In
This Issue
· In
re Kao, Federal Circuit Provides Guidance Regarding Obviousness
Determinations After KSR.
· Federal Circuit Makes
Inequitable Conduct Defense More
Difficult
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In re Kao, (Federal
Circuit Provides Guidance Regarding Obviousness Determinations After KSR Int’l Co. v. Teleflex Inc.
In In re Kao et al., (May 13, 2011), the Federal Circuit (“CAFC”) reversed
the U.S. Patent Office Board of Patent Appeals and Interferences (”BPAI”) on
one of its rulings that the claims in three patent applications were obvious
in view of the prior art.
The three applications, all assigned to
Endo Pharmaceuticals Inc., included claims directed to a controlled-release oxymorphone formulation with a claimed
dissolution rate. The BPAI found all claims
obvious in view of PCT Pub. No. 10/01/08661 (“Maloney”). The parties agreed that controlled-release oxycodone was taught by Maloney. The BPAI found that one of skill in the art
would arrive at the claimed invention by substituting oxymorphone for the oxycodone
and formulation taught by Maloney. The
CAFC disagreed, however, finding that the dissolution rates reported in
Maloney were measured differently from that described in the Endo
applications and there was no factual evidence in the record that the
dissolution rates overlap. The
application is remanded to the PTO for further prosecution.
Notably, the CAFC instructed that, if evidence of
secondary considerations is presented (to overcome an obviousness rejection),
the BPAI must consider the same. The
CAFC emphasized, however, that there must be a nexus between the secondary
consideration and the inventive or novel portion of the claim.
Federal
Circuit Makes Inequitable Conduct Defense More Difficult
On May 25, 2011, the
Federal Circuit (“CAFC”) issued its ruling in the en banc rehearing of Therasense,
Inc. v. Becton, Dickinson & Co. The
CAFC vacated its original ruling and asked the parties to supplement briefing
on inequitable conduct.
In a 6-4-1 decision, the
CAFC held that, to establish inequitable conduct, the accused infringer must
prove, by clear and convincing evidence, that: (i) the patentee acted with specific intent to deceive the PTO; and (ii) “but for” materiality, meaning
that had the withheld reference or information been provided to the PTO, the
PTO, more likely than not, would not have granted the claim. Further, the CAFC held that, even if the
accused infringer proves both intent and materiality, the “district court
must weigh the equities to determine whether the applicant’s conduct before
the PTO warrants rendering the entire patent unenforceable.” Id., at p. 19.
Notably, the CAFC rejected
both the “sliding scale” approach that it had previously embraced, where a
strong showing of either materiality or intent could lead to an inference of
the other with a lesser showing and the “materiality” standard as set forth
in Rule 56 of the Manual of Patent Examining Procedure. |
| |
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