BETWEEN:
and
ATTORNEY GENERAL OF CANADA and
THE MINISTER OF HEALTH
Heard at Ottawa, Ontario, on September 20, 2006.
Judgment delivered at Ottawa, Ontario, on October 27, 2006.
REASONS FOR JUDGMENT BY: PELLETIER J.A.
CONCURRED IN BY: DÉCARY J.A.
LINDEN J.A.
Docket: A-572-05
Citation: 2006 FCA 347
CORAM: DÉCARY J.A.
LINDEN J.A.
PELLETIER J.A.
BETWEEN:
GLAXOSMITHKLINE INC.
Applicant
and
ATTORNEY GENERAL OF CANADA and
THE MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT
[1] This is an appeal from the decision of Layden-Stevenson J., reported at 2005 FC 1444 (Reasons for Order), in which the learned judge dismissed an application for judicial review of the Minister of Health's refusal to add Canadian Patent No. 2,391,111 (the '111 patent) to the patent register with respect to the drugs ADVAIR, ADVAIR DISKUS, FLOVENT HFA, and VENTOLIN HFA. The '111 patent is unique in that it incorporates into a formulation claim, not only the substances whose ingestion is designed to achieve therapeutic results but also the device by which those substances are administered to the patient. There have been other attempts to gain protection for medical devices but, until now, none of those attempts incorporated the device into the formulation of the medicine itself.
[2] The issue in this appeal, as it was in the Federal Court, is whether this novel formulation contains "a claim for the medicine itself, or a claim for the use of a medicine" as those terms are used in subsection 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133, as amended (the Regulations).
THE FACTS
[3] The appellant GlaxoSmithKline Inc. (GSK) holds Notices of Compliances allowing it to sell in Canada the following drugs which contain the following medicines: ADVAIR (salemeterol xinafoate/fluticasone propionate), ADVAIR DISKUS (salemeterol xinafoate/fluticasone propionate), FLOVENT HFA (fluticasone propionate) and VENTOLIN HFA (salbumatol sulphate). Within the 30 days following the issue of the '111 patent, GSK sought to add it to the patent register in respect of each of these drugs. It did so on the basis of claims 1 and 15 of the patent, reproduced below:
Claim 1:
A pharmaceutical formulation comprising an aerosol suspension of a medicine 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:
Use of a pharmaceutical formulation comprising an aerosol suspension comprising a medicine 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.
[4] The Minister refused to list the '111 patent on the basis that it did not contain a claim for the medicines or the use of the medicines in question. The Minister's position is 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.
[Reasons for Order, para. 12.]
[5] GSK brought an application for judicial review. In support of its application, it filed the affidavit of Dr. Christopher Rhodes. The following portions of his affidavit are of particular relevance to this appeal:
13. Formulations are typically a mixture of active and inactive components. Generally, the role of the inactive components is to ensure that the active component or components are delivered to the patient in the appropriate manner and in the appropriate dose. This is true in respect of all types of formulations including tablets, capsules and aerosol formulations, by way of example.
14. Specifically pharmaceutical formulations that are inhaled, such as aerosol formulations, by necessity consist of an inhaled active compound and pharmaceutically inactive materials that provide assistance in the effective therapeutic use of the drug.
15. Typically, these pharmaceutically inactive materials include a propellant. The function of the propellant is to act as a carrier so that the drug reaches the intended site of therapeutic action. Other inactive compounds could include antioxidants and antimicrobial preservatives.
16. An inhaled formulation may also include mechanical components such as a valve that ensures that the aerosol droplets are an appropriate size and that the drug is provided in an appropriate amount. For example, if the droplets are too large, they will become stuck in the patient's mouth. If the droplets are too small, they will reach the intended therapeutic site, but will not remain there to effect the intended therapeutic effect.
[A.B., p. 66-67.]
THE DECISION UNDER APPEAL
[6] The application judge dismissed the application for judicial review. From the very beginning of her analysis, she focused on the difference between a medicine and a device used to administer that medicine (Reasons for Order, para. 25).
[7] After reviewing the jurisprudence, the application judge turned her attention to the '111 patent and concluded that it dealt with a system for the administration of a medicine and did not contain a claim for the medicine itself. The material portion of her reasons provides as follows:
30. …The system consists of a medicine, 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 Hoffmann-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.
[8] As a result, the application judge dismissed the application for judicial review.
THE SUBMISSIONS IN ISSUE
[9] The appellant attacks the application judge's decision on two principal grounds. The first is that the patent was not construed in the manner in which the Supreme Court has held that patents should be construed, namely from the point of view of a person skilled in the art, independently of any consideration of the purpose for which the patent must be construed. (Whirlpool Corp. v. Camco Inc., 2000 SCC 67, [2000] 2 S.C.R. 1067 (S.C.C.) (Whirlpool)). The appellant submits that the only evidence of the point of view of the person skilled in the art is the affidavit of Dr. Rhodes. Since his evidence was uncontradicted, it ought to have been given effect.
[10] The appellant's second line of attack is that the application judge, and the Minister, misconstrued the patent in failing to recognize that it included a claim for a medicine in formulation. The appellant's position is that the valve to which the patent makes reference is simply another inactive ingredient, much like an excipient. In Eli Lilly Canada Inc. v. Canada (Minister of Health), 2003 FCA 24, [2003] 3 F.C. 140, it was held that a claim for a medicine plus an inactive ingredient was a claim for the medicine itself. In this case, a claim is made for a formulation of each of the medicines contained in the drugs for which an NOC has been issued, the formulation including as an inactive ingredient the appellant's special valve.
ANALYSIS
[11] These facts raise the familiar problem of patents which refer to both a drug and a means of administering that drug. In GlaxoSmithKline Inc. v. Canada (Attorney General), 2005 FCA 197 (GlaxoSmithKline Inc.), I reviewed the jurisprudence on this issue and concluded that, in the context of deciding whether a patent contained a claim for the medicine itself, the fundamental question was whether the patent in issue protects the medicine (the payload) or the means by which the medicine is to be administered (the delivery system).
44. If the patent protects the delivery system, then it does not contain a claim for the medicine itself, or the use of the medicine, even if it contains a reference to the medicine as payload. For example, in Janssen-Ortho Inc. v. Canada (Minister of Health), (2003) 229 F.T.R. 268, 2003 FCT 286, confirmed by [2004] F.C.J. No. 242 (F.C.A.), leave to appeal to the SCC denied, August 26, 2004, [2004] S.C.C.A. No. 152, the patent protecting a patch type device specifically refers to the medicine fentanyl but in the context of "a 'transdermal system' or 'device' designed for the transdermal administration of fentanyl...". Heneghan J. found that it was not eligible for listing, in spite of the specific reference to a medicine. She found that the patent described a patch and that the patent contained no claim for the medicine itself. I take the latter ground to be a recognition that a claim for a medicine as payload is not a claim for the medicine itself.
[12] As the application judge noted, a perusal of the specification of the patent discloses a detailed description of the workings of the valve by which the medicines mentioned in the patent are to be dispensed to the patient. The specification, it will be recalled, must "correctly and fully describe the invention and its operation or use as contemplated by the inventor". (See subsection 27(3) of the Patent Act.)
[13] The opening words of the Specification are instructive:
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 medicines, though it is applicable to the dispensing of aerosols generally.
[14] To the extent that the payload/delivery system dichotomy set out in GlaxoSmithKline Inc. is good law, this patent would fall unequivocally on the delivery system side of the dichotomy, even though specific drugs are named in the patent as the payload.
[15] GSK opposes the categorization of its patent as one which protects the delivery system on the basis that the patent claims a formulation of a medicine, which formulation includes, as an inactive element, the valve assembly described in the specification. As a result, the patent is, on its face, one which claims certain medicines in a formulation, thus falling squarely within the decision of this Court in Hoffmann-La Roche Ltd. v. Canada (Minister of Health and Welfare) (1992), 62 C.P.R. (3d) 58 at 72 (F.C.T.D.); aff'd (1995) 67 C.P.R. (3d) 25 (F.C.A.) (claims certain medicines in a formulation, thus falling squarely within the decision of this Court in (Hoffmann-La Roche) leave to appeal dismissed. It is inherent in the appellant's argument that the formulation claimed must be treated as a whole, without parsing the individual elements of the formulation, to determine which are more representative of the nature of the patent.
[16] In this context, it is worth repeating a key paragraph from Hoffmann-La Roche which underlies GSK's argument:
Against this background, it seems clear that the words "drug" and "medicine" as they appear in s. 4(1) of the Regulations are not used in contradistinction and are not intended to draw a line between an active ingredient and a preparation or composition which includes an active ingredient. Both types of substances when capable or intended to be used for the treatment or prevention of a disease are a "medicine" within the meaning of the Regulations and a claim for the medicine itself, whether in the form of a single active ingredient or in the form of a composition comes within the ambit of the Regulations.
[Hoffmann-La Roche, p. 74.]
[Emphasis added.]
[17] The reference to "substances" is a reference to the definition of medicine in the Regulations:
"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. (medicine)
[Emphasis added.]
[18] If one were to substitute the definition of medicine for the word itself where it appears in paragraph 4(2)(b) of the Regulations, the result would be as follows:
|
4.(2) A patent list submitted in respect of a drug must
…
(b) set out any Canadian patent …that contains a claim for [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] itself, or a claim for the use of the [substance intended or capable etc] and that the person wishes to have included on the register. |
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 [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] en soi ou une revendication pour l'utilisation du [substance destinée à servir ou pouvant agir etc], et qu'elle souhaite voir inscrit au registre. |
[19] The terms "claim for the medicine itself" and "claim for the use of the medicine" are also defined terms but the result is the same if the definition of the word "medicine" is substituted for that term in those definitions. In either case, a medicine is a substance.
[20] The question of what is included within the term "substance" was dealt with in Glaxo Group Ltd. v. Novopharm Ltd., [1998] F.C.J. No. 155, where Tremblay-Lamer J. found that :
13. Therefore, in my view, the Regulations do not extend the meaning of the word "substance" to include mechanical devices made of metal and plastic which cannot be ingested into the body. Consequently, I find that the Respondent's allegation is justified.
[21] This Court confirmed this reasoning at [1999] F.C.J. No. 799 where it said:
6. With respect to the substantive issue raised by Glaxo in its cross-appeal, we share the view of the trial judge that the patents at issue, being patents for devices by which medicines can be administered to or by patients rather than patents for the substance being administered, are not a "medicine" within the meaning of the Regulations.
[22] As a result, while the patent in issue may well claim a formulation, it does not, taken as a whole, claim a substance or a combination of substances (such as a medicine and an excipient) since "substance" is not broad enough to include a mechanical device. If the patent does not claim a substance, it cannot, by definition, claim a medicine. This leaves me with my earlier conclusion that, for purposes of the Regulations, the patent protects the delivery system rather than the payload.
[23] While the appellant is correct that Whirlpool is the authority on claims construction, it is also true that the Regulations require the Minister, and the Federal Courts on review, to make an additional legal determination with respect to the patent, that is, whether it contains a claim for a medicine or the use of a medicine as those terms are defined in the Regulations. The jurisprudence draws a distinction between patents that claim the medicine (the payload), and patents that protect a method of administering the medicine (the delivery system). Nothing in Whirlpool precludes the Courts from making such distinctions when determining whether a patent claims a medicine or its use for the purposes of the Regulations.
[24] So far in these reasons, I have addressed only the issue of "a claim for the medicine itself". The '111 patent also contains a claim for the use of the formulation described in the claim for the treatment of respiratory disorders. If the claim for the formulation does not contain a claim for a medicine, then, obviously, a claim for the use of that formulation is not a claim for the use of a medicine.
[25] The appeal should therefore be dismissed with costs.
"I agree
Robert Décary J.A."
"I agree
A.M. Linden J.A."
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-572-05
APPEAL FROM A JUDGMENT OR ORDER OF THE FEDERAL COURT DATED OCTOBER 25, 2005, DOCKET NO. T-1957-04
STYLE OF CAUSE: GLAXOSMITHKLINE INC. and ATTORNEY GENERAL OF CANADA and THE MINISTER OF HEALTH
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: September 20, 2006
REASONS FOR JUDGMENT BY: PELLETIER J.A.
LINDEN J.A.
APPEARANCES:
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Ms. Chantal Saunders |
FOR THE APPELLANT
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FOR THE RESPONDENTS
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SOLICITORS OF RECORD:
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Ottawa, Ontario |
FOR THE APPELLANT
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Deputy Attorney General of Canada Ottawa, Ontario |
FOR THE RESPONDENTS
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