Fournier Pharma Inc. v. Canada (Minister of Health), 2004 FC 1718

Date: 20041214

Docket: T-371-03

Citation: 2004 FC 1718

BETWEEN:

                                                  FOURNIER PHARMA INC. and

LABORATOIRES FOURNIER S.A.

                                                                                                                                           Applicants

                                                                           and

                                                THE MINISTER OF HEALTH and

CIPHER PHARMACEUTICALS LIMITED

                                                                                                                                      Respondents

                                                        REASONS FOR ORDER

_Confidential Reasons for Order issued December 9, 2004_

LAYDEN-STEVENSON J.

[1]                Fenofibrate is a cholesterol-reducing drug. It is a lipid metabolism regulator that reduces the amount of low-density lipoproteins (bad cholesterol) in the blood and increases the fraction of high-density lipoproteins (good cholesterol) in the blood. The Canadian patent with respect to the process for making the active drug substance (fenofibrate) itself has expired. Formulations containing fenofibrate may be patented.

THE APPLICATION AND THE PARTIES

[2]                Laboratoires Fournier S.A. is the owner of Canadian patent 2,219,475 (the '475 patent) and Fournier Pharma Inc. is the exclusive licensee of the patent (together Fournier). Fournier received regulatory approval to market different formulations of fenofibrate in Canada. Fournier's LIPIDIL MICRO brand of fenofibrate capsules has been available in Canada in 67 mg and 200 mg dosage strengths since March, 1995. Fournier's LIPIDIL SUPRA brand of fenofibrate tablets in 100 mg and 160 mg dosage strengths has been available in Canada since May, 2000.

[3]                The '475 patent was listed - under the Patented Medicine (Notice of Compliance) Regulations, SOR/93-133, as amended (the Regulations) - on patent lists for Fournier's 100 mg and 160 mg LIPIDIL SUPRA fenofibrate tablets. The '475 patent relates to compositions of the drug fenofibrate, specifically to immediate release formulations of fenofibrate in particular oral dosage forms.

[4]                Cipher Pharmaceuticals Limited (Cipher) filed an abbreviated new drug submission (ANDS) with the Minister of Health (the Minister) seeking a notice of compliance (NOC) for its 100 mg and 160 mg fenofibrate capsules (Cipher capsules). Cipher's submissions compared the Cipher capsules with Fournier's LIPIDIL SUPRA brand fenofibrate tablets. Cipher, in accordance with the Regulations, served a notice of allegation (NOA) on Fournier alleging that the Cipher capsules will not infringe the '475 patent.

[5]                Fournier filed a notice of application under the Regulations and seeks an order prohibiting the Minister from issuing a NOC to Cipher for its 100 mg and 160 mg fenofibrate capsules until after the expiration of the '475 patent. The Minister administers the Regulations. The Minister did not file submissions and was not represented at the hearing of the application.

THE NATURE OF THE PROCEEDING

[6]                As noted, this proceeding is brought under the Regulations. The history and scheme of the Regulations have been delineated in various decisions of the Federal Court of Appeal and need not be repeated here. See: Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.); AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4^th) 272 (F.C.A.); Novartis AG et al. v. Abbott Laboratories Ltd. et al. (2000), 7 C.P.R. (4^th) 264 (F.C.A.). Basically, issues of non-infringement and validity between the patent holder (first person) and the person seeking a NOC from the Minister (second person) originate with a NOA, served on the first person by the second person, setting out the second person's allegations, including the legal and factual basis in support. The first person may disagree and apply to the court for an order prohibiting the Minister from issuing a NOC to the second person until after expiration of the patent.

[7]                Cipher (the second person) wishes to distribute, in Canada, a formulation containing fenofibrate by comparing the formulation it wishes to market with that of Fournier (the first person) already approved by the Minister. Under section 5 of the Regulations, Cipher provided a NOA to Fournier in respect of the '475 patent that Fournier has listed under the provisions of section 4 of the Regulations. Cipher's NOA relates only to Fournier's LIPIDIL SUPRA formulation. Fournier's application under subsection 6(1) of the Regulations is in response to Cipher's NOA.

[8]                Section 6 proceedings are not to be likened to actions for determining validity or infringement. They are proceedings in judicial review, to be held expeditiously, whose aim is to determine whether the Minister is free to issue the requested NOC. Their scope is confined to administrative purposes: Apotex Inc. v. Canada (Minister of National Health and Welfare) (1997), 76 C.P.R. (3d) 1 (F.C.A.). The determination must turn on whether there are allegations by the second person sufficiently substantiated to support a conclusion for administrative purposes (the issuance of a NOC) that an applicant's patent would not be infringed if the second person's product is put on the market: Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) 209 (F.C.A.).

[9]              By merely commencing the proceeding, the applicant obtains what is tantamount to an interlocutory injunction without having satisfied any of the criteria a court would require before enjoining issuance of a NOC: Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1998), 80 C.P.R. (3d) 368 (S.C.C.); Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General) (2001), 11 C.P.R. (4^th) 539 (F.C.A.). The Regulations allow a court to determine summarily, on the basis of the evidence adduced, whether the allegations are justified. Section 6 proceedings are not adjudicative and cannot be treated as res judicata. The patentee is in no way deprived of all the recourses normally available to enable it to enforce its rights. If a full trial of validity or infringement issues is required, this can be obtained in the usual way by commencing an action: Pfizer Canada Inc. v. Apotex Inc. (2001), 11 C.P.R. (4^th) 245 (F.C.A.); SmithKline Beecham Pharma Inc. v. Apotex Inc. (2001), 14 C.P.R. (4^th) 76 (F.C.T.D.) aff'd. (2002), 21 C.P.R. (4^th) 129 (F.C.A.); Novatis A.G. v. Apotex Inc. (2002), 22 C.P.R. (4^th) 450 (F.C.A.)

THE NOA

[10]            A copy of Cipher's complete NOA is attached to these reasons as Schedule "A". Essentially, Cipher's NOA states that it does not infringe any of claims 1 to 13 or 17 to 20 of the '475 patent. Claims 14 to 16 are process claims. The NOA refers to a purposive construction of the patent and specifies the essential elements of the relevant claims as:

- fenofibrate in an "immediate release" formulation;

- fenofibrate in "micronized form";

- micronized fenofibrate on an "inert hydrosoluble support or carrier".

[11]            The NOA sets out Cipher's position regarding non-infringement. First, it says that the Cipher capsules are not an immediate release formulation. Referring to the disclosure of the patent, Cipher construes "immediate release" to mean a dissolution greater than 10% in five minutes, 20% in ten minutes, 50% in twenty minutes and 75% in thirty minutes (henceforth to be referred to as the "dissolution profile") when measured using a particular method as described in the '475 patent. Second, the NOA states that the fenofibrate in the Cipher product is not micronized. Cipher construes the phrase "micronized form", by reference to the definition in the disclosure, as a substance in particulate form, the dimension of the particles being less than or equal to 20 Fm (one Fm is one millionth of a metre and is usually referred to as a micron). Third, the NOA states that the Cipher capsules contain no support in particulate form and no support that is coated with micronized fenofibrate. In this respect, Cipher relies on the definition of "inert hydrosoluble support" in the disclosure and says that the support must be in the form of a particle that is covered with at least one layer of micronized fenofibrate. Its product contains neither.

[12]            In sum, the NOA states that the Cipher capsules are not immediate release fenofibrate compositions, are not micronized, and contain no support in particulate form and no support that is coated with micronized fenofibrate. The Cipher product, according to the NOA, consists of non-micronized fenofibrate (the medicinal or active ingredient) and other excipients (non-active or non-medicinal ingredients) that are melted together to form, on cooling, a homogeneous phase or paste.

[13]            The NOA also claims that the formulation of the Cipher product is disclosed and claimed by U.S. patent 5,545,628 Deboeck et al. (The "Deboeck patent") and that any litigation would be an abuse of process as a result of the formulation of the Cipher product being disclosed in a patent filed prior to the '475 patent.

[14]            Last, it claims that since the Cipher capsules do not infringe claim 1, they do not infringe claims 2 through 13 of the '475 patent which are dependent claims. Claim 17 is an independent claim that is directed to a suspension of fenofibrate in micronized form with a particle size less than 20 Fm, in a solution of hydrophilic polymer (a water-loving chemical compound or compounds, i.e., will dissolve or form a gel in water). Since the fenofibrate in Cipher's product is not in micronized form and does not exist in the form of particles, the Cipher capsules do not infringe claim 17 and cannot infringe claims 18 to 20, which are dependent on claim 17.

ISSUES

[15]            The legal issue is whether Cipher's allegation of non-infringement is justified. The factual issues are whether, on a proper construction of the '475 patent, the Cipher capsules:

(a)         are an immediate release fenofibrate composition;

(b)         contain fenofibrate in a micronized form; and

(c)         contain at least one layer of micronized fenofibrate on an inert hydrosoluble carrier.   

THE '475 PATENT

[16]            The '475 patent, in the French language, was filed on December 11, 1997, with a priority date of January 17, 1997, and issued on July 9, 2002, in respect of 100 mg and 160 mg fenofibrate tablets (LIPIDIL SUPRA). The patent has been translated. The parties have used the English translation that forms part of the records. The '475 patent is entitled "Fenofibrate Pharmaceutical Composition Presenting High Bioavailability And Its Preparation Process". It describes fenofibrate as a known drug that, because of its low hydrosolubility, is poorly absorbed in the digestive tract. This impacts on its bioavailability (the rate and extent of absorption by the body).

[17]            The '475 patent describes, as prior art, a patented procedure where fenofibrate, co-micronized with a solid surfactant (a chemical compound that decreases surface tension of liquids - used to assist insoluble drugs to dissolve in a solvent) provides improved fenofibrate dissolution and thus increased bioavailability. The patentee states that there is still a need to improve bioavailability to achieve a dissolution profile approaching 100%. The patent teaches "a new method for preparing a pharmaceutical composition in which a suspension of the active ingredient is sprayed on an inert hydrosoluble carrier". The '475 patent relates to immediate release formulations of fenofibrate in particular oral dosage forms.

[18]            As noted earlier, there are 20 claims, 3 of which (14-16) are process claims. Claim 1 and dependent claims 2-13 are directed to an immediate release fenofibrate composition and claims 17-20 describe a suspension of fenofibrate in a micronized form in a solution of hydrophilic polymer. The claims of the '475 patent are attached as Schedule "B". For ease of reference, claim 1 is reproduced here.

1. An immediate release fenofibrate composition comprising:

(a)            an inert hydrosoluble carrier covered with at least

one layer containing fenofibrate in micronized form having

a size less than 20 Fm, a hydrophilic polymer and optionally

a surfactant, said hydrophilic polymer making up at least

20% by weight of (a); and

(b)            optionally one or more outer phase(s) or layer(s).                   

[19]            Thus, the immediate release fenofibrate composition of claim 1 has three ingredients:

(a)         an inert insoluble carrier;

(b)         at least one layer of micronized fenofibrate of less than 20 Fm;

(c)         at least 20%, by weight, of a hydrophilic polymer.         

THE EVIDENCE

[20]            Both Fournier and Cipher submitted affidavits from both formulation experts and corporate officials. All affiants were cross-examined. There was no challenge, from either side, regarding the qualifications and expertise of the proposed expert witnesses.

[21]            Fournier relied on the evidence of two witnesses.

(1)         Mr. Graham Jobson, who swore an affidavit on May 12, 2003, is the president of Fournier Pharma Inc. Mr. Jobson attested to the procedural background relative to this matter and provided information with respect to Fournier's LIPIDIL SUPRA fenofibrate tablets marketed in Canada.

(2)         Dr. Arthur H. Goldberg, who swore an affidavit on May 10, 2003 and a supplementary affidavit on August 26, 2003, is the president and principal consultant of Pharmaceutical Development Group, Inc. in Melo Park, California. He provides various consulting services to the pharmaceutical industry. Dr. Goldberg received his Ph.D. in pharmaceutical chemistry from the University of Michigan in 1968. For approximately 35 years, he has held various adjunct teaching positions at several universities and has approximately 30 years experience in the pharmaceutical industry. He is an inventor on 14 patents (5 of which relate to novel dosage forms) and has written not less than 25 papers, many dealing with the dissolution rates and gastrointestinal absorption of drugs.

[22]            Cipher also relied on the evidence of two witnesses.

(1)         Dr. Ian W. French, who swore an affidavit on June 25, 2003, is the chairman and chief scientific officer of Cipher Pharmaceuticals Limited. Dr. French obtained his Ph.D. in biochemistry at the University of Toronto in 1963. He has more than 35 years experience in the pharmaceutical industry. In addition to his position with Cipher, he has been president and chief operating officer of Pharma Medica Research Inc. since 1997 and president of IWF Consulting Services Ltd. since 1993. Dr. French provided general information with respect to: the drug approval process in Canada; pharmaceutical formulation; the '475 patent; the NOA; and the proceedings under the Regulations. He also provided a description of Cipher's fenofibrate product and the manufacturing process for it. He was not offered as an expert witness.

(2)         Dr. Christopher T. Rhodes, who swore an affidavit on June 26, 2003, is a professor of applied pharmaceutical science at the University of Rhode Island and a consultant to the pharmaceutical industry.    He obtained his Ph.D. from the University of London in 1964. In addition to his academic teaching, research, and service activities, he provides consultancy services to government agencies and various organizations in North America and Western Europe. He has conducted extensive research on the development, evaluation, and regulatory approval of pharmaceutical products and has published in excess of 250 research and review papers, chapters, and texts on a variety of topics including suspensions and other pharmaceutical disperse systems, the properties of disintegrants, and the design and evaluation of dissolution and bioavailability tests.

IMMEDIATE RELEASE

Cipher's Position

[23]            Cipher submits that the term"immediate release" in claim 1 of the '475 patent is properly interpreted by reference to the dissolution profile that is specified in the disclosure as well as in claim 12 of the '475 patent. The fenofibrate contained in the Cipher capsules dissolves much more slowly than the rates specified in the dissolution profile because of the hard gelatin capsule coating. The evidence of Dr. Rhodes describes a lag time (of five to ten minutes) for the gelatin coating to melt and disrupt during which little, if any, of the active ingredient can dissolve.

[24]            When construing this part of the claim, Cipher argues that the relevant question is - what is the problem that the patent is designed to overcome? The disclosure specifically states that there exists a need to improve the bioavailability of fenofibrate in order to achieve, in the shortest time possible, a level approaching 100% or, in any case, exceeding the limitations [of the dissolution profile]. Although there exists a presumption of claim differentiation, the presumption is rebuttable. In the instant case, homage can be paid to both the intention of the inventor and the principles of claim construction.

Fournier's Position

[25]            Fournier maintains that a skilled formulator would not consider the phrase "immediate release" to be limited to the dissolution profile specified in claim 12 of the '475 patent. A skilled formulator would consider a formulation to be immediate release if the formulation does not contain anything that delays dissolution of the active ingredient once the drug product is ingested. The Cipher product, argues Fournier, contains nothing that would delay the release of fenofibrate once the gelatin capsule shell is dissolved.

[26]            Additionally, Fournier asserts that the specification in claim 12 (a dependent claim) of the '475 patent cannot be used to interpret claim 1 (a general claim). It has long been a principle of claim construction that each claim in a patent ought to be given a separate and distinct meaning. Moreover, while Cipher contends that the hard gelatin coating of its capsule delays the release of the fenofibrate, Fournier notes that the book Modern Pharmaceutics, which Dr. Rhodes co-edits, contains an example of the dissolution of a gelatin capsule faster than 10% in 5 minutes.

Analysis

[27]            There is consensus regarding the standard of proof in section 6 proceedings. While citing various authorities - and there exists a plethora - it is common ground that the allegations of non-infringement are presumed to be true and the applicant must disprove, on a balance of probabilities, all of the allegations made which, if left unchallenged, would allow the Minister to issue a NOC: Merck Frosst Canada Inc., supra; SmithKline Beecham Inc., supra. The burden is on the applicant to establish that the evidence that has been provided by the respondent does not justify the allegation: Hoffman-LaRoche Ltd. v. Canada (Minister of National Health and Welfare) (1996), 67 C.P.R. (3d) 484 (F.C.T.D.) aff'd. (1996), 70 C.P.R. (3d) 1 (F.C.A.).

[28]            The parties, by further written submissions after the release of Procter & Gamble Pharmaceuticals Canada Inc. v. Canada ( Minister of Health) 2004 FCA 393, agreed that the judgment of the Federal Court of Appeal does not "change the law with respect to the burden of proof when non-infringement is alleged". To the extent that Cipher's supplementary submissions reiterate its arguments, those submissions have been ignored.

[29]            The first step in the analysis is to construe the claims of the patent as they would be interpreted by a person skilled in the art. The parties agree, for present purposes, that the person skilled in the art is the skilled pharmaceutical formulator. As noted, claims 2-13 are dependent claims that relate back to claim 1. In Canamould Extrusions Ltd. et al. v. Driangle Inc. (2003), 25 C.P.R. (4^th) 343 (F.C.T.D.) aff'd. (2004), 30 C.P.R. (4^th) 129 (F.C.A.), I summarized a number of principles emanating from the companion decisions Free World Trust v. Électro Santé Inc. (2000), 9 C.P.R. (4^th) 168 (S.C.C.) and Whirlpool Corporation v. Camco Inc. (2000), 9 C.P.R. (4^th) 129 (S.C.C.). My comments are apposite for present purposes and the parties agree that the applicable law is derived principally from these sources.

Patent construction is antecedent to issues of validity and infringement.

The patent is to be construed as of the date of its publication. The Patent

Act, R.S.C. 1985, c. P-4 (the Act) and purposive construction promote

adherence to the claims and this in turn promotes fairness and predictability.

The claims perform a public notice function by setting out the scope

of the monopoly so that the public may know where it may go with impunity.

The claim language must be read in an informed and purposive way. Claim

interpretation is neither literal nor based on vague notions such as the

"spirit of the invention".    The more scope for searching for the

"spirit of the invention" and the "pith and substance" of the invention, the

less the claims can perform their public function. A patent falls within the

definition of "regulation" in the Interpretation Act, R.S.C. 1985, c. I-21 and as

such merits a construction that best assures attainment of its objects. The

inventor's intention is manifested in the patent claims as interpreted by a

person skilled in the art. The average person skilled in the particular art

of the patent is not a grammarian or etymologist and does not indulge in a

meticulous and verbal analysis.

The content of a patent specification is regulated by section 27 of the Act.

The disclosure is the quid provided by the inventor in exchange for the quo

of the monopoly. An inventor is not obliged to claim a monopoly on everything

new, ingenious and useful disclosed in the specification. The usual rule is that

what is not claimed is considered disclaimed. Regard may be had to the

specification to understand what is meant by a word in a claim, but not to

enlarge or contract the scope of the claim as written and thus understood.

The claims and the disclosure are construed with a mind willing to understand.

The words chosen by the inventor will be read in the sense that the inventor

intended and in a way that is sympathetic to the accomplishment of the

inventor's purpose, expressed or implicit, in the text of the claims. If the

inventor, however, has misspoken or otherwise created an unnecessary

or troublesome limitation in the claims, it is a self-inflicted wound. The

public is entitled to rely on the words used provided the words used are

interpreted fairly and knowledgeably.          

[30]            Additionally, it is important to recall that while recourse can be had to the disclosure to understand ambiguous terms in the claims, it is not appropriate to use the disclosure to impose limitations on the claims where no such limitations exist on a fair reading of the claims: Dableh v. Ontario Hydro (1996), 68 C.P.R. (3d) 129 (F.C.A.); Apotex v. Wellcome Foundation Ltd. (1998), 79 C.P.R. (3d) 193 (F.C.T.D.) appeal allowed in part but not on this point (2000), 10 C.P.R. (4^th) 65 (F.C.A.) aff'd. (2002), 21 C.P.R. (4^th) 499 (S.C.C.). Where some claims are broad and others narrow, the narrow claim limitations cannot be read into the broad, whether to avoid invalidity or to escape infringement. The principle of claim differentiation is treated as a rebuttable presumption. The presumption is especially strong when the limitation in dispute is the only meaningful difference between an independent and a dependent claim and one party is arguing that the limitation in the dependent claim should be read into the independent claim: Halford v. Seed Hawk Inc. (2004), 246 F.T.R. 1 (F.C.).

[31]            The task of construing a patent's claims lies within the exclusive domain of the [applications] judge: Dableh, supra. Expert evidence may be admitted for the purpose of explaining the meaning of the terms used: Free World Trust, supra. Both Drs. Rhodes and Goldberg provided evidence regarding the meaning of the term "immediate release", which is not defined in the patent.

[32]            Dr. Rhodes expects that a skilled pharmaceutical formulator would interpret the term "immediate release" in accordance with the dissolution profile. He states that the term refers to products whose dissolution is so rapid as to be almost "immediate". He specifically notes the patent's stated purpose, the disclosure, figures 1 and 2, and claim 12, and concludes that the skilled formulator is "given a very strong indication of the intent of the patentee for the importance attached to the very rapid (i.e. immediate) dissolution": Rhodes affidavit at paras. 128 and 129.

[33]            Dr. Goldberg contends that a skilled formulator would consider a solid oral dosage form of a pharmaceutical composition to be an immediate release composition if the composition does not contain a mechanism by which the body's absorption of the drug is delayed by the dosage form. A skilled formulator "would consider a pharmaceutical composition to be an immediate release composition if the composition does not exhibit sustained or delayed release of the active ingredient": Goldberg affidavit at paras. 12 and 43.

[34]            Despite Cipher's forceful submissions, the term "immediate release" in claim 1 should not be construed as incorporating the dissolution profile in claim 12. Such an approach, in my view, does not accord with the jurisprudence. I appreciate that the disclosure incorporates the dissolution profile, but the reference in the disclosure contains wording identical to that in claim 12. To hold otherwise would render claim 12 redundant. The dependent claim 12 cannot be read in to limit the independent claim 1.

[35]            There is no other evidence regarding the meaning of the term and therefore I accept the construction provided by Dr. Goldberg - that a pharmaceutical composition is "immediate release" if it does not contain a mechanism by which the release and absorption of the drug is delayed or controlled. Having construed the term, I turn now to Cipher's allegation that its capsule is not an "immediate release" product.

[36]            Dr. Rhodes maintains that the hard gelatin capsule formulation cannot dissolve quickly. He explains that in vitro dissolution will show a lag period (the time required for the gelatin shell to melt and disrupt to enable the capsule contents to be released). This lag time is between five and ten minutes. During this period little, if any, of the drug is able to dissolve.

[37]            Dr. Goldberg, on the other hand, takes the position that the Cipher product contains no ingredient by which the absorption of fenofibrate by the body will be delayed or controlled. For    example, a coating could be used to delay the release of the drug until the drug is in the intestine. Dr. Goldberg claims that the excipients used in the Cipher product and the method of manufacturing the product will not result in any delay to, or control of, the dissolution of the fenofibrate once the Cipher capsules are ingested.

[38]            Basically, I must determine whether the Cipher product has to contain an ingredient that controls the release of the drug in order for the release to be delayed (as Fournier contends) or if it is sufficient that the hard gelatin capsule, by virtue of the function of the shell, delays the release of the active ingredient such that the Cipher product cannot be said to be "immediate release".

[39]            Based on the evidence, I accept the position of Dr. Rhodes. Dr. Goldberg's evidence does nothing to impeach Dr. Rhodes' testimony in this respect. Dr. Goldberg simply takes the position that Cipher's capsules do not contain excipients to delay or control the dissolution of fenofibrate. The only evidence to counter that of Dr. Rhodes is a single example from Modern Pharmaceutics. The example is said to show the dissolution of a gelatin capsule at a rate greater than 10% in five minutes. Dr. Rhodes was confronted with this information on cross-examination and, understandably, was not able to comment on it in any detail for a number of reasons. He was shown only a single page; he had not edited the article from which it came; he did not see the article; and he did not have the data underlying it. He maintained his position that the hard shell gelatin capsule would, of necessity, delay the release of the fenofibrate.

[40]            The example was not explored or explained in any detail by either of the experts. It does not, in the circumstances, discredit the evidence of Dr. Rhodes. It does no more than suggest the existence of a hard shell capsule (in relation to a drug other than fenofibrate) that releases the active ingredient more quickly than Dr. Rhodes states. Fournier must establish, on a balance of probabilities, that Cipher's allegation of non-infringement is not justified. Figure 2 of the '475 patent (that compares the dissolution of LIPIDIL tablets to a number of other drugs that are contained in gelatin capsules) appears to support the view of Dr. Rhodes.

[41]            On a balance of probabilities, I conclude that Fournier has not established that Cipher's allegation that its fenofibrate capsules are not "immediate release" is not justified. The hard gelatin capsule is the mechanism by which the release and absorption of the drug fenofibrate is delayed once ingested.

[42]            This is sufficient to dispose of the matter since Fournier must, on a balance of probabilities, disprove all of the allegations that, if left unchallenged, would allow the Minister to issue a NOC: Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1995), 60 C.P.R. (3d) 328 (F.C.T.D.) aff'd. (1995), 64 C.P.R. (3d) 450 (F.C.A.); SmithKline Beecham Inc. v. Apotex Inc. (1999), 1 C.P.R. (4^th) 99 (F.C.T.D.) aff'd. (2001), 10 C.P.R. (4^th) 338 (F.C.A.). However, for completeness, I will address briefly the other elements.

MICRONIZED FENOFIBRATE

[43]            The phrase "in micronized form" is defined in the '475 patent as "a substance in a particulate form, with particles less than or equal to about 20 Fm".

[44]            Cipher takes the position that, in claim 1, the phrase refers to fenofibrate in micronized form at the outset of the formulating process. Dr. Rhodes, at paragraph 77 of his affidavit, points to several references with respect to the use of micronized fenofibrate at the beginning of the formulation process and notes the absence of such references (to the size of fenofibrate particles) in the finished product.

[45]            Fournier argues contra and insists that the phrase refers to the finished composition. Dr. Goldberg's evidence is that a skilled formulator would know that the claims of the '475 patent refer to the particle size in the formulated composition.                        

[46]            Claim 1 of the '475 patent constitutes a claim with respect to the finished formulation or composition. Therefore, despite Cipher's vigorous arguments to the contrary, fenofibrate in micronized form refers to the fenofibrate active ingredient in the final product.

[47]            Cipher further submits that even if it is incorrect regarding its interpretation - as I have determined it is - that its final product does not have fenofibrate in a particulate form of less than 20 Fm.

[48]            Fournier refers to Dr. Goldberg's evidence that the micronization of fenofibrate in Cipher's product can be a result of the manufacturing process. The contention is that, since Cipher's formulation process involves the melting of fenofibrate particles with several types of excipients at high temperatures, fenofibrate nuclei will begin to form as the mixture cools below fenofibrate's melting point. As the cooling process continues, more nuclei will form and the fenofibrate will "precipitate out" resulting in the formation of fenofibrate particles in micronized form in the final product.

[49]            In my view, Cipher has seriously and successfully undermined Dr. Goldberg's theory. On cross-examination, Dr. Goldberg agreed that for precipitation to occur, there must be supersaturation (too much solute - in this case fenofibrate) or supercooling. There is no evidence that supercooling or supersaturation takes place in the Cipher process. Dr. Goldberg does not know whether fenofibrate in molten mixture ever forms a supersaturated solution. He admits that he has no data on the solubility analysis of fenofibrate as its temperature decreases. He provided data on the solubility of another drug in his supplementary affidavit, but conceded that the data cannot be extrapolated from one drug to another because solubility is specific to a particular drug and solvent or solution.

[50]            Dr. Rhodes disagreed with Dr. Goldberg's conclusion on the basis that: the Cipher product would not show acceptable bioavailability unless fenofibrate is dissolved (not precipitated out) in the final product; there is a surfactant present which can be expected to solubilize (dissolve) hydrophobic drugs such as fenofibrate; even if the solution became supersaturated, it is possible for it to be metastable and no precipitation would result.

[51]            There is no evidence to establish, even if precipitation of fenofibrate did occur, that it would form micronized particles of less than 20 Fm. Dr. Goldberg opines that fenofibrate will precipitate during the cooling process to form particles with an average size of less than 20 Fm. He maintains that this will happen because of a large differential in solubility but admits that he does not know what the solubility difference is. His theory of particle size is not based upon any experiments or scientific literature and he admitted that it is possible for fenofibrate to precipitate into particles larger than 20 Fm.

[52]            Fournier's submission is based exclusively on Dr. Goldberg's theory. The theory is not premised on evidence or data. Dr. Rhodes has identified several lacunae in Dr. Goldberg's theory. Fournier has not established, on a balance of probabilities, that Cipher's allegation - that the fenofibrate in the Cipher product is not micronized and is not in particulate form or in the form of particles having any specified size; rather, the non-micronized fenofibrate in the Cipher product is melted with other excipients to form, when cooled, a homogenous phase or paste - is not justified.

INERT HYDROSOLUBLE SUPPORT OR CARRIER

[53]            A detailed discussion of the parties' arguments and submissions in relation to this issue would disclose information regarding the scientific characteristics and processes related to the Cipher capsules. That information is protected by a confidentiality order dated March 23, 2003. I will therefore discuss this element in generic terms.

[54]            The term "inert hydrosoluble carrier" is defined in the '475 patent as follows:

In the present invention, the phrase "inert hydrosoluble carrier" is

understood to mean any excipient, generally hydrophilic,

pharmaceutically inert, crystalline or amorphous, in a particulate

form, which does not cause a chemical reaction under the operating

conditions used, and which is soluble in an aqueous medium, in

particular in a gastric acid medium. Examples of such excipients

are sugar derivatives, such as lactose, sucrose, hydrolysed starch

(maltodextrin), etc. Blends are also suitable. The particulate unit

size of the inert hydrosoluble carrier may be, for example, between

50 et (sic) 500 microns.

[55]            Cipher submits that the term refers to an excipient or excipients with the following characteristics: (a) pharmaceutically inert; (b) in particulate form, over 50 Fm in size; (c) generally hydrophilic; and (d) water soluble (not insoluble or practically insoluble in water): Rhodes affidavit at paras. 68-70.

[56]            Cipher claims that none of the compounds in its capsules qualify under this definition. Fenofibrate is not an inert excipient (it is, in fact, the active ingredient), and it is practically insoluble in water. The other excipients used in the formulation either do not dissolve in the appropriate manner, or are not present in particulate form in the Cipher capsules: Rhodes affidavit at para. 108.

[57]            Fournier offers a different interpretation. Fournier claims that an "inert hydrosoluble carrier" in claim 1 of the '475 patent is: (a) generally hydrophilic; (b) has the ability to draw water into and facilitate integration of the dosage form; and (c) is sufficiently soluble so as to facilitate the disintegration of the dosage form in an aqueous medium, such as gastric juice (the liquids produced in the stomach): Goldberg affidavit, para. 16.

[58]            I agree with Cipher that Fournier's interpretation is somewhat "tortured" and adds functions that are not supported by the '475 patent. However, at the end of the day, in my view, the Cipher capsules do not meet either of the proposed interpretations with the result that, again, Fournier has not established, on a balance of probabilities, that Cipher's allegation is not justified.

[59]            Dr. Rhodes identifies a number of problems with Dr. Goldberg's proposed "layered structure" as forming the inert hydrosoluble carrier. There is no reliable, published scientific data to support the existence of a layered structure comprised of these particular excipients. Indeed, Dr. Rhodes expresses consternation that many of the scientific premises used by Dr. Goldberg as bases for his theoretical "layered structure" - such as non-interaction between excipients - are not supported by the scientific data found in the Handbook of Pharmaceutical Excipients. There is no evidence to show that a layered structure of these particular excipients would, given their chemical properties, even form: Rhodes affidavit, paras. 110-115.

[60]            I appreciate Fournier's position that Cipher is limited to the allegations stated in its NOA and I agree that is so. However, it was Fournier's expert who put additional elements of the '475 patent into play and Cipher is entitled to respond.

[61]            Based on the evidence, I accept the position of Dr. Rhodes. It is evident to me that Dr. Goldberg's "layered structure" postulation is long on educated speculation, but it lacks the support of scientific data - he did not provide any data on the solubility of the excipients used in the Cipher capsules nor did he conduct any experiments to ascertain such data. When confronted, on cross-examination, with scientific references that negated essential parts of his theory, Dr. Goldberg was able to provide neither data nor explanation to the contrary. Moreover, Dr. Goldberg's theory, at least in part, appears to rely on the notion that fenofibrate will precipitate out of the Cipher mixture, a concept that I have already rejected.

[62]            On a balance of probabilities, I conclude that Fournier has not established that Cipher's allegation - that its capsules do not contain an "inert hydrosoluble carrier" - is not justified. There is no chemical compound or structure in the Cipher capsules that meets either of the interpretations of the term proffered by the parties.

ABUSE OF PROCESS

[63]            This argument was not seriously advanced at the hearing. Indeed, it was specifically recognized and regarded as a red herring. I do not intend to deal with it further.

CONCLUSION

[64]            Fournier has not established, on a balance of probabilities, that Cipher's allegation of non-infringement with respect to claim 1 of the '475 patent is not justified. Claims 2 through 13 are dependent claims that relate to claim 1. Therefore, Fournier has not established that Cipher's allegation regarding those claims is not justified. For the reasons provided herein, Fournier has not established that Cipher's allegation of non-infringement - that its capsules do not contain fenofibrate in micronized form - is not justified. Consequently, Fournier has not established, on a balance of probabilities, that Cipher's claim of non-infringement in relation to claim 17 is not justified. Since claims 18 to 20 are dependent on claim 17, it follows that Fournier has not established that Cipher's allegation with respect to those claims is not justified. Fournier's application will therefore be dismissed.

COSTS

[65]            Cipher has been successful and will have its costs against Fournier throughout. I entertained submissions from counsel regarding the issue of costs at the outset of the hearing. Each of the parties accused the other of proceeding on the basis of speculation. Cipher seeks increased costs because of delay due to Fournier's motion (and appeal) with respect to the re-attendance of Dr. Rhodes for cross-examination (for which Cipher was awarded its costs). Neither counsel suggested a lump sum award.

[66]            Having considered the submissions of counsel and the pertinent factors set out in Rule 400(3), specifically paragraphs (a), (c), (g), (i) and (k), in the exercise of my discretion, I will award costs to be assessed at the upper end of column III of Tariff B.

[67]            Both counsel for Fournier and Cipher requested directions to the assessment officer regarding specific items. In particular, both requested that directions be provided for the assessment of:

-          second counsel attendance at the cross-examinations and the hearing;

-          reasonable fees for the preparation of expert affidavits;

-          reasonable travel expenses for counsel's attendance on the cross-examinations;

-          reasonable expert disbursements.

Given the parties' agreement in relation to these items, I see no reason why the request for such directions should not be granted. An order will go accordingly.

             « Carolyn A. Layden-Stevenson »

Judge

Ottawa, Ontario

December 14, 2004

                                                             FEDERAL COURT

                                     Names of Counsel and Solicitors of Record

DOCKET:                                          T-371-03

STYLE OF CAUSE:                          FOURNIER PHARMA INC. et al

                                                                                                                                            Applicants

- and -

THE MINISTER OF HEALTH &

CIPER PHARMACEUTICALS LTD.

                                                                                                                                         Respondents

PLACE OF HEARING:                         Toronto, Ontario

DATE OF HEARING:                           November 9 & 10, 2004

FURTHER SUBMISSIONS:                December 3 & 7, 2004

REASONS FOR ORDER BY:       LAYDEN-STEVENSON, J.

_Confidential Reasons for Order issued on December 9, 2004_

DATED:                                                  December 14, 2004

APPEARANCES BY:

Mr. David M. Reive/ Ms. Angela Furlanetto                               For the Applicants                    

Ms. Shonagh McVean/ Mr. Joseph Briante                                For the Respondents

SOLICITORS OF RECORD:         

Dimock Stratton LLP

Toronto, ON                                                                            For the Applicants

Gilbert's LLP

Toronto, ON                                                                             For the Respondents

SOLICITORS OF RECORD:

Morris Rosenberg                                Ms. Shonagh McVean/ Mr. Joseph Briante

Deputy Attorney General                      Gilbert's LLP

of Canada                                            The Flatiron Building

49 Wellington Street East

Toronto, ON M5E 1C9

For the Respondent                              For the Respondent

Minister of Health                                 Cipher Pharmaceuticals Ltd.

FEDERAL COURT OF CANADA

                               Date: 20041214

                                                                 Docket: T-371-03

BETWEEN:

FOURNIER PHARMA INC. et al

                                                                                                                                        Applicants

- and -

THE MINISTER OF HEALTH &

CIPHER PHARMACEUTICALS LTD.

                                                                                                                                  Respondents

REASONS FOR ORDER

AND ORDER

SCHEDULE "A" to the

Reasons for Order issued December 14, 2004 [Confidential Reasons for Order issued December 9, 20041 rendered by Hon. Madam Justice Carolyn Layden-Stevenson in

FOURNIER PHARMA INC. and

LABORATOIRES FOURNIER S.A. v. THE MINISTER OF HEALTH and CIPHER PHARMACEUTICALS LIMITED T-371-03

Re: Notice of Allegation and Detailed Statement for Fenofibrate Dosage form:           Capsules

Strength:          100 mg and 160 mg

Route of administration:            Oral

Cipher Pharmaceuticals Ltd. ("Cipher"). hereby serves on Foumier-Pharma Inc. ("Fournier) this Notice of Allegation and Detailed Statement pursuant to sections 5(3)(b) and 5(3)(c) of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations").

Canadian Patent No. 2,219,475 (the "`475 Patenf) has been listed, at Foumier's request, by the Minister of National Health and Welfare (the 'Minister) on the Patent Register with respect to Fournier's LIPIDIL SUPRAT" products in 100 mg and 160 mg tablets_

Cipher has filed with the Minister an abbreviated new drug submission ("ANDS") for Cipher's fenofbrate in the following strengths_ 100 mg and 160 mg capsules for oral administration ("Cipher Products). Cipher's ANDS compares the Cipher Products with LIPIDIL SUPRA^-1" 100 mg and 160 mg tablets marketed in Canada by Fournier (DIN 02241601 and 02241602, respectively).

Pursuant to paragraphs 5(1)(a) and 5(1)(b)(iv) of the Patented Medicines (Notice of Compliance) Regulations, Cipher alleges that no claim for the medicine fenofibrate or for the use of the medicine would be infringed by the making, constructing, using or selling of the Cipher Products_

The legal and factual basis for this allegation is as follows:

a) the only claims for the medicine or for the use of the medicine in the '475 Patent are claims 1 to 13 and 17 to 20; and

b) claims 1 to 13 and 17 to 20 are not infringed because essential elemanis of these claims are not found in the Cipher Products.

A.          Relevant claims are 1 to 13 and 17 to 20

Claims in the '475 Patent to the medicine and to the use of the medicine in question are claims 1 to 13 and 17 to 20_ The remaining claims, being claims 14 to 16, are process claims and are not properly the subject of proceedings under the Regulations_

B.          No infringement of the relevant claims

The formulation of the Cipher products is disclosed and claimed by U.S. patent 5,545,628 to Deboeck et al (corresponding to Canadian patent application 2,210,985). ("the Deboeck formulation')_ The specific formulation of the Cipher products will be provided under an appropriate confidentiality agreement or protective order_

Briefly, the Deboeck formulation is a non-micronized fenofibrate composition. It is prepared by melting non-micronized fenofibrate (of no particular particle size specification) and excipients, including potyglycolyzed glycerides, to form a homogenous molten solution which is then is filled into hard gelatin capsules.

The Deboeck formulation was specifically distinguished from the formulation of the `475 patent by the patentee of the '475 patent, namely Laboratoires Fournier. S.A. In an office action dated June 29, 1999 on U.S. application 091005,128 (which issued as U.S. patent 6,074,670 and corresponds to the '475 patent), the patent examiner cited U.S. patent 5,545,628 to Deboeck et al along with other fëfOëriciës ^-in ^-a rëject on based'on obviousness_ ^-in ^-its^--response filed^-November 17, 1999, the patentee stated as follows:

Deboeck teaches the addition of stabilizers to a very specific molten solution of fenofibrate-polyglycolyzed glycerides. The amount of glycolyzed glycerides (such as surfactant of the type Poloxamer) is very similar to the one of fenofibrate_ In the application, the amount of surfactant is much lower than the amount of fenofibrate (e.g., by an order of magnitude)_ Thus the ratios of the various components are different between Deboeck and the present invention.

Deboeck requires a molten solution of fenofibrate in glycerides. This necessarily excludes the micronized form of fenofibrate recited in claim 1. In fact, Deboeck teaches that:

(A] need exists for a fenofibrate formulation that avoids the use of co-micronization_

Deboeck at column 2, lines 4-5

Consequently, Deboeck specifically teaches away from the presently claimed invention. [emphasis added]

These statements were made by the same legal entity, laboratoires Fournier, S.A., in respect of the corresponding U.S_ patent, characterizing the same invention as the '475 patent as patentably distinct from the Deboeck formulation. Such statements constitute admissions against interest_

Further, it would be an abuse of process for Fournier to resile from this characterization of the '475 patent as well as the Deboeck formulation in seeking to enforce the '475 patent. Any such action in _.these circumstances would be objectively baseless litigation and could be actionable in either Canada or the United States.

Specifically, the Cipher formulation does not infringe the '475 patent as it does not contain the essential elements of any of the relevant claims of the '475 patent, as is set out in detail below­

i.

No infringement of claim 1

Claim 1 of the '475 Patent is an independent claim directed to a "composition de fénofibrate à libération immediate" (or an "immediate release" formulation of fenofibrate). Claim 1 further requires that a "support inerte hydrosoluble (or inert hydrosoluble support or carrier) be covered with at least one layer of "fenofibrate sous forme micronisée (or micronized fenofibrate) having a size less than 20 um.

On a purposive construction of claim 1, "à liberation immédiate", "sous forme micronisée º and "support inerte hydrosoluble" are essential elements, the meaning of which must also be_ purposively construed. Having regard to the disclosure of the '475 Patent, none of these essential elements are present in the Cipher Products: the fenofibrate in the Cipher Products is not in an "immediate release" formulation, is not in "micronized form`, and is not on an "inert hydrosoluble support".

No "immediate release" fenofibrate in Cipher Products

The first essential element in daim 1 is fenofibrate in an "immediate release" formulation. ^A libération immediate" is described at pate 3 of the disclosure in the following terms:

Il existe donc un besoin pour améliorer la biodisponibilité du fénofibrate afin d'atteindre, dans des temps très courts, un niveau proche de 100% (ou, en tout cas, supérieur aux limites suivantes: 10% en 5 minutes, 20% en 10 minutes, 50% en 20 minutes et 75% en 30 minutes dans un milieu constituté de 1200 ml d'eau additoinnée de 2% de Polysorbate 80 ou de 1000 ml d'eau additionnée de lauryl sulfate de sodium 0,025 molaire, avec une vitesse de rotation de la palette de 75 tlmin).__

In other words, the inventor of the '475 Patent identified a need to improve the rate of dissolution and bioavailability of fenofibrate such that close to complete dissolution would be achieved within a very short time (that is, dissolution greater than 10% in five minutes, 20% in ten minutes, 50% in twenty minutes and 75% in thirty minutes, when measured using the rotating blade method as described in the quoted passage, above). This description accords with the rapid release of fenofibrate illustrated in Figures 1 and 2 of the disclosure of the '475 Patent.

The fenofibrate contained in the Cipher Products dissolves much more slowly. it is not in an immediate release formulation_ It does not exhibit a rate of dissolution equal to or greater than 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes when measured using method described in the quoted passage, above_ On this basis alone, the making, constructing, using or selling by Cipher of the Cipher Products does not infringe claim 1 of the '475 Patent_

No micronized fenofibrate in Cipher Products

The second essential element in claim 1 is fenofibrate in "micronized form". Fenofibrate 'sous forme micronizée' is defined at page 6 of the disclosure as "une substance se trouvant sous une forme particuare, la dimension des particules étant inférieure ou égale 6 environ 20 um"_ In other words, 'micronized form' means a substance in particulate form, the dimensions of the particles being less than or equal to 20 um_

The fenofibrate in the Cipher Products is not micronized. It is not in particulate form. Nor is it in the form of particles having any specified size_ Rather, the non-micronized fenofibrate in the Cipher products is melted with other excipients to form, when cooled, a homogeneous phase or paste. The making, constructing, using or selling by Cipher of the Cipher Products does not irifringe claim 1 of the '475 Patent

•No inert hydrosoluble support in Cipher Products

The third essentiel element in claim 1 is micronized fenofibrate on an "inert hydrosoluble support" or carrier. A 'support inerte hydrosoluble' is defined at page 6 for the disclosure as follows_

On entend, dans le cadre de la présente invention par 'support inerte hydrosoluble » tout excipient, généralement hydrophile, pharmaceutique-mente inerte, cristallin ou amorphe, sous une forme partcuare, ne conduisant pas à une reaction chimique dans les conditions opératoires utilisées, et qui est soluble dans un milieu aqueux, notamment en milieu acide gastrique.' Des exemples de tels excipients sont les dérivés de sucres, tels que lactose; saccharose, de l'amidon hydrolysé (malto-dextrine), etc_

According to this definition, the support must be in the form of a particle (forme partculaire") which is covered ("recouvert") with at least one layer of micronized fenofibrate_ In the Cipher Products, non-micronized fenofibrate and other ingredients are melted together to form, on cooling, a homogenous phase or paste. The Cipher Products contain no support in particulate form, and no support which is coated with micronized fenofibrate_ The making, constructing, using or selling by Cipher of the Cipher Products does not infringe claim 1.

ü. No infringement of claims 2 to 13

Claims 2 through 13 of the `475 Patent are dependent claims, either incorporating the elements of claim 1, or incorporating the elements of a claim which is itself dependent on claim 1_ The Cipher Products do not infringe claim 1. The making, constructing, using or selling by Cipher of the Cipher Products do not, therefore, infringe any of claims 2 to 13, all of which incorporate the elements of clam 1.

No infringement of claims 17 to 20

Claim 17 is an independent claim which is directed to a suspension of fenofibrate in "micronized form' with a particle size less than 20 um, in a solution of hydrophilic polymer. As set out above, the fenofibrate in the Cipher Products is not in micronized form, and does not exist in the form of particles- Rather, the non-micronized fenofibrate in the Cipher Products is melted together with other ingredients to form, on cooling, a homogeneous phase or paste. The making, constructing, using or selling by Cipher of the Cipher Products does not infringe claim 17.

Furthermore, claims 18 to 20. of the '475 Patent are all dependent on claim 17. The elements of claim 17, including the requirement that the fenofibrate be in "micronized form", are therefore incorporated into claims 18 to 20_ The Cipher Products do not infringe claim 17. The making, constructing, using or selling by Cipher of the Cipher Products do not, therefore, infringe any of claims 18 to 20.

For the reasons set out above, the making, constructing, using or selling by Cipher of the Cipher Products does not infringe any of claims 1 to 13 and 18 to 20, and there is no basis upon which Fournier can apply for an order of prohibition pursuant to section 6 of the Regulations.

Yours truly,

lam W French, Ph.D. Chairman and Chief Scientific Officer

cc.      David Reive

Dimock Stratton Clarizio

SCHEDULE "B" to the

Reasons for Order issued December 14, 2004 [Confidential Reasons for Order issued December 9, 2004] rendered by Hon. Madam Justice Carolyn Layden-Stevenson in

FOURNIER PHARMA INC. and

LABORATOIRES FOURNIER S.A. v. THE MINISTER OF HEALTH and CIPHER PHARMACEUTICALS LIMITED T-371-03

CLAIMS

1.          An immediate release fenofibrate composition comprising:

(a)         an inert hydrosoluble carrier covered with at least one layer containing fenofibrate in micronized form having a size less than 20 pm, a hydrophilic polymer and optionally a surfactant, said hydrophilic polymer making up at least 20% by weight of (a); and (b) optionally one or more outer phase(s) or layer(s).

2.          A composition according to claim 1, in which the surfactant is present with the fenofibrate and hydrophilic polymer.

3.          A composition according to claim 1 or 2, in which the hydrophilic polymer is polyvinylpyrrolidone.

4.          A composition according to claim 2 or 3, in which the fenofibrate and surfactant are co-micronized.

5.          A composition according to any of claims 2 to 4, in which the surfactant is sodium lauryl sulphate.

6.          A composition according to any of claims 1 to 5, in which the hydrophilic polymer represents more than 25% by weight.

7.                 A composition according to any of claims 1 to 6, in which the weight ratio fenofibrate / hydrophilic polymer is between 1 /10 and 4/l.

8.              A composition according to any of claims 1 to 7, in. which the weight ratio fenofibrate / hydrophilic polymer is between 1 /2 and 2 /1.

9.              A composition according to any of claims 1 to 8, in which in relation to the weight of (a), the inert hydrosoluble carrier represents from 10 to 75% by weight, the fenofibrate represents from 5 to 50% by weight, the hydrophilic polymer represents from 20 to 60% by weight, and the surfactant represents from 0 to 10% by weight.

10.            A composition according to any of claims 1 to 9, in which in relation to the weight of (a), the inert hydrosoluble carrier represents from 20 to 50% by weight, the fenofibrate represents from 20 to 45% by weight, the hydrophilic polymer represents from 25 to 45% by weight, and the surfactant represents from 0.1 to 3% by weight.

11.            A composition according to any of claims 1 to 10, in which the individual particle size of the inert hydrosoluble carrier is between 50 and 500 microns.

12.            A composition of immediate release fenofibrate according to any of claims 1 to 11, in which the composition has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium consisting of water with 2% by weight of Polysorbate 80 or 0.025 M of sodium lauryl sulphate.

13.A composition according to any of claims 1 to 12, in the form of a tablet.

14.            A method for preparing a composition according to any of claims 1 to 13, comprising the steps of

(a)            Preparing of a fenofibrate suspension in micronized form with a size less than 20 gym, in a solution of hydrophilic polymer and optionally, surfactant;

(b)            Applying of the suspension from step (a) on an inert hydrosoluble carrier by spraying;

(c)Optionally, coating of the granules obtained in this way with one or more phase(s)

or layer(s).

15.         A method according to claim 14, in which step (b) is carried out in a fluidized-bed granulator.

16.         A procedure according to claim 14 or 15, including, in addition, a step for compressing the products obtained in step (b) or (c).

17.         A suspension of fenofibrate in micronized form having a size less than 20 gin, in a solution of hydrophilic polymer and optionally surfactant in solution in a solvent and in which the concentration of fenofibrate is from 1 to 40% by weight, the concentration of hydrophilic polymer is from 5 to 40% by weight and the concentration of surfactant is from 0 to 10% by weight.

18.         A suspension of fenofibrate according to claim 17, in which the concentration of fenofibrate is from 10 to 25%.

19.         A suspension of fenofibrate according to claim 17 or 18, in which the concentration of hydrophilic polymer is from 10 to 25%.

20.         A suspension of fenofibrate according to claim 17, 18 or 19, in which the concentration of surfactant is less than 5% o by weight.