Apotex Inc. v. Merck & Co Inc.

Apotex Inc. v. Merck & Co Inc.
Court (s) Database
Federal Court Decisions
Date
2008-10-21
Neutral citation
2008 FC 1185
File numbers
T-1144-05
Notes
Reported Decision
Decision Content
Date: 20081021
Docket: T-1144-05
Citation: 2008 FC 1185
Ottawa, Ontario, October 21, 2008
PRESENT: The Honourable Mr. Justice Hughes
BETWEEN:
APOTEX INC.
Plaintiff
and
MERCK & CO. INC., MERCK FROSST CANADA LTD.
and MERCK FROSST CANADA & CO.
Defendants
REASONS FOR JUDGMENT AND JUDGMENT
[1] This is an action brought by the Plaintiff, Apotex Inc., under the provisions of section 8 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended (PMNOC Regulations), claiming recovery against the Defendants, Merck Frosst Canada Ltd. and Merck Frosst Canada & Co. (collectively Merck). This is the first such action to proceed to trial on the merits. The parties have raised a number of preliminary issues for determination at this time, leaving the quantification of any award, if required, to a later trial.
[2] The issues required to be determined at this time are twofold. The first deals with the jurisdiction of this Court, enablement and constitutionality of section 8. The second deals with the nature and extent of the remedies afforded by section 8 of the PMNOC Regulations. For the reasons that follow, I find that the Federal Court has jurisdiction to hear and determine actions instituted under section 8 of the PMNOC Regulations, that section 8 is properly enabled and that section 8 is intra vires the constitutional authority of the federal Parliament. As to the second, I find that the Apotex is not entitled to disgorgement of Merck’s profits, if any; that Apotex is entitled to recover its damages or its lost profits, for the period from February 3, 2004 to May 26, 2005; and, that Apotex may claim recovery of damages that occurred during said period and extended beyond that period if said damage could not have been or were not rectified in that period. No party is awarded costs.
FACTUAL BACKGROUND
[3] Counsel for the parties are to be commended for co-operating in providing an agreement as to facts and documents (Exhibit 1). The Plaintiff, Apotex Inc., is what is known colloquially as a generic drug company which manufactures and markets primarily generic versions of pharmaceuticals in Canada. In the PMNOC Regulations, Apotex is referred to as a “second party”. The two Merck Canadian companies Merck Frosst Canada Ltd. and Merck Frosst Canada & Co. (collectively referred to in these reasons as Merck) are the Canadian branch of a multinational organization which manufactures and markets are what are commonly referred to as “brand name” or “originator” or “innovator” pharmaceuticals and are what is referred to as “first person” under the PMNOC Regulations. Merck & Co. Inc., a United States company, was named as a party defendant in this action but shortly before trial, an Order was issued, on consent, discontinuing this action against that entity.
[4] The pharmaceutical of interest in this action is a drug commonly known as alendronate which is used primarily in the treatment of osteoporosis. Merck has an interest in a patent, Canadian Patent 2,294,595 (’595) which, among other things, includes claims directed to a particular dosage regimen for the use of that known drug, alendronate, in the treatment of osteoporosis, a known use. Merck listed the ’595 patent with the Minister of Health under the provisions of the PMNOC Regulations which meant that any generic seeking approval to sell a generic version of alendronate in Canada for the patented dosage regimen for the treatment of osteoporosis and wanting to take advantage of simply referencing approvals already given to Merck for that drug could file an Abbreviated New Drug Submission (ANDS). In so doing a generic is required to send a notice to Merck alleging, among other things, that the ’595 patent would not be infringed or was invalid, thereby permitting Merck to commence an application in this Court to prohibit the generic from marketing its generic version of alendronate in Canada in the dosage regimen claimed in the ’595 patent.
[5] Merck received an NOC approving for sale its version of alendronate in Canada on February 4, 2002. Apotex filed an ANDS for alendronate on February 7, 2003 and sent a Notice of Allegation to Merck on April 14, 2003 alleging that the ’595 patent was invalid for a number of reasons. On May 29, 2003, Merck & Co. Inc. and Merck Frosst Canada & Co. commenced proceedings in this Court, T-884-03, to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex which otherwise would permit Apotex to sell a generic version of the alendronate drug in Canada. On February 3, 2004 the Minister send a letter to Apotex advising it that its application was approved but would be held in abeyance subject to the Court proceedings. On May 26, 2005, Mosley J. of this Court gave Reasons and an Order in T-884-03, dismissing Merck’s application, finding that Apotex’s allegations as to invalidity, on some but not all grounds, were justified. These Reasons are cited as 2005 FC 755. No appeal was taken. On May 27, 2005, the Minister issued a Notice of Compliance to Apotex permitting it to sell its generic version of alendronate, Apo-alendronate, in Canada.
[6] On July 5, 2005, Apotex instituted this action T-1144-05 claiming recovery against Merck under the provisions of section 8 of PMNOC Regulations for the period from February 3, 2004 to May 27, 2005.
[7] By Orders of this Court dated January 24, 2006 and August 14, 2008, the quantification of any amounts found to be properly recoverable in this action is a matter to be determined at a subsequent trial. The two preliminary issues previously referred to are the subject of the present trial.
ISSUES FOR DETERMINATION
1) Merck’s Issues
[8] Merck submits the following issues relating to jurisdiction of this Court, enablement and, constitutionality of section 8:
a) Does the Federal Court lack jurisdiction to hear an action pursuant to section 8 of the PMNOC Regulations;
b) Is section 8 of the PMNOC Regulations ultra vires section 55.2(4) of the Patent Act, R.S.C. 1985 c. P-4 as amended;
c) Is section 8 outside the scope of Parliament’s power to make laws in relation to patents of invention and discovery, and an unlawful intrusion into the exclusive jurisdiction of the provinces pursuant to section 92(13) of the Constitution Act, 1867, R.S.C. 1985, App. II, No. 5.
2) Apotex’s Issues
[9] Apotex raises issues as to the nature and extent of the remedy afforded by section 8 of the PMNOC Regulations, in particular:
Is Apotex entitled to an election as between the damages which it has suffered, if any, and the profits made by Merck, if any? What is the period of time in respect of which Apotex may claim recovery? Is Apotex entitled to recover for damages that continue after the period expires?
[10] A number of other issues were raised in the pleadings of each of the parties but have been resolved or dropped. Merck & Co. Inc. (Merck US) is a named defendant and several issues were raised by Apotex as to the nature and degree of its participation in the events under consideration. By consent Order, this action as against Merck US was dismissed. The two remaining defendants, Merck Frosst Canada Ltd. and Merck Frosst Canada & Co. are Canadian entities only the first of which was in existence at the time that the earlier NOC proceedings decided by Mosley J. were initiated. The second of those two entities came into existence subsequent to the institution of the NOC proceedings (T-884-03). It appears that there was a transfer of assets from the first to the second of these entities. The pleadings take issue as to this transfer and the effect thereof however, these matters are no longer of concern.
[11] In its earlier Statement of Claim, Apotex made a claim for unjust enrichment which claim was dropped at trial. By its counsel at trial, Apotex acknowledged that while during discovery some other grounds of damages were suggested none of such grounds are being pursued. Amended pleadings were filed at trial and are contained in a Trial Record (Exhibit 5). Apotex’s counsel stated at trial that Apotex does not seek any relief other than that specifically claimed in the prayer for relief in its Further Amended Statement of Claim dated October 6, 2008.
Dr. Hollis
[12] Only one witness was called to appear at trial. He was Dr. Aidan Hollis called as an expert witness by Apotex. He is an associate professor of economics at the University of Calgary.
Dr. Hollis’ credentials were not seriously challenged by Merck. He was accepted to be an expert in economics with particular reference in pricing, competition and incentives for entering pharmaceutical markets.
[13] Merck, however, strenuously objected to the introduction of Dr. Hollis’ evidence on the basis of lack of relevance or necessity. After hearing the parties in argument, I admitted Dr. Hollis’ report in the form of an affidavit sworn on September 4, 2008 together with two exhibits AH-1, a curriculum vitae, and AH-2, a published paper by Dr. Hollis and another, into evidence as Exhibit 3, subject to weight. Dr. Hollis was then cross-examined.
[14] I find that Dr. Hollis’ evidence is to be given no weight. It was not referred to in any written argument submitted by any party before trial, and scarcely referred to in skeleton argument submitted at trial or in oral argument at trial by any counsel. Dr. Hollis purports to address two questions from what he describes as an “economic perspective”. The first is directed to whether, under the PMNOC Regulations, Apotex’s remedy is limited to damages or whether it could claim disgorgement of Merck’s profits. Dr. Hollis is not a lawyer, and even if he were, a Canadian lawyer’s opinion as to Canadian law is not admissible in evidence for the purpose of interpreting that law. Even less admissible is the evidence of an economist. An exception may exist where a statute uses wording that is meaningful to those practicing a particular profession (Regina ex rel. Doughty v. Manuel (1982), 38 O.R. (2d) 321 Ont. C.A. at 352-6). However the views of an economist as to the economic incentives or otherwise that may be provided by a regulation is not helpful in interpreting those regulations and will be given no weight.
[15] The second issue addressed by Dr. Hollis was whether Apotex’s claim for damages should extend to a shortened period having regard to a delay if any, in serving the Notice of Allegation. Again, the views of an economist on this issue are not helpful. In any event, when Dr. Hollis took the stand, he made numerous corrections to his affidavit on this point, changing the period of delay to one year from two. His conclusions are summarized in paragraph 48 of his affidavit. He admitted on cross-examination that those conclusions were “perhaps not very well expressed”. He admitted that only in certain cases would his conclusions be accurate while in other cases they would not be accurate.
[16] I have, therefore, given Dr. Hollis’ evidence no weight.
HISTORY OF THE PMNOC REGULATIONS
[17] The historical background to what is now the PMNOC Regulations has been reviewed, at least in part, in several decisions including AB Hassle et al. v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (FCA); Apotex Inc. v. Canada (Attorney General) (2000), 6 C.P.R. (4th) 165 (FCA); Bayer AG v. Canada (Minister of National Health and Welfare) (1993), 51 C.P.R. (3d) 329 (FCA); and Bristol-Myers Squibb Co. v. Canada (Attorney General) (2005), 39 C.P.R. (4th) 449 (SCC) (Biolyse).
[18] Historically a number of countries, Canada among them, have been averse to extending patent monopolies to food or medicines. Canada gradually retreated from this position, allowing patents directed to processes for making food or medicine, then restricting the prohibition to only certain types of medicines and finally, lifting the restrictions entirely. Most, but not all, countries have also lifted such restrictions.
[19] Nonetheless, until 1993, Canada included a scheme in its Patent Act whereby an interested person could apply to the Commissioner of Patents (not the patent owner) and obtain a compulsory licence to sell a patented medicine in Canada. Almost invariably such a licence was granted and at the rate of 4% of the net price of a finished product or 15% for the bulk ingredient. This compulsory licence system was objected to by patentees, claiming that it diminished the rights of those holding patents claiming medicines as opposed to others who may have patents for instance for bicycles.
[20] In the early 1990’s considerable efforts were made by the government, encouraged by lobbyists for many of the interested parties, to abolish the compulsory licence system for medicines, and to put in place a suitable system that would encourage development in the area while making medicines available to Canadians at affordable prices. The parties in this action, by agreement, filed six volumes of material said to comprise selected portions of transcripts of parliamentary committee debates, submissions by lobbyists and speeches in the House of Commons (Exhibit 2). I have not found this material to be helpful. In general, such material is not to be used in interpreting a statute or regulation (e.g. Reference re: Validity of Regulations in Relation to Chemicals, [1943] S.C.R. 1 per Duff CJ. at page 12). However, to get a flavour of the debate in the House of Commons, I repeat part of what was said by Hon. Pierre Blais (Minister of Consumer and Corporate Affairs and Minister of State (Agriculture) - as he then was), on December 10, 1992 in introducing Bill C-91 which Bill included amendments the Patent Act, including section 55.2 at issue here. He said inter alia:
On several occasions since June, I have had an opportunity to explain the main objectives of Bill C-91 and I would like to come back to them a little.
First, Bill C-91 is meant to continue the major undertaking of modernizing Canadian intellectual property legislation, which began some years ago. In the present economic context where knowledge and innovation are the watchwords, I think that everyone will agree that it is an essential element of our competitiveness.
Our purpose is also to align our laws with those of most of our international competitors, so that Canada can provide the same benefits and be as attractive as other countries in terms of international trade and investment.
This bill will help us to stimulate research and development in Canada, as well as growth in a leading-edge sector.
With Bill C-91, we also wanted to strengthen consumer protection, so that consumers can continue to obtain patented medicine at reasonable prices. I think that all Canadians are entitled to that.
[21] Section 55.2 as passed R.S.C. 1993, c. 2, s. 4 provided that it would not be an infringement of a patent to use the invention solely for purposes of developing submissions for regulatory approval or for stockpiling. Section 55.2 was a so-called “early working” exception which is similar to such an exemption provided in United States legislation. However, the Canadian exception is unrestricted as to subject matter of the patent, it applies to medicines, bicycles and anything patented, and unrestricted as to any country not just Canada or province in which regulatory approval may be sought. The amendment also provided for “stockpiling” whereby, a person could make and stockpile patented products but not put them into the stream of commerce until the patent expired (sections 55.2(2) and (3)). These stockpiling provisions were removed in 2001. Section 55.2(4) provided a Regulation making authority. Section 55.2(5) provided that these provisions of the Patent Act and any Regulations passed under them, would, in the case of conflict with other provisions of the Patent Act or Regulation or any other Act or Regulations, have priority.
[22] Section 55.2(6) provided that any right to non-infringement in respect of private, non-commercial activity remained. In this last regard the decision of the Supreme Court of Canada in SmithKline & French Inter-American Corp. v. Micro Chemicals Ltd., [1972] S.C.R. 506 is to be noted in which it was held that experimental use without a licence in the course of bone fide experiments directed to whether a person could make a patented product was not an infringement of a patent.
[23] Section 55.2 as passed in 1993 (omitting subsections (2) and (3)) remains in that form to this day and says:
Exception
55.2 (1) It is not an infringement of a patent for any person to make, construct, use or sell the patented invention solely for uses reasonably related to the development and submission of information required under any law of Canada, a province or a country other than Canada that regulates the manufacture, construction, use or sale of any product.
Regulations
(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
(a) respecting the conditions that must be fulfilled before a notice, certificate, permit or other document concerning any product to which a patent may relate may be issued to a patentee or other person under any Act of Parliament that regulates the manufacture, construction, use or sale of that product, in addition to any conditions provided for by or under that Act;
(b) respecting the earliest date on which a notice, certificate, permit or other document referred to in paragraph (a) that is issued or to be issued to a person other than the patentee may take effect and respecting the manner in which that date is to be determined;
(c) governing the resolution of disputes between a patentee or former patentee and any person who applies for a notice, certificate, permit or other document referred to in paragraph (a) as to the date on which that notice, certificate, permit or other document may be issued or take effect;
(d) conferring rights of action in any court of competent jurisdiction with respect to any disputes referred to in paragraph (c) and respecting the remedies that may be sought in the court, the procedure of the court in the matter and the decisions and orders it may make; and
(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.
Inconsistency or conflict
(5) In the event of any inconsistency or conflict between
(a) this section or any regulations made under this section, and
(b) any Act of Parliament or any regulations made thereunder,
this section or the regulations made under this section shall prevail to the extent of the inconsistency or conflict.
For greater certainty
(6) For greater certainty, subsection (1) does not affect any exception to the exclusive property or privilege granted by a patent that exists at law in respect of acts done privately and on a non-commercial scale or for a non-commercial purpose or in respect of any use, manufacture, construction or sale of the patented invention solely for the purpose of experiments that relate to the subject-matter of the patent.
Exception
55.2 (1) Il n’y a pas contrefaçon de brevet lorsque l’utilisation, la fabrication, la construction ou la vente d’une invention brevetée se justifie dans la seule mesure nécessaire à la préparation et à la production du dossier d’information qu’oblige à fournir une loi fédérale, provinciale ou étrangère réglementant la fabrication, la construction, l’utilisation ou la vente d’un produit.
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 :
a) fixant des conditions complémentaires nécessaires à la délivrance, en vertu de lois fédérales régissant l’exploitation, la fabrication, la construction ou la vente de produits sur lesquels porte un brevet, d’avis, de certificats, de permis ou de tout autre titre à quiconque n’est pas le breveté;
b) concernant la première date, et la manière de la fixer, à laquelle un titre visé à l’alinéa a) peut être délivré à quelqu’un qui n’est pas le breveté et à laquelle elle peut prendre effet;
c) concernant le règlement des litiges entre le breveté, ou l’ancien titulaire du brevet, et le demandeur d’un titre visé à l’alinéa a), quant à la date à laquelle le titre en question peut être délivré ou prendre effet;
d) conférant des droits d’action devant tout tribunal compétent concernant les litiges visés à l’alinéa c), les conclusions qui peuvent être recherchées, la procédure devant ce tribunal et les décisions qui peuvent être rendues;
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.
Divergences
(5) Une disposition réglementaire prise sous le régime du présent article prévaut sur toute disposition législative ou réglementaire fédérale divergente.
Interprétation
(6) Le paragraphe (1) n’a pas pour effet de porter atteinte au régime légal des exceptions au droit de propriété ou au privilège exclusif que confère un brevet en ce qui touche soit l’usage privé et sur une échelle ou dans un but non commercial, soit l’utilisation, la fabrication, la construction ou la vente d’une invention brevetée dans un but d’expérimentation.
[24] The legislation as passed in 1993 contained provisions for review of the amendments by a Statutory Committee on Industry. That review was conducted. A Report was tabled dated April, 1997. The Report indicates that many representations were made on behalf of many interested parties. It recommended, among other things, at page 40 of the Report, that in respect of proposed regulatory amendments a rigorous process for drafting, publication, and receipt of submissions on behalf of the public, be followed.
[25] The PMNOC Regulations first came into effect on March 12, 1993 (SOR/93-133). They were amended effective March 12, 1998 (SOR/98-166), again amended effective October 1, 1999 (SOR/99-379), against amended effective 5 October, 2006 (SOR/2006-242) and last amended effective June 12, 2008 (SOR/2008-211). It is important to note, particularly with respect to SOR/2006-242, that certain transitional provisions provide that certain amendments including some as to Section 8 do not apply to actions commenced prior to the date of coming into force of the amendments. Those amendments came into force October 5, 2006. This action was commenced
July 5, 2005. As a result, certain amendments pertaining to section 8 of the PMNOC Regulations made in October 2006 do not affect what is at issue in this action.
Section 8 – History
[26] In this action, were are concerned with section 8 of the PMNOC Regulations in the form in which that section stood as of the date this action was filed, July 5, 2005. As of that date, section 8 read as follows:
8. (1) If an application made under subsection 6(1) is withdrawn or discontinued by the first person or is dismissed by the court hearing the application or if an order preventing the Minister from issuing a notice of compliance, made pursuant to that subsection, is reversed on appeal, the first person is liable to the second person for any loss suffered during the period:
(a) beginning on the date, as certified by the Minister, on which a notice of compliance would have been issued in the absence of these Regulations, unless the court is satisfied on the evidence that another date is more appropriate; and
(b) ending on the date of the withdrawl, the discontinuance, the dismissal or the reversal.
(2) A second person may, by action against a first person, apply to the court for an order requiring the first person to compensate the second person for the loss referred to in subsection (1).
(3) The court may make an order under this section without regard to whether the first person has commenced an action for the infringement of a patent that is the subject matter of the application.
(4) The court may make such order for relief by way of damages or profits as the circumstances require in respect of any loss referred to in subsection (1).
(5) In assessing the amount of compensation the court shall take into account all matters that it considers relevant to the assessment of the amount, including any conduct of the first or second person which contributed to delay the disposition of the application under subsection 6(1).
8. (1) Si la demande présentée aux termes du paragraphe 6(1) est retirée ou fait l’objet d’un désistement par la première personne ou est rejetée par le tribunal qui en est saisi, ou si l’ordonnance interdisant au ministre de délivrer un avis de conformité, rendue aux termes de ce paragraphe, est annulée lors d’un appel, la première personne est responsable envers la seconde personne de toute perte subie au cours de la période :
a) débutant à la date, attestée par le ministre, à laquelle un avis de conformité aurait été délivré en l’absence du présent règlement, sauf si le tribunal estime d’après la preuve qu’une autre date est plus appropriée;
(b) se terminant à la date du retrait, du désistement ou du rejet de la demande ou de l’annulation de l’ordonnance.
2) La seconde personne peut, par voie d’action contre la première personne, demander au tribunal de rendre une ordonnance enjoignant à cette dernière de lui verser une indemnité pour la perte visée au paragraphe (1).
(3) Le tribunal peut rendre une ordonnance aux termes du présent article sans tenir compte du fait que la première personne a institué ou non une action pour contrefaçon du brevet visé par la demande.
(4) Le tribunal peut rendre l’ordonnance qu’il juge indiquée pour accorder réparation par recouvrement de dommages-intérêts ou de profits à l’égard de la perte visée au paragraphe (1).
(5) Pour déterminer le montant de l’indemnité à accorder, le tribunal tient compte des facteurs qu’il juge pertinents à cette fin, y compris, le cas échéant, la conduite de la première personne ou de la seconde personne qui a contribué à retarder le règlement de la demande visée au paragraphe 6(1).
[27] The history of changes to section 8 since the inception of the PMNOC Regulations in 1993 should be reviewed. Those changes were commented upon in the Regulatory Impact Analyses Statement (RIAS) published together with the proposed amendments in the relevant Canada Gazette. The RIAS do not form part of the Regulations but have been used as an aid to interpreting the Regulations. I refer, for instance to the reasons of the Supreme Court of Canada, Binnie J. for the majority, in Biolyse, supra, at paragraphs 45 to 49, as well as to the reasons of Bastarache J. for the dissenting minority at paragraphs 155 to 159 in which the RIAS were accepted as an aid to interpretation of the PMNOC Regulations.
[28] In the PMNOC Regulations as they appeared originally in 1993 (SOR/93-133) section 8 read as follows:
Remedies
8. (1) The first person is liable to the second person for all damage suffered by the second person where, because of the application of paragraph 7(1)(e), the Minister delays issuing a notice of compliance beyond the expiration of all patents that are subject of an order pursuant to subsection 6(1).
(2) The court may make such order for relief by way of damages or profits as the circumstances require in respect of any damage referred to in subsection (1).
Conclusions
8. (1) La première personne est responsable envers la seconde personne de tout préjudice subi par cette dernière lorsque, en application de l’alinéa 7(1)e), le ministre report la délivrance de l’avis de conformité au-delà de la date d’expiration de tous les brevets visés par une ordonnance rendue aux termes du paragraphe 6(1).
(2) Le tribunal peut rendre toute ordonnance de redressement par voie de dommages-intérêts ou de profits que les circonstances exigent à l’égard de tout préjudice subit du fait de l’application du paragraphe (1).
[29] The RIAS accompanying the publication of the 1993 Regulations said, inter alia:
Alternatives Considered
Under the status quo patentees have the right to pursue patent infringement actions in the courts to obtain interlocutory relief and to be compensated in damages if an injunction is not granted and it turns out that there was infringement. However, with the enactment of Bill C-91 the government has created an exception to patent infringement allowing generic competitors to undertake any activities necessary to work up a submission to obtain regulatory approval of a product. This removes a patent right that may have otherwise been available to patentees to prevent generic competitors from obtaining such regulatory approval of their products.
These Regulations are needed to ensure this new exception to patent infringement is not abused by generic drug applicants seeking to sell their product in Canada during the term of their competitor’s patent while nonetheless allowing generic competitors to undertake the regulatory approval work necessary to ensure they are in a position to market their products immediately after the expiry of any relevant patents.
Autres mesures envisagées
À l’heure actuelle, les titulaires d’un brevet ont le droit d’entamer des poursuites en contrefaçon dans le but d’obtenir un redressement interlocutoire ou des dommages-intérêts si aucune injonction n’est accordée et qu’on découvre par la suite qu’il y avait contrefaçon. En règle générale, les recours judiciaires suffisent pour régler les cas de contrefaçon. Toutefois, avec l’adoption du projet de la loi C-91, le gouvernement fait une exception dans ce domaine en permettant aux fabricants de médicaments génériques d’entreprendre les démarches nécessaires pour obtenir l’approbation réglementaire d’un produit. Par conséquent, le titulaire d’un brevet perd un droit dont il aurait pu se prévaloir pour empêcher ses concurrents de faire approuver leurs produits.
Le présent règlement est nécessaire si on veut éviter que cette nouvelle exception en matière de contrefaçon soit mal utilisée par les fabricants de produits génériques désireux de vendre leurs produits au Canada pendant que le brevet original est encore valide. En vertu du règlement, ces fabricants peuvent toutefois entreprendre les démarches nécessaires pour obtenir l’approbation réglementaire et ainsi commercialiser leurs produits dès que les brevets pertinents arrivent à expiration.
[30] Section 8 was amended in 1998 (SOR/98-166) to the wording that is relevant to this action as is set out at the beginning of this portion of these Reasons. The RIAS accompanying this amendment as published in the Canada Gazette in 1998 said, inter alia:
The following improvements of the NOC Regulations are enacted:
…
Specifying circumstances in which damages or costs can be awarded: A clearer indication is given to the court as to circumstances in which damages could be awarded to a generic manufacturer to compensate for loss suffered by reason of delayed market entry of its drug, and the factors that may be taken into account in calculating damages. The court may also award costs to either a generic manufacturer or a patentee, including solicitor or client costs, as appropriate, consistent with Federal Courts Rules.
The amendments reinforce the balance between providing a mechanism for the effective enforcement of patent rights and ensuring that generic drug products enter the market as soon as possible.
…
Other changes are designed to reduce unnecessary litigation and streamline the litigation process: specifying the circumstances in which parties can be awarded damages and factors that may be taken into account in calculating damages;
Les améliorations suivantes apportées au Règlement sur les médicaments brevetés (avis de conformité) sont promulguées) :
…
Préciser les circonstances ou des dommages-intérêts peuvent être accordés : De plus grandes précisions sont données aux tribunaux en ce qui concerne les circonstances où des dommages-intérêts pourront être accordés à un fabricant afin de le dédommager des pertes subies à cause du report de la mise en marché de son médicament générique, par ailleurs, des précisions sont aussi données sur les facteurs dont on peut tenir compte pour calculer les dommages-intérêts. Les tribunaux peuvent également accorder les dépens à l’une ou l’autre des parties (fabricant de médicaments génériques ou titulaire de brevet), y compris les honoraires professionnels, le cas échéant, conformément aux Règles de la Cour fédérale.
Les modifications envisagées renforceront l’équilibre entre l’assurance d’un mécanisme qui permet de faire véritablement respecter les droits conférés par les brevets et la garantie que les médicaments génériques soient commercialisés aussitôt que possible.
…
D’autres changements visent à réduite le nombre de….inutiles et à rationaliser le processus judiciaire, en précisant les circonstances où les parties peuvent obtenir des dommages-intérêts et les facteurs pouvant être pris en compte dans le calcul de ces dommages;
[31] The last of the changes to affect section 8 came about in 2006 (SOR/2006-242). Section 8 was amended as follows:
5. (1) Paragraph 8(1)(a) of the Regulation is replaced by the following
(a) beginning on the date, as certified by the Minister, on which a notice of compliance would have been issued in the absence of the Regulations, unless the court concludes that
(i) the certified date was, by the operation of An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), chapter 23 of the Statues of Canada, 2004, earlier than it would otherwise have been and therefore a date later than the certified date is more appropriate, or
(ii) a date other than the certified date is more appropriate and
(2) Subsection 8(4) of the Regulations is replaced by the following:
(4) If a court orders a first person to compensate a second person under subsection (1), the court may, in respect of any loss referred to in that subsection, make any order for relief by way of damages that the circumstances require.
(3) Section 8 of the Regulations is amended by adding the following after subsection (5):
(6) The Minister is not liable for damages under this section.
5. (1) L’alinéa 8(1)a) du même règlement est remplacé par ce qui suit:
(a) débutant à la date attestée par le ministre, à laquelle un avis de conformité aurait été délivré en l’absence du présent règlement, sauf si le tribunal conclut :
(i) soit que la date attestée est devancée en raison de l’application de la Loi modifiant la Loi sur les brevets et la Loi sur les aliments et drogues (engagement de Jean Chrétien envers l’Afrique), chapitre 23 des Lois du Canada (2004), et qu’en conséquence une date postérieure à celle-ci est plus appropriée,
(ii) soit qu’une date autre que la date attestée est plus appropriée;
(2) Le paragraphe 8(4) du même règlement est remplacé par ce qui suit :
(4) Lorsque le tribunal enjoint à la première personne de verser à la seconde personne une indemnité pour la perte visée au paragraphe (1), il peut rendre l’ordonnance qu’il juge indiquée pour accorder réparation par recouvrement de dommages-intérêts à l’égard de cette perte.
(3) L’article 8 du même règlement est modifié par adjonction, après le paragraphe (5), de ce qui suit :
(6) Le ministre ne peut être tenu pour responsable des dommages-intérêts au titre du présent article.
[32] The transitional provisions respecting the 2006 amendments provided that these amendments do not affect actions already commenced, such as the present action. The relevant transitional provision says:
8. Subsection 8(4) of the Patented Medicines (Notice of Compliance) Regulations, as enacted by subsection 5(2) of these Regulations, does not apply to an action commenced under section 8 of the Patented Medicines (Notice of Compliance) Regulations prior to coming into force of these Regulations.
8. Le paragraphe 8(4) du Règlement sur les médicaments brevets (avis de conformité), édicté par le paragraphe 5(2) du présent règlement, ne s’applique pas à l’action intentée en vertu de l’article 8 du Règlement sur les médicaments brevetés (avis de conformité) avant la date d’entrée en vigueur du présent règlement.
[33] The RIAS accompanying the 2006 amendments as published in the Canada Gazette said, inter alia:
Last among the substantive changes proposed by these amendments are refinements to the section 8 damages provision. The first such change is to further specify the matters the court may take into account when calculating the period of delay for which an innovator may be held liable under that section. The second is to confirm that the Minister cannot be held liable for any delay under that section. The third is to remove the world “profits” from the provision prescribing the remedies available to a generic manufacturer seeking compensation for any loss arising from the delay.
On this last point, the Government is aware of a number of ongoing section 8 cases in which it is argued that in order for this provision to operate as a disincentive to improper use of the PM(NOC) Regulations by innovative companies, the term “profits” in this context must be understood to mean an accounting of the innovator’s profits. While reserving comment on the proper interpretation of the term in these cases, which have been shielded from this change by transitional provisions, in light of the proposed tightening of this listing requirements under amended section 4, and on the introduction of the frozen register mechanism under amended section 5, the Government believes that this line of argument should no longer be open to generic companies that invoke section 8.
…
Reaction from the innovative industry was more equivocal, with the majority of companies supportive of the proposed increases in data protection but a minority strongly opposed to the proposed tightening of the patent eligibility requirements. As regards the “profits” issue, innovators were pleased with its proposed deletion, noting that there is no equivalent remedy under US law for a generic that has been delayed due to the operation of the automatic stay. For its part, BIOTECanada urged the Government to increase the proposed term of data protection to 10 years for biologics, in light of the longer development time required to bring these protects to market.
Figurant en dernier parmi les changements de fond proposes par ces modifications sont des améliorations de la disposition de l’article 8 concernant les dommages-intérêts. Le premier de ces changements vise à préciser davantage les éléments dont le tribunal peut tenir compte au moment de calculer la période de retard dont l’innovateur peut être tenue responsable en vertu de cet article. Le deuxième sert à confirmer que le ministre ne peut être tenu responsable pour tout retard en vertu de cet article. Le troisième consiste à supprimer le terme «profits» de la disposition relative aux mesures de réparation que le tribunal peut ordonner pour dédommager le fabricant de produits génériques pour les pertes encourues en raison de ce retard.
S’agissant de ce dernier changement, le gouvernement a pris connaissance d’un nombre d’affaires en cours relatives à l’article 8 dans lesquelles on avance qu’afin que cette disposition serve à décourager l’utilisation abusive du règlement de liaison par les fabricants innovateurs, le terme « profits » dans ce contexte doit s’entendre par reddition de compte de bénéfices d