On June 15, 2012, the District Court for the District of New
Jersey released its redacted opinion in litigation between Schering
and Apotex involving mometasone furoate monohydrate (NASONEX) and
US. Patent No. 6,127,353. The '353 patent is generally
directed to the monohydrate form of mometasone furoate and aqueous
nasal sprays containing the same.
In its infringement arguments, Schering did not contend that
Apotex used the claimed monohydrate at the time of manufacture, but
rather that the anhydrous form of mometasone furoate in
Apotex's proposed product converts to the claimed monohydrate
within the two year shelf-life of Apotex's product. The primary
issue at trial was whether this conversion from the anhydrous form
to the patented monohydrate occurred. Whereas Schering's
expert found that conversion begins to occur as soon as the Apotex
ANDA product is manufactured, Apotex's expert provided evidence
that the "Apotex formulation would be stable against
conversion for around 800 years." The Court accepted
Apotex's criticisms of how certain samples were handled by
Schering's expert and concluded that Schering had failed to
demonstrate infringement on a balance of probabilities in respect
of experimental samples that had been shaken or vortexed. In
respect of the remaining samples, the Court concluded that
Schering's analysis of the x-ray powder diffraction (XRPD)
patterns, relying on only one or two XRPD peaks, "was
insufficient upon which to find a match" to the XRPD pattern
depicted in Figure 2 of the '353 patent.
Schering's infringement theory also sought to rely on three
other items that were supportive of conversion to the monohydrate:
(1) preferred orientation; (2) Raman spectroscopy and (3) an XRPD
report produced by a close Apotex affiliate that, according to
Schering, showed conversion in several mometasone furoate
formulations within seven weeks of production. The Court gave
little weight to Schering's preferred orientation theory and
Raman spectroscopy testing, the latter of which is not mentioned in
the '353 patent. The Court concluded that while the XRPD
report prepared by the Apotex affiliate was relevant, the report
was not supported by any first hand evidence by a person performing
or overseeing the testing and did not add much weight to the
evidence of the Schering expert in light of Apotex's
Having concluded that Schering had failed to carry its burden on
a preponderance of evidence, the Court dismissed Schering's
Validity – Anticipation
While the Court concluded that Apotex had waived the issue of
anticipation by failing to raise this issue in the pretrial order,
it also found that Apotex had failed to demonstrate, on the clear
and convincing standard, that an earlier patent directed to
mometasone furoate anticipates the '353 patent. The Court
concluded that Apotex was not able to rebut evidence provided by
the patentee to the USPTO that infrared testing of the compound
generated during the development of the prior art compound
demonstrated that that the prior art compound was not a hydrate.
Further, as the prior art patent did not disclose a
monohydrate it was not subject to an analysis under section
Validity – Obviousness
Apotex's obviousness attack was based on the reference cited
for anticipation and four additional prior art documents that
disclose compounds structurally similar to mometasone furoate. The
Court accepted Schering's position that the skilled person
would not need to have a specific experience in the development of
aqueous nasal suspensions and concluded that Apotex had failed to
meet their burden to establish that the skilled person would have
been motivated to develop a nasal spray of mometasone furoate, in
part because of the uncertainty in the liver metabolism of
mometasone furoate. Having determined that Apotex had failed
to establish a prima facie case of obviousness, the Court
concluded that there was no need to review evidence of the
secondary indicia of obviousness.
A copy of the Court's redacted opinion may be found
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In this case, Apotex claimed damages pursuant to s. 8 of the NOC Regulations, and Pfizer alleged that Apotex should not be entitled to damages, due to the principles of ex turpi causa relating to its alleged infringement of the relevant patent.