Fournier Pharma Inc. v. Canada (Minister of Health)

Fournier Pharma Inc. v. Canada (Minister of Health)
Court (s) Database
Federal Court Decisions
Date
2004-12-14
Neutral citation
2004 FC 1718
File numbers
T-371-03
Decision Content
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. (4th) 272 (F.C.A.); Novartis AG et al. v. Abbott Laboratories Ltd. et al. (2000), 7 C.P.R. (4th) 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. (4th) 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. (4th) 245 (F.C.A.); SmithKline Beecham Pharma Inc. v. Apotex Inc. (2001), 14 C.P.R. (4th) 76 (F.C.T.D.) aff'd. (2002), 21 C.P.R. (4th) 129 (F.C.A.); Novatis A.G. v. Apotex Inc. (2002), 22 C.P.R. (4th) 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. (4th) 343 (F.C.T.D.) aff'd. (2004), 30 C.P.R. (4th) 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. (4th) 168 (S.C.C.) and Whirlpool Corporation v. Camco Inc. (2000), 9 C.P.R. (4th) 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. (4th) 65 (F.C.A.) aff'd. (2002), 21 C.P.R. (4th) 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. (4th) 99 (F.C.T.D.) aff'd. (2001), 10 C.P.R. (4th) 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