Life on the bleeding edge of medical patent law

[major_clanger]

MONDAY: Major Clanger, in the course of explaining the way in which inventions are considered to be genuinely 'new', explains about the rather convoluted way in which you can get a patent for a previously unknown use of a medicine, and how this involves writing your patent application as a so-called 'Swiss-type claim'.

WEDNESDAY: Major Clanger sees the following update from Herbert Smith LLP:

IP newsflash 24 February 2010

EPO holds new and inventive dosage regimes patentable and abolishes so-called Swiss-type claims

NEXT MONDAY: Major Clanger will open his lecture with "Before we move on, a quick update to something I said last week..."

Comments

[ffutures.livejournal.com]

Oh, bad luck!

[surliminal.livejournal.com]

This is why IT/IP is so great. But also why we don't generally give precise practical details in ug lectures:-)

[outerego.livejournal.com]

You might have been saved if you subscribed to the EPO updates RSS feed--it announced g2/08 last Thursday!
[...and I predict this decision in many a footnote to the EQE answers next week;-) ]

[alexmc.livejournal.com]

Don't understand. Is it "unpatentable" or "patentable"?



This is yet another reason why the patent system is bollocks and should be destroyed.

[major-clanger.livejournal.com]

Is it "unpatentable" or "patentable"?

For quite a while now it has not been clear how to interpret the bit of the European Patent Convention that covers whether or not you can get a patent for a new use (even a completely new and previously unsuspected benefit) of a drug. The way of dealing with this was a rather strained way of writing such patent applications so as to avoid the ambiguity. There is now a decision from the European Patent Office that seems to finally resolve this ambiguity and which says that there is no longer any need to use a special form of words to describe your application. If you can prove a genuinely new and innovative way of using an existing drug, you can get a patent for that particular use.

Yes, there are big policy issues about whether you should be able to patent second uses of any product. Or indeed, whether you should be able to patent drugs (after all, you can't patent surgical procedures) or whether there ought to be better provisions for compulsory rights to make essential medications such as anti-retrovirals. Even so, when you say:

This is yet another reason why the patent system is bollocks and should be destroyed.

that's a very broad assertion. Mind backing it up with some reasoned argument?

[alexmc.livejournal.com]

Yes - a rather broad assertion. I realise that the phrase "should be destroyed" may have implied that I thought all patents were wrong. I just believe that the system is out of control and needs to be recreated from scratch.

My argument is that there are far too many cases where (in my opinion) patents work against society instead of for society.

Patents were introduced into a world where inventors needed protection so they could justify making inventions in the first place. They needed a period of time in which they could exploit their inventions commercially before the wider public got their chance.

But nowadays patents are granted on too many things which are simply not inventions. A new use for an existing thing is not an invention. Almost all software patents I have seen are not inventions. And yet these things are patentable as if they were inventions.

In suggesting that the patent system is "bollocks" I am not rejecting outright all patents. I am even happy to discuss why drugs companies should be allowed patents for drugs they develop when it costs them millions of pounds to develop and only the occaisional one works.

But the concept of granting a new patent just for finding a new use for something is abhorrent to me.

The reductio ad absurdum argument for me is for me to think up a new way of walking from St Pauls Cathedral to Tate Modern. If it were software then I would be able to patent it. And apparently from what you say if it were a drug dose then I could patent that too.

[alexmc.livejournal.com]

Please insert "in my opinion" into every sentence above :-)

[major-clanger.livejournal.com]

OK, taking these points in not necessarily the same order you made them.

Firstly, you seem to be criticising the US patent system, which is infamous for allowing patents on software and business processes, and having very desultory checks for novelty and inventiveness. The UK and European patent systems - and I'm not just being chauvinistic here - are far more stringent. Here, you can't patent a business idea. It is very difficult to patent software (there's been a lot of litigation on this lately; the current position is that you can apply to patent a really novel concept that actually, say, makes an OS work a lot better, but the success rate is still very low.) Patents are regularly rejected or revoked because the invention is not new, or is not different enough from what went before, or was not described fully in the patent application.

As for the origin of patents, you say:

Patents were introduced into a world where inventors needed protection so they could justify making inventions in the first place. They needed a period of time in which they could exploit their inventions commercially before the wider public got their chance.

This is, bluntly, a bit of a fairy tale about where patents came from. Patents arose when the old system of Royal Monopolies was abolished in the 17 Century. Until then, you could petition the King for an order (a 'letter patent') that you were the only person allowed to, say, make or import playing cards. Such monopolies were usually granted as political favours and were very unpopular. When they were abolised an exception was made for inventors. The whole 'public benefit bargain' theory is effectively a post hoc rationalisation that came in during the 18th Century. It has a lot of force to it, but it's not really where patents came from.

As for second uses of drugs, lets consider a scenario. A drug company, SmaxoGlithKline (SGK) comes up with a substance that shows promise in treating skin infections. SGK takes it through years of medical trials and expensive regulatory oversight and is eventually granted a patent on this drug (let's call it fintlewoodlepram) for the treatment of skin diseases. It is licensed, for this specific use, and goes into the market. The entire process has taken perhaps 15 years and cost SGK hundreds of millions of pounds. By your argument, SGK is entitled to a limited monopoly in order to recoup this investment.

But during the final trials of fintlewoodlepram a researcher noticed that there were some reports that subjects with bowel problems who took it experienced positive effects. SGK undertake further trials, which suggest that fintlewoodlepram does also help with irritable bowel. But to prove this and get regulatory approval takes years more of trials and tests, and again SGK spends vast amounts of money doing this.

If SGK had discovered the anti-IBS effects of fintlewoodlepram first, should they have been able to secure a patent for it? Presumably yes, there would be no difference from its skin-disease patent claim.

So if SGK ought to get a patent for the effort it put in to bringing fintlewoodlepram to market as a skin disease medicine, and also out to get a patent for the effort it put in to bringing it to market as an IBS cure, why should it not get a patent for both uses?

Yes, there are arguments against this. One is that if some of the people who were taking fintlewoodlepram for skin diseases were also getting a benefit for their IBS (even if they didn't realise it) then the use of fintlewoodlepram for IBS treatment is not new, so the patent is invalid for lack of novelty. But this is by no means an open-and-shut argument.

[alexmc.livejournal.com]

Thanks. That is very interesting. Sorry I wasn't around in the 18th century to check my understanding of the situation first hand :-)

It is possible that I am lumping the US and "European" systems together but I fear that this is not avoidable for me. I live in a world where American law has a deep impact on me even though I have never "worked" there, nor intend to. If I write software in the UK but run it in the US, or even have customers in the US then do you think I can simply ignore American IP lawyers who might claim that I have breached some patent that I have never even heard of?

Yes the European patent system is better than the US one - but does that really make me agree that "the system" is not broken?

The drugs issue is still confusing me.
From your argument above I still don't understand *why* SGK should want the second patent? Is it to extend the time for which it can exploit the drug it developed for one purpose because it found a new purpose? I don't see that as morally right. They could just keep on finding new uses for their existing drugs potentially in perpetuity. Do other people get to make their own versions of the drug in question just so long as they only sell it for the first use? Or are they prevented from doing so because GSK still has the patent on that drug - but now for a second totally different and possibly irrelevant reason?

I would like to bring in more scientists here if we can. Do they feel that their work should be kept from being used by other organisations until their own research costs have been recouped?