Biotech Values

[zipjet]

Thanks tinker,

That certainly helps me understand where you are getting this.

A quote from the link:

"In the Lovenox district court case, the district court went one step further: The court appeared to have shifted the burden to Aventis to disprove deceptive intent (e.g., after finding that Teva/Amphastar had made out a prima facie case of deceptive intent). It will be interesting to see where the CAFC goes with this one."

Is that what happened? Did the District court on its own impose a burden of proof on Aventis? Or did it allow T&A to prove intent and then allow Aventis to refute it?

The article linked all the briefs. That was good. But he did not link the Federal Circuit remand nor the trial court decision.

The Federal Circuit decision that remanded the case, 05-1513 issued 4/10/2006 (don't have the formal cite handy). The FC found that the materiality of the misrepresentation was present to the SJ standard. But it went on to find that "intent to deceive" was not supported for SJ purposes since Aventis offered a plausible claim that it had been denied the right to produce Dr. Uzan in person to explain the basis for comparing different doses. The FC found that the trial court was not correct since it ignored a reasonable inference that failure to disclose the dosing difference occurred purely out of inadvertence.

It appears to me that had the same ruling been entered after a trial that the FC would have affirmed, and that the reversal was a function of SJ rules.

Given the remand what did the trial court try? To an observer, me, the court tried "intent to deceive" - giving wide latitude to Aventis to show any excuse for the failure to disclose that differing doses were being compared without disclosing that to the PTO.

So to me the burden shifting suggestion is simply a means to confuse the issue. TEVA and Amphastar put ample evidence on of the nature of the deception and facts surrounding it to raise the inference of intent. Having done that, Aventis was given freedom to refute the inference raised.

One of the "tells" during the trial was that the Judge cut off Teva and Amphastar from offering evidence and often overruled objections by T&A. Neither of those things happened to Aventis. No matter what Aventis did the judge allowed it and overruled objections to Aventis offers. I have tried enough cases to know what that meant.

Given the narrow remand, a careful 5 day trial on intent, a well written decision by a fine jurist - this one should be affirmed. That is should be will not make it so.

Time will tell.

ij