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Tuesday, 18 June 2013

Myriad: does it make a difference in the real world?

The IPKat is always pleased to receive an email or two from a respectable source, so he was delighted so receive the following brief and to-the-point message from Professor Sir Robin Jacob, helpfully signposted 'IPKat Question' in case its recipient should mistake the sender's intention. It reads like this:
Does Myriad [see earlier Katposts here and here] really make a difference? If you can have patents for cDNA consisting of a gene code but not the isolated gene (with its introns) what difference does that really make in the practical world?
Sir Robin is talking here about the world in which business decisions are taken, new products tested and marketed, investments placed and scientists employed; a world in which manufacturers vie with one another for commercial advantage, and in which patent owners tiptoe through the minefield of prospective patent litigation, regulation of healthcare products and antitrust and abuse of monopoly.  What does the ruling in Myriad mean in this world?  Answers, please.

12 comments:

Anonymous said...

It may not mean a lot to a company concerned with developing small molecule drugs and using biotech research tools, as a full length human gene complete with introns may not matter so much. However I think it does matter a lot to the diagnostic industry where small gene fragments are important, and also to the companies which use genes from organisms which don't have introns, e.g. bacteria.

Anonymous said...

But do these diagnostic companies really need a product claim directed to the gene sequence?

They can still have product claims to the appropriate primers and probes, assuming they are novel and inventive. Also, they can presumably still have diagnostic method claims directed to the use of the gene sequence as a target, again assuming that the methods are novel and inventive, etc.

Anonymous said...

Diagnostic method claims fail as per Prometheus.

Merely diagnosing is not the 'and do more' that the Court wants to see.

Anonymous said...

I suspect a lot less than the Chicken Little brigade in the USA thinks (you know who they are), and somewhat more than the Clark Gable brigade elsewhere, but the US court system can always be relied upon to take a complex situation and make it even worse.

Tim Roberts said...

IMHO, Sir Robin has it right. This is a nice, simple, sensible decision. There's something in it for everybody, like the best decisions the same. Natural DNA is unpatentable, even if 'isolated'. If you change it a bit, so that it's different from what's found in nature, then it is no longer unpatentable (example: cDNA). Of course, if you change it a bit, it may no longer be useful, or as useful: or it may be obvious (whether changed or not). Claims to 'isolated' natural DNA sequences were always a little greedy. They are not chemical compounds (typically) but parts of chemical compounds – it is not customary in other parts of chemistry to claim parts of molecules, leaving it quite open as to what the rest of the molecule is. Nor does it seem quite right to allow what are effectively 'n-1' claims - “I claim an existing sequence except when it is part of what is already known” - this is more or less what a claim to an 'isolated gene' amounts to.

There is also – it seems fortuitously, rather than by intention – a spin-off for public policy. 'Isolated genes' are primarily directly useful in academic research or healthcare (diagnosis). Most countries (not of course USA) have an exemption that allows academic research. Diagnosis can also be carried out by individual physicians without too much difficulty. It is not like a vaccine or drug that requires enormously expensive investment to prove that it works and is suitably safe. The latter will still be patentable (and even if diagnostic methods cannot be patented after Prometheus – which I gravely doubt – big Pharma will still have plenty to do, and to protect).

The decision (unlike Prometheus) is not difficult to apply. The USPTO has promptly issued a practice note, which seems perfectly straightforward. The difficulty with the decision is not practical but theoretical. What is it based on? Is 'natural DNA' excluded subject-matter under 101, or 'known' under 102? Or is it solely based on the 19th century dictum quoted in the judgment “Laws of nature, natural phenomena, and abstract ideas are not patentable.” One fears that it is the latter. Why the Supreme Court thinks this dictum adds something to the current patent statute (rather than imperfectly foreshadowing it) is inexplicable. In what primitive state of patent jurisprudence can it ever have been seriously conceivable that a 'law of nature' could be patented? (This misformulated proposition is directly responsible for Prometheus, of course)

MaxDrei said...

Oh thank you Tim Roberts. I really did enjoy reading that dose of sanity and common sense.

Anonymous said...

Interesting.

Tim Roberts' post reminds me of the position taken by 'anon' at Patently-O with whom you have some terrible difficulties with MaxDrei.

Would you feel comfortable posting at Patently-O that 'anon' provides a dose of sanity and common sense? Or does that piece of humble pie get stuck in your throat?

Department of Minuscule Emendations said...

The first sentence above (Anonymous 14.19) is not clear to us. Is 'MaxDrei' in the vocative case? If so, we suggest the name should be preceded by a comma. We also think that 'which' (second occurrence) should be deleted.

Anonymous said...

The Department of Minuscule Emendations...?

Minuscule should be miniscule
Emendations is also not correct, as your suggestions lack the 'critical' aspect.

Too clever by half.

I suggest that you focus on content rather than form.

Anonymous said...

I suggest that MaxDrei eat his humble pie and post on Patently-O how anon is correct.

I doubt that he will be told that he is wrong.

Department of Minuscule Emendations said...

'minuscule' is correct. The Department is concerned only with form, not substance. It's a thankless job, but someone has to do it.

Anonymous said...

If you are only concerned with form and not substance for posts on internet blogs, not only is it a thankless job, it is an unnecessary and useless job.

With no disrespect intended, get a life.

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