UNION-IP Roundtable on Patent Priority

Today I attended a 'roundtable' meeting of UNION-IP, which was held at the German Patent Office in Munich. I had been invited by Reinier Wijnstra (WijnstraWise B.V) to do a presentation on poisonous priority, following interest in what Reinier had called "Tufty's Law" in an IPKat post from June 2013, referring to my earlier post here, and in light of the recent referral to the Enlarged Board in G 1/15 (which I have written about here).

The meeting, titled "Patent Priority: prosperous or poisonous" involved presentations from the EPO (Heli Pihlajamaa and Tilman Quarch from the Directorate of Patent Law), me, Mr Justice Birss of the England & Wales High Court, Judge Klaus Bacher of the German Federal Court and Judge Edger Brinkman of the Netherlands District Court at The Hague, with the meeting being chaired by Reinier Wijnstra. Each of us talked about issues relating to priority, with the main focus being on how partial priority should to be assessed, particularly in light of the problem around poisonous priority and poisonous divisionals.

The EPO's presentation went into a lot of detail about what the issues were, mentioning a lot of case law along the way. The most useful slide I found was the one shown here, which presents a list of the cases from the EPO Boards of Appeal on the two different sides of how partial priority is viewed. On the left side are those cases where a "literal" view of G 2/98 has been taken, where partial priority has been refused for a generic claim encompassing a narrower priority disclosure, while on the right are cases where a broader "conceptual" approach has been taken, allowing partial priority based on a theoretical division of a generic claim. The broader approach is the one I have been arguing for since I wrote my post on the subject back in 2013. The situation at the moment is that there is a clear inconsistency in the case law, which the referral in T 557/13 aims to resolve by referring questions to the Enlarged Board.

My presentation was about the same case law, with emphasis on the copper/metal example I have used a few times before on this blog. For a bit of fun I got several references to Alice's Adventures in Wonderland into the presentation, which might have made some sense to at least some of the audience. The key point, which I have expressed in this blog a few times, is that the whole issue of poisonous priority and poisonous divisionals goes away if you consider the generic claim to be theoretically divided into two parts, one of which has valid priority and the other of which has a later priority but is inevitably novel. This is essentially the conclusion reached in T 571/10.

The other presentations from judges in the UK, Netherlands and Germany did not concentrate exclusively on partial priority, but also discussed how priority in general was considered in the courts in these countries. There was a general view that these courts tended to be more lenient than the EPO on added matter, and also on priority in general, with one particular example from the German courts (discussed here) resulting in some surprise, not to say disbelief, from members of the audience. There have apparently been no cases from the courts in the Netherlands and Germany relating to partial priority, but this could be a feature of the more relaxed approach taken to allowing priority for a generic claim from a specific disclosed example. In the UK though, there has been a case specifically involving partial priority (Nestec v Dualit, which I have written about here). Mr Justice Birss expressed a clear view that the narrow approach taken in the Nestec case, and the various cases at the EPO, was not the right one, and the idea of poisonous priority was "obviously stupid" (which raised a spontaneous round of applause). In his view, the Enlarged Board would simply have to find a way to make the problem go away, and the conceptual division of claims was clearly the correct approach. He did, however, raise some interesting points about priority in general, and referred to the case of HTC v Gemalto, where the issue was whether a generic claim could have a valid priority right (not a partial one). In his view, it was more a question of support in the application rather than a test based on added matter. If the priority document would justify, in light of its disclosure as viewed by the skilled person, a broader claim then a later application having this broader claim could have a valid right to priority. In many cases this would make the poisonous priority issue go away, but would not work in all cases, one example being the ribonucleotides case of T 1127/00. In those cases though, since refusing priority was contradictory to the examples in the FICPI memorandum, the narrow literal approach was clearly just wrong.

At the end of the presentations, a couple of straw polls were held to see what the audience thought of two issues raised. The first was whether it was possible to have valid priority for a generic claim based on specific examples, where the skilled person and common general knowledge were used to justify the broader scope of the later claim. The audience was roughly split on that one, probably because it would be difficult to define a general rule and each case would depend on the facts. The second poll was about the question of whether the literal or conceptual approach was the correct one to take when assessing partial priority. The audience in that case was quite emphatic that the conceptual approach was correct, with not a single vote for the literal approach. Clearly the presentations on the day had got the point across to the audience. Let's now hope that the Enlarged Board reaches the same conclusion.

Intransigent Inventors and Switching Sides

I wrote a while back about a case involving inventors refusing to sign forms for a US application. In that case, the application had been assigned to another company after the original applicant went bust. The inventors, who were directors of the original applicant company, unsurprisingly became uncooperative once the new applicant took over, and refused to sign declaration and assignment documents for a subsequent US application. The case was resolved by a UK IPO hearing officer deciding in favour of the new applicant because the original intention was to have the application to proceed in the name of the company and not the inventors. It undoubtedly helped the new applicant's case, however, that neither inventor filed anything in their defence, which resulted in the claimant's case being considered to be supported (according to Rule 77(9)).

As I mentioned at the time, cases relating to entitlement under section 12 (relating to foreign and international patents and applications) do not come up very often. I was therefore interested to see that another one was decided last month. This was the case of University of Warwick v Dr Geoffrey Diamond, published as BL O/518/15. The case concerned US application 12/306,505, which happens to have been recently allowed by the USPTO, although the UK proceedings were initiated over two years ago while the application was undergoing examination.

The issue related, as before, to an inventor refusing to sign declaration and assignment documents for the US application. The application identified three inventors, two of whom were cooperative. Dr Diamond, however, refused to sign. Unlike in the earlier case, he contested the claim, and argued that the University had no right to his contribution to the invention. Instead, he argued that his contribution belonged to a company, G-Tronix, which had been spun out from the University and at one point had all of the inventors listed as directors but by the time the proceedings were issued had only Dr Diamond as director (and has now been dissolved).

By the time the hearing took place in June this year, it appears that Dr Diamond had caused the University a great deal of difficulty (and, presumably, expense), having caused the hearing officer at the IPO to issue two preliminary decisions (BL O/208/14 and BL O/225/15), one of which Dr Diamond appealed to the High Court (and had struck out). The argument was largely about whether Dr Diamond was, at the time the invention was made, employed by the University in a capacity where section 39 would indicate that the invention belonged to the University. Dr Diamond argued that he was not, although his arguments were somewhat confused and contradictory. He initially argued that he was employed by G-Tronix but, when cross-examined, said that this was a "slip of the pen". He was also quite vague about how early prototypes of the invention were developed, even though he claimed that they were developed in his workshop at home, and did not appear to have any knowledge of how some of the figures in the patent application were prepared, even though they formed a key aspect of the invention. The hearing officer found Dr Diamond to be unconvincing and not a credible or reliable witness, although did not go so far as to find him dishonest.

You might think that this would fatally damage Dr Diamond's case, but you would be wrong. Since the proceedings were initiated by the University, it was down to them to establish that they were entitled to the invention, and not for Dr Diamond to prove that he was instead. Unfortunately for the University, they failed to do this to the hearing officer's satisfaction. Even though the hearing officer was fairly sure that the invention was made before the inventors became directors of G-Tronix, and Dr Diamond was working with the other inventors at the time, the evidence of whether the invention was made in the course of Dr Diamond's normal duties was not particularly strong on either side and the claimant had failed to show that the invention belonged to them. This left the US application having to proceed in joint names, and presumably with neither side being particularly happy about the outcome.

The moral of the tale in my previous story about section 12 proceedings was that it was sometimes necessary to use a sledgehammer to crack a nut. This time though, to extend the metaphor a bit further, I would say that if you need to use a sledgehammer you should make pretty sure that you have a good one as sometime the nut can be more difficult to crack than you first thought.

As a postscript, while looking through the prosecution files for the family of applications relating to the one in question, I noticed something odd. The US application forms part of a family that includes international application PCT/GB07/050368, which was published as WO 2008/001141. This entered the European regional phase in January 2009 as European application number 07733789.7. In the decision the hearing officer mentioned a few times the patent attorney who was responsible for the PCT application, who Dr Diamond had met and apparently liaised closely with for preparation of the application. This same patent attorney was also responsible for making a request for the application to enter the European regional phase, as evidenced by his electronic signature on the request form. The next year, however, in July 2010 the EP register shows a change of representation, with another representative from the same association of patent attorneys becoming responsible. This is all fairly standard, as representatives change fairly often and responsibilities for applications can change. What happened afterwards, however, was not normal. Only three months later, in October 2010, third party observations were filed, attacking the validity of the application. These were prepared and filed by the same attorney who was originally responsible for the application, but was apparently now representing someone else, having left his previous employ and set up by himself. This other party was identified only as "a well established manufacturer [who] is monitoring with interest the prosecution of this European patent application". Further observations were filed in March 2011 by the same attorney. None of this prevented the application from going on to be granted, which it did in 2012, although the examiner did use the prior art cited by the third party in raising an objection of lack of inventive step in a summons to oral proceedings.

Switching sides is something that would obviously raise alarm bells for any patent attorney. If you were involved with preparing, filing and prosecuting a patent application, it would be a clear conflict of interest to then work for another party in trying to knock down the same application. This is made quite clear in the IPReg Code of Conduct, Rule 7 of which states:

"A regulated person must not act where his interests conflict with those of a client or of a former client, or where he knows or has reasonable grounds for suspecting that the interests of any partner or regulated person or staff of his firm, conflict with those of a client or of a former client.

Provided in all the circumstances it is reasonable to do so, a regulated person may act for two or more clients, or for a client as against a former client, in relation to the same or a related matter in a situation of conflict, or possible conflict but only if all of the parties have given their informed consent in writing."

What I wonder is whether the University gave permission for the attorney to switch sides and start attacking the patent application that he originally prepared and filed. I would be very surprised if they did, since I cannot see how it could possibly be in their interests to do so, but this seems to me to be the only way that this would avoid a clear breach of the IPReg code.

Section 73(1A) Revocation - A Good Hair Day for Jemella

My last post on the subject of revocation following a Patent Office Opinion mentioned three cases where proceedings had been initiated. The first related to a patent from JCB, which I wrote about previously here, but this has not been the first one to get a decision. Instead, the third one, relating to a patent from Jemella, GB2487996, has been the first patent to get a decision on revocation under Section 73(1A). The decision, which issued today (18 December) says in full (with links added):

1. An Official letter dated 18 September 2015 explained that the invention of claims of the above patent was not new or did not involve an inventive step and that revocation of the UK Patent under Section 73(1A) might therefore be necessary.

2. The proprietor contested this view in their letter dated 29 September 2015. I have considered their observations and I make no order for revocation of the UK patent.

As I reported briefly in the update to my previous post here, the patentee had argued that the examiner got it wrong by interpreting the claims incorrectly, and made no amendments to the patent. They could, of course, have done this instead by requesting a review of the opinion and should have got the opinion set aside. We would, however, then have had a decision of why the opinion was wrong. The decision here goes into no detail at all about why the opinion was wrong to decide that the patent was invalid, which it presumably must have been if the patent is not being revoked. I wonder therefore whether the IPO is taking this thing entirely seriously.

Time-Lapse IVF - A53 decision

I last wrote about an opposition case I have been watching for a while, and reported last on a summons to oral proceedings that was issued in March (see here for my comments, and here for an earlier post about the issue). In brief, the opposed patent is about a method of assessing the viability of embryos by the timing of cell divisions, which is monitored by time lapse video microscopy. In simple terms, if the timings are within certain limits the embryo is more likely to be viable. One opponent had argued that this method was excluded for being a diagnostic method under Article 53(c) EPC. My view, as expressed at the outset, was that this argument was very probably wrong because it did not fit the test as laid out in G 1/04. This issue, along with others raised by another opponent, was to be discussed and decided upon by the opposition division at a hearing at the EPO in Munich scheduled for two days from 30 November 2015.

By a lucky coincidence I happened to be at the EPO on the 30 November (handling this case, which I won by the way). My work was done fairly quickly, so I popped along the corridor and slipped into the oral proceedings that were underway (which were, as is normal for opposition hearings, open to the public so anyone could have done the same). I unfortunately missed the arguments about Article 53, as these were dealt with first, but arrived in time to hear the opposition division issue their decision. Unsurprisingly, they decided that Article 53(c) did not prejudice the granting of the patent. The opponent who had raised the issue then indicated they would be appealing and left the proceedings, as they had nothing further to add.

I do not know yet what the outcome of the hearing was on the other issues, but this will appear on the register in due course. Whatever happens, it looks like the A53(c) issue will go to appeal, where the opponent will try to get a referral made to the Enlarged Board if they don't get their way (which, in my opinion, they won't). As I have indicated before, I think this is not going to happen. It will, however, be interesting to see what a Technical Board of Appeal make of it. There are, to my knowledge, no conflicting decisions from the Boards of Appeal on this point. There is, however, the possibility that the Board will consider the issue to relate to a "point of law of fundamental importance" (Article 112 EPC), but it seems unlikely to me that they will think the issue of whether a method of assessing viability of embryos is an excluded diagnostic method is of such importance that a referral would be needed. We will just have to wait and see.

UPDATE 3 March 2016: The interlocutory decision of the opposition division has now issued, and is available on the EP Register here. The OD has decided to maintain the patent in amended form, and confirm that the patented invention is not excluded under Article 53(c) EPC. The OD go into quite a lot of detail on the A53(c) issue, probably in the expectation that this will have to be gone over again on appeal. It looks like this will be one to revisit in a couple of years once the Board of Appeal have taken a look.

UPDATE 22 June 2016: As expected, opponent 2 (Sterckx et al., represented by Julian Cockbain) has filed an appeal against the decision. Their grounds of appeal have just appeared on the EP register, and can be found here. The sole point of appeal is the Article 53(c) issue, and the opponent now wants some questions to be referred to the Enlarged Board because they think that G 1/04 got it wrong. The questions are:

(A) Where a claim is directed to a method of diagnosis of condition X comprising gathering information from a human or animal and determining, on the basis of the information gathered, that the human or animal has (or has not) condition X, must a curative treatment for condition X be available for the method claimed to be a method of diagnosis excluded from patentability under Art. 53(c) EPC? 

(B) Where a claim is directed to a method of diagnosis of condition X comprising gathering information from a human or animal and determining, on the basis of the information gathered, that the human or animal has (or has not) condition X, must condition X be a disease for the method claimed to be a method of diagnosis excluded from patentability under Art. 53(c) EPC?

(C) Where a claim is directed to a method of diagnosis of condition X comprising gathering information from a human or animal and determining, on the basis of the information gathered, that the human or animal has (or has not) condition X, must the determination that the human or animal has (or has not) condition X be in itself fully sufficient to determine the appropriate course of action (or inaction) to be adopted by the physician for the method claimed to be a method of diagnosis excluded from patentability under Art. 53(c) EPC? (In other words, if other information may inform the physician's course of action is the claimed method still excluded from patentability?)

Although the argument sounds faintly plausible, I still think it is a bit of a stretch that there should be a referral because G 1/04 got it wrong. The Technical Board of Appeal in this case would need to conclude that the questions need to be asked to ensure uniform application of the law or if a point of law of fundamental importance arises (Article 112(1) EPC). Neither of these seem to fit. The law can be applied uniformly based on G 1/04, and there are no conflicting T decisions, so that doesn't seem to work, leaving the only option being whether the point is one of fundamental importance. Is it so important that a decision is made on whether a diagnostic method needs to be done "for curative purposes stricto sensu"? I don't know, but I'm fairly sure that the Technical Board of Appeal in this case will think not, not least because the reasoning for applying the same kind of test for diagnosis as for each of the other exclusions of surgery and therapy was that they all related to doing things for curative purposes. Whether or not a cure is actually possible is beside the point.

A Cautionary Tale

When prosecuting a patent application before the EPO, a summons to oral proceedings is usually the end of the line (or at least the beginning of the end) if you haven't managed to persuade the examiner that your client's invention is patentable. You will typically have dealt with at least two substantive examination reports by that stage, and the examiner will be of the opinion that things are not progressing and that the matter should be brought to a close one way or another.

Oral proceedings are not, however, an automatic part of the process. According to Article 116(1) EPC, oral proceedings shall take place at the instance of the EPO if it considers this to be expedient or at the request of any party to the proceedings. If the EPO (i.e. the examiner) does not consider it to be expedient, and there is no request on file, then the only available option is to issue a decision to refuse the application under Article 97(2) EPC.

As a result, in order to avoid a nasty surprise in the form of a refusal of the application, it is normal for a patent attorney to have a standing request for oral proceedings on file for any application. The wording could be as simple as "we request oral proceedings before any decision adverse to the applicant is made". This is easily added to any response that gets filed, and soon becomes second nature when preparing a response. The result is that you get the chance to put the arguments and amendments forward that the client really wants, without the fear that the application will be immediately refused if they don't work. If a summons does arrive, then the task changes to one of trying to figure out whether anything will work and if the applicant is happy to go for it. If there really is nothing left, or at least nothing worth fighting for, then the well-advised applicant (i.e. one where money is in shorter supply than sense) will typically drop the application at that stage and go do something better instead.

The standing request for oral proceedings is such a common feature that, at least in some eyes, it could be viewed as negligent not to have one on file in all cases, since the consequences of getting a refusal are that the applicant will be forced to appeal or to file a divisional to start again, adding further costs and delay to the whole process. A patent attorney that does not have a standing request on file is therefore taking an entirely unnecessary risk of getting their client annoyed and potentially opening themselves up to being stung for costs that would be difficult to justify passing on.

All this brings me to the case of a European application I have been keeping an eye on for a little while. This application (which shall, for obvious reasons, remain unidentified here) has been pending at the EPO since 2007 when the application was filed as a divisional, after which the parent application was refused. The application was then searched and a search opinion with various objections issued, which the applicant's representative filed a response to. An examination report then issued with further objections, and the representative filed a response. Their response, however, contained only amended independent claims and made the following statement:

"As soon as the Examining Division indicates allowability of the presently filed new independent claims or other independent claims with or to be filed by the applicant, new dependent claims adapted to such new independent claims will be filed and the specification will be revised accordingly, in particular by adapting it to such new claims and incorporating an acknowledgement and a discussion of the prior art cited". 

Unfortunately, the examiner was having none of this, and issued a further examination report stating:

"It thus appears that the request on which examination is to be carried out is presently not complete. The applicant is reminded that, in accordance with Article 113(2) EPC the European Patent Office shall examine, and decide upon the European patent application only in the text submitted to it, or agreed by the applicant. In order to avoid an adverse decision (Article 97(2) EPC) based on the lack of a clear request, the applicant is invited to clarify the actual application documents making up his request".

Instead of responding to this by preparing a full set of claims and doing the necessary adjustments to the text to comply with EPO requirements (all of which would be fairly easy to do), the representative then wrote back with a little rant at the examiner about the limited response being done on the "grounds of procedural economy", and included the following statement:

"Nearly 25 years the undersigned representative is working as European patent attorney and has used for the grounds of procedural economy statements [...] in thousands of submissions so far. And the undersigned representative has never experienced such a communication like the present one but the statement in question in the said more than thousands of submissions filed so far has not been objected to.

So, the Primary Examiner is requested to continue with the examination procedure in response to the aforementioned submission [...] as all this colleagues would do.

Finally, the representative reserves his right to bring this case to the attention of responsible superior instances".

Nothing in the response, nor in the previous responses, contained anything about a request for oral proceedings. Rather than issuing another examination report, or go to the trouble of issuing a summons, the examiner then simply issued a decision to refuse the application. The applicant now has to decide whether to go to the trouble and expense of appealing the decision (which would be very unlikely to succeed, in light of the current practice on admissibility of amendments by the Boards of Appeal) or to file a further divisional (with 15 years of renewal fees to pay). Their other option is, of course, to abandon the whole thing, but in my view they might also want to think about getting another patent attorney.

Section 73(1A) Revocations - An Update

To follow up from my previous posts (here, here and here) on the subject of revocation following request for an opinion on validity, this  is to provide a little update on where things currently stand. At the time of writing revocation proceedings have been initiated in three cases. These are:

GB2497956 (JCB): Proceedings were initiated on 7 August 2015, with an initial deadline of 7 October to file observations and/or amendments. This has now been extended to 9 December 2015.

EP1837182 (Fujifilm): Proceedings were initiated on 16 September 2015, providing a deadline of 16 November 2015 (extendable by two months).

GB2487996 (Jemella): Proceedings were initiated on 18 September 2015, providing a deadline of 18 November 2015 (extendable by two months).

Two further opinions, 07/15 and 10/15, look likely to result in initiation of revocation proceedings. The proprietors have until 11 November and 24 November respectively to request a review of the opinion under section 74B.

UPDATE 4 November 2015: It seems that Jemella are keen to defend their patent. Their attorneys have responded with a letter arguing essentially that the examiner got it wrong by interpreting the patent incorrectly, and are not offering any amendments. I'm not sure why they didn't do this previously by requesting a review of the opinion.

Kadcyla & Crown Use

An article in the Grauniad today reports a letter written by The Coalition for Affordable T-DM1 to the Health Secretary Jeremy Hunt.

The letter asks Mr Hunt to "authorise the domestic manufacture and/or importation, use and sale of biosimilar versions of trastuzumab emtansine (T­DM1) used in the treatment of breast cancer, to be supplied to the government for use and sale in the UK", which they argue can be done under the Crown Use provisions of the UK Patents Act 1977 (sections 55 to 59). This is apparently necessary because the medicine is very expensive and unaffordable to patients in the UK, costing in the region of £100k for a year's treatment.

The letter does not indicate what patent would need to be authorised for use, which seems to me a bit strange. I have, however, found one that seems to fit the bill: EP1689846B1, which was granted in March 2013 to ImmunoGen, Inc., claiming a cell-binding agent maytansinoid conjugate with the formula shown above, where Ab is trastuzumab.

T-DM1, more commonly known by its trade name Kadcyla, is an antibody-drug conjugate, being a combination of the monoclonal antibody trastuzumab (trade name Herceptin) with a cytotoxic agent DM1, a maytansinoid. The drug can apparently be of some use in treating HER2-positive metastatic breast cancer, although is not a cure and results show that it might be able to extend life by typically a few months. The National Institute for Health and Care Excellence (NICE) have indicated that the drug is not worth funding, finding last year that it is not recommended for treatment because it was not a cost-effective use of NHS resources.

To my knowledge, the Crown Use provisions in the UK Patents Act 1977* have never been applied to the provision of drugs (although I would be happy for someone to prove me wrong). It would be interesting to see whether this case will establish a precedent, but I strongly suspect that it will not.

*As pointed out in the comments below, Crown Use provisions in the 1949 Act were used. However, apart from the case of Henry Brothers v MOD [1997] RPC 693, which was not about drugs, I am not aware of any cases under the 1977 act relating to sections 55 to 59 and do not know of any patents that have been the subject of an order under section 55. Making an order in this case would therefore seem to be setting a precedent, which I suspect the current government would be very unwilling to do.