Date: 20021202
Docket: T-1918-00
Neutral citation: 2002 FCT 1248
BETWEEN:
ELI LILLY CANADA INC.,
Applicant,
- and -
THE MINISTER OF HEALTH,
Respondent.
[1] In 1994, the applicant Eli Lilly Canada Inc. (Lilly) submitted a patent list for Canadian patent No. 1,328,073 (the '073 patent), relating to Lilly's COMPUDOSE implants, pursuant to the provisions of thePatented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the NOC Regulations). The Minister of Health (the Minister) added the patent to the patent register established under the NOC Regulations. On September 18, 2000, the Minister removed the '073 patent from the patent register. Lilly seeks judicial review of the Minister's decision and requests that it be quashed.
[2] The issue to be determined is whether the Minister erred in finding that COMPUDOSE is not a medicine, or the use of a medicine under the NOC Regulations.
Background
[3] COMPUDOSE is a controlled release implant that is used in the treatment of live stock. Specifically, it is used for the purposes of increasing the rate of weight gain and improving feed efficiency in cattle. It is comprised of a silicone matrix, which contains an anabolic agent estradiol, a naturally occurring estrogen. The silicone matrix is coated in oxytetracycline, a local anti-bacterial. COMPUDOSE is implanted into the animal's ear with a gun-shaped device. Once implanted, estradiol is slowly released into the animal's body over a period of 200 days. The release of the estradiol, over a prolonged duration at a controlled rate, achieves the intended result in the animal.
[4] Lilly obtained ministerial approval for COMPUDOSE and the '073 patent first issued on March 28, 1984. Lilly has been granted 6 notices of compliance by the Minister for its COMPUDOSE product.
[5] When the NOC Regulations came into force in 1993, the Minister was obliged to open and maintain a patent register within 30 days: subsection 3(1). Inclusion of a patent on the register required the person filing to provide and certify, as accurate, the information set out in subsection 4(2) paragraphs (a) to (d) of the NOC Regulations. As stated earlier, Lilly submitted the '073 patent and it was listed on the patent register. In 1998, the NOC Regulations were amended and provided the Minister with authority to audit, to refuse to add, and to remove ineligible patents from the patent list.
[6] As a result of the amendments, the Minister undertook a complete audit of the register. It was in the context of this audit that the Minister, by letter dated February 8, 2000, advised Lilly that the '073 patent did not comply with the NOC Regulations and would be removed subject to any written representations from Lilly. Lilly submitted representations by letter dated March 14, 2000. The Minister confirmed the decision to remove the '073 patent by correspondence dated September 18, 2000. Lilly commenced its judicial review application on October 18, 2000 and by order of the Federal Court Trial Division dated January 24, 2001, the Minister's decision was stayed pending determination of this application.
The relevant statutory provisions
[7] The text of the relevant statutory provisions is reproduced in Schedule A to these reasons. For ease of reference the definition of medicine, contained in section 2 of the NOC Regulations, is included here:
|
"medicine" means a substance 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 |
|
« médicament » Substance destinée à servir ou pouvant servir au diagnostic, au traitement, à l'atténuation ou à la prévention d'une maladie, d'un désordre, d'un état physique anormal, ou de leurs symptômes |
The '073 patent claims
[8] The '073 patent claims are reproduced and attached to these reasons in Schedule B. Claims 1 to 7 are directed to an implant adapted for the controlled release of an anabolic agent. Claims 2 and 5 specify that the anabolic agent is estradiol. Claims 8 and 9 are directed at methods of preparing the implant.
The standard of review
[9] Patent claims construction is a matter of law: Whirlpool Corp. v. Camco Inc. (2000), 9 C.P.R. (4th) 129 (S.C.C.) (Whirlpool Corp.). The standard of review to be applied to the Minister's decision, in these circumstances, is correctness: Novartis Pharmaceuticals Canada Inc. v. The Minister of Health and the Attorney General of Canada 2002 FCT 1042; [2002] F.C.J. No. 1387 (Novartis).
The decision
[10] The correspondence that informs Lilly of the decision to remove the '073 patent from the patent register responds, at its outset, to Lilly's March 14th written representations. The heart of the decision is contained in the following excerpts:
Patent 1,328,073 (the '073 patent) is directed to an anti-microbial coated implant which provides for administration of a controlled release of an anabolic agent, which includes the medicine estradiol as specifically mentioned in claim 2. The '073 patent is therefore directed to an implant for administering a medicament and not to a formulation or composition . . .
An implant differs from a composition which is a mixture of the medicinal and non-medical ingredients. Rather an implant is made up of discrete components which are essential for the release of the drug.
As to whether the implant, in its ability to contain and release the medicine is a "medicine" within section 4 of the PM (NOC) Regulations, the clearest direction given by the Court is found at page 527 of the Glaxo Group decision:
. . . Patents for devices by which medicament can be administered to or by patients rather than for the substance being administered are not a "medicine" within the meaning of the Regulations.
Insofar as the '073 patent does not contain a claim for estradiol or a use of estradiol, it is ineligible for inclusion on the patent register. The '073 patent will therefore be removed from the patent register seven (7) days from the date of this letter.
The positions of the parties
The applicant
[11] The crux of the applicant's position is that the '073 patent claims a drug formulation in that it claims a combination of active and inactive ingredients and as such is not a claim for a medical device. Lilly submits that under paragraph 4(2)(b) of the NOC Regulations, a patent is eligible for listing if it contains a claim to the medicine itself. Obviously, a claim to an active ingredient is a claim to the medicine itself. Lilly relies heavily on the reasoning in Hoffmann-LaRoche Ltd. v. Canada (Minister of National Health and Welfare) (1995), 62 C.P.R. (3d) 58 (F.C.T.D.); aff'd. (1995), 67 C.P.R. (3d) 25 (F.C.A.); leave to appeal dismissed, [1996] 3 S.C.R. xi (Hoffmann-LaRoche). Lilly submits that it is settled law that a claim to a formulation of a drug product combining active ingredients with non-medicinal ingredients is a claim to the medicine itself within the meaning of sections 2 and 4 of the Regulations. In this regard, Lilly refers to the affidavit evidence of its pharmaceutical research scientist who deposes that it is extremely rare for an active ingredient to reach the desired sight of interest in the body if it is not combined with an inactive ingredient that facilitates its delivery.
[12] Next, Lilly submits that COMPUDOSE is a drug by virtue of the definitions contained in the Food and Drugs Act, R.S.C. 1985, c.F-27 (the FDA) and the Food and Drug Regulations, C.R.C. 1978, c. 870 (the FAD Regulations) which distinguish between drugs and medical devices. These categories are mutually exclusive; if a product is classified as one then it cannot be in the other category. Lilly submits that COMPUDOSE is clearly a drug by virtue of these definitions and it is approved as a drug under the FAD Regulations. The Minister, says Lilly, has acknowledged that COMPUDOSE is a drug by granting a NOC at least 6 times.
[13] Lilly additionally argues that a drug formulation can come in a dosage form. The term "dosage form class" is defined in C.01A.001 of the FAD Regulations and allows for designations by the Minister as a dosage form class. The Minister has described COMPUDOSE as the final dosage form in which the medicine estradiol is administered into the animal. Lilly contends that this categorization of COMPUDOSE as a drug under the FDA and its recognition as being within the dosage form class, demonstrate that COMPUDOSE is clearly a drug formulation. Moreover, relying on the affidavit evidence of a pharmacist, Lilly maintains that the primary mechanism of action of COMPUDOSE implants is pharmacologic, not mechanical.
[14] Lilly maintains that COMPUDOSE is a sustained release drug formulation in the form of an implant, its parts (device and active ingredient) cannot be used separately, but are integrated into a singular product. Lilly distinguishes Glaxo Group Ltd. v. Novapharm Ltd. (1998), 79 C.P.R. (3d) 488 (F.C.T.D.); (1999) 97 C.P.R. (3d) 525 (F.C.A.); leave to appeal dismissed, [2000] 1 S.C.R. xii (Glaxo) and notes that the patent in issue in Glaxo related to a beclomethasone dipropionate inhaler. That device came in a pack into which powered medication could be inserted for administration. The device was used to administer the drug, it was not a dispensed drug in and of itself, as is the case here. Lilly submits that COMPUDOSE's intended effect can only occur if the active and inactive ingredients work in concert. The active and inactive ingredients are not separated. Rather, the entire implant is injected into live stock, using the implanter device. Hence, argues Lilly, the inhaler in Glaxo is more analogous to the implant gun in this case than to the implant itself.
The respondent
[15] The Minister submits that to be included on the patent register, the patent is required by the NOC Regulations to contain a claim for the medicine in the drug COMPUDOSE or for the use of that medicine. The medicine contained in COMPUDOSE is estradiol. The patent at issue does not contain a claim for the medicine estradiol itself or for its use. Rather, it claims an implant, which is used to administer estradiol.
[16] Claims for devices used to administer a medicine are not claims for the medicine itself. Accordingly, the COMPUDOSE patent does not meet the regulatory requirements and cannot be included on the register.
[17] The NOC Regulations, submits the Minister, provide for the creation of a register of patents pertaining to drugs approved pursuant to the FAD Regulations. Patentees who hold patents claiming either the medicine (the substance which has the therapeutic effect) contained in a drug or its use are eligible for inclusion. The '073 patent is titled "Antimicrobial Coated Implant". The Minister contends that a reading of the '073 patent's claims shows that the patent does not contain a claim for the medicine estradiol itself or for the use of estradiol, rather it claims an implant, which is used to administer estradiol as well as a method of preparing such an implant. The purpose of the COMPUDOSE implant, argues the Minister, is to administer estradiol. It is implanted in the animal and is designed to slowly release estradiol in the animal's system over a fixed period of time. Based on the teachings of the Federal Court of Appeal in Glaxo, the claims for an implant are not claims for the medicine. Accordingly, the Minister correctly removed the '073 patent from the register.
[18] Lastly, the Minister submits that Lilly's characterization of COMPUDOSE as a formulation of active and inactive ingredients cannot be sustained. Formulations are physical mixtures of active and inactive ingredients. The Hoffmann-LaRoche case has no application because it considered a formulation. The Minister maintains that the active ingredient (estradiol) is not merely mixed with the inactive ingredient (the silicone matrix and the outer coating). Rather, they are all discrete and separate components, as can be seen from the illustration found in Lilly's product literature. The fact that COMPUDOSE is regulated under the FAD Regulations is of no consequence. The Minister readily acknowledges that COMPUDOSE is regulated as a drug under the FAD Regulations, but that has no bearing on whether the claims in the '073 patent are for the medicine estradiol itself as required by the NOC Regulations.
Analysis
[19] A person to whom a notice of compliance (NOC) has been issued pursuant to the FAD Regulations may submit a patent list to the Minister, for inclusion on the patent register pursuant to the NOC Regulations, where the patent contains a claim for the medicine itself or a claim for the use of the medicine: NOC Regulations, sections 2, 4.
[20] The contentious issue in this matter is whether the '073 COMPUDOSE patent contains a claim for the medicine itself or a claim for the use of the medicine. The arguments, both written and oral, refer extensively to two primary authorities, Hoffmann-LaRoche and Glaxo. At the time of the hearing, Novartis had not been decided. In Novartis, MacKay J. provides a comprehensive review of the patents in issue in Hoffmann-LaRoche and Glaxo as well as a concise statement of the ratios of each.
[21] In my view, the Minister did not err in determining that the '073 patent should be removed from the NOC Regulations patent register. My reasons for this conclusion are twofold.
[22] First, I consider Lilly's reliance on Hoffmann-LaRoche misguided. It is correct that the Court determined that the term "claim for the medicine itself" in section 2 of the NOC Regulations is not restricted to a claim for a single substance as the active ingredient to the exclusion of a claim for a composition which includes the active ingredient. Lilly's argument, here, centres not on that determination, but on the reasoning of Noël J., as he then was, in interpreting the provisions of the NOC Regulations relative to the interaction existing between the FDA and the Patent Act, R.S.C. 1985, c. P-4. In particular, Lilly relies upon the following passage from the reasons of Noël J.:
"Drug", therefore, identifies a substance that is a "drug" under the Food and Drugs Act with respect to which an NOC has been sought, and being undefined, it should be given the meaning which most closely reflects its meaning under the Food and Drugs Act, subject to any necessary modification arising under the Regulations.
Looked upon in this light, it seems clear that the phrase "drug that contains a medicine" in s. 4(1) of the Regulations is framed by reference to a drug that contains a medicine as opposed to a drug that contains some other non-medicinal substance and which as such falls outside the scope of the Regulations. That is the only limitation which the Regulations impose by necessary implication on the defined meaning of the word "drug" under the Food and Drugs Act. Otherwise, the word "drug" retains its meaning, and as this meaning is wholly consistent with the defined meaning of the word "medicine" under the Regulations, a "drug that contains a medicine" is a medicine under the Regulations just as such a medicine is a drug.
[23] It must be recalled that Noël J. was dealing with a nasal spray intended for the treatment of inflammation of human nasal mucosa. An active ingredient was mixed with inactive ingredients to effect ideal delivery of the active ingredient to the affected area. In other words, the substance involved was intended or capable of being used for the treatment of a disease, disorder or abnormal physical state, or the symptoms thereof. Hence, the context in which the above comments were made related to paragraph (a) of the FDA definition of "drug", i.e., a substance or mixture of substances manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof, in man or animal.
[24] The similarity between the definition of "drug" in paragraph (a) of the FDA and the definition of "medicine" in section 2 of the NOC Regulations is readily apparent. Here, Lilly does not suggest that COMPUDOSE exists or is used for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals: FDA definition of "drug" paragraph (a). Nor does Lilly submit that COMPUDOSE is a substance that exists or is 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: NOC Regulations definition of "medicine". Rather, Lilly tenders the affidavit of its manager of research and regulatory affairs at Alanco Animal Health, a division of Lilly, who deposes that COMPUDOSE "increases the rate of weight gain in suckling and growing steers greater than 80 kg (175 lbs) in body weight and increases the rate of weight gain and improved feed efficiency in feedlot steers and heifers greater than 260 kg (575 lbs) body weight."
[25] It seems to me that the existence and use of COMPUDOSE, in the present circumstances, relates to paragraph (b) of the FDA definition of "drug", i.e., restoring, correcting or modifying organic functions in human beings or animals. There is nothing in the NOC Regulations, generally, nor in the definition of "medicine" that contemplates, let alone endorses, such use.
[26] Lilly's reliance on the reasoning in Hoffmann-LaRoche must include recognition and acceptance of Noël J.'s statement that his conclusion regarding the definition of "drug" is subject to any necessary modification arising under the NOC Regulations. While paragraph (a) of the FDA definition of "drug" is akin to the NOC Regulations definition of "medicine", the conceptual provisions of paragraph (b) of the FDA definition of "drug" have not been imported into the NOC Regulations. Thus, the argument that the meaning of "medicine" in the NOC Regulations should be determined by reference to the FDA definition of "drug", insofar as it relates to paragraph (b), is wholly without merit.
[27] The reasoning of Noël J. was not intended and cannot be interpreted to create definitions or meanings, which do not exist. The quotation from Hoffmann-LaRoche cited earlier does not extend, nor do I believe that it was intended to extend, to the situation that is before me.
[28] The definition of "medicine" in the NOC Regulations does not include and does not envisage a substance such as COMPUDOSE, when used for the purposes that are advanced in the present circumstances. Therefore, the '073 patent is not properly included on the patent register under the NOC Regulations. If I am wrong , I would nonetheless conclude that the '073 patent should not be included on the register on the basis of patent construction.
[29] Whether the patent contains a claim for the medicine itself or a claim for the use of the medicine involves construction of the patent. Although decided in relation to patent invalidity and patent infringement, the decisions in Whirlpool Corp. and Free World Trust v. Électro Santé Inc., (2000), 9 C.P.R. (4th) 168 (S.C.C.) (Free World Trust) articulate the principles applicable to patent claims construction. An inventor is not obliged to claim a monopoly on everything new, ingenious and useful disclosed in the specification, but the usual rule is that what is not claimed is considered disclaimed: Whirlpool Corp. Two of the principles delineated in Free World Trust are of particular significance here: (a) the claims language must be read in an informed and purposive way and (b) the language of the claims thus construed defines the monopoly. There is no recourse to such vague notions as the "spirit of the invention" to expand it further.
[30] The '073 patent, as mentioned previously, is entitled "Antimicrobial Coated Implant". The claims are found in the attached Schedule B. It is useful, however, to set out, here, the contents of claims 1 and 2, which state:
1. An implant adapted for the controlled silicone polymer matrix, an anabolic agent in said polymer matrix, and an antimicrobial coating, wherein the coating comprises a silicone fluid and an antimicrobial agent in contact with said fluid.
2. An implant as claimed in Claim 1, wherein the anabolic agent is estradiol.
Claims 2 and 7 refer to implants and claims 8 and 9 relate to the method of preparing the implant.
[31] The abstract for the '073 patent reads as follows:
ABSTRACT
Uniform adherent coatings of antimicrobial agents are applied to the surface of implants by applying a film of silicone oil to the surface of the implant and contacting the film-bearing surface with antimicrobial agents in a film-adherent form. A durable antimicrobial coating is formed. The coated implants can be packaged using mechanized implant handling equipment without significant loss of the antimicrobial coating.
[32] The first paragraph of the disclosure statement for the '073 patent states:
IMPROVED ANTIMICROBIAL COATED IMPLANTS
This invention relates to improved implant devices. More particularly, this invention relates to an improvement in infection-resistant drug delivery implants. The coatings applied in accordance with this invention are better retained on the implant surface during mechanized implant packaging operations and are effective to prevent infection which may otherwise result after implantation of the device.
[33] The disclosure encompasses 13 pages and contains detailed descriptions as well as examples of the implant and its coatings. It also describes the method of preparing the implant. There is scant mention of estradiol, or for that matter, an anabolic agent. The most substantive reference to estradiol is contained in the following excerpt:
Preferred implants which can be coated in accordance with this invention are those constructed in accordance with the disclosure of U.S. Patent No. 4,191,741 of Hudson et al., issued March 4, 1980. The implants described in that patent are designed for the controlled release administration of anabolic agents to ruminant animals. Exemplary of anabolic agents which can be released from such implants are estradiol, anabolic estradiol derivatives, including estradiol dipropanate, estradiol benzoate, estradiol valerate and the like, trembolone acetate and certain resorcinol lactones including zearanol and zearalenone.
[34] Applying the principles of patent construction in Free World Trust, I find that the '073 patent claims relate to an implant and a method of preparing that implant. Specifically they relate to an implant that is designed to administer a medicine. They do not relate to a claim for the medicine (estradiol) nor do they contain a claim for the use of the medicine.
[35] In relation to the arguments with respect to whether COMPUDOSE is a device, I have had the benefit of reading the reasons of MacKay J. in Novartis and I adopt his reasoning that whether the Minister erred in referring to the implant as a "device" is not the issue. The issue is whether the Minister "erred in concluding it was not provided for in a patent subject to registration under the NOC Regulations".
[36] In the result, for the reasons stated, I conclude that the Minister did not err in his decision to remove the '073 patent from the patent register.
[37] The application for judicial review is dismissed with costs to the respondent.
_________________________________________
Judge
Ottawa, Ontario
December 2 , 2002
SCHEDULE "A"
to the
Reasons for Order dated December 2, 2002
rendered by The Hon. Madam Justice Layden-Stevenson
in
ELI LILLY CANADA INC.
v.
THE MINISTER OF HEALTH
T-1918-00
Patented Medicines (Notice of Compliance) Regulations
| 2. In these Regulations, "claim for the medicine itself" includes a claim in the patent for the medicine itself when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents; |
2. Les définitions qui suivent s'appliquent au présent règlement. « revendication pour le médicament en soi » S'entend notamment d'une revendication, dans le brevet, pour le médicament en soi préparé ou produit selon les modes du procédé de fabrication décrits en détail et revendiqués ou selon leurs équivalents chimiques manifestes |
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| "claim for the use of the medicine" means a claim for the use of the medicine for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof |
« revendication pour l'utilisation du médicament » Revendication pour l'utilisation du médicament aux fins du diagnostic, du traitement, de l'atténuation ou de la prévention d'une maladie, d'un désordre, d'un état physique anormal, ou de leurs symptômes |
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| "medicine" means a substance 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 |
« médicament » Substance destinée à servir ou pouvant servir au diagnostic, au traitement, à l'atténuation ou à la prévention d'une maladie, d'un désordre, d'un état physique anormal, ou de leurs symptômes |
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| 3. (1) The Minister shall maintain a register of any information submitted under section 4. To maintain it, the Minister may refuse to add or may delete any information that does not meet the requirements of that section. (2) The register shall be open to public inspection during business hours. (3) No information submitted pursuant to section 4 shall be included on the register until after the issuance of the notice of compliance in respect of which the information was submitted. (4) For the purpose of deciding whether information submitted under section 4 should be added to or deleted from the register, the Minister may consult with officers or employees of the Patent Office. |
3. (1) Le ministre tient un registre des renseignements fournis aux termes de l'article 4. À cette fin, il peut refuser d'y ajouter ou en supprimer tout renseignement qui n'est pas conforme aux exigences de cet article. (2) Le registre est ouvert à l'inspection publique durant les heures de bureau. (3) Aucun renseignement soumis aux termes de l'article 4 n'est consigné au registre avant la délivrance de l'avis de conformité à l'égard duquel il a été soumis. (4) Pour décider si tout renseignement fourni aux termes de l'article 4 doit être ajouté au registre ou en être supprimé, le ministre peut consulter le personnel du Bureau des brevets. |
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| 4. (1) A person who files or has filed a submission for, or has been issued, a notice of compliance in respect of a drug that contains a medicine may submit to the Minister a patent list certified in accordance with subsection (7) in respect of the drug. (2) A patent list submitted in respect of a drug must (a) indicate the dosage form, strength and route of administration of the drug; (b) set out any Canadian patent that is owned by the person, or in respect of which the person has an exclusive licence or has obtained the consent of the owner of the patent for the inclusion of the patent on the patent list, that contains a claim for the medicine itself or a claim for the use of the medicine and that the person wishes to have included on the register; (c) contain a statement that, in respect of each patent, the person applying for a notice of compliance is the owner, has an exclusive licence or has obtained the consent of the owner of the patent for the inclusion of the patent on the patent list; (d) set out the date on which the term limited for the duration of each patent will expire pursuant to section 44 or 45 of the Patent Act; and (e) set out the address in Canada for service on the person of any notice of an allegation referred to in paragraph 5(3)(b) or (c), or the name and address in Canada of another person on whom service may be made, with the same effect as if service had been made on the person. (3) Subject to subsection (4), a person who submits a patent list must do so at the time the person files a submission for a notice of compliance. (4) A first person may, after the date of filing of a submission for a notice of compliance and within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date that precedes the date of filing of the submission, submit a patent list, or an amendment to an existing patent list, that includes the information referred to in subsection (2).
(5) When a first person submits a patent list or an amendment to an existing patent list in accordance with subsection (4), the first person must identify the submission to which the patent list or the amendment relates, including the date on which the submission was filed. (6) A person who submits a patent list must keep the list up to date but may not add a patent to an existing patent list except in accordance with subsection (4). (7) A person who submits a patent list or an amendment to an existing patent list under subsection (1) or (4) must certify that (a) the information submitted is accurate; and (b) the patents set out on the patent list or in the amendment are eligible for inclusion on the register and are relevant to the dosage form, strength and route of administration of the drug in respect of which the submission for a notice of compliance has been filed. |
4. (1) La personne qui dépose ou a déposé une demande d'avis de conformité pour une drogue contenant un médicament ou qui a obtenu un tel avis peut soumettre au ministre une liste de brevets à l'égard de la drogue, accompagnée de l'attestation visée au paragraphe (7). (2) La liste de brevets au sujet de la drogue doit contenir les renseignements suivants : a) la forme posologique, la concentration et la voie d'administration de la drogue; b) tout brevet canadien dont la personne est propriétaire ou à l'égard duquel elle détient une licence exclusive ou a obtenu le consentement du propriétaire pour l'inclure dans la liste, qui comporte une revendication pour le médicament en soi ou une revendication pour l'utilisation du médicament, et qu'elle souhaite voir inscrit au registre; c) une déclaration portant, à l'égard de chaque brevet, que la personne qui demande l'avis de conformité en est le propriétaire, en détient la licence exclusive ou a obtenu le consentement du propriétaire pour l'inclure dans la liste; d) la date d'expiration de la durée de chaque brevet aux termes des articles 44 ou 45 de la Loi sur les brevets; e) l'adresse de la personne au Canada aux fins de signification de tout avis d'allégation visé aux alinéas 5(3)b) ou c), ou les nom et adresse au Canada d'une autre personne qui peut en recevoir signification avec le même effet que s'il s'agissait de la personne elle-même. (3) Sous réserve du paragraphe (4), la personne qui soumet une liste de brevets doit le faire au moment du dépôt de la demande d'avis de conformité. (4) La première personne peut, après la date de dépôt de la demande d'avis de conformité et dans les 30 jours suivant la délivrance d'un brevet qui est fondée sur une demande de brevet dont la date de dépôt est antérieure à celle de la demande d'avis de conformité, soumettre une liste de brevets, ou toute modification apportée à une liste de brevets, qui contient les renseignements visés au paragraphe (2).
(5) Lorsque la première personne soumet, conformément au paragraphe (4), une liste de brevets ou une modification apportée à une liste de brevets, elle doit indiquer la demande d'avis de conformité à laquelle se rapporte la liste ou la modification, en précisant notamment la date de dépôt de la demande. (6) La personne qui soumet une liste de brevets doit la tenir à jour mais ne peut ajouter de brevets à une liste que si elle le fait en conformité avec le paragraphe (4). (7) La personne qui soumet une liste de brevets ou une modification apportée à une liste de brevets aux termes des paragraphes (1) ou (4) doit remettre une attestation portant que : a) les renseignements fournis sont exacts; b) les brevets mentionnés dans la liste ou dans la modification sont admissibles à l'inscription au registre et sont pertinents quant à la forme posologique, la concentration et la voie d'administration de la drogue visée par la demande d'avis de conformité. |
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Food and Drugs Act
| "device" means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, (b) restoring, correcting or modifying a body function or the body structure of human beings or animals, (c) the diagnosis of pregnancy in human beings or animals, or (d) the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring, and includes a contraceptive device but does not include a drug; |
« instrument » Tout article, instrument, appareil ou dispositif, y compris tout composant, partie ou accessoire de ceux-ci, fabriqué ou vendu pour servir, ou présenté comme pouvant servir_: a) au diagnostic, au traitement, à l'atténuation ou à la prévention d'une maladie, d'un désordre, d'un état physique anormal ou de leurs symptômes, chez l'être humain ou les animaux; b) à la restauration, à la correction ou à la modification d'une fonction organique ou de la structure corporelle de l'être humain ou des animaux; c) au diagnostic de la gestation chez l'être humain ou les animaux; d) aux soins de l'être humain ou des animaux pendant la gestation et aux soins prénatals et post-natals, notamment les soins de leur progéniture. Sont visés par la présente définition les moyens anticonceptionnels, tandis que les drogues en sont exclues. |
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| "drug" includes any substance or mixture of substances manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, (b) restoring, correcting or modifying organic functions in human beings or animals, or (c) disinfection in premises in which food is manufactured, prepared or kept; |
« drogue » Sont compris parmi les drogues les substances ou mélanges de substances fabriqués, vendus ou présentés comme pouvant servir_: a) au diagnostic, au traitement, à l'atténuation ou à la prévention d'une maladie, d'un désordre, d'un état physique anormal ou de leurs symptômes, chez l'être humain ou les animaux; b) à la restauration, à la correction ou à la modification des fonctions organiques chez l'être humain ou les animaux; c) à la désinfection des locaux où des aliments sont gardés |
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SCHEDULE "B"
to the
Reasons for Order dated December 2, 2002
rendered by The Hon. Madam Justice Layden-Stevenson
in
ELI LILLY CANADA INC.
v.
THE MINISTER OF HEALTH
T-1918-00
CLAIMS
1. An implant adapted for the controlled release of an anabolic agent, said implant comprising a silicone polymer matrix, an anabolic agent in said polymer matrix, and an antimicrobial coating, wherein the coating comprises a silicone fluid and an antimicrobial agent in contact with said fluid.
2. An implant as claimed in Claim 1, wherein the anabolic agent is estradiol.
3. An implant as claimed in Claim 1, wherein the antimicrobial agent is oxytetracycline hydrochloride.
4. An implant as claimed in Claim 1, wherein the silicone polymer matrix and anabolic agent form a coating surrounding a bio-compatible inert core.
5. An implant as claimed in Claim 4, wherein the anabolic agent is estradiol.
6. An implant as claimed in any one of Claims 1 to 5, wherein the silicone fluid has a viscosity of about 200 to about 500 centistokes.
7. An implant as claimed in any one of Claims 1 to 5, wherein the silicone fluid is in contact with the surface of said silicone polymer matrix implant and the antimicrobial agent is in contact with said silicone fluid.
8. A method of preparing an implant adapted for the controlled release of an anabolic agent, comprising coating a silicone polymer matrix, containing an anabolic agent, with an antimicrobial coating, wherein the coating comprises a silicone fluid and an antimicrobial agent in contact with said fluid.
9. A method according to Claim 8 comprising applying a silicone fluid to form a silicone film in contact with the surface of the silicone polymer matrix and then contacting the film-bearing surface with an antimicrobial agent in a film-adherent powder form.
FEDERAL COURT OF CANADA
TRIAL DIVISION
NAMES OF SOLICITORS AND SOLICITORS ON THE RECORD
COURT FILE NO.: T-1918-00
STYLE OF CAUSE: Eli Lilly Canada Inc. v. The Minister of Health
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: September 30, 2002
REASONS FOR ORDER
BY The Hon. Madam Justice Layden-Stevenson
DATED: December 2 , 2002
APPEARANCES:
Mr. Anthony CreberFOR THE APPLICANT
Mr. Patrick Smith
Ms. Marie CroleyFOR THE RESPONDENT
SOLICITORS ON THE RECORD:
Gowlings, Lafleur, Henderson FOR THE APPLICANT
Ottawa, Ontario
Mr. Morris RosenbergFOR THE RESPONDENT
Deputy Attorney General of Canada