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July 03, 2012

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Listed below are links to weblogs that reference Sciele Pharma Inc. v. Lupin Ltd. (Fed. Cir. 2012):

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Considering the CAFC panel found that a Tmax range of 4.67 to 6.33 hours was taught by one of the two references, that would make even claim 3, with the narrower range of 5.5 to 7 hours, obvious. That being the case, there was no need for the panel to spend so much time discussing the printing error on the part of the PTO. Seems to me the panel harped on that particular point to emphasize that even though the PTO made an obvious printing error that the patentee not only chose not to correct, but relied upon in asserting the admittedly-invalid claim 1, that erroneously-issued claim enjoys a presumption of validity. What a bizarre way to treat this case. If the panel wanted to make the point that the presumption of validity applies (i.e. invalidity must be proved by clear and convincing evidence) even in face of already-considered prior are, it could have done so in discussing claim 3. But with regard to claim 1, why not simply say that the district court erred vis-a-vis claim 1 b/c the patentee had already stipulated to that claim's invalidity during prosecution (or alternatively, having disposed of claim 3 as a basis for a p.i., go on to say that of course a question of validity of the broader claim 1 had been raised)? I don't get why the panel went out of its way to say that an admittedly invalid claim is nevertheless transformed to presumptively valid by virtue of a printing error on the part of some low-level PTO employee who prepares documents for printing.

Does anyone seem bothered that the '866 patent issued in March 2005, yet the patentee did nothing to correct the defect in claim 1. When the lawsuit was filed in Jan. 2009, the patent suit asserted claim 1, with its defect.
The litigation continued in earnest, with the patentee getting the automatic 30 month bar, and then filed a PI motion to block the launch.
Why isn't there any Rule 11 violation that any investigation into the the patent and its prosecution history would have revealed the defect, yet the patentee didn't do anything to correct it? Or withdrew the claim. The patentee could have simply filed a disclaimer of claim 1 or other sent it into reexam/reissue.
Seems to me that there's a Rule 11 problem here.

Dan,

Thanks for the comment. With regard to the discussion about the burden of proof, the panel was able to take this opportunity to point out that regardless of what happened at the Office (even something that was a clear mistake) does not change the burden from clear and convincing evidence. Instead, what happened at the Office can be used as evidence, and if the only claims asserted had been the cancelled claims, this would have been a much easier case. However, because claim 3 had been asserted, an obviousness analysis had to be undertaken.

With regard to whether Timmins taught a particular mean Tmax range, the issue was one of fact, not law (and this doesn’t even take into account the other factual determinations required to find that these references rendered the invention obvious). And, the lower court cited evidence that one of skill could not determine the mean Tmax range from the median range. I am not aware of the credibility of the evidence, but giving the Federal Circuit the benefit of the doubt, this still does not appear to be a case where the lower court made a clearly erroneous factual determination. Moreover, this was not an appeal from a finding that the claims were non-obviousness, it was an appeal from the issuing of a preliminary injunction for which the standard is even higher - abuse of discretion. It just didn’t appear from the opinion that the lower court made a clear error of judgment in weighing the relevant factors. That is the reason that it appears that the equities in this case may have played a factor (even if unstated in the opinion).

Andrew

Andrew, I don't disagree, but it still seems to me the decision could have been written more clearly - and logically - to make the same points: start by clearly stating that it's the patent as published by the USPTO that enjoys the presumption of validity; establish that clear and convincing evidence is required to overcome that presumption; say that the prosecution history meets that burden and will almost certainly knock out claim 1 at trial (and mention, without passing judgment, that the fact that this claim was even asserted may ultimately give rise to Rule 11 sanctions - personally I'm with Mac the Knife on this one); and then do the analysis with Timmins to knock out claim 3 (or at least at this stage say it's unlikely that the patentee will prevail on the merits).

To me the big deal here is saying that a clearly mis-printed patent is still a patent. Flip that one around: what if a typo appears in the printed patent that renders the printed patent killer prior art against a later application? Is the later applicant up a creek, or can he point to the file history to show that what the patent teaches is not what's written in the printed document?

I'm in complete agreement with Feigelson and Mac the Knife here.

If ever there was a case ripe for Rule 11 sanctions (and I mean severe sanctions), it's this one.

Mac the Knife,

Without taking a position whether Rule 11 would have been appropriate, I will point out (as Dan also did) that a version of claim 3 (with the narrower scope) was pending the entire time, was allowed by the examiner, and was being asserted by the patent holder. I think it would be a different story if Sciele was only asserting canceled claims. However, I did find it interesting that Sciele’s counsel defended the assertion of claim 1 (a canceled claim) during oral argument because, as he put it, the examiner’s first notice of allowance included claim 1 (although the examiner may have allowed it in error). Nevertheless, the patentees canceled claim 1, and if Sciele wanted to assert it, they should have filed a reissue (or some other mechanism to bring it back). I agree that to continue to argue the validity of claim 1 through appeal seems absurd (especially because it appeared that they could rely on claim 3). Thanks for the comment.

Andrew

Dan,

I completely agree that this case could have been clearer. Also, I think you make an interesting point on whether a misprinted patent can serve as prior art. If it is being used in an obviousness context, then you could argue that the scope and content of the prior art did not really include the limitation (because you could cite to the prosecution history). Even as an anticipating reference, you could still argue that it didn’t really teach the limitation, because of the prosecution history. I would hope such an argument would be successful, but I could also see it coming out the other way. Thanks for the follow-up comment.

Andrew

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