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Tuesday, 11 July 2006

RANBAXY AGAIN


Ranbaxy again

Right: not all racemates end up in court ...

The IPKat recently commented on the Court of Appeal decision in Ranbaxy v Warner-Lambert (the LIPITOR case):

"The IPKat is pleased that the Court of Appeal has spelled out a clear message on the status of racemates; he awaits sight of the judgment before he can say whether there's anything else of pressing legal interest in it".
His friend and patent commentator Luke Dylan Ueda-Sarson adds:
"Now that Ranbaxy has been been BAILII'd, I think that the statement of Lord Hoffmann [in Kirin-Amgen] that the skilled person would know of a particular statement should put the final nail in the coffin of the legal fiction that a "skilled person" has anything remotely to do with an actual chemist working at the bench.

Patents, it seems, are written purely for patent attorneys to read - and not scientists. This has interesting implications for the notion that patents are a primary vehicle for advancing society's knowledge base, if they are inaccesible to those who actually advance knowledge.

So while I applaud the UK's courts' honesty in describing the "skilled person" accurately (Lord Hoffmann said similar things in Kirin-Amgen), it does seem to contradict the public face that IP is often given: a quid pro quo for the monopoly grant. Here there seems to be only quid being given out.

In the US, with their constitutionally-mandated patent raison-d'etre, the courts are not free to say things like this: they state that the quo is being provided in accordance with the Constitution, while hiding the fact that in reality it isn't.

I am not sure UK practice is a huge improvement though; the fact that the disjunction between theory and practice is somewhat more visible to the public at large doesn't change the fact that there is a disjunction.

While it is perhaps good that the court has said something concrete on racemates to the effect that "a claim to one enantiomer only may encompass the racemate as well", this leaves me puzzled as to exactly how one should claim the enantiomer - and only the enantiomer - if you want, say, for novelty reasons, to exclude the racemate. This is a very common thing to wish to do in synthetic chemistry, where racemates get discovered before pure enatiomers do, which is the opposite situation from what happens in natural product chemistry.

Given the reluctance of UK courts to indulge in prosecution history archaeology, how are you to stop a court from saying "he has claimed X, but we interpret this as claiming X and Y, and since Y is known, the claim to X is bad for want of novelty"?

(The Ranbaxy case is very odd, in that it the claim was to X specifically, the court interpreted it to cover X and Y, and one party was trying to say it covered only Y, and not X. Unsurprisingly they lost...)".
The IPKat must be getting cynical. So far as he's concerned, patents are quite correctly addressed to patent attorneys - the claims and accompanying description are designed to map out territory that is monopolised by the person who claims them, not to teach an art. If they didn't do this, there wouldn't be much point in having them. Merpel adds: looking on the bright side, most patents aren't ever infringed and therefore give no-one any trouble: it's only a tiny minority of patents that ever end up in court. They're litigated because they're valuable in the marketplace - and this would be true, regardless of how you (i) interpret the scope of protection or (ii) determine whether they're validly granted.

3 comments:

Filemot said...

Whoa, cynical IPKat, I cannot believe you said that. Even the European commission realises that the patent system exists to ensure the diffusion of scientific knowledge and technologies by an efficient, transparent and complete publication of patent documentation. They have come to realise this as a result of the community patent consultation. This phrase comes from the preliminary findings for tomorrow's public hearing (12 July 2006).

As to Luke's comments I'm not a chemist (just a patent attorney) but when I read this case I had the impression that the court was trying to understand the disclosure as it would be understood by real chemist. We seem to have a dispute of expert evidence here.

Anonymous said...

IAAC (I am a chemist!), and I think that the CoA's decision was entirely correct. A structural depiction (as in that of claim 1) which does not specify optical activity (e.g. (+) or (-)) is usually interpreted (at least where there is more than one chiral centre, as in this case) to refer to a racemate, rather than a specific enantionmer. That is, it depicts the relative rather than absolute stereochemistry. The court then goes on to say that, because of the facts of this particular case, the skilled chemist would not interpret this claim to the trans racemate as excluding a preparation of the R-enantiomer. That seems fair.

In answer to Luke's question, if one wanted to claim (e.g.) the S-enantiomer only (to obtain novelty over a racemate), one would specify the optical activity or stereochemistry explicitly, by putting a (+)/(-) or (R)/(S) in front of the figure.

James Legg said...

There is a thread here that patents are not useful to the wider scientific and engineering community because they are a legal document. That is not so.

Patents are of course written by those wishing to obtain legal protection. The audience for the document is therefore other patent attorneys and ultimately judges (so they do not advise or rule that the patent can be ignored either for infringement/validty or as prior art). This does not mean that they are not a useful resource for informing oneself about advances in technology. In fact the legal requirement to disclose a workable way of implementing the invention usually leads to a more complete and practical dsiclosure than compared to a scientific paper. Anyone who has had to turn a draft scientific paper into a patent application will know that not all the answers to the questions put to the inventor concering the details of the implementation are dull and obvious. Scientific papers also are not without other motives - they are payment for the grant given for doing the work and an advertisement for being given furhter grants, and the standard of disclosure is only really such that the reader trusts that the results are genuine. The point of papers from commercial companies is to get you to buy the product while giving away as little useful information as possbile. Moreover patents are directed to matters of commerical interest so are useful if your interests are commercial.

So if you bear in mind that patents can be a bit long winded and dull in places (out of caution to make sure that the disclosure is legally sufficient) they do provide useful information as to how things are really done.

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