Date: 20000417
Docket: T-1825-99
Ottawa, Ontario, the 17th day of April, 2000
Present: THE HONOURABLE MR. JUSTICE PELLETIER
BETWEEN:
PROCTER & GAMBLE PHARMACEUTICALS CANADA, INC.
and THE PROCTER & GAMBLE COMPANY
Applicants
and
THE MINISTER OF HEALTH
and GENPHARM INC.
Respondents
REASONS FOR ORDER AND ORDER
PELLETIER J.
[1] Procter & Gamble Pharmaceuticals Canada, Inc. and The Procter and Gamble Company ("P & G") have been issued Notices of Compliance under the Patented Medicines (Notice of Compliance) Regulations ("NOC Regulations") with respect to two products, Didronel and Didrocal. Didrocal is approved for use in the treatment of osteoporosis while Didronel is approved for use in the treatment of Paget"s disease and hypercalcemia of malignancy. In both cases the active ingredient is etidronate disodium. P & G has included Patent No. 1,338,376 (""376 patent") in the patent list which it is required to maintain with respect to the Notice of Compliance issued in respect of Didrocal. The subject of the "376 patent is the use of bone resorption inhibiting polyphosphonates (which includes etidonate disodium) as part of a cyclical regimen in the treatment of osteoporosis.
[2] The "376 patent summarizes the invention as follows:
| The present invention relates to a method of treating or preventing osteoporosis, in humans or lower animals afflicted with or at risk to osteoporosis, utilizing a regimen comprising two or more cycles, whereby each cycle comprises a period of from about 1 day to 90 days during which a bone resorption inhibiting polyphosphonate is administered daily in a limited and effective amount, and a rest period of from about 50 days to about 120 days during which no bone resorption inhibiting agent is administered. |
| The present invention further relates to a kit for use in the above-described cyclic regimen, said kit containing the following components: from about 1 to 90 daily doses, with each daily dose containing a limited and effective amount of a bone resorption inhibiting polyphosphonate; from about 50 to about 120 daily doses of a placebo or a nutrient supplement; and a means for having the components arranged in a way as to facilitate compliance with the regimen. |
Of the 37 claims in the "376 patent, 16 relate to the use of a kit in the treatment of osteoporosis and the balance relate to the use of bone resorption inhibiting polyphosphonate in a cyclical regimen for the treatment of osteoporosis without reference to a kit.
[3] The respondent Genpharm Inc. ("Genpharm") has made a submission for a Notice of Compliance pursuant to the NOC Regulations with respect to its product Gen-Etidronate, which is also etidronate disodium, in a 400 mg tablet. It has also applied for a Notice of Compliance with respect to the same product in a 200 mg tablet which is the subject of a companion motion on file T-1970-99, in which separate reasons will issue. Genpharm has served a Notice of Allegation on P & G alleging that its sale of Gen-Etidronate will not infringe the "376 patent because Genpharm"s product "will not be packaged as a kit in combination with any other active ingredient or nutrient supplement". P & G has commenced proceedings pursuant to section 6 of the NOC Regulations to prohibit the Minister from issuing a Notice of Compliance to Genpharm. Because the only knowledge it has of Genpharm"s submission is the Notice of Allegation and a copy of the product monograph for Gen-Etidronate which was voluntarily disclosed after these proceedings were commenced, P & G brings this motion seeking an order pursuant to section 6(7) of the NOC Regulations for disclosure of parts of Genpharm"s submission.
[4] The law relating to disclosure prior to the passage of section 6(7) of the NOC Regulations was canvassed by Evans J. (as he then was) in Novartis Pharmaceuticals Canada Inc. and Novartis A.G. v. Abbott Laboratories, Limited, and The Minister of Health, T-160-99, August 17, 1999, unreported (F.C.T.D.). The learned judge noted that the test for disclosure prior to the adoption of section 6(7) in March 1998 was quite stringent. The reasons for disclosure have been required to be "compelling", "clear or persuasive", "strong" or "essential and necessary". Evans J. concluded that the stringent test should be maintained for the disclosure contemplated by section 6(7). He pointed to the factors justifying such a position: the proceedings are summary and ought not to be delayed by a discovery stage, the failure to obtain a prohibition order does not preclude recourse to an infringement action, the risk of harm arising from the release of proprietary confidential information. Those views are entitled to considerable deference but, with respect, I would add this qualification. The assumption underlying the "stringent" test must be that the initial disclosure in the Notice of Allegation is responsive to the patent claims. It cannot have been the intention of the judges who articulated that test to reward incomplete disclosure by sheltering it behind a stringent test for better disclosure. One must therefore assume that the stringent test does not apply in the same way where the initial disclosure in the Notice of Allegation does not adequately address the claims in the patent(s) in question. In such a case the demands of fairness may result in a lower standard being applied.
[5] In this case, Genpharm seeks the issuance of a Notice of Compliance with respect to Gen-Etidronate. As noted, P & G"s comparable products are Didronel and Didrocal. Didronel is marketed in 200 mg loose tablets while Didrocal is marketed in a kit of 400 mg tablets together with tablets of calcium carbonate. The product monograph for Didronel contains a section under the heading of "Precautions" which deals with the use of Didronel in the treatment of osteoporosis whose intent, according to P & G, is to discourage the use of Didronel in the treatment of osteoporosis. Gen-Etidronate will be available in 200 and 400 mg tablets. The 400 mg tablets will be packaged in 14 tablet blister strips. It is being put forward for use in the treatment of Paget"s disease and hypercalcemia of malignancy but its product monograph does not contain any precautionary comments about its use in the treatment of osteoporosis. This omission, coupled with the packaging of the 400 mg tablets in blister strips suggests to P & G that there may be an intention to position Gen-Etidronate as a substitute for Didrocal.
[6] The Notice of Allegation served upon P & G referred to the "376 patent, which contains claims for the use of a medicine, and denied infringement on the basis of packaging i.e. the product "will not be packaged as a kit...". The "376 patent describes the invention as "a method of treating or preventing osteoporosis". While 17 of the claims relate to the use of a kit in the treatment of osteoporosis, an equal number deal with the treatment of osteoporosis without the use of a kit. The question of a kit would therefore not be dispositive of the issue of infringement.
[7] P & G asks for disclosure of the portions of the Abbreviated New Drug Submission ("ANDS") dealing with labelling (Part 1.6), bioequivalence (Part 3) and test and reference drug products (Part 4.6). Part 3 of the ANDS deals with bioequivalence, the comparison of the new drug to a product (the Canadian Reference Product) whose safety and efficacy is sufficiently established, that a declaration of bioequivalence justifies the sale of the second product on the same basis as the Canadian Reference Product. According to the McClenaghan affidavit, it is also a key factor in some jurisdictions in establishing approved substitutes for branded drugs. Part 4.6: Sectional Report: Test and Reference Drug Products is a related section in which the scientific rationale for the claim of bioequivalence should be found. Both of these would be relevant to the issue of possible infringement. If the Canadian Reference Product is Didrocal, which is used in the treatment of osteoporosis, questions would arise as to the claims that Gen-Etidronate is intended for the treatment of Paget"s disease and hypercalcemia of malignancy.
[8] In my view, the Notice of Allegation served by Genpharm does not adequately address the claims in the patent and would not enable P & G to address the issue of infringement adequately. This disclosure required to remedy the defect is disclosure of the following portions of the Master Volume:
-Part 3: Comprehensive Summary: Bioequivalence
-Part 4.6: Sectional Report: Test and Reference Drug Products
[9] The disclosure of the label information could be helpful to P & G but given that the issue is substitution, the label information is secondary in importance to the question of the reference product and the claim of bioequivalence. On the theory that no more disclosure should be ordered than is necessary, I decline to order production of the label information.
[10] I will also order ancillary relief in the sense of requiring production of any changes to material which I have ordered disclosed (as well as the product monograph voluntarily disclosed by Genpharm) since the date of submission, and any which may be made after the date of my order also be produced. I will also order The Minister of Health to confirm that the product monograph and material ordered disclosed correspond fully to the information on file with The Minister of Health.
[11] Finally the parties requested an order fixing the time for completion of the steps remaining in this application. I am adjourning that portion of the motion to 9:30 a.m. on Thursday May 4, 2000 at the Federal Court in Toronto to be spoken to.
[12] As a result, I make the following order:
ORDER
IT IS HEREBY ORDERED THAT:
1- The respondent Genpharm will produce to the applicants Procter & Gamble Pharmaceuticals Canada, Inc. and the Procter & Gamble Company the following portions of its Abbreviated New Drug Submission ("ANDS") for a 400 mg tablet:
(a) Part 3 of the ANDS entitled "Comprehensive Summary: Bioequivalence" and in particular the identification of the Canadian Reference Product;
(b) Part 4.6 of the ANDS entitled "Sectional Report: Test and Reference Drug Products"
which shall be referred to collectively as the Disclosed Portions;
2- The respondent shall also produce to the applicants any changes that have been made by Genpharm to its ANDS since the date of submission which relate to Part 1.5 of the ANDS entitled "Product Monograph" or to the Disclosed Portions;
3- The respondent shall also produce to the applicants any changes to the Product Monograph or to the Disclosed Portions as they are made;
4- The Minister of Health shall verify that the Product Monograph and the Disclosed Portions, as well as any changes produced pursuant to paragraphs 2 and 3 of this Order, correspond fully to the information on file with The Minister of Health;
5- The applicants shall treat the information received pursuant to this Order as confidential and will enter into a reasonable Confidentiality Agreement acceptable to the applicants and to the respondent Genpharm, providing that if an agreement cannot be reached as to the form of the Confidentiality Agreement, either party may apply to the Court to settle the terms of the
Confidentiality Agreement.
6- The Plaintiff"s request for directions as to the scheduling of further steps to be taken in this matter is adjourned to May 4, 2000 to be spoken to at that time.
7- The costs of the motion shall be costs in the cause.
"J. D. Denis Pelletier"
______________________________
Judge