Date: 19990126
Docket: T-970-98
BETWEEN:
HOFFMANN-LA ROCHE LIMITED and
SYNTEX PHARMACEUTICALS INTERNATIONAL LIMITED
Applicants
- and -
THE MINISTER OF NATIONAL HEALTH AND WELFARE and
GENPHARM INC.
Respondents
REASONS FOR ORDER
REED, J.:
[1] This is an application for an order pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 as amended SOR/98-166, prohibiting the Minister from issuing a Notice of Compliance ("NOC") to Genpharm Inc. for the medicine naproxen (including 250, 375, and 500 mg enteric coated tablets) until after the expiry of Canadian patents 1,131,660 (3660) and 1,135,717 (3717). Syntex Pharmaceuticals, a corporate predecessor to the applicant Hoffmann-La Roche Limited ("Roche"), is the owner of these patents and filed in April 1993, a patent list pursuant to the Regulations that contains reference to those patents.
[2] The respondent Genpharm sent Roche a letter, dated March 20, 1998, containing a Notice of Allegation ("NOA") regarding the naproxen tablets as required by section 5 of the Regulations. The text of the letter is reproduced below:
Notice of Allegation and Detailed Statement
Pursuant to Section 5(3)(a)
of the Patented Medicines
(Notice of Compliance) Regulations
Re: Abbreviated New Drug Submissions (ANDS)
For Naproxen 250, 375, & 500 mg EC Tablets
| This letter constitutes the Notice of Allegation and Detailed Statement of the legal and factual basis for the allegations appearing in Genpharm's Declarations Re: Patent List (Form V's) which we are filing with respect to the above identified drug, as required by the Patented Medicines (Notice of Compliance) Regulations, Section 5. |
| The Allegations |
| 1. The following patents are listed by you in respect of the drug Naproxen for the dosages listed above, namely 250 mg EC tablets; 375 mg EC tablets; and 500 mg EC tablets, namely: |
| Patent No. Date Granted Expiration Date |
| [The letter lists 8 patents, but the two listed below are the only ones in issue in this proceeding.] |
| 1,131,660 14/09/82 14/09/99 |
| 1,135,717 16/11/82 16/11/99 |
| 2. Each of the listed patents aforesaid relate either to a process or to an intermediate product; none of the listed patents relate to the medicine itself. The Federal Court of Appeal in a decision reported as Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1996), 70 CPR (3d) 1, rendered judgement dismissing an appeal from a decision of the Trial Division of that Court (reported at 67 CPR (3d) 484) holding that each of patents 1,131,660; 1,135,717; 1,259,627; and 1,207,338 contain only claims to processes and intermediates. Similarly, patents 1,124,735; 1,186,318; 1,186,319; and 1,199,646 contain only claims to processes and intermediates. |
| 3. Therefore, none of the listed patents aforesaid should have been listed at all with respect to the medicine at issue, and are thereby not relevant to the Genpharm application at issue. |
[3] I do not propose to reproduce the Patented Medicines (Notice of Compliance) Regulations in their entirety, nor do I propose to describe the manner in which they operate. This has been done many times elsewhere; see, for example, Merck Frosst Canada Inc. & Merck & co. Inc. v. The Minister of National Health and Welfare & Kyorin Pharmaceutical Co., Ltd. & Apotex Inc. (file T-1502-96, December 18, 1998).
[4] The applicant, Roche, makes five arguments in support of its request for an order of prohibition: (1) the Genpharm NOA was premature because it was not served in accordance with Regulation 5(3)(c)(i); (2) the NOA was insufficient because it does not contain an allegation that "no claim for the medicine itself and no claim for the use of the medicine would be infringed" as required by Regulation 5(1)(b)(iv); (3) there was no proof of service as required by Regulation 5(3)(d); (4) the reliance on the decision in Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1996), 70 C.P.R. (3d) 1 (F.C.A.) is misplaced since the findings in that case relate only to that case; (5) claim 27 in the 3660 patent and claim 27 in the 3717 patent are not process claims or claims for intermediates but are claims for a medicine itself.
Prematurity of the Notice of Allegation
[5] The Regulations were amended effective March 12, 1998, to require that service of an NOA occur no earlier that at the time the new drug submission ("NDS") is filed. The Regulatory Impact Analysis Statement accompanying the amendment states:
| No premature NOA: An NOA relating to non-infringement may only be served on a patentee by a generic manufacturer when or after it has filed a submission for an NOC with the Minister of Health. |
Prior to the March 12, 1998 amendment, an NOA could be served before an NDS was filed, providing both were available at the date of the hearing: Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [1998] 2 S.C.R. 193; Hoffmann-La Roche Ltd. v. Canada (Minister of National Health & Welfare) (December 22, 1998, T-2730-97). The relevant regulation now reads:
| 5(3) Where a person makes an allegation pursuant to paragraph (1)(b) or subsection (2) the person shall |
| (a) provide a detailed statement of the legal and factual basis for the allegation; |
| . . . |
| (c) if the allegation is made under subparagraph (1)(b)(iv), |
| (i) serve on the first person a notice of the allegation relating to the submission filed under subsection (1) at the time that the person files the submission or at any time thereafter, and |
| (ii) include in the notice of allegation a description of the dosage form, strength and route of administration of the drug in respect of which the submission has been filed; and |
| (d) serve proof of service of the information referred to in paragraph (b) or (c) on the Minister. [Emphasis added.] |
[6] In this case Genpharm's NOA to Roche is dated March 20, 1998. Its NDS to the Minister carries the same date. Both were sent by registered mail to the respective parties on the same day. The Minister's department subsequently sent what is called a "screening clarification" notice to Genpharm on May 25, 1998. This led to a response by Genpharm on June 8, 1998, and an "Acceptance Letter - Screening" from the department on June 10, 1998. Roche argues that there was no NDS filed with the Minister until June 10, 1998, and that the service of the NOA on Roche in March 1998 was therefore premature, and the Minister is without jurisdiction to issue an NOC.
[7] I am not persuaded that this is correct. I agree that the earlier jurisprudence held that an NOA could be served before a NDS was filed, and that such jurisprudence is no longer directly relevant. The approach taken to the interpretation of the Regulations in those cases, however, is still relevant. I would characterize that approach as being that a Court should not be quick to interpret the Regulations in a narrow fashion that impedes the expeditious determination contemplated by the summary procedure provided in the Regulations. I agree with Mr. Hughes' argument that the Regulations allow for service of the NOA "at the time that the person files the [new drug] submission" and do not require waiting until a letter of acceptance has been sent by the Minister's department. In my view, the contemporaneous sending by registered mail of the NOA to Roche and of the NDS to the Minister meets the requirements of subparagraph 5(3)(c)(i) of the Regulations.
Sufficiency of the Allegation
[8] Regulation 5(1) states:
| 5.(1) Where a person files or has filed a submission for a notice of compliance in respect of a drug and wishes to compare that drug with, or make reference to, another drug that has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent on the register in respect of the other drug, |
| (a) state that the person accepts that the notice of compliance will not issue until the patent expires; or |
| (b) allege that |
| (i) the statement made by the first person pursuant to paragraph 4(2)(c) is false, |
| (ii) the patent has expired, |
| (iii) the patent is not valid, or |
| (iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed. [Emphasis added.] |
[9] Roche argues that the Genpharm NOA is insufficient because it does not include an allegation that "no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed."
[10] I am not persuaded that Genpharm's allegation must track the wording of the Regulations. The substance of the allegation is that the patents on which Roche relies are not ones claiming a medicine itself or the use thereof and, therefore, the sale of Genpharm's naproxen will not infringe any such claim. Implicit therein is the allegation contemplated by subparagraph 5(1)(b)(iv). The applicant had no difficulty understanding the basis of the allegation. There was no vagueness or ambiguity. Both parties proceeded to the hearing of this application on the basis of the allegedly insufficient NOA and filed affidavits as to why claims 27 of the two patents should or should not be considered claims for processes and intermediate substances. I find that Genpharm's allegation sufficiently delineated the issue and provided a basis from which Roche could seek to disprove the allegations contained in it.
Proof of Service
[11] Regulation 5(3)(d) provides that a person making an allegation is to serve on the Minister proof that the Notice of Allegation and Detailed Statement has been served on the first person. The text of the relevant part of the Regulation is set out supra in paragraph 5. Genpharm has not established that proof of service on Roche was provided to the Minister.
[12] Nevertheless, I am not persuaded that an applicant can use the failure to provide the Minister with proof of service as grounds for seeking an order that the Minister lacks jurisdiction to issue the relevant NOC. The provision requiring proof of service to be filed on the Minister is for the Minister's benefit, not an applicant's. If actual notice of service of an NOA comes to the Minister attention, any defect arising as a result of not filing proof of service may disappear or become unimportant. As has been noted, the provision in question is designed for the benefit of the Minister and it is for the Minister to rely on it, or not, when deciding whether he has jurisdiction to issue the NOC in question.
Other Proceedings - Abuse of process
[13] The Roche patents relating to naproxen have been the subject of other NOC proceedings in this Court. In those proceedings Roche took the position that the relevant claims are process claims or claims for intermediates and that as such they were not claims for the medicine itself or the use thereof. A different position is taken in this case.
[14] Before assessing the relevance of the earlier admissions, it is necessary to describe what occurred. In Hoffmann-La Roche Ltd. v. The Minister of National Health and Welfare (1996), 67 C.P.R. (3d) 484 (F.C.T.D.), (the Apotex case), a decision issued that dealt with a number of patents. Among them were the 3660 patent and the 3771 patent. Insofar as those patents were concerned an order of prohibition did not issue to prevent the Minister from issuing an NOC for the Apotex naproxen. In the Federal Court of Appeal, Roche dropped its application for an order of prohibition insofar as those patents were concerned. Mr. Justice Stone explained in (1996), 70 C.P.R. (3d) 1, at page 2:
| . . . The Appellants attack that order for refusing to prohibit the Minister from issuing to Apotex Inc. a notice of compliance in respect of the medicine Naproxen until after the expiration of patent Nos. 1,131,660, 1,135,717, 1,259,627 and 1,207,338. In its cross-appeal, Apotex Inc. attacks that order insofar as it prohibits the Minister from issuing a notice of compliance with respect to its 750 mg. and 1000 mg. Sustained Release Naproxen tablets until after the expiration of Patent No. 1,204,671 (the "Patent"). |
| In paragraphs 19 and 25 of their written argument, the Appellants make the following submissions: |
| 19. In view of this Court's decisions in Deprenyl v. Apotex (1995), 60 C.P.R. (3d) 501 (where this Court held that process claims were not covered by the Regulation) and in Eli Lilly and Co. v. Apotex Inc. (14 May 1996) A-598-95 (F.C.A.) (where this Court held that claims for an intermediate were not covered by the Regulations), and the fact that the 660, 717, 627 and 338 patents contain only claims to processes and intermediates, the Appellants will not oppose the dismissal of their appeal as regards these patents without prejudice to any rights of appeal. |
| . . . |
| 25. As indicated in paragraph 19 above, Roche will not oppose dismissal of its appeal with respect to the 660, 717, 627 and 338 patents, without prejudice to any further right of appeal. Accordingly, the sole patent in issue is the 671 patent. |
| At the outset of the oral hearing, after hearing the parties on the point, the Court rendered judgment in the terms of these paragraphs without costs. |
[15] The patents were again in issue in Hoffmann-La Roche Ltd. v. Minister of National Health and Welfare (1998), 79 C.P.R. (3d) 486, (the Novopharm case). Associate Chief Justice Jerome wrote, at paragraph 2: "I accept the submission of the respondents that these claims are to intermediates used in the process of making an active ingredient for pharmaceutical use". He, therefore, found the claims were not for the medicine itself or its use. The Associate Chief Justice referred to the finding that had been made in the Apotex decision as support for his conclusion that the claims were for intermediates. An appeal from the Associate Chief Justice's decision was recently heard by the Federal Court of Appeal (A-92-98 and A-93-98, January 13, 1999). In upholding that decision the Court of Appeal wrote:
| [9] The appellants essentially argue in respect of this issue that the motions judge either made a wrong finding of fact or that he erred in law in considering himself bound by the decision of the Court of Appeal in Hoffmann-La Roche Ltd. v. Canada (Minister of Health and Welfare). |
| [10] To deal with the second question first, this Court in the earlier Hoffmann-La Roche case just cited noted that this same appellant in that case had conceded in its written argument that, inter alia, the claims in patents 660 and 717 contain only claims to processes and intermediates and for this reason it consented to its appeal being dismissed as regards those patents. Such appeals were accordingly dismissed. But the appellants in the present case say that the Associate Chief Justice erred in saying that he was bound by that decision. They argue that the principles of res judicata and issue estoppel do not apply where the parties are different. In the earlier case it was Apotex Inc. which was the party in adverse interest to the appellant, not the present respondent Novopharm. Stare decisis, they say, is irrelevant because it applies only to settled points of law whereas the proper interpretation of a patent claim is a mixed question of law and fact. |
| [11] We find it unnecessary to deal with this question. The Associate Chief Justice in paragraph [2] of his reasons (supra) began by saying he accepted the respondent's argument that "these claims are to intermediates used in the process of making an active ingredient for pharmaceutical use ..." It is true that he went on to state that he was bound by the earlier Hoffmann-La Roche decision in this Court, but he also said that he agreed with it and that he had |
| not been persuaded that the facts in the case at bar are sufficiently [sic] to warrant the relief sought... |
| He thus concluded that the claims of the 660 and 717 patents are claims to intermediates or processes and not claims for the medicine itself. |
| [12] We think it sufficient to conclude that in our view the learned motions judge was entitled to so find, and was correct in so finding, on the evidence before him. It is the applicant for prohibition under these Regulations which has the onus of proving that the respondent's notice of allegations is not justified. In the circumstances of this case, the appellants had the onus of proving that these claims were in respect of the medicine itself, namely the medicine which was the subject of the two notices of allegation concerning various tablet forms of the substance naproxen. In our view the appellants clearly did not meet that onus. They contented themselves with putting in as evidence the text of the two patents. It is certainly not apparent on the fact of these patents that claim 27 in each one claims the medicine itself. The appellants provided no expert evidence to demonstrate to the motions judge that such was the case and they have brought to our attention nothing in the proceeding which should have led the motions judge to this conclusion. |
| [13] This being so, we can see no reviewable error in the decisions by the Associate Chief Justice to dismiss both applications for prohibition. [Footnotes omitted.] |
[16] The parties agree that the Apotex and Novopharm decisions cannot be treated as rendering the issue in this case res judicata. Nor can they constitute issue estoppel. While the applicant is the same in all three cases, the respondents are not. Also, there has been evidence filed in this case that was not filed in either of the earlier cases.
[17] Mr. Justice Rothstein dealt with a somewhat similar situation in Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (T-1363-98, November 12, 1998). He found that the situation in that case constituted an abuse of process:
| [12] Two prior prohibition applications involving virtually identical notices of allegation with respect to the 170 patent have been dismissed. However, the respondents have been different in all cases. Therefore, the doctrines of res judicata and issue estoppel are not applicable. |
| [13] Is the prohibition application in this case an abuse of the process? I have concluded that it is. What is occurring is repetitious litigation on an issue which has been fully litigated and lost in prior proceedings. To allow the applicants to proceed would be to allow a clear abuse of the process. . . . |
Claim 27 - Intermediates or Medicine Itself
[18] Even if I do not characterize the present application as an abuse of process, I still cannot find that the applicant has adduced sufficient evidence to establish that claim 27 of the 3660 patent and claim 27 of the 3717 patent are claims for medicines.
[19] Claim 27 of the 3660 patent reads:
| A mixture of the salts of (")-6-methoxy-á-methyl-2-naphthaleneacetic acid with N-methyl-D-glucamine, when prepared by the process of claim 26. |
Claim 27 of the 3717 patent reads:
| 27. A mixture of the salts of d and 1 2-(6-methoxy-2-naphthyl)-propionic acid with N-R-D-glucamine, wherein R is alkyl having 2 to 36 carbon atoms or cycloaklyl having 3 to 8 carbon atoms, when prepared by the process of claim 1. |
[20] Naproxen is known by the chemical names: (")-6-methoxy-á-methyl-2-naphthaleneacetic acid; and d 2-(6-methoxy-2-naphthyl) propionic acid. The claims are thus mixtures of naproxen and another substance, not naproxen alone.
[21] The applicant argues that the mixtures are medicines because they contain naproxen. This assertion is based on an affidavit by Mr. Henein, the Director, Regulatory Affairs of Roche. He refers to a United States patent, number 3,904,682, as demonstrating that N-methyl-D-glucamine is a methylglucamine and as such is a pharmaceutically acceptable salt of naproxen. He refers to page 8 of the 3717 patent for the conclusion that the N-R-D glucamine salts of naproxen are therapeutically useful:
| The N-R-D-glucamine salts of d 2-(6-methoxy-2-naphthyl) propionic acid are useful as anti-inflammatory, analgesic, and/or antipyrectic agents, platelet aggregation inhibitors, fibrinolytic agents and as smooth muscle relaxants. The aforesaid salts are also useful in the treatment of dysmenorrhoea and are agents for alleviating post-menopausal symptoms. Accordingly, such salts would be useful in the treatment and elimination of inflammation such as inflammatory conditions of the muscular skeletal system, skeletal joints and other tissues, . . . [Emphasis added.] |
[22] Mr. Henein concludes that whether a patient were to consume a naproxen enteric coated tablet or one of the compositions claimed in either claim 27 of 3717 or claim 27 of the 3660 patent, in each case the therapeutically active form of naproxen would be consumed. He asserts that the claims in question, therefore, are claims for substances intended or capable of being used for the diagnosis, treatment, mitigation or prevention of a disease, disorder, or abnormal physical state, or the symptoms thereof.
[23] Mr. Henein, however, does not say that the mixtures are medicines or have been used as medicines. He does not say that the mixtures have ever been placed on any approved list as medicines, or recommended by any authority for use as medicines. An affidavit filed by Mr. Pike on behalf of Genpharm states that the mixture is not a medicine and that as far as he knows no approval has ever been given for its use as such.
[24] I accept counsel for Genpharm"s argument that Roche"s evidence is not sufficient to establish that the mixtures described in the respective claims 27 are medicines. A statement in an affidavit that consumption of a mixture that contains a medicine results in consumption of the medicine is not sufficient to establish that the mixture is in fact a medicine. The reference to a U.S. patent as support for the claim that the mixture described in claim 27 of the "660 patent is therapeutically active is weak evidence. There is no claim in the "660 patent that the mixture is therapeutically active. In addition, the applicants have not said that they were wrong when they previously described the mixtures as intermediates and not claims for medicines. A reading of the patents shows them to be intermediates.
[25] For the reasons given, an order preventing the Minister issuing an NOC will not be issued.
Judge
OTTAWA, ONTARIO
January 26, 1999