This was a motion brought by Apotex pursuant to section 6(5)(b)
of the Patented Medicines (Notice of
Compliance) Regulations (Regulations) to dismiss
Janssen's prohibition application on the basis that it was
"redundant, scandalous, frivolous, or vexatious or otherwise
an abuse of process". The motion raised a unique issue which
appears not to have been decided in any prior proceeding under the
Regulations. In particular, the issue was whether a generic
manufacturer was required to respond to claims in a patent which
changed as a result of a disclaimer filed by the innovator
subsequent to service of the generic's notice of allegation
(NOA) and prior to the commencement of an application to prohibit
the issuance of a notice of compliance (NOC). Or, in the words of
the prothonotary hearing the motion, "using a football
analogy, does the field goal count if the goalposts are moved after
the ball is in the air?"
For background, Janssen filed Canadian patent application no.
2,095,523 (the '523 patent) for a "Pharmaceutical
composition comprising a tramadol material and acetaminophen"
on September 3, 1992. Well after the '523 patent issued on June
22, 2004, Apotex filed its abbreviated new drug submission (ANDS)
on February 1, 2008 and delivered a NOA in respect of the '523
Patent on March 11, 2008. The NOA addressed the claim set of the
'523 patent as it then existed, alleging invalidity of the
claims on the basis of anticipation and over-breadth. Janssen, on
April 22, 2008, filed a disclaimer in respect of the '523
patent, disclaiming all 13 of the original claims, and replacing
them with a narrower set of 13 new claims. Three days later,
Janssen commenced the application at issue in response to
Although it has been held that a motion under s. 6(5)(b) of the
Regulations is an "extraordinary remedy that should only be
granted in limited circumstances", the prothonotary sided with
Apotex and concluded that "this is one of the extraordinary
cases where the application should be struck".
Relying on the "frozen register" concept, it was noted
that a generic manufacturer, such as Apotex, when filing a
submission for a NOC, was only required to address those patents on
the register in respect of the innovative drug as of the filing
date of the submission. In the result, "the rights of the
respective parties crystallized upon the receipt by Janssen of the
Apotex NOA." This principle is grounded in fairness.
If a generic wishes to attack the validity of the claims as
reformulated by the disclaimer, it cannot revise its Notice of
[Allegation] since proceedings, as in this case, have already been
commenced. Apotex cannot raise new grounds for invalidity nor
allege non-infringement since the proceedings in this Court were
initiated immediately after the filing of the Disclaimer thus, in
effect, locking in the Notice of Allegation.
The only proper way to approach the matter is to do so in the
way that the Privy Council did in BVD namely fix a date
prior to the disclaimer for the purpose of construing the
Unfortunately for Janssen, instead of opposing any of
Apotex's allegations as contained in its NOA, Janssen
incorrectly declared in the notice of application that Apotex was
required to "address the claims of the '523 Patent as they
now stand and as they are deemed in law to have stood from the date
of issue". But, by not opposing any of Apotex's
allegations of infringement and invalidity, the application
amounted to a waste of judicial resources since it was bereft of
any chance of success. As stated by the prothonotary, "Janssen
[was] not entitled to have filed a patent that is overbroad and
after being found out, seek to retroactively bootstrap its position
by disclaiming the claims and thereby obtain an advantage that it
otherwise would not have". Accordingly, the application was
dismissed with costs throughout to Apotex.
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