The heart of the matter: one patent, two views

This guest blogpost comes courtesy of Katfriend and occasional contributor Suleman Ali (Holly IP), a patent attorney whose interest lies mainly in the biotech and medical fields --an interest that is quite germane to the case he writes about here about a patent for a collapsible device for filling holes in the heart and how a trial judge and an EPO Opposition Division could reach quite different conclusions when confronted with essentially the same evidence:
AGA Medical Corporation v Occlutech (UK) Limited [2014] EWHC 2506 (Pat) is a decision by Mr Justice Roth in the Patents Court, England and Wales. AGA Medical claimed that Occlutech had infringed its patent EP (UK) No. 0,957,773 to a medical device for occluding defects in the atrial septum of the heart. Occlutech responded that the patent was invalid on the basis of a prior disclosure in a clinical trial and on other grounds. An EPO Opposition Division had revoked the same patent last year, and is in appeal from that decision. 
Issues of Interest 
 This judgment has the following interesting points:
* a discussion of the case law on confidentiality.
* a finding that a clinical trial did constitute novelty-destroying disclosure. The EPO Opposition Division found the same clinical trial to be confidential and thus not novelty-destroying.
* a discussion of when an ‘intermediate generalisation’ adds matter, in particular where features which are not presented as ‘inventively distinct’ and are disclosed in a particular context are used as the basis of amendment. In the present case Mr Justice Roth held that the amendments did not add matter, but the EPO opposition division held that they did. 
The technology 
The patent concerns a device which can be used to fill a ‘hole in the heart’, i.e. a hole in the wall (the septum) between the two parts of the heart. The device is collapsible and in its collapsed form can be passed to the heart through a blood vessel using a catheter, thus avoiding the need for open heart surgery. The device is shown in the adjoining figure in the form it adopts to seal the hole in the septum. It is formed of two discs joined by a thinner cylindrical waist and is made of woven strands of a ‘memory metal’ which resumes its shape after being compressed. When inserted into the hole the discs occupy a position on either side of the wall keeping it in place. At least one of the discs is ‘cupped’ (rather than flat) which means only the perimeter of the disc contacts the septum, and this allows a tight join. 
Claim 1 of the patent as presented in the decision is as follows:
"A collapsible medical device, comprising
(1) a plurality of metal strands forming a tubular braided metal fabric having an expanded preset configuration,
(2) the ends of the strands of the tubular braid being secured in order to prevent the strands from unravelling,
(3) wherein said medical device is shaped to create an occlusion of an abnormal opening in a cardiac septal wall,
(4) whereby said expanded preset configuration is deformable to a lesser cross-sectional dimension for delivery through a channel in a patient's body,
(5) the woven metal fabric having a memory property such that the medical device tends to return to said expanded preset configuration when unconstrained,
(6) the expanded preset configuration comprising first and second expanded diameter portions respectively at distal and proximal ends of the device and a reduced diameter portion disposed between the two expanded diameter portions, said reduced diameter portion having a length dimension which approximates a thickness of the septal wall at the abnormal opening,
(7) wherein at least one of said first and second expanded diameter portions is cupped towards the other of the expanded diameter portions causing, in use, the perimeter edge of the cupped expanded diameter portion to fully engage the sidewall of the septum,
(8) the collapsible medical device further including an occluding fiber retained within said tubular woven fabric."
Other Proceedings 
The parties have been in litigation before in the UK over an earlier patent (see Occlutech GmbH v AGA Medical Corporation [2009] EWHC 2013(Ch), upheld on appeal [2010] EWCA Civ 702, reported by the IPKat [see here and here]. The IPKat has also previously reported litigation between the parties in Sweden [see guest post by Peter Kenamets, here]In the case of the present patent there is ongoing litigation between the parties in a number of jurisdictions, including the Netherlands. As mentioned above, the patent is in appeal at the EPO from a decision of the Opposition Division. 
Prior Use In A Clinical Trial 
Before the priority date a clinical trial was carried out using AGA devices in three children in the Bratislava Children’s University Hospital. Two important issues arose from this:
* did the devices that were used have at least one or two ‘cupped’ discs (rather than flat discs)?
* was the trial confidential?
The doctors that had taken part in the trial gave evidence. Dr Gougen’s evidence indicated none of the devices was cupped, though he admitted this was something he might not have noticed. Professor Masura's recollection was clearer: he said that two of the devices had cupped discs. Mr Justice Roth found him to be ‘a very clear witness’ and ‘found his evidence convincing’. Dr Gavora said all three of the devices had cupped discs. However his evidence was less convincing and it was noted that he had previously given contradictory answers on the same issue before a Dutch Court. Clearly there were significant discrepancies between the evidence of the witnesses, but Mr Justice Roth came the conclusion that ‘at least some of the three devices’ used in the trial had cupped discs. 
The Opposition Division was much more critical of the evidence given by the same witnesses and decided that it was ‘not convinced’ that any of the devices used in the clinical trial had a cupped disc. 
Were the Trials Confidential? 
Mr Justice Roth gave emphasis to the following paragraph from Coco v AN Clark (Engineers) Ltd [1969] RPC 41 on the circumstances in which confidentiality is imposed:
"It seems to me that if the circumstances are such that any reasonable man standing in the shoes of the recipient of the information would have realised that upon reasonable grounds the information was being given to him in confidence, then this should suffice to impose upon him the equitable obligation of confidence. In particular, where information of commercial or industrial value is given on a business-like basis and with some avowed common object in mind, such as a joint venture or the manufacture of articles by one party for the other, I would regard the recipient as carrying a heavy burden if he seeks to repel a contention that he was bound by an obligation of confidence"
He noted that none of the doctors involved in the clinical trial had been asked to sign a confidentiality or non-disclosure agreement. They gave evidence that they had never been given the impression that the devices were confidential. In addition he felt that ‘there is no presumption of confidentiality simply because this was a clinical trial. Everything depends on the facts’. Professor Masura had spoken about the devices in briefing sessions to other doctors at the hospital and had described the device and clinical trials at a presentation at a conference. He had acted in a way that he did not seem to perceive himself to be under a duty of confidence. It was also clear that the doctors were not embarking on a commercial venture, so the disclosure of the devices was not done in a ‘business-like’ way that may have led to an assumption of confidentiality. 
Mr Justice Roth also considered Carflow Products (UK) Ltd v Linwood Securities (B’ham) Ltd [1996] FSR 447 as to the circumstances in which an equitable obligation of confidence arose. In that case Jacob had said that, on an objective basis, an obligation of confidence is not imposed merely because a prototype is being offered for sale. 
Mr Justice Roth concluded the clinical trial had not been confidential and that it therefore destroyed the novelty of the patent. However he added that the EPO's Opposition Division had reached the opposite conclusion: the fact it was a clinical trial gave rise to a prima facie assumption of confidentiality which had not been rebutted. The Opposition Division had based its view on decisions T906/01, T152/03 and T229/06. However, I believe there are EPO decisions that would have supported Mr Justice Roth’s position on whether a clinical trial per se is confidential, such as T158/96 and T7/07.
Obviousness Over an Earlier Prototype 
Dr Gu of AGA had disclosed an earlier prototype of the device in a presentation at a medical congress before the priority date. That device had two flat discs, i.e. no cupped discs. In the present case the obviousness analysis was essentially to determine whether a device with one or two cupped discs was obvious from the disclosure of the earlier prototype by Gu. On this question Mr Justice Roth accepted the view of one of the expert witnesses, Professor Gewillig, that the skilled person presented with the earlier prototype would know that a flat disc device would lead to a serious risk of clotting due to thrombus formation in areas where the flat disc did not fully contact the septum. The skilled person would seek ways to avoid this risk, and adapting the earlier prototype to introduce cupped discs was an obvious modification that could be derived from prior art devices. One of AGA’s expert witnesses had argued that the alternative solution of shortening the waist would be adopted instead. In response Mr Justice Roth pointed out that the fact there may be a number of other obvious modifications did not mean the modification at issue (introducing cupped discs) was not obvious. 
Occlutech’s argument on insufficiency was based on the fact that claim 1 required the disc edge to ‘fully engage with the sidewall of the septum’. They submitted this meant there could be no gaps all the way round the disc edge. That was difficult to achieve and impossible to measure. Mr Justice Roth said the skilled person would not read this feature literally, realising that the septum is not completely flat and there will be points of no contact. Thus ‘full engagement’ does not require ‘perfect engagement’ and any gaps would be ‘insignificant and unintentional’. Construing the feature in this way led to the insufficiency attack failing. 
Added Matter 
Two of the four added matter attacks are discussed here. The first attack alleged that claim 1 added matter because the requirement of each end being ‘contained by means for securing each end’ had been deleted from the claim as filed. The arguments were lengthy and complex on this point, but ultimately Mr Justice Roth found the amendment did not add matter because the application taught a method which could be used to produce a device a device according to claim 1 where one end was not secured. 
The EPO Opposition Division had taken the opposite view. It applied the 3-part test described in the Guidelines at Part H, Chapter V-3.1: 
The replacement or removal of a feature from a claim does not violate Art. 123(2) if the skilled person would directly and unambiguously recognise that: 
(i) the feature was not explained as essential in the disclosure; (ii) the feature is not, as such, indispensable for the function of the invention in the light of the technical problem the invention serves to solve; and (iii) the replacement or removal requires no real modification of other features to compensate for the change.
The EPO found the amendment to fall foul of all 3 limbs of the test and therefore to add matter. 
The second added matter attack of interest was based on introduction of the feature of one or both discs being ‘cupped’. While this feature became important in determination of novelty and inventive step it was not in the claims of the application as filed and is essentially only disclosed as part of specific embodiments shown in the Figures. 
Adding the feature to claim 1 was an ‘intermediate generalisation’. Mr Justice Roth noted from Palmaz’s European Patents (UK) [1999] RPC 47 that:
"If the specification discloses distinct sub-classes of the overall inventive concept, then it should be possible to amend down to one or other of those sub-classes, whether or not they are presented as inventively distinct in the specification before amendment. The difficulty comes when it is sought to take features which are only disclosed in a particular context and which are not disclosed as having any inventive significance and introduce them into the claim deprived of that context. This is a process sometimes called 'intermediate generalisation'."
The application did have some discussion of the cupped feature, describing how it ensured complete contact with the septum and the fact that this would reduce the chance of bacterial endocarditis. Mr Justice Roth felt this made it clear to the skilled person that the feature was not tied to other features of the specific embodiments, and so could be added to claim 1 without adding matter. 
Again the EPO Opposition Division had taken the opposite view, holding that the feature of the discs being cupped was tied to the feature of the discs being of different sizes, and therefore generalising the feature to the device of claim 1 added matter. 
It was decided that, if the patent were valid, Occlutech’s devices would have infringed. 
Occultech had also asked for a declaration of non-infringement for a specific device which did not have fabric within the hollows of the disc. Mr Justice Roth indicated that such a declaration would have been given if the patent had been found to be valid. 

It is striking that Mr Justice Roth and an EPO Opposition Division managed to reach such different conclusions on every point that was being decided on this case, though they had substantially the same evidence in front of them. It is not unexpected that the Opposition Division was stricter on evidence relating to a prior use disclosure and on added matter. However it does lead one to question whether more could be done to achieve harmony between national courts and the EPO.
Thanks so much, Suleman! Readers: could more have been done to achieve harmony between national courts and the EPO?
The heart of the matter: one patent, two views The heart of the matter: one patent, two views Reviewed by Jeremy on Tuesday, July 29, 2014 Rating: 5


  1. HI! Occlutech and AGA were opponents also before the IP court of Milan.
    The judgement on AGA's patent EP' 138 (now on appeal) ended on June 2011 with a declaration of nullity of the patent, caused by a lack of inventive step.

  2. Haven't read the Roth opinion yet, only the nice Suleman write up, however I'm immediately thinking that this is a brilliant case for contrasting EPO proceedings with those of an English judge trying to do justice between two parties, in both infringement and validity, helped by cross-examination of key witnesses of fact.

    The EPO is not used to the idea of finding out the prior use facts by examining real human witneses. It prefers to rely on its status as a person skilled in the art, and tries to do all it can to decide the matter on the disclosure content of written publications. It is a "cop out" to announce simply that one is not "convinced" that the prior use was novelty-destroying (or that the prosecution amendment is devoid of new matter). The test ought to be one that is fair to both sides, not so skewed to one side as the "not convinced" test has it.

    But I'm confident that the TBA, helped by the English court transcript, will restore justice, fairness and harmony and that, as a result, EPO caselaw will thereafter, fortified by the experience, raise its sophistication bar. As Einstein was fond of pointing out, one should keep things simple, but no simpler than the case will admit. The EPO still has much to learn, about balancing fairness to the inventor with fairness to the public.

    Readers from the USA will also find of interest the issue whether validity turns on i) preponderance of evidence or ii) evidence that is clear and convincing or iii) the balance of probability. If the EPO is going to plump for "convincing" then it should refrain from criticising US jurisprudence or its "strong" patent system and instead button its lip. As many have pointed out over the years, we can all learn a lot from the USA. In particular, watch carefully how they do it, and then take care not to make the same mistakes over here.

  3. MaxDrei appears to have a rosy view of the UK system. Witnesses of fact? Pull the other one. They are paid mouthpieces of teams of solicitors more often than not coached on how to perform in the box.
    This case does highlight the differences between the UK and the EPO with regard to the treatment of added subject matter. In the UK, the court will come to an opinion of what a skilled person would understand from the specification whereas the EPO will look at the bare words and say "where is this wording disclosed?".

  4. Witnesses at the EPO are as intensively coached as they are in England. More so, in fact, because at the EPO there is not going to be any expert cross-examination, even while there is every prospect of judges who are suckers for having the wool pulled over their eyes. The English system of giving evidence (including disclosure/discovery as and when) keeps witnesses honest. What keeps them honest, pray, when they are giving their "evidence" at the EPO?

  5. Fairness to the inventor balanced by fairness to the public?


    The EPO knows in its heart that it is the robust defender of the public, allowing monopolies to be granted only when it is sure that by doing so the public's freedom to do the known and the obvious is not fettered. The EPO views the patent system not as a balanced agreement between consenting public and applicants, but as a necessary evil in the furtherance of innovation which should extend only so far and no further as necessary to perform its function.

    How else to explain "direct and unambiguous", PSA from an arbitrary realistic starting point, "requirements specifications" in inventive step of computer implemented invention and the like? The EPO knows it has a moral purpose as well as an administrative one, and takes an appropriate stance. As Gandalf before the Balrog, the EPO stands between the applicant and his monopoly and, where a suspicion that more is being claimed than the applicant is clearly entitled to, roars "YOU SHALL NOT PASS!"

  6. I think it's slightly unsatisfactory that the UK Courts pick and choose which parts of European practice they will follow. In this case Mr Justice Roth could have used the 3 part test from the EPO Guidelines for determining whether deletion of a feature added matter. He did not, and did not explain why he did not. I'm realistic enough to know we won't get harmony between the EPO and UK Courts in the near future, but I do think we need a more formal approach in the UK courts for which parts of EPO law they will follow. It seems slightly farcical for different validity tests to apply to the same patent, any of which will cause its revocation in the relevant territory.

  7. Good point from that last Anon at 10:32. Why doesn't England follow the EPO on Art 123(2)? I think I know. Consider the following:

    1. The EPO is unique, in examining in a foreign language. What I mean is, very very few EPO Examiners have English as their first language. Imagine youself as an English speaker and at the same time an Examiner at, say, the Japan or China or Germany national Patent Office. Applicant amends. You can't find verbatim the wording of his amendment in the app as filed. Applicant swears blind he has not added any matter. Do you believe him? Or are you sceptical, and do you object? Might that explain how EPO Examiners feel?

    2. But anyway, the EPO is reviewing intensively its posture on "new matter". Unlike the established law on obviousness, that on new matter at the EPO is not yet settled beyond any flexibility.

    3. Germany now accepts the EPO's "clearly and unambiguously derivable" test for novelty and for added matter. I think UK does too. But German judges (having donned the Mantel of the skilled person)find themselves able to derive more from German text than an average EPO Examiner can derive unambiguously from English text. Is it not totally unremarkable and banal that an English judge can derive more from English text than can the average EPO Examiner?

    Farcical? I think not!

  8. The three part test is part of the established approach in the UK, see the Nokia v. Ipcom decision referred to:

    "54. Thus the skilled person must be able to recognise directly and unambiguously that (1) the feature is not explained as essential in the original disclosure, (2) it is not, as such, indispensable for the function of the invention in the light of the technical problem it serves to solve, and (3) the replacement or removal requires no real modification of other features to compensate for the change."

    Perhaps it just wasn't relevant for this case?

  9. Well done, Max. Nail on the head, there.

  10. I cannot agree with MaxDrei's opinion that differences arise because examiners work in a foreign language. One only needs to see the sheer amount of German, Austrian, Swiss, French, Belgian and British patent examiners which are obviously also examining in their native language to see that this cannot (only) be the reason. The same applies to the Boards of Appeal. Does a German patent examiner or Board of Appeal member derive less from a German text than a German judge? I do not think so. I believe that the EPO is so strict in its approach as, as said before, it sees itself as the defender of the public against perceived broad patents. And in order to maintain a certain coherence it has established test to analyse novelty, subject-matter, etc. A judge is normally not bound by these tests (obviously depends on jurisdiction as discussed here last week at length)and has therefore more margin to interpret the intention of the applicant.

  11. In response to anonymous at 12:46, part of the problem is this selective approach of which test to apply in what cases. If UK judges have a choice in when they use UK principles and when they use EPO principles that will increase unpredictability and frankly it's more likely they will make a mistake.

  12. Nice comment from anon at 12:48, noting that the same test applies to both novelty and added matter. So, the stricter the test is on admissibility of prosecution amendments, the tougher it is for anybody to sustain a perfectly reasonable novelty attack. I can see that the public needs protecting against claims with a scope so broad that it is not commensurate with the contribution to the art but does not the public also require just as much protecting from the mischief of fecund efflorescences of expertly drafted claims of highly doubtful novelty? Then again, the public certainly needs protecting against prosecution amendments to cover inventions that were still not made at the filing date of the patent application. So the "directly and unambiguosly derivable" universal EPO Standard is right but does demand a wise, experienced and pragmatic old head, to get it right, in real hard cases.

  13. There are no UK principles. There is binding precedent, and there is persuasive obiter remarks. Binding precedent must be followed unless it can be distinguished. Persuasive remarks can be applied if the Judge thinks they are helpful, but he need not do so. The EPO test is persuasive here, but the Judge felt that it was not needed or helpful, so decided the case in accordance with British law.

    British law is fundamentally based on hearing evidence and deciding the outcome on the whole matrix of evidence. There are far fewer three-step tests in British law, often because appellate courts are reluctant to define such tests as bining precedent which may give an unjust outcome on a different set of facts. Far better to set out factors to consider, or approaches, or principles, which can be refined and applied with due regard to justice and to the evidence than to set out tests which must be blindly followed.

  14. Anonymous of 14:47 under the approach you've described which leads to 'justice' would it be possible for a UK judge to be more lenient on patentability because it was clear that the infringer had acted reprehensibly? I ask because I think that does happen, and in the absence of clear 3 step tests is more likely to happen.

  15. In reply to 15:17 - no, I don't think so. The Judge has plenty of sticks in the costs and damages enquiry with which to beat the reprehensible infringer without giving a patent of dubious validity the seal of judicial approval. There's no motivation to do so, and moreover it would be harder for the law to justify.

    But Boards, too, are not immune from the desire to "do justice" - they just tie themselves in greater knots trying to achieve it. The only way to reliably win an Appeal at the EPO is to grab the Rapporteur's attention with your appeal brief, convince him of the justice of the outcome you seek, and then give him the fact pattern and reasoning he needs to write a decision that supports that outcome. If the other side raises inconvenient truths or arguments, give the Rapporteur the tools to disregard them. Then, he can write his decision with a clear heart and an unclouded head.

  16. Anon @ 14:47, I would have thought that the appeal court's use of the word "must" is pretty close to a declaration of binding precedent in the Nokia decision. Delete a feature and the three part test must be passed.

  17. MaxDrei wrote:
    Haven't read the Roth opinion yet (...)

    And you surely didn't go through the trouble of reading the OD's decision either, did you? And still you have an awful lot to say about this case...

    Or is that you have little to say, but simply like to be heard?

  18. Most patent applications were either not drafted by a native speaker or were translated from another language.

    If an English native speaker derives more from a patent application written in English than the drafter himself ever could, or more than was ever present in the original language of the application, then that does not seem to be a good thing to me.

    The reality is that applying the disclosure test does not require extreme language skills. Far more important is the ability to perform a correct technical assessment. If that ability is missing, things will go wrong.

    Most 123(2)-complaints are probably about the application of the "selection from two lists"-principle (and oh how nice this test is when it comes to novelty). That evidently has nothing to do with language skills. Same thing for the question whether an amended claim is based on a single or on two separate embodiments: it is the technical content that counts. Also the 3-part test has practically nothing to do with language skills.

  19. RE: He noted that none of the doctors involved in the clinical trial had been asked to sign a confidentiality or non-disclosure agreement. ... ... It was also clear that the doctors were not embarking on a commercial venture, so the disclosure of the devices was not done in a ‘business-like’ way that may have led to an assumption of confidentiality.

    I would argue that a mere fact that a clinical trial was carried out on a very small group of patients would assume some level of confidentially. Discussions with doctors-colleagues, in the hospital, in my view, should not change the situation since such discussions is a standard procedure during a more or less serious medical treatment.

    Also, I would try to argue that the patented technology is covered by a broader confidentiality obligation than the one the EPC requires. Namely, the confidentiality of a medical treatment, especially if it goes about a clinical trial.

  20. A few times, I had a feeling that EPO examines claim 1 in view of one particular embodiment, persistently overlooking that, usually, protection is sought for a certain level of generalisation described in the application.

    If an invention does not allow a clear "onion"-like structure, with obviously different levels of technical features, discussion with EPO is looming.


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