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« The Tragedy of a Bad Idea | Main | Deloitte White Paper Addresses Unintended Consequences of Follow-on Biologic Regulatory Pathway »

August 26, 2009



As I said on Patently-O, Ortho's reissue patent is hanging by a thread and a weak one at that. Also, now that all of the original claims are essentially "dead" Ortho faces a significant "intervening rights" issue even if the remaining reissued claims survive.


Why does big pharma need to engage in deal-making behind closed doors AND get their 12 year data exclusivity period?

It's almost as if there is no amount of profit that would satisfy them.

What do you think, Kevin?

Dear Keep:

The glib answer is that it's just politics, but the more reasonable answer is that in both instances, corporate executives are trying to adapt to changes that they cannot stop but want to minimize (at least with regard to the effects on their shareholders).

Which doesn't make them evil. Evil would be running ads about death panels and not treating the elderly, or opposing any follow-on biologics program because the drugs would be like Thalidomide (the latter scenario is at least possible if unlikely).

But this isn't what the pharma executives did. They may have made a political accommodation with the Obama administration, but at a cost to them of $80 billion. Now, that's a lot of money to lose; they didn't take alternative approaches, like threatening to hold their breath until they turned blue, or offshore all their drug-making efforts, or do anything else that would be obstructive. You don't have to praise them, but I don't think you should damn them, either.

Finally, there are two things. The $80 billion in savings means that something that cost X now costs some percentage less than X, to account for the savings. This now sets a new floor for branded drugs which is lower than it was. If you ignore the 67% of market that goes to generic drugs, you have now reduced the profits of the companies that invest to make the new drugs of tomorrow. They will still make them, but with less money to do so.

Second, with regard to data exclusivity, 12 years is less than infinity (the current situation), so that even the 12 year number is a big improvement. No one has a crystal ball to be able to "know" what the correct length of the data exclusivity term should be, so think of it as a start. If we find that it's too long, Congress can shorten it. But if we pick a shorter term and it turns out to be too short, so that it hurts innovation in this area, who benefits?

And, of course, the biogenerics could produce their own safety and efficacy data, replicating what the innovator did (which is an advantage because the earlier studies will inform later ones about pitfalls, problems and other complications). It may cost a little more, but then you don't care about the innovator's data and there is nothing the innovator can do to stop you.

Thanks for the comment.

Dear Kevin

What I am not able to understand the FC's ruling is How can a combination of X and Y be Non Obvious while the combination of (a) times X and (b) times Y be Obvious???Please correct me if I am wrong in my interpretation.


The majority affirmed the finding of obviousness as to claim 6 because that claim recites a composition "comprising" tramadol and acetaminophen. Therefore, the fact that the prior art composition contained two other compounds was not relevant, leaving the question of whether the 1:10 prior art ratio created a prima facie case of obviousness with respect to the claimed ratio of "about 1.5" (which the CAFC had earlier decided encompassed ratios of 1:3.6 to 1:7.1). The CAFC believed it did.

As for the other asserted claims (which recite a composition that "consists essentially" of tramadol and acetaminophen), the majority did not determine that they were nonobvious, but rather that the District Court could not decide that issue on summary judgment. In contrast with claim 6, the CAFC focused on whether it would have been obvious to remove pentobarbital sodium and ethoxy benzamide from the prior art four-compound composition. The majority said there was a factual dispute as to this issue. (The dissent, on the other hand, believed these claims were also obvious.)

Thanks for the comment.


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