CAFC decision in Novo Nordisk v. Caraco

From Novo Nordisk v. Caraco

As to reasons for allowance:



The examiner withdrew her rejection, explaining that
her decision was “[b]ased solely upon the Declaration
submitted by Dr. Sturis and reconsideration of the synergistic
effects demonstrated in Example 3.” Id. at 1001.
After additional proceedings not relevant here, the ’358
patent issued on January 13, 2004. Id. Claim 4 of the
patent, which is the sole claim at issue here, was not
amended at any point during prosecution. Id.


Note footnote 4:


For more details about the pharmaceutical applications
that inspired this case, or about the history,
language, and scope of the Hatch-Waxman Act, see Caraco,
132 S. Ct. at 1675-80.



At issue here



Following a bench trial, the district court held that
claim 4 of the ’358 patent was invalid because of obviousness
and that the patent was not enforceable because of
inequitable conduct. Novo appeals these rulings, and we
have jurisdiction under 28 U.S.C. §§ 1292(c)(2) and
1295(a).(...)

Novo attacks the district court’s obviousness ruling on
three grounds. First, it asserts that the district court
misallocated the burden of persuasion in this case by
forcing Novo to “overcome” Caraco’s “prima facie” case of
obviousness with evidence of unexpected results. Second,
Novo argues that even if the burdens were properly
allocated in this case, Caraco’s evidence insufficiently
supported the court’s ultimate obviousness findings.
Finally, Novo believes that the district court should have
deferred to the examiner’s original finding that the Sturis
and Moses studies demonstrated unexpected synergy.


The result


Novo attacks the district court’s obviousness ruling on
three grounds. First, it asserts that the district court
misallocated the burden of persuasion in this case by
forcing Novo to “overcome” Caraco’s “prima facie” case of
obviousness with evidence of unexpected results. Second,
Novo argues that even if the burdens were properly
allocated in this case, Caraco’s evidence insufficiently
supported the court’s ultimate obviousness findings.
Finally, Novo believes that the district court should have
deferred to the examiner’s original finding that the Sturis
and Moses studies demonstrated unexpected synergy.