Event Report: UCL IBIL - Pregabalin: Where stand plausibility and Swiss-form claims? PART 1

In the dark winter months of late 2018, this Kat had the pleasure of revisiting her old PhD haunt, UCL's Cruciform Building, to hear the great and good pass comment on Warner Lambert v Actavis. For the benefit of those who couldn't make it to the IBIL UCL event, IPKat is here with a summary of the discussion. The following Part I will focus on plausibility. 

IPKat's summary of the Supreme Court decision (Warner-Lambert v Actavis [2018] UKSC 56) can be found here. Further in-depth commentary on the plausibility and infringement aspects of the case can be read here and here.

The Cruciform Building
The panel at the UCL-IBIL event were as follows:
  • Lord Hoffman 
  • Judge Edgar F. Brinkman (Senior Judge, Court of The Hague)
  • Dr Matt Fisher (UCL IBIL)
  • Dr Ursula Kinkeldey (Former Chair of a Technical (Biotech) Board of Appeal of the European Patent Office; Former Permanent Member of the Enlarged Board of Appeal of the European Patent Office)
  • Dr Matthias Zigann (Presiding Judge at the Regional Court Munich I)
Prof. Sir Robin Jacob chaired the discussion. Each member of the panel were first invited to comment on the plausibility aspect of the decision.

Judge Edgar F. Brinkman (Senior Judge, Court of The Hague) commented that the prima facie test for plausibility appeared to be on the high side. The Judge further observed that in Dutch law, the onus is on the party challenging the validity of a patent to demonstrate that a claim is implausible. To Judge Brinkman, this is logical, given that the same burden of proof applies for both novelty and inventive step. Judge Brinkman and Dr Matthias Zigann had also prepared some slides, which can be found here and here.

Lord Hoffman commented that he had no major issues with the reasoning of the Supreme Court, and thought they had come to a sound judgement. Not wishing to paraphrase Lord Hoffman, here is his take on the decision:

"On the question of sufficiency it seems to me that there is a range of options available open to the court. At one extreme, you can say the specification is sufficient only if it enables you to make the product or perform the process...if it turns out not to work it will have been a waste of money...but no harm will have been done. The objection to that, and the objection made by the minority, as I thought rightly so, was that it will enable someone who has made no contribution to human knowledge to stake out a monopoly, like a miners claim in some area of research, with the view then afterwards to do the digging to discover whether he has struck gold or not. That seems to me to be not what the patent system is about.

Second-medical use "gold"
At the other end of the range, you can require that the specification provides experimental evidence to show that it works, but for many pharmaceuticals that would be very difficult to satisfy. You can do it in vivo, you can feed it to rats, but only clinical trials will show whether it does work or not. To refuse a patent until the effect can be shown is to block potentially valuable life-saving research, particularly when it's difficult to get funding for the research, and you won't be able to get funding unless there is some way to prevent competitors from getting in ahead of the inventor.

That need for compromise seemed to me very similar, although this wasn't mention in the case, to the problem which faced the Supreme Court a few years ago in deciding whether when an invention can be said to be of industrial application. You have a new product but is it of industrial application? At what level of generality do you have to specify the potential application of a new pharmaceutical product? Do you have to be able to identify the disease? Or is it enough to specify a very broad class of diseases? Again, the question that came to me in that one, was at what point in research into the potential use of a new product, or new use of an old product, can you stake out your monopoly, under cover of which you can then raise funds to carry out further research.

Although the court in this case [Warner Lambert v Actavis], was divided 3 to 2, I think there was very little between them. The majority said that you must demonstrate in the light of the common general knowledge, that the claim they refuted was plausible. It may be made plausible by the specification that something was worth trying for a reason; not just because there was an abstract possibility it might work, but because of reasonable scientific grounds that it might work. That's the difference [according to the Judge] between speculation and contribution to the art. That seemed to me to be very persuasive. Lord Hodge for the minority said he agreed that the specification must disclose some scientific reason that it might well have the claimed therapeutic effect. He said that what he objected to was that there was a prima facie case for a therapeutic effect".

Lord Hoffman concluded that he found Lord Sumption's judgement entirely convincing.

Dr Ursula Kinkeldey: (Former member of the TBA and EBoA) began by expressing her gratitude that the Supreme Court analysed the decisions of the Technical Boards of Appeal, and her belief that they did this well, although noting that "perhaps they left out the one or the other which might not fit well into the concept". Dr Kinkeldey then proposed the question of what the EPO case from the Supreme Court decision?

The plausibility pendulum
Dr Kinkeldy commented that the plausibility problem started with decision T1329/04 (John Hopkins), in which the expression plausibility was born: "The idea was to approach the problem of speculative inventions in the area of medicine and medical use inventions. The pendulum was in favour of the arm chair inventor. The Board really thought they had to correct something, where one at least has to have something at hand to come to a fair judgement. In the light of this, we have the development of quite a number of cases which were interpreted and analysed in the Supreme Court Judgement, we came to a conclusion that I would consider more or less the message of the Supreme Court."

Dr Matt Fisher argued that it was important to remember that the issue of plausibility was in the context of a second medical use claim, and that it is necessary to have a slightly higher standard where we are dealing with second use claims, than where we are dealing with pharmaceuticals in the first place. Dr Fisher went on to argue that he thought Swiss Form claims are "crippled form of claim anyway, and that this should be reflected not just for infringement purposes, but also in a slightly higher standard for sufficiency".

Questions from the audience

Opening up the discussion, Prof. Sir Robert Jacob asked whether it would be better if we took away the restriction that you can't patent methods of medical treatment, or would the problem still be there? In his words "they don't have this problem in America" (there was a certain amount of murmuring in the audience following this observation - what about the written description requirement?).

Application of the plausibility requirement to other claim forms?

The first question from the audience was to what extent the decision was relevant to product claims. Is there a different test for sufficiency based on the claim category (i.e. second medical use, versus product claim)? or is it because of the nature of the invention relative to the prior art? The questioner noted that the Supreme Court relied on a lot of the product claim case law from the EPO.

Prof. Sir Robert Jacob
first referred the question to Lord Hoffman, who commented that it was his understanding that when you have a new product claim, sufficiency is satisfied by being able to make the product. The point raised in the question transfers itself to the question of industrial application, i.e. what is the use of this new product? Dr Fisher was also very clear in his opinion that the plausibility test was not transferable to product claims, or even first medical use claims: If you are thinking about a second medical use claim, as far as I am concerned, you're sashimi slicing so that you are getting closer and closer to what has already been disclosed".

Sashimi slicing
However, as commented by the audience member, why doesn't the "sashimi slicing" argument apply to a compound patent, in which you are selecting a particular compound from all the known compounds? A product claim may also take the form of a selection invention, in which a sub-range is selected from a known range (see EPO guidelines for Examination, G-IV, 8. Selection Inventions).

Dr Fisher countered that he couldn't see any real reason why you would need to pinpoint the exact benefit that a product contributes if it contributes a benefit by creating and producing it.

[Merpel wonders about the difference between "sashimi slicing" and the more common English idiom "salami slicing", do readers have any insights?]

Another member of the audience noted that the EPO have demonstrated that they can use inventive step to apply the plausibility test to products. They noted that it seemed ironic that since the Warner-Lambert decision has come out, the arguments for sufficiency have spread into the mechanical arena, as a squeeze in relation to inventive step as against sufficiency. They commented that perhaps the idea of plausibility is really what one needs to make it clear that there isn't a squeeze between inventive step and sufficiency, because sufficiency is a much lower threshold than inventive step? Will we see plausibility creeping back into inventions relating to mechanical apparatus, where there is a significant degree of uncertainty as to the underlying principle as to why it operates?

Plausible but wrong

Prof. Sir Robert Jacob raised the question of whether, if the description provides wrong reasoning for why an invention works, would the invention be considered plausible? Lord Hoffman pointed out that, if an invention is shown to work, the question of plausibility does not arise. Sir Robert Jacob persisted that "this was not the case of second medical use patents, but it is true for first use apparently".

Another member of the audience noted that the discussion regarding second medical use claims was being held in the context of the facts of the pregabalin case. In contrast to pregabalin, there is not an authorized first medical use for the majority of second medical use claims. The only use many generics are directed to is therefore the patented use. The second medical use claim form is used to overcome prior art which suggest an earlier use, which has never been authorized or used in the clinic. In this context second medical use claims may seem less like an unjustified land grab.

Application of the plausibility requirement to EPC 2000 claims?

An interesting question from the audience regarding whether the plausibility test should be applied equally to Swiss-style claims and EPC 2000 claims, was unfortunately not tackled by the panel. The discussion was instead moved into a debate on whether it is possible to apply for Swiss-style claims at the EPO. Prof. Sir Robert Jacob insisted that this is still possible, but judging from the response from the audience, many didn't agree. Following  G 2/08, the Official Journal of the EPO provided that EP patents will not be granted for Swiss-Form claims with an earliest priority date of 29 January 2011 or later (OJ EPO 2010, 514).

Further thoughts

At drinks and canapés, it was clear that many in the audience were somewhat dissatisfied with the discussion on plausibility, although this Kat admits that her audience sample may have been biased towards patent attorneys. European patent attorneys in the biotech and pharmaceutical fields face plausibility objections from the EPO on a daily basis, as part of both insufficiency or inventive step objections. Many therefore felt that it would have been valuable to hear more from Dr Ursula Kinkeldey on the issue of plausibility. Unfortunately, Dr Kinkeldey was not invited comment during the audience questions on this issue.

The panel also did not discuss one of the main points of the case, the degree to which plausibility must be shown across the entire scope of a claim.

Perhaps the most interesting issue to come out of the panel discussion was that of the possible applicability of plausibility to types of claim other than second medical use claims. An interesting example to consider is the invention at issue in Jushi v OCV (IPKat post here). Whilst the issue under consideration by the Court is this case was one of novelty, it is nonetheless an interesting example of a product claim that slices out a part of the known art. Claim 1 of the disputed patent specified a fibreglass strand composed of a number of constituents at percentage weights within specified ranges. The prior art disclosed glass compositions composed of exactly the same compounds as that of the patent, at the same or overlapping percentage weights. Importantly, a skilled person would thus know how to make fibreglass according to the invention from the prior art.

The Court of Appeal found the claim novel, after applying the test for selection inventions established by the EPO: i.e. a skilled person would not have "seriously contemplated" operating in the claimed range, in view of the broader ranges provided in the prior art. However, is this type of invention not also "sashimi slicing"?  Should the inventors of sub-types of fibreglass thus be made to demonstrate that the claimed invention plausibly works over the entire scope of the claim?

The discussion on infringement will be covered in Part II. Stay tuned!

By Rose Hughes
Event Report: UCL IBIL - Pregabalin: Where stand plausibility and Swiss-form claims? PART 1 Event Report: UCL IBIL - Pregabalin: Where stand plausibility and Swiss-form claims? PART 1 Reviewed by Rose Hughes on Wednesday, January 09, 2019 Rating: 5

2 comments:

Alan said...

On the important question of the distinction between salami slicing and sashimi slicing, I would suggest that:

a) although in both cases the quality of the knife/cutting blade is paramount, there is more risk to the finished article in the case of sashimi
b) sashimi slicing requires a higher level of skill and experience, as the raw fish can be cut in different ways and not all produce a good result. Salami slicing is easier as direction of cut is inherently determined by the packaging of the salami itself
c) The thickness of the slice is less paramount in sashimi slicing. Although it should be correct, there is a proportionately greater influence on the end result in the case of salami, where too thick a slice may be almost inedible.

Others will have to comment on the significance of these points in the context of the discussion.

Interested Observer said...

On Sir Robin Jacob’s proposal about patenting medical methods, I would say that the human body is not a technical item. Why does one medicine works with one person and not with another? That’s the body’s mystery.

Inventions are there to solve a “technical” problem. Can restoring health or alleviating pain merely be a “technical” problem? With a "true" technical process, be it a process of manufacture or a way of using a device, the correct input values always lead to a reproducible result. In the medical field, the expected result does not always occur, the human or animal body having his own laws.

The physician is only obliged to practice his “skills” or his “art”. You cannot call a doctor to court if he has not cured you, you can only do so if he did not practice his skills or art in a correct way. A doctor has an obligation of making his skills available to the patient but he has certainly not an obligation of result.

That means that the physician cannot be made liable for the expected result, i.e. the recovery of the patient. The patient-doctor relationship is by nature a very confidential one, and it is anything but correct to interfere with it for the sake of license fees or the like.

Those are for me compelling enough reasons for not patenting medical methods. And on top of it the EPO had proposed to delete Art 52(4)EPC 1973, but the contracting states refused, and the content was simply transferred to Art 53, c) EPC 2000.

As far the comment about “"they don't have this problem in America", is concerned I would like to draw the attention to US US-A-5 080 111. After having obtained his patent, an ophthalmic surgeon sued colleagues who, without paying any license fees, used the patented method of a particularly shaped incision in cataract surgery. At the time this has shaken the medical community and put in the limelight the inherent problems linked with such liberal approach. At the time even a legislation amending 35 USC § 287(c) was considered, but it was not pursued. Some senators even proposed to align the US legislation to the EPC. So far for not having a problem in America.

As far as the relationship between sufficiency and inventive step is concerned, I would like to refer to T 2001/12. In a nutshell the decision says the following: if an effect is not achievable, or it is not plausible that it can be achieved, two possibilities are open:
-if the effect is claimed, then the objection is lack of sufficiency;
-if the effect is not claimed, then the objection is lack of inventive step as the problem cannot be solved.

Without a fair basis in the original description, then sufficiency might be at stake. It should at least be shown that it may be effective in the treatment of a given illness or to have the desired effect on the metabolism.

In case of a second medical use claim, or even for a first medical use of a known product, the medical use, i.e. the effect is necessarily part of the claim, be it alleviating pain or helping to cure a disease, or even having a prophylactic effect, the objection thus lies in lack of sufficiency, rather than in lack of inventive step.

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