Date: 20050912
Docket: T-2368-03
Citation: 2005 FC 1231
Ottawa, Ontario, September 12, 2005
PRESENT: THE HONOURABLE MR. JUSTICE BEAUDRY
BETWEEN:
AXCAN PHARMA INC.
Applicant
and
PHARMASCIENCE INC.
and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
[1] This is an application pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, amended by SOR/98-166 and SOR/99-379 (Regulations) by which the Applicant (AXCAN or the First Person) seeks an order prohibiting the Minister of Health (MINISTER) from issuing a Notice of Compliance (NOC) to the Respondent, PHARMASCIENCE INC. (Pharmascience or the Second Person) in respect of the drug ursodiol, until after the expiration of the Canadian patent number 1,318,590 ('590 patent).
ISSUE
[2] The issue is as follows:
1. Has the applicant discharged its burden of establishing that Pharmascience's Notice of Allegation (NOA) is not justified?
[3] For the following reasons, I must answer this question negatively. Therefore, this application shall be dismissed.
BACKGROUND
[4] Ursodiol was approved by Health Canada from September 12, 1991 to January 30, 2001 for the dissolution of gallstones. This approval was held by Jouveinal Inc., which appears to have transferred its rights to AXCAN.
[5] On November 18, 1987, AXCAN or its predecessor applied for the '590 patent. It obtained a patent for its product named URSO (ursodiol) and benefit from the statutory monopoly until June 1, 2010. On January 23, 2001 AXCAN amended its product monograph to remove the indication for the treatment of gallstones. The '590 patent only reserves exclusive rights to sell ursodiol in Canada as a treatment for the management of cholestatic liver diseases, such as primary biliary cirrhosis (PBC).
La présente invention a pour objet l'utilisation de l'acide ursodésoxycholique pour la fabrication de moyens destinés au traitement de la cirrhose biliaire primitive (Applicant's record, vol.1, p. 13)
[6] The '590 patent does not contain any claims for the compound itself. The '590 patent has only one use claim which reads as follows:
1. Composition pharmaceutique pour le traitement de la cirrhose biliaire primitive caractérisée en ce qu'elle comprend de l'acide ursodesoxycholique ainsi qu'un véhicule et le cas échéant des excipients pharmaceutiques, ladite composition étant conditionnée sous une forme permettant ledit traitement de la cirrhose biliaire primitive selon une posologie comprise entre 13 B 15 mg/kg/jour.
[7] AXCAN's product is not currently listed for the treatment of gallstones. However, the '590 patent recognizes that the use of ursodiol for the dissolution of gallstones is an old use.
L'acide ursodésoxycholique est un composé connu utilisé pour le traitement dissolvant de la lithiase bilaire cholestrolique.
[8] Pharmascience filed an Abbreviated New Drugs Submission (ANDS) dated October 24, 2003 in respect of ursodiol 250mg tablets. Pharmascience served on AXCAN a NOA dated October 27, 2003. It seeks a NOC to sell a pharmaceutical product containing ursodiol for the old use of the dissolution of gallstones and treatment of associated symptoms at a recommended dose of 8 to 10 mg/kg/day.
[9] On December 15, 2003, AXCAN filed a Notice of Application opposing Pharmascience's request for a NOC.
APPLICANT'S SUBMISSIONS
[10] AXCAN denies Pharmascience's allegation that patent '590 will not be infringed by the making and selling of the Pharmascience's product (pms-URSODIOL). It alleges that the evidence shows that physicians will inevitably prescribe Pharmascience's product for the treatment of cholestatic liver diseases such as PBC even if only approved for the treatment of gallstones. In such circumstances, it submits that the issuance of the NOC should be prohibited.
[11] AXCAN submits that consideration of infringement is not limited to acts of the producer. It argues that infringement can result by the patients using the product for a use protected by the patent. Accordingly, Pharmascience will infringe its patent by the selling of its product for a use that is protected by AXCAN's patent.
Affidavit of Dr. Shaffer
[12] Dr. Shaffer is a medical doctor and a professor of medicine with many years of experience in research and clinical use of the drug ursodiol. Dr. Shaffer mentioned that he is familiar with URSO (Axcan's product) and that he prescribes it on a regular basis since 1996 for the treatment of PBC.
[13] Dr. Shaffer indicated that the treatment of gallstones is not included in AXCAN's product monograph. He alleged that gallstones are no longer treated with ursodiol in Canada. In fact, to his knowledge there is no approved use for the drug ursodiol in Canada other than for PBC. He declared that he and other medical doctors will not use Pharmascience's product if approved for the treatment of gallstones as the medical profession accepted that the standard treatment for gallstones is the surgical removal of the stones.
Dr. Shaffer's cross-examination
[14] Dr. Shaffer acknowledged that ursodiol was listed for the dissolution of gallstones when it first came out. He explained that ursodiol could only be used with cholesterol gallstones. All other types of gallstones would not dissolve using ursodiol. He further stated that laparoscopic cholecystectomy (surgical removal of the gallstones) became the accepted and standard treatment for gallstones in 1991-1992 because it was safe and more effective than oral dissolutions.
[15] Dr. Shaffer submitted that he would never recommend oral dissolutions for gallstones larger than one centimetre, as it is not effective, the stone will not dissolve. However, he stated that oral dissolution can still be used in rare conditions. He indicated that gallstones that are less than five millimetres long can efficiently be dissolved in six to twelve months using oral dissolutions. Only 3% of gallstones are less than five millimetres long. He added that bigger stones (less than one centimetre) could also be dissolved using oral dissolutions but he specified that it would take up to two years to dissolve and that it would only be successful in 18% of the cases. However, even if successful, Dr. Shaffer explained that there is a 50% chance of recurrence within the next five years and 100% chance of recurrence within ten years, although most of the gallstones recurrence is asymptomatic.
[16] Dr. Shaffer was questioned about a text he wrote in 1991 following a study on gallstones. In that text he stated that his study demonstrated that URSO, in high doses, was effective in dissolving approximately 37% of cholesterol gallstones. Questioned about the difference in the success rate he just testified about, he explained that it was due to the fact that the patients for this study were very carefully selected. They were all patients with very small stones. This particularity is not mentioned anywhere in his 1991 text.
[17] Dr. Shaffer was also questioned about a book he wrote in 1996-1997 in which he stated that if the stones are less than one centimetre, fifteen to twenty percent (15%-20%) of patients are candidates for ursodiol therapy (oral gallstone dissolution). When asked to explain how those statistics could reconcile with his testimony, he mentioned that the 1996-1997 textbook was outdated. He added that this comment was taken out of the 2000 edition. He also stated that if this type of information was found in recent authoritative texts, it was only there for historical purposes.
[18] Dr. Shaffer claimed that he will use Pharmascience's product to treat PBC even if not approved as it is the same drug as the one produced by AXCAN.
Affidavit of Mr. Andrew
[19] Mr. Andrew is a licensed pharmacist in the provinceof Manitoba who practiced since 1996. He indicated that he is familiar with the AXCAN's product as he regularly filled medical doctor's prescription for URSO for the treatment of PBC.
[20] He is familiar with AXCAN's product monograph. To his knowledge the treatment of gallstones is not included in it. According to his experience, ursodiol is not approved in Canada for the treatment of gallstones.
[21] Mr. Andrew explained that pharmacies are notified of new drugs marketed by generic manufacturers. According to him it would be unusual for any generic drug coming to the market to have different therapeutic indications than the brand name product it is based upon.
[22] If Pharmascience's product is approved as a generic alternative to AXCAN's product, Mr. Andrew indicated that he will offer it to its patient as an alternative for cost saving. According to him, if Pharmascience's product is approved, it will be dispensed and interchanged for AXCAN's product by himself and other pharmacists for the treatment of PBC.
Mr. Andrew's cross-examination
[23] Mr. Andrew does not prescribe any drug. He fills out prescriptions, sees almost 300 clients per day and dispenses URSO once or twice a month. However, he cannot say for sure if URSO is used for the treatment of PBC or if it is used to treat something else as he does not have access to his patients' medical file. He assumes that it is prescribed for the treatment of PBC as it is the only indication it is approved for.
[24] He admitted that he does not know for sure if ursodiol is still used to treat gallstones. He only knows that the URSO's product monograph no longer indicates that it can be used to treat gallstones. He mentioned that he is not aware of any other medicine used for the oral dissolution of gallstones.
[25] Mr. Andrew was given the name of two different products (Wellbutrin and Zyban) which contain the same active ingredient (Buproprion hydrochloride). The indication for both products is different. One is used as an anti-depressant for mood disorder while the other one is listed for smoking cessation. Mr. Andrew testified that he would not dispense Zyban if he had to fill a prescription for Wellbutrin even if it is the same drug because their use is different.
RESPONDENT'S SUBMISSIONS
[26] Pharmascience alleges that it is not seeking approval to market ursodiol for the treatement of PBC. It is seeking approval of its product for the dissolution of gallstones, a use that is not within the scope of AXCAN's '590 patent. Pharmascience submits that it will take a certain number of measures to ensure that its product does not infringe AXCAN's patent.
[27] Pharmascience contends that the evidence shows that physicians will not prescribe its product for the treatment of PBC but they would continue to prescribe URSO. Pharmascience's product monograph will clearly indicate that pms-URSODIOL is not approved for the treatment of PBC.
[28] Furthermore, it submits that a generic manufacturer should not be kept off the market based solely on a mere theoretical future possibility of infringement. It must be demonstrated that infringement will inevitably occur.
Affidavit of Mr. Gallo
[29] Mr. Gallo is the Regulatory Affairs Manager at Pharmascience. Mr. Gallo has a degree in Chemistry and has been employed with Pharmascience since 1993. He is responsible for the management of all of Pharmascience's submissions to the federal government of Canada such as ANDS.
[30] Mr. Gallo provided a summary of the information on ursodiol available through Health Canada.
|
Date
|
Brandname
|
Holder
|
Comment
|
| Sept. 12, 1991
|
Urosfalk
|
Jouveinal Inc.
|
250 mg capsules
Litholytic agent
|
| March 11, 1996
|
Urosfalk
|
Jouveinal Inc.
|
New indication: management of cholestatic liver diseases such as primary biliary cirrhosis
|
| August 12, 1997
|
Urosfalk
|
Axcan Pharma Inc.
|
Appears to be a change of manufacturer/holder Jouveinal Inc. to Axcan Pharma Inc.
|
|
Date
|
Brandname
|
Holder
|
Comment
|
| Nov. 1, 1998
|
Urso
|
Axcan Pharma Inc.
|
Provides for new dosage form (250 mg tablets). Change in product name from Ursofalk to Urso
|
| Jan. 30, 2001
|
Urso
|
Axcan Pharma Inc.
|
Removal of indication for gallstone dissolution
|
| June 19, 2002
|
Urso
|
Axcan Pharma Inc.
|
New strength 500 mg for cholestatic liver diseases
|
| Sept. 9, 2002
|
Urso
|
Axcan Pharma Inc.
|
Change of name of 500 mg tablets form Urso to Urso DS
|
[31] Attached to his affidavit, is the product monograph for Jouveinal Inc.'s product URSOFALK and AXCAN's product URSO. In 1991, the product monograph of USROFALK indicated that it was used "for the dissolution of gallstones and the treatment of associated symptoms". The 1996-revised version of their product monograph provided that ursodiol could be used for gallstone dissolution and cholestatic liver diseases such as PBC. However, the January 2001 product monograph was amended to remove the indication of gallstone dissolutions.
[32] Mr. Gallo confirmed that Pharmarscience's product monograph, filed with respect to its product (pms-URSODIOL) mentions that their product will only be used as a litholytic agent for the dissolution of gallstones. The product monograph shows that pms-URSODIOL is not approved for the treatment of cholestatic liver diseases such as PBC. Mr. Gallo also confirmed that the entry for pms-URSODIAL that will be placed in the Compendium of Pharmaceutical Specialities (CPS) will say that the product has not been approved for the treatment of PBC.
[33] Finally, Mr. Gallo provided information that ursodiol was used in Canada between 1991 and 2001 for the treatment of gallstones and that it is still used in many other countries.
Mr. Gallo's cross-examination
[34] He testified to the effect that he did not know if Pharmascience's sale representatives were trained, but they follow the Canadian regulations and they refer solely on the regulatory document approved in promoting their product monograph.
[35] Mr. Gallo's stated that pharmaceutical companies are only allowed to promote the product for what it is approved. In this case, Pharmascience requests the approval of its product for dissolution of gallstones. Therefore, if not approved for the treatment of cholestatic liver diseases such as PBC it cannot be used for that indication or at least it should not be used for that indication.
[36] During his cross-examination, he was asked if he was able to tell for sure if Pharmascience's product (pms-URSODIOL) would or would not be used for the treatment of PBC. Mr. Gallo answered that Pharmascience would only promote its product for the dissolution of gallstones. Consequently, pms-URSODIOL should not be used for the treatment of PBC.
[37] Mr. Gallo explained that his department was responsible for distributing the product monograph to product managers and to the Medical Information Department and also for the approval of the label found on the product.
Affidavit of Dr. Macdonald
[38] Dr. Macdonald is a general surgeon practicing medicine in Halifax, Nova Scotia. He received his degree in medicine in 1963 and completed his residency in 1967 and performs cholecystectomies or laparoscopic cholecystectomies, which involve the removal of the gall bladder when gallstones are present. In his affidavit, he indicated that he has patients who require treatments for gallstones but are not suitable candidates for surgical procedure. In those cases, he prescribes URSO even if this product is no longer approved as he is aware that it was previously indicated for dissolutions of gallstones.
[39] When a medication is used for a non-approved indication, it is typically referred to as an "off-label" use. The "off-label" is used when physician and patient concur that it is in the patient's best interest. However, physicians are generally reluctant to use an "off-label" because it may potentially expose them to criticism if there are side-effects or complications. The only reason he feels comfortable at prescribing URSO as an "off-label" is because he worked with URSO for so many years inclusive of those when the medication was intended for the dissolution of gallstones and he is not aware of any safety reasons why URSO should not be prescribed for that purpose.
[40] However, he is of the opinion that a physician who recently started to practice and has no previous experience with URSO, he would be more likely to prescribe URSO only for its listed indications. Therefore if Pharmascience's product is approved for the dissolution of gallstones, chances are that it will only be used for its listed indications. Moreover, PBC is a serious life threatening disease. Prescribing Pharmascience's product for the treatment of PBC when expressly mentioned that it is not approved for such a use would be too risky.
Affidavit of Dr. Davies
[41] Dr. Davies is an internist specializing in digestive disease and has been practicing for over 25 years. He received his degree in medicine in 1974 and became a specialist in 1978. Dr. Davies has an extensive experience in the treatment of gallstones.
[42] He agrees with Dr. Shaffer that the accepted and standard treatment of gallstones is laparoscopic cholecystectomy (the surgical removal of the stones and the gallbladder). However, he specifies that there is a number of patients with symptomatic gallstones for whom surgery is not a suitable option. Those patients require an alternative treatment. Dr. Davies however disagrees with Dr. Shaffer opinion regarding asymptomatic gallstones. He has prescribed URSO as a treatment to dissolve gallstones because surgery was not an option.
[43] Attached to his affidavit are excerpts from a publication from AXCAN dated 2000 which contain studies relating to the efficacy of ursodiol in the dissolution of gallstones.
[44] When prescribing a medication, Dr. Davies refers to the product monograph or the entry in the CPS. He indicated that the prescription of URSO for the dissolution of gallstones is considered an "off-label" use. He is reluctant to prescribe and "off-label" medication because of legal concerns and associated risks. He may prescribe an "off-label" when there is no other medication, or when there is no indication to the contrary, or when it is a generally accepted practice or when a patient as a medical condition for which there is no other suitable treatment available.
[45] Dr. Davies explained that URSO is listed on the Ontario Formulary as a Limited Use product. He therefore needs to complete an Ontario government prescription form to allow his patients to be covered by the Ontario Drug Plan.
[46] He stated that he will be using Pharmascience's product for the dissolution of gallstones if approved by Health Canada and declared that he would not prescribe Pharmascience's product for treatment of PBC if its product monograph specifically states that it is not approved for the treatment of cholestatic liver diseases.
[47] Dr. Davies and Dr. Macdonald were not cross-examined.
ANALYSIS
Has the applicant discharged its burden of establishing that Pharmascience's Notice of Allegation (NOA) is not justified?
[48] In the present case the second person is requesting the issuance of a NOC for the use of a known compound for the treatment of gallstones. The first person detains a patent to use ursodiol for the treatment of PBC. The crux of AXCAN's submissions is that the market for ursodiol for the dissolution of gallstones is small and declining. Consequently, if approved, Pharmascience's product will not only be sold for the dissolution of gallstones but will also be used by pharmacists, physicians and patients as a cost saving alternative medication for the treatment of PBC. The use of Pharmascience's product to treat PBC will infringe the '590 patent.
[49] A NOC must be obtained before a drug which contains a medicine can be sold in Canada. A NOC is issued under section C.08.004 of the Food and Drug Regulations. The Food and Drug Regulations, C.R.C. 1978, c. 870, as amended, together with the Patented Medicines (Notice of Compliance) Regulations, SOR/99-133, as amended, provide a legal scheme which imposes two processes: an administrative one designed to ensure the safety and the efficacy of the drug and a judicial one that is designed to protect the interest of the patentee. The Minister cannot issue a NOC without regard to the findings established by the two processes (Roger T. Hughes and John H. Woodley, Hughes and Woodley on Patents, 2nd ed. volume 1 (Markham, LexisNexis Canada Inc., 2005) at 210).
[50] This Court is responsible for the judicial process which deals with the right of the patentee. Its role is to ensure that the "second person" is not infringing on the statutory monopoly detained by the "first person". In the present case, the claim at issue is a use claim for the treatment of PBC. As mentioned in Procter & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health) (Genpharm Inc. v. Minister of Health et al), [2003] 1 F.C. 402, (C.A.), at paragraphs 42 to 44:
The patent claims at issue in the appeal are use claims. Therefore, the words that are relevant in subparagraph 5(1)(b)(iv) are "no claim for the use of the medicine would be infringed by the ... selling by that person [the generic producer] of [its] drug.
The phrase "would be infringed" is not qualified. In other words, subparagraph 5(1)(b)(iv) does not say, as Genpharm argues, that the act of infringement must be the act of the generic producer. Indeed, by expressly referring to sales by the generic producer ("the selling by that person"), the Governor in Council turned his mind to when it is relevant to associate actions with the generic producer under the Regulations. By not using that same phrase "by that person" in respect of the act of infringement within the same subparagraph, the Governor in Council cannot be said to have intended that infringement must necessarily be limited to acts of the generic producer itself. For Genpharm to suggest that the act of infringement must be by the generic producer reads words into the Regulations which the Court must not do.
In the case of a use patent, if the generic producer sells its product and infringement results by patients using the product for a use protected in a patent, there will be infringement of that patent for purposes of the Regulations. The connection between the generic producer and infringement by the patient is in the generic producer selling its product"
[51] It is trite law that infringement of a use patent, under the Regulations, is not limited to the act of the generic company. It includes infringement by third parties such as patients. Infringement occurs when third parties use a medicine sold by a generic company even if there is no inducement of procurement by the generic company (Procter & Gamble (Genpharm), supra) and Zeneca Pharma Inc. v. Canada (Minister of National Health and Welfare) (1995), 61 C.P.R. (3d) 190 (F.C.T.D.), at page 203).
[52] In this regard, paragraph 55.2(4)(e) of the Patent Act prevent the infringement of a patent by direct or indirect means.
| 55.2(4) The Governor in Council may make such regulations as the Governor in Council considers necessary for preventing the infringement of a patent by any person who makes, constructs, uses or sells a patented invention in accordance with subsection (1), including, without limiting the generality of the foregoing, regulations
(e) generally governing the issue of a notice, certificate, permit or other document referred to in paragraph (a) in circumstances where the issue of that notice, certificate, permit or other document might result directly or indirectly in the infringement of a patent.
|
|
55.2(4) Afin d'empêcher la contrefaçon d'un brevet d'invention par l'utilisateur, le fabricant, le constructeur ou le vendeur d'une invention brevetée au sens du paragraphe (1), le gouverneur en conseil peut prendre des règlements, notamment :
e) sur toute autre mesure concernant la délivrance d'un titre visé à l'alinéa a) lorsque celle-ci peut avoir pour effet la contrefaçon de brevet.
|
Burden as to Non-Infringement
[53] The party alleging non-infringement must furnish a detailed statement supporting its position so that the patentee can reasonably rebut the allegations of non-infringement. However, the final burden rests on the applicant to demonstrate that the evidence provided by the respondent does not justify the allegation of non-infringement (Nu-Pharm Inc. v. Eli Lilly and Co., [1996] F.C.J. No. 904, (F.C.A.) (QL) at 16-22; Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [1998] F.C.J. No. 1882 (T.D.) (QL)).
[54] In a use claim, the mere selling of the product by a generic company, without more, is not sufficient to establish infringement. Infringement will be established where there is evidence to conclude that the second person's actions and intentions would inevitably lead to the use of its product for the indication protected by the first person's patent. It is for the first person to establish, on a balance of probabilities that future infringement will occur. To obtain an order for prohibition, the first person must prove that if a NOC is issued and the second person were to sell its product, patients or other third parties would infringe the first person's use patent (AB Hassle v. Canada (Minister of National Health and Welfare) (2002), 22 C.P.R. (4th) 1 (F.C.A.)).
Construction of the patent
[55] Before turning to the issue of infringement, I must identify the essential elements of the invention claimed by AXCAN in its '590 patent (Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067 at paragraph 43).
[56] As mentioned above, the '590 patent contains only one claim. The essential components of the '590 patent can easily be summarized as follow: use of ursodiol to treat cholestatic liver diseases such as PBC.
Analysis
[57] Technically, the question that now needs to be answered is whether AXCAN provided evidence on a balance of probabilities, which would demonstrate that Pharmascience's non-infringement allegations are not justified. Here, I have adopted the reasoning of Sexton J. of the Federal Court of Appeal in AB Hassle, supra at paragraph 57:
[...] If there was any likelihood that a patient would consume a generic product for a patented use, then the generic product would not be approved. This would prevent new uses from being approved for existing drugs because there is always the possibility that someone somewhere will use the drug for the prohibited, patented purpose. This would result in a real injustice: since a generic company cannot possibly control how everyone in the world uses its product, the prevention of the generic from marketing the product would further fortify and artificially extend the monopoly held by the patent holders. The patent holder, would, therefore, effectively control not just the new uses for the old compound, but the compound itself, even though the compound itself is not protected by the patent in the first place. The patent holders, as a result, would obtain a benefit they were not meant to have. In the end, society would be deprived of the benefit of new methods of using existing pharmaceutical medicines at a lower cost. [my emphasis]
[58] In the case at hand, Pharmascience filed before this Court its product monograph and a copy of the labelling for the bottles of its product. A product monograph must be submitted to set out the proposed use for which the product may be put on the market once approved by the Minister. Once approval has been granted, a final product monograph is issued by the Minister as part of the NOC documents.
[59] The product monograph filed in respect of the submission sought approval for the use of pms-URSODIOL as a litholytic agent for the dissolution of gallstones (Respondent's record, vol.1 tab J, p. 255) reads as follows:
Indication and Clinical Use
pms-URSODIOL is indicated for the dissolution of gallstones and the treatment of associated symptoms in patients with radiolucent, noncalcified gallstones of less than 20 mm size in well opacifying gallbladders in whom cholecystectomy would be undertaken except:
- for patients who refuse surgery,
- for the presence of increased surgical risk due to systemic disease, advanced age and idiosyncratic reaction to general anesthesia. [...]
[60] The product monograph specifically states that Pharmascience's product is not approved for the management of cholestatic liver diseases (Respondent's record, vol.1 tab J, p. 256):
[...] pms-URSODIOL is not approved for the management of cholestatic liver diseases, such as primary biliary cirrhosis (PBC).
[61] The labelling provided reads as follows:
| Label Text - pms-URSODIOL 250 mg Tablets - 100's
|
| LITHOLYTIC AGENT
Each tablet contains: 250 mg Ursodiol USP
Adult Dosage: 8 to 10mg/kg/day, in 2 divided doses, 1 tablet in the morning with breakfast and 2 to 3 tablets before bedtime with snacks. Maximum 5 tablets daily.
The safety and efficacy of pms-Ursodiol in children has not been established. Keep this medication and all other medication out of the reach of children.
Product Monograph available to health professionals on request.
Pharmacist: Dispense with enclosed Patient Information Leaflet.
Store at controlled room temperature (15o to 30oC) in a closed container
PHARMASCIENCE INC
Montréal, CANADA H4P 2T4
|
100 Tablets DIN 00000000
Comprimés
Pr pms-URSODIOL
Ursodiol Tablets UPS
Comprimés d'ursidiol UPS
250 mg
|
AGENT LITHOLYTIQUE
Chaque comprimé contient : 250 mg ursodiol USP.
Posologie chez l'adulte : 8 à 10 mg/kg/par jour en 2 doses fractionnées, 1 comprimé le matin avec le petit déjeuner et 2 ou 3 comprimés avant de se coucher avec de la nourriture. Maximum 5 comprimés par jour.
L'innocuité et l'éfficacité de pms-Ursodiol chez les enfants n'ont pas été établies. Garder ce médicament et tous les autres médicaments hors de la portée des enfants.
Monographie du produit disponible sur demande aux professionnels de la santé. Pharmacien: Distribuer avec le dépliant d'information aux patients, ci-inclus.
Conserver à température contrôlée (15o to 30oC) dans des contenants fermés
LOT
EXP.
|
[62] In addition, Pharmascience submitted the affidavit of Dr. Davies and Dr. Macdonald, who both agreed that Pharmascience's product would be useful in certain types of situation and that they would not prescribed it for a use other than what it is approved for. As they mentioned, PBC is a life threatening disease. Prescribing a medicine that is not approved for the treatment of this disease would expose doctors to criticism and legal problems should patient suffer complications or side-effects. In addition, prescribing a drug to a patient for PBC in light of the statement that the product is not approved could create unnecessary anxiety in a patient.
[63] In an attempt to demonstrate that the Applicant's NOA was not justified, AXCAN submitted the affidavit of Dr. Shaffer and Mr. Andrew. Mr. Andrew mentioned in his affidavit that he would offer Pharmascience's product to his patients as an alternative for cost saving. However in cross-examination, when asked if he would dispense Zyban instead of Wellbutrin to fill out a prescription for Wellbutrin, Mr. Andrew indicated that he would not as the use for both medicines are different. However, when questioned on those two products, he clearly indicated that the active ingredient for both products is the same and that the dosage is also the same. If Mr. Andrew is not ready to substitute Zyban for Wellbutin despite the fact that they are the same drug, why would he do so for URSO and pms-URSODIOL His testimony on this undermines the probative value of his evidence.
[64] On the issue of to the assessment of the evidence by the three physicians, I prefer Dr. Davies and Dr. Macdonald's explanations as to why they would not prescribe Pharmascience's product for the treatment of PBC. I find Dr. Shaffer's affidavit and cross-examination to be less reliable as his explanations regarding statistics he submitted and those found in authoritative text books are questionable.
[65] AXCAN alleges that the evidence demonstrates that Pharmascience's intention would lead inevitably to the use of its pms-URSODIOL product for the treatment of PBC as pms-URSODIOL is not approved for the dissolution of gallstones and because it has included studies in its product monograph that compares the bioequivalence of its product to AXCAN's product.
[66] It is true that pms-URSODIOL is not approved yet for the dissolution of gallstones. However, as mentioned above a NOC will only be issued if (1) it is not infringing a patent and (2) if there is evidence filed before the Health Minister to prove that the use sought by Pharmascience is safe and effective. Therefore, it is up to the Minister to decide if he wants to approve pms-URSODIOL for the dissolution of gallstones based on the evidence before him. If the Minister decides that Pharmascience's product is not a safe and effective drug for the treatment of gallstones, a NOC will not be issued.
[67] AXCAN's argues that the reference to its product used by Pharmascience in its product monograph will inevitably lead to infringement. I disagree. As mentioned above in order to obtain a NOC a generic company needs to demonstrate that its drug is safe and effective. To do so, the legislation provides that the information can be submitted by way of NDS or ANDS. When using an ANDS a party may make reference to the drug of another party who has already received a NOC and show that its drug and the other party's drug are bioequivalent, and provide other information, all of which is less substantial and less costly.
[68] This is exactly what Pharmascience did. It partially relied on AXCAN's research information to provide the information regarding the safety and efficacy of its product. Therefore, it is perfectly normal that Pharmascience somehow relied on it. There is no prohibition to that effect in the legislation. In my view, it does not demonstrate Pharmascience's intention of selling its product for the treatment of PBC.
[69] Accordingly, I find that AXCAN has failed in its burden on a balance of probabilities to establish that Pharmascience's NOA is not justified.
ORDER
THIS COURT ORDERS that:
1. The application is dismissed. Costs to the respondent.
2. The Minister of Health made no written representations. Therefore, there will be no cost in his favour.
"Michel Beaudry"
Email this Content