Here’s more detail on the Lovenox case from the ‘Law 360’ newsletter. (I do
not have link for this article, which I received from an anonymous iHub reader.)
›High Court Asked To Review Inequitable Conduct Ruling
By Erin Coe
January 29,2009
Subsidiaries of Sanofi-Aventis have asked the U.S. Supreme Couft to weigh in on a decision that upheld a lower court's finding that Aventis' patents for its anti-clotting drug Lovenox were invalid due to inequitable conduct.
Aventis Pharma SA and Aventis Pharmaceuticals Inc. filed a petition for a writ of certiorari with the Supreme Couft on Jan. 23 that seeks to reverse the U.S. Court of Appeals for the Federal Circuit's 2-1 opinion that affirmed a district court's ruling in favor of generics makers Amphastar Pharmaceuticals Inc. and Teva Pharmaceuticals USA Inc. and allowed generic versions of Lovenox to make their way toward the U.S. market.
Enlisting attorneys from Gibson Dunn & Crutcher LLP and Finnegan Henderson Farabow Garrett & Dunner LLP to make their case, the Aventis units have tried to pick up where Judge Randall R. Rader left off in his dissenting opinion that inequitable conduct should be limited to "only the most extreme cases of fraud and deception."
Under the doctrine of inequitable conduct, a federal court can decide not to enforce an otherwise valid patent if it is found that it was procured through fraud or deceit. In this case, the Federal Circuit concluded that Aventis' failure to disclose drug dosage information evidenced intent to deceive and affirmed the finding of inequitable conduct. The units argued that the Federal Circuit should not have upheld the use of a standard inferring intent from the materiality of the information that was withheld.
"As Judge Rader recognized in his dissent, decisions tike this one impair the effective functioning of the patent system. A lax standard for inequitable conduct not only encourages unwarranted litigation and threatens investments in research and development, but also interferes with the ability of the PTO to effectively examine patent applications by encouraging applicants to deluge the PTO with hundreds of minimally relevant references," the petition stated.
The petition noted that the Supreme Court has invoked the doctrine only in extreme circumstances involving "deliberate," "corrupt," "sordid" and "highly reprehensible" misconduct, and while some Federal Circuit panels have followed suit, other 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 in this case is whether a court can arrive at an inequitable conduct determination "premised on a sliding scale between intent and materiality, effectively permitting a finding of fraudulent intent to be predicted on gross negligence," according to the petition.
The Aventis units said the Supreme Court should take up the case because lower court decisions were in conflict and the "internally divided Federal Circuit has been unable to rein in the unwarranted expansion of the doctrine."
Amicus briefs in support of Aventis' position are due Feb. 25.
Representatives for Amphastar and Teva did not return calls seeking comment.
The Aventis units sued the generic companies for patent infringement in 2003 in the U.S. District Court for the Central District of California over U.S. Patent No. 5,389,618, which was later reissued as U.S, Patent No. RE 38,743.
The '618 patent-in-suit covers mixtures consisting of the drug enoxaparin. During its patent application, Aventis needed to prove that its new drug was different from an enoxaparin drug for which the company had a European patent. The European patent was revoked in October 1990.
After five years of prosecution, the U.S. Patent and Trademark Office granted approval when Aventis showed that the new drug had a significantly longer plasma half-life than the old drug. However, Aventis never disclosed that its comparison of the half-life of the drugs involved different dosages of each drug.
During the December 2006 bench trial before Judge Mariana R. Pfaelzer of the California district court, Aventis scientist Dr. Andre Uzan testified that there were many valid scientific reasons for comparing the drugs at different dosages.
But Judge Pfaelzer found that similar doses would have made the drugs' half-lives much closer and likely would have prevented Aventis from receiving a patent. Judge Pfaelzer called Uzan's omission of the doses "inconceivable" and "intentional."
The Aventis units appealed the decision to the Federal Circuit, trying to explain its lack of disclosure of the dosage information and claiming the district court had not understood that during the patent prosecution Aventis was answering both anticipation and obviousness objections made by the examiner.
In May, the Federal Circuit ruled that Judge Pfaelzer had "properly found that the half-life comparisons were intended to address both the anticipation and obviousness rejections, and, to the extent that they were intended to address the anticipation rejection, the failure to disclose the dosage information evidenced intent to deceive."
However, one member of the three-judge panel, Judge Rader, dissented from the majority opinion, stating that he would have overturned the lower court's inequitable conduct finding. "To my eyes, this record does not show clear and convincing evidence of intent to deceive the U,S. Patent and Trademark Office," Judge Rader said at the time. "Moreover, my reading of our case law restricts a finding of inequitable conduct to only the most extreme cases of fraud and deception."
Lovenox was first approved for sale in Europe in 1987 and in the U,S. in 1993. Lovenox has generated billions of dollars in sales and has been prescribed to more than 118 million patients in 96 countries.
The patents in the case are U.S. Patent Number 5,389,618 and U.S. Reissue Patent Number 38,743.
Aventis Pharma SA and Aventis Pharmaceuticals Inc. are represented in this matter by Finnegan Henderson Farabow Garrett & Dunner LLP and Gibson Dunn & Crutcher LLp.
The case is Aventis Pharma S.A. et al, v, Amphastar Pharmaceuticals Inc. et al., case number OB-937, in the U.S. Supreme Court.‹
Market Data 
Markets 
AI
