Ottawa, Ontario, February 22, 2007
PRESENT: The Honourable Mr. Justice Phelan
BETWEEN:
WARNER-LAMBERT COMPANY, LLC
and
RANBAXY LABORATORIES LIMITED
REASONS FOR ORDER AND ORDER
[1] This is an appeal of a decision of the Learned Prothonotary granting leave to Pfizer to serve and file a further Fresh As Amended Notice of Application and extending the 24-month stay under section 7(1)(e) of the Patented Medicines (Notice of Compliance) Regulations (the Regulations).
[2] The issues in this appeal are:
(a) whether a part of a NOC proceeding which had been discontinued can be re‑instituted; and
(b) whether the Learned Prothonotary had properly exercised the jurisdiction to extend time.
[3] Ranbaxy Laboratories Limited’s (Ranbaxy) principal argument is that once a proceeding in respect of one patent has been discontinued, the 24-month stay in respect of that patent expires and the Regulations create an absolute bar to reviving the proceeding in respect of that patent. Ranbaxy submits that no matter the reason for the discontinuance, even fraud, deception or misrepresentation, the bar is absolute and the only remedies may be in an infringement action.
II. FACTS
[4] By letter dated January 31, 2005 (the NOA), Ranbaxy made allegations under the Regulations with respect to the six (6) patents then listed by Pfizer for its atorvastatin calcium tablets. Specifically Ranbaxy made allegations of non-infringement and invalidity in respect of the 018 and 455 Patents.
[5] In Pfizer’s Notice of Application dated March 17, 2005, Pfizer attacked Ranbaxy’s allegations in respect of the two patents.
[6] Even before the Application was filed, there was an exchange of information in March between the parties including the “March Spectra” data which Ranbaxy says should have alerted Pfizer to what patents and processes would be in issue.
[7] Nevertheless, on March 30, 2005, Pfizer sought reassurances that the March data was intended to comprise the full details of the relevant Ranbaxy product, formulation and manufacture.
[8] Ranbaxy gave that reassurance on April 4, 2005 that “the documents enclosed with the letter of March 11th comprise everything that we have at present that is relevant to the Ranbaxy product, formulation and manufacture”.
[9] As a result of this reassurance and the productions which had been delivered by Ranbaxy, Pfizer amended its application and discontinued its contentions in respect to the 018 and 455 Patents. It was the unchallenged evidence of an officer of Pfizer that this would not have occurred but for the actions and assurances of Ranbaxy.
[10] In another later and related proceeding, Ranbaxy’s productions showed that the assurances given to Pfizer were not correct. Ranbaxy has acknowledged that certain statements made by it to Pfizer were not accurate due to a miscommunication between the company and its then counsel.
[11] When Pfizer became aware of the true state of affairs, that the assurances received were not entirely accurate, it sought to amend its Notice of Application to bring the two patents back into this proceeding.
[12] The parties are, in addition to this proceeding, also involved in two other proceedings related to atorvastatin calcium such that the 24-month statutory stay in those proceedings will not expire until May or June 2008.
[13] The Learned Prothonotary allowed Pfizer to amend its application to include again allegations in respect of the 018 and 455 Patents, as well as extending the 24-month stay.
III. ANALYSIS
A. Standard of Review
[14] As the decision in respect of the amendment to the Application is an issue of law and would, if overturned, be final and dispositive in respect of the issues related to the two patents, the standard of review is correctness as to the Court’s jurisdiction. (See Housen v. Nikolaisen, [2002] 2 S.C.R. 235)
[15] Further, if the Court has jurisdiction, the exercise of that jurisdiction is so important and so final as regards the two patents, it should be considered de novo. The decision to extend the statutory stay is not so vital or dispositive and therefore should only be reviewed if there has been a wrong principle applied, based on a misapprehension of facts or clearly wrong.
B. Jurisdiction
[16] With the greatest respect, I do not accept Ranbaxy’s submissions that the Regulations are a complete code which imports nothing of the Rules or principles in the Rules. I also do not accept the strict constructionist approach taken that would deprive the Court of jurisdiction to remedy a deprivation of rights caused by the actions of the other party particularly by a misrepresentation which caused the loss of those rights.
[17] The Regulations are not a complete code. There are numerous aspects of NOC proceedings which are governed either by the Federal Courts Act or its Rules. The Regulations enjoy supremacy only in respect of matters which conflict with the more general provisions found in the Act or the Rules.
[18] The fundamental requirement under the Regulations is that an application to the Court must be commenced within 45 days of the notice of allegation. The Court has no jurisdiction to extend the 45 days because the general rule on extensions would be in direct conflict with Regulation s. 6(1). (Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1997), 72 C.P.R. (3d) 453)
[19] However, once the matter is commenced within the statutory time limits, the Federal Courts Rules apply except where there is a conflict. The Act and Rules apply to a number of matters not specifically addressed in the Regulations including the right to appeal. (Bayer AG et al v. Canada (Minister of Health and Welfare) (1993), 51 C.P.R. (3d) 329 (F.C.A.) at 336)
[20] The applicable rule in this instance is Rule 77:
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77. The Court may allow an amendment under rule 76 notwithstanding the expiration of a relevant period of limitation that had not expired at the date of commencement of the proceeding. |
77. La Cour peut autoriser une modification en vertu de la règle 76 même si le délai de prescription est expiré, pourvu qu’il ne l’ait pas été à la date du début de l’instance. |
The relevant section of the Regulations is s. 7(4) which reads:
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7.(4) Paragraph (1)(e) ceases to apply in respect of an application under subsection 6(1) if the application is withdrawn or discontinued by the first person or is dismissed by the court hearing the application. |
7.(4) L’alinéa (1)e) cesse de s’appliquer à l’égard de la demande visée au paragraphe 6(1) si celle-ci est retirée ou fait l’objet d’un désistement par la première personne ou est rejetée par le tribunal qui en est saisi. |
[21] There is nothing in the Regulations which suggests that they should be so strictly construed as argued by Ranbaxy. The interpretation of the Regulations is still subject to s. 12 of the Interpretation Act.
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12. Every enactment is deemed remedial, and shall be given such fair, large and liberal construction and interpretation as best ensures the attainment of its objects. |
12. Tout texte est censé apporter une solution de droit et s’interprète de la manière la plus équitable et la plus large qui soit compatible avec la réalisation de son objet. |
[22] I can see no reason in principle why Rule 77 could not be invoked in the appropriate circumstances particularly, as in this case, to allow Pfizer to be put back in the same position it was in initially except for the inaccurate assurances of Ranbaxy. I see nothing in s. 7(4) which requires a Court to ignore unfairness and injustice nor would to do so be consistent with the rules of statutory interpretation.
[23] The Regulations do not prohibit directly or indirectly an amendment to an application. It only goes so far as to prohibit the operation of a stay where the application is withdrawn, discontinued or dismissed by the Court.
[24] Section 7(4) cannot be interpreted to mean that discontinuances or withdrawals secured by misrepresentation or even fraud should still have legal effect and deprive an innocent party of its rights.
[25] Even applying Ranbaxy’s strict construction approach to the Regulations, the application at issue was not discontinued, withdrawn or dismissed. I interpret the Regulation to cover only an application as a whole and does not cover partial amendments and re‑amendments.
[26] Further, as held in Abbott Laboratories v. Canada (Minister of Health) (2004), 36 C.P.R. (4th) 505, a proceeding can be reinstated. There a motion to strike was granted and the 24-month stay fell away as per Regulation s. 7(4). However, the decision was reversed by the Court of Appeal and the proceeding was re-instituted. This is because, at the very least, in law the proceeding had never truly disappeared because it had not been properly dismissed by a Court.
[27] Likewise, in the case at bar, but for Ranbaxy’s misrepresentation, the proceedings in respect of the two patents never were intended to be terminated if the true facts were known.
[28] Therefore, the Learned Prothonotary was correct in concluding that the Court had jurisdiction to permit Pfizer to amend its application to re-institute proceedings in respect of Patents 018 and 455.
C. Amendment
[29] Whether one considers the decision to allow the amendment as a discretionary one, having accepted Court jurisdiction, or one that should be reviewed de novo, the decision should stand.
[30] The cause of the amendment was Ranbaxy’s misrepresentation. It ought not to be allowed to benefit from its actions. To the extent that Pfizer bears any part of the responsibility for its amendment (of which I find none), there is no substantial prejudice caused by allowing it to re‑amend its application.
D. Extension of Time for Stay
[31] Section 7(5) of the Regulations grant the Court a discretion to extend the 24-month stay when a party has failed to reasonably cooperate in expediting the application. This is a decision by the Learned Prothonotary that is within its discretion and subject to review on error in law or principle or misapprehension of the facts.
[32] There is no checklist of conduct which would constitute failure to cooperate or to expedite. Dictionary definitions are of only limited use. The Court of Appeal in Merck Frosst Canada Inc. v. Apotex Inc. (1997), 72 C.P.R. (3d) 170 at 178 has only given examples of such instances. Those examples share some common characteristics in that they are unilateral, unjustified and have an adverse effect on the other party and the conduct of the litigation – as in this case.
[33] In this instance, there was no malice or fraudulent misleading. Confusion between counsel and clients is not uncommon, particularly where several different counsel are acting for a client on related matters. It is not necessary to find malice or fraud. Here the representation was wrong – in the context of the Regulations it cannot be said that one is cooperating when one is making inaccurate statements to induce another party to act against their interest. The effect has been to delay the proceedings by causing an unnecessary amendment and resisting a re-amendment to restore the status quo.
[34] Therefore, I can find no reason to question the Learned Prothonotary’s exercise of discretion and to substitute my view, even if I had a different one, which I do not.
IV. CONCLUSION
[35] For these reasons, this appeal is dismissed with costs.
ORDER
IT IS ORDERED THAT this appeal is dismissed with costs.
FEDERAL COURT
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-507-05
STYLE OF CAUSE: PFIZER CANADA INC. and
WARNER-LAMBERT COMPANY, LLC
and
THE MINISTER OF HEALTH and
RANBAXY LABORATORIES LIMITED
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: January 29, 2007
APPEARANCES:
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Mr. John B. Laskin Mr. W. Grant Worden
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Mr. Ronald E. Dimock Ms. Angela M. Furlanetto
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FOR THE RESPONDENT, RANBAXY LABORATORIES LTD.
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SOLICITORS OF RECORD:
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TORYS LLP Barristers & Solicitors Toronto, Ontario
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DIMOCK STRATTON LLP Barristers & Solicitors Toronto, Ontario |
RANBAXYLABORATORIES LTD. |