Thursday, March 14, 2019

CAFC vacates validity ruling of D. Del./Robinson in Forest case on "motivation to combine" issue

The outcome

Following a bench trial, the district court held Appellants had not established
claims 1–2, 4–6, and 9–10 to be
invalid and held Forest had not established infringement
of claims 4, 9, and 10 as to Alembic and Breckenridge. Appellants appeal the
district court’s construction of claim 1
and its determination that the claims have not been established to be invalid. Forest cross-appeals,
arguing the district court’s finding that Breckenridge and Alembic do not
infringe claim 4 was clearly erroneous. We have jurisdiction under 28 U.S.C. § 1295(a)(1).
We vacate and remand
the district court’s validity determination, and we vacate
and remand for it to reconsider infringement under a corrected claim construction.

Of interest as to clinical trials

Appellants object to this reasoning, arguing that the
only reason the cardiotoxicity issue was not publicly known
was because Organon concealed and misrepresented the
events suffered by patients in clinical studies when it reported the
results of those studies. While the actions alleged may raise a variety of concerns, we do not see how
they affect the district court’s obviousness analysis.
Ultimately, we see no clear error in the district court’s consideration
of the unknown nature of the problem solved by the
inventors and the factors that would teach away from their


Here, the district court found it was “surprising and
unexpected” that the claimed “sublingual route of administration successfully resolved the serious cardiotoxic event
reported in the ’476 patent.” J.A. 74. However, as the district court found, there was nothing in the prior art that
indicated cardiotoxic problems existed with other routes of
administration. J.A. 68. We explained in Soni that the
reason why unexpected results support a conclusion of nonobviousness is simple:
“that which would have been surprising to a person of ordinary skill in a particular art
would not have been obvious.” 54 F.3d at 750. At the time
of the claimed invention, a person of ordinary skill could
not have been surprised that the sublingual route of administration did not result in cardiotoxic effects because
the person of ordinary skill would not have been aware that
other routes of administration do result in cardiotoxic effects. The district court, therefore, erred in its analysis of
unexpected results.


We vacate the district court’s judgment that Claims 1
and 4 are not invalid and remand for it to consider the limited question of whether compliance concerns with patients
who have trouble swallowing would provide a motivation
to combine and its impact on the obviousness analysis.


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