Date: 20021118
Docket: T-2280-00
Neutral Citation: 2002 FCT 1195
BETWEEN:
MERCK FROSST CANADA & CO.,
and
MERCK & CO., INC.,
Applicants
AND:
THE MINISTER OF HEALTH
and
APOTEX INC.,
Respondents
REASONS FOR ORDER
ROULEAU, J.
[1] The applicants commenced the within application pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/98-166. They seek an order prohibiting the Minister of Health from issuing to the respondent Apotex a Notice of Compliance for the medicine simvastatin until after the expiry of Merck's Canadian Letters Patent No. 1,199,322. The '322 Patent includes claims for the medicine simvastatin prepared by the methods and processes of manufacture particularly described and claimed or by obvious chemical equivalents. Simvastatin is a cholesterol-lowering agent used for the treatment of hypercholesterolemia, atherosclerosis and coronary heart disease.
[2] On January 26, 1998, Apotex sent a Notice of Allegation to Merck in respect of the '322 Patent. Specifically, Apotex alleged that its simvastatin would be made by a process different from and non-infringing of the processes claimed in the '322 Patent. Following the issuance of a Protective Order, Apotex provided Merck with its process details including a synthetic scheme and a detailed process description, detailing each of the steps involved in the Apotex process to manufacture simvastatin. These documents are referred to as the "Detailed Process Description" or the "DPD".
[3] Thereafter, it was ascertained that the second and third intermediates in the disclosed chemical process has been misidentified. Apotex then provided Merck with a document which correctly identified the second and third intermediates but in which the process steps were not changed. This document is referred to by the parties as the "Brief Outline". However, the misidentification of the second and third intermediates is a matter of absolutely no relevance since it does not, in any way, modify the chemical process disclosed in the DPD.
[4] The proceeding in Court File No. T-418-98 was ultimately heard by Mr. Justice O'Keefe. He determined that, in accordance with the transitional provisions which accompanied the amendments to the Regulations in 1998, subparagraph 5(3)(c)(i) was applicable and therefore, since Apotex' Notice of Allegation had been served before its submission for an NOC had been filed, the Notice of Allegation was premature.
[5] Subsequently, by letter dated October 23, 2000, and sent by registered mail, Apotex served upon Merck the Notice of Allegation which gives rise to this proceeding. The Notice of Allegation reads as follows:
This is a Notice of Allegation pursuant to the Patented Medicine (Notice of Compliance) Regulations.
We have filed with Health Canada an Abbreviated New Drug Submission for Apo-Simvastatin Tablets containing the medicine Simvastatin in strength of 5mg, 10mg, 20mg, 40mg and 80mg for oral administration.
With respect to Patent 119,322, we allege that no claim for the medicine itself and no claim for the use of the medicine would be infringed by our making, constructing, using or selling of such tablets.
The legal and factual basis for the aforesaid allegation is as follows:
The Patent has claims for simvastatin only as made by specific processes.
We will not use of sell simvastatin made by any process claimed in this patent. More specifically, simvastatin used or sold by us will be made by the route disclosed in the enclosure included herewith which was also disclosed to you in Court File No. T-418-98.
As you did not dispute that the route was non-infringing in Court File No. T-418-98, in our view it would be an abuse of process if you were to do so now.
[6] In response to the Notice of Allegation, Merck commenced the within application.
[7] The relevant sections of the Regulations read as follows:
| 5. (1) Where a person files or has filed a submission for a notice of complicance in respect of a drug and compares that drug with, or makes reference to, another drug for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics and that other drug 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
(b) allege that
(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.
6. (1) A first person may, within 45 days after being served with a notice of an allegation pursuant to paragraphg 5(3)(b) or (c), apply to a court for an order prohibiting the Minister from issuing a notice of compliance until after the expiration of a patent that is the subject of the allegation.
(6) For the purposes of an application referred to in subsection (1), where a second person has made an allegation under subparagraph 5(1)(b)(iv) or (1.1)(b)(iv) in respect of a patent and where that patent was granted for the medicine itself when prepared or produced by the methods or processes of manufacture by their obvious chemical equivalents, it shall be considered that the drug proposed to be produced by the second person is, in the absence of proof to the contrary, prepared or produced by those methods or processes.
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5.(1) Lorsqu'une personne dépose ou a déposé une demande d'avis de conformité pour une drogue et la compare, ou fait référence, à une autre drogue pour en démontrer la bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, cette autre drogue ayant été commercialisée au Canada aux termes d'un avis de conformité délivré à la première personne et à l'égard de laquelle une liste de brevets a été soumise, elle doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre qui se rapporte à cette autre drogue:
(b) soit une allégation portant que, selon le cas:
(iv) aucune revendication pour le médicament en soi ni aucune revendication pour l'utilisation du médicament ne seraient contrefaites advenant l'utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l'objet de la demande d'avis de conformité.
6. (1) La première personne peut, dans les 45 jours après avoir reçu signification d'un avis d'allégation aux termes des alinéas 5(3)b) ou c), demander au tribunal de rendre une ordonnance interdisant au ministre de délivrer un avis de conformité avant l'expiration du brevet visé par l'allégation.
(6) Aux fins de la demande visée au paragraphe (1), lorsque la seconde personne a fait une allégation aux termes des sous-alinéas 5(1)b)(iv) ou (1.1)b)(iv) à l'égard d'un brevet et que ce brevet a été accordée pour le médicament en soi préparé ou produit selon les modes ou procédés de fabrication décrits en détail et revendiqués ou selon leurs équivalents chimiques manifestes, la drogue que la seconde personne projette de produire est, en l'absence d'une preuve contraire, réputée préparée ou produite selon ces modes ou procédés.
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[8] Subsection 6(6) places an evidentiary burden upon Apotex to go beyond a mere assertion of non-infringement and to adduce evidence disclosing some difference between its own proposed process and that claimed in Merck's Patent '322. In the absence of such evidence, Merck can rely upon subsection 6(6) to establish as a fact that Apotex' process is the same as that claimed in the patent. However, once Apotex adduced the evidence of its expert witnesses that its process is different, the burden of proof fell upon Merck to establish that Apotex' allegation of non-infringement is not justified.
[9] In Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994) 58 C.P.R. (3d) 302, the Federal Court of Appeal held that the initiator of a section 6 proceeding, being the person having the carriage of the litigation, bears a difficult burden of proof because it must disprove some or all of the allegations in the notice of allegation which, if left unchallenged, would have allowed the Minister to issue a notice of compliance.
[10] Similarly, in Pfizer Canada Inc.. v. Nu-Pharm Inc. (1998), 83 C.P.R. (3d) 1, this Court stated at p. 3 as follows:
"It is well established that in order to grant a prohibition order, the Court must find that the patentee has established, on a balance of probabilities, that the second person's allegations are not justified. In determining the nature of the burden to be met by the applicants, it is important to remember that the proceeding under subsection 6(2) is not an ordinary infringement action. Rather, it is a summary proceeding intended to allow a patent owner to protect its patent rights where the generic's allegations of non-infringement or invalidity have no merit. Accordingly, if a patent owner cannot establish that the generic's allegations have no merit, a prohibition application should be dismissed and the issue left to be resolved by more conventional measures."
[11] In my view, Merck's evidence does not discharge the burden placed upon it by the Regulations.
[12] In support of its application, Merck filed the affidavits of Drs. Weissman and Just. Dr. Weissman is an employee of Merck. His first affidavit is with respect to experiments he conducted almost three years earlier, pursuant to which he attempted and purportedly failed to successfully carry out the process disclosed in the DPD to make simvastatin. These experiments, which were conducted in relation to the proceedings in Court File T-418-98, led him to the conclusion that the Apotex process was not workable to produce simvastatin. It seems to me that if it was Merck's intention to lead probative evidence with respect to operability, it should have retained the services of an independent expert to test the operability of Apotex' process. In any event, the affidavit does not answer the question which this Court must determine because it is not directed towards the question of whether the Apotex process infringes the process in Patent '322.
[13] Nor does Dr. Just's first affidavit provide any opinion or evidence in respect of the question of infringement. Rather his evidence is restricted to a consideration of Dr. Weissman's experiments to produce simvastatin using the Apotex process.
[14] In response to the proceeding, Apotex filed the affidavit evidence of Drs. James Hendrickson, Robert McClelland and George Olah. All three experts addressed the questions of whether the process disclosed in the Brief Outline infringes the '322 Patent as well as the operability of Apotex' process. In paragraphs 13 through 24 of his Affidavit, Dr. Hendrickson, a Professor of Chemistry at Randeis University in Waltham, Massachusetts who is recognized internationally as an expert in chemical synthesis, provides a thorough analysis of his unqualified opinion that Apotex' process as disclosed in the Brief Outline does not infringe the '322 Patent. He states:
Additionally, nowhere does the Application to the Federal Court by Merck or the Affidavits filed by Merck provide any evidence that the Apotex process infringes the '322 Patent. Merck only asserts that the Apotex process is invalid because it is "covered by the '322 Patent". I strongly reject this statement. The claims of the '322 Patent include nothing of the Apotex process except the final product, simvastatin.
[15] Indeed, Dr. Hendrickson expresses the view that, given his conduct, Dr. Weissman did not make a bona fide effort to carry out Apotex' process:
In my opinion the steps taken as outlined by Dr. Weissman, in his affidavit indicate to me that he did not seriously attempt to repeat the Detailed Process Descriptions also referred to as the BCI process. It is clear to me that he took such steps with the Detailed Process Description (the BCI process) with the intent that it should fail. In fact the third step, according to Dr. Weissman did fail because he did not obtain any "solid product (crude Simvastatin)".
[16] Dr. McClelland was first introduced to the Apotex process as developed by Brantford Chemicals Inc. in September of 1997. He also concluded that the process disclosed in the Brief Outline was neither a literal infringement of any of the processes claimed in the '322 Patent nor an obvious chemical equivalent of any of the claimed processes.
[17] Dr. George Olah, a chemist of international reputation and acclaim and who in 1994, was the recipient of the unshared Nobel Price in chemistry, agreed with the findings of Drs. Hendrickson and McClelland. With respect to infringement, Dr. Olah expressed his unqualified view that the Apotex process does not infringe the '322 Patent. In paragraph 27 of his Affidavit he states:
The Apotex process . . . is an entirely different approach than claimed in the '322 Paent. Merck's own experts have not expressed any argument or opinion about this in their affidavits and testimony . . None of the claims of the '322 Patent in any way can be considered of any relevance to the Apotex process. Consequently, no question of infringement can arise.
[18] After Apotex filed its initial evidence in this matter, Merck sought and obtained leave to file further affidavit evidence, including a second affidavit of both Drs. Weissman and Just. Again however, the evidence does not address the question of infringement but rather the operability of Apotex' process. Both affidavits attempt to respond to certain deficiencies in Dr. Weissman's experiments but they do not, in any way address the sole and exclusive issue to be determined in this proceeding of whether Apotex' process infringes the process claimed in Patent '322.
[19] Simply stated Merck has not established that if Apotex is issued an NOC for its simvastatin product, it will infringe the process claimed in the '322 Patent. Rather, it is Merck's position that Apotex' process to manufacture simvastatin does not work and, therefore, that it is not a "valid" chemical process.
[20] However, the concepts of operability or workability of Apotex' process is of no concern to Merck and, based upon jurisprudence from this Court and the Federal Court of Appeal, is entirely irrelevant to the matters in issue in this proceeding. In Pfizer Canada Inc. v. Apotex Inc. (1997), 73 C.P.R. (3d) 446 at 447-8 Noel, J. made the following comments in this regard:
I note to begin with that commercial workability and safety concerns are not matters relevant to the justification of an allegation of non-infringement made pursuant to the Patented Medicine (Notice of Compliance) Regulations, SOR\93-133. A non-infringing process, if established, will justify an allegation of non-infringement in a section 6 proceeding irrespective of whether or not the end product proves to be commercially viable or whether it is reliable from a safety point of view. Matters of safety, if they should arise, will be addressed by the Minister in conformity with the prescriptions of the Food and Drug Regulations, C.R.C. 1978, c. 870, and matters of commercial workability are of concern to Apotex only.
[21] In my view, Merck has provided no answer or evidence to dispute Apotex' evidence of non-infringement and accordingly its application must be dismissed.
[22] Finally, the applicant raises the question of whether Apotex has strictly complied with the timing requirements set out in the Regulations. I am not satisfied that there is any merit to Merck's complaint in this regard. Pursuant to subparagraph 5(3)(c)(i) of the Regulations, where a Notice of Allegation alleging non-infringement is given, as in the case at bar, such Notice of Allegation must be "served" upon Merck at the time that Apotex files its submissions for an NOC or at any time thereafter.
[23] In the present case, the Notice of Allegation is dated October 23, 2000 and was sent to Merck by registered mail. Pursuant to subsection 9(2) of the Regulations, the Notice of Allegation is therefore deemed to have been served upon Merck on October 28, 2000. Merck acknowledges in paragraph 61 of its Memorandum that Apotex' ANDS was sent to the Minister under cover of a letter dated October 24, 2000 and was acknowledged as having been received by the Minister on October 26, 2000. The ANDS was therefore filed two days before Apotex' Notice of Allegation was served.
[24] Accordingly, it is clear that Apotex has complied with subparagraph 5(3)(c)(i) and, in particular, served the Notice of Allegation herein "at a time thereafter" the date of the filing of its submission with the Minister for an NOC.
[25] For all of these reasons the application is dismissed. Costs to the respondent Apotex Inc.; if the parties cannot agree as to costs they should be taxed in accordance with column V of Tariff B.
JUDGE
OTTAWA, Ontario
November 18, 2002
FEDERAL COURT OF CANADA
TRIAL DIVISION
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-2280-00
STYLE OF CAUSE: Merck Frosst Canada & Co., and other
The Minister of Health and Apotex Inc.
PLACE OF HEARING: Vancouver
DATE OF HEARING: October 8th, 9th, 10th, 2002
REASONS FOR Order : The Honourable Mr. Justice Rouleau
DATED: November 18, 2002
APPEARANCES:
Mr. Patrick E. Kierans and
Ms. Judith Robinson FOR APPLICANTS
Mr. H.B. Radomski and
Mr. Andrew R. Brodki FOR RESPONDENTS
SOLICITORS OF RECORD:
Ogilvy Renault
Toronto, Ontario
Montreal QC FOR APPLICANTS
Goodmans LLP
Toronto, Ontario FOR RESPONDENTS
Mr. Morris Rosenberg
Deputy Attorney General of Canada FOR RESPONDENTS
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