Infringement & Validity Study Guide to the
Paten t E xa min a t i o n B o a rd Final Diploma 4 Examination
Philip Barnes
Infringement & Validity Study Guide to the
Patent Examinat i o n B o ard Final Diploma 4 Examination
By Philip Michael Barnes
2024
The moral rights of the author have been asserted. All rights reserved. No part of this publication may be translated, reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the author. © Philip Michael Barnes, 2024 Published and placed on sale by: The Chartered Institute of Patent Attorneys 2nd Floor Viaro House 20 – 23 Holborn London EC1N 2JD United Kingdom Tel: +44 20 7405 9450 Fax: +44 20 7430 0471 Website: www.cipa.org.uk
ISBN 978-0-903932-85-1 Printed and bound by Hobbs – www.hobbs.uk.com
FOREWORD It has been a while since the CIPA FD4 Study Guide was updated, for which I apologise! A bit of history: in 2018, I was asked by CIPA to update their FD4 Study Guide but only had time to edit what had previously been written and updated for several years by Nigel Frankland. If I had had more time, I would have rewritten the whole book in my own style. I had always intended to re-write the whole book shortly thereafter, as a future edition. Since then, there have been many incremental changes to the FD4 examination. Every year, these changes increasingly make me think that FD4 Study Guide needs updating, as they move the exam further and further away from the position in the book. I am pleased to report that I have finally done so. My attempt at a complete re-write started in 2020 during lockdown and has taken (much) longer than expected, but I hope you think the results are worth it. I am no longer an examiner for FD4, but actively tutor candidates for the exam both in my firm and on revision courses. This has helped me test what works for candidates to pass the exam. I now plan to update this study guide annually to avoid the incremental changes to the examination building up between updates of the study guide. Hopefully, by declaring this publicly, here, I will be kept honest and actually review and update the study guide each year shortly after the exam results are published (which will allow me to update the book having reviewed the previous year’s exam, marking schedule and examiner’s comments). Philip Barnes Windsor, May 2024
CONTENTS
1. Introduction to FD4................................................................................... 1 2. The Legislation.......................................................................................... 7 3. The Case Law.......................................................................................... 37 4. The FD4 Examination.............................................................................75 5. Interpretating Patent Claims .............................................................. 83 6. Assessing Infringement........................................................................ 91 7. Assessing Novelty.................................................................................. 97 8. Assessing Inventive Step.................................................................... 101 9. Assessing Sufficiency......................................................................... 107 10. Identifying Amendments.................................................................... 111 11. Preparing Advice.................................................................................. 115 12. Preparing For FD4................................................................................ 119 13. Conclusions..........................................................................................121
CHAPTER 1
INTRODUCTION TO FD4
FD4 in a nutshell The ‘Final Diploma 4: Infringement & Validity’ (usually referred to as ‘FD4’ and previously known as, and still commonly referred to in the profession as, ‘P6’) examination seeks to test a candidate’s ability to prepare an infringement and validity opinion for a set of (typically granted) patent claims for (at least) one potentially infringing article and in view of (at least) one piece of prior art. Different variations on this theme are possible, for example where the patent is still pending or where there are more than one potentially infringing articles or more than one pieces of prior art. I will go into some of the possible permutations later in this book. To answer the question paper, candidates need to attempt to prepare a summary of key points of interpretation for the claims being considered, assess the likelihood of infringement by any potentially infringing articles and then assess the likely validity of the claims being considered; following which candidates should prepare a short analysis of whether there are any sufficiency issues worth f lagging, and propose any potential amendments that might potentially fix any issues with the validity of the claims being considered while maintaining that infringement is likely; and then finally some advice is prepared to summarise the situation and both pro-actively offer relevant advice to the ‘client’ and reactively advise the ‘client’ in response to a set of questions posed in a letter from the ‘client’.
In just over five hours. People who have previously sat this paper will probably tell you that one of the top challenges about this paper is either the amount of work to do, or the time available (essentially variations of the same theme, as you will appreciate: time). This isn’t true for everyone, as some people can complete the paper in the time available once
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CHAPTER 2
THE LEGISLATION
At first glance, this exam should seem easy in terms of theoretical knowledge: you need to understand the law on (a) validity and (b) infringement. However, this isn’t the whole story. There are also the matters of sufficiency and amendment, which are two separate sections of the paper each of which score marks for an answer. You will also need to know a little bit about a lot of patenting issues in order to be able to give a solid answer to the advice section. In the advice section, the fictitious client will either need answers to their questions (set out in the client letter in the exam paper) or they will raise issues somehow, in their letter or by virtue of the situation they find themselves in, that need to be f lagged to them and/or on which they might need some more concrete advice. Throwaway comments in the client letter (in the exam paper) are rarely able to be dismissed completely. Typically, these are cues from the examiners to advise on a particular legal point, like inventorship or ownership to pick some example issues that might be raised (and have been in the past). Consequently, it is useful to have done the FD1 exam recently, or to be doing it at the same time as doing the FD4 exam, as this will provide most if not all of the legal knowledge needed to advise in a typical FD4 exam. To assist with preparation for the FD4 examination, I have put together a brief guide to the relevant sections of the legislation that you should study in relation to each section of the paper. I have also prepared summaries of some of the relevant case law. All sections mentioned are those of the Patents Act (as amended) at the time of writing so do be careful to check in case any updates have been made!
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THE LEGISLATION
Declaration of non-infringement This doesn’t seem to have come up that often in recent papers, but certainly should be a tool of which you are aware. You will need to know about and research Section 71 of the Act. This provision allows third parties to write to patent proprietors with full details of what they are doing and with a formal request for the patent proprietor to confirm in writing that this is accepted as non-infringement of their patent. If the patent proprietor fails to reply or refuses to give such a declaration, then the court or the comptroller can be requested to make such a declaration. The third party does need to give the patent proprietor sufficient time to consider the request. There have been some examples where third parties have written to the patent proprietor requesting a declaration of non-infringement and either on the same day or the next day brought proceedings for non-infringement at the Court, which was viewed dimly by the Court! When going to the Court or Comptroller with a request for a declaration of noninfringement, the third party needs to show that they have complied with the details of Section 71 and show copies of any relevant correspondence with the proprietor and evidence that they have sent the proprietor the required evidence etc.
European Patents Where the patent is an EP(UK), bear in mind that the parent European patent may still be within the nine-month opposition period, so check this and it might be worth offering up as advice the option to challenge the European patent centrally via filing an opposition.
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CHAPTER 3
THE CASE LAW
List of cases Actavis UK Ltd v Eli Lilly and Co [2017] UKSC 48...................................... 57 Adhesive Dry Mounting v Trapp (1910) 27 RPC 341.................................. 39 Aerotel Ltd v Telco Holdings Ltd and Macrossan’s Patent Application [2006] EWCA Civ 1371 ......................... 67 Ancon Limited v ACS Stainless Steel Fixings Limited [2009] EWCA Civ 498............................ 49 Astron Clinica Ltd & Others [2008] EWHC 85 (Pat)........................... 69
BOS GmbH & Co KG v Cobra UK Automotive Products Division Ltd [2012] EWPCC 38 ..............................53 Catnic v Hill & Smith Ltd [1982] RPC 183....................................... 41 Conor Medsystems Inc (Respondents) v Angiotech Pharmaceuticals Inc and others (Appellants) [2008] UKHL 49..................................... 71 Improver Corp v Remington Consumer Products Ltd [1990] FSR 181........................................ 43
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Kirin-Amgen Inc and others (Appellants) v Hoechst Marion Roussel Limited and others (Respondents); Kirin-Amgen Inc and others (Respondents) v Hoechst Marion Roussel Limited and others [2004] UKHL 46..................................47 Lubrizol v Esso BL C/110/96 and [1998] RPC 727.................................................. 45 Napp Pharmaceutical Holdings v Dr Reddy’s Laboratories (UK) [2017] EWHC 1517 (Pat)........................ 61 Pozzoli SPA v BDMO SA & Other’s [2007] EWCA Civ 588............................ 65 Smith & Nephew Plc v ConvaTec Technologies Inc [2015] EWCA Civ 607............................ 55
Virgin Atlantic Airways Ltd v Premium Aircraft Interiors UK Ltd [2009] EWCA Civ 1062.......................51 Warner-Lambert v Generics [2018] UKSC 56...................................... 73 Windsurfing International Inc v Tabur Marine (Great Britain) Ltd [1985] RPC 59......................................... 63
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THE CASE LAW
second medical use patents shouldn’t be allowed for speculative use cases but that the patentee should be required to disclose some reason for regarding the assertion of a second medical use as plausible (but that it seemed generally accepted that the threshold for this plausibility test was low in order only to prevent speculative claims). Legal test proposed from this case: The claims must be supported by the description. Further reading: n/a
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CHAPTER 4
THE FD4 EXAM
Introduction It is always worth reviewing the syllabus for FD4 each year, especially to note any changes from previous syllabi as this can give you an indication of any planned shift in the ‘direction’ of the examination that will manifest in this year’s paper. The current version of the syllabus is the 2024 edition at the time of writing and is unchanged from the 2023 edition. It is divided into several sections: (i) some guidance for candidates; (ii) the syllabus in table format; (iii) a reading list; and (iv) an overview of the structure of the paper.
Guidance In the guidance section, there is some general information on what the final diplomas are versus the foundation level examinations and in particular that the difference between the two sets of exams is primarily that the final diploma examinations test the core competencies expected of a patent attorney. The guidance section also sets out what candidates need to demonstrate and what is being tested. Specifically, the following are listed as things candidates need to demonstrate: – a thorough knowledge and understanding of the law; – application of this knowledge in a manner that is appropriate to the facts and the client’s needs; and – providing advice expressed in a clear and consistent manner.
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CHAPTER 10
IDENTIFYING AMENDMENTS
Introduction The amendment section also tends to be pretty short. Depending on each candidate’s answer up to this point in the examination, candidates sometimes find themselves having very little to say, or very different amendment source material to consider compared to what the examiners were expecting. Generally, what the examiners want is either for candidates to propose sensible options for amendment, or they want candidates to propose the best available amendment (preferably one that both is infringed and valid, but at the very least restores validity if this is an issue). The amendment section has changed over time (in the exam papers), in my opinion, between rewarding finding ‘THE amendment’ and rewarding finding a selection of useful amendments. Over the last ten years of papers from 2013 to 2023, initially the examiners seemed to be looking for one amendment that restored validity and infringement but over this time the examiners seemed to accept that there were multiple options for amendment and that candidates didn’t always reach the same conclusions as the examiners in order to then reach the same one amendment that the examiners had in their marking schedule. As a result, the examiners moved to a more flexible position where they awarded marks for a range of possible amendment that candidates could flag for consideration, nominally by the client. The more recent papers (2020 onwards) seem again to concentrate on rewarding finding ‘the’ amendment (i.e. one that restores validity and maintains infringement) but, interestingly, also introduces the (potentially more realistic) possibility that there is no useful amendment to be found as the possible amendments might restore validity
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CHAPTER 11
PREPARING ADVICE
Introduction The advice section is probably one of the worst-answered sections of the FD4 exam purely because it is the last section most candidates reach when writing their answer and therefore the section that is most time-pressured. Some candidates either don’t reach this section because they have already run out of time, while others reach this section with very little time remaining and aren’t able to write very much in the time they have remaining in the examination. This section requires relatively little writing to score the points available, as the examiners have always made it clear that they are able to accept ‘note-form’ answers rather than fully written out detailed pages of writing per point of advice. Typically, the advice expected is driven by the conclusions reached by the candidate combined with the question(s) asked by the client in the client letter. Some of the advice expected is reactive to the conclusions reached while other advice is expected in reaction to the questions posed in the client letter by the client.
What do the examiners say? the examiner will, pretty much every year, say something along the lines that ‘few candidates provided anything other than superficial advice to the client’ or ‘the advice from most candidates was superficial at best’. As a more general statement, the examiners have also previously reminded candidates that ultimately the problem presented in this paper is one of advice for the client and while credit is given for the underlying work, the advice itself is important but in most cases an afterthought. I completely agree with this general statement but personally note that the marks allocated to the advice section are typically 10% of the total marks
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