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(Message started by: bwashburn on Jun 13th, 2006, 4:48am)

Title: Is this new method of use patentable?
Post by bwashburn on Jun 13th, 2006, 4:48am
Assume the following situation.

1.  A prior art publication discloses that compound X is suitable for the treatment of depression. It further notes that compound X is in the same class of drugs as compound Y. Compound Y is previously known to be very effective for depression, albeit with some undesirable side effects.  Compound X, the publication claims, is free of these side effects. The publication further suggests a daily dosage of 300mg, which is comparable to the daily dosage commonly used for compound Y. The prior art publication only includes studies in a small group of rats.

2.  Subsequently, in the course of clinical trials, it is surprisingly discovered, that compound X is in fact 200 times more potent than compound Y. Based on this surprising discovery, it is concluded, that the suggested daily dosage should be 1.5 mg.

Question:

Would a claim covering a “method of treating depression with compound X in daily doses of about 1.5 mg”, be patentable over the prior art publication?

Title: Re: Is this new method of use patentable?
Post by Wiscagent on Jun 13th, 2006, 5:41am
The invention, i.e. "treating depression with compound X in daily doses of about 1.5 mg," is certainly useful and novel.

It also appears to be non-obvious.  A treatment method that requires only 1/200th of the prior art dosage appears unexpected.

Since the invention is useful, novel, and non-obvious it should be patentable.

Of course the scenario is a simple hypothetical situation.  In an actual patent application it is likely that the examiner will also cite prior art suggesting that the higher potency X was obvious.

Richard Tanzer

Title: Re: Is this new method of use patentable?
Post by Isaac on Jun 13th, 2006, 5:42am
Possibly.

But almost certainly the publication says more than is described here.  Even though the publication recommends 300mg, the publication may contain data which would disclose or suggest lower doses.  

Title: Re: Is this new method of use patentable?
Post by bwashburn on Jun 15th, 2006, 5:44pm
Thanks Richard and Issac for your replies.

Please let me clarify my question.

The inventors or the prior art publication simply mistook compound X to be comparable to compound Y in terms of effectiveness.  Based on this understanding they suggested a daily dosage of about 300mg for compound X.

However, subsequently, in the course of clinical trials it is discovered that compound X is 200 times more potent than compound Y.  Thus, the recommended dosage for compound X is just 1.5 mg.

Now, this is no doubt a very surprising discovery.

However, if the claim includes “comprising of” a dose of 1.5 mg, wouldn’t a dose of 300mg anticipate the 1.5 mg dose?  In other words, isn’t a 1.5 mg dose inclusive in the 300 mg dose?  

While I may want to use “consisting of”, the transitional phrase “comprising of” is much more desirable.

Thanks,
Brian

Title: Re: Is this new method of use patentable?
Post by Isaac on Jun 15th, 2006, 8:51pm

on 06/15/06 at 17:44:01, bwashburn wrote:
However, if the claim includes “comprising of” a dose of 1.5 mg, wouldn’t a dose of 300mg anticipate the 1.5 mg dose?  In other words, isn’t a 1.5 mg dose inclusive in the 300 mg dose?


I don't think so.  In any event  a claim to an exact dosage would be very limiting.  You probably won't to claim a range or else claim a calcuated dose.  

The difference between comprising and consisting is not helpful here.

Title: Re: Is this new method of use patentable?
Post by Wiscagent on Jun 15th, 2006, 9:10pm
I agree with Isaac that you would probably want to claim a range of dosages.  More particularly you might want to claim a range of dosages per unit weight of patient with a certain frequency.

You might have clinical data indicating that beyond a certain dosage range, additional X is ineffective or has an increased probability of undesirable side effects.  That sort of information would help support an upper bound for the dosage claim.

Additionally, because a much lower dosage is effective there may be methods of administering X that would have not been practical if a 200 mg dose were required.  That could be the basis for some claims too.

Richard Tanzer



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