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Thursday, 26 February 2015

Warner-Lambert v Actavis Mark 3: a "lyrical" solution to a painful patent dispute

On 21 January fellow Kat Darren posted "No pain for Actavis - Warner-Lambert fail to stop launch of generic pregabalin" (here).  This blogpost reported the Patents Court ruling of Mr Justice Arnold in Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWHC 72 (Pat). In short, Warner-Lambert (part of the Pfizer group) had a patent for pregabalin, which it sold as a treatment for epilepsy, generalised anxiety disorder ("GAD") and neuropathic pain under the romantic-sounding trade mark LYRICA. While the original product patent expired, leaving competitors free to make and sell their own pregabalin, Warner- Lambert received a "second medical use" patent claiming the use of pregabalin or a pharmaceutically acceptable salt of it for the preparation of a pharmaceutical composition for treating pain, and use according to Claim 1 where the pain for which it is prescribed is neuropathic pain. A generic pharmaceutical company marketing pregabalin for that purpose (but for no other) would infringe this indication.

What normally happens here is that the generic company can launch a product with a "skinny label", this being edited product leaflet that mentions only the permitted indications. However, in reality, since prescriptions do not mention the indication for which a drug is prescribed, neither a pharmacist nor a generic manufacturer will know the reason why pregabalin was prescribed. This poses huge practical problems for Warner-Lambert when pondering how best to enforce its patent rights. Refusing interim injunctive relief, Arnold J noted:
" ... the best solution to the problem which arises in this case is to try to ensure that prescribing doctors prescribe pregabalin for the treatment of pain by reference to the brand name Lyrica rather than by reference to the generic name pregabalin. That will ensure that pharmacists only dispense Lyrica when presented with prescriptions for pregabalin which are (at least so far as the prescriber is concerned) for pain without requiring the pharmacist to know the indication for which pregabalin has been prescribed.
The parties were back in court again pretty soon, as Darren's follow-up post explains. In "Warner-Lambert v Actavis Mark 2, still at first instance: more on Swiss claims, Skinny Labels, and no Strikeout" (here), posted on Friday 6 February. This time, at [2015] EWHC 223 (Pat), Actavis sought to strike out Warner-Lambert's action while Warner-Lambert applied to amend its particulars to as to plead a case of subjective intention.  Arnold J refused to strike out the infringement action and to allow amendment of the particulars of claim in what he described as a "developing area of the law".

Today's news was broken to this Kat by a couple of comments posted by anonymous readers.  One read
"Today was the showstopper! Pfizer sought and got a High Court Order against the NHS [that's the National Health Service] requiring it to issue central guidance that when pregabalin is prescribed for pain the prescription must say LYRICA. This is a big first in the enforcement of a second medical use patent. Very innovative Court application by Pfizer based on the NHS being an intermediary or conduit and relying on jurisprudence from trade mark and ISP cases eg Cartier [this being another Arnold J decision, extending relief through blocking injunctions against ISPs from copyright infringements to trade mark infringements: judgment here, Eleonora's Katpost here]. So, there will be no pain for anyone now- the position is clear and simple!"
Another said:
"After today the IPKat can change its headline " Pfizer gets the best pain relief imaginable" - an Order from the High Court that NHSE must issue central guidance that prescribers must prescribe LYRICA when using pregabalin for pain and for those prescriptions pharmacists must dispense LYRICA. That's a super neat solution and is far better than any preliminary injunction against one or more generics. Pretty impressive strategy by Pfizer!"
Darren will surely be adding to this topic when the opportunity arises.

66 comments:

Anonymous said...

As a U.S. attorney, I cannot see how this is a real victory for Pfizer. They also seemed to struggle a great deal in the previous two hearings. My reading is that they simply followed the Judge's guidance after they lost the first hearing. But happy to be convinced otherwise.

SKR said...

and at the same time, we have UK doctors asking for this:

http://blogs.wsj.com/pharmalot/2015/02/25/the-eyes-have-it-uk-docs-urge-off-label-avastin-use-as-pharma-protests/

Anonymous said...

I find it kind of amazing that a court would take a step like this in guiding (or forcing) the hand of the physician.

Surely the point of excluding methods of treatment from direct patentability is to prevent this kind of thing?

Anonymous said...

It's not a method of treatment.

The doctor is not prevented in treating his patient. The doctor simply has to write 'Lyrica' on the prescription rather than 'pregabalin'. In doing so he assists Actavis in their diligent efforts to avoid infringing the patent. Actavis do not wish to infringe and Pfizer (Warner Lambert) understand this and want to help them in their efforts to stay clean, taking things one day at a time.

What right have doctors to cause trouble for Actavis?

Anonymous said...

To the US attorney, its one thing a High Court judge commenting that the NHS should issue guidance on prescribing by brand....its vastly different achieving a High Court order to require the NHS to do this. It seems to me that Warner Lambert has been innovative and successful. They wont have wanted to sue NHS (no doubt their biggest customer in the UK)- so they devised a legal solution when the NHS refused to issue the guidance they requested, they positioned them as an "intermediary" in the patent infringement litigation and on that basis got the court Order for this simple effective solution.

Anonymous said...

The fact that the NHS must now issue this guidance on prescribing by brand for the patented indication must surely be the right way forward for enforcing second medical use patents.

On the remaining questions on infringement (which I understand are on appeal) surely the fact that prescribers and dispensers desperately needed this guidance from the NHS shows the reality of the situation and that, Actavis knew and understood very well that their product would be dispensed and used for pain.

Tufty the Cat said...

I wonder what would happen if a doctor chose not to follow the guidance and prescribed pregabalin for pain. What happens to doctor-patient confidentiality?

Anonymous said...

It's a legal issue not a clinical one. No doubt prescribers will follow the guidance.

If they don't then the dispensing pharmacist will infringe when he dispenses generic pregabalin for pain.

Anonymous said...

Nothing happens to doctor-patient confidentiality. Why would it? Your comment is an open-ended what-if, but fails to provide substance for discussion.

What if I commit an illegal act, but no-one will ever find out?

The doctor may be free to prescribe generic pregabalin for pain, but then he ay be dropping others in it, such as the pharmacist, the prescription-software provider, the NHS.

Anonymous said...

The gushing remarks about Pfizer's strategy in quotes genuinely looks like propaganda material written by its lawyers! I do hope IPKat reports cases truly independently?

Anonymous said...

Anon@08:38 here. I just wanted to clarify my comment. I didn't say this was a method of treatment. What I said was that I thought methods of treatment were excluded to prevent "this kind of thing", by which I meant patents hindering a physician's freedom to determine the best care for their patients. I guess we can argue about whether this is truly a hindrance, but I still find it a surprising move for the court to take.

It's undoubtedly a clever solution to the enforcement of second medical use patents (in the UK at least). My first reaction was to say that the NHS would ignore it or appeal in some way, but now I'm not so sure.

In response to Tufty's comment: If I had to guess I'd say individual doctors can prescribe generic pregabalin for pain if they really want to with little or no consequence, but I don't imagine that many will have sufficiently strong feelings on the subject to break from the guidelines.

Anonymous said...

It always struck me that when Arnold J gave his PI decision he assumed ( incorrectly) that this guidance would be in place and hence the Actavis product wouldn't go for pain. He was wrong on that. But as some- one has said this is much more effective than a PI.

Anonymous said...

Pfizer had to give cross undertakings to generics etc but I guess that is worth it for this type of relief ( and what Pfizer would have had to do anyway if they had got their PI).

Anonymous said...

This has big ramifications for generics business plans surrounding second medical use patents. On the upside if this type of NHS guidance is obtained in other cases then the position is clear for them and their paths for the non patented indications will be clear. On the downside they won't be able to gain those sales for the patented use that they may have hoped for - if the NHS has spoken!

Anonymous said...

Anon at 14.29

the prescription won't say "pregabalin for pain", it will simply say "pregabalin".

therefore infringement will only be established on matching the clinical diagnosis of the patient to the acts of the pharmacist.

so i fail to see how this can effectively prevent infringement.

this appears a pyrrhic victory to me, and one that will likely alienate the company's largest customer.

maybe i'm missing something.

Anonymous said...

Anonymous @ 16:46,

I was thinking of the same thing.

It is the doctor that prescribes FOR something, but this "FOR" need not be communicated to the pharmacist.

The pharmacist simply fills a prescription OF medication - he need not be concerned with WHAT the medication is FOR.

It appears that he patent suffers from "poor writing" in that it takes more than one party to act in concert to infringe, while there is no LEGAL compunction available to MAKE the parties to act in concert.

One may believe themselves quite lyrical when singing alone in the shower, but that does not mean that one should sing in public.

EVEN IF doctors use a "prescribed" name, pharmacists have no duty to the name and only have a duty for the underlying product. This decision cannot force a doctor's role unto a pharmacist, such is just not with the particular judge's range of authority.

As a doctor, I might prescribe "blue snhizzles" for my patient and write so on the script. The pharmacist will likely call me and ask me what product "blue snchizzles" really is. The pharmacist won't care beyond that what my nomenclature is - nor should, and nor can he by the judge's authority - make it so.

Anonymous said...

To the last comment, the prescription will say Lyrica ( when it is for pain) and the pharmacist will dispense Lyrica in turn.

Anonymous said...

16:46: If all doctors prescribed "pregabalin" for their pain patients, this would show up in the pharmacy sales figures proving that infringement is taking place. I would suggest that Pfizer would then be entitled to a lot of compensation from the NHS. I don't know if the current financial control doctors have over their spending extends to prescriptions such that it is beneficial to them to deliberately prescribe a cheaper product. if it is, their benefit will be short lived with a damages claim. If ther eis no direct benefit to the doctors then i fail to see why they would deliberately ignore the instructions from the NHS.

Pfizer is not overly concerned about stopping all generic prescribing, just the majority. If doctors are sensible people, Pfizer will have succeeded.

Regarding the proving of infringement for specific cases, the doctors prescribing software may have it covered. When they fill out their patients details and prescribe for pain, the software should only allow the selection of Lyrica. If doctors are going to make up fake illnesses on the record, that would be a bad thing.

Anonymous said...

The prescriber will prescribe Lyrica ( when it's for pain). Problem solved.

Anonymous said...

To both Anonymice saying "Rx says Lyraca, problem solved" - you quite miss the point that the "problem" remains.

A pharmacist cannot be forced to provide a name brand over a non-name brand.

A pharmacist fills a prescription for a product - no matter what name that product may go under.

The doctor is the one that is limited by the name (for the related medical condition). The doctor alone.

The problem here is that the system has bifurcated the duties and the judge here is not empowered to un-bifurcate them just so that the patent reaches the combined action.

Anonymous @ 20:31,

You are correct that such data would indicate potential infringement - EXCEPT for the fact that you have no infringer.

Such is an inherent problem with this type of patent. And it resolves upon the patent holder to prove her case, which means that there are NO deep pockets to go after, and it is only (possibly) the end users left to go after - which of course, is simply economically unfeasible.

Anonymous said...

The NHS guidance the Court has ordered also tells pharmacists to dispense Lyrica when the prescription says Lyrica. So, the problem should be solved ( if the prescribers and pharmacists follow the NHS guidance).

Anonymous said...

To anon at 20.31 the Department of Health told the Court in this case ( read the previous judgments) that if an NHS prescription specifies the brand name, then a pharmacist must dispense the brand name ( and will be reimbursed for it). That seems to be the basis on which the Court has ordered this. Of course, if that is wrong there may still be an infringement problem.

Anonymous said...

To the writer at 23.51, if you are right about no infringer then It seems second medical use patents are of no value. I guess it's only the Court of Appeal or Supreme Court that can truly answer this.

Anonymous said...

"A pharmacist cannot be forced to provide a name brand over a non-name brand."

The pharmacist must fulfil the prescription as written. If it says Lyrica, they must provide Lyrica.

Anonymous said...

Firstly, let's not remember that Swiss claims are valuable and enforceable. The primary object of preventing generics marketing for the patented indication has been achieved. All generics abide by the exclusion and their products have a skinny label.

The issue of off-label use is another, more complicated, issue. Enforceability is dependent upon the structure of national markets for pharmaceuticals. If a national body or insurance company invites tenders for pregabalin for the pain market, generics cannot apply. If it was simply a tender for pregabalin, the generics could be excluded by the size of the order being tendered for - evidence that the drug will be given for pain patients.

For other drugs, the nature of the party inviting tenders may be sufficient to prove the intended use is the patented indication.

20:31 has several infringers: Doctors, NHS, software provider, generic supplier. Infringement may be either either direct or arguably as joint tortfeasors (not my area at all).

The question can only be answered if the scope of the Swiss claim is fully tested in court. Arnold has messed up on this and Allen & Overy may not have been up to the task. We should never forget that the interpretation such large legal points is dependent on the quality of the players on the pitch. The quality of both sides, claimant and defendant, are important as is the judge. There are so few pharma cases being tried these days in the UK, that I look to the US courts for their position on key matters (e.g. equivalence). Difficult to track European cases because of language. How many pharma infringement cases are there in Germany, for example?

On the claim itself, we know it is a process claim and not a product claim. One thing that has been settled. It is not a method of treatment claim, but it is drafted to be as close as possible while still being legal. One way of looking at it is to cover every 'process' act that is not a method of treatment. Once MOT has been defined (!) every other act is infringement if it falls under S.60(1)(b)(c) or S.60(2).

Support for the "covers 'everything' to do with MOT except the MOT itself" comes from the drafting practice as allowed by the EPO. Swiss claims frequently start out as method of treatment claims, as drafted by our US comrades. After EPO objection, amendment to Swiss format is allowed without there being an added matter objection (maybe here should be?) with sole basis coming from the MOT claim.

Anonymous said...

Anonymous @ 12:19,

You are unmistakably and utterly wrong.

The prescription is for a compound - no matter what the name.

If your view were to be correct, then ALL generics would be endangered and no amount of labelling - skinny or otherwise would suffice.

It just is not so.

Anonymous said...

or rather,
"let us remember" or "Let us not forget",
although some may believe I was right first time.

Anonymous said...

18:58
Guess where the following statement came from?

"
Prescriptions

As noted above, the great majority of prescriptions identify the drug prescribed by reference to its international non-proprietary name ("INN"), that is to say, its generic name. Where this is the case, the pharmacist is in principle free to dispense a branded drug or a generic one. Where the prescription specifies a particular brand (such as Lyrica), the pharmacist must dispense that brand. Prescribers are encouraged to prescribe generically by a number of mechanisms, including professional guidance, guidance from NHS England, pressure from CCGs and Health Boards and prescription software. There are certain limited circumstances in which it is recognised that doctors may properly prescribe by reference to a brand name, however. One example is the Selected List Scheme, which covers drugs which have been prescribed for a particular purpose to a particular class of patients.
"

Anonymous said...

18:58 probably has a discount for being such a good customer:

www.thehumblepie.co.uk

Anonymous said...

Why is the intention of the doctor or pharmacist relevant? Nominally, a Swiss claim is a claim to a manufacturing process, and the "for" part relates to the manufacturer's purpose. Surely the only relevant intention is that of the manufacturer.

Anonymous said...

Would love to see the Order and the guidance. This indeed seems like a very simple, effective outcome. I wonder what bases Arnold J has used for the Order since he said ( albeit I disagree) that Actavis do not infringe- no subjective intention to use for pain on the part of the manufacturer.

Has he changed his mind ( he seemed very firm on this based on instalments 1 and 2 on IPKat)? Did Pfizer rely on some other public law basis? Very interested to know what those are.

Anonymous said...

Hmmm,

Does the claim really call out (as opposed to any unstated "custom") that infringement can only occur along the vector of "make?"

Are all other patent rights of exclusion (i.e., "use") thereby surrendered by this custom?

Anonymous said...

To 8:30, you are repeating the mistake of J.Arnold (one of them anyway) in limiting the claim to a manufacturing process, i.e. one that occurs in the plant. The claim is a process claim, but that does not mean it should be limited to the chemical manufacturing process.

It may be read to cover any/many or all process steps en-route to the patient. The act of writing a prescription is a process step, although this may be considered a 'method of treatment'. The action of the pharmacist in fulfilling the script by placing a medicine into a bag and handing it to the patient is a process step, but the pharmacist is not the doctor and is therefore not treating the patient. Arguably = infringement.

It is these and other potential process steps that require consideration when determining the scope of a Swiss claim.

Anonymous said...

When will we get to see this decision published?

Anonymous said...

Arnold has made such a big mess on claim construction here. When will the court of appeal sort this out?

At least his judgment on the PI has otherwise been sorted out by virtue of this Court order for NHS guidance.

Anonymous said...

Judgment and Order now published
http://www.bailii.org/ew/cases/EWHC/Patents/2015/485.html

Anonymous said...

On its face, the statement of "It may be read to cover any/many or all process steps en-route to the patient." is absolutely false.

Infringement of an action - if that action as other non-infringing uses - is not (and cannot) be infringement.

Actors of individual steps easily escape infringement when those same actions rise merely to a "may be" non-infringing.

Think of someone selling screws that may be used in fabricating a patents larger machine. Since screws have alternative non-infringing uses, the making and selling of screws - one of your "parts" or "steps" (or whatever) of your larger claim - DO NOT rise to the level of infringement.

This is the very real drawback of the type of claim to a new use of a non-patented (out of patent, non-patentable, or whatever) object.

Anonymous said...

Supplying screws ( a commodity) for a large patented machine is a world apart from supplying the medicine (for which a second medical use is patented) when 79% of the time it will be used for the patented second medical use.

The Court should not hide behind some purist interpretation of the Swiss claim which is devoid of the reality that every generic knew ( before the NHS guidance) that 79% of their product would go for pain.

Anonymous said...

The screw analogy is not an appropriate analogy. Forget the analogy and stick to the facts of this case. My statement had no 'on the face of it' assertion.

Medical use (first or second) patents are highly valuable. There are drawbacks with all patents.

Anonymous said...

The screw analogy is expressly apt. Merely wanting to dismiss the analogy without addressing the factual and legal parallels is just not compelling.

Point of fact is that for such a patent, the product itself is not - and cannot be - protected.

You cannot simply ignore this factor when considering the value of the secondary use patent.

A better response (for example) would be to explore the legal parameters of what level of "other use" - be it commodity or something else - has been found to be a limit (if any).

Sure, "use" patents (first or second) may have value, but there are real world limitations inherent in those second use patents expressly because a first patent has run its course. There are - and should be - such natural limitations and drawbacks to what amounts to an evergreening and less than full dedication to the public of a first-now-expired-patent.

Anonymous said...

There will be a latin term for describing the reverse argument against the bad analogy argument, but I don't know it.

So in English:
"No, that's you that is"

You can't use an analogy and ignore the facts then dismiss criticism of the analogy for not sticking to the facts by stating the dismissal fails to address the facts.

Anyhow, as agreed by another, the analogy is a bad analogy. Medical use claims (Swiss/compound for use) are patentable, whereas new uses of a screw are not patentable. If you think it is you need a screwdriver!

Anonymous said...

Anyhow cont.

Lyrica is protected by a second medical use patent, the drug itself being off-patent and shortly to be sold by many generic suppliers. Those generics are prevented by the patent from including the pain indication on their label and from marketing their product as suitable for pain. NHS prescribers will not as of this afternoon be prescribing generic pregabalin for pain, but will be presribing by the Lyrica brand. When presented with a Lyrica prescription, every pharmacist must prescribe Lyrica.

So, when you say such patent 'may' have value, the facts prove just how big that value is. Take a look at the UK sales figures alone to see juts how valuable this patent is.

Anonymous said...

The Anonymous @ 18:29 who declares that a new use of a screw is not patentable is grossly mistaken.

New uses of old things are eminently patentable as process patents.

"No, that's you that is" - indeed.

Anonymous said...

I'm sure by the context of the discussion you understand that I was referring to "A screw for use.." style claim.

But, if that is a considered a victory, you are welcome to it.

Swiss claim = ? Use of a screw in the manufacture of a fixing means for fixing a 'novel thing'?

It is still a bad analogy.

Anonymous said...

A screw for use

and

use of a screw

Are two radically different things (even in Switzerland).

Your mocking "call that a victory" aside, you can call your defeat anything you want.

Anonymous said...

We know use of a screw and a screw for use are different. The point with pharma claims is determining their scope.

Screws are still a bad analogy and the use of any analogy is unnecessary. fell free to get back to the facts. I have no problem with 'defeat' but you haven't done anything to deserve it yet.

Anonymous said...

You keep on saying "bad analogy" - but nothing else.

It is you that has done nothing here. I await some hint at reasoning.

On the other hand, the scope of a "use" patent is clear - as is it abundantly clear that a "use" patent for some THING in the public domain is necessarily constrained. Exactly as the analogy would indicate.

Anonymous said...

Analogies are for those who do not understand an issue and need it dumbing down to compare it to something they do understand (screw, hammer, doughnut). Analogies are therefore inherently bad. The term 'bad' is inherent in an analogy, hence my use of 'bad analogy' is an error as I am saying bad bad. This, aside from the fact that your analogy is bad for being about a thing that cannot be patented in a use-limited way like a pharmaceutical, it is simply bad for being an analogy.

Notice that two people (one of the me) at the same time and without knowledge of one another's existence, each independently sated that your analogy was bad.

Does that answer your question?

Now, rather than get hung up on the defence of your analogy why not discuss the facts and legalities of the case? No need to dumb things down on our behalf.

Anonymous said...

Oh sweet Jesus. Silence, please, children.

Anonymous said...

Less of the blasphemy.

Anonymous said...

Analogies are for dumbing down...?

With all due respect, you are just far too full of yourself. Combine that with your errors and that is just not a good combination.

Best of luck to you in understanding this.

Anonymous said...

Miss, Miss, he's being mean to me again, Miss!!! Send him back to the corner with his hat miss.

Anonymous said...

The Wellcome Trust is very well respected and their comments on the issue are of value.

http://blog.wellcome.ac.uk/2012/10/29/lost-in-translation/

Anonymous said...

What examples are there of patented new uses of screws? A screw is a known fixing means and therefore its use as a fixing means for a new (itself patentable) article would be obvious. Are people saying that the use of a screw may have been obvious to try, but without any reasonable chance of success, but then in practice it was unexpectedly shown to work? I would say this makes the argument against obviousness a complete fallacy.

In the Lyrica case the patented new use, pain, was not something that could have been expected or considered worthy of testing for.

On infringement, without any credible patentable invention for the new use of a screw, I fail to see how it is possible to debate the comparison with a drug, and specifically Lyrica.

If there was such a patent and the screw is a standard screw then, as highlighted earlier, it would surely be considered a staple commercial product. Section 60(2) (supplying means relating to essential element) does not apply by virtue of S.60(3). Pregabalin could not be considered to be a staple commercial product.

Of course, Justice Arnold completely dismissed 60(2) out of hand, but he was clearly wrong to do so. The position requires more analysis. Pfizer have been criticized for a weak case, but I see the problem lying firmly at the door of their counsel. In the US, litigation counsel would not be left floundering in court unprepared and unable to respond in such a fashion. I fear UK patent law practice has lost its way.

If the screw is not a staple commercial product, supply of the screw in accordance with S.60(2) would be infringement. Proving infringement would rest on the availability of evidence, which may be in the form of promotional material from the supplier. However, even if it is decided the screw is not a staple commercial product, it is general sold in such a way so that tracking its sale and intended use would be practically impossible.

In the Lyrica case the situation is very different. In every single example the reason for the prescription is known. The pharmacist, NHS, CCGs, etc, all know the reason for the majority of the sales of the drug.

This is chalk and cheese.

Anonymous said...

The Anonymous at 9:46 fights too hard to refute the analogy, and simply evidences a lack of understanding of what analogies are for.

Clearly, medicine is not the same as fastening devices.

The (rather clear) point though is that like a screw, if the medicine has alternative - and off-patent - uses, it too may qualify for the description of a staple commercial product.

Perhaps in a hurry not to see this, the one so aggrieved with the analogy skipped actually reading the first comment at 15:54 and the express points that the analogy was used for. (and for your own sake, try not to think of this as "dumbing down" as you tend to simply stop thinking when you do that - dumbing yourself down.

Anonymous said...

So pregabalin is a staple commercial product?

In fact, you are saying that everything that isn't patented is a staple commercial product?

Therefore, in order to infringe Section 60(2), the means supplied must itself be patented.

Interesting. I shall ponder that over afternoon tea.

Anonymous said...

Regulation 167 of Human Medicines Regulations 2012 allows a doctor in the UK to prescribe drugs off licence and also to prescribe drugs with no marketing authorisation in the first place. There is nothing in the Patents Act 1977 (as amended) which would mean that a doctor writing a prescription for pregabalin for pain would breach the Act, and similarly nothing being breached by the pharmacists etc.

Breaches of several legal instruments (including conditions of marketing authorisation, various parts of the HMR 2012 etc.) would occur if the manufacturer and/or distributer of the generic product marketed the generic product with a claim for use in pain; however no breach is committed if they do not market the product for such an indication, whatever the final or intended use by the prescriber.

In terms of confidentiality, the pharmacist, the wholesaler and the manufacturer do not have an automatic legal right to know the diagnosis of the patient. In fact, neither do NHS management.

Anonymous said...

1. HMR 2012 does not override the UK Patents Act 1977.

2. The generics in this case have marketing authorisations or are in the process of obtaining them. They will launch their products with a skinny label in order not to infringe. There are no breaches of other 'legal instruments' because they have marketing approval.

3. No-one is interested in or has proposed breaching patient confidentiality.

Your point is?

Anonymous said...

I think the question is:

Is pregabalin an off-patent item that has another (substantial) non-infringing use?

Clearly, the answer to that question is yes.

Thus, in the legal context, yes, pregabalin can be treated as a "screw" - that this, um, screws the separate "use" patent that seeks a subset of the freely available product is - and should be - a severe limitation on what can only be (rightfully) called an evergreening patent.

Anonymous @ 13:46 supplies the final nails to those unwilling (or unable) to recognize the very real limitations of Swiss claims concerning items that being off-patent MUST be considered - of themselves - to be in the open domain for all. One cannot - and should not - be able to cheat the system on a item patent with ANY type of evergreening trick.

Anonymous said...

Evergreening trick?

Nothing wrong with evergreening unless you are a cheapskate Indian generic company that takes but never gives and who can only survive because of their parasitic activity on the back of Western pharmaceutical companies.

Nothing wrong with generics generally, either as that is how the system works. Just don't go whinging about it being a trick, when provided patentability criteria are met, patents for new uses are perfectly allowable.

I'm not sure if you noticed, but anon at 13:46 was shown to commenting on irrelevancies. They are perfectly correct in one aspect, however, which is that if you are a cheapskate Indian generic with poor quality production practices, a lack of appropriate record keeping, an inability to keep equipment clean, or a tendency to falsify documents, for example, the US FDA will bean you from selling your trash in their country.

I see Ranbaxy have still failed to prove their facilities meet FDA requirements.

A lot of comments note the worthlessness of Swiss claims, yet they appearing to be putting the final nails in a coffin that does not contain Lyrica. Check out the decision that has gone Pfizer'a way. Maybe screws would have been better than nails?

Anonymous said...

I would guess that Anonymous @ 16:57 is the same Anonymous who continues to "dumb himself down" when it comes to analogies.

The emotional (instead of reasonable) response to the word "evergreening" is a giveaway.

Not sure exactly how a rant about the policies of the sovereign nation of India fits into the current thread discussion, but perhaps when the poster calms down and composes a more lucid offering, we may be able to see what (if any) points the author wanted to make.

Great job 13:46.

Anonymous said...
This comment has been removed by a blog administrator.
Anonymous said...

Will Mr. Anonymous please settle down and refrain from the poor ad hominem attacks?

If you have a point to make, please try to do so in a reasonable manner. There is no need (and even less effectiveness) in taking the avenue that you are taking.

Anonymous said...

Shakespeare's plays still have resonance in the modern world

To screw or not to screw?

Taming of the screw.

Anonymous said...

You forgot "is this a fixing means which I see before me?"

Anonymous said...

I prefer the 80's classic "Srewloose".

Most apt to the discussion (for those that see behavior reminiscent of a football match as a discussion) is "The Merchant of Screws", a tale of woe where an ironmonger (The Merchant) is locked in the stocks for daring to sell screws for off-label, un-regulated purposes, while the patentee can only look on and do nothing, except cry.

Meanwhile in the adjacent stocks, Pfizer shareholders are enjoying throwing rotten tomatoes at their enemies thanks to a decree from Good King Arnold.

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