This morning the Supreme Court denied Ferring B.V.'s cert petition in Ferring v. Barr, a closely-watched inequitable conduct case. The case concerns Barr's ANDA to market a generic version of DDAVP (desmopressin acetate), a treatment for diabetes insipidus with annual sales of $200 million.
Last February, the Federal Circuit affirmed a district court decision holding, on summary judgment, that Ferring's U.S. Patent No. 5,047,398 is unenforceable due to inequitable conduct (click here for Fed. Cir. opinion). According to the Federal Circuit, four out of five declarations submitted to the PTO in support of the patent application during prosecution were written by scientists who had been employed or had received research funds from Ferring, and Ferring should have informed the patent office of those relationships.
Judge Newman strongly dissented from the majority opinion, writing:
Today my colleagues on this panel not only ignore Kingsdown and restore a casually subjective standard, they also impose a positive inference of wrongdoing, replacing the need for evidence with a "should have known" standard of materiality, from which deceptive intent is inferred, even in the total absence of evidence. Thus the panel majority infers material misrepresentation, infers malevolent intent, presumes inequitable conduct, and wipes out a valuable property right, all on summary judgment, on the theory that the inventor "should have known" that something might be deemed material.
Amicus briefs in support of Ferring's cert petition had been filed by PhRMA, BIO, and the Washington Legal Foundation.
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