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Thursday, 28 May 2015

Warner-Lambert v Actavis; the Court of Appeal has its say on second medical use claims in the UK

The IPKat is delighted to receive from a Katfriend this brief summary of an important decision handed down this morning. More detailed consideration may follow in due course.

IPKat readers who have followed this saga will know that earlier this year Mr Justice Arnold gave the first detailed consideration of what a Swiss-form claim means, see blog post here and here.  Today the Court of Appeal handed down its decision in the latest of this ongoing litigation involving Warner-Lambert's blockbuster Lyrica product.

As a brief refresher, in Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWHC 72 (Pat) Arnold J construed the Swiss form claim as requiring the infringer (for example a generic producer) to “subjectively intend” the medicine to be used for the patented indication. Under this test the patentee would not be able to succeed on infringement unless it could show that the generic company had aimed at or targeted the patented use in some way.  In his subsequent judgment dated 6 February 2015, Arnold J ordered that Warner-Lambert’s claim for indirect infringement under section 60(2) of the Patents Act be struck out.

In a judgment handed down today Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWCA Civ 556 the Court of Appeal (led by Lord Justice Floyd) has put forward a wider test for the infringement of second medical use patents.  On direct infringement under section 60(1)(c) of the Patents Act, Lord Justice Floyd departed from Arnold J’s subjective intent test which amounted in effect to requiring that the patentee prove that it is the generic’s “wish or desire” to sell some medicine for the patented indication.  Floyd LJ concluded that it was sufficient for infringement that the producer knows (including constructive knowledge) or can reasonably foresee that the medicine would ultimately be intentionally used for pain.  Floyd LJ commented that on his construction of the claim “it is plain that Warner-Lambert have an arguable case of infringement”.  Infringement will now be considered at the trial at the end of June.  On indirect infringement under section 60(2) of the Patents Act, the Court also allowed Warner-Lambert’s appeal against the striking out of that claim.

The Court of Appeal did however decline Warner-Lambert’s proposed interim relief.  Warner-Lambert had sought (1) that a contractual condition be included in any agreement entered into by Actavis with any pharmacy or with any intermediary for the supply to a pharmacy of its generic pregabalin product that the pharmacy use reasonable endeavours to ensure generic pregabalin would not be supplied or dispensed to patients who have been prescribed pregabalin for pain; (2) that Actavis inform Warner-Lambert’s solicitors of the name of any intermediary they intended to supply their product to; and (3) that Actavis’ generic pregabalin product be supplied in bulk packaging bearing a notice stating legibly 'This product should not be dispensed for pain.' The Court of Appeal commented that, even if infringement is found at trial, “it does not follow that unqualified relief will follow as of right”.  This case has already seen the grant of a novel order addressed to NHS England requiring it to give central guidance to prescribers and dispensers. No doubt other developments will follow.

60 comments:

Anonymous said...

And the mystery is why Mr J.A. didn't come to this conclusion in the first place.

Anonymous said...

Not a big mystery. Paragraphs 125, 130 and 132 deal with a few strong arguments supporting Arnold's approach. (I might still agree with Floyd, but I have not made up my mind yet.)

Anonymous said...

I don't specialise in this area, so be kind.

But it reads to me as though for 2nd med use claims (or perhaps only in the Swiss-type form?) the judgements are seeking to imply a similar test to primary infringement as is explicity stated in the act in relation to secondary infringement (bar the means relating to an essenial element part).

Useful take-home message, or have the point and I yet to be aquainted?

Anonymous said...

As a slight aside to the judgement, but relevant to the issue, the prescribing of 'pregabalin' for pain rather than 'Lyrica' must be considered off-label prescribing, because only Lyrica is licensed for pain. Prescribing generically will often result in the dispensing of an un-licensed product.

GPs are permitted to prescribe off-label in this way, but they have increased obligations when doing so. One of which is that they must be satisfied that it would better serve the patient’s needs than an appropriately licensed alternative.

Clearly, they have to, at least, give additional consideration to their choice of prescription even if they decide that prescribing the generic is appropriate. However, the current system of prescribing is dictated by the GPs prescribing software, which takes the consideration and choice out of the GPs hands. As such, the above-mentioned obligation is not being honoured.

Anonymous said...

For many years people have complained about the scope of protection afforded to pharmaceuticals. They have bemoaned that for a new molecule, protection is afforded to the molecule per se and not limited by the use for which it had been invented. Complainants are often patent attorneys from non-chemical fields with their "it's not fair that pharmaceuticals are treated better than our inventions" arguments. Other complainants include retired attorneys who made a very good living out of the system, but then became all philosophical once left to watch daytime TV in their holiday cottage.

If nothing else, this case shows that limiting the protection of new molecules to their first-demonstrated pharmaceutical use is a very unworkable system and will not provide certainty of monopoly for pharmaceutical companies. The result being zero investment in pharmaceutical research and no new drugs. I'm all for philosophy and living by owns own ideals, but a touch of pragmatism is required to make many things work.

Anonymous said...

"Other complainants include retired attorneys who made a very good living out of the system, but then became all philosophical once left to watch daytime TV in their holiday cottage."

or worse yet they spew forth spurious interpretations on divisional and priority practice that are clearly misaligned with the law and the intent of the law, causing a headache for those of still practicing.

Mr P said...

The judgement makes a very interesting point about direct infringement under Section 60(1)(b).

"How does one tell whether a manufacturer is using the manufacturing process of the claim, and therefore rendering himself liable for patent infringement? The answer must be when he manufactures pregabalin when he knows or foresees that users will intentionally administer it for pain".

This is great news for innovators second medical uses but does appear to come at the risk of generating a great deal of legal uncertainty for third parties - including other innovators. The risk here comes from the possibility that knowledge / foreseeability will change with time, with the result that what represents non-infringing manufacture one day will become infringing the next.

The Court of Appeal makes it clear that the harshness of this result will be tempered by the nature of the relief granted to the patentee in such circumstances. This presumably means that the patentee will not be granted an injunction. However, those preparing to launch a new pharmaceutical product might still need to account for the damages / license fees that might become payable as and when it becomes foreseeable that their product will be used off-label for one or more newly-patented uses. As it will be impossible to predict if and when such new uses will be invented, let alone when their off-label use will become "foreseeable", this will make it very hard indeed to predict the return on investment that will be achieved post-launch.

Perhaps the courts will come up with some clever way of dealing with this issue, but it will certainly add to the complexity of providing clearance opinions in the meantime!

THE US anon said...

Fair warning (and perhaps a call for setting the context) - I have not yet read the decision, and this comment comes from merely reading this post:

At first blush I take the gist here to mean that the scope of the claim at issue will not be necessarily limited by any type of practical guidance as to that claim's efficacy in being put into practice. That is, the claim on its face may create an overlapping circle of scope with existing claims and that circle will not carve out practices that may post grant merely enforce part of the claim's circle of coverage (that part which is conveniently separate from any circle of coverage of any earlier claim).

Am I proceeding with an accurate viewpoint?

Anonymous said...

I had hoped the Court of Appeal would give more consideration to whether a Swiss style claim is like an EPC 2000 medical use claim. I think it is better for 'intention' to be linked to a product rather than a manufacture, and then the intention of importers, packagers, pharmacists etc potentially becomes relavant.

Isn't it very artifical for infringment to be decided based on the intention of a party that is carrying out a step (manufacturing) which is not relevant to the validity of the claim? Isn't it illogical for infringement to be decided differently depending on the availability of claim formats (Swiss+EPC200 medical use) for exactly the same types of invention (i.e. drugs for treating specified conditions). The same contribution which is distinguished over the prior art using the SAME validity tests has now got a different infringement test based on which claim type was used. Isn't that incorrect?

MaxDrei said...

When it comes to 2nd medical use claims, I take it that disputes are between Big Boys ie innovative pharma and the generics industry. This is not assymmetric warfare but equality of arms. So I'm not too bothered how hard it is to do an FTO study or decide whether or not any particular act is an infringement, in this very highly esoteric field of patent law. Bio Start-ups have to draft new patent applications as best they can, but bigger fish wil be doing the litigation, years down the line.

Or are there repercussions here for shallow-pocketed SME's?

Anonymous said...

"with the result that what represents non-infringing manufacture one day will become infringing the next"

Yes, either on a day when a patent is granted or the facts of the manufacture change.

"..it very hard indeed to predict the return on investment that will be achieved post-launch"

No, because the predicted ROI will only over sales for the then-known utility and not the unknown future patented utility. Future sales off-label for the patented utility subject to damages claims would not eat into the ROI, otherwise they would not be limited to the damage caused by the off-label use.

"Am I proceeding with an accurate viewpoint?"

I am thinking of a number. If you try and guess what I am thinking there is a remote possibility you will guess right, but most likely you will guess wrong.

" Isn't that incorrect? "

No, different claim wording results in different claim scope. The explanation of a Swiss claim being a purpose limited process claim, whereas a compound for use claim is a purpose limited product claim, seems reasonable to me. The tricky bit is what follows from that.

Anonymous said...

Anon at 13:53 why doesn't the different wording result in a different vaildity test?

Mr P said...

Anonymous 13:53 - I think that you have got your dates wrong. Why would the mere grant of a patent suddenly make it "foreseeable" that the product would be used off-label for the patented indication? I very much doubt that the prescribing practices of doctors are influenced to any great extent by patent grants. The difficulty of establishing when (or even whether) a particular off-label use has become "foreseeable" does rather make my point that providing clearance opinions will become a lot more complex.

However, I do take your point about liability for off-label use not eating in to ROI for the indication(s) on the product label.

Nevertheless, although it is perhaps a relatively minor point, would not the cost of defending (potentially frivolous) litigation eat into ROI? And how exactly do you think that the courts will be able to pin down the precise proportion of sales that are due to any specific indication? Just because sales go up, it does not mean that a product is being prescribed off-label. Who is going to pay for gathering the necessary evidence?

Anonymous said...

Validity of a second medical use claims is decided on the basis of whether a disclosure has been previously made of the indication identified in the claim.

If the drug is Compound X and the known indication is heart disease, the new indication stroke, then:

Swiss claim covers manufacture of medicament for treating stroke.
EPC2000 claim covers Compound C for use in the treatment of stroke.
Compound X is known.
Use of X in the treatment of heart disease is known.
Novelty resides in X being identified as suitable for treating stroke.
If use for stroke is unknown then both Swiss claim and EPC2000 claim are novel.
If use for stroke is known then both Swiss claim and EPC2000 claim lack novelty.

Infringement determination does not come down to knowledge of potential utility of compound X, but is assessed based on the specific acts of an alleged infringer, whether those acts are covered by the specific wording of the relevant sections of the Act covering infringement, and the specific wording of the claims; the wording of Swiss and EPC2000 claims being different - i.e. purpose limited product/process.

Anonymous said...

Mr P: Your forseeable query was in respect of the manufacturer, i.e. he who would be sued for infringement. One day there is no patent and there is therefore no risk of his product being sold for a non-patented indication. The next day the patent exists and he can then see there is such a risk.

Your last point on expense and complications is correct and the Appeal Court understands this. It will come down to a damages enquiry in court and these are always complicated. Provided an infringement party is cooperative the costs involved in such a determination will be relatively insignificant in comparison to the sales made in the pharmaceutical market. As Max pointed out this is a game for big boys and girls only. The barrier for entry into the generic pharmaceutical market is generally low, but on these occasions it will be a little higher, though not excessively so.

Anonymous said...

@Anon:
Isn't it very artifical for infringment to be decided based on the intention of a party that is carrying out a step (manufacturing) which is not relevant to the validity of the claim? Isn't it illogical for infringement to be decided differently depending on the availability of claim formats (Swiss+EPC200 medical use) for exactly the same types of invention (i.e. drugs for treating specified conditions). The same contribution which is distinguished over the prior art using the SAME validity tests has now got a different infringement test based on which claim type was used. Isn't that incorrect?

No, it is not. The wording of a claim actually matters. That EPC 1973 allowed Swiss-type claims but not Art. 54(5) EPC 2000-type claims does not mean that they should therefore have the same scope. No reason for that at all.

(Btw, if one wants to derive from the travaux préparatoires of EPC 2000 that they do have the same scope, that would mean the 54(5)-claims are to be given the scope of the earlier Swiss-type claims, not the other way around. EPC 2000 cannot have had the effect that old claims became broader in scope.)

Anonymous said...

Just because the Swiss claim refers to 'manufacture' it does not mean that the intention to treat the specified condition needed to be the manufacturer's. That works for the factual scenario in this case, but won't work for other scenarios, and I suspect the Courts will regret a lot of the interpreting of Swiss claims that they are presently doing.

Anonymous said...

I was watching in Court earlier this year when Arnold J shouted ( literally! ) at Pfizer that infringement was outside the control of Acatvis. Of course it's not and Acatvis ( and any other generic) can take reasonable precautions to minimise the use of their product for the patented indication ( in this case pain).

It's a huge relief to see the Court of Appeal adopting an objective and fair test and overturning Arnold J's legal analysis (although probably not his inner thoughts!).

As an aside has anyone ever worked out why Mr Justice Arnold had such an explosion over breakfast about the misuse of pregabalin in the UK in prisons etc as a " legal high"?

In any event this Court of Appeal judgment is a "legal high" of a different form!

Anonymous said...

Just because the Swiss claim refers to 'manufacture' it does not mean that the intention to treat the specified condition needed to be the manufacturer's.

How do you imagine finding a manufacturer liable of infringement of a Swiss-type claim on the basis of the state of mind of someone else?

THE US anon said...

Anonymous @ 16:16 stated: "Validity of a second medical use claims is decided on the basis of whether a disclosure has been previously made of the indication identified in the claim."

Q: why the different treatment of items of medical nature? Why not just use "normal" rules of patent law that would apply to any other item in any other art field?

The first person with a patent on an item has a patent for the item no matter what the use, previously indicated or not. You come up with a novel use, then you can have a method claim. But you cannot have rights to the item. Your method claim scope quite naturally has overlap with the product claim scope (i.e., if the product is still under patent protection, you do not have unfettered rights to practice the method). But this overlap too applies to all art fields and is merely a reflection that the patent right is a negative right - not a right to actually practice. In fact, the rather large majority of patents are the so-named improvement patents that face this situation.

It seems to me that intricate hoops have been formulated because the person or persons who would infringe any such method claim would be the rather disperse (and typically shallow pocketed) end users. It is only the end users (as several commentators have pointed out) that would possess the necessary intent (and final steps of action) that would actually infringe a proper method claim (seeing as ANY justified other uses extant in the world liberate a manufacturer). To attempt to reach back to the manufacturers simply expands the power of the secondary method claim beyond what patent law provides for any other art field.

MaxDrei said...

To US Anon. The EPC has methods of teatment of the human or animal body as ineligible for a patent.

So when you write:

"come up with a novel use, then you can have a method claim"

that might well be so in your jurisdiction, but not under the EPC.

The complexity of special rules for 2nd medical uses follows from that.

Anonymous said...

There is no "reaching back" beyond that provided for in any other field:

UK Act:

(b) where the invention is a process, he
uses the process or he offers it for use in
the United Kingdom when he knows, or it
is obvious to a reasonable person in the
circumstances, that its use there without
the consent of the proprietor would be an
infringement of the patent;

Swiss claim is a process claim. A skinny-label-generic who supplies a drug to pharmacists knowing the pharmacist will dispense the drug for use in a patented indication is (in my view as not yet decided by any UK court) offering the process with the requisite knowledge. Both the gneric supplier and the pharmacist could be direct infringers, or are joint infringers by jointly offering the process.

S60(2) also seems to me to be clearly applicable as the drug is an essential means for the Swiss preparation of a medicament. i.e. the act of the pharmacist of preparing the medicament for the patient.

Finally, I appreciate US attorneys are not EU practitioners, but I would expect and EU-based attorney to understand many of the principles of the US patent system as regards method of treatment, and the same should apply to a US attorneys knowledge of EU law.

Anonymous said...

@US anon:
Q: why the different treatment of items of medical nature? Why not just use "normal" rules of patent law that would apply to any other item in any other art field?

It is the law that makes a difference. The EPC excludes "methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body" from patentability. So if you find a new medical use for a known product, you can't claim that use, since it amounts to an excluded method for treatment.

To partially make up for this, under EPC 1973 there was Art. 54(5) that essentially stated that any known substance or composition for use in such an excluded method was to be regarded as new, provided that its use for "any [such] method" was new.

According to the early decision T 128/82, it follows from Art. 54(5) that the first one to discover that a particular known substance has some specific medical application may get a patent on that substance for any medical use. Conversely, that (apparently) meant that if it was already known to use that substance for some specific medical use, that destroyed the novelty of that substance for any other medical use as well.

Since its revision in 2000, the EPC also provides that any known substance or composition for a _specific_ use in an excluded method is new, provided that this specific use is new.

So under EPC 1973, one could only get a patent on a known substance for its first (general) medical use. Under EPC 2000, one can also get a patent on a known substance for specific second and further medical uses.

Since the lack of protection for second medical uses under EPC 1973 was found unsatisfactory, decision G 5/83 declared that it was possible to claim the use of a known substance for the manufacture or preparation of a medicament for a specific (second) medical use. This is the Swiss-type claim.

It would probably have made more sense if Art. 54(5) EPC 1973 had been interpreted from the start as only allowing claims to specific (disclosed and actually invented) medical uses. Ignoring the exclusion of methods for treatment, I can't see how one could get a patent on "use of substance X for any medical treatment" if the application only discloses the use of X for one specific medical treatment. Similarly, if X is known it should not be possible to get a patent on "X for any medical use" if only a specific use was invented. But in 1982 the case law was still in a very early stage of development.

(If someone spots a big mistake in what I write, please correct me.)

Anonymous said...

The debate is very erudite but it seems very clear that Warner Lambert had an arguable case for infringement all along. Arnold J was quite simply wrong. If he had got the law and analysis right then Wraner Lambert may have had a decent shot at the interim relief they asked for initially.

Who is going to pay for the losses Warner Lambert will have suffered from the date of launch of the generic products ( which would not have occurred if Arnold J had got things right). Surely the Ministry of Justice ( or whoever employs Arnold J) should pay a significant chunk of these damages!

Anonymous said...

The trouble I have with second medical use patents is that the 'invention' sits between a simple discovery (I have been working on a drug for people having breathing difficulties - one didn't work too well but the testers had great sex) and the presentation of information (take two of the aspirin you use for headaches to keep your heart ticking along happily). Any protection they are granted should be limited correspondingly and for this reason J.A.'s decision was actually a good balancing act.

Anonymous said...

I see your trouble as not understanding research in general, let alone the highly complex area of pharmaceutical R&D. As such, it is impossible for you to provide balance in your opinion, because that requires an understanding of both sides of an issue.

Anonymous said...

In defence of anon of 9:52, it is useful for pharma attorneys to keep in perspective how odd intention-based invalidity and infringement can be to those that deal with normal infringement. We are then in the realms of 'types' of intention, and we need to make sure that we don't make things too complicated in how we define the monopolies that are being granted and enforced. We don't want a system where a Court cannot easily decipher what is and what is not an infringement.

Anonymous said...

Who is going to pay for the losses Warner Lambert will have suffered from the date of launch of the generic products ( which would not have occurred if Arnold J had got things right). Surely the Ministry of Justice ( or whoever employs Arnold J) should pay a significant chunk of these damages!

Section 2(5) of the Crown Proceedings Act 1947:
"No proceedings shall lie against the Crown by virtue of this section in respect of anything done or omitted to be done by any person while discharging or purporting to discharge any responsibilities of a judicial nature vested in him, or any responsibilities which he has in connection with the execution of judicial process."

And according to Sirros v Moore [1975] QB 118 and Arenson v Arenson [1977] AC 405, you can't sue the judge himself.

So Actavis, being the infringing party, will have to pay.

THE US anon said...

My thanks to MaxDrei and Anonymous @ 17:44.

I hesitate to comment further (having not as of yet digested the ruling), but I will remark that it appears fully here the "complexity" arising may well be faulted to the law itself.

To wit, if the law was not attempting to create a loophole in the first instance to the explicit notion of not allowing something - as MaxDrei puts it: "The EPC has methods of treatment of the human or animal body as ineligible for a patent." you would not have this mess to begin with.

It is merely in the attempt to work around the directive of a first law, that the second law (Swiss claim) issues arise. I am reminded of the (medical) maxim: "First, do no harm."

Is not a simpler solution then to examine whether that first law should remain on the books?

If you (the proverbial Royal "You") are going to go through conniptions to effectively get around that first law, and by doing so make a mess of general patent law (and eviscerate that first law anyhow), why not just eliminate that first law and apply patent law as it is applied in every other art field?

If the policy of NO medical treatments is indeed meant to be uphold, the Swiss claim simply should not be allowed in the first instance. Semantics of the sort here to provide protection "in another form" is merely "scrivining" (as our Supreme Court would call it), and should not be allowed. That your sovereign DOES allow it is their call, and I will respect it - but from this (overseas) perspective, the ramifications and subsequent issues are part and parcel of the choice to have conflicting laws, and a better solution would come from firstly recognizing the underlying policy/law genesis of the problem, rather than layering on another level of complexity and band-aids.

Anonymous said...

to 13:20.

People need to appreciate that some things are complicated and that dumbing down to meet their needs is not the answer. If human beings aren't being bred and/or educated at intelligence/educational levels that can cope with complex and challenging issues then it is time for the dolphins to run the world. I am regularly dismayed by many of those I work with that can't cope with having to contribute to patent decision making processes. All I hear is "oh, patents are so complicated", when all I ask is "what countries are important for this technology", never to receive a reply. Obviously, deep down, I know the failings are mine and I can't be explaining things clearly/simply enough, but there must be a reason why the arts and psychology graduates who dominate my company chose to study such subjects rather than a rigorous, demanding, science or engineering degree. But then, the Good Book does say the meek shall inherit the earth, once the incompetent have destroyed it.

Anonymous said...

Surely US Anon has now had time to read the judgement, but still feels the need to comment on a law and case without knowledge.

THE US anon said...

Read? Yes.

Absorb and integrate into a proper foreign sovereign understanding? No.

That said, my comments very much still apply - as they go to a basic fundamental rubric of law itself, and need not be burdened down with eh intractable web that the foreign (to me) law makers have decided to weave. My comments are NOT as you would implicate them to be - you need to pay attention to what I have actually written, my friend.

Anonymous said...

To US Anon, I must apologise. I thought you had said:

"if the law was not attempting to create a loophole", when in fact you had said:

"if the law was not attempting to create a loophole"

I was therefore wrong to criticize simply because the law is not creating a loophole. I shall hesitate for longer in future.

MaxDrei said...

Suleman Ali might have a view, on the relative merits of the EPC path and the USA path. I think both bring difficulties.

Under the EPC, methods of treatment of the human or animal body by surgery or therapy are ineligible. A blow then, for their inventors.

Under the USA, you can patent your method of treatment, but the difficulties arrive when the time comes to enforce the claims you took to issue. For the USA, bless their cotton socks, also think it unseemly for lawyers to march in to an operating theatre and enjoin the doctors doing their life-saving work and the patent statute reflects that view.

As I suggested above, the EPC way loads the difficulties on to the drafters, the patent office examiners, innovative pharma, the generics companies and the patents judges. I shed no tears for any of those groups. Indeed, it is the job of the judges and (in England at least) they do not shrink from doing their level best, even if the statute is tough to apply fairly.

Turning to the USA, the method claims are issued and liable to be enforced. I take it that applicants have a reason for taking them to issue. Typically, who might they threaten to sue? for example, who exactly is busy at work, practising the claimed methods? I guess they need good legal advice if they want to continue.

I'm reminded of those cases in which NPE holders of US patents on, say, a "fax to email" protocol, start to assert against small charities, in order to build a "war chest" to fund enforcement against bigger fish. Why not also, with medical method claims, against healthcare providers? Isn't this a problem with allowing medical method claims to issue?

Not my field though. I'm only asking.

THE US anon said...

Anonymous @ 8:32, what you should apologize for is the misplaced snark.

To wit: your statement of "I was therefore wrong to criticize simply because the law is not creating a loophole." assumes your conclusion to be true, despite the quite obvious fact of the contrary. Swiss claims ARE a loophole, a "scrivining" to achieve indirectly what an earlier law has directly forbidden.

Please spend less time trying to be snarky and more time recognizing basic legal concepts.

Anonymous said...

Perhaps the all-knowing, highly educated and supremely competent anon of 19:45 can explain to a simpleton of the mechanical arts why an applicant in the pharmaceutical field should be able to obtain a patent for a new medical use for a drug but I cannot obtain a patent for a known physical device (let's call it a stent) to be used in a novel and inventive manner of treatment.

Suleman Ali said...

MaxDrei, I have little experience in enforcement of method of treatment claims in the US.

In terms of Europe I think the prohibition on methods of treatment, in vivo diagnosis and surgery causes all sorts of problems which don't seem to be to be to anyone's advantage. We've ended up with a system where the Swiss style and EPC2000 medical use claims don't cover all the different types of medical inventions, e.g. second medical use of a device, multi step treatments which have an analysis or diagnostic step, and we end up with very artifical ways of defining inventions sometimes as a consequence (cosmetic, not medical etc). I do think it is worth shedding a tear for innovators in technical areas where such issues cause problems.

MaxDrei said...

Thanks. Since posting you at 09:24 I have read a Case Comment from a UK law firm, which discusses the infringement landscape for the British NHS. This leaves me thinking, like you, that the EPC provisions cause more nuisance than they are worth.

I wonder, could the English Courts sometimes bring themselves to the point of declining to enjoin, even when an asserted "medical method" claim is held to be infringed and not invalid. Perhaps because it would not be conscionable, or proportionate, or necessary in order to meet the "overriding objective" of doing justice between the parties, to enjoin the infringer. If so, well then the troublesome statutory provision could be done away with.

Might this be something to look out for, even in this particular case?

Anonymous said...

This post and the number of comments illustrates just how important and critical this Englsh Court of Appeal judgment is. The eyes of Europe and the U.S. are watching. There are many more very important Swiss style second medical use claims for blockbuster products that other Courts will have to look at in the near future. No doubt those Courts will look to this now celebrated UK case.

Anonymous said...

"Perhaps the all-knowing, highly educated and supremely competent anon of 19:45 can explain to a simpleton of the mechanical arts why an applicant in the pharmaceutical field should be able to obtain a patent for a new medical use for a drug but I cannot obtain a patent for a known physical device (let's call it a stent) to be used in a novel and inventive manner of treatment. "

Yes, I can. And, it has nothing to do with loopholes.

Anonymous said...

Perhaps the US solution is the better one - allow patents for methods of treatment but bar enforcement against the medical practitioner leaving the tort of inducement to infringe for actions against the manufacturer.

Anonymous said...

"Perhaps the all-knowing, highly educated and supremely competent anon of 19:45 can explain to a simpleton of the mechanical arts why an applicant in the pharmaceutical field should be able to obtain a patent for a new medical use for a drug but I cannot obtain a patent for a known physical device (let's call it a stent) to be used in a novel and inventive manner of treatment. "

New medical use = use = process claim. Use is not known, therefore is novel.

Known physical device = device = product claim. Product is known therefore lacks novelty.

Use of a device in new method = use = process claim = allowable.

Swiss claim = use claim = allowable claim scope to be used because method of treatment claims are not permitted.
Swiss claim not = method of treatment claim, therefore not a loophole to patent a method of treatment. Treating a patient with a drug covered by a Swiss claim is not infringement of the method claim, hence again, is not a loophole.

"New" claim format = Compound for use = specifically permitted by the patent statute, therefore allowable.
Device for use = not specifically permitted by the Act, therefore not allowable.

Anonymous said...

It would appear that Mr Smart can answer the questions put. I wonder....

Perhaps the all-knowing, highly educated and supremely competent anon of 19:45 can tell me which day will be good for a rain-free tennis outing at Wimbledon this year?

Anonymous said...

Mr. Smart, if it is he, has explained why you can, not why you should be able to.

Anonymous said...

@US anon:
Swiss claims ARE a loophole, a "scrivining" to achieve indirectly what an earlier law has directly forbidden.

You are certainly right. In 1973 the legislator clearly did not intend there to be patent protection for second medical uses. This is very clear from the minutes of the Munich Diplomatic Conference. It also clear from the law itself.

About 10 years later, the Enlarged Board created the loophole of Swiss claims. In that decision the EBA stated that it could not find any intention in the preparatory documents that the legislator did not want second medical uses to be protected, but it made no attempt to explain away the clear statements in those minutes. And of course the law itself should not have left any doubt in the first place.

I don't have a good explanation for what happened there. Maybe it was clear at the time that the majority of contracting states supported this change, but even then... Policy changes of this magnitude should be left to the legislator (who did end up approving the change in 2000).

The overall effect is now that for pharmaceutical inventions broader protection is available than for other inventions:
- the first to find a medical use for a known composition gets protection for ALL uses,
- inventors of further medical uses of that composition get protection for their specific uses.

Without the exception, a composition could be patented just once. One could then patent specific uses as method claims, but the first one to invent such a use of a known composition would not get a monopoly on ALL medical uses of that composition.

Anonymous said...

Any potential infringer can take some proactive steps to remove himself from the CoA "foreseeability" test for infringement. If he is anxious as to whether what he plans is good enough he can take the proactive step to seek a declaration of non infringement for his proposed plan in good time. This is workable and fair. What I don't understand is Arnold j' strong views that the generic carries no responsibility or fault. That is his mindset.

Anonymous said...

Mr Smart is smart, but is not responsible for the decisions of others. However, allowability of compound for use is compensation for the prohibition on method of use. There is no prohibition on patenting novel uses of devices.

First Thursday should definitely be avoided unless you have Centre Court seats.

Anonymous said...

"It also clear from the law itself"

Which section, pray tell?

"the EBA stated that it could not find any intention in the preparatory documents that the legislator did not want second medical uses to be protected"

Possibly bribed by big pharma then? Or maybe there was no intention and you are misreading things? In any case, the intentions of legislators are those written in the statutes. If there is no exclusion, there is no exclusion.

"I don't have a good explanation for what happened there."

Not surprising.

"for pharmaceutical inventions broader protection is available than for other inventions:"

Now you are being silly.

"the first to find a medical use for a known composition gets protection for ALL uses"

And this is broader how?

" inventors of further medical uses of that composition get protection for their specific uses."

So a new development is entitled to narrow protection. Again, broader how?

"One could then patent specific uses as method claims"

Light bulb moment: An exclusion in the pharma field that doesn't exist elsewhere. I get it now, it's like added matter at the EP - add a disclaimer that limits the scope of a claim and you get added matter, which is therefore broadening.

I'm with you now.

But it still isn't a loophole - see above explanation.

Anonymous said...

"It also clear from the law itself"

Which section, pray tell?

Art. 52(4) EPC 1973 and Art. 54(5) EPC 1973.

Use of a known composition X for treating disease Y was excluded by Art. 52(4) EPC 1973 (well, "not susceptible of industrial application").
That same composition X for treating Y would not be new under Art. 54 EPC 1973 if a single "first" medical use of X was already known, Art. 54(5) EPC 1973.

If there is no exclusion, there is no exclusion.
A Swiss-type claim was not excluded by Art. 52(4) EPC 1973, but those claims would trivially have lacked novelty if the composition was known per se and the EBA in G 5/83 had not instituted the "praetorian rule" (G 2/08) that for those claims novelty is suddenly assessed differently than for any other type of claim.

"the first to find a medical use for a known composition gets protection for ALL uses"

And this is broader how?

Try to get protection for ALL uses of a known composition in field X by disclosing only a single narrow use of that composition in field X, where X is any field that is not the medical field. You won't succeed.

Anonymous said...

Mr Smart is smart, but is not responsible for the decisions of others. However, allowability of compound for use is compensation for the prohibition on method of use. There is no prohibition on patenting novel uses of devices.

There certainly is a prohibition on patenting novel uses of devices if the use is a medical one. It is exactly the same prohibition as the one for novel uses of compositions. The difference is that the law (over?)compensates the latter and does nothing for the former.

The prohibition is in Art. 53(c):
"methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body"

The compensation is in Art. 54(4) and (5):
"... shall not exclude the patentability of any substance or composition, ..."

Medical devices are neither substances nor compositions, see the case law.

Anonymous said...

Yes, I accept that prohibition exists. Such devices, however, are part of the world of pharmaceutical patents that I am defending. Also, however, the prohibition is not as problematic as would be the case if second medical uses of pharmaceuticals were not patentable in some way. The difference being the regulatory hurdles that have to be met for obtaining approval for a new medical indication. Without patent (or other exclusivity protection) such development will simply not happen.

Anonymous said...

"Which section, pray tell?
Art. 52(4) EPC 1973 and Art. 54(5) EPC 1973"

Sorry, but my copy of the EPC does not mention any ban on Swiss claims and the following are not Swiss claims. Swiss claims do not prevent the use of a drug for treating a disease. Happy for an explanation if I am wrong.

"Use of a known composition X for treating disease Y was excluded by Art. 52(4) EPC 1973 (well, "not susceptible of industrial application").
That same composition X for treating Y would not be new under Art. 54 EPC 1973 if a single "first" medical use of X was already known, Art. 54(5) EPC 1973."


"If there is no exclusion, there is no exclusion.
A Swiss-type claim was not excluded by Art. 52(4) EPC 1973, ..."

Okay, so you do agree.

"and the EBA in G 5/83 had not instituted the "praetorian rule""

So the Romans are responsible for this valuable contribution? I'm happy to give credit where it is due, but must admit I didn't realise the travaux préparatoires was that old.

"Try to get protection for ALL uses of a known composition in field X "

I could try, but if a pharmaceutical is known for a specific purpose then I'm sure I wont get protection for ALL uses of that composition in medicine either when I disclose a new use. Why don't you try? Let me know how you get on.

Whining about pharma patents is a little sad, with the "it's not fair" nonsense. Try drafting your operatively connected widgets having a distal end and a proximal end on an atomic level rather than functionally and you may get a broader scope yourself.

Anonymous said...

Who is Anonymous at 22:31 having a discussion with, and why is he venturing into a diatribe against claims with descriptions based on function?

Anonymous said...

"diatribe"?

Some people get so over-excited and hyper-critical when a commentator relies on law and facts rather than personal attacks.

Anonymous said...

To anonymous @ 00:36 about anonymous @ 22:31& 08:40 from anon anonymous:

I should still have a look at the times stamp of said anonymous, but I am becoming slowly positive that Ipkat got the attention of "anon" of Patentlyo comments fame.
I shiver. He contributes greatly to the comments there being unreadable.

I would recommend the site admninistrator to keep an eye on it and to start thinking how to nip it in the bud.

And no, Anon, I am not Malcom, nor Maxdrei, just an European lurker who wanted to tell you since about ever that you should calm down and stop ruining the blogs for others.

Anonymous member of the society of anonymii said...

I agree with the anonymous American. Who is this anonymous that dares to have an opinion? We (whoever 'we' are) have a right to know.

Anonymous said...

To Anon at 10:53

In what way are the comments you criticize spoiling this blog for others? Is it the correction of the statements made about the law referred to? If so, have you considered the fact that the EPO and many other patent offices and national courts have no problem with the allowability of Swiss claims or second medical use claims in other formats?

You may be smiling at your patently-o insult, and you are welcome to your moment of pleasure.

MaxDrei said...

I agree, that the entity that posts on Patently-O as "anon" is now active on this blog. It is my fault, I suspect. I have been known to encourage readers of Patently-O to take a look at this blog.

The entity is a blog troll, in that it feeds on responses. If you want to be shut of it, don't feed it.

But if you can't get rid of it, make the best of it you can. Enjoy the experience of reading its barely understandable writings, and ponder what particular mental condition it suffers under. Think about it generally. How many patent attorneys are some of the way along the path leading to autism/Asperger's? The troll has obsessions (for example anything it perceives as a slight against the sovereignty of the United States of America), holds the letter of "the law" of the USA sacred, and reads it voraciously, but has great difficulty expressing itself clearly enough to be understood.

I recommend Patently O. There's a very witty contributer called "MM" who is a sharp thinker who always expresses himself cogently and is brilliant at pouring scorn on the likes of "anon". But you have to accept that the Patently O threads are inclined to be burdened with long streams of rubbish, because anon is inexhaustively addicted to provoking angry responses and because the trenchant postings of MM upset the many head-bangers that frequent the most active American patent blog. Let's all try to protect this blog from such degeneration, shall we? Don't feed the troll.

THE US anon said...

Dear multiple anonymous,

Your opinion that I "ruin the blog" over at Patently-O is just that: an opinion.

It is completely missing in substance though. I use real facts and real law there and it is the anti-patent monologuers that have ruined the blog with their internet style shoutdowns and flooding each and every thread with the same mantra. Funny how you don't seem to recognize what is really going on there, and funny too that here you seem to align with a view that somehow claims using functional terms must be junk.

I suggest - as I do over at Patently-O - that you inform yourself of the actual law, learn from history and apply those lessons, and engage in a true dialogue where the counter points raised are actually integrated into the conversation, instead of the rampant eyes-closed bland repetition of mantra.

Is that too much to ask?

Anonymous said...

"and ponder what particular mental condition it suffers under. Think about it generally. How many patent attorneys are some of the way along the path leading to autism/Asperger's?"

If anyone should be censored it is the fool that writes this. Mental illness shouldn't be used in such a flippant manner.

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