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« Neuralstem Announces Grant of European Patent for Neural Stem Cells | Main | Pfizer's Lipitor '893 Patent Survives Reexamination »

April 30, 2008


Nice summary, Kevin. You ought to send a shorter version to the NYT.

I would like to take issue with a couple of the central tenets here...

First of all, rarely do patentable ideas represent the totality of drug development cost. As such linking drug development costs to patent reform is a bit of a red herring... Most of the patents covering biotech or pharma products arrive out of the lab - with either the bench chemist or biologist discovering a new compound, biologic, or target. This doesn't represent the huge total costs of drug development. It is akin to the kid with a modem taking on the electronics industry. As a case in point, many drugs are developed after licensing to a University or other 3rd party to secure necessary rights.

Secondly, any metric for litigation is mired by vagaries since most litigations are settled and thus are not played out through the courts or through appeal. As inequitable conduct has such a high burden of proof, it is almost certainly ripe for an appeal and thus a small finding is not evidence of it’s “plague on the system.” Given the huge dollars at stake in some industries, it is naiveté to think that abuse of a government run system does not occur with some frequency. To weaken the already difficult task of defending oneself by attacking the patent holder’s conduct will certainly invite further abuse of the system. While I think the NYT is being sensationalistic in their characterization, I also think BIO has advocated for a position that is equally disengenuous.

Well, Gene, I doubt the Federal Circuit is guilty of naivete about inequitable conduct, since they see it so often and with so little evidence to support it. No one wants patents to be obtained through fraud, but the point is that thousands of cases allege fraud and so very few actually find it. It is good litigation strategy to do so, but poor use of the judiciary's time. Which is why several courts have used Fed R Civ Pro 9 to require the defense to be pled with particularity (something that rarely happens because the defendant cannot meet the evidentiary standard) and strike the pleading on that basis.

As for your first point, naivete is believing that the funding given to researchers at universities is comparable to the costs of bringing a drug to market. Besides the costs of obtaining FDA approval, there are the investment costs of taking a lab-scale preparation and translating it to a commercial scale. Patents are differentially important to the biotech/pharma industry (in ways they are not to IT, who have alternative ways of protecting their investment by copyright) and patent protection drives investment. University researchers will continue to research, discover and invent; the question is whether they, and their universities, benefit from commercial exploitation of those discoveries and inventions.

One thing not mentioned in the post was that while happily trying to destroy the patent system, the IT community is supporting draconian penalties for copyright infringement (see the post later today). Nothing like eating your cake and having it, too.

Thanks for the comment.

Sorry, I meant to say Glen, of course. Great example of a Freudian typo.

A university research project is most certainly not the same thing as a biotech or pharma company bringing a drug to market.

How many great University ideas have completely bombed toxicity or pharmacokinetics b/c they were developed in small animal model systems rather than in large animals/the clinic?

Furthermore, an inbred small animal is a very gross approximation of the highly outbred genus of humans.

Someone in position to know better than myself (i.e. an actual practicing scientist) can probably come up with even more substantive differences.

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