simple fact that a fitting coffee pouch is necessary to apply the patented assembly that this pouch constitutes a means relating to an essential element of the invention…’ • fitting pouch is not an element distinguishing the invention from prior state of the art Art. 26(2) Community Patent Convention ‘Paragraph 1 shall not apply when the means are staple commercial products, except when the third party induces the person supplied to commit acts [amounting to patent infringement].’ = recognition that mass articles may have non-infringing as well as infringing uses • additional requirement: supply for inducing a person to infringe the patent Indirect patent infringement? A is holder of an Italian process patent for the production of ‘father’ discs at a particular pressure. He wants to prevent B from supplying the Italian producer C with means for working his patent. In India, B supplies C with the means necessary to work A’s patent. C brings these means into Italy and works A’s patent there. Indirect patent infringement? A is holder of a German process patent for the production of ‘father’ discs at a particular pressure. He wants to prevent B from exporting means for working his patent to Canada. In Germany, B makes up kits of the parts needed to operate A’s patent. He exports these kits to Canada where A’s competitors use the kits to work the patent. Patent infringement in transit cases? producer of generics in India owner of European patent rights importer of generics in Brazil Art. 41(1) of the TRIPS Agreement ‘…ensure that enforcement procedures […] are available […] to permit effective action against any act of infringement of intellectual property rights covered by this Agreement, including expeditious remedies to prevent infringements and remedies which constitute a deterrent to further infringements.’ ‘These procedures shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse.’ CJEU, December 1, 2011, case C-446/09, Philips/Nokia • infringement (-) as long as goods are truly in transit to another country ‘The Court has repeatedly deduced from that fact that goods placed under a suspensive customs procedure cannot, merely by the fact of being so placed, infringe intellectual property rights applicable in the European Union…’ (para. 56) CJEU, December 1, 2011, case C-446/09, Philips/Nokia • infringement (+) the moment the goods may be put on the internal market ‘On the other hand, those rights may be infringed where, during their placement under a suspensive procedure […], or even before their arrival […], goods coming from non-member States are the subject of a commercial act directed at European Union consumers, such as a sale, offer for sale or advertising.’ (para. 57) World policing in transit cases? Legitimate trade in generics Illegitimate trade in fake drugs Right to compensation EPC registration procedure publication application examination formal substantive refusal grant a. novelty b. further requirements compensation period opposition Art. 32(1) Community Patent Convention ‘Compensation reasonable in the circumstances may be claimed from a third party who, in the period between the date of publication of a European patent application in which the Contracting States are designated and the date of publication of the mention of the grant of the European patent, has made any use of the invention which, after that period, would be prohibited by virtue of the Community patent.’ = compensation for use of the invention prior to the grant Art. 67(2) European Patent Convention ‘In any event, each State shall ensure at least that, from the date of publication of a European patent application, the applicant can claim compensation reasonable in the circumstances from any person who has used the invention in that State in circumstances where that person would be liable under national law for infringement of a national patent.’ = compensation for use of the invention prior to the grant Exceptions Private, non-commercial use ‘The rights conferred by a Community Patent shall not extend to: [...] acts done privately and for non-commercial purposes.’ (art. 27(a) Community Patent Convention) • cumulative requirement of private and non-commercial nature? • activities of governmental, educational and charitable institutions outside the scope of the exception? Experimental use ‘The rights conferred by a Community Patent shall not extend to: [...] acts done for experimental purposes relating to the subject-matter of the patented invention.’ (art. 27(b) Community Patent Convention) • allows testing of claimed properties or different indications • requirement: experiments are directed to the substance itself • problematic: use as research tool Objective underlying experimental use disclosure rationale: experimental use exception: patent law as a means to make technical knowledge available facilitates the use of this knowledge to advance science German Bundesgerichtshof, July 11, 1995, Clinical Trials I • plaintiff: – holds patent rights to the medicine ‘Interferongamma’. • defendant: – uses Interferon-gamma to produce the drug ‘Polyferon’ under a compulsory license. – uses Interferon-gamma for clinical trials aiming to identify new uses of the substance. German Bundesgerichtshof, July 11, 1995, Clinical Trials I • scope of experimental use – all kinds of experiments as long as the use serves scientific research on the subject matter of the patented invention – covers research on applications of the invention • not decisive whether – the experiments are undertaken merely to review the patent specification – user has further intentions, such as use of the results for commercial purposes German Bundesgerichtshof, April 17, 1997, Clinical Trials II • scope in case of commercial research – all experimental acts that relate to the subject matter of the invention – regardless of whether the tests produce purely scientific or industrially exploitable results – defence applies as long as the research does not specifically aim at impeding or frustrating the sale of the original product = liberal approach to experimental use Differences in experimental use regimes • distinction between purely scientific and (partly) commercial research • distinction between research ‘on’ and research ‘with’ the patented technology broad scope (Germany) narrow scope (USA) position between these two poles in many European countries Dutch Hoge Raad, December 18, 1992, ICI/Medicopharma • ICI: – is the holder of a Dutch patent on the medicine ‘Atenolol’. – patent expires on February 20, 1990 • Medicopharma and Pharbita: – use Atenolol to obtain regulatory approval for the marketing of a generic version of the medicine. Dutch Hoge Raad, December 18, 1992, ICI/Medicopharma • decisive: unauthorized use must be justified by the research objective ‘This is only the case when the person carrying out the research argues and substantiates that the research is of an exclusively scientific nature, and that it aims exclusively at realizing one of the objectives underlying the Patent Act, such as the further advancement of science and technology.’ Dutch Hoge Raad, December 18, 1992, ICI/Medicopharma • in the case of tests for obtainig marketing approval for drugs (-) ‘With their research, Medicopharma and Pharbita aimed [...] only to carry out, during the term of patent protection, the tests [...] necessary to be able to market themselves the already known medicine enjoying patent protection directly after the expiry of the patent.’ Extension of experimental use • art. 10(6) of Directive 2001/83/EC, as amended by Directive 2004/27/EC ‘Conducting the necessary studies and trials with a view to the application [for marketing approval for generic versions of patented drugs] and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products.’ = so-called ‘Bolar’ exception ‘Bolar’ exception • exempts use of the patented invention for tests necessary to obtain marketing approval for generic drugs • US: Roche Products vs. Bolar Pharma generic version protected medicine expiry Counterbalance: extended term of protection • ‘The term of protection available shall not end before the expiration of a period of twenty years counted from the filing date.’ (art. 33 TRIPS) • longer periods? • extensions in certain technical fields? Supplementary Protection Certificate for Medicinal Products ‘The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorization to place the product on the market in the Community reduced by a period of five years.’ (art. 13(1) EC Regulation 1768/92 (1992)) Supplementary Protection Certificate for Medicinal Products ‘Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect.’ (art. 13(2) EC Regulation 1768/92 (1992)) market approval patented medicine extension expiry Farmer’s exception ‘The protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention shall extend to any biological material derived from that biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics.’ (art. 8(1) Biotech Directive 98/44/EC) = biotech patents expanded to material derived by propagation or multiplication Farmer’s exception ‘By way of derogation from Articles 8 and 9, the sale or other form of commercialisation of plant propagating material to a farmer by the holder of the patent or with his consent for agricultural use implies authorisation for the farmer to use the product of his harvest for propagation or multiplication by him on his own farm…’ (art. 11(1) Biotech Directive 98/44/EC) • farmer’s own use of seed exempted • same rule for breeding of animals Exhaustion Partitioning markets Netherlands: 100 EUR Denmark: 125 EUR Greece: 75 EUR • patent protection as a weapon against parallel imports? • (+) in case of national exhaustion • (-) in case of international exhaustion Art. 28 Community Patent Convention ‘The rights conferred by a Community patent shall not extend to acts concerning a product covered by that patent which are done within the territories of the Contracting States after that product has been put on the market in one of these States by the proprietor of the patent or with his express consent, unless there are grounds which, under Community law, would justify the extension to such acts of the rights conferred by the patent.’ = community exhaustion Prior use Different know-how strategies A B trade secret protection patent protection (disclosure) Determining the patent owner • general principle: The first applicant obtains the patent, not the first inventor. • exceptions: – unfair competition (espionage) – employed inventor Persons eligible for prior use rights persons who used persons who have in the invention prior good faith made to the patent grant effective and serious without making it preparations to use available to the the invention public (infringing acts about to be done) Time scheme: EPC registration procedure publication application examination formal substantive refusal grant a. novelty b. further requirements compensation period opposition Right of prior use • scope depends not necessarily on form and extent at the time of acquisition – grows together with the business – expansion into other products problematic • only defence against patent owner, no right against third parties • no licensing permitted • assignment only together with the relevant business Compulsory licenses Art. 45(1) Community Patent Convention ‘Any provision in the law of a Contracting State for the grant of compulsory licences in respect of national patents shall be applicable to Community patents. The extent and effect of compulsory licences granted in respect of Community patents shall be restricted to the territory of the State concerned.’ • national compulsory licensing regimes not harmonized in CPC • nonetheless: harmonization because of the international TRIPS Agreement Art. 31 of the TRIPS Agreement • detailed list of requirements, such as – efforts to obtain regular authorization – national emergency – limited scope and duration according to purpose – non-exclusive, non-assignable – predominantly for the domestic market – payment of adequate remuneration – judicial review of decisions relating to the compulsory license Reasons for compulsory licensing necessitated by public interest lack or insufficiency of exploitation required to put into effect a later invention that depends on patented technology Example: dependent patents • specific international requirements – ‘important technical advance of considerable economic significance’ in relation to the patented prior invention – cross-license on reasonable terms for the owner of the first patent – use authorization with regard to the first patent is non-assignable except with the assignment of the second patent (art. 31(l) TRIPS Agreement) Appropriate standard of ‘important technical advance’? • problematic in sectors with incremental evolution of new technology • example: innovation in the software industry invention 1 invention 2 Innovation in the software industry • ‘important technical advance’? • ‘considerable economic significance’? Conclusion No unitary patent infringement standard in Europe • differences with regard to – claim interpretation – scope of exclusive rights – scope of exceptions • resulting in different decisions on – patent validity – infringing acts • European patent ≠ uniform assessment of the patent in European countries The end. Thank you! For publications, visit www.ssrn.com and search for ‘senftleben’. contact: m.r.f.senftleben@vu.nl