Guest Post by Paul Cole, visiting professor of IP law at Bournemouth University
Dosage Regime/ABBOTT RESPIRATORY G 0002/08 – 19 Feburary 2010
Patentability of the present application was governed by EPC 2000 rather than EPC 1973, and the referring Appeal Board considered it an important point of law whether medicaments for use in therapeutic treatments could be considered novel where the only feature of novelty was a dosage regime. The claim before the Board was directed to:
"The use of nicotinic acid or a compound metabolized to nicotinic acid by the body … for the manufacture of a sustained release medicament for use in the treatment by oral administration once per day prior to sleep, of hyperlipidaemia … "
The Enlarged Board was first asked to consider the general question: when a medicament was known for use to treat an illness could patents subsequently be granted further new and inventive treatments of the same illness. Under EPC 1973, such further patents had been granted with Swiss-form use claims directed to treatment of new patient groups (T 0019/06, T 0383/90 and T 0233/96), new modes of administration (T 0051/93 and T 0138/95) and different technical effects relating to truly new applications (T 0290/86. T 0254/93 and T 1020/03). The Board held that it was not the intention of the legislators in framing EPC 2000 to change the patent protection available for further therapeutic uses. Use of a composition as a medicament for unspecified therapy was permitted as a first medical indication and for a specified therapy was permitted as a second medical indication.
A second and more specific question was directed to patentability where the only novel feature was a new and inventive dose regime. The Enlarged Board held that this question should be answered in the affirmative provided that there was a new technical effect, see also UK decision Activis v Merck [2008] EWCA Civ. 444 and German decision X ZR 236/01 Carvedilol II, 19 December 2006.
As to any appropriate change in EPO practice, simple use claims were now permitted under the changes introduced by EPC 2000. Since the reasons for granting Swiss-form use claims had disappeared with the entry into force of EPC 2000, there was no reason to maintain the "praetorian" approach suggested in case G 0005/83, and such claims would no longer be permitted. As to the transitional provisions governing this change in practice:
"The Enlarged Board of Appeal is aware of the fact that patents have been granted and many applications are still pending seeking patent protection for claims of this type. In order to ensure legal certainty and to protect legitimate interests of applicants, the abolition of this possibility by the interpretation of the new law given by the Enlarged Board in this decision shall therefore have no retroactive effect, and an appropriate time limit of three months after publication of the present decision in the Official Journal of the EPO is set in order for future applications to comply with this new situation. In this respect the relevant date for future applications is their date of filing or, if priority has been claimed, their priority date."
The present decision can be seen as an uncontroversial but welcome restatement of the law that will give greater certainty both for applications and oppositions before the EPO and for the enforceability of the resulting patents in the EPC contracting states. Connoisseurs of verbal abuse may, however, wonder whether it was wise to attach the label "praetorian" which at least to English readers has implications of dishonesty, corruption and perhaps subversion to the former Swiss form claim practice whose acceptance by the national courts of the EU contracting states was at times grudging.
“…that English instinct always to apologise.”
So THAT’s where the Canadians got it from.
Paul, but for the coincidence of the Garner Tip of the Day, MGM would not have come to the idea of writing. I would say that no apology is necessary here. My advice, when you are out and about internationally: curb that English instinct always to apologise. (Sorry for being so direct.)
MG: Apologies for miscommunication. When you have a specialist subject and generalist readers, it is always diffcult to pitch things just right – either you bore the specialist or you are too terse for the generalist. The object, I think, is to indicate the general subject matter and alert the specialist so that he or she can then plough through the pages of Euro-speak in the original decision.
Prof. Cole,
On your original post: a very succinct analysis; too succinct. Clearly some of the readers understood it. However, I failed to grasp about half of the analysis, and because I am a regular reader of this blog, I am necessarily a part of your audience. Please be mindful of the following quote, which I just read on Garner’s Usage Tip of the Day:
“There is only one way to make sure of the communication of ideas: to demand that what is being said to you shall be said in terms understandable to you, and to discipline your own language so that it says what you want it to say.” Royal Bank of Canada, The Communication of Ideas 27 (rev. ed. 1972).
Further investigation of the significance of “praetorian” in the context of Roman Law shows a reference to the Praetor Urbanus who apparently had the function of supervising the courts and during the late Republic and early years of the Imperial system published an annual edict setting out how the law would be applied. Although the edict was not strictly part of the law, it apparently incorporated equitable principles, and gave rise to the so-called ius praetorium. In civil law the discretion of the praetor, as distinct from the leges, or standing laws referred to that kind of law which the praetors introduced for the purpose of aiding, supplying, or correcting the civil law for the public benefit.
So now we know, and the intention was apparently to refer to equitable principles rather than to arbitrary power. The reference was to the praetor urbanus and not to the praetorian guard.
OK EG but do I understand it right? You are actually in favour of patents for inventions that are new and unobvious dosage regimes, and so do approve of creative decision-making in the courts of European countries,to give effect to that public policy objective, right?
Of course, doing away with Swiss claims hasn’t done away with use claims. Quite the reverse. They are thriving. Are they a puzzle to you too? Or is it just the Swiss use claim that puzzles?
Max,
Thanks for correcting me on who made the comment about “praetorian.” The Swiss-style claim may be an “elegant escape” from the clutches of a puzzling EPC provision (at least to us in the US), but I’m frankly glad that it may now be as obsolete as the “praetorian guard.”
Malcolm you are of course entitled to your opinion. In fact, I wager it is shared by most of Europe. Perhaps this is why Europe’s response was to amend the statute, in order to eliminate any need for the Swiss form of claim.
But in the meantime, until Europe could get 30 plus Member states to agree to amend the European Patent Convention, the Swiss held the pass. Can you and I agree that, indeed, it’s a sham, but nevertheless a neat one?
“Me too, but some have refused.”
If you use a se xier voice you might have better luck.
“I’m just pointing out how this claim limitation would fail to fly in the US, and marvelling at the freedom of applicants to use plain and ordinary language in the EPO without all the hairsplitting BS and GOTCHA Examiner tactics we have in the States.”
Maybe if you learned to draft with specificity you wouldn’t get had. As often 🙂
Plus, when did upholding USC 151 become a “tactic”?
“Funny how all this bad claim drafting and short-sighted prosecution gets blamed on the examiner. Maybe he just needs more time allocated to this obviously complex case.”
PREACH IT BROTHER !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!1111111111111ONEOENONEEONEONEONEOENEONEONEONEONEONE1111111111!!!!!!!!!!!!!!!!!!!!!!!!!!!1111111111111111111
Broje et al.’s always tryin’ to do that sht.
MD Most people see the “Swiss form of claim” (The use of molecule X in the manufacture of a medicament against disease Y) as rather an elegant escape from the straitjacket of the statutory provision in the EPC (in its original 1973 version).
Really? It always struck me as a sham.
EG, it is not Paul Cole who characterizes but, rather the one who wrote the Decision on which he comments. I think the writer was quite taken with the word. It is all over the Decision. I do not yet quite see why it is not completely apt (setting aside its negative connotations).
And why “antiquated”? Most people see the “Swiss form of claim” (The use of molecule X in the manufacture of a medicament against disease Y) as rather an elegant escape from the straitjacket of the statutory provision in the EPC (in its original 1973 version).
Care for another dig, archaelogical or otherwise?
Paul,
I like how you characterize the old Swiss-style claims as the “praetorian” approach. Definitely as antiquated as ancient Rome.
****The word “freedom” is one of the last words that comes to mind when contemplating amending claims in the EP*****
I should have said “apparent freedom.” Just based on this claim.
Did the same claim fly in the USPTO?
Marcus, thanks. I doubt there’s much between us. If it’s not obvious how to make the pure enantiomer, and you enable that making, then in I accept you should get a patent on the enantiomer, per se, even if everybody knew all along that it’s there for the finding.
As to the brevity and clarity of claims in Europe, they are to be read by the PHOSITA, in any one of 36 Member States, so they have to be kept clear of lawyerly obfuscation.
And Malcolm’s right: if you don’t say it on filing, you’re not going to be allowed to say it belatedly. That’s First to File at work. Brutal on poor draftspersonship. Best to say at the outset, before the Paris year expires, what your invention is.
Max: Clearly, you have some distance between yourself and the lab bench.
To simulate a molecule, one must first choose the range of molecules which you want to look at – choose your part of the world to explore. Even if a molecule is simulable, it is unlikely to be synthesizable – you may think an island ought to exist somewhere, but successfully navigating the treacherous winds and shoals around the shore may be something else entirely. If you identify a new molecule, and successfully teach how to get to it, ought you not to have a shot at a patent over the molecule itself?
Of course, if someone says that the island was only a short sail from another island, or that we were all exploring this newly-discovered archipelago, so someone was bound to happen upon it sooner or later, that is a question of obviousness. If the new island were merely lying in the shipping lanes, clearly it was “ob via”. In which case the island entire of itself is not patentable, but the botanist who lands and finds the new herb growing on the island ought to have a crack at patentability. Of course, one then must look at what the botanists were all up to.
Proper determination of protective scope, therefore, should lie with proper determination of inventive step as well as novelty. If your new molecule is merely an obvious derivative of a known molecule, you might satisfy novelty, but you don’t get your broad monopoly because you’re obvious.
broje In the US, that limitation would draw a 112 for failure to specify in the claim that the sleep was the previous day’s sleep, that day’s sleep, tomorrow’s sleep, or sleep at an even earlier or later date. Then the [deleted to save threadspace]
You’re going to go through a lot of kleenex if you keep crying that like, broje.
Geezis.
marvelling at the freedom of applicants to use plain and ordinary language in the EPO
Do you actually practice before the EPO? The word “freedom” is one of the last words that comes to mind when contemplating amending claims in the EP.
****1. I’ve had examiners talk to me after final.****
Me too, but some have refused. I’m just pointing out how this claim limitation would fail to fly in the US, and marvelling at the freedom of applicants to use plain and ordinary language in the EPO without all the hairsplitting BS and GOTCHA Examiner tactics we have in the States.
Then the Examiner would 102 it, tossing down some art teaching dosage first thing in the morning, and say it is “before sleep.”
And he’d be right. Because it’s logically true, and you know that if you ever found someone administering the dosage in the morning you’d be arguing for that construction in court.
Then he would reject as new matter any attempt to amend the claim to say “substantially immediately” before sleep or anything else that will overcome the rejection.
Even a half-decent spec should more than support such an amendment.
Or you could file a declaration explaining what a person skilled in the art understands “before sleep” to mean. Or not mean, if you live in constant fear of estoppel.
He’d also throw down some additional art teaching dosage several times per day. Only after filing an RCE to get an interview will you discover his rationale is that the claim does not specify “exactly” once per day.
1. I’ve had examiners talk to me after final.
2. If your claim doesn’t specify only once per day, you should expect a teaching of multiple dosages throughout the day to anticipate, especially if one is in the evening.
Funny how all this bad claim drafting and short-sighted prosecution gets blamed on the examiner. Maybe he just needs more time allocated to this obviously complex case.
******treatment by oral administration once per day prior to sleep, of hyperlipidaemia*****
In the US, that limitation would draw a 112 for failure to specify in the claim that the sleep was the previous day’s sleep, that day’s sleep, tomorrow’s sleep, or sleep at an even earlier or later date. Then the Examiner would 102 it, tossing down some art teaching dosage first thing in the morning, and say it is “before sleep.” Then he would reject as new matter any attempt to amend the claim to say “substantially immediately” before sleep or anything else that will overcome the rejection. He’d also throw down some additional art teaching dosage several times per day. Only after filing an RCE to get an interview will you discover his rationale is that the claim does not specify “exactly” once per day.
7: Rule 137(3) EPC (one shot only at amendment) has been there since 1978. Isn’t it standard negotiating technique, to begin your pitch further away from the eventual closure point than the other fellow? In the context of prosecution at the EPO, mindful of Rule 137(3), starting out this way concentrates the mind of the Applicant wonderfully.
In the early days, the EPO Examiner cadre was, broadly, humble, and polite. But they are unfortunate victims of their own success. These days, they observe what a shambles is prosecution in every other Patent Office round the world, and it makes some of them a bit cocky.
Blame EPO-PSA. It disposes of obviousness in very short shrift. When an EPO Exr sees what a mess other PTO’s make of obviousness, it makes him even more cocky.
But, basically, EPO Exrs are still, in the main, customer-friendly. The “You scratch my back and I’ll scratch yours” attitude is not unknown or, as the Germans say, more succinctly, “One hand washes the other”. It’s sometimes regrettable, but it’s a far cry from the boring adversarial mindset one sometimes sees illustrated on this blog.
Max,
This is off topic, but what do you think of the changes at the EPO that take effect in April? No longer any right to amend, and can do so only at the examiner’s discretion?
Do you think EPO examiners will use this to simply kill cases they don’t like? I really hope not…
In numerous of my european cases, the examiner has started off very negatively, pretty much flat out saying YOU WILL NEVER GET A PATENT GO AWAY. Yet, over the course of prosecution, via amendments and arguments, I eventually brought the case to issue.
Marcus, my point is that Molecule X is not like an island 500 years ago, awaiting “discovery”. Rather, it is something “lying in the road” (ie obvious) generated in innumerable multitudes purely mechanically on a computer screen, without any invention, or any inventor. The patentable contribution to the state of the art comes first when somebody enables a non-obvious specific use for that molecule. Give that inventor a patent. But limit the scope of protection to the magnitude of the contribution.
MaxDrei:
If molecule X is new per se, the world would be without it without Inventor Y’s disclosure of how to obtain it.
One something exists, it may consequently be tested for a variety of uses, and the disclosures of each use are necessarily a smaller contribution than that which brought it into useful existance.
Metaphor time: compare a sea-captain’s discovery of a new island, with a botanist’s discovery of a new variety of herb existing only on that island. If we are to get rights commensurate with what we contribute, might not there be an argument for giving the sea-captain (or his king, by whom he is paid to explore) the rights over the island, but the botanist, perhaps, rights over the herb?
Thanks Marcus for exposing the tension that exists when an inventor discovers that Molecule X has a great utility. Does one follow the traditional approach, of giving the inventor a monopoly of all uses of Molecule X, or the EPO way, of giving the inventor a scope of protection confined to that specific use. Easy, when Molecule X is no longer new per se. But me, I am dubious whether absolute protection can ever be commensurate with the contribution to the art, even when Molecule X is new per se.
“Use of unobtanium to treat halitosis” is a medical method. “Unobtanium for use in treating halitosis” and “Unobtanium for use in treating halitosis by oral administration of 1kg twice daily” are not medical methods, they are products which, by agency of Art 54(4) and 54(5) EPC, are treated as though the wording following “for use in” were a technical feature.
David French writes:
This is an opportunity for me to observe that I have never understood why a claim in the form: “The use of a compound to treat a disease comprising administering the compound (according to a specific protocol)” is not disqualified as being a method of medical treatment.
Thanks Paul. You didn’t mention that although the Enlarged Board clarified the situation regarding the claiming of second medical uses and said these are in principle patentable (even if the novelty in the use is in the dosing regimen), the board shot down the particular claim at issue. Do you think there might have been an alternative wording that would have saved this claim?
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