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« Court Report | Main | Biotech/Pharma Docket »

March 01, 2009


Good post Kevin.

1. I'm perplexed per a point pertaining to patent prosecution: since when can an obviousness-type double patenting rejection be made over a combination of references? I believe that such a rejection is made on the basis of the *claims* of the earlier-issued patent (and *not* the entire disclosure thereof) against the claims of the pending application - in contrast to a normal 103 rejection where the entire teaching of a combination of references can be utilized. With o.t.d.p., we're not worried about the claimed invention being obvious per se over the prior art, we're worried about the patentee extending its period of exclusivity (under the old 17-years-from-grant system; since the switch to 20 years from earliest filing, the only reason for o.t.d.p. rejections is to avoid "vexatious litigation" by patentees parceling the patents out to different parties) by claiming in a later app what it could have claimed in an ealier app. In which case, there shouldn't be resort to other prior art.

2. You seem to be in favor of l etting the patentee enjoy a quiet time with its patent after grant. How about letting the rest of world get on with using what is now old technology? This is the second recent high-profile biotech case of which I'm aware (Amgen v Roche re EPO is the other) in which the patentee was able to effectively procure 30 years or more of patent protection. Here the original app was filed in 1983 - what in the blazes are we doing giving these guys exclusivity over recombinant antibody technology until 2018?! I realize that this is a hold-over from the old, evil 17-years-from-grant-and-let-Lemelson-submarine-us regime, and that as time passes we will see fewer and fewer of these cases, but still - where is the *public's* interest in this case being considered? This is OLD technology at this point, and I'm sorry that Genentech had to wait so long for a patent, but why the heck should we suffer high prices? Better, why are we forcing manufacture and sale of products covered by this process offshore, to places like Europe that had 20-year-from-earliest-filing terms all along? Here the USA's being out of step with ROW is letting it shoot itself in the foot.

Take a look at the Amendment filed by Genentech leading to the Notice of Intent to Issue Reexamination Certificate. You will see in the disclosure of related matters that there is a pending Cabilly III, also pre-GATT, which just emerged victorious in yet another interference with Boss. Boss, predictably, appealed. While it is not possible to know what the claims look like, Cabilly III could be in force until nearly 2030.

Anyone have a problem with this?

Dear Here and Humorless:

Both of you raise the issue of how long the effective term for the Cabilly and Amgen patents have turned out to be. As you both recognize, this is in part a holdover from the prior regime, of granting 17 years from issue. Accordingly, if we had not changed the patent term to 20 years from earliest filing the result would be less striking.

However, the only way to solve the problem would to enact a hard limit on patent term, no matter what. This would disproportionately impact pharma compared with other technologies, given the differences in obsolescence horizons.

Also, for a pharmaceutical we can consider the following hypothetical. If the Cabilly patent was for a pharmaceutical, and if the 20 year term had been in effect at the time the application was filed, we could have had the following result. The term, would have expired in 2003 except that it would be extended for at least 8 years because of the interference (and maybe 10 years or so if the district court proceedings are included). This brings us to an expiration date in about 2010 to 2012; if you add 5 years of patent term extension for regulatory approval delay, we are out to the patent expiring in about 2016 or so.

Now, if Congress limits the maximum term to 25 years from filing (which is the minimum in view of the maximum Hatch-Waxman term extension), then the patentee would have lost about 7 years of term (about the same amount of time as the interference). Besides providing an avenue for delaying applications, this would penalize just those inventors working in the "hottest" areas (where there may be the most competition and the most likelihood or incentive for interferences).

I agree that the results for Cabilly and Amgen are anomalous, but how much do we want to restrict patent rights for all on the basis of the few exceptions? I think it is almost impossible to find an equitable "maximum" term life, but I would be happy to hear what you think.

Thanks for the comments.

Dear Humorless:

To get to your first point, the Office seems to have performed the analysis as if it was a 103 rejection, with the consequence being the requirement to file a terminal disclaimer rather than a determination of unpatentability. I have seen that in at lease one other case, but I don't have the cite handy (I'll let you know if I find it).

Thanks for the comment.

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