Recent Decisions June 2007
I. FEDERAL COURT DECISIONS
(a) Patents
1. Wyeth et al. v. Ratiopharm and The Minister of Health, March 19, 2007 FCTD (Hughes J.) Motion to Dismiss/Judicial Review/ Patent Listing/ Patented Medicines (Notice of Compliance) Regulations
Motion by Ratiopharm to dismiss an application for judicial review brought by Wyeth. The motion sought to challenge the listing of the '778 patent ("Patent") in respect of certain NOCs issued to Wyeth. Wyeth had obtained a number of NOCs for its medicine containing venlafaxine hydrochloride sold as EFFEXOR and EFFEXOR XR. Wyeth subsequently obtained additional NOCs on the basis of supplementary NDSs. The Patent, which is directed towards an extended release formulation, was listed against six different NOCs. Ratiopharm argued that the Patent was improperly listed as the various NOCs against which the Patent was listed had nothing to do with the patented invention. Wyeth argued that two of the NOCs, including one relating to nausea reduction and another relating to maintenance of major depression are sufficient to sustain the listing of the Patent. Wyeth conceded that one of the NOCs concerning a manufacturer name change was administrative in nature and failed to raise issues as to the remaining three NOCs.
Held: Motion dismissed in part. A Court must find that there exists a sufficient relationship between the "patented invention" and the NOCs such that the listing of the patent against those NOCs should not be set aside. Two of the six NOCs should not be set aside as there exists a sufficient relationship between the "patented invention" of the Patent and the NOCs related to the "maintenance treatment of major depressive disorder" and to "revision to product monograph regarding nausea treatment", respectively. The balance of the NOCs should be removed given the concessions of Wyeth's counsel and the lack of evidence presented. In Hoffman-LaRoche v. Canada (2006 FCA 335), the Court held that bona fide substantive changes to a product monograph can sustain a patent listing against the related NOC. While the law is in a state of flux in this area, the law as it currently stands (Bristol-Myers Squibb v. Canada, [2005] 1 S.C.R. 533 and AstraZeneca v. Canada, 2006 SCC 49) directs the Minister to determine if there is a "relationship" or "relevance" between the "patented invention" of the Patent and the subject matter of the NOCs in question. The Minister has, in law, created such relationship by listing a patent against an NOC. Where there is a reasonable dispute as to the facts and opinions necessary to establish such relationship, deference must be given to the Minister.
2. Ferring v. The Minister of Health and Apotex and Novopharm; Sanofi-Aventis Canada v. The Minister of Health and AG Canada and Novopharm; Sanofi-Aventis Canada v. The Minister of Health and AG Canada and Apotex; Novopharm v. The Minister of Health and AG Canada and Sanofi-Aventis Canada, March 20, 2007 FCTD (Hughes J.) Judicial Review/Second Person/Section 5(1)/Functus Officio/Patented Medicines (Notice of Compliance) Regulations
Five separate applications by Ferring, Sanofi and Novopharm for judicial review of actions taken by the Minister following the AstraZeneca Canada Inc. v. Canada (Minister of Health) [2006] 2 S.C.R. 560 decision ("AstraZeneca"), which held that the Minister needed to look only at patents listed against the NOC extant as of the filing of the ANDS by the generics (or purchase date of comparator drugs). The Minister issued NOCs to Apotex and Novopharm notwithstanding patents listed by innovators Ferring and Sanofi. In one instance, the Minister did not issue an NOC and required Novopharm to address two patents. Ferring and Sanofi argued that the Minister was functus, and could not re-address the issue as to whether the generics were "second persons" once previous decisions regarding the status had been made. Ferring argued that the Minister should have required the generics to address its patents and that it was unfair and contrary to the principles of natural justice for the Minister to make decisions to grant an NOC without warning and without providing Ferring an opportunity to be heard. Novopharm argued that Ferring did not qualify for status to seek review of the Minister's decision that Novopharm was not a "second party", whereby it received the NOC it sought without engaging the Regulations. Sanofi argued that the Minister should have required the generics to address its '387 and '549 patents (the "HOPE" patents). The Minister maintained that Novopharm had to address Sanofi's non-HOPE patents. Sanofi also argued that the Minister erred in issuing an NOC to Apotex in light of material in Apotex's product monograph that encouraged use of its product for the HOPE indications.
Held: Applications dismissed. The Minister's decision in each case was correct. The Minister was not functus officio. The Minister was acting in a purely administrative capacity in evaluating applications for NOCs and was entitled to revisit circumstances where appropriate in deciding whether to issue NOCs. The Minister has a duty to issue an NOC without delay if persuaded that the generic is not a "second person", despite commencement of proceedings under s. 6(1) of the Regulations. When Apotex and Novopharm filed their ANDSs, no relevant patent remained in respect to any relevant NOCs to Ferring, and thus the Minister's decisions to issue NOCs were correct. The Minister was not required to inform Ferring as to a generic's pending NOC submission, nor was Ferring entitled to be heard. Ferring lacked status to seek judicial review of the Minister's decision that Novopharm was not a "second person"; the opportunity to commence NOC proceedings is merely a commercial interest and not sufficient to support status. When Apotex filed its ANDS, none of the HOPE or non-HOPE patents were on any patent list respecting any NOC issued to Sanofi. The two non-HOPE patents added retroactively were no longer at issue since the Sanofi proceedings in respect of them were dismissed. Novopharm was required to address the non-HOPE patents in an NOA since a generic must address patents "linked to" the NOC that is relevant to the comparator drug. The Minister's decision regarding the Apotex product monograph was reasonable given his expertise and responsibilities, the record before him, and the evidence of the parties.
3. Leo Pharma v. AG of Canada, March 21, 2007 FCTD (Blais J.) Judicial Review/ Patented Medicine Prices Review Board/ Sections 83 & 85 Patent Act
Application for judicial review in respect of a decision of the PMPRB ("Board"), where the Board held that the medicine Dovobet was being sold at an excessive price. The application raised 4 issues: 1) Did the Board err in its determination of the proper therapeutic class under s. 85(1) of the Act?; 2) Did the Board err in its application of the test of international pricing comparison under s. 85(1)(c) of the Act?; 3) Did the Board err by refusing to consider the impact of the applicant's distribution of free Dovobet on the calculation of the average transaction price?; and 4) Does the Board lack sufficient institutional independence and impartiality to provide a fair hearing in accordance with the principles of fundamental justice? The proper standard of review for the first three issues was reasonableness while the last issue was correctness.
Held: Application allowed in part. The Board's decision with respect to the determination of the maximum non-excessive price was reasonable; however, the Board erred in determining the average price of Dovobet as a result of its failure to consider the impact of the free goods distributed by the applicant. With respect to the first issue, the Board did not err in its determination of the proper therapeutic class. The Board's decision to compare the price of Dovobet to the combined prices of the two active ingredients that are sold as separate medicines was reasonable. This is the usual Board policy unless the applicant can demonstrate that the combination medicine is a 'material improvement' over its active components used in combination. In both the test for expanding the therapeutic class and the "substantial improvement" test required for a Category 2 drug product classification, the Board requires evidence of statistically significant clinical trials, distinguishing between the two tests with respect to the degree of improvement. While expressing concern over this line drawn by the Board, the Court found this concern insufficient to conclude that the Board's decision was unreasonable. On the second issue, the approach taken by the Board, including its decision to follow the Guidelines closely, was reasonable. While the Board noted that the Guidelines would consider the price of a medicine sold in Canada to be excessive if it is higher than in any of the comparator countries, the Board also stated that this was merely a presumption that could be challenged by the patentee. Since the Board did not consider itself bound by the Guidelines and simply found them appropriate in this case, the Board did not err in applying them. The Board also did not err in first comparing the price of Dovobet in the comparator countries and then comparing the price of drug products in the same therapeutic class, and giving more weight to the first comparison. Common sense dictates that the exact same product should be used for comparison when available, and therapeutic class comparison should be secondary. On the third issue, the Board erred in refusing to consider the impact of free Dovobet on the grounds that it was not a genuine compassionate use program. The Board's decision was unreasonable. There is no 'compassionate' requirement in the Regulations. The Regulations do not draw a distinction as to the intent of the patentee in distributing free products; it is reasonable to assume that Parliament drafted the Regulations to provide incentives for patentees to distribute free medicine in order to increase access to patented medicines. On the fourth issue, the Board did not lack institutional independence and impartiality. The overlap of the Board's functions as investigator, prosecutor, and adjudicator does not create a reasonable apprehension of bias.
4. Pharmascience v. The Minister of Health and Abbott et al., April 5, 2007 FCA (Sexton, Letourneau, Evans JJ.A.) Appeal/ Issue Estoppel/ Multiple NOAs/ Patented Medicines (Notice of Compliance) Regulations
Appeal from a decision precluding Pharmascience from relying on allegations of invalidity in its second NOA on the basis of issue estoppel in respect of the '732 patent ("Patent") owned by Abbott. Pharmascience sought to market a generic version of Abbott's BIAXIN (clarithromycin). Pharmascience's first NOA respecting the Patent was held to be insufficient in respect of non-infringement allegations and the allegations of invalidity were found to be unjustified. Pharmascience's second NOA, which was directed to the Patent along with five other patents, alleged that the patents were invalid on a number of grounds, including anticipation and obviousness. In this appeal, Pharmascience argued that the Court below should not have had recourse to the doctrine of issue estoppel because Abbott failed to plead issue estoppel and because O'Keefe J. incorrectly identified and applied the test for issue estoppel. Pharmascience also argued that the issues in the present proceeding differ from those in the previous proceeding, and further argued that the question of invalidity of the Patent was not fundamental in the decision of the first Applications Judge. Pharmascience also argued that the Applications Judge in the present action should have exercised his overriding discretion not to apply estoppel based on the facts of the case.
Held: Appeal dismissed. Generics should in most circumstances be precluded by the doctrine of issue estoppel from alleging for a second time that a patent is invalid, unless the basis relied upon for the subsequent allegation cannot be determined with reasonable diligence at the first instance, or some special overriding circumstance exists to warrant a Judge to exercise his/her discretion not to apply issue estoppel on the facts of the particular case. Here no such extraordinary circumstances exist; thus O'Keefe J. correctly applied issue estoppel. Abbott took the reasonable step of raising issue estoppel in its Memorandum of Fact and Law. Having failed to contest Abbott's reliance on estoppel at the earliest opportunity, Pharmascience has no grounds to object to it now. The first Application Judge's assessment of the invalidity allegation was a fundamental component of the decision. Pharmascience raised the issue of the invalidity of the Patent in earlier proceedings. The specific grounds on which the second person wishes to demonstrate invalidity do not constitute separate issues to the purpose of issue estoppel but are merely different bases on which the second person may address invalidity. Multiple NOAs from the same generic relating to a particular pharmaceutical and alleging invalidity of a particular patent will generally not be permitted, even if different grounds for establishing invalidity are put forward in each, subject to the exception described above. Pharmascience has failed to provide sufficient support for its contention that O'Keefe J.'s decision not to exercise his discretion to refuse to apply issue estoppel was not open to him.
5. Abbott et al. v. The Minister of Health and Apotex, April 19, 2007 FCA (Sharlow, Malone, Ryer JJ.A.) Appeal/ Prohibition Order/ Hoffmann Principle/ Patented Medicines (Notice of Compliance) Regulations
Appeal by Abbott of a decision dismissing an application for an order prohibiting the Minister from issuing an NOC to Apotex for its formulation of clarithromycin Form II, the active ingredient in BIAXIN, until after the expiry of Abbott's '732 patent ("Patent"). The Patent covers both processes and the clarithromycin Form II compound made by the processes. Apotex alleged that claims for clarithromycin Form II compound were invalid, to which Abbott responded by filing an application for an order of prohibition which failed, resulting in this appeal. Apotex argued that the appeal was moot because of Abbott Laboratories v. Canada (Minister of Health), 2006 FC 1558 where the Judge dismissed an application for an order prohibiting the issue of an NOC to Apotex for Apo-Clarithromycin tablets until after the expiry of a number of patents including the Patent (Abbott has challenged this on appeal, however it did not challenge the correctness of the decision with respect to the Patent). Abbott nevertheless argued that this appeal should be heard despite being moot, because of the part of the decision under appeal that was based on Hoffmann-La Roche v. Commissioner of Patents, [1955] S.C.R. 414 ("Hoffmann"). In Hoffmann, a claim was granted for a new process of making the known substance aldehyde, but a claim for aldehyde made by that process was not granted. Abbott argued that the principle in Hoffmann was incorrectly applied in the case. Abbott argued that clarithromycin Form II, unlike aldehyde, was not "known" at the relevant date and therefore the Hoffmann principle should not have applied since the facts were not analogous. The Court allowed the appeal on this one point only based on the grounds that this principle is being relied upon in a number of other matters soon to be heard in the Federal Court.
Held: Appeal dismissed. The Judge did not err in finding that clarithromycin Form II was known at the relevant time. Earlier jurisprudence was not clear on how to discern whether a substance is "known" for the purpose of applying the Hoffmann principle. In this case, it was assumed that a substance is "known" if a hypothetical claim for its invention would fail on the ground of anticipation or lack of novelty, while leaving open the possibility that a substance might be "known" if a hypothetical claim for its invention would fail for other reasons. In light of the existence of prior art describing a process of producing clarithromycin Form II, and the patent disclosure representing that the method described in Example 10 results in clarithromycin Form II, the Judge did not make a palpable and overriding error. The decision was also supported by evidence relating to the creation of clarithromycin Form II by a heating technique known before 1996.
6. Lundbeck et al. v. The Minister of Health and Genpharm, April 19, 2007 FCTD (Martineau J.) Application for Protective Order/ Patented Medicines (Notice of Compliance) Regulations
Motion by Lundbeck for a protective order in respect of proceedings concerning the filing of an ANDS by Genpharm for the issuance of an NOC for its formulation of escitalopram (oxalate), the active ingredient of CIPRALEX claimed in the '452 Patent ("Patent"), which Genpharm alleges is invalid. Similar proceedings in Australia and the UK to declare the corresponding patents invalid have been protected by confidentiality agreements. While both parties agreed that the information disclosed in these proceedings should remain confidential, the issue of contention was as to whom the confidential information ought to be divulged for the purposes of the present proceeding. Lundbeck's draft order stated that confidential information already disclosed in the UK and Australian proceedings be divulged only to a number of "designated persons". The draft order also created a category of "restricted confidential information" that includes all information that has not been disclosed in parallel proceedings in other jurisdictions, which Lundbeck proposed only be divulged to the "designated persons", but would exclude Genpharm, Generics (the party that instituted the UK proceedings) and Generics’ UK counsel (Taylor). Genpharm submits that Genpharm, Generics and Taylor should be allowed to instruct Genpharm’s counsel (Osler) in this proceeding and so should have access to this information.
Held: Motion allowed. A protective order in the form set out in the Lundbeck draft order shall issue (annexed as Schedule A). Where the parties themselves are competitors, preventing disclosure to the opposing party is a perfectly legitimate purpose for a protective order particularly when there is evidence that the disclosure to the opposing party could injure the other party's proprietary, commercial and scientific interests. Lundbeck has met the initial burden of proving that a protective order containing "counsel's eyes only" provisions in the case of undisclosed "restricted confidential information" should issue. The bald assertion that Osler will need to show the "restricted confidential information" to Genpharm, Generics or Taylor in order to receive instructions is not persuasive. Disclosure of confidential information would create potential harm if divulged to persons other than the "designated persons" since such confidential information is valuable enough to provide a competitive advantage to competitors, for which there could be no adequate remedy. The parties themselves may challenge the true confidentiality of specific documents, and the Court will also be prepared to hear challenges by third parties (i.e. Generics), whether or not the terms of the order so provide. Since Generics is not a party to this proceeding and Taylor is not counsel on record for Genpharm, it is difficult to determine to what extent the Court can ensure that the protective order is enforced outside Canada, which forces this Court to be very prudent. Nothing prevents Genpharm or any interested party from seeking in the future a more permissible condition of disclosure on the basis of specific allegations supported by proper evidentiary material and reasonably enforceable conditions outside Canada.
7. Actelion Pharmaceuticals v. Commissioner of Patents, April 23, 2007 FCTD (Legace D.J.) Reinstatement / Section 73(3) Patent Act / Judicial Review
Actelion sought judicial review of a purported decision of the Commissioner of Patents dated August 1, 2006 where the Commissioner refused to accept payment of the patent application maintenance fee and the reinstatement fee during the one year reinstatement period. Actelion requested a Writ of Certiorari to quash the Commissioner's decision and a Writ of Mandamus requiring CIPO to reinstate the application. Actelion had an application that originated from a PCT international application that had an international file date of July 31, 2002. The second anniversary of filing was July 31, 2004, which was the first date by which payment of the maintenance fee was to be paid. However, the maintenance fee was not paid and the application was abandoned. Actelion stated that this error was the result of a clerical input error where a clerk at the Canadian agent entered the filing date as July 21, 2003 instead of 2002. CIPO sent a Notice of Abandonment to Actelion on September 27, 2004, but Actelion maintains that this notice was never received. Actelion wrote a letter on July 15, 2005 instructing CIPO that they were paying the maintenance fee. In response, CIPO sent a letter refusing to accept the maintenance fee, because the 12 month period for reinstatement had lapsed. Actelion argued that even though it did not know that the application had been abandoned, their letter of July 15th contained a general authorization statement and inherently contained a request for reinstatement. The Commissioner characterized the issue as "whether the evidence establishes that Actelion in fact took the actions that the law requires to avoid abandonment of the application or to reinstate the abandoned application".
Held: The Court dismissed the application for judicial review and stated that the question is whether the Commissioner was correct to refuse the payment of the 2nd anniversary maintenance fee since Actelion had not made a specific request for reinstatement as required by s. 73(3) of the Patent Act. Legace D.J. held that the argument made by Actelion is unacceptable for the following reasons: 1) the letter of July 15, 2005 did not specifically indicate a desire for reinstatement, 2) there is no authority under the Patent Act or Patent Rules to allow the Commissioner to accept a general authorization statement in place of a specific letter indicating a request for reinstatement, 3) Actelion failed to take steps "that should have been taken in order to avoid the abandonment", and 4) Actelion did not know at the time of the July 15 letter that the application in issue was deemed to have abandoned.
8. Sanofi-Aventis Canada v. Novopharm and The Minister of Health, April 23, 2007 FCA (Sexton, Sharlow, Nadon JJ.A.) Appeal/ Motion to Dismiss/ Abuse of Process/ Relitigation/ Section 6(5)(b)/ Patented Medicines (Notice of Compliance) Regulations
Appeal from a decision allowing Novopharm's motion to dismiss Sanofi's application regarding the '206 patent ("Patent") for the drug ramipril. Sanofi had applied for an order of prohibition and argued that Novopharm's allegations that the Patent was invalid on the basis of lack of sound prediction were not justified. Sanofi's application was found to be an abuse of process under s. 6(5)(b) of the Regulations by virtue of an earlier application against Apotex in which Sanofi was unsuccessful. Sanofi argued that the Applications Judge erred in allowing Novopharm's motion, given that Novopharm failed to allege abuse of process in its NOA. Sanofi also argued that the issue of whether an invention has been soundly predicted is a question of fact and one Court's finding of fact is not binding on another Judge considering a similar issue. Further, new evidence had been adduced in the application that mandated a different conclusion from that reached previously. Sanofi also argued that relitigation alone is not an abuse of process and for conduct to be abusive there must be some other additional element of misconduct. Finally, Sanofi asserted that relitigation is possible within the scheme of the Regulations. Novopharm argued that the Application Judge's order was consistent with the purposes of the Regulations, which are to promote fairness, effectiveness and reduce unnecessary litigation.
Held: Appeal dismissed. A decision to dismiss a proceeding as an abuse of process is discretionary and will not be reversed on appeal unless there is an error of law or principle, or a failure to exercise the discretion judicially. Permitting the same innovator to relitigate the same issues repeatedly poses a severe threat to the integrity of the adjudicative process, the principle of finality and the efficiency of the judicial system. The innovator is prevented from relitigating an issue already decided in a proceeding to which it was a party with the aid of additional evidence it chose not to adduce in the earlier proceedings. Novopharm is not required to allege abuse of process. The types of allegations that must be described in the NOA are those relating to the patent in issue, not to potential procedural bars that the patent holder may raise in argument. The Novopharm NOA was in all material respects the same as the Apotex NOA despite the fact that the allegations in the Novopharm NOA were longer, more detailed and more specific than those in the Apotex NOA; thus all of the same issues would be relitigated should Sanofi's application be allowed to proceed and would give rise to the possibility of inconsistent judicial decisions. There is no reason to think that a second proceeding would lead to a more accurate result than the first. Sanofi was required to put their best foot forward in the earlier proceedings. In dissent, Nadon J.A. held that: 1) relitigation of an issue with a different party is not, per se, an abuse of process without "some additional element", which is not present in this case; 2) the Regulations do not expressly or implicitly prevent a patentee from relitigating an issue previously litigated against another generic drug manufacturer; and 3) the issue herein is primarily of fact and thus it would be open to the trier of fact to come to a different conclusion.
9. Pfizer v. The Minister of Health and Ratiopharm, April 26, 2007 FCTD (Barnes J.) Motion to Strike/ Application for Prohibition/ Judicial Comity/ Abuse of Process/ Section 6(5)(b)/ Patented Medicines (Notice of Compliance) Regulations
Motion by Ratiopharm to strike an application by Pfizer for an order prohibiting the Minister from issuing an NOC to Ratiopharm for amlodipine besylate, on the basis that it is plainly without merit and constitutes an abuse of process. Pfizer argued that the issuance of an NOC to Ratiopharm would infringe its '493 patent ("Patent") which is listed against Norvasc. The Patent is for the R(+) enantiomer of amlodipine. Norvasc is a racemate, consisting of equal amounts of the R(+) and S(-) enantiomers. Ratiopharm claimed that a generic version of Norvasc cannot infringe the Patent because the Patent is limited to the single R(+) enantiomer and does not include the R(+) enantiomer as constituted in the racemate form. The construction issue framed by the parties was identical to the issue that was before the Court in two recent decisions (Pfizer v. The Minister of Health and Pharmascience (2007 FC 188) ("Pharmascience") and Pfizer v. The Minister of Health and Cobalt Pharmaceuticals (2007 FC 197) ("Cobalt")), where Hughes J. held that the Patent did not include the use of the R(+) enantiomer in the racemic formulation. Ratiopharm argued that the principle of judicial comity applies to Pfizer's application and the Court must therefore follow the recent decisions. Pfizer contended that because the evidentiary record before the Court here is different, the principle of comity does not apply. Pfizer also argued that Hughes J.'s decisions are wrong because they conflict with the Minister's policy of allowing a patent holder to list a patent on the Register for a single drug against a combination medicine, including the listing of an enantiomer against a racemate which contains it. Ratiopharm also argued that Pfizer has abused the regulatory scheme and its application is devoid of merit because it has blocked Ratiopharm's right to an earlier NOC for its generic version of Norvasc.
Held: Motion allowed. The principle of comity applies and decisions reached by Hughes J. are adopted. The Patent should not be listed against Norvasc. Pfizer's proceedings as they relate to the Patent are struck out. There is no dispute that this case raises an identical issue of patent construction to the issues before the Court in Pharmascience and Cobalt. The principle of comity applies because Hughes J.'s decisions in the previous cases turned solely on his construction of the Patent without any reliance or reference to extrinsic evidence. This Court must also construe the Patent without resorting to extrinsic evidence, absent a finding that Hughes J. was "manifestly wrong". Hughes J. did not err in law by construing the Patent without resorting to the evidence of expert witnesses. Even if the principle of comity does not strictly apply, the need for consistency and predictability remains. There is no basis for Ratiopharm's abuse of process argument; a litigant cannot be faulted for taking full advantage of strategic advantages that are conferred by statute.
10. Abbott et al. v. AG of Canada and The Minister of Health, April 26, 2007 FCTD (Mactavish J.) Judicial Review/ Patent Register/ By-Product/ Section 4(2)(b)/ Patented Medicines (Notice of Compliance) Regulations
Application for judicial review of the Minister's decision refusing to add the '736 patent ("Patent") to the Register with respect to SNDSs relating to clarithromycin (BIAXIN). The Patent claims compounds produced during the synthesis of clarithromycin, one of which is an oxime of erythromycin ("the Oxime"). Abbott asserted that the Oxime is a "medicine", and that it is an active pharmaceutical ingredient made in the process of synthesizing clarithromycin, which is contained in BIAXIN. Abbott argued that since NOCs have issued for BIAXIN, and given that the Patent contains a claim to that medicine, it follows that the Patent should be listed on the Register. The Minister decided that the Patent did not contain a claim for the medicine clarithromycin or its use as required by the Regulations. Abbott asserted that "a claim for a medicine itself" includes a single active ingredient or a combination of substances, and could include a product not identified in or approved by the NOC. Abbott also argued that the approval process for new drugs covers the drug as a whole in the final dosage form as it is used or sold, which drug may contain more than one substance capable of treating a disease. Abbott argued that the Minister would have considered and assessed the safety and efficacy of the Oxime as an active medicinal ingredient in issuing the NOC for BIAXIN. Abbott submitted expert evidence stating that the Oxime has some therapeutic value, and is thus a "medicine", and that some is inevitably present in the final product since it would not be completely removed in the purification process. Abbott also argued that Oxime is an intermediate with therapeutic value. The Minister ultimately found that the Oxime derivative was not "the medicine", and that only clarithromycin had been approved for use through the issuance of the NOC for BIAXIN.
Held: Application dismissed. The Patent was not eligible for listing. The Minister's interpretation of s. 4(2)(b) of the Regulations was correct. The only active medicinal ingredient covered by the NOCs in relation to BIAXIN is clarithromycin. In the absence of a copy of the NDS relating to BIAXIN, the Court inferred that the Oxime was not identified as a medicinal ingredient in BIAXIN. The Oxime was not previously approved as a medicine through the NOCs issued in respect of BIAXIN, nor was it considered as such by Health Canada. None of the materials before the Court, apart from the expert evidence submitted by Abbott, identified the Oxime as a medicine. Abbott's product monograph for BIAXIN discloses that the only medicinal ingredient is clarithromycin. The expert evidence submitted by Abbott indicated that the Oxime is a by-product for one of the manufacturing processes of clarithromycin, which does not appear to be desirable given that the manufacturer would try to remove it from the formulation. Abbott is not entitled to have the Patent added to the Register as an intermediate, since the case law relied upon by Abbott only stated that intermediates were not specifically precluded from meeting the requirements of s. 4(2)(b) of the Regulations and further because the Oxime is a by-product and not a true intermediate.
11. Bayer et al. v. Sandoz, April 26, 2007 FCTD (Mactavish J.) Motion for Interim or Interlocutory Injunction/ Irreparable Harm/ Patented Medicines (Notice of Compliance) Regulations
Motion for an interim or interlocutory injunction restraining Sandoz from using Sandoz's or any other intravenous (IV) formulation of ciprofloxacin, on the basis that such activities would infringe Bayer's '006 patent ("Patent"), which covers infusion solutions of ciprofloxacin. Sandoz had received a NOC for its ciprofloxacin product and was in position to enter the marketplace with its ciprofloxacin IV formulation. Bayer claimed that unless Sandoz was enjoined from entering the market, Bayer would suffer irreparable harm through: 1) deprivation of an unrecoverable market share and non-compensable revenue for the period between the expiry of the Patent and the trial of this matter; 2) risks to its marketing plan to transition from Cipro IV to Avelox IV; and 3) irreparable loss of the time-limited monopoly right granted to Bayer in exchange for having disclosed its invention. Bayer asserted that it would suffer irreparable harm because the advantage gained by Sandoz as a result of its premature entry into the market would continue to result in losses to Bayer in the months immediately following the expiry of the Patent.
Held: Motion dismissed. Damages are both quantifiable and recoverable, and do not amount to irreparable harm. An Applicant seeking a quia timet injunction may establish that it will suffer irreparable harm through inferences that can reasonably be drawn from the evidence before the Court. Plaintiffs must adduce "clear and not speculative" evidence of "harm which either cannot be quantified in monetary terms or which cannot be cured, usually because one party cannot collect damages from the other". Mere assertions of harm through loss of personnel or sales are insufficient to prove irreparable harm. While losses may be difficult to quantify, mere difficulty in quantifying losses does not amount to irreparable harm, provided there is some reasonably accurate way of calculating those damages. It was entirely speculative for Bayer to argue that it will not be able to recover damages for any losses that it may suffer in the post-expiry period. Bayer's submissions are not supported by the evidence; Bayer's expert testified that losses could be quantified on an after-the-fact basis. Damages are recoverable whether caused before or after expiry. Bayer failed to prove that its lost sales will be near the order of magnitude estimated by the company, or that it will lose its capability to transition. Loss of the time-limited monopoly right that is granted in exchange for disclosure can be readily compensated through an award of damages. The unique dynamic of the pharmaceutical industry, in which the innovator predictably loses a substantial portion of its market share to generics, without any realistic expectation that the innovator will be able to recover that market share in the future, distinguishes it from other industries in which the potentially permanent loss of market share resulting from a defendant's early market entry has been found to be an irreparable harm.
12. Novopharm v. Sanofi-Aventis et al. and The Minister of Health, April 27, 2007 FCA (Nadon, Sharlow, Ryer JJ.A.) Appeal/ Motion to Dismiss/ Application for Prohibition/ Section 6(5)/ Patented Medicines (Notice of Compliance) Regulations
Appeal from a decision dismissing Novopharm's motion to dismiss a prohibition application by Sanofi for the use of ramipril in the treatment of hypertension. Sanofi has a number of NOCs permitting it to market ramipril under the name "Altace" for certain uses including treating hypertension. No patent was alleged in this case for ramipril itself, or of the use of ramipril in the treatment of hypertension. Sanofi's '089 and '948 patents ("Patents") contain claims for certain "new uses" of ramipril for which no NOCs have issued. Before the Patents issued, Novopharm filed an ANDS to obtain an NOC for a generic version of ramipril for use only in the treatment of hypertension. Novopharm alleged that its proposed product would not infringe the Patents and that it would not induce infringement by others. The Judge rejected this argument because the evidence on the question of infringement was not yet complete and because, given the time already taken to get the proceedings to this stage, Sanofi should not be deprived of its opportunity to complete cross-examinations of the affidavits even though there is only a slim chance of any improvement in the evidentiary foundation for its application. Novopharm also submitted that the Judge dismissed its motion for delay, and argued that delay is not a proper basis for denying relief under s. 6(5)(b) of the Regulations.
Held: Appeal allowed. Motion to dismiss prohibition application granted. The Judge erred in law in rejecting Novopharm's argument on the issue of infringement. Sanofi's argument that something might emerge on cross-examination is entirely speculative and should have been rejected. Once the speculative possibility of additional evidence is set aside, Novopharm's non-infringement allegation is justified and the prohibition application would fail. The issue of whether delay by itself can be a complete answer to a motion under s. 6(5)(b) to dismiss prohibition proceedings was not addressed.
13. Eli Lilly et al. v. Apotex and The Minister of Health, April 27, 2007 FCTD (Gauthier J.) Application for Prohibition/ Selection Patent/ Anticipation/ Obviousness/ Double Patenting/ Mislead Patent Office/ Section 53 Patent Act/ Section 29 Patent Rules/Patented Medicines (Notice of Compliance) Regulations
Application by Lilly for an order prohibiting the Minister from issuing an NOC to Apotex for its formulation of olanzapine, the active ingredient in Zyprexa®, until the expiry of Lilly's '113 Patent ("Patent"). The Patent is a selection patent from the '687 patent. The '687 patent encompasses a broad genus of chemical compounds including olanzapine, although olanzapine is not specifically disclosed. The Patent claims olanzapine and its use for the treatment of schizophrenia, although it does not expressly claim the special advantages of olanzapine over other compounds in the genus. Lilly contested Apotex's allegation that the Patent was an invalid selection patent on the grounds that this was a new issue not raised in the NOAs. Apotex alleged that for a selection patent to be valid, the special advantages described in the disclosure must be specifically referenced in the claims akin to a "new use" patent. There is no compelling rationale for requiring a selection patent to set out its advantages within its claims. The discrepancy between what appears in the NOA and what is ultimately argued can be sufficiently important as to affect a first person's decision of whether or not to proceed with an NOA, thus Apotex's arguments were limited to allegations raised in its NOAs. Apotex argued that olanzapine was anticipated by the '687 patent and a prior art publication, and also argued that the combination of these references would render the Patent obvious. Apotex also argued that the Patent is invalid on the ground of obviousness and double patenting in light of the '687 patent. Apotex also argued that Lilly purposely withheld relevant prior art from the examiner, and that the information conveyed by Lilly was misleading and thus violated s. 53 of the Act.
Held: Application granted. The allegations in the NOA are not justified. The Patent was not anticipated. The properties of olanzapine could only be ascertained through empirical research. A selection patent can only be granted for compounds that have not been made before and whose properties cannot be predicted with any confidence without empirical research. Compounds will not be anticipated by publication of a disclosure in general terms or their class or by enumeration of the members of the class through mere recital of their names. The '687 patent left the field open for another inventor to claim olanzapine as a new compound. The prior art reference did not anticipate the Patent since the chemical formula disclosed differed from olanzapine. The Patent was not obvious. Expert evidence showed that the vast majority of candidates selected for drug development fail. Apotex's experts failed to satisfactorily explain why they would have included olanzapine in their 'short' list of candidates for drug development from the thousands of compounds claimed in the '687 patent without any empirical research or hindsight. The special advantages of olanzapine were not obvious from the prior art. The Patent was also not obvious on the basis of double patenting. Lilly did not violate s. 53 of the Act. With regard to prior art allegedly withheld from the Examiner, Apotex has not established that there is an obligation in Canadian law to produce all prior art known to an applicant. According to r. 29, the examiner defines through its request(s) to the applicant what should be disclosed, and Lilly complied with all such requests. There was no direct evidence of knowledge or of an intention to mislead on Lilly's part. Based on the evidence, the Court cannot infer an intention to deceive.
14. G.D. Searle and Pfizer Canada v. Novopharm and The Minister of Health, April 30, 2007 FCTD (Noël, Sexton, and Malone JJ.A.) Applicant/Grace Period/ Obviousness/ Abandonment/Section 73 Patent Act/Patented Medicines (Notice of Compliance) Regulations
Appeal from judgment dismissing an application to prohibit the Minister from issuing an NOC to Novopharm for celecoxib tablets before expiry of Searle's '576 patent ("Patent"). Novopharm filed an NOA alleging the Patent was invalid on the basis of abandonment, obviousness, lack of utility, and insufficiency. The Applications Judge held the Patent to be invalid on the basis of abandonment and obviousness. The Applications Judge held that a disclosure in June 1994 by a Searle scientist (Seibert) before the filing date rendered the Patent obvious and the disclosure did not fall within the grace period under s. 28.3 of the Act. The Applications Judge further held that the Patent was abandoned because of the failure to identify the June 1994 disclosure as prior art to the Examiner. The appellants argued that the filing date was not the proper claim date, since the Patent claimed priority from two U.S. applications filed prior to June 1994. In the alternative, the appellants submitted that the case was decided on issues not raised in the NOA, and as such was procedurally unfair since the NOA defines the issues to be determined in proceedings under the Regulations. The Appellants argued that Seibert derived her knowledge from her employer Searle, and thus the June 1994 disclosure fell within the grace period under s. 28.3(a). Consequently, the June 1994 disclosure could not be considered with respect to obviousness, and was also not prior art which the appellants were obliged to provide to the Examiner in response to the requisition. As such, the appellants argued the Patent was not abandoned. Novopharm argued that if the subject matter was not abandoned or obvious, it lacked utility as of the filing date.
Held: Appeal allowed. Minister prohibited from issuing an NOC to Novopharm. The Applications Judge was correct in determining the Canadian filing date as the claim date since the priority applications did not disclose the same invention as the Patent. However, it was not open to the Applications Judge to hold that Searle was not the applicant as of the claim date, both as a matter of procedural fairness and based on the record before him. Thus, Searle as applicant fell within the grace period provided in s. 28.3(a), and the June 1994 disclosure was exempt from consideration as to obviousness. Consequently, the June 1994 disclosure was not prior art that had to be disclosed to the Examiner, and thus there was no deemed abandonment. There was no need to address the lack of utility issue as the Application Judge's finding of utility as of Nov. 1994 was a finding of fact that was not contested nor alleged by Novopharm in its NOA.
(b) Trade Marks
1. Nissan v. BMW, March 22, 2007 FCA (Sexton J.A.) Stay/Irreparable Harm
Motion by Nissan for a stay pending disposition of an appeal from the March 7, 2007 FCTD judgment that restrained Nissan from using the trade marks M and M6.
Held: Stay granted. Nissan has established that it will suffer irreparable harm in that it “will be unable to rely on its family branding in promoting the Infiniti M family of vehicles, as is the practice among other luxury vehicle manufacturers.” If successful on appeal, Nissan would revert to family branding in promoting its Infiniti M vehicles to maintain consistency with the advertising message used both in the U.S. and with respect to its other lines of Infiniti vehicles. An affiant swore that such a disruption in Nissan’s marketing strategy would cause customers to mistakenly wonder if there was a problem with the cars being promoted. Also, BMW has not provided an undertaking as to damages, which would prevent Nissan from recovering expenses that it would incur to revise its promotional materials to remove references to M and M6.
2. See You In – Canadian Athletes Fund v. Canadian Olympic Committee, April 18, 2007 FCTD (Phelan J.) Judicial Review/Publication of Official Marks/What Constitutes Adoption and Use/Applicant’s Right to File Evidence
Application for judicial review of the Registrar’s decision to publish notice of the official marks SEE YOU IN TORINO, SEE YOU IN BEIJING and SEE YOU IN VANCOUVER in the name of the respondent. The applicant had already used these marks and applied to register them.
Held: The Registrar’s decision to publish is quashed. The Registrar’s procedure is anomalous in that it requires some evidence of “public authority” but accepts without enquiry unsworn statements by counsel that a mark has been adopted and used. “The potential effect on third parties of the Registrar’s decision to publish certainly justifies some better level of diligence.” It would be unfair to prevent the applicant from putting forward evidence that challenges the conclusion of the Registrar, particularly since it had no prior ability to do so; leave to adduce evidence granted. The Registrar’s decision to publish was neither correct nor reasonable; not only was there insufficient evidence before the Registrar upon which to conclude that the respondent had adopted and used the marks, but there were also applications pending for the exact same marks by the applicant. The applicant adduced evidence that the official marks were not used by the respondent prior to their publication and the respondent failed to evidence that they had been. An official mark is not used for commercial purposes or in the course of trade but the use and adoption of an official mark both require an element of public display, of which there was none established here. Internal discussion or memoranda do not constitute adoption and use. The Registrar’s finding that the respondent is a public authority is entitled to deference and the Court could find no basis for concluding that the respondent does not exist for the public benefit.
An appeal has been filed.
3. Spirits International v. Reg. TMs and SC Prodal 94, April 19, 2007 FCA (Sexton, Pelletier, Malone JJ.A.) Registrar’s Practice of Issuing a Second Section 45 Notice
Appeal from FCTD decision that upheld a s. 45 decision of the Registrar.
Held: Appeal dismissed. The Applications Judge did not commit any error when he concluded that the Registrar’s decision to maintain the registration was reasonable. That said, the Registrar’s practice of maintaining a registration and simultaneously issuing a second s. 45 notice is to be discouraged.
4. CanDrug Health Solutions et al. v. Thorkelson, April 19, 2007 FCTD (Teitlebaum J.) Section 57 Expungement/ Clearly Descriptive/ Deceptively Misdescriptive/ Section 12(2)/ Historical Web Sites
Application to expunge registrations for CANADA DRUGS and CANADADRUGS.COM on the basis that they contravene s. 12(1)(b).
Held: Registrations expunged because each mark is both clearly descriptive and deceptively misdescriptive of the registrant’s services, namely the online operation of a drugstore based in Canada. “[P]ermitting this combination of words common to the trade to be trademarked would result in an undue disadvantage for legitimate competitors.” The marks are deceptively misdescriptive because an ordinary consumer would expect that the drug prescriptions are always filled by a Canadian pharmacy, which is not the case. The Court considered if the registrant could rely on s. 12(2) but found that there was insufficient evidence in support of such a claim given that there had been only a few months’ use prior to the material date. The applicant introduced historical web sites to show that others have used the marks but, in the absence of evidence that Canadian consumers visited those sites, no weight can be ascribed to such evidence.
5. Baxter International v. P.T. Kalbe Farma, April 30, 2007 FCTD (Pinard J.) Section 45 Appeal/Filing New Evidence
Appeal from Registrar’s decision to expunge the registration for RENAMIN under s. 45. The registrant contends that it did not receive the s. 45 notice. The respondent is not opposing the appeal.
Held: Appeal allowed. Even though the evidence indicates that the notice was sent to the correct address of the applicant and to the applicant’s representative for service, the Court should accept the applicant’s new evidence on appeal.
6. Coastal Culture v. Wood Wheeler, May 2, 2007 FCTD (O’Keefe J.) Opposition Appeal/Unpleaded Ground of Opposition/ Assessing Sufficiency of Pleadings/Section 30(b)
Appeal from Registrar’s decision that rejected the appellant’s opposition to the registration of DIRT SHIRT. The statement of opposition did not plead a s. 30(b) ground and so the Registrar did not consider the evidence that was directed to the issue of whether the respondent had used its mark since the date claimed. The appellant submitted that the Court is bound to determine any arguments raised by a party on appeal, even if they were not raised before the Registrar or in the pleadings.
Held: Appeal allowed. The Registrar did not make an interlocutory ruling with respect to the sufficiency of the pleadings, but instead considered whether a s. 30(b) ground had been pleaded without considering the already-filed evidence. It was clear from the evidence and argument that the appellant was arguing a s. 30(b) ground and the respondent filed evidence on this point. Therefore the Registrar erred in not ruling on a s. 30(b) ground of opposition. The Court held that the opposition should succeed on the basis that the respondent never used DIRT SHIRT simpliciter, but instead used P.E.I. DIRT SHIRT.
(c) Practice
1. Apotex v. The Wellcom Foundation and GlaxoSmithKline, March 1, 2007 FCTD (Gibson J.) Judicial Review/Motion to Set Aside Order
Both parties seek an order setting aside orders of a Prothonotary requiring parties to provide answers to questions posed during examination for discovery and in follow-up written interrogatories. The Prothonotary gave no reasons. Apotex argues that given the lack of reasons, the Court has no basis to discern how she applied principles of law and thus no deference should be accorded her decision. Both parties argue that questions go beyond scope of pleadings.
Held: Both motions denied. The Prothonotary was not "clearly wrong" nor was discretion exercised "based upon a wrong principle or upon a misapprehension of the facts". The questions at issue are relevant to claims made in the pleadings, in that they go to allegations of common enterprise and thus to computation of damages. With regard to the first motion, the questions, when answered, are likely to advance the defendants' position or contribute towards settlement. With regard to the second motion, the questions, when answered, may prove or disprove allegations of fact which have not been admitted and are likely to advance the legal positions of the parties. Weighing the probability of the usefulness of the answers against the time, trouble, expense and difficulty in answering tilts towards upholding the questions.
2. Novopharm v. Janssen-Ortho and Daiichi Pharmaceutical, March 3, 2009 FCA (Sharlow J.A.) Costs
Motion for costs under r. 400 for an order dismissing a motion by Novopharm for a stay of the judgment of the Federal Court pending the disposition of the appeal. Janssen et al. had requested costs during the proceeding, but the judgment on the stay motion was silent on costs.
Held: Janssen et al. is not precluded from seeking costs even though the judgment is silent since they requested costs during the proceeding. However, the appropriate remedy in such a case is filing a motion under r. 397 for reconsideration, on a timely basis, which has now lapsed. Alternatively, r. 403(2) permits such a motion. In this instance it is appropriate to exercise judicial discretion under r. 55 and treat the current motion as though it properly invoked r. 397. However, as the success on the stay motion was divided, each party shall bear their own costs.
3. Apotex v. Merck and Merck Frosst Canada, March 6, 2007 FCTD (Mosely J.) Judicial Review/ Rule 51/ Examination for Discovery
Appeal by motion, pursuant to r. 51, to set aside the order of a Prothonotary ordering Apotex to provide answers to questions posed on discovery by Merck. As is common in interlocutory proceedings, the Prothonotary declined to provide reasons. Apotex objects to answering the questions that Merck raised during examination for discovery on the basis that they are irrelevant to the issues between the two parties.
Held: Discretionary orders of a Prothonotary should be afforded deference unless: (a) the motion raises issues vital to the final issue of the case, or (b) the orders are clearly wrong, being based either on a wrong principle or a misapprehension of the facts. It might also be appropriate to withhold deference if the orders have not been made as a result of the Prothonotary's ongoing management function. Lack of reasons alone does not automatically preclude deference and give rise to de novo review. Moreover, Apotex failed to meet the burden for justifying de novo review under the above three exceptions. The questions posed by Merck were relevant and the order was based upon a clear understanding of the facts of the case.
4. Winnipeg Enterprises et al. v. Fieldturf (IP), March 7, 2007 FCA (Decary, Desjardins, Nadon JJ.A.) Status Review/Motion to Dismiss
Appeal by Winnipeg Enterprises from an order of the Federal Court dismissing: (a) an appeal from a status review order of a Prothonotary (the case manager) allowing the proceeding to continue and setting out a new case timetable, and (b) a motion to dismiss the proceeding for delay as being premature.
Held: Appeal dismissed. A decision made on status review is vital to a final issue of the case, as it may in fact result in dismissal of the action. The test for status review under r. 382 is that the plaintiff must show (a) the reasons why the case has not moved forward faster and that the delay is justified, and (b) the proposed steps to move matter along; while considering prejudice caused to the defendant. The Court held that the claim should proceed, after considering numerous reasons for delay including the illness of a witness, the multiple corresponding cases specially managed by the case manager, and that both parties share blame for the delay. During a status review no further steps should be taken in the proceeding, and as filing a motion to dismiss the proceeding for delay is a further step, it is premature and should await the final disposition of the status review.
5. Riaz A. Lari v. The Canadian Copyright Licensing Agency ("Acess Copyright"), March 28, 2007 FCA (Letourneau J.A.) Contempt of Court/Copyright Infringement
Appeal by Lari from a contempt of court conviction. Lari was charged with violating three court orders and a judgment of the Federal Court. The violations consisted of making and selling copied textbooks by publishers associated with Access Copyright and refusing to give access to his premises, as ordered, to remove unauthorized copies of such textbooks.
Held: Appeal dismissed. Direct evidence on record proved Lari's involvement in the unauthorized making of textbooks either through his employees or in cooperation with other persons. Moreover, the judge correctly evaluated the circumstantial evidence as a whole, and not as isolated events, to find that Lari participated in the making and selling of unauthorized material and controlled the premises where the large-scale infringement took place.
6. Novozymes A/S v. Genencor International and Commissioner of Patents, March 28, 2007 FCA (Desjardins, Letourneau, Noel JJ.A.) Re-examination of Patents/Parties to be Included as Respondents
Appeal by Novozymes of a decision granting Novozymes ten days to formally re-apply to the Federal Court for leave to intervene in an appeal filed by Genencor pursuant to s. 48.5 of the Patent Act (i.e. an appeal of a decision by the re-examination board). Novozymes submitted that it is a proper respondent in the appeal.
Held: Appeal dismissed. Novozymes was not a proper respondent since it was not a "party in the first instance" within the meaning of r. 338(1)(a). The re-examination of patents is a two-stage process as set out in s. 48.1 to 48.5 of the Patent Act. The first stage involves the filing of a request by a requester, the establishment of a re-examination board by the Commissioner in response to this request and the preliminary decision by the re-examination board as to whether the request raises a substantial new question of patentability. The second stage follows the re-examination board's determination that a substantial new question of patentability is raised. Only the re-examination board and the patentee are parties to the second phase. Although Novozymes, as the requester, triggered the re-examination process, it did not and could not participate in the second stage of the re-examination process.
7. Les Laboratoires Servier et al. v. Apotex, March 30, 2007 FCTD (Snider J.) Costs of Injunction Motion
Motion by Apotex for their costs relating to interim and interlocutory injunction motions brought by Servier. Servier had commenced an action against Apotex for infringement of their '196 patent. Servier was granted an interim injunction but was denied an interlocutory injunction against Apotex. Servier submitted that costs should not be ordered since the Court found there was a serious issue to be tried and there was an admission of infringement by Apotex. In the alternative, Servier argued that if costs were awarded, the quantum thereof should be left to the Trial Judge.
Held: Costs awarded to Apotex. Federal Court r. 400 gives full discretionary powers over the amount and allocation of costs to the court. The Motions Judge has the discretion to award the costs of a motion to either party, regardless of the outcome of the main matter. Here, the issues in this motion are discrete. Therefore, it is appropriate to award costs on this motion separate from and in advance of the trial. The results of the proceeding favoured Apotex. With respect to the quantum of the costs, the Court concluded that Apotex would not have been able to respond adequately to the motions without involving more than one lawyer on the file. However, Apotex may have gone beyond a reasonable level in retaining their experts and should therefore bear some of the associated costs. Apotex's disbursements were capped at $100,000 as the Court was concerned about the reasonableness of some of them.
8. Pharmascience v. GlaxoSmithKline et al., April 3, 2007 FCTD (Hughes J.)
Judicial Review/Protective Order
Appeal by GlaxoSmithKline et al. from a confidentiality order made by a Prothonotary, as it did not include a "highly confidential" category of documents, and specifically, for counsel's eyes only. GlaxoSmithKline argued that the Prothonotary failed to consider an authority and overlooked uncontradicted evidence.
Held: Appeal dismissed with costs. A Prothonotary's decision to grant a "highly confidential" category in a confidentiality order is not vital to, or dispositive of, an issue in the proceeding, and should only be reversed if it is clearly wrong. In this instance, the Prothonotary considered and weighed the evidence on record, and the reasons given were sufficient and should not be read microscopically.
9. Fournier et al. v. The Minister of Health and Apotex, April 23, 2007 FCTD (Lafrenière J.) Costs/Discontinued Proceedings/Patented Medicines (Notice of Compliance) Regulations
Motion by Apotex to recover its costs of a discontinued proceeding under the Regulations. Fournier did not dispute Apotex's entitlement to its costs of the proceeding, but questioned the proprietary of the claim for solicitor and client costs, the sufficiency of the evidence adduced in support of the claim for disbursements, and the jurisdiction of this Court to revisit costs awarded by the FCA. Apotex submitted that it should be allowed to recover its costs on a solicitor-client scale on four grounds: 1) Fournier persisted in prosecuting its application without merit; 2) Fournier brought frivolous appeals; 3) Fournier made baseless allegations of fraud; and 4) Fournier brought the application for a collateral and improper purpose. The issues to be determined include: 1) Apotex's entitlement to solicitor-client costs; 2) if not, whether Apotex is entitled to increased costs; and 3) whether the disbursements claimed are reasonable and properly incurred.
Held: Motion allowed in part. Solicitor client costs are to be awarded only in exceptional circumstances, which have not been established in this case. The fact that a party's claim has little merit or is weak is not a basis for awarding solicitor-client costs. The proceeding brought by Fournier was not bereft of any possibility of success, as indicated by the extensive evidence filed by Apotex. If the application was completely without merit, Apotex should have moved to dismiss the proceeding as frivolous or vexatious, or an abuse of process. The fact that a party did not succeed on a motion for production or on appeals does not establish that the application is without foundation. Taking issue with the correctness or veracity of statements in an NOA, or the credibility of a deponent, is not, in itself, improper in the context of litigation. Finally, Apotex failed to establish that Fournier brought the application for the collateral and improper purpose of frustrating Apotex's entry into the market for a time sufficient to permit Fournier to list another patent on the Patent Registry. The Court should not discourage parties from acting responsibly by penalizing them with substantial costs when discontinuing unmeritorious proceedings. Nevertheless, the proceeding required a substantial amount of work by counsel involving relatively complex facts and expert evidence, and thus costs should be awarded in excess of Column II of Tariff B. Disbursements were not awarded as Apotex failed in its onus to establish, with proper evidence, that they were related to defending the proceeding and that they were reasonable in the circumstances.
10. Eli Lilly et al. v. Apotex, May 3, 2007 FCTD (Blais J.) Judicial Review/Case Management/Discovery
Applicants (Eli Lilly) seek an order setting aside an order of a Prothonotary requiring that applicants answer certain questions during discovery. Parties had agreed to limit discovery to the issues of compulsory license and alleged termination. Respondent successfully brought a motion to compel answers. Applicants argue the questions exceed the agreed-upon scope of discovery and are thus irrelevant. Applicants also argue that the prothonotary erred in changing draft consent order submitted by parties such that it no longer reflects oral directions given at hearing.
Held: Motion denied. The Prothonotary was not "clearly wrong" in ruling that the questions were relevant and needed to be answered. The standard of review of a prothonotary's decision requires that an order be "clearly wrong" when "the prothonotary has fallen into error of law" by exercising discretion "based upon a wrong principle or upon a misapprehension of the facts". The threshold for relevance for the purpose of discovery is fairly low. A high level of deference should be given to decisions of a case management Prothonotary to discharge case management functions. The Prothonotary's change of the draft consent order falls within the category of "clerical mistakes, errors or omissions in an order" and is sent back to the Prothonotary for clarification.
11. Pfizer and Warner-Lambert v. The Minister of Health and Ranbaxy Laboratories, May 10, 2007 FCTD (Mosley J.) Judicial Review/Rule 312/Patented Medicines (Notice of Compliance) Regulations
Appeal by Pfizer from the order of a Prothonotary declining to grant leave to Pfizer under r. 312 to file the additional affidavit of Dr. Myerson. Pfizer originally declined to file after being granted leave to amend its notice of application and only sought leave to file under r. 321 once Ranbaxy made further production of information, namely the affidavits of Dr. Cunningham and Dr. Hollingsworth. The Prothonotary declined to grant leave on the basis that the need to respond could have been anticipated by Pfizer.
Held: Appeal allowed in part. The Prothonotary applied the correct test for reply evidence, which incorporates a foreseeability/anticipation requirement. Pfizer did not meet this requirement in respect of the Hollingsworth affidavit because they anticipated a response but elected not to put it forward from the outset. However, Pfizer did meet this requirement in respect of the Cunningham affidavit because the issues raised there were not previously raised, meaning Pfizer could not have foreseen the need to respond from the outset. Leave to file the portions of the Myerson affidavit that address the Cunningham affidavit is granted. Leave to file portions of the Myerson affidavit that address the Hollingsworth affidavit is denied.
II. OPPOSITION BOARD DECISIONS
1. Canadian Generic Pharmaceutical Association v. Sanofi-Synthelabo, December 14, 2006 (Herzig) Distinguishing Guise/ Evidence of Distinctiveness/ Relying on Evidence Filed During Examination
Use-based application for Plaquenil Pill design for pharmaceutical preparations, namely preparations for treatment of malaria, rheumatoid arthritis, systemic lupus erythematosus and similar conditions. The mark is an hourglass shaped distinguishing disguise. Opposition based, inter alia, on s. 13. The applicant did not file any evidence.
Held: Application refused on the basis that there is no evidence that the applicant’s mark was distinctive as of the filing of its application. Although the applicant filed evidence that overcame a registrability objection during examination, the onus on an applicant is heavier in an opposition than it is during examination. Moreover, the applicant has not indicated, other than by oblique reference in its counter statement, that it would be relying on the affidavit filed during cross-examination. As that affiant was not available for cross-examination, it would be unfair for the Board to take that evidence into account.
2. Glaskoch B. Koch Jr. v. Anglo Canadian Mercantile, December 19, 2006 (Carrière) Confusion
Proposed-use application for LEONARDO DA VINCI for glassware. Opposition based, inter alia, on s. 16(3)(a) due to confusion with LEONARDO previously used by the opponent for a variety of wares including some glassware.
Held: Application refused in view of the similarities between the marks, the overlapping wares, and the fact that the opponent’s mark has been used more extensively and for a longer period of time than the applicant’s mark.
3. Anglo Canadian Mercantile v. Glaskoch B. Koch Jr., December 19, 2006 (Carrière) Section 12(1)(a)
Use-based application for LEONARDO & Design for technical devices and apparatuses with glass case made of glass namely oil burner, etc.; timekeepers; lighting appliances; household products; gift articles... Opposition based, inter alia, on s. 12(1)(a) because the mark is primarily merely the name of an individual.
Held: Opposition rejected. The opponent’s evidence does establish that LEONARDO is the surname of individuals living in Canada. However, the applicant evidenced that searches on the Internet mainly located references to LEONARDO as the first name of individuals, including Leonardo daVinci and Leonardo DiCaprio. This led the Board Member to “conclude that the average Canadian, on a balance of probabilities, would not perceive the word LEONARDO as primarily (first in importance) merely (nothing more than) a surname or name of an individual but rather as a first name.” He therefore dismissed the s. 12(1)(a) ground.
4. Kabushiki Kaisha Kaminomoto Hompo v. Ajinomoto, December 20, 2006 (Martin) Confusion
Proposed-use application for AJINOMOTO & Design for chemicals for use in industry … prepared foods … hydrolysed proteins for seasoning purposes … animal foodstuffs … milk and dairy products … dietetic foods and beverages adapted for medical purposes. Opposition based on s. 12(1)(d) due to confusion with KAMINOMOTO registered by the opponent for health and beauty products.
Held: Opposition rejected. Confusion is not likely given the inherent distinctiveness of both marks, the differences between the parties’ wares and trades and the state of the register evidence respecting third party MOTO-suffixed marks. Although the number of third party MOTO-suffixed marks is not extensive (more than a dozen), it was sufficient for the Board Member to conclude that at least a few of such marks are in active use in Canada.
5. Courtyard Restaurant v. Marriott Worldwide, December 21, 2006 (Tremblay) Confusion
Use-based application for COURTYARD for hotel, restaurant, catering and bar services; operation of lounges; provision of facilities for meetings, conferences and exhibitions; reservation services for hotel accommodations. Opposition based, inter alia, on s. 16(1)(a) due to confusion with COURTYARD previously used for restaurant services.
Held: Application refused only with respect to restaurant, catering and bar services; operation of lounges. The extent to which each mark had become known favoured the opponent, as did the length of time that each mark had been in use. However, hotel services and restaurant services are separate services. The statement of services does not suggest that the applicant’s restaurant services are incidental to its hotel services. There is no evidence that the opponent ever used its mark with hotel services or with overlapping services such as provision of facilities for meetings, conferences and exhibitions or reservation services for hotel accommodations.
6. Bonneterie D’Armor v. Le Château, December 28, 2006 (Tremblay) Confusion
Use-based application for ARMOR JEANS & Design for various clothing and the operation of departments within retail stores selling clothing. JEANS disclaimed. Opposition based, inter alia, on s. 12(1)(d) due to confusion with ARMOR LUX registered for clothing.
Held: Application refused. The balance of probabilities was found to be evenly balanced between a finding of confusion and a finding of no confusion. As the onus is on the applicant, this resulted in the opposition succeeding.
7. Gemme Canadienne P.A. v. Corona Jewellery, January 3, 2007 (Herzig) Confusion
Proposed-use application for MAPLE LEAF DIAMONDS for diamonds, diamond jewellery, printed materials, packaging materials, wholesale and retail jewellery services, etc. Opposition based, inter alia, on s. 12(1)(d) due to confusion with Diamond & Maple Leaf Design registered for jewellery.
Held: Opposition rejected. Both marks are inherently weak; both have acquired a significant reputation. The parties’ wares, services and trades overlap, but they occupy different specialty niches in the jewellery trade, the applicant’s niche being Canadian diamonds and the opponent’s niche being imported pearls. Despite this overlap and the contemporaneous use of both marks, there have been no instances of confusion. The applicant submitted that confusion was unlikely since jewellery is not purchased casually and noted that the opponent’s use of the words CANADIAN GEM beside its design mark may have caused clients to interpret the design as comprising a gem and a maple leaf, rather than a diamond and a maple leaf. Overall, the visual impacts of the two marks are decidedly different. The ideas suggested are similar to the extent that both marks suggest that the jewellery originates in Canada. Small differences suffice to distinguish weak marks.
8. Procter & Gamble v. Colgate-Palmolive Canada, January 3, 2007 (Bradbury) Section 30(e)/Ornamental Design
Proposed-use application for Striped Toothp
