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« Court Report | Main | Hatch-Waxman Watch: Personal Jurisdiction Edition »

December 29, 2014


The real question is: consider gabapentin story; is it really something unexpected and inventive to try pregabalin in pain? Did Pfizer really made an "Eureka" discovery?..and please take a look at claim 18 of the product patent. Regards, Carlos

Gazing quickly over the story and the comment by Carlos C, I am struck with the seemingly alignment of Carlos's question of "Did Pfizer really made an 'Eureka' discovery?" and the express sentiments of the US Congress to remove the doctrine of Flash of Genius from US patent law.

Are you familiar with this history, Carlos?

Are we (the royal WE), repeating history that we are unaware of?

Back to a more indepth read...


Same old, same old: doctors believe that drug R&D, like money, grows on trees.

Thanks for the update. I guess that if I do prescribe pregabalin again, then 2017 may be a good time to start. Gabapentin (although it is in my opinion under attack to get us docs to steer from prescribing it) and Topamax seem to be just as efficacious in my neuropathic pain populations.😀

Thanks very much for the post. Unfortunately I fear it is difficult for people to grasp the longer term effects of anti-patent behavior, and some of those effects would be the lack of development of new life-saving drugs, which of course is difficult to explain or to demonstrate.

Also I think Carlos C's citation of claim 18 of the product patent (EP 0641330, I believe) is misplaced, as it simply recites a compound "for use in therapy." But I guess we will find out in the litigation to begin shortly. Also note that Pfizer just concluded a limitation of the EP pain patent in December and so must have confidence in the limited claims.

Dear Carlos:

The simple answer is that various patent offices believed the new indication to be independently patentable; if not, Pfizer would not have had protection for this indication and the issue would not have arisen.

But that doesn't change the point that a company that develops a drug for indication A will have little incentive to develop the drug for indication B unless there is sufficient return in investment to justify the expense of satisfying the regulatory agencies regarding the efficacy of the drug for indication B.

We can think of a counterfactual to illustrate the point. Let's say you are right, and patent offices around the globe decided that the new use was not patentable. If indication A had a market value of $1 million/year, and indication B had a market value of $100 million/year, a company might be happy to sell 100-fold more drug during the time of the composition patent and still get regulatory approval for indication B (and thus avoid the "off-label" use issue entirely). Not usually the case, of course.

Alteratively, we could make off-label use illegal, so that civil or criminal penalties would attach to a pharmacists filling a prescription for the use, and/or have the physician face professional censure or loss of license for doing so. After all, such use already can incur malpractice liability issues in some circumstances, and there is a case to be made that drugs should not be used for anything that has not gotten FDA approval and thus is included on the label.

I do not advocate either of these measures. But neither can I advocate permitting physicians to ignore the economic realities of developing safe and effective pharmaceuticals and the incentives that are required to do so. Such "white coat self-righteousness" is easy to espouse but is really just another form of the position that "the rules don't apply" to physicians. And that proposition I do reject.

Thanks for the comments, and Happy New Year to our readers.

No patent can prevent a doctor prescribing a medicine in Europe.
For this reason for many years it was not possible in Europe to obtain a patent for a 2nd indication of treatment - only for manufacture

Dear Pope:

That is de facto the situation in the US as well - doctors don't get sued (although they could under the law - the healthcare professional exemption excludes pharmaceuticals).

I think the Pfizer letter was directed, as it would be in the US, to the "deep pockets" providers of the drugs - pharmaceutical companies, hospitals, formularies, etc. In the US, these individuals could be liable if they knowingly provided gabapentin for the pain indication, and the letter was no doubt intended to provide the "knowingly" part.

And, unless I am mistaken even in Europe there are so-called "second medical use" claims that can be asserted in like manner against drug providers.

Thanks for the comment.

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