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« Court Report - Part II | Main | Court Report - Part III »

April 18, 2012

Comments

This decision seems to be at odds with the CAFC's "inherent anticipation" jurisprudence (ignoring for the moment the problems with that line of case law). Per that jurisprudence, the claims at issue would be anticipated by a prior art reference describing the use of orally administered dihydrospirorenone to treat any one of the three conditions recited in the claims, since the simultaneous treatment of the other two by administration of this compound would be an inherent effect of the oral administration of the compound. But if that's the case, then it should be true that what anticipates before infringes after (and vice versa), so that apparently the generics' product would infringe the claims of the patents, regardless of whether or not there was a labeling "carve-out" for ANDA purposes. At the very least, the question of infringement of the patent claims should have been examined, and the case not dismissed solely on the pleadings. It seems that under the majority's logic, Bayer would have had a better chance by suing for infringement outside the ANDA context, i.e. by waiting for launch of the generic, in which case Orange Book listings and FDA approvals wouldn't have mattered. So the majority undermines the purpose of the Waxman-Hatch scheme. Score one for Judge Newman - again - but it would be nice if more of her colleagues listened to her more often.

Dan,

You're point is well-taken, as is Judge Newman's in dissent. In my opinion, the majority relies upon a very hyper-technical view of where the other two effects (antiandrogenic effect and antialdosterone effect) appear on the label. That sort of hyper-technical view was just scorched by SCOTUS in the Caraco Pharm case in interpreting the applicability of the counterclaim provisions added to Hatch-Waxman where there's been potential mislisting in the FDA Orange Book.

Dan,

Thanks for your comment. I think the answer to your concern is in the differences between the acts of infringement for a 271(e)(2) action versus a 271(a)-(b) action. If this were an infringement case outside the ANDA context, then Bayer would not only have to prove that someone actually infringed its method patent, but that the generic companies induced that infringement (because they aren’t going to sue the patients or the doctors). However, I think you are correct that Bayer would have had an easier time in this context, because in addition to looking at the label, they could have looked to other actions of the ANDA filer (such as marketing, etc.). However, for a 271(e)(2) action, inducement doesn’t need to be proved – or more accurately, the inducement is the submission of a proposed label. As such, the majority limited the inquiry to the indication. I think Judge Newman’s position that the finding of non-infringement should not have been made on the pleadings was more correct than the majorities, because Bayer should have been given the chance to show that the entire label (or ANDA filing) would induce one to infringe its patent. However, I’m not sure Bayer would have been ultimately successful. One thing that I had not considered is whether not being successful in the Hatch-Waxman context would be preclusive to bringing a separate infringement action after launch (I’m not aware of a case that deals with this).

Also, I’m not sure I agree that this case is at odds with the inherent anticipation jurisprudence, because the proof requirements are just too different for infringement and invalidity – especially at the pleading stage. In fact, if this case had proceeded, that likely would have been a defense asserted by the ANDA filers. However, I think the “carve-out” discussion in the case was a little misplaced for the reasons you state – it is not that the other two effects were part of the indication, but instead they were inherent properties of using the drug as an oral contraceptive. As such, these effects could not be “carved-out.”

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