Ottawa, Ontario, October 25, 2005
PRESENT: THE HONOURABLE MADAM JUSTICE LAYDEN-STEVENSON
BETWEEN:
and
ATTORNEY GENERAL OF CANADAand
THE MINISTER OF HEALTH
REASONS FOR ORDER AND ORDER
[1] This matter concerns the refusal of the Minister of Health (the Minister) to include the applicant's Canadian Patent No. 2,391,111 (the '111 patent) - in connection with the drugs ADVAIR, ADVAIR DISKUS, FLOVENT HFA and VENTOLIN HFA - on the patent register established under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the NOC Regulations).
GENERAL BACKGROUND RELATIVE TO THE NOC REGULATIONS
[2] Drug manufacturers who wish to advertise or sell a new drug in Canada must first obtain a notice of compliance (NOC) permitting them to do so. To obtain a NOC, a manufacturer files a new drug submission (NDS) with the Minister pursuant to Division 8, Part C of the Food and Drug Regulations, C.R.C. c. 870.
[3] Once a NOC has been granted, a manufacturer must file a supplemental new drug submission (SNDS) to approve any significant changes made to the drug. In general, a SNDS is required where any change occurs that may impact the safety or efficacy of the new drug.
[4] Under the NOC Regulations, a manufacturer who files a NDS for a NOC, or has been previously granted a NOC, may submit a list of eligible patents for addition to the patent register in connection with the drug for which the NOC is sought or has been issued. The patent register is maintained by the Minister pursuant to section 3 of the NOC Regulations. The Minister (pursuant to subsection 3(1) of the NOC Regulations) may refuse to add a patent list submitted by a manufacturer if the submitted patent is ineligible for inclusion (under the requirements of the NOC Regulations) on the patent register. The eligibility criteria for the inclusion of a patent list on the patent register are set out in section 4 of the NOC Regulations. The patent specified in the patent list must, among other things, contain a claim for the medicine, or for the use of the medicine contained in the drug for which the relevant NOC is being sought or has been issued.
[5] In accordance with the Guidance for Industry: Patented Medicines (Notice of Compliance) Regulations, specifically section 3.3.3, an initial assessment regarding the eligibility of each patent list (known as a patent audit) is conducted at the time the patent list is received. If, at the conclusion of this audit, it appears that the patent list does not meet the requirements of section 4 of the NOC Regulations, a letter is sent to the manufacturer setting out the apparent grounds of ineligibility. The manufacturer then has 30 days to submit written representations to the Minister as to why the patent should not be rejected. These representations are taken into consideration when the final decision as to the eligibility of the patent for addition to the patent register is made.
THE DRUGS AND THE PATENT
[6] ADVAIR is an inhalation aerosol containing the medicine salmeterol xinafoate/fluticasone propionate. It is a bronchodilator and corticosteroid used for the treatment of chronic obstructive pulmonary disease and other related disorders. A dry powder inhalation of salmeterol xinafoate/fluticasone propionate is also approved in Canada as ADVAIR DISKUS. Four ADVAIR submissions are relevant to this matter. Each of the four is an approved SNDS.
[7] FLOVENT HFA is an inhalation aerosol containing the medicine fluticasone propionate. FLOVENT HFA is a corticosteroid used for the treatment of asthma and related disorders. Two FLOVENT HFA submissions are relevant here, each of which is an approved SNDS.
[8] VENTOLIN HFA is an inhalation aerosol containing the medicine salbutamol sulphate. VENTOLIN HFA is a bronchodilator used for the treatment of bronchospasm. VENTOLIN HFA was first approved on the basis of a NDS. An administrative NDS was later filed to approve a change in the name of the manufacturer.
[9] The application for the '111 patent was filed on December 23, 1997. The patent issued on June 22, 2004. It has 22 claims. Claim 1 relates to the invention and claim 15 relates to the use of the invention. All other claims are dependent claims.
Claim 1 reads:
A pharmaceutical formulation comprising an aerosol suspension of a medicament selected from the group consisting of salbutamol, salmeterol, fluticasone propionate, beclomethasone dipropionate, terbutaline and any salts, esters and solvates thereof and any mixtures thereof, in a propellant, said formulation further comprising an aerosol container comprising a valve for administering the aerosol suspension, said valve comprising a valve body having at least one orifice to allow a quantity of the suspension to pass from the container into the valve, characterised in that the valve further comprises a ring disposed around the valve body, the ring providing a trough around the valve body, wherein said trough is below the at least one orifice to reduce the volume of suspension that can be accommodated within the container below the at least one orifice when the container is orientated with the valve at the bottom.
Claim 15 reads:
Use of a pharmaceutical formulation comprising an aerosol suspension comprising a medicament selected from the group consisting of salbutamol, salmeterol, fluticasone propionate, beclomethasone dipropionate, terbutaline and any salts, esters and solvates thereof and any mixtures thereof, in a propellant, for the treatment of respiratory disorders, said formulation further comprising an aerosol container comprising a valve, and the aerosol suspension being dispersed in the container, said valve comprising a valve body having at least one orifice to allow a quantity of the suspension to pass from the container into the valve, characterised in that the valve further comprises a ring disposed around the valve body, the ring providing a trough around the valve body, wherein said trough is below the at least one orifice to reduce the volume of suspension that can be accommodated within the container below the at least one orifice when the container is orientated with the valve at the bottom.
FACTS
[10] On July 20, 2004, the applicant, GlaxoSmithKline (Glaxo), pursuant to subsection 4(3) of the NOC Regulations, submitted a patent list for the '111 patent with respect to the following:
(a) ADVAIR salmeterol xinafoate/fluticasone propionate, 25/50 mcg, 25/125 mcg and 25/250 mcg inhalation preparation;
(b) FLOVENT HFA fluticasone propionate, 50 mcg, 125 mcg and 250 mcg inhalation preparation; and
(c) VENTOLIN HFA salbutamol sulphate, 100 mcg inhalation preparation.
On August 31, 2004, Glaxo submitted a patent list for:
(d) ADVAIR DISKUS salmeterol xinafoate/fluticasone propionate, 50/100 mcg, 50/250 mcg and 50/500 mcg inhalation preparation.
[11] By correspondence, dated August 3, 2004, the Director of the Therapeutic Products Directorate (TPD) in the Office of Patented Medicines and Liaison, Health Products and Food Branch, Department of Health, informed Glaxo that an audit of the first patent list submitted in respect of ADVAIR, FLOVENT HFA and VENTOLIN HFA revealed that the patent does not contain a claim to the medicines or the use of the medicines as required under paragraph 4(2)(b) of the NOC Regulations. The Director extended an invitation for responsive representations from Glaxo within 30 days. Similar correspondence, dated September 17, 2004, relating to ADVAIR DISKUS, relayed the same message.
[12] Glaxo forwarded its representations in response to the Director's letters. By correspondence dated October 26, 2004, the Director informed Glaxo that:
[W]hile there are claims within the '111 patent to a delivery system or device which could be used in the administration of a variety of medicines, there is no claim within the '111 patent for any of the medicines listed in the above noted products [ADVAIR, ADVAIR DISKUS, FLOVENT HFA, VENTOLINHFA] or their use as required under subsection 4(2)(b) of the PM(NOC) Regulations.
ISSUE
[13] The only issue is whether the Director, the ministerial delegate, erred in concluding that the '111 patent is ineligible for listing on the patent register by virtue of having failed to meet the requirements of section 4 of the NOC Regulations.
THE STANDARD OF REVIEW
[14] The parties agree and I concur that the applicable standard of review is correctness: Eli Lilly Canada Inc. v. Canada(Minister of Health), [2003] 3 F.C. 140 (C.A.)
THE ALLEGATIONS OF ERROR
[15] Glaxo's argument centres on claims construction. It alleges that the Minister construed the '111 patent improperly and in a manner contrary to the principles enunciated by the Supreme Court of Canada and the Federal Court of Appeal.
[16] Glaxo asserts that the Minister construes Claim 1 in a manner that determines only whether the patent contains a claim to the medicine itself and neglects to ascertain if it contains a claim for a formulation. This, according to Glaxo, is in direct contravention to the statement of Mr. Justice Binnie in Whirlpool Corp. v. Camco Inc. (2000), 9 C.P.R. (4th) 129 (S.C.C.) (Whirlpool) at page 147 where he stated that patent claims should receive one construction for all purposes. Moreover, at the same page, Mr. Justice Binnie also stated that patent claims should be construed through the eyes of one skilled in the art.
[17] The Minister, in Glaxo's estimation, is not skilled in the art and therefore it is incumbent upon the Minister to seek out the advice of one who is, when construing a claim. Failure to do so violates the rules of patent construction.
[18] Glaxo contends that the '111 patent addresses the problem of the physical instability of pharmaceutical suspensions that make it difficult for patients to inhale the product and/or receive an appropriate dose. The claims set forth in the '111 patent, it says, are for a pharmaceutical formulation comprising an aerosol suspension of a medicament including an aerosol container comprising a valve for administering the suspension and the use of that pharmaceutical formulation. Glaxo emphatically denies that the '111 patent includes a claimfor the "device" to administer the formulation.
[19] Pointing to and relying upon the evidence of its expert, Dr. Christopher T. Rhodes, which stands uncontradicted, Glaxo claims that the '111 patent constitutes a claim for a formulation. It notes that Dr. Rhodes defines a formulation as a mixture of active and inactive components. The function of the inactive components is to ensure that the active components are delivered effectively to the patient. The aerosol container and valve referred to in the '111 patent simply constitute a mechanical component of the formulation designed to ensure that the aerosol droplets are of the appropriate size and that the drug is delivered in an appropriate amount. The conclusion of Dr. Rhodes, a person skilled in the art, is: "[b]ased on [his] understanding of pharmaceutical formulations, the '111 patent claims a formulation comprising the following: a medicament, a propellant and a container".
[20] Glaxo claims that the '111 patent is on all fours with that in Hoffmann-La Roche Ltd. v. Canada(Minister of National Health and Welfare) (1995), 62 C.P.R. (3d) 58 (F.C.T.D.) aff'd. (1995), 70 C.P.R. (3d) 206 (F.C.A.) (Hoffman-La Roche). There, the Federal Court of Appeal acknowledged that it is generally necessary for active ingredients to be combined with stabilizing agents or absorption vehicles to allow for effective ingestion. A substance does not cease to be a medicine because it is combined with another substance. In Glaxo's submission, this reasoning should apply to the '111 patent. The inclusion of the container and valve in the claim does not detract from the fact that salmeterol xinafoate/fluticasone propionate, fluticasone propionate and salbutamol sulphate are medicines.
[21] In sum, according to Glaxo, the nature or point of the invention is irrelevant when construing the claims for the purpose of the NOC Regulations. Regard to the nature of the invention leads to misconstruction. This was the Minister's folly. The Minister, asserts Glaxo, improperly construed the claim by focussing on the fact that a mechanical component was included in the formulation when it was clearly not claimed in the '111 patent. Glaxo maintains that it bears repeating that the purpose of the NOC Regulations is to prevent infringement of a patent. Glaxo markets the products included in the '111 patent and, by not including it on the patent register, the Minister has denied it the protection afforded by the Regulations.
THE RELEVANT STATUTORY PROVISIONS
[22] Paragraph 4(2)(b) of the NOC Regulations provides:
| Patented Medicines (Notice of Compliance) Regulations, SOR/1993-133
4(2) A patent list submitted in respect of a drug must [...] (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;
|
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Règlement sur les médicaments brevetés (avis de conformité), DORS/1993-133
4(2) La liste de brevets au sujet de la drogue doit contenir les renseignements suivants : [...] 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;
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[23] The definitions of "medicine", "claim for the medicine itself" and "claim for the use of the medicine" are set out in section 2.
| 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;
"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;
"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; [...]
|
|
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.
« 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.
« 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. [...] |
ANALYSIS
[24] Despite the compelling arguments advanced by Glaxo, I am unable to conclude that the Minister erred in refusing to list the '111 patent on the patent register. Since the advent of the NOC Regulations, the Court has been called upon to interpret the provisions therein and specifically those at issue in this matter.
[25] The Federal Court of Appeal has held that the NOC Regulations protect only the substances which are administered to patients. They do not protect devices by which a substance is administered: Glaxo Group Ltd. v. Novopharm Ltd. (1999), 87 C.P.R. (3d) 525 (F.C.A.), leave to appeal dismissed, [2000] 1 S.C.R. xii (Glaxo Group). In Glaxo Group, the Court determined that an inhaler used to administer a medicament to patients did not contain claims to the medicine itself or to the use of that medicine.
[26] In a number of subsequent cases, the Court was required to determine whether a given patent contained a claim for the medicine itself or a claim for the use of the medicine. In Novartis Pharmaceuticals Canada Inc. v. Canada(Minister of Health) (2002) 22 C.P.R. (4th) 361 (F.C.T.D.), Mr. Justice MacKay determined that patents relating to estrogen patches were for systems of administration of medicine, not for medicine itself. Madam Justice Heneghan reached the same conclusion, in relation to patents regarding a patch used to continuously administer analgesics through the skin into the bloodstream, in Janssen-Ortho Inc. v. Canada (Minister of Health) (2003), 24 C.P.R. (4th) 438 (F.C.T.D.). Similarly, in Eli Lilly Canada Inc. v. Canada(Attorney General) (2003), 26 C.P.R. (4th) 360 (F.C.T.D.), Madam Justice Dawson, in construing a patent for a capsule placed within the stomach (the "rumen") of the patient (a cow), concluded that the invention was not a medicine; it was for the administration of a medicine.
[27] Mr. Justice MacKay's decision in Novartis, supra, was affirmed on appeal. In Novartis Pharmaceuticals Canada Inc. v. Canada (Minister of Health) (2003), 28 C.P.R. (4th) 1 (F.C.A.), at paragraph 18, the Federal Court of Appeal articulated the test to be applied to determine whether the patent claim was to be construed as containing a claim to the medicine. The proper test to "determine if the patches are medicine under the NOC Regulations is whether they are administered to the patient or whether they administer substances to the patient". In dispensing with the appellant's allegation that Mr. Justice MacKay's decision conflicted with the reasoning in Glaxo Group, supra, the Court stated:
The Applications Judge did not hold that only active ingredients can comprise medicine. The underlying theory of the Applications Judge's determination was that the patches are not administered, but instead administer medicine, and this is a direct application of the Glaxo decision.
[28] I have, as requested by Glaxo, reviewed the patents at issue in Hoffman-La Roche, supra, (Canadian Patent No. 1,083,963 - the '963 patent) and in Glaxo Group, supra, (Canadian Patent No. 1,272,917 - the '917 patent). In my view, the subject matter of the '111 patent is more analogous to the subject matter of the '917 patent in Glaxo Group than it is to the '963 patent in Hoffman-La Roche.
[29] The subject matter of the patent in Hoffman-La Roche, supra, related to a "composition" of substances within a container. The active and inactive ingredients were physically mixed together in a formulation and, for that reason, the formulation constituted a "medicine" within the meaning of the NOC Regulations. The subject matter of the patent in Glaxo Group, supra, related to a device for administering medicaments. I reiterate that the Court held that, as such, it did not contain a claim for the medicine itself within the meaning of the NOC Regulations.
[30] The subject matter of claim 1 of the '111 patent, in my opinion, relates to a system for the administration of medicine and does not contain a claim for the medicine itself. The system
consists of a medicament, a discrete propellant and a separate container using a special valve. It is not a composition (or formulation) of explicit active and inactive ingredients physically mixed together as in Hoffman-La Roche. On its face, the claim is directed primarily to a valve associated with an aerosol container having certain characteristics designed to promote the more efficient administration of an aerosol formulation. The fact that the claim is described as a "formulation" is not determinative in this respect. Dr. Rhodes does not address this issue in his affidavit and his evidence, therefore, provides no assistance.
[31] As I construe the claim, the patent does not claim a medicine (nor, of necessity, a use for the medicine) as defined and required under the NOC Regulations. Although I find it unnecessary to refer to the disclosure of the '111 patent to arrive at this result, I do find support for my conclusion in so doing. In English, the '111 patent is entitled 'Pharmaceutical Formulation and Use'. In French, the title of the '111 patent is 'Valve Pour Bombe Aerosol".
[32] The special valve described in Claim 1 is illustrated in one of the two representative drawings associated with the patent as follows: :
[33] On page one of the disclosure, the invention is described as follows:
This invention relates to a valve for an aerosol container with the aid of which a quantity of the contents thereof can be dispensed. The invention has particular application to the dispensing of metered doses of medicaments, though it is applicable to the dispensing of aerosols generally.
[34] On page two, the characterization of the invention is stated as:
According to the present invention there is provided a valve for an aerosol container for dispensing a suspension of a substance in a liquid propellant contained therein, the valve comprising a valve body having at least one orifice to allow a quantity of the suspension to pass from the container to the valve...
[35] There are numerous, similar references throughout the disclosure, in addition to the claims themselves. The invention here is not the medicine. Rather, it is the design of a system, including particularly a special valve, for the delivery or administration of medicaments. To construe the patent in the manner suggested by Glaxo would require me to disregard appellate court authority. That is not an option for that authority is binding on me.
[36] The Minister did not err, as alleged, and was correct in refusing to list the '111 patent on the patent register established under the NOC Regulations. Consequently, the application for judicial review will be dismissed with costs to the respondent. If the parties are unable to agree on costs (and they are encouraged to do so), each may file written submissions, not to exceed two pages (double-spaced), not later than November 1, 2005. I remain seized with jurisdiction to dispose of the issue of costs, should it be necessary.
ORDER
THIS COURT ORDERS THAT the application for judicial review is dismissed with costs.
"Carolyn A. Layden-Stevenson"
Judge
FEDERAL COURT
NAME OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-1957-04
STYLE OF CAUSE: GLAXOSMITHKLINE INC.
v.
ATTORNEY GENERAL OF CANADA and
THE MINISTER OF HEALTH
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: October 3, 2005
REASONS FOR : LAYDEN-STEVENSON J.
APPEARANCES:
Mr. James Mills
Ms. Chantal Saunders FOR APPLICANT
Mr. F.B. Woyiwada FOR RESPONDENTS
SOLICITORS OF RECORD:
Gowling Lafleur Henderson LLP
Mr. John H. Sims, Q.C.
Deputy Attonery General of Canada
Ottawa, Ontario FOR RESPONDENTS