Patent Decisions
Patent anticipated by hearsay documents that met the test of necessity due to failure to comply with Federal Courts Rules
Gilead Sciences, Inc. v. Canada
(Health), 2016 FC
856
The Federal Court dismissed Gilead's application for
prohibition in respect to the combination drug TUVADA® covered
in the '475 Patent. This combination drug is comprised of the
drug VIREAD®, which is a medicine patented by the '619
Patent. In the companion case concerning the validity of the
'619 Patent, the Court granted the prohibition application (see
2016 FC 857; our summary here). In the case at bar,
Apotex alleged that the '475 Patent was invalid on the basis of
anticipation, obviousness, lack of sound prediction of or
demonstrated utility; infringement was conceded by not alleging
non-infringement.
On the issue of expert blinding, the Court made the same comments
as those in the companion case; the blinding issue is a question of
relevance, reliability and weight, and is not a doctrinal
matter.
On the ground of anticipation, the parties disagreed on the
admissibility of certain documents put forward by Apotex. The Court
found that the purported Press Release and the purported Conference
Call Transcript were the most relevant documents to this
proceeding. The Press Release states there would be a conference
call and the Conference Call Transcript confirms the Conference
Call took place before the key date for anticipation. The documents
were both attached by Apotex to its NOA. Neither document was
authenticated or introduced by affidavit or oral testimony of
anyone associated with its preparation, nor was the truth of its
contents deposed to by anyone associated with its preparation. As a
result, Gilead objected to the reliance on both documents on the
ground that they both constitute hearsay. The Court agreed that the
documents were both hearsay, but held that the documents were
admissible. When refusing to produce the documents, Gilead did not
argue that the documents were not under its control, nor did it
seek relief from production under Rule 94(2) of the Federal
Courts Rules. Instead, Gilead unilaterally refused to make the
required production under Rule 94(1). The Court found that
Gilead's non-compliance with Rule 94(1) resulted in the
documents meeting the test of necessity. The documents were also
found to be reliable and were admitted.
The Press Release was not found to disclose the invention, and
therefore, not anticipate the '475 Patent. However, the
Conference Call, as reflected in the Conference Call Transcript,
was found to both disclose and enable the invention. The Court
concluded that the '475 Patent was anticipated. Even though the
patent was held to be anticipated, the Court still considered the
other allegations of invalidity. Apotex's allegations of
obviousness and obvious to try were successful, but its allegation
of invalidity based on utility was not justified.
Amendments allowing a new defence of anticipation and issue estoppel are allowed in part
Alcon Canada Inc. v. Apotex Inc., 2016 FC 1055The Federal Court has allowed Apotex to amend its statement of
defence to include a new anticipation claim and a new defence of
issue estoppel and abuse of process in part.
This is a ruling in a bifurcated infringement action scheduled to
proceed to trial on November 27, 2017. This infringement action
follows a prior PM(NOC) application between the parties.
Apotex moved to amend its statement of defence and counterclaim to
add a new ground of invalidity by anticipation, a defence of ex
turpi causa based on anti-competitive conduct, and two new
defences based on the concepts of issue estoppel, abuse of process
and the doctrine of election, arising from the prior prohibition
proceedings commenced by Alcon in relation to the same patent and
product.
The parties agreed the ex turpi causa defence relates
solely to the quantification of damages, and thus it was adjourned
to be addressed in the second half of the proceeding.
The new invalidity by anticipation defence alleges that the
invention was disclosed to the public by Alcon during an annual
conference, and in an abstract published at the conference. The
Court held that the proposed amendments were sufficiently
particularized and have a reasonable prospect of success.
The new allegations of issue estoppel, abuse of process and cause
of action estoppel are based upon findings that were made in the
prior PM(NOC) proceeding involving the same patent and parties. The
delay in raising them was not found to be prejudicial, but the new
defences would only be permitted to the extent that they raise an
arguable defence.
The new allegation that Alcon is precluded from "contesting
or making any allegation inconsistent with" Justice Kane's
findings "that the patent is invalid on the basis of
obviousness" was found to offend the Federal Court of
Appeal's express ruling that cause of action estoppel in
respect of the validity of a patent does not disclose a reasonable
defence. Thus, this new pleading was not allowed.
The new defence of issue estoppel and abuse of process was allowed
in part, with the Court striking the part stating that Alcon is
precluded from "making any allegation inconsistent with"
a prior finding of fact. That was held to preclude a party from
leading evidence different from that led in the prior proceeding
and cannot disclose an arguable defence.
The new defence of election was not allowed given the prior
jurisprudence that both an application under the PM(NOC)
Regulations and an infringement action can both be pursued.
Furthermore, the jurisprudence provides that it is permissible to
introduce in an action a better evidentiary record than on a prior
prohibition proceeding between the same parties. Therefore, what
prior art experts considered when considering obviousness was not
held to be fixed by the prior PM(NOC) proceeding.
Supreme Court Updates
Amgen Canada Inc., Amgen Inc. v.
Apotex Inc., Minister of Health (FC)
(Civil) (By Leave) (37124)
On October 27, the Supreme Court will announce the result of a
leave application which asks, in determining whether to hear moot
appeals, should appellate courts apply categorical rules for
certain classes of cases that will eliminate any right of appeal
for entire class, or are courts required to exercise discretion on
a case by case basis in accordance with the decision in
Borowski v. Canada. The following summary was provided by
the Supreme Court.
Intellectual property – Patents – Medicines –
Patented Medicines (Notice of Compliance) Regulations,
SOR/93-133 – Appeals – Mootness – Federal Court
dismissing Amgen's motion for order of prohibition and Minister
issuing notice of compliance to Apotex to market generic version of
Amgen's drug – Apotex bringing action for section 8
damages – Amgen appealing after issuance of notice of
compliance – Apotex's motion to dismiss appeal as moot
granted – In determining whether to hear moot appeals, should
appellate courts apply categorical rules for certain classes of
cases that will eliminate any right of appeal for entire class, or
are courts required to exercise discretion on a case by case basis
in accordance with decision in Borowski v. Canada (Attorney
General), [1989] 1 S.C.R. 342?
Amgen applied for an order under the Patented Medicines (Notice of Compliance)
Regulations, SOR/93-133
("Regulations") prohibiting the Minister of Health from
issuing a notice of compliance to Apotex for its generic version of
Amgen's filgrastim pharmaceutical drug. The Federal Court
dismissed this application and Amgen appealed that decision. Before
the appeal could be heard, however, the Minister issued a notice of
compliance to Apotex for its generic version of filgrastim. Apotex
moved to dismiss the appeal on the ground that the subject-matter
of the appeal was moot as there was no longer anything to
prohibit.
AstraZeneca Canada Inc.,
AstraZeneca Aktiebolag, AstraZeneca UK Limited v. Apotex Inc.,
Apotex Pharmachem Inc. (Federal Court
of Appeal) (Civil) (By leave) (36654)
On November 8, the Supreme Court is scheduled to hear
AstraZeneca's appeal in its application which asks the correct
applicable standard for patent utility in Canada and whether a
promised utility doctrine properly exists. The following summary
was provided by the Supreme Court.
Intellectual property – Patents – Medicines –
Utility – Validity of patent for drug used in treatment of
gastric acid conditions challenged in infringement and impeachment
action – Whether a promised utility doctrine properly exists
– Whether lower courts erred in law in finding that the 653
patent invalid: (i) on the basis of a "promise of the
patent" utility doctrine; and/or (ii) by applying an incorrect
standard for patent utility.
The appellants, (collectively, "AstraZeneca") owned the
Canadian '653 patent for the compound, esomeprazole, a proton
pump inhibitor used in the reduction of gastric acid, reflux
esophagitis and related conditions. It was sold under the name
Nexium, and was a very successful drug for AstraZeneca. The
respondents (collectively, "Apotex") applied to the
Minister of Health to obtain a Notice of Compliance which would
allow it to sell its generic version of the drug. In response,
AstraZeneca brought a prohibition application under the
Patented Medicines (Notice of Compliance) Regulations,
SOR/93-133 to prevent Apotex from entering the market until after
the expiry of the '653 patent. In 2010, that application was
dismissed and Apotex received its Notice of Compliance and
commenced sales of its generic esomeprazole. AstraZeneca brought an
action against Apotex for patent infringement. Apotex
counter-claimed to impeach the '653 patent on several
grounds.
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