On December 6, 2011, the Federal Court granted Apotex's
impeachment action in respect of the '777 Patent, which relates
to PLAVIX®. The Court declared the claims of the '777
Patent to be invalid. As a consequence of the declaration of
invalidity, the relief sought in sanofi's infringement action,
heard at the same time, was dismissed. This was Apotex's second validity challenge to the '777
Patent. In a previous PM(NOC) Proceeding,
Apotex' allegations of invalidity were found to be unjustified
by all three levels of the Canadian courts. Of significance the
validity of the '777 Patent had been upheld by the Supreme
Court of Canada in 2006. The Court there had affirmed the decisions
below that Apotex's allegations of anticipation, obviousness
and double patenting were unjustified. In the impeachment proceeding, the Federal Court rejected
Apotex' allegations that the '777 Patent was invalid for
lack of novelty, insufficient disclosure, overbreadth and double
patenting. However, the Court held that the '777 Patent
was invalid since it lacked utility. Further, in obiter,
the Court stated that, if necessary, that it would have found that
the patent was obvious – in direct contradiction to the
Supreme Court decision on this issue in the previous
litigation. The finding in favour of impeachment was made on the allegation
of inutility, and in particular lack of a sound prediction. The
Court held that the '777 Patent "promised" that
clopidogrel could be used in humans. The Court then held that although the patentee had an ample
factual basis and sound line of reasoning for the utility, there
was insufficient disclosure of these two elements in the patent
specification. This finding was made despite the fact that the
Court had held that sanofi had met its statutory disclosure
requirement. The Court also held that if the '777 Patent had been valid,
it would have held that Apotex infringed it. The full text of this decision can be accessed at: "http://decisions.fct-cf.gc.ca/en/2011/2011fc1486/2011fc1486.html" This proceeding under the NOC Regs dealt with two
patents covering Allergan's COMBIGAN product. Crampton J.
granted an order of prohibition with respect to the more recently
issued of the two patents (the '764 Patent) , finding that it
was not obvious. In obiter, he then denied Allergan's
request for a prohibition order regarding the more recent of the
two patents (the '626 Patent), holding that Sandoz's
product monograph would not induce infringement of the patent. Sandoz's only attack on the '764 Patent was that it was
invalid as being obvious. While using the Sanofi framework
in conducting his obviousness analysis, Crampton J. rejected
Sandoz's argument that the inventive concept must be determined
solely from the language in the claims. A court may only look
beyond the claims in determining the inventive concept when the
claims are confined to a bare chemical formula or to a selection
patent. Crampton J. found that it is "both necessary and
permissible" to look to the whole of the disclosure in
determining the inventive concept in cases where the inventive
concept is not readily discernible from the claims themselves. Sandoz alleged that they would not infringe the '626
Patent. The issue before the Court was whether Sandoz's
product monograph would induce infringement. The three-part
test for inducement from AB Hassle v Canada ([2002] 3 FC
221) was followed. It was found that infringement was likely
to occur if the NOC was issued, however, Allergan failed to
establish that Sandoz's product monograph would influence
doctors and pharmacists to the point that the infringement would
not take place without the monograph, and thus did not satisfy part
two of the test. Despite the above finding, Crampton J. addressed Sandoz's
argument that the '626 Patent was invalid for lack of utility.
Crampton J. quickly dismissed this allegation, finding that the
'626 Patent exhibited both demonstrated and soundly predicted
utility. The full text of this decision can be accessed at: "http://decisions.fct-cf.gc.ca/en/2011/2011fc1316/2011fc1316.pdf" Teva Canada Limited v. Wyeth LLC, December 9,
2011, 2011 FC 1442, venlafaxine This was a successful motion by the defendants to dismiss the
plaintiff's action for s.8 damages following a recent decision
by Hughes J. (2011 FC 1169) in which he held that the plaintiff
Teva was not permitted to continue ratiopharm's claim for s. 8
damages following their merger. The motion was allowed despite the fact that the plaintiffs had
filed an appeal. This was because Hughes J. was sceptical that
there would be adequate time to prepare for the February 11, 2013
trial date once all appellate rights had been exhausted, and
because the backlog in the courts has created a need to give
consideration to other litigants seeking trial dates. The full text of this decision can be accessed at: "http://decisions.fct-cf.gc.ca/en/2011/2011fc1442/2011fc1442.pdf" This was a motion to add four parties as plaintiffs to the
action. By way of history, Janssen Inc. and Daiichi Limited were
successful in a 2006 infringement action against Novopharm (now
Teva). Prior to this decision, a bifurcation order had been issued
that separated the issues of patent invalidity and infringement
from that of monetary remedies. The parties who sought to be joined
to the remedies action were related to the plaintiff Janssen Inc.
and were involved in either the manufacture, sale or distribution
of levofloxacin. Their motive for joining the action as plaintiffs
was the potential for recovery of damages under s. 55(1) of the
Patent Act as "persons claiming under the
patentee". Hughes J. found that a determination of whether these parties
were in fact "persons claiming under the patentee" could
only be determined following a trial, and that this trial might
require discovery, further evidence, expert evidence and
submissions from the parties regarding this new evidence. He
distinguished prior case law (2004 FCA 57) where such a motion was
allowed on the basis that in the prior case law the proceedings
were still at an early stage, and thus the additional evidence and
discovery required could more easily be accommodated. Hughes J. noted that, if he were to join any of the new parties,
their claim(s) for damages would be limited to six years from the
filing of the present motion, which took place on August 30, 2011.
Given that Teva's infringement was found to have taken place
between November 29, 2004 to November 17, 2006, the effect of the
limitation period would have been to preclude the new plaintiffs
from approximately nine months of damages. Hughes J. also made it clear that any or all the four parties
seeking joinder were free to start a new action for damages at this
time. The full text of this decision can be accessed at: http://decisions.fct-cf.gc.ca/en/2011/2011fc1480/2011fc1480.html This appeal dealt with a number of issues relating to s. 8
of the PM(NOC) Regulations. First at issue was the interpretation
of the word "pending" in a transitional provision of the
1998 Regulations. The question was whether the 1993 or the 1998
version of the Regulations applied in determining s. 8 damages. The
second issue was whether the 1998 Regulations were invalid
because they cause retroactive or retrospective effects, or
interfere with vested rights, without authorization in the
Patent Act. The final question was whether the Federal
Court erred in concluding that Apotex suffered a loss as a result
of Merck's prohibition application. The FCA confirmed O'Reilly J.'s trial decision that the
prohibition application was pending as of the relevant date for the
transitional provision, and thus the 1998 Regulations applied. At
this date, the prohibition application had been heard by the
Supreme Court but a decision had not yet been released. It was held
that an application is "pending" if it "remains
alive either at first instance, or on appeal". In this case,
it would have been pending until the release date of the Supreme
Court's judgment. The FCA rejected Merck's argument that the 1998
Regulations were invalid because they retrospectively imposed a set
of rules that were fundamentally different from those that applied
when Merck applied for the prohibition. It was held that the new s.
8 did not revolutionize the substantive law, that the legislative
amendment did not deprive Merck of any rights that it previously
held, that there is no right to the continuance of the
substantive standards in laws and that any change in the law was
such that Merck would not have been prejudiced by reliance that
Merck may have placed on any part of the 1993 Regulations
that was affected by the 2008 amendments. Merck's submission that the FC erred in concluding that
Apotex suffered a loss as a result of the prohibition application
was also rejected. The FCA found that there was a sufficient
factual basis for the FC to make the factual findings that it did.
One of Merck's arguments under this heading was that Apotex
could not have acquired norfloxacin from Novopharm under its supply
agreement as to do so would have been an contrary to the terms of
Novopharm's compulsory licence. This argument was rejected as
res judicata and subject to issue estoppel, having been
considered by the Supreme Court in its previous consideration of
this case ([1998] 2 S.C.R. 193). The full text of this decision can be accessed at: http://decisions.fca-caf.gc.ca/en/2011/2011fca329/2011fca329.pdf Canadian Generic Pharmaceutical Association v.
Canada (Minister of Health) and GlaxoSmithKline Inc., December
15, 2011, 2011 FCA 329, fluticasone furoate: This appeal affirmed two lower decisions (2011 FC 465 and 2010
FC 1211) where it was held that the CGPA lacked standing to bring
the application to dispute the listing of fluticasone furoate on
the Patent Register on the basis that it was not directly affected.
The FCA affirmed that the FC and the prothonotary both applied the
correct legal principles in denying standing. The CGPA was also denied public interest standing on the basis
that it failed to establish that generic manufacturers do not have
a reasonable and effective means at their disposal to challenge the
listing of a drug on the Register. For a summary of the decision at the Federal Court, see: Pharmacapsules @ Gowlings, June 1, 2011 - Volume 10, Number 3
at: The full text of the FCA decision can be found at: http://decisions.fca-caf.gc.ca/en/2011/2011fca357/2011fca357.htmlApotex Inc. v. sanofi et al., December 6, 2011, 2011
FC 1486, Plavix
Allergan Inc. v. Canada (Health), November 17, 2011,
2011 FC 1316, Combigan:
Janssen Inc. v. Teva Canada Limited, December 15,
2011, 2011 FC 1480, levofloxacin:
Merck Frosst Canada & Co. v. Apotex Inc., November
25, 2011, 2011 FCA 329, norfloxacin:
http://www.gowlings.com/KnowledgeCentre/enewsletters/pharmacapsules/HtmFiles/V10N03_20110601.en.html#recent
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