Replies to post #121881 on Biotech Values

[mouton29]

<<IC means that the applicant was not playing fair with the PTO. It does not require that the patent would not have been granted anyway. >>

The recent Therasense v. Becton case in fact does require such a showing except in cases of egregious misconduct such as filing a deliberately false affidavit. The Bloomberg article cited by Dew states: " Except in egregious cases, patents would be unenforceable only if information withheld would have affected whether the invention was approved, the court ruled." http://www.bloomberg.com/news/2011-05-25/abbott-wins-ruling-to-narrow-patent-misconduct-standard.html

The court stated (see pages 28-30 of the decision at http://www.cafc.uscourts.gov/images/stories/opinions-orders/08-1511.pdf)

Because inequitable conduct renders an entire patent (or even a patent family) unenforceable, as a general rule, this doctrine should only be applied in
instances where the patentee’s misconduct resulted in the unfair benefit of receiving an unwarranted claim. See Star, 537 F.3d at 1366 (“[j]ust as it is inequitable to permit a patentee who obtained his patent through deliberate misrepresentations or omissions of material information to enforce the patent against others, it is also inequitable to strike down an entire patent where the patentee committed only minor missteps or acted with minimal culpability”). After all, the patentee obtains no advantage from misconduct if the patent would have issued anyway. ...

Although but-for materiality generally must be proved to satisfy the materiality prong of inequitable conduct, this court recognizes an exception in cases of affirmative
egregious misconduct. This exception to the general rule requiring but-for proof incorporates elements of the early unclean hands cases before the Supreme Court, which dealt with “deliberately planned and carefully executed scheme[s]” to defraud the PTO and the courts. HazelAtlas, 322 U.S. at 245. When the patentee has engaged in affirmative acts of egregious misconduct, such as the filing of an unmistakably false affidavit, the misconduct is
material. See Rohm & Haas Co. v. Crystal Chem. Co., 722 F.2d 1556, 1571 (Fed. Cir. 1983) (“there is no room to argue that submission of false affidavits is not material”); see also Refac Int’l, Ltd. v. Lotus Dev. Corp., 81 F.3d 1576, 1583 (Fed. Cir. 1996) (finding the intentional omission of
declarant’s employment with inventor’s company rendered the affidavit false and that “[a]ffidavits are inherently material”). After all, a patentee is unlikely to go to great lengths to deceive the PTO with a falsehood unless it believes that the falsehood will affect issuance of the
patent. See id. at 247 (pointing out that patentee’s lawyers “went to considerable trouble and expense” to manufacture false evidence because they believed it was needed
to obtain issuance of the patent). Because neither mere nondisclosure of prior art references to the PTO nor failure to mention prior art references in an affidavit
constitutes affirmative egregious misconduct, claims of inequitable conduct that are based on such omissions require proof of but-for materiality. By creating an exception to punish affirmative egregious acts without penalizing the failure to disclose information that would not have
changed the issuance decision, this court strikes a necessary balance between encouraging honesty before the PTO and preventing unfounded accusations of inequitable conduct.