Wednesday, 23 December 2015

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.

Friday, 18 December 2015

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.

Wednesday, 2 December 2015

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.

Thursday, 19 November 2015

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.

Wednesday, 7 October 2015

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.

Thursday, 1 October 2015

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.

Thursday, 13 August 2015

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.