Case Name: Sciele Pharm. Inc. v. Lupin Ltd., Case
No. 2012-1228, 684 F.3d 1253 (Fed. Cir. July 2, 2012) (Circuit Judges Lourie, Prost,
and Moore presiding; Opinion by Moore) (Appeal from D. Del., Kugler, J.)
Drug Product and Patent(s)-in-Suit: Fortamet® (metafomin
hydrochloride extended-release tablets); U.S. Patent No. 6,866,866 (“the ’866
Nature of the Case and Issue(s) Presented: The ’866
patent claims dosage forms with a “mean time to maximum plasma concentration
(Tmax) of the drug which occurs at 5.5 to 7.5 hours after oral administration on
a once-a-day basis to human patients.” During prosecution, the applicant
discussed the importance of Tmax and the examiner indicated that the closest prior
art, the Cheng reference, suggests the general teaching of a Tmax of eight hours.
In response, the applicant cancelled a number of claims which had an upper Tmax
range of 7.5 hours, and re-wrote a then-pending claim, which had an upper Tmax range
of seven hours, into independent form. Despite cancelling the rejected claims,
the applicant received a notice of allowance. The applicant contacted the
Patent Office and explained that the notice of allowance mistakenly allowed cancelled
claims. Even though the Examiner issued a supplemental notice acknowledging
the amendment, removing the cancelled claims, and allowing the amended claims, as
issued, the ’866 patent contained the cancelled claims from the first notice
of allowance—not the supplemental notice of allowance. Subsequently,
plaintiffs asserted the claims of the ’866 patent against Lupin, including
the claim that referenced a Tmax of 7.5 hours.
On December 6, 2011, the district court granted a preliminary injunction, which
the Federal Circuit subsequently vacated and remanded because the district court
failed to address Lupin’s obviousness arguments. On remand, the district
court reinstated the preliminary injunction based on two principle findings: (i)
that it was required to defer to the Patent Office, notwithstanding the odd sequence
of events that gave rise to the issuance of the ’866 patent; and (ii) that
KSR was not directly applicable to the current case because the prior art
was before the PTO when the ’866 patent issued. The Federal Circuit
held that the district court misinterpreted the law, and, once again, vacated the
preliminary injunction and remanded.
Why Lupin Prevailed: Lupin argued that the presumption of validity
should not attach because of the erroneous issuance of the cancelled claims.
Plaintiffs argued that there should be a heightened presumption of validity because
the prior art references that Lupin relied on were before the Patent Office during
prosecution. The Federal Circuit found that both parties were wrong.
First, deference to the Patent Office is reflected in the “clear and convincing”
evidence burden for proving invalidity. “[W]hether a reference was before
the PTO goes to the weight of the evidence…[b]ut the presumption of validity
and accompanying burden of proof, clear and convincing evidence, are not altered.”
Second, the presumption of validity applies to all issued patents, and rejecting
the issued claims of the ’866 patent because of “quirks in the prosecution
history” is inconsistent with that presumption. But that does not mean
that courts should ignore the prosecution history. Other than recognizing
that the prosecution history was “puzzling,” the Federal Circuit found
that the district court did just that, ignored the prosecution history. The
Court then went on to find a substantial question of validity of the claims of the
’866 patent in view of the Cheng reference, among others. The Federal
Circuit further held that the district court clearly erred in its conclusion that
there was no motivation to combine Cheng with other prior art references.
For these reasons, the Court vacated the preliminary injunction and remanded the
case back to the district court.
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