Date: 20040220
Docket: T-472-02
Citation: 2004 FC 257
Ottawa, Ontario, this 20th day of February, 2004
PRESENT: The Honourable Justice Johanne Gauthier
BETWEEN:
BIOVAIL CORPORATION and
GALEPHAR P.R. INC.
Applicants
and
THE MINISTER OF HEALTH and
RHOXALPHARMA INC.
Respondents
REASONS FOR JUDGMENT AND JUDGMENT
[1] The applicants seek an order prohibiting the Minister of National Health and Welfare from issuing a Notice of Compliance to Rhoxalpharma Inc. ("Rhoxal") for diltiazem hydrochloride capsules of strengths ranging from 120 mg to 360 mg until after the expiration of Canadian Patent No. 2,111,085 entitled: Extended-release form of diltiazem (the "'085 Patent").
[2] Diltiazem is a well-known drug that is not the subject of an extant patent. Alone or in combination with other drugs, it is useful in the treatment of angina pectoris and hypertension. 19As its title indicates, the '085 Patent discloses a once daily extended-release formulation of the drug.
[3] Galephar P.R. Inc. is the owner of the '085 Patent and Biovail Corporation is its exclusive licensee under the said patent. Biovail placed the '085 Patent on the Patent Register (section 4 of the Patented Medicines (Notice of Compliance) Regulations, SOR 93/133, March 12, 1993, amended by SOR/98-166; SOR 99-379) (the "Regulations") and two notices of compliance were issued in respect of two distinct once daily extended-release formulations of diltiazem hydrochloride. Biovail sells one under the brand name Tiazac® and the other under the brand name Cardizem®.
[4] On January 31, 2002, Rhoxal sent to Biovail a Notice of Allegation (NOA) pursuant to subparagraph 5(1)(b)(iv) of the Regulations stating that its proposed product would not infringe the '085 Patent and that, if it was found to infringe any of the claims contained therein, those claims would be either obvious or anticipated and therefore invalid. Rhoxal included the detailed statement required under subsection 5(3)(a) of the Regulations in its NOA. On March 19, 2002, Biovail filed the present proceeding in which it asserts, among other things, that the Rhoxal formulation infringes claims 34 to 37 of the '085 Patent. It does not dispute Rhoxal's allegation of non-infringement of claims 1-33 and 38.
[5] After a protective order was issued in April 2002, Rhoxal supplemented its NOA by providing further details of its formulation, the description of its manufacturing process and a summary flowchart of the process used to make its capsule.
[6] Thereafter, Biovail filed the affidavit of Dina Khairo, its Manager of Legal and Regulatory Affairs and an affidavit of Maria Susanna Diaz, an articling student working for the solicitors of Biovail. Biovail did not file any expert evidence to support its assertion that Rhoxal's allegation of non-infringement with respect to claims 34 to 37 of the '085 Patent is not justified. There are a few paragraphs (39 to 43) in Ms. Khairo's affidavit which deal with this issue but this affiant was not presented as an expert nor is she considered one by the Court.
[7] Rhoxal filed two affidavits of Dr. Norman Weiner, Professor Emeritus of Pharmaceutics at the College of Pharmacy of the University of Michigan. Both were sworn on June 28, 2002, one deals with Rhoxal's allegation of non-infringement of claims 34 to 37 and the other with prior art and the invalidity of those claims.
[8] Biovail argues that Dr. Weiner's affidavit on invalidity should be disregarded because he is not qualified to give an opinion on such issue. Biovail also raises several deficiencies in Dr. Weiner's methodology and with respect to the "prior art" he used. However, during the hearing, it was conceded that Dr. Weiner is qualified to opine on the non-infringement issue particularly on his understanding of wetting agents and their ability to maintain solubility of drugs in pharmaceutical compositions.
[9] Dr. Weiner and Ms. Khairo were cross-examined.
ISSUES
[10] Biovail argues that the NOA is inadequate because Rhoxal does not address all the claims at issue in the '085 Patent and all of the inventive elements of claims 34 to 37. Furthermore, Rhoxal does not explain its interpretation of the '085 Patent particularly, it uses expressions such as "within the meaning of the Patent" without defining what this means and it refers to the "functional language" in claims 34 to 37 without addressing how Rhoxal maintains the solubility of the diltiazem in its capsules. Finally, the NOA does not specifically or efficiently detail the grounds on which Rhoxal relies to allege that claims 34 to 37 are invalid.
[11] Biovail argues that the evidence of Dr. Weiner goes beyond what is alleged in the NOA.
[12] This applicant also submits that in any event, it has established, through the cross-examinations of Dr. Weiner, that the allegation of non-infringement was flawed and thus, not justified. Finally, Biovail claims that Rhoxal has not properly "put into play" the invalidity of claims 34 to 37 and that their evidence in that respect is insufficient to rebut the presumption of validity of those claims.
[13] Given that Rhoxal only alleges invalidity as a subsidiary argument and only in so far as a specific claim would be infringed, the Court will first assess whether or not the NOA is adequate in respect of the allegation of non-infringement. If it is, the Court will determine whether or not Biovail has established, on a balance of probability, that the allegation of non-infringement is not justified. If it has not, it will not be necessary to decide the issues relating to Rhoxal's allegation of invalidity.
ANALYSIS
[14] The claims at issue read as follows:
[...]
34. An extended-release galenical composition of one or more pharmaceutically-acceptable salts of Diltiazem which comprises beads containing an effective amount of one or more of said Diltiazem salts as the active ingredient, each bead containing one or more of the Diltiazem salts and an effective amount of a wetting agent to maintain the solubility of the Diltiazem in each bead, ensuring that the solubility of the Diltiazem is unaffected by the pH of the gastrointestinal tract or other adverse conditions which the composition will meet therein, said beads being coated with a microporous membrane comprising at least a water-soluble or water-dispersible polymer or copolymer, and a water-, acid and base-insoluble polymer and pharmaceutically-acceptable adjuvant, and wherein the wetting agent is selected from the group consisting of sugars, C12 - C20 fatty acid esters of sucrose or xylose, glycerides of sucrose, fatty acid esters of polyoxyethylene, ethers of fatty alcohols and polyoxyethylene, esters of sorbitan, esters of polyoxyethylene sorbitan, alcohol-polyglycide esters, glyceride-polyglycides, lecithins and a combination thereof.
35. The formulation of Claim 34 wherein the water-soluble or water-dispersible polymer or copolymer is hydroxypropyl methylcellulose and the water-, acid- and base-insoluble polymer is an acrylic polymer.
36. The formulation of claim 35 wherein the acrylic polymer is Eudragit NE 30 D.
37. The formulation of claim 34, 35 or 36 wherein the wetting agent is selected from sucrose stearate and sugars.
[...]
[my emphasis]
[15] In its NOA, Rhoxal describes its product as follows:
The Rhoxal capsule contains beads having a neutral and solid sugar core coated with multiple superimposed layers of a mixture of diltiazem hydrochloride (a diltiazem salt) and common adjuvants namely, ethylcellulose, and polyvinylpyrrolidone, these multiple layers being topped with an outer enteric coat. Thus, sugar in the Rhoxal capsule is used as a solid support otherwise known as a "seed", on which other substances are layered by coating in a fluidized bed apparatus. Thus, sugar in the Rhoxal capsule is used as a solid support otherwise known as a "seed", on which other substances are layered by coating in a fluidized bed apparatus. Thus sugar is not in "admixture".
[16] Rhoxal also makes the following factual statements to support its allegation that its product would not infringe claims 34 to 37 (only the relevant portions of the NOA are reproduced):
At pages 14 and 15,
[...]
The Rhoxal capsule does not contain, within the meaning of the patent:
. beads containing an effective amount of a wetting agent to maintain the solubility of the diltiazem in each bead, ensuring that the solubility of the Diltiazem is unaffected by the pH of the gastrointestinal tract or other adverse conditions which the composition will meet therein;
. for greater certainty none of the wetting agents listed in the claim.
This claim is similar to claim 1. However, it does not contain the word "admixture" when describing the relation of diltiazem and wetting agent. Instead, it uses functional language to explain the alleged role of a the wetting agent. Such a claim is not infringed by the Rhoxal capsule ... It is important to repeat that the Rhoxal capsule contains beads having a solid sugar core surrounded by a mixture of diltiazem hydrochloride (a diltiazem salt) and common adjuvants namely, ethylcellulose, and polyvinylpyrrolidone. Unlike the claimed product, the sugar present in the Rhoxal capsule does not play the role of a wetting agent but rather the role of a solid support seed to start a bead on which the diltiazem hydrochloride and other excipients are layered. Furthermore, among the other excipients accompanying the diltiazem, none are wetting agents, let alone wetting agents listed in the claim.
More specifically, and as well explained above in relation to Claim 11, the sugar present in the Rhoxal capsule does not play the role a wetting agent aiding in-vivo dissolution of the diltiazem hydrochloride. The claimed product contains the wetting agent, in admixture with the diltiazem hydrochloride, prior to ingestion so as to act as a wetting agent. Thus, the admixture must necessarily be present prior to ingestion. This interpretation is supported by the use of the word "galenical" which is defined as referring to the presentation, preparation or conservation of a given medicament. Nowhere in the '085 patent is it envisaged that a heterogeneous layered product could materialise itself after ingestion. Such a suggestion would be disingenuous and totally unsupported by the '085 patent.
Accordingly, claim 34 of the patent will not be infringed by us, whether directly or indirectly. Claims 35 to 38, which are dependent on claim 34, will not be infringed for the same reasons.
[...]
at page 9 (in relation to Claim 11)
[...]Furthermore, it is important to point out that no components in the Rhoxal product acts to ensure that "the solubility of the diltiazem is unaffected by the pH of the gastrointestinal tract or other adverse conditions which the composition will meet therein."
A sugar core is not a classic wetting agent because it is itself highly water soluble. Sugar could only act as a wetting agent in its dry form since it will draw water towards it and act as a wicking agent. It would thus draw water toward the diltiazem and help the diltiazem get wet. However, this would not affect the diltiazem solubility. Furthermore, once the sugar is in solution; i.e., after ingestion, it does not even possess the wicking effect. Once the sugar has associated with water, it does not have any drawing power.
Also, wicking agent only works when it is well dispersed within the material In vivo, the water will enter the bead, encounter the diltiazem HCI first, dissolve that, and once multiple layers of diltiazem HCI are dissolved, will enter the sugar sphere and dissolve the sugar. Under principles of mass transfer of solids, solid sugar will not migrate into the diltiazem layer. Thus, the only sugar that can ever mix at all (certainly not to a homogeneous state) is sugar solution. Because sugar solution is not a wicking agent and therefore not a wetting agent by any conceivable definition, the sugar in the Rhoxal capsule can never meet this claim limitation.
Further, sugar in the Rhoxal capsule is never in "admixture" while in solid form. [...]
[my emphasis]
[17] In its NOA, Rhoxal also refers to other proceedings in the U.S. involving Biovail:
As you know, the Rhoxal capsule formulation is identical to the one which was the subject of proceedings in the case of Biovail Corporation International, Bioval Laboratories, Inc. and Galepharm P.R. Inc. Ltd. v. Andrx Pharmaceuticals, Inc., 239 F.3d 1297; 2001 U.S. App. Lexis 2092; 57 U.S.P.Q.2D, where a judgment holding the formulation non-infringing was rendered on February 13, 2001 by the United States Court of Appeals for the Federal Circuit (upholding the decision of the United States District Court, Southern District of Florida, dated March 6, 2000). We have already disclosed the Rhoxal capsule formulation under cover of a confidentiality agreement. We have even provided you with samples under cover of the same confidentiality agreement so that you had ample time to perform tests on the samples to satisfy yourself of an absence of infringement.
[18] The Court agrees with Biovail that for the purpose of the present proceeding, it is not useful to consider these American decisions made on the basis of claims in a corresponding patent in the U.S. (US Patent no. 5,529,791) that did not read exactly like claims 34 to 37. The American courts also referred to and applied concepts that have no equivalent in Canadian law such as their doctrine of prosecution history estoppel. At best, these decisions indicate that Biovail was well aware of Dr. Weiner's views with respect to the classical definition of a wetting agent, the characteristics of dry sugar as a wicking agent and the inability of sugar in solution to maintain the solubility of diltiazem in the body (in vivo), since he testified as an expert on those issues in the American proceedings. These technical points are basically what Rhoxal relies upon to support the allegation of non-infringement in its NOA.
a) Adequacy of the NOA
[19] Considering the statements quoted at paragraph 16 above, the Court is satisfied that the detailed statement in Rhoxal's NOA, with respect to its allegation of non-infringement of claims 34 to 37 in the NOA, meets the requirement of paragraph 5(3)(a) of the Regulations (AB Hassle v. Canada, (Minister of National Health and Welfare), [2000] F.C.J. No.855 (F.C.A.) online: QL, SmithKline Beecham Pharma Inc. v. Apotex Inc., [2001] F.C.J. No. 3 (F.C.A.) para. 25-27, online: QL, Merck Frosst Canada Inc. v. Canada (Minister of Health), [2001] F.C.J. No. 915 (F.C.A.) para. 17, online: QL). We are far from the situation where the second person makes a bald statement of non-infringement unsupported by any factual assertions. The NOA contains sufficient information to make Biovail fully aware of the grounds on which Rhoxal seeks a Notice of Compliance.
[20] With respect to claims 35 to 37 (the dependent claims), it was sufficient for Rhoxal to state that because it would not infringe the independent claim 34, it would not infringe claims 35 to 37. (Procter & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health), [2002] F.C.J. No. 1018, para. 22 to 24 online: QL.) There is no need for Rhoxal to address any other element of those claims unless the variant on which it relies to support its allegation of non-infringement relates to an element specific to those claims. This is not the case since the variant referred to in the NOA is the absence of an effective amount of wetting agent to maintain the solubility of the diltiazem in the gastrointestinal tract, allegedly an essential element of the independent claim 34..
[21] The decision of the Court of Appeal in Procter & Gamble, supra, is clearly distinguishable on the facts. (See paragraph 25)
[22] Biovail also alleges that the NOA is defective because it does not state how Rhoxal maintains solubility of the diltiazem in its beads if it does not use a wetting agent. This argument appears to be based on a misunderstanding of the present proceeding. Rhoxal only needs to allege the grounds supporting its allegation of non-infringement. It does not need to disclose anything more.
[23] Rhoxal clearly explains at page 14 of the NOA, how the sugar in the core of its beads does not play the role or function described in claim 34 (so called "functional language"). It specifies that solid sugar cannot maintain solubility unless it is in an admixture with the diltiazem. It also states that once sugar is in solution (in vivo), it does not even possess a wicking effect and cannot "by any conceivable definition" fall within the monopoly defined by claim 34. This is adequate and Rhoxal is not asking the Court to rely on any fact that exceeds what it laid out in its NOA.
[24] As to the expression "within the meaning of the patent" Biovail says that even Dr. Weiner could not give them a satisfactory explanation. He simply stated that he understood this to mean "based on what on the patent says" (Dr. Weiner's cross-examination at page 27). Rhoxal says that it simply refers to the general principle that terms in the claims should be given the sense in which the patentee used them; they must be read in context. It appears from the NOA that Rhoxal construed the word "wetting agent" as including a wicking agent such as "dry sugar in admixture with diltiazem." The NOA is not incomplete or ambiguous.
b) Scope of the evidence filed by Rhoxal
[25] Rhoxal concedes in their NOA that its capsule contains all the elements described in claims 34 to 37 except for "an effective amount of a wetting agent to maintain the solubility of diltiazem in each bead, ensuring that the solubility of diltiazem is unaffected by the pH of the gastrointestinal tract or other adverse condition..." This was confirmed at the hearing.
[26] In the circumstances, the Court need not deal with Biovail's argument that Dr. Weiner's evidence goes beyond the content of the NOA because it deals with matters such as the definition of a microporous membrane, the role of adjuvants or the assessment of whether these elements were essential elements. These matters are not relevant to the issues to be determined by the Court.
[27] In its affidavit on non-infringement, Dr. Weiner states that an effective amount of wetting agent to maintain the solubility of the diltiazem in the gastrointestinal tract is an essential element of claim 34. This is not evidence that goes beyond what is alleged in the NOA. Rhoxal's allegation is supported by the assertion that its product could not infringe because of the absence of such an element. It is thus implicit in the NOA that Rhoxal considers it an essential element of this claim.
c. Allegation of non-infringement
[28] The Court is bound to assume that the factual statements supporting the allegation of non-infringement are true. (Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare), [1996] F.C.J. No. 1333 (F.C.A.), at page 8, online: QL, and Merck Frost Canada Inc., supra, at para. 18. ) Thus, to succeed in its application, Biovail had to convince me (balance of probability) that (i) even if those statements were true, they would not in law give rise to the conclusion that the patent would not be infringed by Rhoxal's capsule because, for example, the variant does not involve an essential element of the claims at issue, or (ii) all or most of the statements are wrong (Hoffman-LaRoche Ltd., supra).
[29] The Court is satisfied that claim 34 construed purposively does not cover a composition which comprises beads that do not contain an effective amount of a wetting agent to maintain the solubility of the Diltiazem unaffected by the pH of the gastrointestinal tract or other adverse conditions which the composition would meet therein. (Free-World Trust v. Électro Santé Inc., [2000] S.C.J. No. 67, online: QL).
[30] In reaching this conclusion, I considered among other things, the evidence of Dr. Weiner on how a person skilled in the art would read claim 34 (paragraphs 19 and 42 of his affidavit on non-infringement) and his cross-examination in that respect.
[31] In light of his curriculum vitae and his experience which includes consultation for pharmaceutical companies, the Court finds that Dr. Weiner is qualified to give an opinion on this issue. Whether or not he could qualify as a person skilled in the art, is not determinant or relevant to his ability to act as an expert in that respect. (Crila Plastic Industries Ltd. v. Ninety-Eight Plastic Trim Ltd., [1987] F.C.J. No. 1030, online: QL, at page 14). The fact that he is not an expert in extended-release formulation only goes to the weight of his evidence, not to its admissibility.
[32] Even if I were to give no weight to Dr. Weiner's evidence and was left with no evidence at all as to how a person skilled in the art would have read this claim, I would reach the same conclusion that the presence of a wetting agent maintaining the solubility of the diltiazem is an essential element of claim 34 based on the language of this claim read in context including the disclosure (Free-world Trust, supra, and Whirlpool Corp. v. Camco Inc. [2000] S.C.R. 1067).
[33] Finally, Biovail appears to have conceded that the presence of such wetting agent is an essential element of claim 34. In its submissions with respect to Rhoxal's allegation of invalidity of claim 34, Biovail argues that this is the very essence of the invention covered by this claim; it is the one element that is not found in any of the prior art cited by Rhoxal.
[34] This means that unless Biovail establishes that Rhoxal's factual assertions in the NOA are wrong, its application will fail.
[35] As mentioned earlier, Mrs. Khairo's affidavit is the only evidence produced by Biovail to contradict the factual assertions made by Rhoxal to support its position that its capsule will not contain an essential element of claim 34.
[36] She states at paragraph 41 of her affidavit that:
41. When a membrane comprising Eudragit NE30D and HPMC surrounds a bead or pellet, its role is to enable the contents of the bead surrounding the core to be hydrated by bodily fluids as such fluids enter. The fluids penetrate through the diltiazem and excipients into the seed which is dissolved. The dissolved sugar solution permeates the entire core thereafter to ensure that the solubility of the diltiazem is maintained and is unaffected by the gastrointestinal tract or other adverse conditions which the composition will meet therein.
[37] During her cross-examination, she stated that she had not performed any test that would enable her to make this statement. Also, Biovail confirmed during her cross-examination that she was not put forth as an expert and that she could not be asked questions of opinion (see transcript of her examination at pages 48, 49 (Q. 157 to 163)).
[38] In the circumstances, I give no weight whatsoever to this evidence and I consider the statements in the NOA unchallenged.
[39] But, Biovail asserts that Dr. Weiner, in his cross-examination, confirmed that it was theoretically possible for water to make its way through Rhoxal's beads from the outside to the sugar in the core without having to dissolve the diltiazem first. This would directly contradict a statement made by Rhoxal at page 9 of its NOA.
[...] In vivo, the water will enter the bead, encounter the diltiazem HCI first, dissolve that, and once multiple layers of diltiazem HCI are dissolved, will enter the sugar sphere and dissolve the sugar. Under principles of mass transfer of solids, solid sugar will not migrate into the diltiazem layer. Thus, the only sugar that can ever mix at all (certainly not to a homogeneous state) is sugar solution. Because sugar solution is not a wicking agent and therefore not a wetting agent by any conceivable definition, the sugar in the Rhoxal capsule can never meet this claim limitation.
[my emphasis]
[40] Even if this proposition was accepted, it would have little impact on Biovail's case for it leaves intact the most important factual assertions supporting Rhoxal's allegation of non-infringement. (solid sugar must be in admixture with the diltiazem to act as wicking or wetting agent and sugar in solution could not be considered a wetting agent by any conceivable definition).
[41] Having reviewed the transcript of the cross-examination of Dr. Weiner, it appears that this affiant did not contradict other factual assertions made by Rhoxal in its NOA with respect to non-infringement. In fact, Dr. Weiner confirmed those assertions (see for example the transcript of his cross-examination at pages 225, 235, 241 to 246).
[42] Biovail argues that the Court should give little weight to Dr. Weiner's opinion and that in fact, I should consider Rhoxal's allegation of non-infringement unjustified because it implies that one read the words "in admixture" into claim 34. It states that these words are present in claims 1 to 33 but they are not included in claims 34 to 37. Thus, Claim 34 should be given a distinct meaning because of this change in language.
[43] Dr. Weiner did testify that the words "an effective amount of wetting agent to maintain solubility of the diltiazem in the gastrointestinal tract" necessarily imply the use of dry sugar in admixture with the diltiazem.
[44] There is no evidence before this Court that dry sugar is an effective wetting agent even when it is not mixed with the drug having a solubility problem.
[45] There is no evidence that sugar in solution is an effective wetting agent that could maintain solubility of the diltiazem in the gastrointestinal tract.
[46] There is no evidence that dry sugar in the core of Rhoxal's beads acts as an effective wetting agent maintaining the solubility of the diltiazem in the gastrointestinal tract.
[47] In the absence of any such evidence, the Court cannot simply disregard the factual assertions assumed to be true.
[48] This is especially so where there appears to be another explanation for the use of a different language in claim 34. In effect, the parties agree that there are at least two methods of drafting claims, one which uses structural language while the other uses functional language. Rhoxal submits that the change in language in claim 34 simply shows that the inventor was attempting to cover his invention using both methods.
[49] Finally, Biovail submits that Dr. Weiner's evidence was flawed because he used examples of problems occurring during the manufacturing process and addressed a presumed wetting problem as opposed to the solubility problem disclosed in the '085 Patent.
[50] The Court reviewed the cross-examination of Dr. Weiner and is not satisfied that this is so. (see for example page 249, lines 21 to 50 of the transcript).
[51] Once again, even if the Court accepted Biovail's argument in that respect and gave no weight whatsoever to Dr. Weiner's evidence, I would still be left with the unchallenged factual assertions in the NOA and would reach the same conclusion.
[52] Biovail has simply not met its burden of establishing that Rhoxal's allegation of non-infringement is unjustified.
[53] In view of the foregoing, Biovail's application is dismissed with costs.
JUDGMENT
THIS COURT ADJUDGES that:
1. The application of the applicants is dismissed with costs.
"Johanne Gauthier"
Judge
FEDERAL COURT
Names of Counsel and Solicitors of Record
DOCKET: T-472-02
STYLE OF CAUSE: Biovail Corporation et al. v. The Minister of Health et al.
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: January 27, 2004
REASONS FOR ORDER BY: GAUTHIER J.
DATED: February 20, 2004
APPEARANCES BY:
Ms. Heather Watts For the applicant
Ms Marie Lafleur and For the respondent RhoxalPharma Inc.
Martin F. Sheean
SOLICITORS OF RECORD:
Ms. Heather Watts For the applicant
Ms. Marie Lafleur For the respondent RhoxalPharma Inc.
FEDERAL COURT
Docket: T-472-02
BETWEEN:
BIOVAIL CORPORATION and
GALEPHAR P.R. INC.
Applicants
- and -
THE MINISTER OF HEALTH and
RHOXALPHARMA INC.
Respondents
REASONS FOR JUDGMENT
AND JUDGMENT
This is the second notice of allegation sent with respect to Rhoxal diltiazem capsules and the '085 Patent. The first one was delivered to Biovail on July 24, 2001. Biovail filed a notice of application in reply thereto in September 2001 which was finally dismissed on October 29, 2002, with costs to Biovail because Rhoxal had withdrawn its notice of allegation.
Another affidavit of Ms. Khairo, sworn on September 17, 2002, was not considered by the Court as the parties agreed that it was not properly filed.
This argument was not discussed during the hearing. Both parties agree that the reference to a galenical composition simply indicates that the composition is in dosage form.
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