K = Na. Is the genie out of the bottle? PART 2

This is part 2 of the report on "K = Na. Is the genie out of the bottle?" This report covers numerical limits in claims, relevance of the file history, harmonisation, and a vote as to whether the decision in Actavis v Eli Lilly has improved the law.

Claims with numerical limits

Sir Robin Jacob continued with a question for the panel submitted by a patent attorney: Do claims that contain numerical limits restrict the extent of protection, or under the DoE, do they now cover anything that works?

Lord Neuberger explained that he had got close to considering this question when considering an application for permission to appeal in Smith & Nephew v Convatech [2012] EWCA Civ 1638, although the case settled before it was decided upon by the Supreme Court.  The Court of Appeal had found that there was infringement, even though the amount of silver in the infringing product was higher than that specified in the claims.  There is an argument that where a patentee has defined their monopoly in a claim by 'book-ending' a range with two numerical limits, the patentee does not intend to go beyond that specified range.  However, although that might be persuasive, one also needs to read the claims in the context of the specification which might indicate otherwise.  Lord Sumption observed that the issue of numerical limitations would be considered by the Court in the context of question 3 of the Actavis v Eli Lilly questions - the parties may have deliberately indicated a range with precision.
Judge Kate O'Malley, US Court of Appeals for the
Federal Circuit.  
Judge O'Malley explained that typically there is a very good reason why a patentee has specified numerical limitations - to avoid prior art.  She suspected that this is why she does not see many DoE cases involving numerical limitations, but there are exceptions, and the DoE could extend a claim slightly beyond numerical limits, provided there is no prior art issue.  Claims are often drafted as "approximately X", thereby giving the Court the ability to analyse the issue more broadly.

Judge Kalden recalled a recent difficult case about emulsion, where there was a numerical limitation about particle size in the claims.  The size specified in the claims was said to be an 'average' size, and some particles in the infringing product were outside that range - the Dutch Court found infringement on the basis of the DoE.  As a general rule, it is difficult to sustain arguments about the DoE on numerical limitations, but there are exceptions.

From a German perspective, Judge Meier-Beck recognised that the DoE has a very narrow role in claims with numerical ranges, but it is not excluded.

What role should the file history have in the DoE, and should examination of the file history be confined to the patent office of the jurisdiction in question?

Judge Meier-Beck said that he subscribes to the view that life is too short to look at the file history, certainly the worldwide file history!

Lord Sumption stated that the English position is clear - the prosecution history is only referred to in exceptional circumstances [Merpel - are those exceptional circumstances clear?].

Judge O' Malley confirmed that in the US, Courts look only to the file history of the US patent office, not other jurisdictions.  In the Actavis v Eli Lilly case, the US Court would not have been able to say that the examiner was wrong to insist on a limitation to pemetrexed disodium.  In the US, if the examiner requires a limitation, you have the choice to either challenge that decision of the examiner at the relevant time, or accept the limitation.  If you accept the limitation, you have to live with that limitation.  The Actavis case would have been pretty clear in the US - the argument on equivalents would not have survived the prosecution file history estoppel.

Lord Neuberger
There was agreement from members of the panel that the examiner in the pemetrexed case had got it wrong - disodium was only an example of a way to perform the inventive concept and the limitation to disodium was too restrictive.

Is it possible to harmonise European patent law? Or is harmonisation a chimera? 

Judge Kalden said that we do not have the UPC at the present time, but harmonistaion has been achieved to a great extent.  The UK Supreme Court decision in Actavis is a good example of a further step in this harmonisation process, and is a welcome development.  Different decisions from different Courts often turn on the evidence, sometimes on the procedural rules (which may not be desirable, but is nevertheless what happens), and also on an appreciation of the facts in the case.  Judges are human and the way in which they interpret evidence will be different (indeed courts in one jurisdiction will have different opinions - which was why we were all at the event in the first place).  The European Courts are doing very well at present in terms of harmonisation.

Judge Meier-Beck confirmed that the Actavis decision from his perspective is an important step in harmonising law on Article 69 of the EPC.

THE VOTE - has the decision in Actavis v Eli Lilly improved the law? 

Sir Robin first asked lawyers in the audience to respond with a show of hands - has the decision in Actavis v Eli Lilly improved the law?  It seemed to the author that a small but significant majority of lawyers attending think that the decision has not improved the law (although there were many abstainers). Next, Sir Robin asked patent attorneys in the audience to respond to the same question - here, a more sizeable majority thought that the decision has not improved the law.

Sir Robin rounded the event off by giving Lord Neuberger a speech to mark his retirement from the UK Supreme Court.   The author notes that this marks the end of an era for Lord Neuberger, but the beginning of another for UK patent practitioners.

Postscript: a film of the event can be found here.
K = Na. Is the genie out of the bottle? PART 2 K = Na. Is the genie out of the bottle? PART 2 Reviewed by Eibhlin Vardy on Thursday, November 09, 2017 Rating: 5


MaxDrei said...

You report the consensus that "The examiner got it wrong". I disagree, and here's why.

The judges all agree that the "inventive concept" was the use of the pemetrexed ion, Vitamin B12 combo. But it is the job of the patent attorney, when filing a patent application, to announce in the application as filed, the statements of invention and/or the claims, what is the concept, the contribution to the art, the solution to the technical problem. Fair's fair, right, readers of WO publications need to know and are entitled to know. Yet here, right(?), the drafter failed. Look at the WO publication. Where do you see the concept of pemetrexed + B12? Nowhere. Instead, you get as (ludicrously wide) Claim 1 the use of an antifolate. The only dependent claim narrowing is to the Applicant's proprietary product ALIMPTA, that is, disodium.

So, instead of calling out the EPO Examiner as a failure, let's instead turn the spotlight on the PCT filing at the USPTO, and debate "best practice" in the USA when drafting patent applications. In my book, it was over there where somebody screwed up.

Don't get me wrong. UK needs a DoE and Lord Neuberger has had a career-long yen to get one in, finding a vehicle just in time. History won't notice whether the EPO Examining Division and established caselaw of DG3 on "undisclosed intermediate generalisation" "got it wrong" because this was a case about Art 69 EPC, not Art 123(2) EPC. But, for the record, I say there wasn't any getting it wrong at the EPO, and I think the English patent judges up to but not including Lord Neuberger, would agree with me.

The EPO is very quick to pass the buck to the poor drafter, shrugging its shoulders and telling us patent attorneys that we are the authors of our own misfortune, because we fail to draft our cases competently. That is harsh and insensitive, but sometimes they are right.

EPO speakers travel the world, trying to improve drafting standards. Let's give the EPO some credit for something shall we, rather than using it once again as a punch bag.

Gilman Grundy said...

Not surprising to see that in general the UK patent attorney profession sees Actavis as a bit of a mess.

Mr Blobby-Obvious said...

These summaries are an accurate representation of the discussion, so well done. On the numerical range point, I understood Judge Meier-Beck to believe the position was significantly stricter for numerical ranges compared to other claim limitations, because numbers are clearer, or words to that effect. This takes me back to my comment on part 1, where I note that 'sodium' is a clear definition.

I would treat them both the same. "Approximately 10" is a difficult one to construe. "10" itself, is also not as straightforward as one might imagine, as we have seen recently with arguments over decimal points, rounding up, and significant figures. But, "sodium" is a simple and clear as it gets. "Approximately sodium", I accept, may encompass potassium, but I doubt such wording has ever been included in a patent application, let alone granted. I would love to be wrong on this, so examples welcome, and something to try in my next draft.

Mr Blobby-Obvious said...

Max is right and the judges should be less quick to criticise when they have clearly not considered the facts. But as they say, they decide on the arguments on the day and don't consider the issues. Jolly good show from one side wins through every time chaps!

Even if the EPO examiner had been wrong about 123(2) (and the Supreme Court didn't been appreciate this was the issue having commented on the inventive concept - pith and marrow, don't mean narrow, chaps!) where was the argument from Lilly? The US drafter didn't draft the desired invention properly, but maybe this wasn't considered the valuable subject matter at the time? However, the EP attorney gave in without a fight, clearly agreeing with the examiner on added matter.

Personally, if I was in the his position faced with a brand name disclosure, I would have argued that the skilled person would have derived 'pemetrexed' as the active agent from the application and not limited to specific salts. Certainly one to test the EPO's strict added matter approach at appeal and I suspect this would get through without much difficulty.

Tim Jackson said...

Mr Blobby: "... I would have argued that the skilled person would have derived 'pemetrexed' as the active agent from the application and not limited to specific salts. Certainly one to test the EPO's strict added matter approach at appeal and I suspect this would get through without much difficulty."

When I first read the case it struck me that the Examiner's Art.123(2) objection was absolutely standard EPO practice in the circumstances. Faced with a lack of explicit disclosure that the pemetrexed ion generally was effective, I can understand why the representative would reluctantly limit to the disodium salt. If the importance had been perceived, I suppose you could accept the narrow claim and file a divisional to try to pursue something broader.

I'm not sure whether a Board of Appeal would have overruled the objection. I think the reason that Lord Neuberger saw it as directly and unambiguously derivable was because he had had the benefit of a huge volume of expert evidence about how the invention worked and what the skilled person would derive from the original disclosure.

Would a Board of Appeal have been prepared to consider a similar volume of expert evidence? If they did, maybe they would come to the same conclusion as Lord Neuberger. But as a practical matter, the EPO is not very receptive to the idea of hearing large volumes of expert evidence, and possibly not very good at assessing it if they do, either in first instance examining and opposition divisions, or in the Boards of Appeal. They tend to say that they themselves are skilled in the art, so why do they need all this background stuff?

With the benefit of hindsight, it's easy to criticise the original drafting of the application for not providing an explicit basis for the pemetrexed ion generally, but I'm reluctant to do that without knowing all the facts. For example, at the time it wasn't known that dipotassium and other salts would work. Testing other salts would have been a routine task, but it hadn't been undertaken at the time. Though I admit that would presumably apply also to some of the other anti-folates covered by the originally-filed claim.

maxdrei said...

Thanks for that contribution, Tim Jackson. As to criticism of the drafting, I appreciate that the only antifolate they had tested was their own proprietary product ALIMPTA (pemetrexed disodium) but that didn't inhibit them from claiming in their independent claim an antifolate as such. Given that the antifolate in ALIMPTA is the pemetrexed ion, and the worked Example in the PCT as filed is the pemetrexed ion, is it not at the level of a "no brainer" to include a dependent claim, wherein the antifolate is the pemetrexed ion?

Tim Jackson said...

Max, as far as I know, the worked example in the PCT application just disclosed Alimta (pemetrexed disodium), with no mention that the pemetrexed ion more generally was the effective agent.

Maybe it should have said that, though I'm no chemist and I'm reluctant to criticise for the reasons stated. However, it wasn't as straightforward as saying that the worked example was the pemetrexed ion, so it was a no-brainer to include a dependent claim for it.

Mr Blobby-Obvious said...

I agree that the EPO made the standard, expected, objection. Lilly made the standard "acceptance of the expected objection" response. The drafter used a brand name to describe a chemical product - bad idea, resulting in the expected objection. therefore incompetent drafting. The claim was narrowed to a commercially weak scope (should have been useless and would have been if it was not for the Supreme Court).

It is on the basis of the lack of commercial value of the allowed scope that Lilly should have fought for more, but failed to do so.

If the invention related to functional aspects of the formulation (e.g. solubility) then there is an argument that the replacement of sodium with potassium would have achieved a different result. The EPO Appeal Board would not have accepted the broader scope in this scenario, even if they had access to expert evidence. But then, this case would never have gotten to the Court if this was the invention.

As appreciated by all, the invention related to the combination therapy, and the decided fact is that the skilled person would have appreciated this to be dependent on the active ingredient, irrespective of salt form. This does not require significant expert evidence and the EPO examiners and Appeal Boards are perfectly capable of appreciating this point. The dilemma for the EPO is the strict added matter application, but as I stated previously, I suspect this case would have succeeded. The question is what would the skilled person have derived from the teaching, not what literal wording is used in the application.

Based on the importance of the patent and the need for commercially valuable claims, Lilly erred in not challenging the examiner. It is wholly inappropriate for the Supreme Court to criticise the examiner.

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