SPC system simple, transparent and easy to apply? By Peter Damerell, Ayesha Raghib and William Hillson Powell Gilbert LLP
|
|
- Amber Tucker
- 5 years ago
- Views:
Transcription
1 SPC system simple, transparent and easy to apply? By Peter Damerell, Ayesha Raghib and William Hillson Powell Gilbert LLP
2 The strength and depth of our intellectual property expertise is second to none, with our lawyers having been involved in some of the most high-profile and technically complex cases in the UK and across Europe. This has included representing clients in highstakes patent cases before the UK courts, whilst also pursuing parallel EPO opposition proceedings and developing multijurisdictional litigation strategies. We have successfully represented clients in cases before all levels of the UK courts and in referrals to the European Court of Justice and the EFTA Court. " universally acknowledged as one of the finest life sciences patent litigation practices in the land" Chambers UK Our experience spans across many sectors, including small molecule drugs, monoclonal antibodies and biologics, genetic engineering methods (including CRISPR/cas9), formulations, dosage regimens, vaccines, cell culture processes, diagnostic tests, RNAi, delivery systems, stem cells and industrial enzymes. Our technical excellence is unmatched, with almost all our lawyers holding degrees in fields such as chemistry, biochemistry and biological sciences, including several PhDs in immunology, molecular biology and a medically qualified doctor. Our patent litigators are supported by lawyers with specialist healthcare regulation knowledge and experience. Our team have been actively helping shape the future of patent law in Europe. We have been involved in consulting, and commentating, on the proposals for centralised European patent litigation in the Unified Patent Court. We have also been involved in the organisation of mock trials under the draft UPC rules of procedure and are assisting in the training of UPC judges. +44 (0)
3 Powell Gilbert LLP SPC system simple, transparent and easy to apply? By Peter Damerell, Ayesha Raghib and William Hillson, Powell Gilbert LLP Patent term extensions for human and veterinary medicaments and plant protection products are available in Europe through the grant of supplementary protection certificates (SPCs), which effectively extend the term of a granted patent in relation to a particular product that is the subject of a marketing authorisation. SPCs are sui generis rights intended to compensate patentees for the time taken between filing a patent application and obtaining regulatory approval to bring such products to market. An SPC comes into force only after the expiry of the corresponding patent. It has a five-year maximum duration, but can be extended a further six months when the SPC relates to a human medicinal product for which data from clinical trials conducted in accordance with an agreed paediatric investigation plan has been submitted. As the European Commission s Explanatory Memorandum to EU Regulation 469/2009 (the SPC Regulation) makes clear, the SPC system is intended to be a simple, transparent system which can easily be applied. Further, the national patent offices should be able to conduct the grant procedure without being subject to an excessive burden. In this chapter we examine recent court decisions and consider whether these objectives are being achieved. When is a product protected by a basic patent? SPCs are granted for a product which is the active ingredient, or combination of active ingredients, of a medicinal product for which a marketing authorisation has been granted. A fundamental condition for obtaining an SPC is that the product must be protected by a basic patent in force (Article 3(a) of the SPC Regulation). To a patent lawyer, guided by Article 69 of the European Patent Convention (EPC) and its protocol, the concept of what a patent protects is not complex, so it might be expected that an assessment for determining whether to grant an SPC would be relatively straightforward. However, situations arise where it is not so simple. In particular, combination products have proved difficult to fit into this regime, as mismatches can arise between the active ingredients in the medicinal product covered by a marketing authorisation and the claims of the basic patent said to protect those active ingredients. Questions have also arisen where patent claims define the coverage of active ingredients functionally or by Markush formulae. In a line of decisions starting with Medeva (C-322/10), the European Court of Justice (ECJ) has considered when a product is protected by a basic patent, stating that a product is protected only if it is specified or identified in the wording of the patent claims. Early cases concerned combination products, the key issue being whether it was sufficient for the patent claims to focus on just one of the active ingredients (on the basis that dealings in the combination product would infringe) or whether each of the active ingredients would need to fall within the scope of the claims. The ECJ opted for the latter approach. However, requiring the active ingredients to be specified or identified in the wording of the patent claims has resulted in further confusion, since patent claims do not necessarily identify specific active ingredients, but seek to define the limits of a monopoly. This has resulted in a flurry of further cases seeking to ascertain how 63
4 Requiring the active ingredients to be specified or identified in the wording of the patent claims has resulted in further confusion, since patent claims do not necessarily identify specific active ingredients, but seek to define the limits of a monopoly much specificity is required, including three ECJ referrals in the past year. Gilead Truvada Before Medeva, Gilead obtained SPCs in respect of Truvada (tenofovir and emtricitabine). Gilead s patent discloses a range of new compounds said to be useful in treating HIV. Tenofovir is specifically identified in the patent claims, but emtricitabine is not referred to anywhere in the patent. In arguing that the combination was protected, Gilead relied on a claim that covered a pharmaceutical composition comprising a compound according to any one of the earlier claims (which included tenofovir) together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients. Peter Damerell Partner peter.damerell@powellgilbert.com Peter Damerell is a partner of Powell Gilbert LLP, a London-based specialist IP law firm. He specialises in IP litigation, advising clients on disputes across a diverse range of technologies, including pharmaceutical products and formulations, biotechnology and medical devices. He has extensive experience in handling complex and high-value patent litigation before the UK courts, as well as in formulating and coordinating multijurisdictional patent litigation strategies. Mr Damerell s scientific background provides him with a firm understanding of technical issues. He has particular experience in providing freedom-to-operate advice to pharmaceutical companies in relation to patent matters and advising on SPC filing strategies, notably where such applications are contested. Ayesha Raghib Associate ayesha.raghib@powellgilbert.com Ayesha Raghib is an associate at Powell Gilbert LLP, a London-based specialist IP law firm. She advises on European medicines regulatory law and IP law. Dr Raghib obtained a PhD in pharmacology from University College London and has also worked as a research scientist in pharmacology and molecular biology in the United States and United Kingdom. Her scientific background enables her to understand complex technical issues readily. She has also gained valuable commercial experience having worked in the pharmaceutical and biotech industry as a research scientist and lawyer. 64
5 When the case came before the English Patents Court, Mr Justice Arnold considered the ECJ case law and decided that the test for determining whether a product is protected by a basic patent remains unclear. He noted that national courts were interpreting Article 3(a) differently. He therefore decided to once again refer the following question to the ECJ: What are the criteria for deciding whether the product is protected by a basic patent in force in Article 3(a) of the SPC Regulation? The judge also suggested his own preferred answer, namely that the combination product must embody the inventive advance (or technical contribution) of the basic patent. The ECJ hearing took place on February (C-121/17). The judge-proposed inventive advance test could be said to be inconsistent with the objective William Hillson Associate william.hillson@powellgilbert.com William Hillson is an associate at Powell Gilbert LLP, a London-based specialist IP law firm. He has worked on a range of contentious IP matters. Dr Hillson obtained a BSc in biochemistry from the University of Birmingham, including one year of study at the University of Montpellier, France, and a DPhil in molecular pathology from the University of Oxford following research in the field of immunology and vaccine design. His experience includes multi-jurisdictional patent litigation in the life sciences sector, including patent and SPC validity and infringement analysis, litigation strategy in light of patent lifecycle management, preliminary injunctions and coordinating the activities of local counsel across Europe. of a simple, transparent and easily applied SPC system. However, patent examiners routinely assess the inventive advance of patent applications, so are well positioned to undertake such analysis. Despite its complications, including such a requirement would assist in ensuring that SPCs are granted only in respect of products that are genuinely at the heart of the patented subject matter. Searle Prezista Whether SPCs can be granted by reference to claims consisting of Markush formulae has also been uncertain since Medeva. In January 2018 the English Court of Appeal referred to the ECJ the question of whether, for Markush claims, all the compounds defined by the claimed formula satisfy the requirements of Article 3(a), or whether the only compounds that satisfy the requirements are those within the claimed formula whose substituents could be derived by the skilled person from a reading of the patent claims based on their common general knowledge. Searle had obtained a UK SPC in relation to Prezista (darunavir). The patent disclosed and claimed a wide range of compounds, identified by means of Markush formulae, which were said to be retroviral protease inhibitors suitable for treating HIV. Darunavir is not mentioned in the specification, but falls within the scope of protection of the claims when applying Article 69 of the EPC and the protocol. There was evidence that darunavir contained an unusual substituent, which was not disclosed in the patent and which did not form part of the skilled team s common general knowledge at the priority date. The Court of Appeal s provisional conclusion was that darunavir is protected and that it should be unnecessary to further assess whether its substituents are among those that the skilled person could derive, based on common general knowledge, from reading the patent claims. Such an approach seems at odds with the objective of the SPC system being simple, transparent and easily applied by patent offices. Royalty Pharma Januvia The application of Article 3(a) to functionally defined claims was addressed in Lilly v HGS (C- 493/12). The ECJ confirmed that it is unnecessary for an active ingredient to be identified by a structural formula in the patent claims, provided that the claims relate implicitly but necessarily and specifically to the active ingredient. While the 65
6 The creation of a unitary European SPC would greatly assist in simplifying the SPC system, particularly in the context of the intended creation of a unitary patent and unified patent court English courts and many national patent offices have simply applied Article 69 of the EPC to determine this question, some patent offices have nonetheless declined to grant SPCs where the product has not been specifically identified in the claims. Royalty Pharma applied for a German SPC in relation to Januvia (sitagliptin) based on its patent disclosing the use of inhibitors of the enzyme dipeptidyl-peptidase IV (DPP IV) in the regulation of blood glucose levels in diabetes, the relevant claim being to an activity lowering effector [of DPP IV] for use in lowering the blood glucose level. Sitagliptin, which satisfies this functional definition, is not disclosed in the patent and was developed after its filing date. The German Patent Office, having adopted a practice of allowing SPCs only where the active ingredient in question is disclosed in the patent as a specific embodiment, refused Royalty Pharma s SPC application. On appeal, the Federal Patent Court noted the diverging approaches to the application of Article 3(a) to such claims across Europe and referred several questions to the ECJ relating to the German Patent Office s approach, while also stating that it considers the English Patents Court s inventive advance concept to be relevant only to Article 3(c), not to Article 3(a). It is hoped that the ECJ will provide clear guidance on the application of Article 3(a) in response to these referrals. If the SPC system is to be simple, transparent and easily applied, it would greatly assist users if a consistent approach to Article 3(a) is adopted across the board, including for combination products, Markush formulae and functional claims. Has a relevant marketing authorisation been granted? Another requirement for obtaining an SPC is that a marketing authorisation has been granted in accordance with EU Directive 2001/83/EC (the Medicines Directive), or the veterinary equivalent, to place the product on the market as a medicinal product (Article 3(b) of the SPC Regulation). Generally, it is straightforward to determine whether this condition is satisfied, but two recent cases have raised issues in this regard. In Case C-567/16 Merck Sharp & Dohme (MSD) had relied on an end of procedure notice under Article 28(4) of the Medicines Directive in support of its UK SPC application for Atozet (ezetimibe and atorvastatin), as the UK marketing authorisation had not been granted by the deadline for filing the SPC application. MSD subsequently filed a copy of the UK marketing authorisation when granted, but the application was rejected. In an unsurprising decision, the ECJ decided that an end of procedure notice may not be treated as equivalent to a marketing authorisation, and the absence of such authorisation at the time of filing the SPC application does not constitute an irregularity that can be cured. Although delays in the filing and assessment of marketing authorisation applications can therefore be fatal to SPC applications, this decision provides clarity as to what is necessary for obtaining an SPC. In Case C-527/17 the German Federal Patent Court referred questions to the ECJ in relation to an SPC application filed by Boston Scientific for paclitaxel as a medicinal component of a paclitaxel coated-stent. Boston Scientific relied on a CE mark issued by the notified body following a formal assessment under EU Directive 93/42/EEC (the Medical Devices Directive). Although the German Patent Office rejected the application, the German Federal Patent Court s view was that the CE mark should be treated as equivalent to a marketing authorisation granted under the Medicines Directive, consistent with the purpose of the SPC Regulation to reward innovative research undertaken by patentees. The ECJ s decision will hopefully provide much-needed clarity in SPC protection for drug-device combinations. Can SPCs be obtained for the new formulation of an old active ingredient? Case C-443/17 is a ECJ referral from the English Patents Court concerning whether an SPC can 66
7 be granted for a new formulation of an old active ingredient. The case relates to Abraxis Bioscience s UK SPC application in respect of Abraxane, which comprises paclitaxel in a new formulation, namely as albumin bound nanoparticles or nab-paclitaxel. Abraxis faced two difficulties in obtaining an SPC for its new formulation. First, ECJ case law is clear that the product for which an SPC can be obtained is the active ingredient. Abraxis contended that the active ingredient of Abraxane is nab-paclitaxel, but the Patents Court rejected this, holding that the active ingredient is paclitaxel and that albumin is a carrier. Second, as marketing authorisations had been granted previously for paclitaxel, Abraxis ran into problems with Article 3(d), which requires the marketing authorisation relied on to be the first marketing authorisation to place the product on the market as a medicinal product. Abraxis drew an analogy between new formulations and second medical uses, arguing that the approach adopted in the earlier ECJ decision in Neurim (C-130/11) should also be applied to new formulations. In that case, Neurim had applied for an SPC for melatonin, relying on a marketing authorisation and a basic patent for the use of melatonin for treating insomnia, but a marketing authorisation had previously been granted for a veterinary use of melatonin. The ECJ held that the mere existence of the earlier [marketing authorisation (MA)] obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product for which an MA has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC. Nevertheless, the court referred this issue to the ECJ, stating that the scope of the Neurim decision remains unclear and noting divergent decisions across Europe for Abraxis s Abraxane SPC applications. Whether new inventive formulations of old active ingredients justify SPC protection is a contentious issue. From the perspective of a simple, transparent and easily applied system, having to investigate the formulations in earlier marketing authorisations adds complexity, arguably more so than having to check the indications in earlier marketing authorisations (as required following Neurim). However, from a policy perspective, it is unclear why inventive new formulations should not be deemed worthy of SPC protection. Amending SPC term to correct marketing authorisation date In C-492/16 (Incyte) the ECJ confirmed that patent offices must allow appeals to rectify SPC duration, following Seattle Genetics (C 471/14), where the ECJ held that the date the decision to grant the first marketing authorisation was notified to the marketing authorisation applicant should be used to calculate SPC duration, not the date that the marketing authorisation was actually granted. Since there have been inconsistent approaches across Europe as to whether national patent offices would amend SPC terms to reflect Seattle Genetics, this ECJ decision provides clarity for SPC owners. The future The European Commission is consulting on the SPC system, particularly in relation to creating a unitary European SPC and a proposed waiver for generic manufacturing during the SPC term. The outcome of the consultation is awaited with some trepidation from those within the industry. There is concern that any re-negotiation of the SPC Regulation at this stage may serve to introduce additional uncertainty rather than improve clarity. However, the creation of a unitary European SPC would greatly assist in simplifying the SPC system, particularly in the context of the intended creation of a unitary patent and unified patent court. Since the implementation of this new European patent system continues to suffer setbacks, there may yet be an opportunity to resolve the issues surrounding the grant of a unitary SPC before the new system comes into effect. Penny Gilbert assisted in the preparation of this chapter. Powell Gilbert LLP 85 Fleet Street London EC4Y 1AE United Kingdom Tel Fax Web 67
United Kingdom. By Penny Gilbert, Kit Carter and Stuart Knight, Powell Gilbert LLP
Powell Gilbert LLP United Kingdom United Kingdom By Penny Gilbert, Kit Carter and Stuart Knight, Powell Gilbert LLP Q: What options are open to a patent owner seeking to enforce its rights in your jurisdiction?
More informationSUPPLEMENTARY PROTECTION CERTIFICATES: THE CJEU ISSUES ITS DECISION IN TWO SEMINAL CASES
58 CASE COMMENTS SUPPLEMENTARY PROTECTION CERTIFICATES: THE CJEU ISSUES ITS DECISION IN TWO SEMINAL CASES DR MIKE SNODIN, DR JOHN MILES AND DR MICHAEL PEARS* Potter Clarkson LLP On 24 November 2011, the
More informationEffect of Brexit on IP protection
Effect of Brexit on IP protection Contents Introduction 1 Patents 2 UK Patents 6 International Patent Applications 7 Unitary Patent and Unified Patent Court 8 Supplementary Protection Certificates 10 Plant
More informationDHS Patentanwaltsgesellschaft mbh Munich. RECENT RULINGS OF THE EUROPEAN COURT OF JUSTICE ON SPCs
Dr. Stefan Danner December 2011 German and European Patent Attorney danner@dhs-patent.de RECENT RULINGS OF THE EUROPEAN COURT OF JUSTICE ON SPCs In the last few months, the European Court of Justice (ECJ)
More informationSuzannah K. Sundby. canady + lortz LLP. David Read. Differences between US and EU Patent Laws that Could Cost You and Your Startup.
Differences between US and EU Patent Laws that Could Cost You and Your Startup Suzannah K. Sundby United States canady + lortz LLP Europe David Read UC Center for Accelerated Innovation October 26, 2015
More informationCOMMENTARY EUROPE S HIGHEST COURT DECIDES ON PATENT TERM EXTENSIONS FOR FIXED-COMBINATION MEDICINAL PRODUCTS JONES DAY
DECEMBER 2011 JONES DAY COMMENTARY EUROPE S HIGHEST COURT DECIDES ON PATENT TERM EXTENSIONS FOR FIXED-COMBINATION MEDICINAL PRODUCTS Several national patent term extension proceedings regarding fixed-combination
More informationRECENT EUROPEAN DEVELOPMENTS REGARDING PATENT EXTENSIONS (SPCs AND PAEDIATRIC EXTENSIONS)
KUIPERS, DOUMA AND KOKKE : RECENT EUROPEAN DEVELOPMENTS REGARDING PATENT EXTENSIONS (SPCs AND PAEDIATRIC EXTENSIONS) : VOL 12 ISSUE 4 BSLR 123 RECENT EUROPEAN DEVELOPMENTS REGARDING PATENT EXTENSIONS (SPCs
More informationSwitzerland. Esther Baumgartner Christoph Berchtold Simon Holzer Kilian Schärli Meyerlustenberger Lachenal. 1. Small molecules
Esther Baumgartner Christoph Berchtold Simon Holzer Kilian Schärli Meyerlustenberger Lachenal 1. Small molecules 1.1 Product and process claims Classic drug development works with small, chemically manufactured
More informationEuropean Commission Questionnaire on the Patent System in Europe
European Commission Questionnaire on the Patent System in Europe Response by: Eli Lilly and Company Contact: Mr I J Hiscock Director - European Patent Operations Eli Lilly and Company Limited Lilly Research
More informationSupplementary protection certificates (SPCs) (Skeleton)
42 nd AIPPI Congress, Paris Supplementary protection certificates (SPCs) (Skeleton) Workshop Pharma I 5 October 2010, 9:00 to 10:30 am Moderator: Élisabeth-Thouret Lemaître, from Lavoix, France Speakers:
More informationIPFocus LIFE SCIENCES 9TH EDITION WHEN IS POST-PUBLISHED EVIDENCE ACCEPTABLE? VALEA
IPFocus LIFE SCIENCES 9TH EDITION WHEN IS POST-PUBLISHED EVIDENCE ACCEPTABLE? VALEA 2011 EPO: INVENTIVE STEP When is post-published evidence acceptable? Ronney Wiklund and Anette Romare of Valea discuss
More informationMerck Sharp & Dohme & Anr. v Glenmark Pharmaceuticals Ltd
BIOTECH BUZZ International Subcommittee December 2015 Contributor: Archana Shanker Changing trends in Indian patent enforcement In the history of the Patent Litigation in India, at least since 1970, only
More informationUNIFIED PATENT SYSTEM: A NEW OPPORTUNITY FOR INTELLECTUAL PROPERTY IN EUROPE
March 2013 UNIFIED PATENT SYSTEM: A NEW OPPORTUNITY FOR INTELLECTUAL PROPERTY IN EUROPE After four decades of negotiations, on 19 February 2013 24 EU states signed the agreement on a Unified Patent Court
More informationPharma Session 1: The endgame: patent term extensions and SPCs
Pharma Session 1: The endgame: patent term extensions and SPCs Tuesday, September 25 09:00-10:30 www.aippi.orgg Alexa von Uexkuell, Vossius & Partner (Moderator) MaryAnne Armstrong, BSKB LLP Makoto Ono,
More informationGoing full circle: Bolar in Europe and the UPC
Going full circle: Bolar in Europe and the UPC ENGLAND, ROYLE AND DE COSTER : GOING FULL CIRCLE: BOLAR IN EUROPE AND THE UPC : VOL 14 ISSUE 2 BSLR 1 Article 10(6) of the Directive provides that the following
More informationPatent reform package - Frequently Asked Questions
EUROPEAN COMMISSION MEMO Brussels, 11 December 2012 Patent reform package - Frequently Asked Questions I. Presentation of the unitary patent package 1. What is the 'unitary patent package'? The 'unitary
More informationPatentable Subject Matter and Medical Use Claims in the Pharmaceutical Sector
Patentable Subject Matter and Medical Use Claims in the Pharmaceutical Sector 2012 LIDC Congress, Prague, 12 October 2012 Dr. Simon Holzer, Attorney-at-Law, Partner 3 October 2012 2 Introduction! Conflicting
More informationSlide 13 What rights does a patent confer?
Slide 13 What rights does a patent confer? The term of the European patent shall be 20 years from the date of filing of the application (Article 63(1) EPC. However, nothing in Article 63(1) EPC shall limit
More informationComparative Analysis of the U.S. Intellectual Property Proposal and Peruvian Law
!!! Dangers for Access to Medicines in the Trans-Pacific Partnership Agreement: Comparative Analysis of the U.S. Intellectual Property Proposal and Peruvian Law ! Issue US TPPA Proposal Andean Community
More informationYoung EPLAW Congress. Bolar provision: a European tour. Brussels, 27 April 2015 Guillaume Bensussan Kathy Osgerby Agathe Michel de Cazotte
Young EPLAW Congress Bolar provision: a European tour Brussels, 27 April 2015 Guillaume Bensussan Kathy Osgerby Agathe Michel de Cazotte Introduction Bolar provision: a European tour Part 1 UK A) Recent
More informationBrexit Implications on the Life Sciences Sector
Brexit Implications on the Life Sciences Sector Holger Stratmann Attorney at Law, Partner 1 Life Science IP Seminar 2017 Separating Facts From Fiction Impact On Existing IP The Unknown Future What To Do
More informationSecond medical use or indication claims. Winnie Tham, Edmund Kok, Nicholas Ong
Question Q238 National Group: Title: Contributors: Reporter within Working Committee: AIPPI SINGAPORE Second medical use or indication claims Winnie Tham, Edmund Kok, Nicholas Ong THAM, Winnie Date: 17
More informationPROPOSALS FOR CREATING UNITARY PATENT PROTECTION IN THE EUROPEAN UNION
PROPOSALS FOR CREATING UNITARY PATENT PROTECTION IN THE EUROPEAN UNION The idea of a Community Patent, a single patent that can be enforced throughout the European Union (EU), is hardly new. The original
More informationThe Unitary Patent Plan Beta Update on National Case Law in Europe
The Unitary Patent Plan Beta Update on National Case Law in Europe Leythem Wall 28 November 2013 Declarations of Non-Infringement Article 15 of the Unified Patent Court (UPC) Agreement sets out the areas
More informationCOMPULSORY LICENCE in Germany. Markus Rieck LL.M.
COMPULSORY LICENCE in Germany Markus Rieck LL.M. 1 1877 - GERMAN PATENT ACT Bundesarchiv, Bild 183-R68588 / P. Loescher & Petsch / CC-BY-SA 3.0 2 Public interest Dependent patent Plant breeders privilege*
More informationD2 a copy of a Commission Decision of 22 January 2009 for a new oral formulation of COZAAR suitable for paediatric use.
Decision in Respect of an Application by E.I. Du Pont De Nemours & Company for the Grant of an Extension of Duration of the SPC No. 1996/028 for COZAAR 1. This decision relates to an application by E.I.
More informationPatents in Europe 2016/2017. Helping business compete in the global economy
In association with Greece Maria Athanassiadou and Henning Voelkel Dr Helen G Papaconstantinou and Partners Patents in Europe 2016/2017 Helping business compete in the global economy Dr Helen G Papaconstantinou
More informationEXPLANATORY MEMORANDUM ON THE DRAFT PROPOSAL FOR RULES ON THE EUROPEAN PATENT LITIGATION CERTIFICATE AND OTHER APPROPRIATE QUALIFICATIONS
EXPLANATORY MEMORANDUM ON THE DRAFT PROPOSAL FOR RULES ON THE EUROPEAN PATENT LITIGATION CERTIFICATE AND OTHER APPROPRIATE QUALIFICATIONS According to Article 48(2) of the Agreement on a Unified Patent
More informationIBC s 20 th Conference on. Paediatric Extensions Issues and Challenges. Christopher Stothers 22 February 2012
IBC s 20 th Conference on Biotech & Pharmaceutical Patenting 2012 Paediatric Extensions Issues and Challenges Christopher Stothers 22 February 2012 1 Overview of this Session Problem/Solution Opportunity/Threats
More informationSupplementary Protection Certificates
Supplementary Protection Certificates Guide For Applicants Intellectual Property Offi ce is an operating name of the Patent Offi ce This booklet aims to give a short introduction to the procedures for
More informationEUROPEAN GENERIC MEDICINES ASSOCIATION
EUROPEAN GENERIC MEDICINES ASSOCIATION POSITION PAPER POSITION PAPER ON THE REVIEW OF DIRECTIVE 2004/48/EC ON THE ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS JUNE 2011 EGA EUROPEAN GENERIC MEDICINES ASSOCIATION
More informationAn introduction to European intellectual property rights
An introduction to European intellectual property rights Scott Parker Adrian Smith Simmons & Simmons LLP 1. Patents 1.1 Patentable inventions The requirements for patentable inventions are set out in Article
More informationGeneral Information Concerning. of IndusTRIal designs
General Information Concerning Patents The ReGIsTRaTIon For Inventions of IndusTRIal designs 1 2 CONTENTS INTRODUCTION 3 1. What is a patent? 4 2. How long does a patent last? 4 3. Why patent inventions?
More informationSecond Medical Use Patents in Europe: Are the UK and Germany Swapping Approaches?
WHITE PAPER January 2019 Second Medical Use Patents in Europe: Are the UK and Germany Swapping Approaches? The UK Supreme Court s ruling in Warner Lambert v Actavis resulted from deliberations over the
More informationPatent litigation. Block 3. Module UPC Law Essentials
Patent litigation. Block 3; Module UPC Law Patent litigation. Block 3. Module UPC Law Essentials Article 32(f) of the UPC Agreement ( UPCA ) states that subject to the transitional regime of Article 83
More informationUnitary patent and Unified Patent Court: the proposed framework
Unitary patent and Unified Patent Court: the proposed framework The adoption of two key regulations late last year have paved the way for the long-awaited unitary patent and Unified Patent Court By Rainer
More informationConstruction of second medical use claims. The Hon. Mr Justice Richard Arnold
Construction of second medical use claims The Hon. Mr Justice Richard Arnold The problem Claim 1 of European Patent (UK) No. 0 934 061 reads: Use of [pregabalin] or a pharmaceutically acceptable salt thereof
More informationThe Royal Society of Chemistry IP Law Case Seminar: 2017 in the U.S.
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP The Royal Society of Chemistry IP Law Case Seminar: 2017 in the U.S. Anthony C. Tridico, Ph.D. 2017 1 Agenda U.S. Supreme Court news 2017 U.S. Court
More informationThreats & Opportunities in Proceedings before the EPO with a brief update on the Unitary Patent
Threats & Opportunities in Proceedings before the EPO with a brief update on the Unitary Patent MassMEDIC Jens Viktor Nørgaard & Peter Borg Gaarde September 13, 2013 Agenda Meet the speakers Threats &
More informationSelected UK IP highlights for 2013
United Kingdom United Kingdom Selected UK IP highlights for 2013 By Will James, Will Jensen and Esther Ford, During 2013 the United Kingdom saw significant developments in IP-related law. As well as the
More informationEuropean Patent with Unitary Effect and
European Patent with Unitary Effect and Unified dpatent t 20 th Annual Conference on Intellectual Property Law & Policy at Fordham IP Law Institute April, 12 th 2012, New York by Dr. Klaus Grabinski Federal
More informationpct2ep.com Guide to claim amendment after EPO regional phase entry
pct2ep.com Guide to claim amendment after EPO regional phase entry Claim amendments in the EPO Guide to the issues to consider After a PCT application enters the EPO regional phase, and before any search
More informationHow patents work An introduction for law students
How patents work An introduction for law students 1 Learning goals The learning goals of this lecture are to understand: the different types of intellectual property rights available the role of the patent
More informationSeeking Preliminary Injunction for Pharmaceutical Patent Infringement in Sweden
Seeking Preliminary Injunction for Pharmaceutical Patent Infringement in Sweden - A Comparative Law Analysis of Pharmaceutical Patent Protection and Injunction Proceedings in the Nordic Countries By Erik
More informationUnitary Patent in Europe & Unified Patent Court (UPC)
Unitary Patent in Europe & Unified Patent Court (UPC) An overview and a comparison to the classical patent system in Europe 1 Today s situation: Obtaining patent protection in Europe Direct filing and
More informationThe Unified Patent Court explained in detail. Managing Intellectual Property European Patent Reform Forum 19 September 2013 Munich
The Unified Patent Court explained in detail Managing Intellectual Property European Patent Reform Forum 19 September 2013 Munich The Panel Alex Wilson Lawyer Powell & Gilbert London Christine Kanz Lawyer
More informationStrategies for successful Patent Enforcement in Germany. Michael Knospe, Partner, SJ Berwin LLP
Strategies for successful Patent Enforcement in Germany Michael Knospe, Partner, SJ Berwin LLP 1 Overview 1. Some statistical data 2. Why Germany? 3. Infringement proceedings 4. Preliminary injunction
More informationSecond medical use or indication claims. Mr. Antonio Ray ORTIGUERA Angara Abello Concepcion Regala & Cruz Law Offices Philippines
Question Q238 National Group: Title: Contributors: Reporter within Working Committee: PHILIPPINES Second medical use or indication claims Mr. Alex Ferdinand FIDER Mr. Antonio Ray ORTIGUERA Angara Abello
More informationPatent Protection: Europe
Patent Protection: Europe Currently available options: National Patent European Patent (EP) Centralised registration procedure (bundle of nationally enforceable patents) Applicant designates the states
More informationThe Patented Medicines (Notice of Compliance) Regulations: What patents are eligible to be listed on the register?
The Patented Medicines (Notice of Compliance) Regulations: What patents are eligible to be listed on the register? Edward Hore Hazzard & Hore 141 Adelaide Street West, Suite 1002 Toronto, ON M5H 3L5 (416)
More informationUnderstanding the Unified Patent Court: The Next Rocket-Docket for Patent Owners?
Understanding the Unified Patent Court: The Next Rocket-Docket for Patent Owners? By Kevin R. Greenleaf, Michael W. O Neill, and Aloys Hüettermann Kevin R. Greenleaf is a counsel at Dentons US LLP where
More informationNorway. Norway. By Rune Nordengen, Bull & Co Advokatfirma AS
Norway By Rune Nordengen, Bull & Co Advokatfirma AS 1. What are the most effective ways for a European patent holder whose rights cover your jurisdiction to enforce its rights in your jurisdiction? Cases
More informationIP in a World of Change: Europe and Brexit; United States and its exit from the TPP: Where does IP Protection come in?
IP in a World of Change: Europe and Brexit; United States and its exit from the TPP: Where does IP Protection come in? Europe and Brexit - Exhaustion and litigation issues Ari Laakkonen, Powell Gilbert
More informationTO THE PRESIDENT AND MEMBERS OF THE COURT OF JUSTICE OF THE EUROPEAN UNION WRITTEN OBSERVATIONS
EUROPEAN COMMISSION Ref. Ares(2011)701410-29/06/2011 ORIGINAL Brussels, 29 June 2011 sj.a(2011)776202 TO THE PRESIDENT AND MEMBERS OF THE COURT OF JUSTICE OF THE EUROPEAN UNION WRITTEN OBSERVATIONS submitted
More informationPatent litigation. Block 2. Module Jurisdiction and procedure Complementary reading: Unified Patent Court Agreement ( UPCA )
Essentials: Patent litigation. Block 2. Unified Patent Court Agreement ( UPCA ) PART I - GENERAL AND INSTITUTIONAL PROVISIONS The Unified Patent Court (UPC) will be a specialised patent court common to
More informationEricsson Position on Questionnaire on the Future Patent System in Europe
Ericsson Position on Questionnaire on the Future Patent System in Europe Executive Summary Ericsson welcomes the efforts of the European Commission to survey the patent systems in Europe in order to see
More informationSecond medical use or indication claims. [Please insert name last name in CAPITAL letters please]
Question Q238 National Group: Title: Contributors: Reporter within Working Committee: New Zealand Second medical use or indication claims Michael BROWN, Partner Helen BELLCHAMBERS, Associate A J Park [Please
More informationSWITZERLAND: Patent Litigation CHAMBERS 2017 DOING BUSINESS IN BRAZIL: Global Practice Guides. Switzerland LAW & PRACTICE: p.<?> p.3. p.<?> p.
CHAMBERS SWITZERLAND AUSTRIA BRAZIL Patent Litigation Global Practice Guides LAW & PRACTICE: Switzerland p. p.3 Contributed by Fialdini Pestalozzi Einsfeld Advogados Contributed by Pestalozzi The Law
More informationEuropean Patent Litigation: An overview
European Patent Litigation: An overview Tuesday 28 September 2010 Hogan Lovells in partnership with the Association of Corporate Counsel Europe Your speaker panel Co-Chairs: Marten Bezemer Associate General
More informationVIRK - Västsvenska Immaterialrättsklubben
VIRK - Västsvenska Immaterialrättsklubben Response to the Commission s Consultation on the patent system in Europe Issue description The Directorate General for Internal Market and Services is consulting
More informationINTELLECTUAL PROPERTY LAWYERS ASSOCIATION
INTELLECTUAL PROPERTY LAWYERS ASSOCIATION Response to the Questionnaire on the Patent System in Europe Introduction: Who IPLA Are The Intellectual Property Lawyers Association (previously known as the
More informationHaving regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof;
DIRECTIVE 75/319/EEC Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ No L 147 of
More informationWhere are we now with plausibility?
/0/7 Where are we now with plausibility? Jin Ooi, Allen & Overy LLP (UK) Monday April 7 What s the big deal with plausibility? For the first time since the first edition in 188, the 18 th edition of Terrell
More informationUnitary Patent Guide. Obtaining, maintaining and managing Unitary Patents
Unitary Patent Guide Obtaining, maintaining and managing Unitary Patents 1 st edition August 2017 Unitary Patent Guide Obtaining, maintaining and managing Unitary Patents 1st edition, 2017 Contents A.
More informationFrance Baker & McKenzie SCP
Baker & McKenzie SCP This text first appeared in the IAM magazine supplement Patents in Europe 2008 April 2008 France By Jean-François Bretonnière and Tania Kern, Baker & McKenzie SCP, Paris 1. What options
More informationPATENT. After Actavis UK patent decisions post Actavis v Lilly. no.65. Full Story Page 02. June 2018 In this issue:
PATENT no.65 June 2018 In this issue: Unified Patent Court 03 Next steps following UK ratification Inter partes review 04 Challenges at the US Supreme Court Supplementary protection certificates 05 AG
More informationPATENT SYSTEM STATUS OFREFORMS
THE UNITARY PATENT SYSTEM STATUS OFREFORMS 1. STATUS OF REFORMS* On December 11, 2012 the EU Parliament approved the implementation of the Unitary Patent System based on a Unitary Patent Regulation (Council
More informationCMS European Patents Review
CMS Adonnino Ascoli & Cavasola Scamoni CMS Albi ~ nana & Suárez de Lezo CMS Bureau Francis Lefebvre CMS Cameron McKenna CMS DeBacker CMS Derks Star Busmann CMS von Erlach Henrici CMS Hasche Sigle CMS Reich-Rohrwig
More informationDraft Rules relating to Unitary Patent Protection revised version of Rules 1 to 11 of SC/16/13
SC/22/13 Orig.: en Munich, 22.11.2013 SUBJECT: SUBMITTED BY: ADDRESSEES: Draft Rules relating to Unitary Patent Protection revised version of Rules 1 to 11 of SC/16/13 President of the European Patent
More informationIntellectual Property Laws Amendment Bill 2013 No., 2013
00-0-0-0 The Parliament of the Commonwealth of Australia HOUSE OF REPRESENTATIVES Presented and read a first time Intellectual Property Laws Amendment Bill 0 No., 0 (Industry, Innovation, Climate Change,
More informationRESPONSE TO. Questionnaire. On the patent system in Europe INTRODUCTION
RESPONSE TO Questionnaire On the patent system in Europe INTRODUCTION PRIVACY STATEMENT I do consent to the publication of my personal data or data relating to my organisation with the publication of my
More informationLATVIA Patent Law adopted on 15 February 2007, with the changes of December 15, 2011
LATVIA Patent Law adopted on 15 February 2007, with the changes of December 15, 2011 TABLE OF CONTENTS Chapter I General Provisions Section 1. Terms used in this Law Section 2. Purpose of this Law Section
More information4. COMPARISON OF THE INDIAN PATENT LAW WITH THE PATENT LAWS IN U.S., EUROPE AND CHINA
4. COMPARISON OF THE INDIAN PATENT LAW WITH THE PATENT LAWS IN U.S., EUROPE AND CHINA Provisions of the Indian patent law were compared with the relevant provisions of the patent laws in U.S., Europe and
More informationIP IN A POST-BREXIT EUROPE ENSURING YOUR EUROPEAN IP RIGHTS ARE PROTECTED DATE: 10 NOVEMBER 2016 PRESENTERS: CHRIS FINN, BEN GRAU AND GRAHAM MURNANE
IP IN A POST-BREXIT EUROPE ENSURING YOUR EUROPEAN IP RIGHTS ARE PROTECTED DATE: 10 NOVEMBER 2016 PRESENTERS: CHRIS FINN, BEN GRAU AND GRAHAM MURNANE BACKGROUND A fundamental aspect of the European Union
More informationEuropean Patent with Unitary Effect
European Patent with Unitary Effect and the Unified Patent Court May 2013 Dr Lee Chapman lchapman@jakemp.com www.jakemp.com Where are we? Regulations relating to the EPUE and translation arrangements were
More informationEUROPEAN MEDICINES AGENCY DECISION. of 29 February 2008
European Medicines Agency Doc. Ref. EMEA/96630/2008 P/9/2008 EUROPEAN MEDICINES AGENCY DECISION of 29 February 2008 on the application for agreement of a Paediatric Investigation Plan for Cozaar and associated
More informationPatent Basics for Emerging Companies. Maria Laccotripe Zacharakis, Ph.D. Thomas Hoover Daniel J. Kelly McCarter & English, LLP
Patent Basics for Emerging Companies Maria Laccotripe Zacharakis, Ph.D. Thomas Hoover Daniel J. Kelly McCarter & English, LLP Cambridge Innovation Center March 20, 2013 BOSTON // HARTFORD // NEW YORK //
More information11th Annual Patent Law Institute
INTELLECTUAL PROPERTY Course Handbook Series Number G-1316 11th Annual Patent Law Institute Co-Chairs Scott M. Alter Douglas R. Nemec John M. White To order this book, call (800) 260-4PLI or fax us at
More informationA guide to GMC investigations and fitness to practise proceedings
A guide to GMC investigations and fitness to practise proceedings Contents Introduction 2 What is the GMC s role? 3 Stage 1 Initial complaint 5 Stage 2 Formal investigation 6 Stage 3 Conclusion of investigation
More informationIntellectual Property Department Hong Kong, China. Contents
Intellectual Property Department Hong Kong, China Contents Section 1: General... 1 Section 2: Private and/or non-commercial use... 3 Section 3: Experimental use and/or scientific research... 3 Section
More informationDawn of an English Doctrine of Equivalents: immaterial variants infringe
Dawn of an English Doctrine of Equivalents: immaterial variants infringe November 2017 The Supreme Court reinvents patent infringement The Supreme Court s landmark judgment in Actavis v Eli Lilly is a
More informationItaly Orsingher-Avvocati Associati
Orsingher-Avvocati Associati This text first appeared in the IAM magazine supplement Patents in Europe 2008 April 2008 Italy By Matteo Orsingher and Fabrizio Sanna, Orsingher-Avvocati Associati, Milan
More informationE U C O P E S y n o p s i s
E U C O P E S y n o p s i s Based on Regulation (EU) No 1235/2010 as published in the Official Journal of the European Union (L 348/1, 31.12.2010) Rue d Arlon 50 1000 Brussels www.eucope.org natz@eucope.org
More informationA Guide through Europe s New Unified Patent System
A Guide through Europe s New Unified Patent System June 2013 (Version 2) 1 1 This is an updated version of version 1 of the Guide. Boston Brussels Chicago Düsseldorf Frankfurt Houston London Los Angeles
More informationEUROPEAN COMMISSION COMMUNITY PATENT CONSULTATION COMPTIA S RESPONSES BRUSSELS, 18 APRIL
EUROPEAN COMMISSION COMMUNITY PATENT CONSULTATION COMPTIA S RESPONSES BRUSSELS, 18 APRIL 2006 http://www.comptia.org 2006 The Computing Technology Industry Association, Inc. The Patent System in Europe
More informationThe potential impact of Brexit on the European Patenting landscape
The potential impact of Brexit on the European Patenting landscape 1 November 2016-1 - Europe Economics is registered in England No. 3477100. Registered offices at Chancery House, 53-64 Chancery Lane,
More informationCA/PL 7/99 Orig.: German Munich, SUBJECT: Revision of the EPC: Articles 52(4) and 54(5) President of the European Patent Office
CA/PL 7/99 Orig.: German Munich, 2.3.1999 SUBJECT: Revision of the EPC: Articles 52(4) and 54(5) DRAWN UP BY: ADDRESSEES: President of the European Patent Office Committee on Patent Law (for opinion) SUMMARY
More informationFINLAND Patents Act No. 550 of December 15, 1967 as last amended by Act No. 101/2013 of January 31, 2013 Enter into force on 1 September 2013
FINLAND Patents Act No. 550 of December 15, 1967 as last amended by Act No. 101/2013 of January 31, 2013 Enter into force on 1 September 2013 TABLE OF CONTENTS CHAPTER 1 General Provisions Section 1 Section
More informationHUNGARY Patent Act Act XXXIII of 1995 as consolidated on March 01, 2015
HUNGARY Patent Act Act XXXIII of 1995 as consolidated on March 01, 2015 TABLE OF CONTENTS PART I INVENTIONS AND PATENTS Chapter I SUBJECT MATTER OF PATENT PROTECTION Article 1 Patentable inventions Article
More informationClinical Trial Research Agreement
Clinical Trial Research Agreement Investigator-Initiated, Company Supported Studies The body of the Agreement is not to be amended. Revisions are to be detailed in Schedule 3 with appropriate cross-referencing
More informationAssisted by Ms Stéphanie Nabot, Chief Court Clerk.
TRIBUNAL DE GRANDE INSTANCE OF PARIS ORDER IN PRELIMINARY PROCEEDINGS handed down on 12 February 2010 Docket No.: 10/51453 No.: 1/FB Summons of: 2 February 2010 by Ms Marie-Christine Courboulay, Vice Presiding
More informationDealdoc. Licensing agreement for PI3K-delta research and development program, including XL499. Merck and Co Exelixis. Dec
Dealdoc Licensing agreement for PI3K-delta research and development program, including XL499 Merck and Co Exelixis Dec 21 2011 Licensing agreement for PI3K-delta research and development program, including
More informationDesigns. Germany Henning Hartwig BARDEHLE PAGENBERG Partnerschaft mbb. A Global Guide
Designs 2015 Henning Hartwig A Global Guide ... IP only. BARDEHLE PAGENBERG combines the expertise of attorneys-at-law and patent attorneys. Selected teams of legally and technically qualified professionals
More informationINTELLECTUAL PROPERTY LAWS AMENDMENT (RAISING THE BAR ACT) 2012
INTELLECTUAL PROPERTY LAWS AMENDMENT (RAISING THE BAR ACT) 2012 AUTHOR: MICHAEL CAINE - PARTNER, DAVIES COLLISON CAVE Michael is a fellow and council member of the Institute of Patent and Trade Mark Attorneys
More informationBIO Advanced Business Development Course. Intellectual Property
BIO Advanced Business Development Course Intellectual Property Philadelphia, June 2015 Patrick Duxbury, Partner, Wragge Lawrence Graham & Co LLP, London What are we going to cover? Intellectual Property
More informationWorld Intellectual Property Organization
WIPO Special Update on WIPO Alternative Dispute Resolution GRUR Annual Meeting Hamburg September 27-30, 2017 Erik Wilbers, WIPO Arbitration and Mediation Center World Intellectual Property Organization
More informationthe UPC will have jurisdiction over certain European patents (see box The unitary patent and the UPC: a recap ).
THE UNITARY PATENT CENTRAL ENFORCEMENT OF PATENTS IN EUROPE In the second of a two-part series, Susie Middlemiss, Adam Baldwin and Laura Balfour of Slaughter and May examine the structure and procedures
More informationIP Litigation in Life Sciences Germany 2016
IP Litigation in Life Sciences Germany 2016 Dr. Jan B. Krauss, Patent Attorney, Munich 2016 WIPO Conference Life Sciences Dispute Resolution Agenda The current landscape of life sciences enforcement in
More information[English translation by WIPO] Questionnaire on Exceptions and Limitations to Patent Rights
Questionnaire on Exceptions and Limitations to Patent Rights The answers to this questionnaire have been provided on behalf of: Country: Chile... Office: National Institute of Industrial Property (INAPI)...
More informationPatents in Europe 2011/2012. Greece Lappa
Patents in Europe 2011/2012 Lappa By Eleni Lappa, Drakopoulos Law Firm, Athens 1. What are the most effective ways for a European patent holder whose rights cover your jurisdiction to enforce its rights
More information