Tuesday, August 19, 2014

CAFC affirms inequitable conduct against Apotex in Moexipril case

The CAFC affirmed the district court (SD Fl) holding of inequitable conduct
against Apotex as to the prosecution of US '556 in
Apotex v. UCB
. Judge Reyna authored the precedential opinion,
which is a useful guide for understanding "inequitable conduct" post-Therasense.

The drug at issue is Moexipril, an ACE inhibitor, and is available
from Schwarz Pharma under the trade name Univasc.

During prosecution before the U.S. Patent and
Trademark Office (“PTO”)the ’556 patent
received three obviousness rejections.

First, the Examiner rejected the claims
based on the combination of the ’450 patent and
U.S. Patent No. 4,344,949, which discloses using
moexipril tablets to treat hypertension

The problem for Apotex and Dr. Sherman began at the point where
they argued "combination was not reaction" in the case of Univasc®:

In response, Dr. Sherman’s counsel argued that
the cited prior art did not disclose a reaction,
but disclosed only combining moexipril
hydrochloride and an alkaline magnesium compound

Thus, Apotex argued Univasc includes magnesium oxide “unreacted but com-

In all, the Examiner made three rejections, and Apotex appealed to the Board.
Apotex also submitted the expert declaration of Dr. Michael Lipp who asserted the
magnesium compound was a stabilizer, which by the meaning of a stabilizer, was

In view of this, an agreement was reached with claim 1 including
a limitation requiring “greater than 80%” conver-
sion of the moexipril or moexipril acid addition salt to
moexipril magnesium.

The CAFC appeal related to a lawsuit filed by Apotex against UCB on April 20, 2012.

The district court had found inequitable conduct on the part of Apotex.
Among other things:

Lastly , the district court found that Dr.
Sherman lied in the ’556 patent
application by including certain examples
of experiments that were never conduct-
ed. The court noted that each example is written in the
past tense as if it had occurred, but
Dr. Sherman admit-
ted at trial that the experiments
were made up in his head

Also, a relevant PCT application of Apotex was not disclosed during
the prosecution of the '556 case.

the district court found that Dr. Sherman would
have known about the ’560 PCT and understood
its rele-
vance to the prosecution of the ‘556 patent.
The ’560 PCT , however, was never disclosed to the Examiner handling
the prosecution of the ’556 patent.

The district court found Dr. Sherman's action met the "but-for" standard
of Therasense, but further noted:

In the alternative, the district court found that a find-
ing of but-for materiality was not necessary because Dr.
Sherman engaged in egregious misconduct during prose-
cution of the ’556 patent application

The CAFC affirmed the but-for determination, but did not explicitly reach the
consequences of the past-tense use or of not citing the PCT.

District court decision: Apotex, Inc. v. UCB, Inc. ,
970 F. Supp. 2d 1297 (S.D. Fla. 2013)

As to ACE inhibitors, increased levels of bradykinin stimulate in the
production of prostaglandin E2 (PGE2) [13] and nitric oxide (NO).


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