1.What is FD4 all about?

What is FD4 all about?

Coverage

The syllabus for FD4 is considered, and the nature of a typical paper is discussed.

After you have read this chapter, you should be aware of:

1. The main features of the syllabus.

2. The format of a typical paper.

3.The overall structure of a typical marking schedule.

4. The main components of a successful answer.

Infringement and Validity is a paper that has been sat by generations of candidates seeking entry on the register of patent attorneys, or, formerly, the register of patent agents. The examination started in the 1930s as ‘Infringement and Criticism of Specifications’, and towards the end of the century had become papers ‘I’ and ‘J’ – both called ‘Infringement and Validity’, and both of which had to be passed in a single year. In the early 1990s a single paper ‘P6’ was introduced, and this became FD4 in 2015.

For many years there was no published syllabus, but this omission was rectified in 2006 with a syllabus that set out 14 different ‘competencies’ that the examination set out to test. Following the establishment of the Patent Examination Board a totally new syllabus was issued for the 2015 examination and has been updated each year since then.

The latest published syllabus at the time of writing may be found at http://www.cipa.org.uk/EasySiteWeb/GatewayLink.aspx?alId=8559. The syllabus can be summarised briefly as requiring candidates to be able to construe patent claims, and to be able to determine the patentability of the claims, with special regard to novelty and inventive step, and to evaluate the possibility of amending the claims so as to ‘improve’ their validity, while maintaining at least an argument that the claims are infringed, with the reasons why the claims are valid and infringed being given. Candidates must also be able to determine questions of infringement, and be able to consider ‘design around’ possibilities, as well as being familiar with the procedures for challenging the validity of a patent. Finally, candidates must be able to advise a lay client covering various points, but especially providing, with reasons, a recommended course of action.

The syllabus lists the various legal provisions in The Patents Act 1977, Patents Rules 2007, and EPC 2000 that should be familiar to the candidate.

As most candidates should hopefully know, the Supreme Court has handed down its judgment in Actavis v Lilly ([2017] UKSC 48). This is a landmark decision and, as such, will form the basis of all infringement analyses henceforth. As the decision was handed down more than six months before the date of the 2018 Final Diploma examinations it is applicable to the 2018 FD4 examination. It will be important that this decision has been read and understood by candidates for the 2018 examination.

It is recommended that you download and read the syllabus, which also includes a reading list, and indicates that the examination paper will include a letter from a client and a set of accompanying documents (and it reasonable to expect those documents to include at least one patent that might be infringed and some prior art) and an instruction to prepare a memorandum of advice prior to a meeting with the client.

All of this sounds very much like a typical day in the office – but FD4 is in many ways a very different experience (mainly because of the time constraints and the subject-matter involved being unfamiliar). Please also bear in mind that the examination is an artificial construct designed to test your skills in relation to infringement and validity analysis rather than your knowledge of the subject-matter involved.

You will be expected to read the documents provided, and determine which patent(s) might be infringed by any of the activities of any of the parties in the scenario, and whether the patent(s) is/are valid, or can be amended to become valid. Then, on the basis of the infringement and validity conclusions that you have reached, you are expected to provide a memorandum of advice.

The situation may be very straightforward, with a client wishing to launch a new product, which is described and illustrated. An infringement clearance search may have revealed one potentially infringed patent, and some documents that are ‘prior art’ against that patent. However, the situation may be more complicated, with the client holding a patent that is infringed by a competitor, and the competitor holding a patent that is infringed by the client. As in real life, you are presented with a situation, and first of all you have to understand the situation before considering the documents in detail.

Of course, patent attorneys should be able to understand patents relating to the technical area in which they operate. However, the technical areas where innovation is common are now very diverse, and are frequently very complicated or technically challenging. Clients appreciate this and generally do not expect a patent attorney who is, for example, active in the field of biotechnology to advise on a case involving advanced electronics. Because a single paper has to be sat by candidates with very different technical backgrounds, FD4 examiners will choose an area of technology that is relatively simple and straightforward.

In real life, when a client writes a letter to a patent attorney it is almost inevitable that the client will provide some information that the patent attorney will not need, and it is also quite common for the patent attorney to need further specific items of information which are not fully disclosed by the client before a final opinion can be formed. You must be able to identify and concentrate on the information that you need to consider. You must be able to disregard anything that is irrelevant, while concentrating on the relevant information provided to get as close to an opinion as possible. So, in a typical FD4 paper the examiners may well include some

information that is absolutely irrelevant to any of the points at issue, and may well omit some critical data. It is also common for there to be issues on which advice may be required, but these are ancillary to the main tasks at hand (assessing infringement and validity) which candidates need to treat cautiously to avoid spending too much time preparing an answer to in order to concentrate on gaining the bulk of the core marks available for the main tasks.

Consequently, you must not be surprised if some critical information is missing, which may be information that would make all the difference to the final opinion.You may need, for example, the precise publication date of a document, or the precise date that the client first produced and sold his product. If information is missing, you must be able to work out what missing information you need, and then remember to ask for it!

In many leading cases the whole question of whether the patent is valid and infringed, or not, has hung on a single word or phrase. In the long-running saga of Kirin-Amgen v Hoechst Marion Roussel [2005] RPC 9, [2004] UKHL46 (and http://www.bailii.org/uk/cases/UKHL/2004/46.html), which ended in the House of Lords a matter of days before the patent expired, everything hung on what was, and what was not, a ‘host’ cell. (The bio-tech subject-matter of this case will almost certainly be totally unintelligible to all except bio-tech experts –for physicists and engineers it should be mentioned that the main claim included a reference to the host cell, and also contained the words ‘product of eukaryotic expression of an exogenous DNA sequence’ – the word exogenous clearly suggested that a ‘host’ cell was being used to receive the DNA that was finally expressed.) The putative infringement used a different technique to express the DNA, and it was argued that this technique did not use a ‘host’ cell as required in the patent. This must be considered to be a ‘real-life’ example of a ‘finely balanced point’.

It is not unusual in leading patent cases for a lot to depend on a little in this way, with one or two words making all the difference. In Catnic v Hill & Smith Ltd [1982] RPC 183,everything depended on the meaning of the words extending vertically, and in Improver Corp. v Remington [1990] FSR 181 the precise ambit of a helical spring was the point at issue.

So in each of these ‘real-life’ cases, there was only one principal point that was finely balanced, and the whole case would topple one way or the other depending upon the resolution of this single point.

In FD4, however, you can expect the examiners to introduce several points that are ‘finely balanced’ into the paper. This will help you if you miss one of the balanced points, as you can demonstrate your skills when tackling another one. In this respect, a typical FD4 paper, while seeking to emulate real life, can be seen to take things to a bit of an extreme or unreal position – but a position that is at least almost believable. Candidates should try to remain watchful that they have not taken extreme positions on points in the paper that the examiners expect them to discuss, as taking an extreme position may give the satisfaction of a quick and clear answer but this is unlikely to allow them to discuss the point fully and receive all of the available marks available for that point.

You should be able to identify the ‘finely balanced’ points, and especially any ‘finely balanced’ points which, if they fell one way would lead to one conclusion on infringement or validity, and if they fell the other way would lead to a very different conclusion. You should be able to appreciate the two ways that each point could fall, and then be able to choose one as being appropriate, and somehow provide a reasoned justification of that choice.

You can expect the paper to have a letter from a client that sets the scene, and which may ask for advice on specific points, such as whether a specific act infringes a patent, or whether the patent is valid. To obtain maximum marks you must make sure that you provide advice on all of these points. You will have the patent, of course, and some indication of the nature of the infringing act or acts, which may be in the letter from the client, or in a separate document. There will also be some prior art, some of which may be prior used or prior proposed products or processes acknowledged as prior art in the patent, or which may be prior use identified in the letter from the client. Typically, the prior art includes at least one prior patent specification, and at least one non-patent disclosure, such as a textbook, a publicity leaflet, or an instruction leaflet which makes a possibly relevant technical disclosure. The prior art may be used to generate a ‘novelty’ attack on at least some of the claims of the patent, and also a ‘lack of inventive step’ attack.

The examiners will try and make the scenario as life-like as possible, but inevitably, where a situation is concocted for examination purposes it may seem a bit surreal from the technical point of view, and sometimes also from the commercial point of view. However, you must ‘play the game’ and accept the situation as it is presented to you.

In recent years the FD4 marking schedule has been published, but some information on the breakdown of marks in years prior to this was available in the examiners’ comments. It is clear that the marking schedule each year has the same overall form, with marks being awarded in a consistent set of sections (precisely what has to be done to obtain the marks in each section is the subject-matter of subsequent chapters of this book). However, the actual number of marks in each section of the schedule varies with the details of the paper. To give you an idea as to how the marks are divided between the sections here is a table analysing the marking schedules in a ten-year period.

Year Interpretation Infringement Novelty Inventive step Sufficiency Amendment Letter Float

2008 27.5 27 24 11 1 3 6.5 –

2009 26.5 23 24.5 15 1 2 8 –

2010 27 20.5 22 15 0.5 6 9 –

2011 20 22.5 30.5 14 1 4.5 7.5 –

2012 21.25 18.75 34.5 14 0.5 2 9 –

2013 20 27 27.5 12 0.5 5 8 –

2014 24 20 24 18 2 2 10 –

2015 18.5 27 18.5 21 4 1 10 –

2016 20.5 14 26.5 20 5 2 12 –

2017 19 19.5 24.5 19 3 3.5 12 –

The first section of the marking schedule always relates to ‘construction’ or ‘interpretation’, and we will come to what this means and how it is done later on. In a ten-year period the highest mark was

27.5 and the lowest was 18.5. The next section of the schedule relates to ‘infringement’ where the features of each possible infringement have to be compared with the features specified in the claims, and here the marks range between 14 and 27. The ‘novelty’ section relates to a comparison of the teaching of the prior art and the claims, to see if any claim or claims are anticipated, and the marks range between 18.5 and 34.5. The ‘inventive step’ section relates to an analysis as to whether the claims can be considered ‘obvious’, and here the marks range between 11 and 21.

These first four sections of the marking schedule account for a very large proportion of the marks, but each year there have between half a mark and five marks for discussing sufficiency issues, one to six marks for discussing possible amendments to the patent and between 6.5 and 12 marks for the advice to the client. It might be thought that the distribution of the marks between the sections should be predetermined and fixed. However, when a client presents a problem in the office, before you look at the papers you do not know if the problem involves difficulties on infringement, or on novelty, or on inventive step. Sometimes the question of infringement can take seconds, and novelty can take days. The attorney has to be able to see where the problem lies, and direct attention in an appropriate manner. The marking schedule to FD4 reflects real life, in that it cannot be predicted.

The marking schedules for the 2014 examinations onwards have been published by the Patent Examination Board, and can be found online. It is recommended that you download and study the recent marking schedules (perhaps once you have done the relevant papers!), as it will begin to give you an idea as to what the examination is all about.

The first thing to observe when reviewing the marking schedules is that the great majority of the marks were awarded as single marks or half marks. There was no ‘key point’ that attracted a large number of marks. Consequently, even if you missed several of the ‘points’ that the examiner had woven into the question, you could still pass with a good mark.

The second thing to observe is that in each of the first three sections, namely construction, infringement and novelty, the marks are spread fairly evenly, both among the individual claims, and among the features in each claim. Thus, completing as much of the paper will aid candidates in accessing the marks available.

At the beginning of the infringement section there is reference to the fact that to score marks candidates must refer to the relevant part of the disclosure relating to the infringement, and no marks can be awarded for simply saying that a feature is there without indicating precisely where the feature is to be found. From the nature of the comments in the novelty section it is clear that the same rules apply, and candidates must show exactly where each feature is disclosed for the marks to be scored. Therefore, candidates should ensure that they consistently give page and line references (and sometimes Figure references, or both) when completing these sections.

So, what is it that the examiners want to see in a good attempt at a the FD4 paper? Briefly, the examiners find it easiest to deal with an answer having seven separate sections corresponding to the seven sections of the marking schedule. The sections will be summarised briefly now, and will be discussed in detail in subsequent chapters. It is important to appreciate that the examiners really want to see the candidates’ work product in all of the sections of the answer, and previous examiners’ comments have suggested that it may be, at the very least, extremely difficult to pass FD4 if candidates do not actually get as far as writing the memorandum of advice to the client. So, the examiners would like to see all seven sections of

the marking schedule clearly reflected in your written answer, and you must make sure that you write a memorandum of advice, even if you have to skimp on some of the earlier sections to be able to do this.

The examiners have indicated in the past that they would like to see the answer to the question begin with an initial section simply titled ‘Construction’ or ‘Interpretation’ – with no preface outlining what is to be done. Candidates will do well to note that there are no marks for any sort of introduction in any case so some time can be saved by simply diving straight into writing the meat of your answer. In this section candidates are expected to set out the meaning of the claims, especially selecting for discussion any words or phrases in the claims of the patent that have a meaning that is not totally clear, and where the precise meaning can have an effect on the determination of infringement and/or validity. The precise meaning of each selected word or phrase should be deduced from information provided in the paper, and the meaning should be explained in such a way that when the word or phrase is subsequently compared with a feature in the infringement or in the prior art, it is easy to conclude whether the feature is within the ambit of the claim, or is excluded from the claim. However, it is important that the reasoning behind your interpretation should be outlined, and the information that is the basis for the reasoning should be identified.

You should then discuss the questions of infringement and validity, and it has been suggested that things are often simplest if infringement is dealt with before the question of validity is considered.

As you begin the infringement section the examiners simply expect you to compare the (or each) infringing product or method with the wording of the claim, as interpreted in the initial section, to conclude whether all of the features of the claim are, or are not, found in the infringing act(s). At this stage you should be applying the meaning that you have given to the wording of the claim in construction. The examiner expects candidates to be consistent. However, you must show your reasoning, to demonstrate how you have reached your opinion, again identifying the information that is the basis of your reasoning. Usually the marking schedule has marks for considering one or more specific features of every one of the claims, and so all of the claims should be considered (even if a conclusion of non-infringement is reached with regard to a principal claim) if you are to ‘shoot at’ all of the marks.

The next section that the examiners expect to see should relate to the question of novelty, where the wording of each claim, as interpreted, is compared with at least the closest item(s) of prior art to determine whether the features of the claim are, or are not, found in the prior art.

There may be several potential prior art disclosures, including prior art discussed in the preamble of the patent itself, and other items discussed in the preambles of other patents, as well as the main teaching of the prior patents or other documents brought to your attention. All of these items should be identified, and reasons should be given as to why any irrelevant disclosures are not considered in detail. Again you should show your reasoning, clearly showing the passages of the document you rely on and how you deduce that the feature being considered is present or absent.

It is common in FD4 that more than one prior art item is potentially relevant, and needs close consideration. It may also be necessary to ‘interpret’ a prior art document, to see what it really discloses to the skilled person.

Subsequently, the question of inventive step should be considered, using a structured approach, and again the marking schedule will carry marks for considering the inventive step of the sub-claims as well as the main claim.

Next, you should at least consider if there are any points of ‘sufficiency’ that should be discussed. It is not unknown for the claims to include references to things that have not been mentioned at all in the body of the specification. Even if the invention(s) of all of the claims is sufficiently described, there is probably a mark for just saying this, and concluding that the specification is sufficient.

Subsequently, you must discuss any possibility of an amendment that can be made to improve the position of the patentee. Even if no amendment is possible, you should outline the amendments that you considered and then discarded, explaining why the amendment did not really improve the situation.

Every year a proportion of the candidates simply do not address the question of internal validity or amendment. However, every year there are marks that are available, and at least some of these marks may be obtained simply by addressing the matter. If sufficiency and amendment are not mentioned at all in your answer the examiner cannot award any marks!

As to what should be present in the memorandum of advice, remember to include:

– whether there is a ‘saving’ amendment, and advice on how best to implement this amendment; – noting that the patent is granted and in force, with a relevant comment on renewal fees, – a recommended course of action, – a justification for that course of action, – details on options for taking action in the courts or at the patent office – answers to the questions put to you by the client in their letter, – an indication of any further information that might be needed – and here it will be best to explain how that information may shape or alter your advice, and – comments on any relevant practice points and commercial/portfolio advice.

The marking schedules are a useful study aid in preparing a mental checklist of what advice to give in the examination, in that the same categories of advice come up every year.

And what do the examiners not want to see in an answer to a FD4 paper?

The examiners do not want to see anything that is a waste of time. While, when dealing with a lay client, a full explanation of what an attorney is going to do in connection with any specific matter may be of great value, in the context of the FD4 examination it is irrelevant except in the advice letter (but this you must keep brief because of the time limitations). The examiners do not want to see any sort of preamble or introduction to the answer – which sets out what the candidate is going to do – they just want to see you getting on and doing it. Bear in mind that the examiners are all patent attorneys and so shorthand can be used (as long as it is “common parlance” so to speak).

The examiners will not actually take marks away if you put things in your answer that they really do not want to see, but if you do, you will just be wasting time, and in FD4 time is of the essence. Every minute must be used to try to score marks

The examiners do not want to see illegible handwriting. The examiners want to give you marks, but can only do this when, from the answer presented, the examiner can see that you deserve the marks.

Some candidates complain about the Infringement and Validity paper on the grounds that it is not really clear what you have to do. The paper does not say that you must consider novelty of Document C or inventive step over Documents D and E. The paper does not say that you are expected to consider ways in which the infringer could ‘design around’ the patent. The criticisms are true, but FD4 is trying to emulate real life. A client seldom asks the questions that ought to be asked, and it is not uncommon for a patent attorney to have to consider a pile of documents to work out which, if any, are relevant to novelty, and which, if any, combinations of documents may be of any use at all in an ‘obviousness’ attack. The attorney often has to work out, from incomplete instructions, what advice the client really needs, and must prepare that advice, quite often against a tight timetable, without any further input from the client.

So, in summary, FD4 is an examination that sets out to test many competencies by presenting a ‘situation’ that involves a patent, an alleged infringement, and some prior art, where there are several points that are ‘finely balanced’ as to whether a specific feature of a claim is present in the alleged infringement and/or in the prior art. There is most usually a reasonable argument that the patent has at least some claims lacking in novelty, and that at least some claims lack inventive step. There is sometimes a minor sufficiency issue, and nearly always room to make some sort of amendment. Even if no amendment can be made that gives a valid infringed claim, there are still marks for analysing the possibilities and reaching that conclusion.

You must address the relevant issues to form an opinion regarding infringement and validity, but you must also clearly indicate your reasons for reaching the opinion. Then a memorandum of advice must be prepared, addressed to the client, and written in language that a client can understand. This memorandum must outline sensible advice that is appropriate on the basis of the conclusions that you have reached on infringement and validity, and also appropriate for the client having regard to the commercial situation.

All of this must be achieved in five hours, which can be a real challenge if you are not used to writing extensively by hand. Time control is a major skill requirement, as many unsuccessful candidates simply run out of time. Practice!!!