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.

Partial Priority - Questions for the Enlarged Board

Back in January I wrote about an appeal case at the EPO where a referral to the Enlarged Board on the question of partial priorities was going to be made. The Board in T 557/13 has now finally issued their decision, which is available here. Although it has taken them over six months to get there, I can see why it has taken so long, since the decision runs to 64 pages and is very comprehensive (as you might expect for such an important case).

In brief, European patent EP0921183 (which, by the way, expired in June this year) was opposed for lack of novelty, among other things. The opposition division concluded that claim 1 as granted was a generalisation of a more specific disclosure in the priority document, which had also published as an EP application. The priority document therefore became prior art under Article 54(3) EPC. Since, in the opposition division's view, the granted claim did not give rise to the claiming of a limited number of clearly defined alternative subject matters (referring to G 2/98), the claim was not entitled to priority and lacked novelty over the priority document.

On appeal, the patent proprietor argued that the claim was novel because a divisional application could not have a different priority date from its parent, backing its arguments up with various documents, which included a post from this blog (mentioned as D22 in the decision). The proprietor also cited the FICPI memorandum that was referred to in G 2/98, and proposed various questions to be referred to the Enlarged Board (which were mentioned in my previous post). The Board indicated that the issue of novelty might hinge on whether a patent could validly claim a right of priority when claiming more generically than a priority disclosure, and drew the parties attention to decision T 571/10, which is quite clear on the subject.

Following oral proceedings, which were held on 17 December 2014, the Board decided that it would refer questions to the Enlarged Board, the form of which were to be decided. This decision now sets out the reasoning behind the questions being referred. As the Board states at point 8.4 of the reasons, "the decision on novelty of the subject-matter of Claim 1 may depend on what approach is adopted in assessing entitlement to partial priority for a generic "OR"-claim. The concrete question to be resolved here is whether Claim 1 enjoys partial priority to the extent that the use of the product of Example 1 as disclosed in D16 is encompassed by the more generic definition of Claim 1, rather than being spelt out in it". In my view, this is the core of the issue, and one that has been much debated here and elsewhere. The question is in effect one of whether it is correct to take a broad or narrow view of the "limited number of clearly defined alternative subject-matters" as defined by G 2/98.

The Board goes into a lot of detail discussing the background to the issue of claiming partial priorities. They refer to the FICPI memorandum, and note that it was "an essential element in the process of drafting the EPC provision allowing the claiming of multiple priorities for one and the same claim which was finally adopted" (point 11.7). This seems to disagree with comments from some who have accused me of putting too much emphasis on the memorandum. In my view the memorandum is key, and has to play a very important role in resolving the issue if G 2/98 is to be followed at all (which, of course, it might not be). The Board also discuss the conflicting case law of the EPO, as well as two relevant judgments from the England and Wales High Court (Nestec v Dualit and HTC v Gemalto) where partial priority made an appearance. All of the issues should already be familiar to readers of this blog, so I won't go into the details again.

In a preamble to the actual questions themselves, the Board outline the main issues and comment on the fundamental importance of the point of law. At point 17.2.2 the Board states:

"The right of priority being one of the cornerstones of the patenting system, the Board considers that clarification of issues arising in the present connection is of fundamental importance. As argued by the appellant, the way in which entitlement to priority is assessed in cases of generic "OR"-claims is of great practical importance for claim drafting and filing strategies. "

The Board refers to another pending appeal case, T 624/14 concerning EP2157457, where a request for a referral has also been made. They also draw attention to two further publications, one of which is an article I wrote (in my real life persona) with Renaud Fulconis for the CIPA journal in December 2013 (cited as D30 and available in preprint form here), setting out the two opposing views on partial priorities. The Board mention that the jurisprudence before and after G 2/98 has not been applied uniformly in the assessment of partial priority for generic "OR"-claims, resulting in two divergent approaches developing. Clarification from the Enlarged Board is therefore needed. Given the fundamental nature of the issue, the questions have been formulated in broader terms than those suggested by the parties, and are as follows:

1. Where a claim of a European patent application or patent encompasses alternative subject-matters by virtue of one or more generic expressions or otherwise (generic "OR"-claim), may entitlement to partial priority be refused under the EPC for that claim in respect of alternative subject-matter disclosed (in an enabling manner) for the first time, directly, or at least implicitly, and unambiguously, in the priority document? 

2. If the answer is yes, subject to certain conditions, is the proviso "provided that it gives rise to the claiming of a limited number of clearly defined alternative subject-matters" in point 6.7 of G 2/98 to be taken as the legal test for assessing entitlement to partial priority for a generic "OR"-claim? 

3. If the answer to question 2 is yes, how are the criteria "limited number" and "clearly defined alternative subject- matters" to be interpreted and applied? 

4. If the answer to question 2 is no, how is entitlement to partial priority to be assessed for a generic "OR"-claim? 

5. If an affirmative answer is given to question 1, may subject-matter disclosed in a parent or divisional application of a European patent application be cited as state of the art under Article 54(3) EPC against subject-matter disclosed in the priority document and encompassed as an alternative in a generic "OR"-claim of the said European patent application or of the patent granted thereon?

The questions posed look very comprehensive to me, and very thoroughly thought out. I suspect the answer to them is not going to be a straightforward "no" to question 1, as that would be too easy (although would seem to me to be the correct one; see here for my reasons why). The key part is likely to be question 3, which is where the FICPI memorandum will come into play, unless the Enlarged Board decides to throw out that part of G 2/98 and start afresh (which they can do).

What happens next is the interesting part. I suspect the EPO will invite observations on the questions being referred, and then in a year or two we should get the answer. Let's hope it's the right one.

See further analysis from PatLit here and the IPKat here.

UPDATE 3 November 2015: As announced on the EPO's website here, third parties are now given an opportunity to comment on the referral by filing written statements. The deadline for filing is 1 March 2016.

UPDATE 16 December 2016: The answer to question 1 is NO. See here.

Opinions and Revocation - JCB is the Guinea Pig

Following my earlier posts here and here about the new provision under section 73 of the UK Patents Act for automatic revocation following an opinion, I have noticed that the first step has been taken today in relation to Opinion 25/14. As mentioned in my post here, this opinion found GB2497956 to lack novelty over a patent cited by the requester. The period for requesting a review expired on 11 May 2015 with no request being filed. After taking nearly three months to think about it, the UK IPO has now written to the proprietor, stating the following:

"Under Section 73(1A) your patent has been reviewed by a Deputy Director on behalf of the Comptroller who considers that claim 1 is not novel in view of US 3485037 and also not inventive, in particular in view of US 2007/175209 and EP1439310.

Before beginning revocation proceedings, you are invited to amend your patent and/or to comment on the citations before [7 October 2015]."

This is the first time the new provision under section 73(1A) has been used to initiate action. The proprietor, JC Bamford Excavators Limited, now has two months to decide what to do to try to avoid getting their patent revoked. I will, of course be keeping a close watch to see what happens.

An Analysis of TKDL at the EPO

Following my recent post on the IPKat here about (at least partly) false claims made by the Indian government regarding the relevance of the Traditional Knowledge Digital Library (TKDL), I thought I would have a good look at a bigger sample of the recent claims that have been made. These are listed on the TKDL website here as 'major milestones'. Another list is available here on the TKDL website indicating all instances where the TKDL has been used in third party observations, but without any claims to the relevance of the observations.

The major milestones page claims that things have happened, such as applications being refused or withdrawn, "based on the TKDL evidences". Based on the cases I have seen so far, these claims have turned out not to be true. The recent announcement by the Indian government to have "foiled an attempt by consumer goods giant Colgate-Palmolive to patent a mouthwash formula containing herb extract by citing ancient texts that show it was traditionally used in ancient medicinal practices" was just one recent example, as I showed in my recent post.

I wondered whether there had been any cases where the TKDL had been actually relevant in determining the outcome of an application. The only way to find out was to look at each of the cases and see what actually happened. The table below, which is derived from the TKDL's own list, shows for each European application in the list a summary of what happened, and whether the claim is true or false (or perhaps somewhere inbetween). You don't need to take my word for it though, as links are provided in each case for verification if needed.

Where I have indicated that the TKDL claim is false, this is based on there being no objections raised by the examiner in relation to the TKDL documents or, in some cases, that the examiner has specifically stated that the references were not as relevant as those already cited, and therefore could not possibly have made any difference. Where I have indicated that the claim is true, this is where either the examiner has specifically raised objections and/or the applicant has responded to the references by amendment. Whether any subsequent deemed withdrawal has anything to do with the TKDL citations is, of course, unknown, but I have given the TKDL the benefit of any doubt where any objections have been raised during prosecution.

TKDL Claim	Evidence from EP Register	True or False?
BASF Beauty Care Solutions France SAS, France has amended the claims of the application no. EP2157966 for "MC-1R, MC-2R, and/or [mu] opioid receptors simulation" based on the TKDL evidences.	No mention of TKDL evidence in summons to oral proceedings dated 9 Jan 2015. Applicant responded to TKDL evidence with no amendments.	FALSE
Based on TKDL evidences, MORINAGA MILK INDUSTRY CO., LTD. 33-1, Shiba 5-chome Minato-ku, Tokyo 108-8384 / Japan has amended the claims of application no. EP1941899 for "Agent for promoting glucagon-like peptide 1 secretion, food or drink for promoting glucagon-like peptide 1 secretion, agent for inhibiting postprandial increase in blood sugar level and food or drink for inhibiting postprandial increase in blood sugar level" and then the application was deemed to be withdrawn.	Last examination report dated 8 Jan 2015 cites two documents, neither from TKDL. No response filed, application deemed withdrawn.	FALSE
Based on TKDL evidences, Phenolics, LLC, P.O. Box 2439, 846 San Carlos Avenue, El Granada, CA 94108-2439 / United States has amended the claims of application no. EP1572219 for "Efficient method for producing compositions enriched in total phenols" and then the application was deemed to be withdrawn.	TKDL observations mentioned in examination report dated 13 Jan 2011, but documents already cited by examiner used in novelty/inventive step objections.	FALSE
Based on the TKDL evidences, Application no. EP2328598 (Phenolics, LLC United States) for "Novel compositions containing isolated tetrameric type a proanthocyanadin and methods of use and manufacture", is deemed to be withdrawn.	Inventive step objection based on document D1 cited by examiner in last examination report dated 7 March 2014. TKDL observations also mentioned. Application subsequently deemed withdrawn due to no renewal fee payment.	TRUE (partially)
Based on the TKDL evidences, application no. EP2464363 (M/S Medasani, Munisekhar / India) for "Natural extract from whole banana fruit (Musa Spp.)", is refused.	Decision to refuse dated 20 March 2015 based on objections in examination report dated 17 March 2015, cites document D8 (WO 2004/069143) as main reference for novelty & inventive step, D10-12 & D18 used in inventive step. None of cited documents from TKDL.	FALSE
Based on the TKDL evidences, Application no. EP2689806 (Colgate-Palmolive Company/ United States of America) for "Oral compositions containing extracts of myristica fragrans and related methods", is deemed to be withdrawn.	Last examination report dated 6 October 2014 cites document not from TKDL as main reference.	FALSE
Avon Products / U.S. has amended the claims of the application no. EP1827362 for "Compositions and methods of their use for improving the condition and appearance of skin" based on the TKDL evidences.	Examination report dated 7 Aug 2014 cites TKDL observations in novelty & inventive step arguments. Applicant subsequently amends claims.	TRUE
Based on the TKDL evidences, Nestec S.A. / Switzerland have withdrawn their Application No. EP2243383 for "A method and composition for nutritionally improving glucose control and insulin action."	Summons to oral proceedings dated 1 Aug 2014 specifically mentions third party observations not being more relevant than documents already on file.	FALSE
Based on the TKDL evidences, Application no. EP2266586 (Lifeline Nutraceuticals Corporation 6400 South Fiddler's Green Circle, Suite 1970 Englewood, CO 80111 / United States) for "Compositions and method for alleviating inflammation and oxidative stress in a mammal", is deemed to be withdrawn. Application was closed on 18-Mar-15.	TKDL evidence mentioned in last examination report dated 30 April 2014, but examiner cited documents used in novelty & inventive step objections.	FALSE
Nestec S.A. Avenue Nestlé 55 1800 Vevey / Switzerland has amended the description of the application no. EP1750651 for "Composition for improving skin, hair and coat health containing flavanones" based on the TKDL evidences.	Novelty objections raised in last examination report based on examiner cited documents and TKDL evidence. Examiner also raises novelty objection citing orange juice with pulp as prior art.	TRUE (partially)
M/S Indena S.p.A. / Italy has amended the claims of the application no. EP2046324 for "Treatment and prevention mucositis by anthocyanidin derivatives.	Novelty & inventive step objections raised in last examination report based on 35 documents cited by examiner. TKDL evidence not used.	N/A (no claim made)
Based on the TKDL evidences, Application no. EP1558271 (Metaproteomics, LLC / United States) for "Compositions that treat or inhibit pathological conditions associated with inflammatory response", is deemed to be withdrawn. Application was closed on 09-Jan-15.	Examiner considered claims to be new and inventive over cited documents and TKDL documents in examination report dated 3 March 2014. Minor clarity objections raised. No response filed, application deemed withdrawn.	FALSE
Based on the TKDL evidences, Application no. EP2419508 (Somalabs, Inc., 40 Allen Road, South Burlington, VT 05403 / United States) for "Method for the induction of a reward response by modulation of dopaminergic systems in the central nervous system", is deemed to be withdrawn. Application was closed on 12-Nov-14.	TKDL observations used in examination report dated 7 March 2014 for inventive step argument. Application then deemed withdrawn due to missing renewal fee.	TRUE
Unitika, Ltd./ Japan has amended the claims of the application no. EP2226071 for "Composition for oral administration" based on the TKDL evidences.	Novelty objection in examination report dated 20 Feb 2015 based on document cited by international examiner. TKDL evidence not mentioned.	FALSE
Based on the TKDL evidences, Unigen, Inc. / US, have amended the claims of application no. EP1881839 for "Compositions of Bakuchiol and methods of making the same" and then the application was withdrawn. Application was closed on 12-Nov-2014.	Intention to grant issued 17 Feb 2014. No response filed, application deemed withdrawn. TKDL references stated to be not relevant in examination report dated 11 March 2010.	FALSE
Laboratoires Expanscience / France has amended the claims of the application no. EP2506724 for "Vigna unguiculata seed extract and compositions containing the same" based on the TKDL evidences.	Inventive step objections in examination report dated 12 March 2014 based on TKDL evidence. Claims amended in response.	TRUE
New Chapter, Inc. / US has amended the claims of the application no. EP2435057 for "Compositions and methods for modulating lipid composition" based on the TKDL evidences. Application was refused on 17-Jun-2015.	Amendments made in response to documents cited by examiner. Examination report dated 7 March 2014 indicates that "third-party observations has been taken into account", but novelty & inventive step objections based only on examiner cited documents. Reasons for refusal in summons to oral proceedings dated 10 March 2015 made no mention of TKDL references.	FALSE
Mimozax Co., Ltd. , 4291-1, Miyauchi Hatsukaichi-shi, Hiroshima 738-0034 / Japan has amended the description of the application no. EP2052731 for "Composition for preventing and/or treating itching containing component originating in the bark of tree belonging to the genusacacia." based on the TKDL references.	No third party observations have been filed.	FALSE
Nanyang Polytechnic/ Singapore has amended the claims of the application no. EP2416793 for "A plant extract comprising statins and preparation techniques and uses thereof" based on the TKDL evidences.	Search opinion dated 25 July 2013 invited applicant to comment on TKDL references. Applicant responded on 6 June 2014 with amendments.	TRUE
Based on the TKDL evidences, Application no. EP1901701 (Ott, David M., 777 Panoramic Way, Berkeley, CA 94704 / US) for "Personal care and medicinal products incorporating bound Organosulfur groups", is deemed to be withdrawn. Application was closed on 14-Aug-14.	Examination report dated 9 October 2013 raised novelty objections relating to examiner cited documents. Third party observations mentioned, but no specific objections raised. No response filed, application deemed withdrawn.	FALSE
Based on the TKDL evidences, Application no. EP2293689 (Mars, Incorporated / US) for "Food product", is deemed to be withdrawn. Application was closed on 04-Aug-14.	Examination report dated 22 November 2013 considered third party observations to be relevant for inventive step. No response filed, application deemed withdrawn.	TRUE
Based on the TKDL evidences, Application no. EP2269598 (Metaproteomics, LLC/ United States) for "Curcuminoid compositions exhibiting synergistic inhibition of the expression and/or activity of cyclooxygenase-2", is deemed to be withdrawn. Application was closed on 18-Jul-14.	Search opinion dated 23 May 2011 cited TKDL references mentioned in third party observations, raising novelty objections based on these. Subsequent deemed withdrawal due to non-payment of renewal fee.	TRUE
Based on the TKDL evidences, Application no. EP1993522 (Kao Corporation 14-10, Nihonbashi-Kayabacho, 1-chome Chuo-ku Tokyo 103-8210 / Japan) for "Resveratrol and/or grape leaf extract as i.a. endurance improver, anti-aging agent, muscle strength improver", is deemed to be withdrawn. Application was closed on 23-May-14.	Examination report dated 29 March 2011 mentioned third party observations, but considered documents already cited by examiner to be more relevant.	FALSE
Universiti Putra Malaysia, UPM Serdang, 43400 Selangor Darul Ehsan / Malaysia has amended the claims of the application no. EP2349302 for "Cardioprotective effects of nutraceuticals isolated from nigella sativa seeds" based on the TKDL evidences.	Search opinion dated 10 July 2012 indicated that TKDL references were not considered to be as relevant as examiner cited documents.	FALSE

Out of a total of 23 cases where a claim has been made that something happened "based on the TKDL evidences", 15 turn out to be completely false. There are no cases where an application has been refused based on TKDL evidence, but several where an application has lapsed for one reason or another after TKDL evidence has been submitted. It looks to me like the TKDL is a potentially useful source of prior art in limited circumstances, but is nowhere near as significant as it is made out to be. Perhaps the Indian government could be a little more honest and make claims where they are actually justified.

Don't let your patent go up in smoke

Renewal fees are payable to the UK IPO on GB and EP(UK) patents each year, by the end of the month in which the anniversary of the filing date falls (rule 37). If this is missed, an extra six months is allowed for paying the fee, with surcharge (section 25(4)). If, after this period passes, the renewal fee is still not paid the patent lapses. It is possible to have such a lapsed patent restored, but only if it can be shown that the proprietor unintentionally failed to pay the fee (section 28). This is usually a fairly low hurdle to get over, and it is quite common for proprietors to be able to get their lapsed patents restored provided they can show that there was an underlying intention to keep it. An important point to note, however, is that although anyone can pay a renewal fee it is the proprietor who must be shown to have the intention to pay.

EP1409166, relating to processing of waste material, and originally applied for in the name of Strumat Limited, was granted to Globally Greener Solutions Limited in 2010, after recordal of a transfer was made during prosecution. The patent then lapsed in the UK due to failure to pay the renewal fee that was due by the end of July 2012. Unfortunately, as it turns out, the transfer to GGSL was apparently made by one of the directors of Strumat without the permission of the others. Following dissolution of GGSL, which seems to be connected to a large fire at their premises involving 5000 tonnes of stockpiled waste material, and which resulted in two of GGSL's directors being jailed for failure to comply with environmental regulations, ownership of GGSL's assets passed to the Crown, under section 1012 of the Companies Act 2006. As an aside, very large fires at recycling plants seem to have been quite a common occurrence recently, a few examples being in Linconshire, Salford, Wrexham, Rainham, Swindon, Melton and Smethwick (the large plume of smoke from which was visible from my office).

To return to the issue in question, since the Crown was the proprietor at the time the patent could have been renewed, on the face of it the intention that would count regarding whether the patent could be renewed would be theirs. Unfortunately, the Crown makes no effort to maintain patents that are acquired as a result of them being bona vacantia, so the intention test would never be met. This was clearly a problem for Strumat, who claimed that the application had been transferred fraudulently and should therefore never have been recorded as being in the name of GGSL. They applied under section 37 to have the question of entitlement resolved by the comptroller, but the comptroller declined to deal with the issue (see the decision here), as it was one that related only to non-patent law issues. Strumat then went to Court, and were granted a Vesting Order which ordered:

“the Patent Number EP02747559 granted as EP1409166 be and is hereby vested in Strumat Limited for all the estate and interest therein which immediately prior to its dissolution were vested in Globally Greener Solutions Limited”.

Strumat argued in their application for restoration that this meant they had always been the proprietor and it was therefore their intention to maintain the patent that counted. The hearing officer disagreed because it was quite clear that the order took effect as of its date, and was not retrospective. As a result, only the intention of the Crown could be relevant, and they had no intention to maintain the patent. The application for restoration therefore had to be refused (see decision BL O/248/15).

The case is quite an unusual one, but does suggest at least one lesson to be learned, which is to keep an eye on your own patents if they are important to you. If the issue had been spotted earlier, which it could easily have been (the transfer took place in 2007, long before the patent was granted), the patent might have survived. Getting others to look after them might save you some time and effort, but it's always worth doing a quick check now and then to make sure your patent is not about to spontaneously combust.

Opinions & Revocation - Continued

Earlier this year I wrote about the first couple of Patent Office opinions under section 74A that issued under the new provisions of section 73(1A)&(1B), where the comptroller now has the option of initiating revocation if an opinion finds a patent to lack novelty or inventive step.

The question I had at the time was how the comptroller would decide where initiating revocation proceedings would be justified. The two opinions issued so far seemed to me to be fairly "clear cut" (in the words of the Office's own guidance on the matter), since both found claim 1 of the patent to lack novelty over a prior publication. I therefore expected that we should see the first action to initiate revocation shortly after the 3 months period for requesting a review expired on the first one, which was in April (no review was requested).

After a couple of months to think about it, the Patent Office has now written to the proprietor in a letter dated 12 June that states in part:

"Whilst opinion [23/14] did conclude that your patent was invalid the comptroller does not consider it appropriate to initiate revocation proceedings against your patent.  

You should note that the decision not to initiate action under section 73(1A) does not alter or set aside the conclusion in the opinion. You may still wish to amend your patent."

The opinion, which was written by a senior examiner, was quite clear in finding that claim 1 lacked novelty over a prior published Chinese utility model publication. This makes me wonder what it would take for the comptroller to decide when a case met the "clear cut" criterion. How clear cut does it have to be? There is no real further guidance in the Manual of Patent Practice, which simply states that the group Deputy Director (DD) "should consider whether action under section 73(1A) is necessary. Action under this section should only be initiated if the DD considers that the patent is clearly invalid due to lack of novelty or inventive step. The opinion should be considered but the DD is in no way bound by it". Based on this, it appears that the comptroller could decide not to take action for any reason at all, however subjective it might be. This does not sound to me like a good way to implement the new provisions.

Perhaps we will know more when a decision is made regarding the second opinion that resulted in a finding of invalidity, which should issue soon. The situation at the moment does appear to be in need of some clarification.

Obfuscation

Those of you who are already up to date on the issues surrounding partial priority and poisonous divisionals (the latest state of play on which is summarised here) can safely ignore this post. Others who have a more masochistic disposition may wish to read on.

The issue of poisonous divisionals was first raised by Malcolm Lawrence in 2011 a few years ago while he was at HLBBshaw (since rebranded as Avidity). The original paper on the subject was published in issue 2/11 of epi information (which is available here). It has since prompted a lot of discussion, mostly among patent professionals in Europe. I have written about it a few times over the past few years, and have proposed a general solution that is in line with two decisions from the EPO Boards of Appeal. Since the latest development of a referral to the Enlarged Board, there has been nothing further to note on the subject, as we can now wait for the questions to be raised and then answered by the Board before we see what can or should be done about the issue. Or so I thought.

Mr Lawrence, however, thinks there is a lot more to say on the subject, and to prove it has written another article in this month's epi information (available here). This runs to just over 12 pages, and is (as usual) not an easy read. I would not bother to comment, as it doesn't seems to be actually saying anything new, but it does make lots of references to an article I co-wrote in the December 2013 issue of the CIPA journal (a preprint copy of which is available here; the relevant points made are also detailed in these two posts: here and here), which put forward opposing viewpoints on the partial priority issue in light of G 2/98. In essence, the issue boils down to whether you take a narrow or a broad view of the requirement stated in reason 6.7 of G 2/98, which states that multiple priorities are allowed "provided that it gives rise to the claiming of a limited number of clearly defined alternative subject-matters". The narrow view is that there needs to be basis for each of the alternative subject-matters, in a similar way as this would be required if the claim were to be split up into separate claims, and that a limited number would probably not apply to continuous ranges. This view inevitably gets bogged down in all kinds of complications about disclaimers and what is actually disclosed in the as-filed application. The broad view (being my own view), which takes support from the FICPI memorandum cited in G 2/98, is that it doesn't make sense to get involved with basis for amendments and disclaimers because no amendment is necessary, which I pointed out in my earlier post about imaginary claims here. As I stated in my article:

"The only criteria required would be: i) that the claim scope entirely encompasses the priority disclosure; and ii) that there is no issue regarding public disclosures between the priority date and the date of filing of the application. Provided such criteria are met, and of course all other requirements of the EPC are met for the claim scope (in particular Article 83 EPC, as the broader scope would need to be justified by the application as a whole), the validity of a partial priority would defuse any possibility of the priority application, if published, becoming Article 54(3) prior art. This is because the published priority application would not be prior art for the portion of the claim scope having a valid claim to priority, while the rest of the scope of the claim would inevitably be novel. It must be emphasised, however, that this is only applicable when there are no intervening public disclosures within the scope of the later broader claim but outside of the scope of the earlier disclosure, since the only solution to this would be to amend the scope of the later claim."

To me, this seems pretty straightforward. Provided these criteria are met, the issue about poisonous priority simply goes away, and should never have been an issue in the first place. Mr Lawrence, however, seems to think otherwise, and apparently disagrees with me, stating in footnote 33 to his article (he is very keen on footnotes; there are 62 in all) that the above solution is not correct, but fails to explain how. He also considers that too much weight is attached to the FICPI memorandum in my article (see point 1.1.5), but again fails to explain why this is wrong, other than offering an assertion. He goes on to provide some examples, one of which is illustrated using a hypothetical chemical case (see the figure and table on the right, taken from page 29 of the article). Why it has to be chemicals is a bit beyond me, as the point would seem to be the same with any numerical values. It then all gets a bit complicated, with lots of talk about different domains, targets and missiles, which all seem to be deliberately designed to confuse the reader. While there might be a valid point in there somewhere, I'm afraid I am currently at a loss to see how he has shown that my general solution is wrong. The concluding remarks in the article, referring to "challenging algebraic thinking" suggest that the author thinks the issue is indeed a lot more complicated that I might have thought. I cannot see how this is the case, but perhaps I'm just not clever enough. Can anyone illuminate further?

Time-Lapse IVF & Article 53 revisited

I wrote a while back about a journal article and subsequent opposition to European patent EP2430454, which claims a method of assessing competence of a human embryo through measurements of time intervals between the first few cell divisions (an illustration of cytokinesis is shown on the right, taken from this web page). The opposition, filed jointly by the European Society of Human Reproduction and Embryology and the authors of the journal article (one of whom happens to be a European Patent Attorney), argued that the patent claimed a diagnostic method that was excluded under Article 53(c) EPC. The problem with this, as I explained at the time, was that the Enlarged Board of Appeal determined in G 1/04 that for a claim to fall within the Article 53(c) exclusion (which at the time was Article 52(4)), it required all of the following features to be present:

(i) the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision phase as a purely intellectual exercise,
(ii) the preceding steps which are constitutive for making that diagnosis, and
(iii) the specific interactions with the human or animal body which occur when carrying those out among these preceding steps which are of a technical nature.

Step (i) of the requirements is clearly missing from the claimed invention, so it seemed fairly clear to me at the time that the opposition would inevitably fail, for the obvious reason that an opposition division would not make a decision that was clearly contrary to a decision of the Enlarged Board.

Following a response from the patent proprietor and a further response from the opponent, the opposition division has now decided to hold oral proceedings at 09:00 on 30 November 2015 at the EPO in Munich (which will be open to the public). The proceedings are expected to last two days.

The opponent's main argument is explained in my earlier post here, and is set out in their opposition here, as well as in the journal article here (to which I responded in a letter in the same journal here, to which the authors responded here, all of which are mentioned in the opposition proceedings as document D12). The opponent has, however, since then expanded on their reasoning as to why they consider the exclusion should apply. Their letter explaining this is available here on the EP register. Some of the argumentation is unusual, to say the least. In response to the argument that G 1/04 required there to be a diagnosis for curative purposes, the opponent has stated:

We accept that these requirements might possibly be inferred from opinion G-1/04. However, to the extent that that may be the case, we respectfully submit that the Enlarged Board erred in suggesting these requirements and we ask the opposition division to hold that these are not in fact requirements for a claimed method to be to an excluded method of diagnosis.

They then go on to explain why G 1/04 was wrong in deciding that a diagnosis would need to be made for curative purposes. In support of this, they have obtained signed statements from 29 physicians across Europe, who have all stated that there can be a medical diagnosis in a human subject without that condition being a disease condition, and even if no curative treatment is known.

The opponent seems to acknowledge that their chances of success are slim, as they then go on to state that "Whichever way you decide, an appeal will almost certainly be filed, and at the appeal stage we fully expect that a referral to the Enlarged Board will be sought. Addressing the Art. 53 EPC point now thus offers to expedite the final disposition of the opposition". How they think a referral to the Enlarged Board would be justified, given the decision in G 1/04, is beyond me but they are of course welcome to have a go. I would guess that any question would have to be along the lines of whether a "diagnosis for curative purposes" requires there to be a condition for which it is possible to determine a treatment.

For what it's worth, my prediction is that on 30 November the opposition division will decide to reject the A53(c) ground. If the opponent appeals the decision, the Board of Appeal will then, after about 2 or 3 years, decide to dismiss the appeal on the grounds that G 1/04 was quite clear on this point, and will not refer any question to the Enlarged Board. The patent might, however, be revoked on the more conventional grounds anyway, so this issue will probably not be up for discussion if the patent does not survive the novelty and inventive step attacks.

UPDATE 20 March 2015: Now that the summons itself has appeared on the register (here), it appears I was jumping the gun a bit in originally saying that the OD would only be considering the A53(c) objection at the summons. They will in fact be considering all grounds of opposition raised. The post above has consequently been edited a bit compared to the original version published yesterday. Interestingly, the OD will also be considering the additional ground of A53(a) of their own volition,  because neither opponent has raised it. The OD states that the claimed invention "may be regarded as involving the use of a human embryo for industrial or commercial purposes" (point 3 of the annex to the summons), and raise this for discussion without coming to an opinion one way or the other. It is surprising this was not picked up by the second opponent, although I can see why the first one would not want to raise it even if they had considered it. The preliminary view of the OD appears to be that the A53(c) exception does not apply, given the narrow scope indicated by G 1/04, but that A53(a) might.