Date: 20010103
Docket: A-340-95
(T-1454-93)
A-341-95
(T-1968-95)
| C O R A M: STRAYER J.A. |
LINDEN J.A.
SEXTON J.A.
B E T W E E N:
APOTEX INC.
Appellant
(Respondent)
-- and --
ZENECA PHARMA INC.
Respondent
(Applicant)
-- and --
THE MINISTER OF NATIONAL HEALTH AND WELFARE
and MERCK & CO., INC.
Respondents
(Respondents)
Heard at Ottawa, Ontario on Tuesday, December 19, 2000
ORDER delivered from the Bench at Ottawa, Ontario on Tuesday, December 19, 2000
REASONS FOR ORDER BY: STRAYER J.A.
Date: 20010103
Docket: A-340-95
(T-1454-93)
A-341-95
(T-1968-95)
| C O R A M: STRAYER J.A. |
LINDEN J.A.
SEXTON J.A.
B E T W E E N:
APOTEX INC.
Appellant
(Respondent)
-- and --
ZENECA PHARMA INC.
Respondent
(Applicant)
-- and --
THE MINISTER OF NATIONAL HEALTH AND WELFARE
and MERCK & CO., INC.
Respondents
(Respondents)
REASONS FOR ORDER
(Delivered from the Bench at Ottawa, Ontario
on Tuesday, December 19, 2000)
STRAYER J.A.
[1] On October 10, 1996, this Court allowed appeals from decisions of Richard J. of May 26, 1995 in which he had issued prohibition to prevent the respondent Minister from issuing a Notice of Compliance to Apotex Inc. ("Apotex") for the sale of lisinopril. The same facts applied in both appeals A-340-95 and A-341-95. In allowing the appeals, we set aside the orders of prohibition. In doing so we stated two conclusions.
| (1) that section 56 of the Patent Act, which permits anyone possessing material obtained before the issue of a patent to sell that material, has the effect of making such dispositions non-infringement of a patent and thus within the non-infringing uses contemplated by subsection 5(1) of the Patented Medicines (Notice of Compliance) Regulations;1 and |
| (2) that the mere fact that a "second person", as defined in these Regulations, holds less than enough inventory of such material to cover normal sales for the remaining life of the patent should not preclude it from obtaining a notice of compliance. In this connection we noted that if such person should exceed its rights by selling material not protected by section 56, the patentee would have the normal remedies in law to prevent infringement. |
Subsequent to this judgment the Minister issued a Notice of Compliance to Apotex on October 18, 1996.
[2] Since this order was issued in 1996 the moving parties have learned that by 1999 at least Apotex, the second party, had available to it lisinopril other than the pre-patent inventory that was at issue in this Court in 1996. Apotex confirmed in July, 2000 that it was in fact using this licensed lisinopril for its own products and was supplying pre-patent material to Nu-Pharm Inc.
[3] Merck & Co. Inc. ("Merck") and Zeneca Pharma Inc. ("Zeneca") now have commenced these proceedings in respect of both appeal decisions of 1996, asking this Court
| (1) to set aside its judgment of October 10, 1996, because of "a matter that arose . . . subsequent to the making of the order . . . ." as provided by subsection 399(2) of the Federal Court Rules; |
(2) an order quashing the Notice of Compliance of October 18, 1996;
| (3) an order restoring the prohibition order of May 26, 1995; or in the alternative |
| (4) an injunction to prevent Apotex from selling any lisinopril other than that which it obtained prior to the issue of the patent; or |
| (5) an order limiting Apotex' sales of lisinopril to a certain quantity; or |
| (6) an order requiring Apotex to surrender its Notice of Compliance once it has sold the quantity of lisinopril referred to in (5) supra. |
[4] We have concluded that none of these remedies is available to the moving parties in this Court.
[5] It should first be noted that this Court has said on several occasions that the scheme established by the Patented Medicines (Notice of Compliance) Regulations2 does not replace the private rights of action open to patentees to protect themselves against infringement.3
[6] This principle is relevant to the main remedy sought in this proceeding, namely that the Court reconsider its judgment of October 10, 1996 and restore the order of prohibition originally issued by Richard J. to stop the issue of the Notice of Compliance. It is said that the new matter, namely the acquisition after October 1996 of the licensed material, if it had been known to the Court in October 1996, would almost certainly have led to a different decision. We do not agree. What the Court was concerned about in 1996 was whether there was any basis, on the facts as they then existed, for the Trial Division to prohibit the issuance of a Notice of Compliance. It concluded there were no such facts and that conclusion was correct at the time it was reached. The Court specifically recognized that possible future changes in facts might lead to an ordinary action for infringement, but were not a basis for refusal of a Notice of Compliance at that time. The Court stated:4
| There is no reason why the Regulations as now framed should be used, through denial of a Notice of Compliance, to prevent a party from selling any quantity of a drug otherwise free from infringement just because there is a theoretical possibility that such party might use that Notice of Compliance to sell infringing material some time in the future. The respondents will have available to them the same remedies they had before the adoption of the Regulations with respect to preventing the appellant from exceeding its rights under section 56. |
Therefore the evidence before us today is not a "new matter" which would have brought about a different result at the time the judgment was issued. Rule 399 cannot be used as a vehicle for revisiting judgments every time a change occurs in the facts.
[7] Therefore, as there is no basis for reconsidering the 1996 judgment, there is no basis for quashing the Notice of Compliance issued in conformity with that judgment nor to restore the prohibition order which that judgment quashed.
[8] As for the alternative remedies numbered above as (4), (5) and (6), to the extent that they are predicated on the existence of some continuing jurisdiction in this matter none such exists. The Court is functus officio as regards the 1996 judgment or its modification other than as authorized by the Rules such as 397 and 399. To the extent that these remedies would assume some new original jurisdiction in this Court to undertake a new judicial review as if at first instance, that is not within our jurisdiction either.
[9] The motion in each appeal will therefore be dismissed, with one set of costs to the respondents.
(s) "B.L. Strayer"
J.A.
__________________1 SOR/93-113.
2 Ibid.
3 See e.g. Pharmacia v Canada (Minister of Health & Welfare) (1994) 58 C.P.R.(3d) 209 at 217, Merck Frosst Canada Inc. et al v Minister of Health & Welfare (1994) 55 C.P.R.(3d) 302 at 319-20, approved of in S.C.C. Novopharm Ltd. v Eli Lilly & Co. Ltd. (1998) 80 C.P.R.(3d) 321 at 361-62; Eli Lilly & Co. v. Apotex Inc. [2000] F.C.J. No. 1905 (A-273-99, November 22, 2000).
4 (1996) 69 C.P.R.(3d) 451 at 453-4.