Federal Court Decisions

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Decision Content

Date: 20070329

Docket: T-243-06

Citation: 2007 FC 340

Toronto, Ontario, March 29, 2007

PRESENT:     The Honourable Mr. Justice Hughes













[1]               This is a motion brought by the Respondent ratiopharm to dismiss this application for judicial review brought by the Applicants Wyeth under the Patented Medicines (Notice of Compliance) Regulations SOR/93-133 (NOC Regulations).  The motion seeks to challenge the listing of a patent in respect of certain Notices of Compliance (NOC) issued to Wyeth for its drug known as EFFEXOR XR.  The motion was brought under the provisions of both sections 6(5)(a) and (b) of those Regulations as amended October 5, 2006. Counsel for ratiopharm has restricted the grounds to those arising only under 6(5)(a).  For the reasons that follow I find that the motion is to be dismissed in respect of certain NOC listings and not others.


[2]               Section 6(1)(a) of the NOC Regulations as amended October 5, 2006 permits a second person such as ratiopharm to make a motion to this Court to dismiss the application in whole or in part in respect of those patents that are not eligible for inclusion on the register as listed in respect of certain NOCs issued to the first party Wyeth.  This is not a ground which a second party can raise prior to the institution of Court proceedings in its notice of allegations to a first party (compare section 5(1)(b) of the NOC Regulations).  A generic drug company that may, at some time, become a second party has no status to challenge the listing of a patent on the register in the absence of pending proceedings under the NOC Regulations (Apotex v. Canada (Minister of Health and Welfare), (2003), 3 CPR (4th) 1 (FCA)).


[3]               The basis upon which the Court will proceed under a section 6(1)(a) motion was recently reviewed in Pfizer Canada Inc. v. Canada (Minister of Health), 2007 FC 187.  Where the law can be applied to admissions and relevant evidence that is reasonably found to be undisputed or plain and obvious, the Court has a duty to make a determination.


[4]               On this motion, ratiopharm, has not raised any issue that it is not a “second party”.  It challenges the listing of Canadian Patent number 2,199,778 (the ‘778 patent) by Wyeth on the Register kept by the Minister of Health under the provisions of section 3(1) of the NOC Regulations as listed against several NOCs issued to Wyeth.


[5]               Section 4(2) of the NOC Regulations sets out the criteria to be met for listing a patent on the Register kept by the Minister.  The NOC Regulations were amended effective October 5, 2006, however, the Transitional Provisions, section 6 provide that patents listed prior to June 17, 2006 (such as the ‘778 patent) are to be governed by the pre-amendment provisions of section 4 of the NOC Regulations.


[6]               The ‘778 patent was granted on December 20, 2005 and contains 30 claims many of which pertain to an extended release formulation of a drug known as venlafaxine hydrochloride without any restriction as to use.  Claim 1, for example, reads as follows:

An extended release formulation of venlafaxine hydrochloride comprising a composition containing spheroids comprised of venlafaxine hydrochloride, microcrystalline cellulose and hydroxypropylmethylcellulose, the spheroids being coated with a film coating comprising ethyl cellulose and hydroxypropylmethylcellulose.



[7]               Other claims such as Claim 29 are directed to the use of the extended release formulation of venlafaxine in the treatment of depression with diminished levels of nausea and emesis.  Claim 29 reads (as corrected by a certification of correction):

Use of an extended release formulation of venlafaxine hydrochloride for the treatment of depression with diminished levels of nausea and incidences of emesis, wherein, in use, the formulation provides a therapeutic blood plasma concentration of venlafaxine over a twenty four hour period and wherein the formulation eliminates the troughs and peaks of drug concentration in blood plasma and provides a peak blood plasma concentration of venlafaxine in from about four to about eight hours, and a peak blood plasma level of no more than about 150 ng/ml.


[8]               Wyeth has obtained a number of Notices of Compliance (NOC) for its medicine containing venlafaxine hydrochloride sold under the name EFFEXOR and EFFEXOR XR, the first of which was issued on July 18, 1994.  A number of NOC have subsequently been issued to Wyeth based on Supplementary New Drug Submissions.  There are eight such further NOCs issued since July 18, 1996 up to September 1, 2005.


[9]               The ‘778 patent was submitted by Wyeth to the Minister for listing on the Register the same day it was granted, December 20, 2005.  Listing of the patent was made as against six different NOCs granted to Wyeth, the earliest of which was submitted March 14, 2003, with subsequent NOCs granted on dates ranging up to September 1, 2005.


[10]           The basis for ratiopharm’s argument that the ‘778 patent was improperly listed rests upon its argument that the various NOCs against which that patent was listed have nothing to do with the patented invention.


[11]           Wyeth argues that it has six NOCs against which the ‘778 patent is listed.  One NOC, it agrees, is administrative only in nature, a manufacturer name change.  Wyeth places no reliance upon it.  Some of the others, including one that relates to nausea reduction and another that relates to maintenance of major depression, Wyeth argues, are sufficient to sustain the listing of the ‘778 patent.


[12]           The Federal Court of Appeal in Hoffman-LaRoche Ltd. v. Canada (Minister of Health), 2006 FCA 335 released October 18, 2006 reviewed the decisions of both this Court and that Court in which consideration was given as to whether a particular S/NDS and the resulting NOC could sustain the listing of a particular patent. This decision was released about two weeks before the decision of the Supreme Court of Canada in AstraZeneca Canada Inc. v. Canada (Minister of Health),[2006] 2 SCR 560, 2006 SCC 49.


[13]           In Hoffman-LaRoche, supra, paragraph 15, the Federal Court of Appeal said that a supplement to a new drug submission (S/NDS) may or may not be a sufficient foundation for the filing of a new or amended patent list, depending upon why the supplement was filed.  Thus a change to a brand name for the drug, or change in a manufacturing site or merger of corporations giving rise to a change of the manufacturer were held to be incapable of supporting an addition of a patent to a list.  On the other hand a new indication for an existing drug or particular changes in a product monograph to cross-reference a supplier of a combination drug were held to be sufficient to sustain the listing of a patent.  In Hoffman-LaRoche the Court held in the circumstances of that case that it would be improper to list a patent in respect of an S/NDS which reflected the acquisition by the first party of part of the business relating to drug products of a third party.


[14]           What is important to learn from Hoffman LaRoche is not any detail as to what could or could not sustain the listing of a patent.  Rather, it is the fact that the Court held that some S/NDS’s and resultant NOCs would sustain such a listing and others not.  An inquiry must be made in each circumstance.

[15]           The nature of that inquiry depends on the use of the term “relevance”.  Section 4(7)(b) of the NOC Regulations uses that word in connection with a statement that the first party has to make that the patent sought to be listed in “relevant to the dosage form, strength and route of administration of the drug.”  That is not the issue here.


[16]           The issue of “relevance” was considered by the Federal Court of Appeal in Eli Lilly Canada Inc. v. Canada (Minister of Health), [2003] 3 FC 140, a decision subsequently referred to in AstraZeneca by the Supreme Court.  In Eli Lilly the Federal Court of Appeal considered section 4(7)(b) of the NOC Regulations and the position taken by the Minister that “relevance” required a relationship between the drug named in the notice of compliance and the patent sought to be listed, Sharlow, J.A. for the majority (there was a dissent) said at paragraphs 28 to 30.

28      I need not analyse the requirements of paragraph 4(7)(b) in any detail. I understand that counsel for the Minister has not taken the position that the '969 patent is not "relevant to the dosage form, strength and route of administration" of Tazidime.


29      Based on the foregoing ordinary and grammatical reading of the PM(NOC) Regulations, the '969 patent should be eligible for inclusion on the patent lists for Tazidime. That is the interpretation that should be adopted unless the words of the PM(NOC) Regulations can reasonably bear a different meaning that would accord better with the purpose of the PM(NOC) Regulations.


30      Counsel for the Minister argued that the PM(NOC) Regulations require a relationship, which he referred to as "relevance", between the drug named in the notice of compliance and the patent sought to be included in the patent register. He submitted that the requisite relationship does not exist if the invention disclosed in the patent is not somehow included or embodied in the drug. In this case, for example, it is undisputed that Tazidime makes no use of the invention disclosed in the '969 patent. It is in this sense that counsel for the Minister argues that the '969 patent is not "relevant" to the notice of compliance for Tazidime.



[17]           The Minister’s argument was rejected by the majority of that Court for two reasons, first the wording of section 4(7)(b) did not require consideration of any relationship between the drug named in the notice of compliance and the patent sought to be listed.  Second, they held that the first party should be able to list a patent that had the potential of preventing infringement.  Sharlow, J.A. said at paragraphs 34 to 36:

34      I am unable to read those words as the Minister argues they should be read. Subsection 4(1) addresses the question of who may submit a patent list, not the permitted contents of the patent list. Similarly, the emphasized words in paragraph 4(7)(b) do not describe any relationship between the drug named in the notice of compliance and the patents that may be included on the patent list. Rather, "the drug in respect of which the submission for a notice of compliance has been filed" is, simply, Tazidime.


35      According to Eli Lilly, the Minister's interpretation would tend to defeat the objectives of the PM(NOC) Regulations. It is theoretically possible that a generic drug manufacturer could produce a drug consisting of a formulation of ceftazidime and amorphous lactose that is bioequivalent to Tazidime (even though it would not be exactly the same as Tazidime because Tazidime does not contain amorphous lactose). Such a product could infringe the '969 patent. If the '969 patent is not permitted to stay on the patent lists for Tazidime, Eli Lilly will be deprived of its right to apply to stop the issuance of a notice of compliance for the new drug until after the expiry of the '969 patent. [page159] If that happens, the PM(NOC) Regulations will not have been permitted to operate as intended. I note that a similar argument was accepted in Apotex Inc. v. Canada (Minister of Health) (1999), 87 C.P.R. (3d) 271 (F.C.T.D.), but only in obiter dicta, in the context of the PM(NOC) Regulations before the 1998 amendments.


36     On balance, it seems to me that the interpretation propounded by Eli Lilly should be favoured over the interpretation propounded by the Minister, for two reasons. First, it is more consistent with the words of the PM(NOC) Regulations. Second, it has at least the potential of preventing infringement of the '969 patent, while the Minister's interpretation cannot possibly have that result.




[18]           This decision was put to the Supreme Court of Canada in AstraZeneca and particularly commented upon by that Court in paragraph 23 of its unanimous reasons.  That Court emphasized that particular patents are to be linked to particular submissions.  It is clear that the Supreme Court did not approve the listing of patents simply because the drug was the same and rejected the Federal Court of Appeal’s analysis in Eli Lilly.  They said:

23     AstraZeneca relies on Eli Lilly Canada Inc. v. Canada (Minister of Health), 2003 FCA 24 (CanLII), [2003] 3 F.C. 140, 2003 FCA 24, for the proposition that a patent list is submitted in respect of a drug and not in respect of any particular submission.  This is also the view taken by the majority judgment of the Federal Court of Appeal in this case.  On this view a “first person” could carry on “evergreening” its product indefinitely by the addition of new patents of marginal significance which would trigger an indefinite series of 24-month statutory freezes even though such subsequently listed patents are not the subject of “early working” by the generic manufacturer, and from which (as in the circumstances here) the generic manufacturer derives no advantage.  As this case further illustrates, AstraZeneca even managed to piggy-back the 037 and 470 patents onto an administrative SNDS.  An interpretation that would freeze the generic product out of the market vacated by AstraZeneca in 1996 for a further two years or more in these circumstances flies in the face of the limited purpose authorized by s. 55.2(4) of the Patent Act.  It is not to be presumed that s. 4(5) of the NOC Regulations insisted on linking particular patents to particular submissions for no purpose.



[19]           Paragraphs 39 and 40 of the AstraZeneca reasons serve to emphasize that the Supreme Court requires that, in order to list a patent, it had to be relevant to the NOC against which it is to be listed:

39       ... In my view, s. 5(1) of the NOC Regulations requires a patent-specific analysis, i.e. the generic manufacturer is only required to address the cluster of patents listed against submissions relevant to the NOC that gave rise to the comparator drug, in this case the 1989 version of Losec 20.


40     If AstraZeneca had brought to market a Losec 20 product pursuant to the later NOCs and if Apotex had made reference to that modified product for the purpose of demonstrating bioequivalence, Apotex would have been required to file a notice of allegation with respect to the 037 and 470 patents.



[20]           The use of the words “comparator drug” and “modified product” by the Supreme Court indicate that the NOC and the listed patent be related in the manner proposed by the Minister in Eli Lilly.  A relationship is required, that is, “relevance” between the drug named in the notice of compliance and the patent sought to be listed.


[21]           The question then arises as to how that relationship is established.  The Supreme Court of Canada in Bristol-Myers Squibb Co. v. Canada (Attorney General), [2005] 1 S.C.R. 533 (Biolyse) discussed this issue.  Binnie, J. for the majority of paragraph 53 cautions that it is not every use of a patented invention that will trigger the NOC Regulations:

53   Secondly, it is not every use of the patented invention that will trigger the NOC Regulations.  Section 55.2(4) is specifically directed to preventing infringement by persons who use “the patented invention” for the “early working” exception and the “stockpiling” exception set out earlier in ss. 55.2(1) and 55.2(2).  That is all the Governor in Council is authorized to regulate.  (The stockpiling exception was repealed by S.C. 2001, c. 10, s. 2(1); assented to June 14, 2001.)




Binnie J. pointed out in paragraph 52 of Biolyse that regard is to be given to the patented invention which is not necessarily co-extensive with the patent claims.  The Regulations are directed to the “patented invention”:

Firstly, the regulations are to be directed to persons who are making use of the “patented invention”.  As pointed out by this 52 Court in Monsanto Canada Inc. v. Schmeiser, 2004 SCC 34 (CanLII), [2004] 1 S.C.R. 902, 2004 SCC 34, the patented invention is not necessarily co-extensive with the patent claims.  The distinction was critical in that case to the issue of remedy.  While farmer Schmeiser had used the patented product (Roundup Ready Canola seed), he had not taken advantage of the patented invention (its herbicide resistant property) because he had not sprayed his crop with Roundup.  The Court thus rejected Monsanto’s claim to Schmeiser’s profits from his canola crop.


 The difficulty with the trial judge’s award is that it does not identify any causal connection between the profits the appellants were found to have earned through growing Roundup Ready Canola and the invention.  On the facts found, the appellants made no profits as a result of the invention.  [Emphasis in original; para. 103.]


 The use of the expression “patented invention” in s. 55.2 is therefore an important clue to the scope of the regulations it authorizes to be made.  BMS did not invent or discover paclitaxel.



[22]           Given AstraZeneca and Biolyse it can be seen that what the Minister must do under section 3(1) of the pre-October 5, 2006 NOC Regulations for purposes of determining whether a patent is to be listed as against a particular NOC is to look at the “patented invention” and determine if there is a “relationship” between that “patented invention” so as to make it “relevant” to the particular NOC against which it is sought to be listed or, if listed, to be de-listed.


[23]           Taking this approach, the ‘778 patent will be examined to determine what the “patented invention” (not necessarily the claim) is.  Turning to the specification at page 1, line 32 to page 2, line 7, the previously known drug form (prior art), is described as a tablet which, because it releases the medicine quickly, is known to cause nausea and vomiting:

Venlafaxine, 1-[2-dimethylamino)-1-(4-methoxphenyl)ethyl]cyclohexanol, is an important drug in the neuropharmacological arsenal used for treatment of depression.  Venlafaxine and the acid addition salts thereof are disclosed in US patent 4,535,186.  Venlafaxine hydrochloride is presently administered to adults in compressed tablet form in doses ranging from 75 to 350 mg/day, in divided doses two or three times a day.  In therapeutic dosing with venlafaxine hydrochloride tablets, rapid dissolution results in a rapid increase in blood plasma levels of the active compound shortly after administration followed by a decrease in blood plasma levels over several hours as the active compound is eliminated or metabolized, until sub-therapeutic plasma levels are approached after about 12 hours following administration, thus requiring additional dosing with the drug.  With the plural daily dosing regimen, the most common side effect is nausea, experienced by about 45 percent of patients under treatment with venlafaxine hydrochloride.  Vomiting also occurs in about 17 percent of the patients.



[24]           There follows, at page 2, a brief description of the invention, it is an encapsulated  formulation that provides release of the medicine over a twenty-four hour period.  At lines 12 to 15:

In accordance with this invention, there is provided an extended release (ER), encapsulated formulation containing venlafaxine hydrochloride as the active drug component, which provides in a single dose, a therapeutic blood serum level over a twenty-four hour period.




[25]           The use of this formulation as described at page 2, lines 28 to page 3, line 2, provides a moderation of blood plasma peaks and valleys and reduction of nausea and emesis:

Hence, in accordance with the use aspect of this invention, there is provided a method for moderating the plural blood plasma peaks and valleys attending the pharmacokinetic utilization of multiple daily tablet dosing with venlafaxine hydrochloride which comprises administering to a patient in need of treatment with venlafaxine hydrochloride, a one-a-day, extended release formulation of venlafaxine hydrochloride.


The use of the one-a-day venlafaxine hydrochloride formulations of this invention reduces by adaptation, the level of nausea and incidence of emesis that attend the administration of multiple daily dosing.  In clinical trials of venlafaxine hydrochloride ET, the probability of developing nausea in the course of the trials was greatly reduced after the first week.



[26]           Claim 1, previously set out, is a broad claim directed to a formulation of the medicine in coated spheroid form.  Claims 16 and 17 are directed to encapsulation of those spheroids.  None of claims 1 to 21 claim any particular use or benefit.  Claim 22 however claims that the formulation “provides diminished levels of nausea and incidence of emesis.”  Claims 23 to 25 and 29 and 30 are directed to the use of the formulation “for treating depression providing diminished levels of nausea and incidence of emesis” and contains certain blood plasma level profites.


[27]           Thus, the “patented invention” for purposes of the NOC Regulations can be seen to be a formulation of a known medicine in spheroids suitable for encapsulation such as to enable relatively uniform release of the medicine into the body over a twenty-four hour period so as to reduce nausea and emesis.


[28]           The next step is to review the NOCs issued for the drug.  They are indicated in the Table below with an asterisk beside the NOCs against which the ‘778 patent is presently listed.


Submission No.

Submission Date

NOC Date



October 21, 1991

July 18, 1994

New Drug:  EFFEXOR Tablets


December 23, 1996


February 16, 1998

New Dosage Form:  EFFEXOR XR Capsules



September 28, 1999

New indication:  symptomatic relief of anxiety in patients with generalized anxiety disorder


February 21, 2003

March 14, 2003

Manufacturer name change *


August 9, 2000

(or March 1, 2001)

April 25, 2003

New indication:  Maintenance Treatment of Major Depressive Disorder             *                      


October 10, 2001

June 13, 2003

New Indication:  Social Anxiety Disorder                  *


February 25, 2003

September 13, 2004

Revisions to the product monograph regarding nausea reduction                               *


November 14, 2003

December 10, 2004

“description of clinical trial in treatment of SAD”:  submission of additional long and short term safety and efficacy data for cleared indication                             *


Sep 22, 2004

Sep 1, 2005

New indication:  symptomatic relief of panic disorder        *




[29]           The first of these, that issued July 18, 1994 relates to the “prior art”, the old tablet form.


[30]           The second of these, issued February 16, 1998, relates to the new encapsulated form. The ‘778 patent is not listed against that form.  At the time of submission, December 23, 1996, the application for the ‘778 patent had not been filed in Canada.  A priority application had been filed in the United States Patent Office on March 29, 1996 but the Canadian application had not been filed until March 12, 1997.  It is only the Canadian filing date that will trigger the right to list a patent under the NOC Regulations, (Pfizer Canada Inc. v. Canada (Attorney General) 2003 FCA 138 at paragraph 13).  I pause here to comment on my Reasons in Ferring Inc. v. Canada (Minister of Health) 2007 FC 300 at paragraph 43 where I spoke, in the last sentence of the deemed filing date according to PCT obligations.  Counsel argued in the present motion that since the PCT date could also refer to the priority date in some circumstances, I must have been speaking of the priority date.  Definitely not so, I was speaking of the deemed Canadian filing date.


[31]           Thus the most logical NOC against which to list the ‘778 patent was unavailable because the Canadian patent application had not been filed before the application for the NOC, thus section 4(4) of the NOC Regulations precluded filing.


[32]           The ‘778 patent was listed as against the remaining six NOCs.  Wyeth’s counsel concedes that the NOC issued March 14, 2003 directed to a manufacturer’s name change does not, as the jurisprudence reviewed in Hoffman-LaRoche bears, support a valid listing.  Of the remaining five, Wyeth’s counsel raised issues only as to two, that of April 25, 2003 directed to a new indication, “Maintenance Treatment of Major Depressive Disorder” and September 13, 2004, “Revisions to the product monograph regarding nausea reduction.”  The remaining three, on the uncontradicted evidence of ratiopharm’s expert witness, Dr. Schneider, do not bear any relationship to the ‘778 patent.


[33]           As to “Maintenance Treatment of Major Depressive Disorder” Dr. Schneider distinguished between “maintenance” and “single episode” or “recurrent” disorders.  He referred to examples in the ‘778 patent and opined at paragraphs 33 to 35 of his affidavit that those examples would not lead a psychiatrist or physician to conclude that “maintenance” was under consideration.


[34]           Wyeth’s counsel argues that Wyeth’s product monograph in the section entitled “Indications and Clinical Use” expressly states that the drug is to be used for “symptomatic relief of major depressive disorder” and “maintaining an anti-depressive response”.  Wyeth further argues that claims 23 to 30 of the ‘778 patent include a direct reference to the treatment of depression.


[35]           As to the NOC respecting “Revisions to the Product Monograph regarding nausea reduction”, those revisions are additions at pages 6 and 11 to the revision dated December 7, 2004.  They are:

At page 6:

Results of testing in healthy volunteers demonstrated differences in the gastrointestinal tolerability of different formulations of venlafaxine.  Data from healthy volunteers showed reduced incidence and severity of nausea with EFFEXOR XR capsules, compared with immediate release tablets.


At page 11:

Analysis of safety data from this trial showed that the incidence of treatment-emergency nausea and nausea severity over time were lower with EFFEXOR XR than with immediate release tablets.  Additionally, the incidence of vomiting was lower with EFFEXOR XR than with immediate release tablets.



[36]           Counsel for ratiopharm argues that these changes to the product monograph were insubstantial and did not serve the support a “relationship” between the “778 patent and that particular NOC.  Wyeth’s counsel argued that the changes were specific to nausea and emesis and were clearly related to the patented invention.


[37]           The jurisprudence as reviewed by the Federal Court of Appeal in Hoffman-LaRoche, supra, particularly at paragraphs 19 and 20 in dealing with a product monograph indicates that bona fide substantive changes to a product monograph can sustain a patent listing against the related NOC.  Further, consideration must be given to the expertise of the Minister as stated by the Federal Court of Appeal  in Abbott Laboratories v. Canada (Minister of Health) (2004), 31 C.P.R. (4th) 321 at paragraph 21, questions of law are reviewable on a correctness standard while questions of fact and factual inferences are reviewed on the palpable and overriding standard.


[38]           While it can reasonably be said that the law is in a state of flux in this area, the law as it now stands directs the Minister to determine if there is a “relationship” or “relevance” between the “patented invention” of the ‘778 patent and the subject matter of the two NOCs in question namely “maintenance treatment of major depressive disorder” and “revisions to product monograph regarding nausea reduction”.  The Minister has, in law, created such relationship by listing the ‘778 patents against those NOCs.  While there is no record as to what factual deliberations, if any, the Minister undertook in establishing such relationship, one must presume that he did so deliberate and determined, factually, that such relationship existed.  This presumption would not arise in all cases where for instance, it was clear no such relationship existed.  However, where there is a reasonable dispute as to the facts and opinions necessary to establish such relationship, deference must be given to the Minister.


[39]           Therefore, the Court must conclude that there exists a sufficient relationship between the “patented invention” of the ‘778 patent and the NOCs of April 25, 2003 “maintenance treatment of major depressive disorder” and September 13, 2004, “revisions to product monograph regarding nausea reduction” such that, on this motion, listing of that patents against those NOCs should not be set aside.  As to the balance of the NOCs against which the ‘778 patent was listed, on the evidence and concessions of Wyeth’s counsel, those listings should be removed.


[40]           The motion is therefore dismissed in respect of the April 25, 2003 and September 13, 2004 NOCs and allowed in respect of those of March 14, 2003, June 13, 2003, December 10, 2004 and September 1, 2005.  Given the newness of the law in this area, and divided success there shall be no order as to costs.











            For the Reasons given, THIS COURT ORDERS that:


1.                  The motion is dismissed in respect of EFFEXOR XR capsule NOCs issued April 25, 2003 and September 13, 2004;


2.                  The motion is granted in respect of such NOCs dated March 14, 2003; June 13, 2003; December 10, 2004 and September 1, 2005 and the Minister is directed to de-list Canadian Patent No. 2,199,778 in respect of those NOCs.


3.                  No order as to costs.




“Roger T. Hughes”







DOCKET:                                          T-243-06


STYLE OF CAUSE:                          WYETH CANADA and WYETH v.

                                                            RATIOPHARM INC. and

                                                            THE MINISTER OF HEALTH



PLACE OF HEARING:                    Ottawa, Ontario


DATE OF HEARING:                      March 26, 2007



AND ORDER:                                   Hughes J.


DATED:                                             March 29, 2007





Mr. Anthony Creber

Mr. James E. Mills                                                                    FOR THE APPLICANTS


Mr. Glen Bloom                                                                       FOR THE RESPONDENT,

Mr. Markus Klee                                                                     RATIOPHARM INC.





Gowling Lafleur Henderson LLP

Ottawa, Ontario                                                                       FOR THE APPLICANTS


Osler Hoskin & Harcourt LLP                                                  FOR THE RESPONDENT,

Ottawa, Ontario                                                                       RATIOPHARM INC.


John H. Sims, Q.C.                                                                  FOR THE RESPONDENT,

Deputy Attorney General of Canada                                         MINISTER OF HEALTH

Ottawa, Ontario                                                                      


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