Aventis Pharma v. Amphastar Pharmaceuticals and Teva (on petition for a writ of certiorari)
In a split 2008 decision, the Federal Circuit affirmed a lower court decision holding two Aventis patents unenforceable due to inequitable conduct. The patents cover a low molecular weight form of the blood thinner heparin and is marketed under the Lovenox brand. The alleged offense involved an Aventis failure to report that its tests showing improved drug half-life used a different dosage than the tests on prior-art compound. Inequitable conduct requires proof of both materiality and intent to deceive. Here, the intent was shown only through circumstantial evidence.
In a strongly worded dissent, Judge Rader argued that inequitable conduct law should be restricted to "only the most extreme cases of fraud and deception." Rader also discusses how past inequitable conduct should be correctable.
Now, Aventis has hired Supreme Court powerhouse (and champion of the Federalist Society) Ted Olson and has asked the Supreme Court for its view. Aventis posits as an extension of Judge Rader's dissent - arguing that inequitable conduct should not be a viable cause of action when the mens rea evidence only rises to gross negligence. The question presented:
Under the judge-made doctrine of “inequitable conduct,” a federal court may decline to enforce an otherwise valid patent that was procured through fraud or deceit. Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806 (1945). As befits the punitive nature of the doctrine, this Court has invoked it only in extreme circumstances involving “deliberate,” “corrupt,” “sordid” and “highly reprehensible” misconduct. Some panels of the Federal Circuit have similarly limited the inequitable conduct doctrine to deliberately planned and carefully executed schemes to defraud, but other Federal Circuit panels—including the majority in this case— have adopted a “sliding scale” under which “less intent” is required as the materiality of an omission or misrepresentation increases. The question presented is:
Whether a court may refuse to enforce an otherwise valid patent on the basis of an inequitable conduct determination premised on a sliding scale between intent and materiality, effectively permitting a finding of fraudulent intent to be predicated on gross negligence.
Aventis has written a strong petition, amici briefs in support of the Aventis position would be due by February 25.