Reversal Orders – More Trouble Than They are Worth

Reversal Orders – More Trouble Than They are Worth

Pfizer Canada Inc.
v Apotex Inc.
, [2013
FC 1036
]

 

Background

This is a decision of Prothonotary Aalto dealing with the
consequence of a reversal
order
. The Prothonotary notes that the practice direction was intended to
streamline the NOC process however, in many circumstances, it has failed to
achieve this.

 

In this case there was a partial reversal of evidence. Pfizer
delivered its fact evidence first followed by Apotex’s evidence on validity
followed by Pfizer’s evidence on validity. Pfizer’s experts relied on clinical
studies, monographs and other documents which Apotex argues should have been
disclosed as part of the ‘fact’ evidence.

 

Apotex brought a motion to strike substantial portions of
the evidence of Pfizer’s experts as a result. Pfizer has, in response, served
Apotex a ‘with prejudice’ offer to resolve the motion on the basis of the Court
granting a right of reply to Apotex subject to some restrictions.[15]

 

Argument was also made that because the scheduling was a
Direction of the Court rather than a formal order it has lees impact. The
Prothonotary indicates that Directions of the Court carry the weight of
judicial decisions and are not mere suggestions.

 

Analysis

Pfizer and Apotex argued over what was and was not a
‘fact’ for the purposes of the Direction. Pfizer argued that it is an expert
relying on a study to support an opinion so it is not Pfizer relying on the
fact but the expert.[22] Apotex in turn cited twenty-two separate incidents
where the Pfizer witness had failed to abide by the Direction to Attend and
properly inform himself. The entire trouble is a result of competing views on
the extent of factual evidence.

 

Pfizer argued that their understanding of ‘fact evidence’
referred to evidence of the fact witnesses Pfizer would lead. It is clear that
counsel cannot be expected to know all publicly available literature that an
expert might rely upon. At the same time Pfizer had significant knowledge
concerning what literature would be relied upon – preparation of affidavits in
a parallel proceeding was well underway when the first set of fact evidence of
Pfizer was served in this case.[31]

 

Pfizer also argued that the evidence is relevant and
admissible. Relying on Graat v R. Pfizer argued that the distinction between fact and opinion
evidence is not clear.

 

Finally the striking of affidavits is an exceptional
remedy and may only be done where the affidavits are scandalous, abusive or
clearly irrelevant.[34] The prejudice to Pfizer should the evidence be struck
must also be considered.

 

Disposition

Apotex argued that the only remedy available is to have
the evidence struck while Pfizer argues that their with prejudice offer to file
reply evidence is sufficient. The two proposed remedies represent the two
possible extremes in terms of resolution. A remedy in this case must reach some
middle ground.

 

The Prothonotary identifies several passages in Pfizers
expert reports that are critical of Apotex’s experts and the facts on which
they relied. These paragraphs are struck. Apotex is also entitled to file reply
evidence.

 

With respect to costs Pfizer’s initial demand for a full
reversal of the evidence is ultimately what has caused this mischief. Apotex is
entitled to compensation for the extra cost of preparing reply evidence.

 

Commentary

This case, as indicated by the Prothonotary, is a prime
example of why courts should be reluctant to utilize reversal orders in PM(NOC)
proceedings. Reversal orders can be helpful at streamlining the litigation
process where there is a strong likelihood that the generic may be unable to
satisfy the requirement of putting invalidity issues ‘in play’. At the same
time it is difficult to assess whether this will be the case absent a complete
evidentiary record. This case serves as a reminder that reversals of
evidentiary order are, more often than not, more mischief than they are worth.