Biotech Values

[mouton29]

<<I assumed that the "but for" rule was that the patent MIGHT not have been approved "but for" the issue at hand. Is it "might" or "would"? >>

I am a tax lawyer, not a patent lawyer, so all I can do is parse the words of the opinion. The paragraph prior to the one I quoted previously uses the word "would" but as a logical matter, one needs to examine whether the statement is a positive or negative. I.e., is the test, the patent would have been issued without the inequitable conduct, or must the defendant (the party seeking to establish the patent is invalid) show that the patent would not have been issued. The second and third sentences in the quote below state the rule in the alternative, so it seems to me it not so clear how the test would be applied if the answer is that the patent might, or might not, have been issued absent the conduct.

This court holds that, as a general matter, the materiality required to establish inequitable conduct is but-for materiality. When an applicant fails to disclose prior art
to the PTO, that prior art is but-for material if the PTO
would not have allowed a claim had it been aware of the
undisclosed prior art. Hence, in assessing the materiality
of a withheld reference, the court must determine
whether the PTO would have allowed the claim if it had
been aware of the undisclosed reference. In making this
patentability determination, the court should apply the
preponderance of the evidence standard and give claims
their broadest reasonable construction. See Manual of
Patent Examining Procedure (“MPEP”) §§ 706, 2111 (8th
ed. Rev. 8, July 2010). Often the patentability of a claim
will be congruent with the validity determination—if a
claim is properly invalidated in district court based on the
deliberately withheld reference, then that reference is
necessarily material because a finding of invalidity in a
district court requires clear and convincing evidence, a
higher evidentiary burden than that used in prosecution at the PTO. However, even if a district court does not invalidate a claim based on a deliberately withheld reference, the reference may be material if it would have blocked patent issuance under the PTO’s different evidentiary standards. See MPEP §§ 706 (preponderance of the evidence), 2111 (broadest reasonable construction).