The Intellectual Property Review Editor Robert L Baechtold

Law Business Research

The Intellectual Property Review

Reproduced with permission from Law Business Research Ltd. This article was first published in The Intellectual Property Review, 1st edition (published in August 2012 – editor Robert L Baechtold). For further information please email [email protected]

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The Intellectual Property Review Editor

Robert L Baechtold

Law Business Research Ltd

Contents

The Law Reviews The Mergers and Acquisitions Review The Restructuring Review The Private Competition Enforcement Review The Dispute Resolution Review The Employment Law Review The Public Competition Enforcement Review The Banking Regulation Review The International Arbitration Review The Merger Control Review The Technology, Media and Telecommunications Review The Inward Investment and International Taxation Review The Corporate Governance Review The Corporate Immigration Review The International Investigations Review The Projects and Construction Review The International Capital Markets Review The Real Estate Law Review The Private Equity Review The Energy Regulation and Markets Review The Intellectual Property review

www.TheLawReviews.co.uk 4

Contents Publisher Gideon Roberton business development manager Adam Sargent marketing managerS Nick Barette, Katherine Jablonowska marketing assistant Robin Andrews editorial assistant Lydia Gerges production manager Adam Myers production editor Joanne Morley subeditor Anna Andreoli editor-in-chief Callum Campbell managing director Richard Davey Published in the United Kingdom by Law Business Research Ltd, London 87 Lancaster Road, London, W11 1QQ, UK © 2012 Law Business Research Ltd No photocopying: copyright licences do not apply. The information provided in this publication is general and may not apply in a specific situation. Legal advice should always be sought before taking any legal action based on the information provided. The publishers accept no responsibility for any acts or omissions contained herein. Although the information provided is accurate as of July 2012, be advised that this is a developing area. Enquiries concerning reproduction should be sent to Law Business Research, at the address above. Enquiries concerning editorial content should be directed to the Publisher – [email protected] ISBN  978-1-907606-34-2 Printed in Great Britain by Encompass Print Solutions, Derbyshire Tel: 0844 2480 112

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acknowledgements

ABDULAI, TAIWO & CO. ANAND AND ANAND ANDERSON MŌRI & TOMOTSUNE BIRD & BIRD LLP BRISTOWS BUGGE, ARENTZ-HANSEN & RASMUSSEN ADVOKATFIRMA (LAW FIRM BA-HR) DEEP & FAR ATTORNEYS-AT-LAW DEREK rumpff HARMS DI BLASI, PARENTE & ASSOCIADOS DITTMAR & INDRENIUS DLA CLIFFE DEKKER HOFMEYR DM KISCH INC FERRAIUOLI LLC FITZPATRICK, CELLA, HARPER & SCINTO GÓMEZ-ACEBO & POMBO GORODISSKY & PARTNERS HECHANOVA BUGAY & VILCHEZ

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Acknowledgements

HOGAN LOVELLS (PARIS) LLP HORTEN KIM & CHANG LIU, SHEN & ASSOCIATES MARVAL, O’FARRELL & MAIRAL McCLURE NAISMITH MEISSER & PARTNERS AG MOLITOR AVOCATS À LA COUR NORTON ROSE CANADA LLP VIEIRA DE ALMEIDA & ASSOCIADOS – SOCIEDADE DE ADVOGADOS, RL

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contents

Editor’s Preface

...........................................................................................ix Robert L Baechtold

Chapter 1

Argentina....................................................................1 Martín Bensadon, Ivan Poli and Ignacio Sanchez Echague

Chapter 2

BRAZIL............................................................................13 Gabriel Di Blasi and Paulo Parente Marques Mendes

Chapter 3

CANADA.........................................................................26 Jason Markwell and Adam Haller

Chapter 4

CHINA.............................................................................36 Jay Sha

Chapter 5

DENMARK.....................................................................46 Anders Valentin

Chapter 6

FINLAND........................................................................60 Markus Mattila and Gabrielle Hjelt

Chapter 7

France..........................................................................72 Stanislas Roux-Vaillard  

Chapter 8

Germany......................................................................86 Wolfgang von Meibom and Felix T Rödiger 

Chapter 9

INDIA..............................................................................96 Pravin Anand and Reuben Cheriyan

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Contents

Chapter 10

Japan............................................................................114 Yasufumi Shiroyama

Chapter 11

KOREA..........................................................................125 Jung-Ae Suh and Cy Kim

Chapter 12

Luxembourg............................................................137 Claire Leonelli

Chapter 13

NIGERIA.......................................................................150 Ladi Taiwo and Bunmi Binitie

Chapter 14

NORWAY.......................................................................158 Are Stenvik

Chapter 15

PHILIPPINES................................................................169 Editha R Hechanova

Chapter 16

PORTUGAL..................................................................184 António Andrade

Chapter 17 PUERTO RICO.............................................................193 Eugenio J Torres-Oyola, Maristella Collazo-Soto and Ángel L Casiano-Ruiz Chapter 18

Russia..........................................................................205 Nikolay Bogdanov

Chapter 19 SOUTH AFRICA..........................................................221 Derek Rumpff Harms with Eben van Wyk and Willem (‘At’) van Rooy Chapter 20

Spain.............................................................................235 Eduardo Castillo and Sergio Poza

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Contents

Chapter 21

SWITZERLAND...........................................................246 Marco Bundi and Benedikt Schmidt

Chapter 22

Taiwan........................................................................260 C F Tsai and Yu-Li Tsai

Chapter 23 United Kingdom..................................................267 Edward Nodder, Alan McBride, Claire Purkiss and Euan Duncan Chapter 24

United States.........................................................288 Robert L Baechtold, Brian V Slater and Jason A Leonard 

Appendix 1

About the Authors............................................301

Appendix 2 Contributing Law Firms’ Contact Details...................................................319

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Editor’s Preface

It is not an overstatement to say that essentially all business is global, and the protection of intellectual property is the lifeblood of all business. The scope and implementation of that protection, however, varies from country to country. It would be ideal if there were one universal set of laws, rules and procedures. But, while the efforts of many dedicated individuals have accomplished much in harmonising intellectual property protection, we remain defined as much by our differences as by what we have in common. It therefore is incumbent on all of us, as advisers to our clients, to be conversant with the individual practices in each of the economically significant countries. The goal of this review is to provide that guidance. We have assembled a body of leading practitioners to explain the opportunities for intellectual property protection in their respective jurisdictions, together with the most significant recent developments and any aspects that are unique to their country. While we have striven to make the book both accurate and comprehensive, we must note that, in light of the limited pages available, it is necessarily a summary and overview, and we strongly recommend that the reader seek the advice of experienced advisers for application of the principles to any specific factual matter. It is our hope that the reader will find this compilation a useful and oftenconsulted guide. Robert L Baechtold

Fitzpatrick, Cella, Harper & Scinto New York July 2012

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Chapter 23

United Kingdom Edward Nodder, Alan McBride, Claire Purkiss and Euan Duncan1

I

FORMS OF INTELLECTUAL PROPERTY PROTECTION2

i Patents Patents protect inventions, namely the application of ideas but not the idea itself. Patents are rewards given by the state for public disclosure as to how an invention works. They are granted in respect of products or processes, or a mixture of both. A patent gives its owner a 20-year monopoly to prevent third parties from using the invention.3 Patents are by far the most important intellectual property right to impact on the commercialisation of any process or product. The relevant legislation is the Patents Act 1977 (as amended). In order to obtain patent protection, an invention must be: novel; inventive; capable of industrial application; and not excluded.4 The patent itself must sufficiently describe the invention. We discuss the subject of patents in more detail in Sections III and IV, infra.

1 Edward Nodder is a partner and Alan McBride and Claire Purkiss are associates at Bristows and Euan Duncan is a partner at McClure Naismith. 2 The United Kingdom comprises three jurisdictions: England and Wales, Scotland, and Northern Ireland. This chapter is primarily written from an English and Welsh law perspective. Although substantively the same, there are subtle differences (mainly procedural) between the jurisdictions. A few of the major differences are highlighted in this chapter. 3 Additional protection of up to a maximum of five years can be sought for certain medicinal and plant protection products in the form of a supplementary protection certificate to compensate for the delay incurred when obtaining a marketing authorisation. A further six months’ protection can be obtained in the form of a paediatric extension where certain further trials are conducted. 4 Further details in Section III: ‘Obtaining protection’, infra.

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United Kingdom ii

Trademarks (UK and Community)

A trademark is defined under the Trade Marks Act 19945 as ‘any sign capable of being represented graphically which is capable of distinguishing the goods or services of one undertaking from those of other undertakings’. Trademarks are registered in respect of particular goods and services and may include but are not limited to: words, letters, designs, numerals, the shape of goods and packaging, colours, sounds and smells. There are 45 classes: 34 for goods and 11 for services. A trademark may be registered for the UK alone by the UK Intellectual Property Office (‘UKIPO’)6 or for all Member States of the European Union by the Office of Harmonisation for the Internal Market (‘OHIM’), which is based in Alicante. The Trade Marks Act 1994 specifies categories of sign that may not be registered. These include signs that are devoid of distinctive character; signs that designate kind, quality, intended purpose, value or geographical origin; signs customary in the current language of the trade; signs contrary to public policy, etc. Some of these grounds may be overcome if the applicant can show that through use in the market the trademark has acquired a distinctive character. Applications for trademark registration will also be refused if the marks are too similar to marks that have already been registered.7 If a particular mark is not registrable, it may still be used as a trademark, albeit an unregistered trademark. Unregistered trademarks are identified using the superscript ‘™’ and registered trademarks by the superscript ‘®’. The initial term of a registered trademark is 10 years but this may be renewed indefinitely for successive periods of 10 years. iii

Passing off

The common law tort of passing off may protect marks that have not been registered in cases where: the sign has sufficient goodwill in the UK; the defendant has made a misrepresentation; and the claimant has suffered damage as a result.8 The registration of marks is preferable, as passing off can be difficult to prove. There is no similar, EU-wide protection for unregistered marks. iv Copyright Copyright confers the right to exclude others from making certain uses of protected subject matter. Copyright may be thought of in terms of: the subject matter in which it subsists (‘works’); the uses of those works it reserves to its owner; and the acts permitted in respect of works notwithstanding its subsistence. The relevant legislation is the Copyright, Designs and Patents Act 1988 (‘CDPA 1988’).9

5 Trade Marks Act 1994, s. 1(1). 6 For further information see www.ipo.gov.uk/types/tm/t-applying.htm. 7 For information on the so-called relative grounds of refusal see Trade Marks Act 1994, s. 5. 8 Often coined the ‘classic trinity’ per Lord Oliver in Reckitt & Colman Products Ltd v. Borden Inc [1990] 1 All ER 873. 9 CDPA 1988 came into effect on 1 August 1989 and applies to works created on or after that date. Generally for works created before that date it is necessary to refer to the Copyright Act 1956 and the Copyright Act 1911.

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United Kingdom Copyright is a property right that subsists automatically (i.e., it is not a registered right) in three descriptions of work, namely original literary, dramatic, musical or artistic works; sound recordings, films or broadcasts; and typographical arrangements of published editions.10 Layers of copyright can often exist in the same end product or work. In order to be protected, works must be original and fixed in a permanent form. Copyright provides different lengths of protection depending on the type of work, although protection is usually from 25 years (for published editions) to the life of the author plus 70 years (for literary, dramatic, musical or artistic works).11 v

Database rights

Database rights subsist independently of copyright protection,12 where there has been substantial investment in obtaining, verifying or presenting the contents of the database, without registration requirements. The rights subsist for 15 years from the end of the calendar year in which the database was completed and when it was made available to the public. A further term of 15 years is afforded for substantial changes to the database. vi

Moral rights

Moral rights are non-assignable rights that attach to authors and directors and (for the right of false attribution) individuals in general. The CDPA 198813 confers three moral rights on the author, director or commissioner of certain copyright works, whether or not he or she owns their copyright: the right to be identified as the work’s author or director;14 the right to object to derogatory treatment of the work;15 and the right to privacy in respect of certain photographs and films.16 vii

Design rights

Registered design rights (UK and Community) The appearance of the whole or part of a product, including the lines, contours, colours, shape, texture or materials of a product can be protected as a design. Registered designs must be novel; have individual character (i.e., create a different overall impression on the informed user); and not be excluded.17 They can be applied for in the UK, or as Community registered designs, which provide protection in all EU countries.

10 11 12 13 14 15 16 17

CDPA 1988, s. 1(1). For further information please see CDPA 1988, ss. 12-15. Under the Copyright and Rights in Databases Regulations 1997 (SI 1997/3032). Chapter IV of Part 1 of the CDPA 1988. CDPA 1988, s. 77. CDPA 1988, s. 80. CDPA 1988, s. 85. Under the Registered Designs Act 1949, which has been substantially amended by the CDPA1988, the Registered Designs Regulations 2001 (SI 2001/3949) and the Regulatory Reform (Registered Designs) Order 2006 (SI 2000/1974).

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United Kingdom Unregistered design rights (UK and Community) Protection is also available for unregistered designs, which are designs of any aspect of the shape or configuration of the whole or part of an item; original and not commonplace; recorded in a design document; and not excluded. In the UK, protection is afforded for 15 years from the end of the year in which the design was recorded, or 10 years from when the design was first marketed. Community unregistered designs provide protection in all EU countries for three years from first disclosure in the EU. viii

Confidential information and trade secrets

In order to be protected, confidential information must have the necessary quality of confidence (i.e., not be in the public domain) and must be disclosed in circumstances importing an obligation of confidence.18 Protection lasts for as long as the information is confidential. ix

Regulatory data protection

Regulatory data protection (‘RDP’) and marketing protection arise as a result of the regulatory process leading to the grant of a marketing authorisation for pharmaceutical products. They provide protection for the data generated in support of an application for marketing authorisation for eight years, and prevent generic entry for 10 years. Further extensions are available for certain new therapeutic indications. x

Plant breeders’ rights

Plant breeders’ rights are a special type of IPR whereby protection for new plant varieties is offered by the Plant Variety Rights Office and Seeds Division of the Department for Environment Food and Rural Affairs.19 To obtain protection, plant varieties must be distinct (clearly distinguishable by one or more characteristics), uniform, stable and novel (subject to certain exceptions). Such rights last for 25 years from the date of grant (and 30 years for potatoes, trees and vines). Plant breeders may also apply for a Community Plant Variety Right, offering protection for new plant varieties throughout the European Union. II

RECENT DEVELOPMENTS

i

Patents County Court reforms

Patent (and other IP) cases are either heard by the Patents Court of the Chancery Division of the High Court or the Patents County Court (‘PCC’). A new set of simplified procedural rules for the PCC was implemented in October 2010 to attract lower value, less complex IP cases. The PCC has one full-time, IP specialist judge, HH Judge Colin Birss QC. The statements of case must be concise but set out all of the facts on which the parties intend to rely. Shortly after statements of case have been filed an early case management conference

18 19

Coco v. A N Clark (Engineers) Ltd [1969] RPC 41. Under the Plant Varieties Act 1997.

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United Kingdom will occur at which the course of the whole action is set, including all deadlines and the date of judgment (which is generally within a few weeks of trial). There is no standard disclosure, provision for exchange of evidence, experiments, surveys or skeleton arguments as standard. Trials will last a maximum of two days and are heard only on the basis of the statements of case, advocates’ oral submissions and any written evidence that has been permitted: cross-examination of witnesses or experts, if allowed, is strictly limited. There is a recoverable costs cap of £50,000, broken down into a maximum amount recoverable for each stage of an action resulting in greater certainty for the parties. There is also a recoverable damages cap of £500,000. It is hoped that a new small claims track will be introduced in the PCC for copyright, trademark and unregistered design cases valued at not more than £5,000. ii

New Court of Appeal judges

In recent years, there have been some changes at the IP bench. In particular, Jacob LJ retired following eight years at the Court of Appeal, where he heard the vast majority of its IP cases. Kitchin and Lewison LJJ have been elevated to the Court of Appeal leaving two specialised IP first instance judges – Floyd J and Arnold J. iii

New location of the first instance IP courts

The Patents Court and the PCC are now both located in the Rolls Building, Fetter Lane, London. iv

Patent case law updates

Human Genome Sciences v. Eli Lilly [2011] UKSC 51 In November 2011, in its first ever patent case, the Supreme Court20 gave guidance on the concept of ‘industrial applicability’,21 which as explained above is one of the requirements for patentability. The case concerned a protein that is a member of the tumour necrosis factor family that had been discovered by bioinformatics.22 The patentee had made certain predictions regarding the protein’s utility based on its membership of the superfamily but the patent itself contained no experimental data. At first instance the patent was held to be invalid for lack of industrial applicability. The decision was upheld at the Court of Appeal. However, the Supreme Court agreed with the European Patent Office (‘EPO’) Technical Board of Appeal, which had previously held for the patentee. The leading judgment from Lord Neuberger suggests a policy decision – to bring the English courts in line with the jurisprudence of the EPO. The court held that it was not necessary for the utility of the new protein to be specified as a new therapeutic use; it was enough that the plausible use be use as a research tool that could be used in the development of the diagnosis and treatment of diseases in due course.

20 21 22

The Supreme Court replaced the Appellate Committee of the House of Lords as the highest court in the UK in October 2009. According to Article 57 EPC. The application of computer science and information technology to the field of biology and medicine.

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United Kingdom Schlumberger Holdings Ltd v. Electromagnetic Geoservices AS [2010] EWCA Civ 819 The Court of Appeal held that the skilled person (see Section III.i, infra) may vary depending on the question in issue (e.g., obviousness, novelty, sufficiency). The patents in suit taught the use of marine Controlled Source Electromagnetic (‘CSEM’) surveying to locate oil or gas. For the purposes of sufficiency, an exploration geophysicist and a CSEM expert would form the skilled team implementing the invention. In contrast, for the purposes of obviousness (a pre-patent issue), the skilled team would not comprise both types of expert, since the geophysicist would have had no apparent use for CSEM technology. In holding the two patents in issue to be valid, the Court of Appeal overturned the first instance finding that the skilled team is always the same as well as its subsequent decision that the two patents in issue were obvious. It is the authors’ understanding that the case settled before reaching the Supreme Court. It is therefore currently good law that the identity of the skilled team can vary in the pre-priority date or post-priority date arena and secondary evidence on obviousness has more importance than was previously thought to be the case. Cephalon v. Orchid [2011] EWHC 1591 (Pat) The English courts continue to follow the approach laid down by the House of Lords in Kirin-Amgen23 regarding claim construction, asking the question: ‘What would the skilled person have understood the language of the claim to mean?’ In this case the main claims were to modafinil particles of a particular size but the issue was whether this meant the size of the particles of the active ingredient within the tablet or before it was formulated. Floyd J held that the skilled person would have understood that the particle size of the active ingredient before it was formulated would be crucial despite the fact that, construed ‘literally and acontextually’, the patent claimed the particle size within the dosage form. Schütz (UK) Limited v. Werit UK Limited [2011] EWCA Civ 1337 The Court of Appeal examined the boundary between repair and making under the English implementation of Article 25 of the Community Patent Convention. The claimants’ patent in question was for intermediate bulk containers (‘IBCs’), in particular IBCs comprising two parts: a cage and a large plastic bottle that fits inside the cage but that can be replaced as and when the bottle is damaged. The defendants engaged in the practice of cross-bottling: manufacturing replacement bottles and using these to replace damaged bottles in the original cage from the claimants. The court had to decide whether that amounted to infringement by making a product falling within the claims of the patent. At first instance, the court had ruled that the correct approach24 was to ask whether, when the part in question was removed (in this case the bottle), what was left embodied the ‘whole of the inventive concept’ of the claim. In this case, the feature of the IBC patent that was novel and inventive was the cage, which by itself embodied the whole of the inventive concept. Therefore putting a new bottle into the cage did not constitute ‘making’ the patented IBC and thus the patent was not infringed.

23 Kirin-Amgen v. Hoechst Marion Roussel [2005] RPC 9. 24 Applying United Wire v. Screen Repair Services [2000] UKHL 42.

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United Kingdom The Court of Appeal held that the case of United Wire could not be construed in such a fashion and did not establish a ‘whole of the inventive concept’ test. Jacob LJ held that the correct interpretation of United Wire instead required the court to ask whether there had been a ‘making’ of a product falling within the claims of the patent. In this case, the IBC sold by the claimants ceased to exist once the original bottle was removed. What then remained at that stage was merely an important component from which a new IBC could be made. Once the replacement bottle was introduced, the defendants had ‘made’ a product falling within the claims of the patent and therefore there was infringement. Earth Closet Orders25 – Fresenius v. Carefusion [2011] EWHC 2052 (Pat) Earth Closet orders provided that if a party challenging a patent introduced a new ground of invalidity late in the proceedings, and the patentee consented to revocation based on the new ground, the challenger could be ordered to pay the costs of the proceedings from the date of service of the original grounds of invalidity onwards. Having to pay the vast majority of the costs could act as a major incentive to a challenger to investigate its case thoroughly and not to hold back any argument. The Court of Appeal in this case held that Earth Closet orders should no longer be made and instead standard civil litigation procedures should be followed: parties should be allowed to discontinue claims in the normal way26 and the usual order for costs will be that the discontinuing party will bear the costs of the proceedings but the court always has a wide discretion to award costs.27 Servier v. Apotex [2011] EWHC 730 (Pat) In 2006, Servier obtained an interim injunction against Apotex for the infringement of a patent relating to its antihypertensive product, perindopril. In order to obtain this, Servier gave a cross-undertaking in damages. The patent was subsequently held to be invalid and Servier were ordered to pay £17.5 million under the cross-undertaking in damages. Apotex’s product was manufactured in Canada. Following the damages inquiry but prior to judgment, Servier’s Canadian patent was held to be valid and infringed by Apotex’s manufacture. Servier then sought to amend its defence to include a claim that Apotex were not entitled to the damages due to the ex turpi causa rule: in claiming damages for lost profits in the UK, Apotex had relied on illegal acts in Canada. The trial judge refused but the Court of Appeal disagreed and allowed the amendment and referred the case back to another first instance judge. At the subsequent hearing, the court disagreed with Apotex’s contention that only criminal activity or dishonesty would invoke the rule: Servier had not induced Apotex’s illegality. Apotex was aware of the patent and the nature of the infringing acts, and had committed the infringing acts intentionally (by making a commercial decision to launch at risk). While it would not have been illegal for Apotex to import and sell perindopril in the UK, it had to rely on its illegality in Canada to establish

25 From Baird v. Moule’s Patent Earth Closet Co Ltd (1881) LR 17 ChD 139 but sometimes referred to as See v. Scott Paine Order from [1933] 50 RPC 56. 26 Pursuant to CPR Part 38.6. 27 Pursuant to CPR Part 44.

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United Kingdom its loss, and had chosen to manufacture in Canada to increase profits. The ex turpi causa rule therefore applied, and Servier recovered £17.5 million. The case is still under appeal. Omnipharm Limited v. Merial [2011] EWHC 3393 (Pat) In December 2011, the Patents Court again considered whether patents covered inventions that were obvious to try, and hence lacking in inventive step. In this case, the patents covered a ‘spot-on’ application of flea treatment as opposed to the sprays that were known in the art. The court held that the question of whether an invention is ‘obvious to try’ must be considered alongside whether there was a fair expectation of success: is it obvious that the invention (claimed plausibly) would achieve a given effect? In this instance, would the skilled person consider (with a fair expectation of success) that a spot-on formulation would distribute over the surface of the skin. There was no basis in the prior art for predicting that the result could be achieved, therefore irrespective of the fact that the patentee had encountered no problems in developing the formulation, the patent was held to have an inventive step and was upheld. Omnipharm’s standing to apply for a declaration of non-infringement was also at issue, as they were merely intending to apply for and then sell marketing authorisations in the products. The court held that dealing in the patented product was one of many options available to Omnipharm, which was therefore entitled, under Section 71 of the Patents Act 1977, to apply for a declaration of non-infringement. III

OBTAINING PROTECTION

i Patentability Pursuant to Section 1(1) of the Patents Act 1977, patentable inventions must: Be novel Patents are considered novel where they relate to inventions that are new and do not form part of the state of the art.28 Inventions form part of the state of the art when they have been made available to at least one member of the public in any form (including orally) anywhere in the world.29 The UK has no grace period. Involve an inventive step The invention must not be obvious to a person skilled in the art who has been imputed with common general knowledge (‘CGK’). This person is an uninventive but skilled person in the relevant field. However, in an appropriate case, the skilled ‘person’ can comprise a team with each member bringing a particular skill. CGK is information that is common knowledge in the art to which the invention relates and that people engaged in the art know and generally accept at the priority date of the patent in suit. Not all publicly available information is CGK, only that information which the majority of skilled workers retain in their memories as a result of their technical backgrounds. 28 29

Patents Act 1977, s. 2(1). Patents Act 1977, s. 2(2).

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United Kingdom Be capable of industrial application Industrial applicability is construed broadly and includes all manufacturing, extracting and processing activities of enterprises that are carried out continuously, independently and for commercial gain,30 and generally covers inventions that have a useful purpose.31 The skilled person must be able to derive the industrial application from the patent specification. That is, the technical purpose of the invention must be described in definite technical terms. It must not be left to the skilled man to conduct further experiments. However, a substance disclosed with an essential function for human health will immediately suggest industrial application. Inventions are not to be considered unpatentable simply because they concern products consisting of or containing biological material (including gene sequences) or processes for producing or using such products.32 They are examined on the usual criteria of novelty, inventive step and industrial application. It is established practice that the first isolation of a natural substance is considered novel, despite always being present in nature. However, a discovery alone is not patentable. Therefore, a discovery that a known material has an unknown characteristic is not patentable, unless the invention also relates to a use (or industrial application) of the material or a process based on the discovery.33 For example, a DNA sequence alone is not an invention, but the process for isolating and extracting it may be patentable, as may the product of the process34 assuming that there is evidence for an industrial application of such; and, where the applicant had discovered a use for a given protein, that protein and the DNA encoding it could also be patentable.35 Not be excluded Exclusions under the Patents Act 1977 include: a a discovery, scientific theory or mathematical method; b literary, dramatic, musical, artistic or aesthetic work; c a scheme, rule or method for performing a mental act, playing a game or doing business, or a program for a computer;36 d the presentation of information; e inventions the commercial exploitation of which would be contrary to public policy; this includes, but is not limited to: • processes for cloning human beings; 30 31 32 33 34 35 36

Eli Lilly v. Human Genome Sciences [2008] RPC 29. Chiron Corporation v. Murex Diagnostics [1996] RPC 535. Section 76A and Schedule 2A of the Patents Act 1977, as amended by the Patent Regulations 2000 to implement the Biotechnology Directive (98/44/EC). Genentech Inc’s Patent [1989] RPC 147. See footnote 23. Howard Florey Institute of Experimental Physiology [1995] 6 OJEPO 388 (V 08/94). However, the scope of this exception in relation to computer software and business methods is not clear. The EPO has taken a more liberal approach in its interpretation of this exception, finding on several occasions that software-related inventions are patentable. The UK courts adopt a more stringent approach, which includes an assessment of the technical contribution to the state of the art: see Symbian Limited v. Comptroller General of Patents [2008] EWCA Civ 1066.

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United Kingdom

f ii

• processes for modifying the germ line genetic identity of human beings; • the use of human embryos for industrial or commercial purposes; • the processes for modifying the genetic identity of animals that are likely to cause suffering without substantial medical benefit;37 and • a method of treatment, or method of diagnosis practised on, the human or animal body;38 and plant or animal varieties or biological process for the production of animals or plants. Applying for a patent

Patent protection in the UK can be obtained by the following routes. UK national patent A UK national patent is a patent granted by the UKIPO and is restricted in territory (as its name suggests) to the UK. The priority date (i.e., the effective date of filing when considering novelty and inventive step) is the date of filing, although it is possible to claim priority from an application filed within the previous year in the UK or abroad. In order to establish priority, a patent application must satisfy certain basic requirements, which include containing a request for the grant of a patent on the appropriate form; containing the applicant’s contact details; and describing the invention (i.e., containing a specification), or referring to an earlier application for the same invention which does so. The applicant must also pay the required fee. Within one year of making the initial application, a complete specification must be filed. This must disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.39 The complete specification will contain more details, the claims, worked examples, the abstract and the formal drawings. It is from the date of filing of the complete specification that the 20-year protection runs. The UKIPO must be instructed by the applicant to carry out a search to identify any prior art, either before or after the complete specification is filed. The applicant must pay the fee for this search. The specification is then published, along with the search results. Third parties are then able to draw the attention of the examiner to any prior art documents. The examiner need not take these into account, nor provide any reasons for not so doing. Substantive examination then takes place, which involves the identification of how the claims differ from the prior art. After the scope of the claims is agreed, the patent is granted and published. European (UK) patent Applications can be made for a European patent under the European Patent Convention (‘EPC’), resulting in a bundle of national patent rights in each European country designated by the applicant. A single application is made to the EPO designating the European countries in which protection is sought. The EPO conducts the searches. The 37 38 39

For the application of this provision, see Harvard/Oncomouse OJEPO 2005 229 (T0315/03). Patents Act 1977, s. 4A. Patents Act 1977, s. 14(3).

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United Kingdom effect of grant is that separate national patents are issued in each designated state. IV

ENFORCEMENT OF RIGHTS

Infringement and validity proceedings are heard and determined together.40 For the purposes of this chapter we shall concentrate on patent infringement and revocation actions only. i

Possible venues for enforcement

England and Wales First instance proceedings are commenced in the Patents Court in the Chancery Division of the High Court, which generally hears high-value, more complex matters involving extensive expert and fact evidence. Alternatively, cases (typically lower value claims less than £500,000) may be heard in the PCC. Scotland In Scotland only the Court of Session in Edinburgh is competent to hear patent proceedings. First instance patent proceedings are commenced in the Outer House of the Court of Session. The Court of Session has dedicated rules in terms of dealing with intellectual property matters (Chapter 55 of the Court of Session Rules) and dedicated judges (currently, Lady Smith, Lord Hodge, Lord Glennie, Lord Malcolm and Lord Pentland). A decision of the Outer House of the Court of Session can be appealed to the Inner House of the Court of Session. The Inner House comprises a bench of three judges and is the highest civil court in Scotland. Just like England and Wales, the Supreme Court (normally comprised of a panel of five judges) is the court of final appeal. If the appeal to the Supreme Court is from the Inner House of the Court of Session and relates to the whole merits of the case, permission to appeal is not required. However, the notice of appeal must be signed by two counsel who must certify that the appeal is reasonable. Northern Ireland First instance proceedings are commenced in the High Court of Northern Ireland. There has only been one patent case41 heard before the High Court in modern times. In that case, Siemens commenced proceedings against Seagate for patent infringement seeking an injunction to prevent the manufacture of read heads for hard disk drives containing artificial antiferromagnets in Springtown, Northern Ireland. Seagate counterclaimed that the patent was invalid. The judge construed the claim so as to limit it only to certain specifically identified magnetoresistance technologies and therefore concluded that, on the facts, Seagate’s products did not infringe.

40 41

Although this is not always the case, see Canady v. Erbe Elektromedizin [2005] EWHC 2946 (Pat). Siemens AG v. Seagate Technology (Ireland) Limited [2011] NICh 12.

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United Kingdom The High Court of Northern Ireland applies the Rules of the Court of Judicature (Northern Ireland) 1980, as opposed to the Civil Procedure Rules that apply in England and Wales, leading to subtle procedural differences. ii

Requirements for jurisdiction and venue

The general rule is that proceedings must be started in the defendant’s domicile but there is a further rule that patent validity can only be determined in the country where the patent has been registered. Accordingly, English courts will generally not hear cases dealing with infringement of non-UK patents if validity is at issue. Further, a claimant may bring an infringement action in the jurisdiction where the infringement occurred. iii

Obtaining relevant evidence of infringement and discovery

Disclosure Pursuant to Rule 31.6 of the Civil Procedure Rules, parties are generally automatically obliged to disclose documents on which they rely, those that adversely affect their or another party’s case or those that support another party’s case. In invalidity actions, disclosure is limited to documents coming into existence two years either side of the priority date (i.e., a four-year window). In infringement actions, disclosure is generally limited to a full and accurate product and process description relating to the potentially infringing product. Inspection of such documents can be withheld where they attract privilege. There are many forms of privilege; these include litigation and legal advice privilege. Confidentiality can be protected with a contract establishing persons entitled to see the documents and the terms on which they may do so (‘a confidentiality club’). Expert witnesses The primary evidence in patent actions is given by the parties’ experts. The court will determine whether experts may be instructed. In some cases, the parties are required to use a single agreed expert. However, it is more usual that the court will allow both parties to instruct experts, whose reports and replies to each other’s reports are exchanged prior to the trial and who may subsequently be cross-examined in court. Each party is generally allowed one expert unless there are several technical fields at issue. The parties’ experts give evidence as to the identity and attributes of the skilled person, the CGK that person would possess and the way in which that person would, as a matter of routine, approach problems within the relevant art. The experts are not intended to exemplify the skilled person, but are there to assist the court. Ideally experts should have been active in the relevant field at the priority date.42 An accepted approach43 is to ask an expert to consider the relevant prior art and priority documents before they consider the patent in suit. This ensures that they formulate a view on the prior art without knowledge of the invention. Additionally, any advocacy or perception of bias on their part attracts criticism and can be very detrimental to a party’s case. The correct selection and preparation of an expert without compromising 42 43

Datacard Corporation v. Eagle Technologies Ltd [2011] EWHC 244 (Pat). Medimmune v. Novartis [2011] EWHC 1669 (Pat).

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United Kingdom true independence is therefore crucial. Experts may be paid their usual fees and expenses. Experiments Where a party wishes to prove facts by way of experiment, he must serve a notice on the other side at least 21 days prior to the service of the application notice for directions, or later as directed by the court. Assuming that the facts are not admitted, the experiments are then conducted and the other party may request to inspect repeats. Usually an agreed report of the experiments is prepared for the convenience of the court. iv

Trial decision-maker

Generally, Patent Court cases with a high technical difficulty rating (4 or 5) will be heard by Floyd J or Arnold J. Cases in the PCC are heard by HH Judge Colin Birss QC. v

Structure of the trial

Types of patent action Various types of patent actions can be brought in the UK. The most important are as follows: a patent infringement action – for infringement of a UK patent or a granted European patent with the UK as a designated contracting state (‘EP(UK)’); b revocation action – to revoke a UK patent or an EP(UK); c declaration of non-infringement of a UK patent or an EP(UK); d application to amend a UK patent; and e entitlement proceedings over a UK patent or an EP(UK), applications for the same and any other application claiming priority from a UK patent. Structure of patent litigation procedure in the Patents Court The following is a very general overview of the patent litigation procedure: a issuance of claim form (usually served within four months of issue); b statements of case (particulars of claim, particulars of infringement/invalidity); c case management conference (sets the timetable for the rest of the action); d disclosure; e experiments; f exchange of expert evidence; g trial; h judgment; and i appeal (if any). Burden and standard of proof The burden of proving title and infringement lies with the claimant and validity with the defendant. The standard of proof is generally on the balance of probabilities.

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United Kingdom vi Infringement Infringing acts To be liable for infringement of a valid product patent, one must, without the patentee’s consent, make, dispose of, offer to dispose of,44 use, import45 or keep the product (for disposal or otherwise).46 To infringe a process patent, one must use or offer the process for use in the UK with knowledge (or where, in the circumstances, it would have been obvious to the reasonable person) that its use would be infringing;47 or alternatively dispose of, offer to dispose of, use, import or keep the product directly obtained by the process (for disposal or otherwise).48 UK patent law also provides for liability for indirect infringement (subject to limited exceptions) against a person that supplies or offers to supply in the UK any of the means relating to an essential element of the invention, for putting the invention into effect; where that person knew (or where, in the circumstances, it would have been obvious to the reasonable person) that the ‘means’ were suitable for the infringing purpose and intended infringement in the UK. Exemptions to infringement Section 60(5) of the Patents Act 1977 provides some statutory exemptions to infringement, including private, non-commercial acts; certain acts done for experimental purposes or for conducting a clinical trial; acts of preparing in a pharmacy or dealing with a medicine in accordance with a prescription; use of products or processes in specified vehicles that are temporarily or accidentally in territorial waters; and certain uses by farmers of the products of their harvest for propagation or multiplication or certain uses of breeding stock or patented animal reproductive material in agriculture. Further, Section 64 of the Patents Act 1977 states that acts done before the priority date and continued thereafter are not infringing, but the ‘act’ must be substantially the same.49 Claim construction In construing the claims, the court must ask: ‘What would the skilled person have understood the patentee to be using the language of the claim to mean?’50 The claims will be construed without reference to the infringing product. Recent cases have held that the

44 Note that it is possible to offer to supply a product prior to patent expiry, where the supply would only take place after expiry (Gerber Garment v. Lectra Systems [1995] RPC 383). 45 Liability for infringement by the act of importing is limited by the doctrine of exhaustion of rights, i.e., parallel patents may not be enforced against an imported patented product which was placed on the market within the EEA by the patentee or with the patentees consent. 46 Patents Act 1977, s. 60(1)(a). 47 Patents Act 1977, s. 60(1)(b). 48 Patents Act 1977, s. 60(1)(c). 49 Lundbeck v. Norpharma [2011] RPC 23. 50 See footnote 23.

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United Kingdom skilled person has a limited knowledge of patent law, such as a knowledge of divisionals51 and a knowledge of basic drafting conventions.52 The doctrine of equivalents has never been applied as such under English law. vii Defences Section 60(5) of the Patents Act 1977 provides some statutory exemptions to infringement including private, non-commercial acts; certain acts done for experimental purposes or for conducting a clinical trial; acts of preparing in a pharmacy or dealing with a medicine in accordance with a prescription; use of products or processes in specified vehicles which are temporarily or accidentally in UK internal or territorial waters; and certain uses by farmers of the products of their harvest for proapagation or multiplication or certain uses of breeding stock or patented animal reproductive material in agriculture. In some instances the Comptroller may grant a compulsory licence under section 48(1) of the Patents Act 1977. In others, it may be argued that a fair, reasonable and nondiscriminatory (‘FRAND’) licence must be granted for ‘essential’ patents. Revocation Although it is not actually a defence, it is not uncommon for a party defending an infringement action to commence a revocation action, for the determination of the validity of the patent in question. Such actions will likely be heard together. There are various grounds on which a patent may be revoked before the UK courts.53 These include where the invention is not patentable (i.e., lacks novelty or inventive step, is not industrially applicable, or is of excluded subject matter); lack of entitlement; insufficiency; added matter; and impermissible post-grant amendment. Lack of novelty (anticipation) Patents are considered to lack novelty where they relate to inventions that are disclosed and where that disclosure is enabling. In order to be ‘enabling’, the ordinary skilled man must be able to perform the matter disclosed, by using only the disclosure and CGK: he is not expected to display any degree of invention or prolonged research, inquiry or experiment.54 Parties seeking to invalidate for lack of novelty (or obviousness) are expected to restrict the citation of prior art to their best cases and excessive prior art may result in an adverse costs award. Lack of inventive step (obviousness) In order to determine obviousness, the court must consider at a general level whether the invention is obvious. To do so, it applies the following four-stage test (as put forward in

51 52 53 54

Virgin v. Premium Aircraft [2010] RPC 8. Ranbaxy v. AstraZeneca [2011] FSR 44. Patents Act 1977, s. 72. Mölnlycke v. Brightwake [2011] EWHC 376 (Pat) and General Tire v. Firestone Tyre (No. 1) [1971] FSR 417.

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United Kingdom Windsurfing55 and refined in Pozzoli 56), which, in short, requires it to: a identify skilled addressee and impute with CGK; b identify inventive concept of claim; c identify differences between prior art57 and claim; and d consider whether the differences would be obvious (without using hindsight). The UK courts have said that the question of ‘obviousness’ under point d must be considered on the facts of each case. Relevant weight must be attached to each factor, including the motive, to find a solution to the problem that the patent addresses, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success.58 Investigations of success may reveal contemporaneous reactions of others in the field (where high praise suggests a good invention) or commercial success (high sales suggest a good invention). For a patent to be valid, purported inventions must equally not be ‘obvious to try’ with a fair expectation of success.59 The expectation of success will be suitably decreased where, despite knowledge that the invention works in some cases at the priority date, it was not known how or why.60 Additionally, where there are a series of steps that need to be taken, and any one of those steps, or the series as a whole, were not obvious to try, the patent is likely to be valid.61 Lack of industrial application62 The skilled person must be able to derive the industrial explanation from the patent specification. That is, the technical purpose of the invention must be described in definite technical terms. It must not be to the skilled man to conduct further experiments. However, a substance disclosed with an essential function for human health will immediately suggest industrial application. Insufficiency In order to be valid, a patent must disclose the invention clearly enough for the skilled person to perform it: the patent must provide ‘enabling disclosure’ of the invention. The court, therefore, must first identify the invention by construing the claims (for a product, the making or obtaining of the product; for a process, working the process). Sufficiency must then be assessed on the basis of the specification, description and claims, taking into consideration that the addressee is the skilled person with CGK.

55 Windsurfing v. Tabur Marine [1985] RPC 59. 56 Pozzoli v. BDMO [2007] FSR 37. 57 It is irrelevant that the prior art was published only a few days before the priority date of a patent, even where the parties can prove that there was insufficient time to experimentally arrive at the invention from the prior art (Teva v. Merck [2011] EWCA Civ 382). 58 Generics v. Lundbeck [2007] RPC 32 at 72. 59 Conor v. Angiotech [2008] UKHL 49. 60 Omnipharm v. Merial [2011] EWHC 3393 (Pat). 61 Gedeon Richter v. Bayer Schering [2011] EWHC 583 (Pat). 62 See Section III.i, supra.

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United Kingdom The patent need not disclose every way of producing the patented product,63 nor teach every use of a broadly claimed method,64 but the specification must allow the invention to be performed without undue burden, over the whole scope of the claim. Lack of entitlement Section 72(1)(b) of the Patents Act 1977 provides that a patent may be revoked if the patent was granted to a person who was not entitled. Inventors are generally entitled to inventions, subject to employment contracts and licensing considerations.65 Added matter Section 72(1)(d) of the Patents Act 1977 states that a patent may be revoked if ‘the matter disclosed in the specification extends beyond that disclosed in the application for the patent, as filed’.66 viii

Time to first level decision

The timing of proceedings can vary depending on whether infringement, validity or both is in question, the technical complexity of the case and the number of grounds of invalidity and prior art citations pleaded. First instance proceedings generally take between 12 and 15 months to trial. Proceedings may be expedited at the court’s discretion, where there is ‘objective urgency’ and the other party is not prejudiced by the expedition. Such circumstances can include a party being subject to an interim injunction whereby expedition of the trial will give them a commercial advantage.67 The fact that there is ongoing litigation on an EP patent in another jurisdiction and a UK validity decision could be persuasive in that jurisdiction is a factor that may be considered,68 but is not decisive.69 ix Remedies Injunctive relief (interim and final) Interim injunctions may be granted where patentees have an arguable case and can prove that they will not be adequately compensated by a damages award at full trial. On rare occasions, such injunctions can be granted without notice but normally the substantive hearing is inter partes. Generally, the fact that a party has been found to infringe is sufficient basis for a court to infer that the party intends to continue to infringe and for the court to grant injunctive relief.

63 See footnote 49. 64 Medimmune v. Novartis [2011] EWHC1669 (Pat). 65 Inventions created in the course of an employee’s duties, or that might reasonably have been expected to result from those duties, generally belong to the employer. 66 Triumph Actuation Systems v. Aeroquip-Vickers [2007] EWHC1367 (Pat). 67 Warner-Lambert Company LLC v. Teva UK Ltd & others [2011] EWHC 2018 (Ch). 68 HTC Europe Co Ltd v. Apple Inc [2011] EWHC 2396 (Pat). 69 ZTE (UK) Ltd v. Telefonaktiebolaget LM Ericsson [2011] EWHC 2709 (Pat).

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United Kingdom An interim injunction can be obtained very quickly in the UK,70 but where such an injunction is obtained, the UK courts are increasingly likely to order an expedited trial.71 Additionally, it is almost always the case that patentees are required to give the defendant (and possibly any other parties who suffer loss) a cross-undertaking in damages prior to the grant of an interim injunction.72 Final injunctions are normally granted for the remaining term of the patent in cases of infringement, except where an entry is made on the register noting that licences of right are available. Damages or account of profits A successful patentee can choose either damages in respect of the infringement or an account of profits. Damages are not punitive but compensatory, based on the foreseeable loss suffered by the patentee as a result of the infringement. The intention is to restore the patentee to the position it would have been in had the wrongful act not been committed. However, where a defendant infringes knowingly, or with reasonable grounds to know, the court can award punitive damages, although this is rare. Damages are generally determined by assessing a reasonable royalty rate had the infringer taken a licence on the patentee’s normal terms; or, where the patentee does not grant licences, a reasonable price based on the rate a potential licensee that is not already on the market would pay, taking into account the licensing trends in the industry. Where the patentee is a manufacturer, it may also include any loss of profits due to the sale of infringing goods or other damage caused by the unauthorised sale. The patentee must prove its loss. Alternatively, the patentee may elect an account of profits, thereby depriving the defendant of its profits made as a result of infringement (after deduction of its allowable costs: R&D, financing, manufacturing and distribution costs and corporation tax, which may cumulatively reduce the profits substantially). Such profits can only be claimed to the extent that invention has been used, and so they will be apportioned where the patent protection is only infringed by part of the defendant’s product or process. Once damages or profits have been ordered the issue is res judicata and subsequent revocation73 or amendment74 of the patent at EP level does not change the patentee’s right to damages or profits. Delivery up or destruction In addition to damages or an account of profit, the court can award an order for the delivery up or destruction of the infringing goods that are in the defendant’s possession, power or control. This includes those goods that are held by a third party for delivery, but generally not those that have been sold to third party retailers.

70 71 72 73 74

Warner Lambert Co v. Teva [2011] EWHC 1691. Warner Lambert Co v. Teva [2011] FSR 44. Compare the cases of Lilly v. 8pm Chemists [2010] FSR 4 and Servier v. Apotex [2011] RPC 20. Unilin Beheer v. Berry Floor [2007] EWCA Civ 364. Virgin v. Contour [2011] EWCA Civ 163.

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United Kingdom Dissemination of judgment Where the court finds infringement, the patentee can request dissemination of the judgment at the infringer’s cost. Declaratory relief The patentee may request a declaration of validity and infringement. Costs Although the court has a wide discretion, the general rule is that the losing party in litigation will be ordered to pay the winner’s costs. In reality, the winning party will not receive a full indemnity in respect of his costs since the losing party will invariably challenge particular costs, for example high charge out rates or inappropriate level of fee earner on a particular task. Where a party has acted particularly unreasonably, the court may award higher indemnity costs against it or, in really exceptional cases, against its lawyers. As well as the basis on which the court is assessing costs, the court must also take account of various factors in deciding the amount the receiving party is entitled to: a the value involved; b the conduct of the parties (and in particular the efforts made in order to try to resolve the dispute); c the complexity of the case; and d the time spent on the case. Lawyers are required to provide estimates of cost for their clients at the outset and as the case progresses. Contingency fees are not permitted but discounts for failure and uplifts for success can be negotiated and some forms of insurance for legal costs are available. x

Appellate review

In England and Wales, the Court of Appeal (comprises a panel of three judges) hears appeals from the Patents Court. All appeals require permission from the Patents Court or the Court of Appeal itself. The Supreme Court (normally comprised of a panel of five judges) is the court of final appeal. Appeals are only allowed where the decision of the court of first instance is wrong in law. Appeal courts will not reopen factual issues previously decided unless there is good reason to do so. Appellants’ notices must be filed within 21 days of the decision, and the respondents’ notices within 14 days of service of that notice. No further evidence will be admitted, unless that evidence could not, with reasonable diligence, have been obtained for use in the first trial; would probably have an important (albeit not necessarily decisive) influence on the result of the case; and it is apparently credible. xi

Alternatives to litigation

Alternative dispute resolution (‘ADR’) involves an independent third party who helps parties to a dispute to resolve that dispute. ADR can provide a quick and relatively inexpensive means of resolving a dispute in a commercially sensible manner although often the result may not be entirely in accordance with the parties’ legal rights and cannot be enforced in the same way as a court judgment. Various ADR procedures are available,

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United Kingdom including mediation, arbitration and expert determination. In addition, the UKIPO can offer non-binding opinions on infringement and validity (novelty, inventive step or both only) of a UK patent, following the submission of written papers by the party applying for the opinion. The other party may file observations, but does not become a party to the proceedings. Currently the procedure costs £200 and the process takes approximately three months. None of these forms of ADR can result in injunctive relief and consequently such procedures are not much favoured by patentees. V

TRENDS AND OUTLOOK

i

Unified Patent Court

The concept of a unified patent litigation system (‘UPLS’) for Europe has been publicly discussed for many years. However, some significant developments occurred in the last year. In early 2011, an ‘enhanced cooperation’ procedure was approved by the Legal Affairs Committee of the EU for agreeing a unitary patent (with the exception of Spain and Italy). On March 2011, the Court of Justice of the European Union (‘CJEU’) delivered a judgment that the UPLS was not compatible with EU treaties, primarily because national courts would be deprived of their power to make references to the CJEU. The EU Presidency then put forward a proposal taking into consideration the CJEU’s objections, and the Council of the European Union subsequently agreed that two draft Regulations (one relating to how patentees obtain European patents and the other dealing with translation arrangements) would be sent to the European Parliament for approval. The new proposal limits the agreement to EU Member States only; a new international treaty would be put in place for the non-EU Member States. With the critical draft documents in place, the Polish EU Presidency pushed forward its proposals. Many commentators question the proposals. The most major concerns included the proposed significant role of the CJEU in patent litigation going forward and the optional bifurcation of validity and infringement issues. A Competitiveness Council meeting took place in December 2011 at which there was a stalemate, with Munich, London and Paris each bidding for the location of the important Central Division and no compromise being possible. A statement issued after the Council meeting on the 30 January 2012 noted that ‘the participating Member States commit to reaching at the latest in June 2012 a final agreement on the last outstanding issue in the patent package’, namely the seat of the Central Division. The Hague, Budapest and Milan have all now entered the bidding. What happens next is currently impossible to predict as a result of the incoming new Danish EU Presidency, which has yet to make its intentions clear. ii

Court of Appeal

The effect of changes in the UK Court of Appeal panel will become apparent over the coming year, as further decisions of Kitchin and Lewison LJJ are handed down. In particular, their interpretation and application of the principles formulated by Jacob LJ will be eagerly anticipated, as will any new guiding principles.

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United Kingdom iii

Patents County Court

The revamp of the PCC has been welcomed. The new procedures offer a cheaper forum for less complex IP cases. The popularity of the PCC is likely to increase over time as decisions of the court and its flexible approach to case management become clearer and more certain.

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Appendix 1

About the Authors

EDWARD NODDER Bristows Edward Nodder has specialised in intellectual property, especially patent litigation, for over 30 years. Edward is experienced in all technical fields, including electronics, but is particularly active in the life sciences sector, acting for some of the largest pharmaceutical, biotechnology and medical devices companies. He has developed successful strategies, combining patent and regulatory law, to assist his pharmaceutical clients facing the challenge of generics. In such matters, he has often coordinated cross-border litigation and advice within Europe and beyond. Most recently, he jointly leads the team successfully obtaining preliminary injunctions and other relief for Novartis against generic suppliers in many countries around the globe. ALAN McBRIDE Bristows Alan McBride specialises in contentious intellectual property law, particularly patent litigation in the life sciences sector. He has assisted in pharmaceutical patent litigation proceedings before the High Court, the Court of Appeal and the House of Lords (Supreme Court). His background in biochemistry gives him a solid grounding in the technical aspects of intellectual property matters. Alan works as part of a team of associates who are responsible for global pharmaceutical product coordination projects, in which he manages IP litigation in the UK and in a number of other jurisdictions. He regularly works alongside lawyers and patent attorneys in various jurisdictions within Europe, Asia and Australasia.  CLAIRE PURKISS Bristows Claire Purkiss specialises in intellectual property litigation and has a particular interest in the life sciences sector. Her biochemical background lends itself to the technical aspects of intellectual property matters, particularly in the pharmaceutical and biotechnology fields. She is part of a team of associates who are responsible for a global pharmaceutical product coordination project.

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About the Authors EUAN DUNCAN McClure Naismith Euan Duncan is a partner in McClure Naismith’s corporate unit, specialising in intellectual property protection and commercialisation; software licensing and IT system development; all e-commerce IT and internet regulatory issues, media contracts and sponsorship. His clients include a number of UK banks (including an online/virtual bank) and various other financial institutions, and he has been involved in Court of Session actions relating to claims of trade infringement; passing off and unregistered domain rights. Bristows 100 Victoria Embankment London EC4Y 0DH United Kingdom Tel: +44 20 7400 8000 Fax: +44 20 7400 8050 [email protected] [email protected] [email protected] www.bristows.com McClure Naismith 292 St Vincent Street Glasgow G2 5TQ United Kingdom Tel: +44 141 204 2700 Fax: +44 141 248 3998 [email protected] www.mcclurenaismith.com

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