Pfizer Canada Inc. v. Rhoxalpharma Inc., 2005 FC 487

                                                                                                                                  Date: 20050412

Docket: T-807-03

Citation: 2005 FC 487

BETWEEN:

                                          PFIZER CANADA INC. and PFIZER INC.

                                                                                                                                           Applicants

                                                                           and

                          RHOXALPHARMA INC. and THE MINISTER OF HEALTH

                                                                                                                                      Respondents

                                                        REASONS FOR ORDER

KELEN J.

[1]                This is an application pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (Regulations) for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to the respondent Rhoxalpharma Inc. (Rhoxal) for the drug azithromycin until after the expiration of Canadian Patent No. 1,314,876 ('876 patent).

FACTS

Background

[2]                Pfizer manufactures antibiotic tablets containing azithromycin, which it markets under the trade-name Zithromax. The specific form of azithromycin manufactured and sold by Pfizer is crystalline azithromycin dihydrate (dihydrate). The dihydrate is disclosed in the '876 patent.

[3]                Rhoxal is seeking approval from the Minister of Health to market generic azithromycin tablets. As required by the Regulations, Rhoxal served Pfizer with a Notice of Allegation (NOA) in which it alleged that no claim for the medicine itself and no claim for the use of the medicine would be infringed by its plan to market azithromycin tablets.

[4]                In response to the NOA, Pfizer commenced this prohibition proceeding. The main issue is whether the NOA is deficient, not justified, and in the words of the Court of Appeal, "misleading or deceptive".

[5]                The Minister of Health filed no materials in response to the application and did not appear at the hearing.

The '876 Patent

[6]                The '876 patent was filed on July 7, 1988 and consists of five claims. The parties agree that the only claim relevant to this proceeding is Claim 1, which reads:

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. Crystalline azithromycin dihydrate.

[...]

[7]                Crystalline azithromycin dihydrate refers to a solid structure (i.e., a crystal) for which there are two water molecules for each molecule of azithromycin. It is to be distinguished from crystalline azithromycin monohydrate, for which there is one water molecule for each molecule of azithromycin.                   

[8]                The parties and the Court agree on the proper construction of Claim 1 of the patent. It claims a composition of matter and is a product per se claim that covers crystalline azithromycin dihydrate, regardless of how it is made. Therefore, if another party makes or uses dihydrate at any point during its manufacturing process or sells a product that contains dihydrate, they will have infringed Pfizer's patent.

The Notice of Allegation       

[9]                In a letter dated March 31, 2003, Rhoxal provided Pfizer with an NOA pursuant to subparagraph 5(1)(b)(iv) of the Regulations with respect to the '876 patent. Rhoxal alleged that:

[...]

...the Patent will not be infringed by issuance to Rhoxalpharma of the Notice of Compliance for the Rhoxalpharma Product. In particular, Rhoxalpharma alleges pursuant to section 5(1)(iv) of the Regulations that no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling of the Rhoxalpharma Product since the Rhoxalpharma Product does not contain azithromycin dihydrate, as defined in the patent disclosure.

[10]            The following legal and factual bases were provided in support of the allegation of non-infringement as required by paragraph 5(3)(a) of the Regulations:

Claim 1 claims "crystalline azithromycin dihydrate"

[...]

Crystalline azithromycin dihydrate, the invention, is defined in the disclosure to be "a "crystalline, non-hygroscopic dihydrate, prepared by crystallization from tetrahydrofuran and an aliphatic (C5-C7) hydrocarbon in the presence of at least two molar equivalents of water" (disclosure p. 2, lines 7-11)

A person skilled in the art would understand Claim 1 to mean that crystalline azitromycin which is crystallized in the presence of less than two molar equivalents of water, but stabalized in some other manner, would not infringe the Patent.

The Rhoxalpharma product will not infringe Claim 1, nor its dependent claims, because it will not be crystalline azithromycin dihydrate, as defined in the disclosure, or as the claim would be understood by a person skilled in the art in light of the disclosure, or at all; it will not be prepared by crystallization in the presence of at least two molar equivalents of water.

[...]

Further details of the Rhoxalpharma product will be provided when an appropriate confidentiality order is in place.

[11]            In these reasons, I will refer to the legal and factual bases as the "detailed statement".

Subsequent Disclosure

[12]            On June 18, 2003, a protective order was issued by Prothonotary Aronovitch.

[13]            On June 20, 2003, Rhoxal provided Pfizer with a copy of the Abbreviated New Drug Submission (ANDS) it had filed with the Minister of Health. The ANDS indicated that the raw material to be used in Rhoxal's tablets was azithromycin monohydrate. It also indicated that Rhoxal would not be manufacturing its own raw material, rather the material would be supplied by [Rhoxalpharma's supplier], a company based in Israel. [Rhoxalpharma's supplier] provided information about its manufacturing process directly to the Minister in a Drug Master File (DMF). Certain portions of the DMF were incorporated into the ANDS provided to Pfizer.

[14]            On July 23, 2003, Rhoxal provided Pfizer with samples of its raw and tableted azithromycin.

[15]            On March 12, 2004, Pfizer was provided with an unredacted copy of the DMF submitted to the Minister by Rhoxal's supplier. A revised (or more current) version of the DMF was also provided to Pfizer on May 15, 2004.

Evidence Before the Court

[16]            Pfizer retained two experts in support of its application for prohibition. Dr. Stephen Byrn is the Charles B. Jordan Professor of Medicinal Chemistry at Purdue University in Indiana and an industrial consultant who has acted on behalf of a number of pharmaceutical companies. He deposed that it is possible that dihydrate could be formed during the manufacture of another form of crystalline azithromycin (such as monohydrate). However, according to Dr. Byrn, the DMF provided Pfizer with insufficient details to reproduce the manufacturing process and determine whether dihydrate is likely formed. Dr. Byrn also deposed that the NOA contains a false statement of fact with respect to the number of molar equivalents of water (or "moles of water") used in the preparation of the raw azithromycin.

[17]            Pfizer's other expert, Dr. Robert Burk, is an Associate Professor of Chemistry at Carleton University in Ottawa. He confirmed that, based on the information contained in the DMF, Rhoxal's NOA contains a false statement regarding the number of moles of water used in the preparation of raw azithromycin.

[18]            Rhoxal also retained the services of two experts. Dr. Srebri Petrov is a research associate at the Department of Chemistry, University of Toronto. He tested samples of the finished azithromycin tablets as well as samples of the raw material using powder x-ray defraction, a tool used for      characterization of crystalline solids. He found the material to be azithromycin monohydrate and to contain no detectable amounts of dihydrate. Dr. Petrov also conducted an experiment to determine whether dihydrate or monohydrate is the more stable form of azithromycin. He placed azithromycin anhydrate (a non-crystalline form) in a container with a humidity level of 100 percent for a period of 48 hours. He then tested the material with a high resolution scan and found that the amorphous azithromycin had converted to azithromycin monohydrate with no detectable amounts of dihydrate present. Based on this evidence, Dr. Petrov concluded that the monohydrate used by Rhoxal is the more stable form of azithromycin and is unlikely to convert to dihydrate.

[19]            Rhoxal's other expert, Dr. Dennis Stynes, is an Associate Professor of Chemistry at York University in Toronto. He has developed considerable expertise in the area of crystallography. Dr. Stynes deposed that, based on the information contained in the DMF, a chemist skilled in the art would not expect azithromycin dihydrate to be formed during the manufacture of the raw material. Dr. Stynes also reviewed the experiment conducted by Dr. Petrov and concluded that the testing was done in an appropriate manner.

Related Proceedings

[20]            The patented medicine has been the subject of two previous prohibition proceedings in this Court. In Pfizer Canada Inc. v. Apotex Inc. (2004), 31 C.P.R. (4^th) 214, Justice Snider dismissed Pfizer's application for a writ of prohibition. She concluded that the NOA contained more than a bald statement of non-infringement and that there was sufficient information in the detailed statement to allow Pfizer to evaluate the allegation of non-infringement and prepare its case. Justice Snider also refused to draw an adverse inference against Apotex because it had failed to provide samples of its finished product and raw material to Pfizer. Pfizer had been given a copy of the ANDS and therefore had the means to determine, on a balance of probabilities, whether Apotex's product contained dihydrate. Finally, Justice Snider concluded that the evidence before the Court failed to establish that Apotex's allegation of non-infringement was not justified. In particular, she found that there was insufficient evidence to demonstrate that azithromycin monohydrate (contained in Apotex's product) was likely to convert to dihydrate over time.

[21]            In Pfizer Canada Inc. v. Novopharm Ltd. (2004), 36 C.P.R. (4^th) 117, Justice Gibson granted Pfizer's application for a writ of prohibition. He found the NOA to be inadequate because it did not address whether Novopharm's supplier would use or produce dihydrate during the manufacture of the raw azithromycin monohydrate. It appears that Novopharm argued that the manufacturing process was irrelevant because it took place outside Canada; therefore, it could not infringe a Canadian patent. Justice Gibson, relying on the decision of the Supreme Court of Canada in Monsanto Canada Inc. v. Schmeiser ,[2004] 1 S.C.R. 902, held that the manufacturing process was relevant and that if dihydrate was produced by the supplier, then Pfizer would be deprived indirectly of the monopoly granted by its patent.

ISSUES

[22]            This application raises two issues:

1.          Is the NOA, deficient, deceptive, misleading and not justified; and

2.          In the alternative, if the NOA can be construed as alleging that the Rhoxal product will not infringe Claim 1 of the '876 Patent because it will not contain dihydrate, has Pfizer demonstrated on a balance of probabilities that the allegation is not justified.

RELEVANT REGULATORY PROVISIONS

The Patented Medicines (Notice of Compliance) Regulations

[23]            In summary, the obligations of the generic drug company under these Regulations are to:

1.          make an allegation that the generic drug does not infringe the patent in issue; and

2.          provide a detailed statement of the legal and factual basis for the allegationof non-infringement.

ANALYSIS

Issue No. 1:     Is the NOA deficient, deceptive, misleading and not justified?

The jurisprudence regarding adequate and sufficient NOAs

[24]            Applications for prohibition under the Regulations are not actions for determining whether a patent is valid or whether a generic drug infringes a patent, rather they are proceedings to determine whether the Minister of Health may issue a Notice of Compliance. Before addressing whether the NOA in the present case is sufficient, it is useful to review the jurisprudence and highlight key principles with respect to NOAs. In Pharmacia v. Canada (1994), 58 C.P.R. (3d) 209, the Federal Court of Appeal held at page 216 that an application for prohibition turns on whether the allegations by the generic company are sufficiently substantiated to support a conclusion for the purpose of the Regulations that the applicant's patent would not be infringed.

[25]            In AB Hassle v. Minister of National Health and Welfare (2002), 7 C.P.R. (4^th) 272, the Court of Appeal held that the entire factual basis for the allegation of non-infringement be set forth in the detailed statement, rather than revealed piecemeal. The Court held at paragraph 23:

... The intent appears to be that the entire factual basis be set forth in the statement rather than be revealed piecemeal when some need happens to arise in a section 6 proceeding. This Court has cautioned persons in the position of the respondent that they assume a risk that a particular allegation may not be in compliance with the Regulations and that the deficiency cannot be cured by the Court in a section 6 proceeding.

This means that a generic drug company cannot cure deficiencies in the NOA as the evidence proceeds. In Pfizer v. Apotex, supra, Justice Snider held a generic can, subsequent to the issuance of an NOA, elaborate on the reasons why its generic drug will not infringe the patent. However, such elaboration cannot raise new reasons not already contained in the NOA.

[26]            In AB Hassle v. Apotex Inc. (2002), 21 C.P.R. (4^th)173 (F.C.T.D.), aff'd (2003), 29 C.P.R. (4^th) 23 (F.C.A.), I held that:

¶ 62.        The required scope of the NOA is higher than the mere assertion that the new drug lacks a subcoating between the core and the enteric coating. The NOA must provide adequate and sufficient details of the factual and legal basis for     claiming non-infringement.

¶ 63.         The NOA must provide all of the facts the generic producer intends to rely upon in subsequent prohibition proceedings and it cannot rely on facts that exceed those laid out in the NOA. The NOA must address all of the patent claims that describe the basic invention or else its NOA will be defective and not in compliance with s. 5 of the Regulations. See Procter & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health), 2002 FCA 290 ("Genpharm") [now reported 20 C.P.R. (4^th) 1], per Rothstein J.A. at paras. 22 to 25:

[22] However, the notices of allegation and the detailed statement of legal and factual basis for the allegation must provide all the facts the generic producer intends to rely upon in subsequent prohibition proceedings. It cannot rely on facts that exceed those laid out in its detailed statement. See Merck Frosst Canada Inc. v. Canada (Minister of Health) [(2001), 12 C.P.R. (4^th) 447] at para. 19 per Stone J.A.

[23] The requirement of subpara. 5(1)(b)(iv) that the generic producer "allege that ... no claim for the medicine itself and no claim for the use of the medicine would be infringed" necessarily implies that the detailed statement must provide the legal and factual basis for the allegation that none of the patent claims will be infringed.

...

[27]            As the Court of Appeal held in Bayer AG v. Minister of National Health and Welfare (1995), 60 C.P.R. (3d) 129 at page 134:

... those who fail to file Notices of Allegation, or inadequate Notices of Allegation, must assume their own risks when it comes to attacks on the adequacy of such allegations once prohibition proceedings are commenced before the Court.

[28]            Justice Hugessen held in Glaxo Group Inc. v. Minister of Health and Welfare (1998), 80 C.P.R. (3d) 424 (F.C.T.D.) at paragraph 7:

... The allegation is, in my view, a specific allegation of fact which is at the foundation of an assertion of non-infringement ...

[29]            As the Federal Court of Appeal held in Merck Frosst Canada Inc. v. Minister of National Health (1994), 55 C.P.R. (3d) 302, Hugessen J.A. (as he then was) at page 319:

As I understand the scheme of the regulations, it is the party moving under section 6, in this case Merck, which as the initiator of the proceedings, has the carriage of the litigation and bears the initial burden of proof. That burden, as it seems to me, is a difficult one since it must be to disprove some or all of the allegations in the Notice of Allegation which if left unchallenged, would allow the Minister to issue a Notice of Compliance.

The jurisprudence regarding misleading or deceptive NOAs

[30]            The Federal Court of Appeal has held that if a generic producer files a deceptive or misleading NOA, it risks serious consequences, which include an order of prohibition. In Syntex (U.S.A.) LLC v. Canada (Minister of Health) (2002), 20 C.P.R.(4th) 29 at paragraph 11 per Rothstein J.A.:

... Under the Regulations, a deceptive or misleading notice of allegation may be found to be defective with the result that the allegation of non-infringement will be determined not to be justified by the generic producer, in which case, an order of prohibition will be granted. ...

[31]               In Hoffmann-La Roche Ltd. v. Minister of National Health and Welfare (1996), 70 C.P.R. (3d) 206 at page 213, the Federal Court of Appeal held per Stone J.A.:

... The obligation of the Respondent under the Regulations was to faithfully comply with the requirements of subsections 5(1) and (3). With reference to subparagraphs 5(3)(a) this meant the providing of a detailed statement of the "legal and factual basis for the allegation"(Emphasis added). ... I have no doubt, nevertheless, that such an allegation is intended to be accurate. Once a second person's product reaches the market the first person is in a position to test the accuracy of the detailed statement; if it were shown to be inaccurate, the consequences for a second person could well be very grave indeed.

...

[32]            The jurisprudence indicates that an application for prohibition may be granted if the NOA is misleading or deceptive.

Construing the NOA in this case

[33]            To properly construe the NOA in this case, it is necessary to consider the actual language used by Rhoxal. The allegation states that the patent will not be infringed because the "Rhoxalpharma Product does not contain azithromycin dihydrate, as defined in the patent disclosure." Rhoxal urges the Court to read the allegation broadly to mean that the product "will not contain crystalline azithromycin dihydrate", and to disregard "as defined in the patent disclosure".

However, to read the allegation in such a fashion is to ignore part of the sentence specifically included in the allegation. Every word is presumed to have a meaning, and the Court cannot ignore certain words because they do not advance the interpretation sought by Rhoxal. The qualifier "as defined in the patent disclosure" must have a meaning.

[34]            A review of the detailed statement confirms this conclusion. The detailed statement provides that:

Crystalline azithromycin dihydrate, the invention, is defined in the disclosure to be "a "crystalline, non-hygroscopic dihydrate, prepared by crystallization from tetrahydrofuran and an aliphatic (C5-C7) hydrocarbon in the presence of at least two molar equivalents of water" (disclosure p.2, lines 7-11)

A person skilled in the art would understand Claim 1 to mean that crystalline azitromycin which is crystallized in the presence of less than two molar equivalents of water, but stabalized in some other manner, would not infringe the Patent.

The Rhoxalpharma product will not infringe Claim 1, nor its dependent claims, because it will not be crystalline azithromycin dihydrate, as defined in the disclosure, or as the claim would be understood by a person skilled in the art in light of the disclosure, or at all; it will not be prepared by crystallization in the presence of at least two molar equivalents of water.

[35]            In my view, the detailed statement states that the Rhoxal product will not infringe Claim 1 because it will not be prepared in the presence of at least two molar equivalents of water. In its written memorandum, Rhoxal implies that the detailed statement actually provides two bases for why its product will not infringe the '876 patent. The first is that the proposed product will not be prepared in the presence of at least two molar equivalents of water. The second is that the Rhoxal product "will not be crystalline azithromycin dihydrate...at all." In other words, it will not contain dihydrate. At the hearing, counsel for Rhoxal made no submissions with respect to the meaning of the words "at all". However, because Rhoxal has raised the issue in its written memorandum, I have tried to understand and give meaning to the phrase. In my view, these words are not clear and I cannot find that they mean that the generic drug will not infringe because it will not contain dihydrate. This interpretation is reinforced by the semi-colon which follows the words "at all" and links the previous parts of the paragraph to the fact that the generic drug will not infringe because "it will not prepared by crystallization in the presence of at least two molar equivalents of water." I conclude that, on a plain reading of the detailed statement, the reference to two molar equivalents of water serves as the sole factual basis for why the proposed product will not contain dihydrate and will not infringe the '876 patent.

[36]            As did McGillis J. in SmithKline Beecham Inc. v. Apotex Inc. (1999), 1 C.P.R. (4^th) 99 and Snider J. in Pfizer v. Apotex, supra, I have analyzed the wording of the NOA in its totality to determine if it could be construed as submitted by the generic, i.e., that Rhoxal's drug would not infringe because it would not contain dihydrate. As hard as I have tried, I cannot come to this conclusion.

[37]            Justice McGillis and Justice Snider in their respective cases were satisfied that the NOA, while failing to address certain issues, was so broadly framed that it could be construed as being sufficient. This cannot be said about the NOA in this case.

[38]            While the respondent submits that Pfizer did not have to guess at the real grounds why the generic drug would not infringe the patent, I think the opposite is true. The NOA was so deficient that Pfizer needed to guess at other reasons why the generic drug would infringe. Although Pfizer submitted alternative arguments and addressed some evidence in support of these arguments, the thrust of its evidence was focused on the detailed statement and the allegation contained therein that Rhoxal's drug was not crystalized in the presence of at least two molar equivalents of water. Pfizer tried unsuccessfully to introduce further evidence once it discovered in cross-examination that the reference to two moles of water was incorrect. If the NOA and detailed statement had clearly set out other reasons why the generic drug would not infringe the patent (for example, that it would not contain dihydrate), then it is likely Pfizer would have adduced different evidence at the outset of the proceedings.

The Evidence

[39]            There is clear evidence that Rhoxal's azithromycin product will be prepared in excess of two molar equivalents of water. Drs. Byrn and Burk, on behalf of Pfizer, deposed that hundreds of moles of water are used at each stage of the production of Rhoxal's raw azithromycin material.

[40]            Moreover, Dr. Dennis Stynes, an expert retained by Rhoxal, was cross-examined on this point. He agreed that the raw material is crystallized in the presence of more than two molar equivalents of water. At the hearing, counsel for Rhoxal conceded that the product will be prepared in the presence of at least two molar equivalents of water. In view of the uncontradicted evidence, the Court concludes that the allegation contained in Rhoxal's detailed statement that the proposed product "will not be prepared in the presence of at least two molar equivalents of water" is incorrect.

Conclusion with respect to the NOA

[41]            An NOA frames the case which the patentee must meet. If the NOA contains false information and is deficient, the Court should allow the application for prohibition and prohibit the Minister from issuing the NOC.

[42]            In the case at bar, Pfizer has satisfied its heavy burden of proof. It has proven that the allegation that the Rhoxal product does not infringe because it is crystallized in the presence of less than two moles of water is false. Accordingly, the NOA is not justified, and contains false information which could be considered deceptive and misleading. Rhoxal asked the Court to construe the NOA to mean that its drug would not contain dihydrate. The Court cannot read the NOA in this fashion. Therefore, the NOA is deficient in this regard.

[43]            Rhoxal can file a new NOA and Pfizer can file a new application for prohibition. However, Rhoxal cannot rewrite its NOA in the middle of the proceeding as this could prejudice Pfizer. The NOA is a legal document intended to have legal effect.

Issue No. 2:     In the alternative that the NOA can be construed as alleging that the Rhoxal product will not infringe Claim 1 of the '876 Patent because it will not contain dihydrate, has Pfizer demonstrated, on a balance of probabilities, that the allegation is not justified?

[44]            If I am wrong in my conclusion with respect to Issue No. 1, I find that the applicants have not demonstrated, on a balance of probabilities, that dihydrate would be formed during the manufacture of the raw azithromycin material, or that the finished tablets would contain dihydrate. In this alternative, I would dismiss the application for the following reasons.

[45]            Dr. Petrov, on behalf of Rhoxal, tested the raw and tableted azithromycin using powder X-ray defraction and found no detectable levels of dihydrate. Pfizer was provided with samples of the raw material and finished tablets on July 23, 2003, but chose not to conduct its own tests to determine if the materials contained dihydrate. At the hearing, counsel for Pfizer conceded that there was no evidence that the Rhoxal tablets or raw material contained dihydrate. Accordingly, the Court concludes that Pfizer has not discharged its burden on this point. Similarly, Pfizer has provided insufficient evidence to demonstrate that the raw material or tablets are likely to convert to dihydrate while in storage.

[46]            Pfizer submits that although the final materials may not contain dihydrate, it is possible that dihydrate could be formed as a by-product during the purification and manufacture of the raw azithromycin material. However, Pfizer says that it cannot substantiate this because the DMF contains insufficient details to enable it to replicate [Rhoxalpharma's supplier's] manufacturing process. Accordingly, Pfizer urges the Court to draw an adverse inference against Rhoxal with respect to whether dihydrate is produced during the manufacture of raw azithromycin. I have reviewed the DMF and am satisfied that it contains sufficient information to allow Pfizer to evaluate whether dihydrate is likely formed during any of the purification steps and to conduct reasonable tests. I do not draw an adverse inference against Rhoxal on this point.

CONCLUSION

[47]            I am satisfied that Pfizer has proven that the NOA is not justified, is deficient, and contains false information which could be considered deceptive and misleading. For this reason, I will allow this application for an order prohibiting the Minister of Health from issuing the NOC in this case.

                                       "Michael A. Kelen"                                                                                                       _______________________________

             JUDGE

OTTAWA, Ontario

April 12, 2005

                                                             FEDERAL COURT

                            NAMES OF COUNSEL AND SOLICITORS OF RECORD

DOCKET:                                           T-807-03

STYLE OF CAUSE:              PFIZER CANADA INC. and PFIZER INC.v.

RHOXALPHARMA INC. and THE MINISTER OF HEALTH

PLACE OF HEARING:                     Ottawa, Ontario

DATE OF HEARING:                       March 29^th and March 30^th , 2005

REASONS FOR ORDER :             KELEN J.

DATED:                                              April 12^th, 2005            

APPEARANCES:

Mr. Anthony Creber and

Ms. Jennifer Wilkie                                FOR THE APPLICANTS

Mr. Edward Hore and

Mr. Kevin Zive                         FOR THE RESPONDENT RhoxalPharma Inc.

No appearance                                     FOR THE RESPONDENT Minister of Health

SOLICITORS OF RECORD:

Gowling Lafleur Henderson LLP

Ottawa, Ontario                                    FOR THE APPLICANTS

Hazzard & Hore

Toronto, Ontario                                   FOR THE RESPONDENT RhoxalPharma Inc.

John H. Sims

Deputy Attorney General of Canada     FOR THE RESPONDENT Minister of Health

                         FEDERAL COURT

                                                          Date: 20050412

                                                       Docket: T-807-03

BETWEEN:

PFIZER CANADA INC. and PFIZER INC.

                                                                   Applicants

and

RHOXALPHARMA INC. and THE MINISTER OF HEALTH

                                                              Respondents

REASONS FOR ORDER