Janssen-Ortho Inc. v. Canada (Minister of Health), 2005 FC 765

                                                                                                                                  Date: 20050530

                                                                                                                               Docket: T-881-04

                                                                                                                        Citation: 2005 FC 765

BETWEEN:

JANSSEN-ORTHO INC.

                                                                                                                                            Applicant

                                                                           and

                                                THE MINISTER OF HEALTH and

THE ATTORNEY GENERAL OF CANADA

                                                                                                                                      Respondents

                                                        REASONS FOR ORDER

de MONTIGNY J.

[1]                This is an application for judicial review brought by Janssen-Ortho Inc. (applicant) in respect of a decision of the Minister of Health (Minister) dated April 5, 2004, wherein the Minister refused to add Canadian Letters Patent 2,222,133 ('133 patent) to the Patent Register, in relation to the applicant's EVRA norelgestromin/ethinyl estradiol transdermal system.

[2]                The applicant seeks orders in the nature of declaration, certiorari, and mandamus, that would require the Minister to include the '133 patent on the Patent Register, in accordance with the Patented Medicines (Notice of Compliance) Regulations SOR/93-133 (Regulations).

BACKGROUND

[3]                As described in the drug's Product Monograph, EVRA is a hormonal contraceptive in the form of a transdermal system or "patch". The medicine in EVRA is a combination of two active ingredients, norelgestromin and ethinyl estradiol.

[4]                Janssen-Ortho filed a new drug submission for EVRA on April 2, 2001. This submission was issued a Notice of Compliance ("NOC") on August 20, 2002, pursuant to section C.08.004 of the Food and Drug Regulations.

[5]                The Product Monograph describes the EVRA system as consisting of 3 plastic layers. The innermost layer is removed just prior to application of the system to the patient's skin. The middle layer consists of non-medicinal components (including an adhesive and a polyester fabric) and the active components norelgestromin and ethinyl estradiol. It adheres to the skin and is supported and protected by the outer layer. Together, the layers operate so as to ensure delivery, through the patient's skin, of a specific measured amount of each of the two active ingredients to the bloodstream, at a specific measured rate, in combination.

[6]                The '133 patent was applied for on June 6, 1996, and was granted on December 24, 2002. It is owned by Ortho-McNeil Pharmaceutical, Inc., US, who gave permission to the applicant to include the '133 Patent on the Form IV patent list that was submitted to the Minister on January 10, 2003, to have it put on the Patent Register in connection with EVRA.

[7]                The '133 Patent is entitled "Transdermal Patch and Method for Administering 17-Deacetyl Norgestimate Alone or in Combination with an Estrogen". Within the patent, the invention is described as follows:

This invention relates to transdermal drug delivery. More particularly, it concerns patches and methods for transdermally administering 17-deacetyl norgestimate either alone or in combination with an estrogen, particularly ethinyl estradiol.

[8]                In its "disclosure", the patent describes the two aspects or embodiments of the invention in part as follows:

a. "¼a transdermal patch for preventing ovulation in a woman comprising: a backing layer; and a matrix layer underlying the backing layer, the matrix layer comprising a mixture of 17-d-Ngm and a pressure sensitive adhesive¼"

b. "¼a transdermal patch for administering 17-d-Ngm and estrogen to a woman, the patch comprising: a backing layer; and a matrix layer underlying the backing layer, the matrix layer comprising a mixture of 17-d-Ngm, an estrogen, and a pressure sensitive adhesive¼"

[9]                The '133 patent contains 51 claims. Claims 1 through 38 are explicitly directed towards one or the other of the patches described in these two aspects of the invention. Claims 39 through 51 are directed towards the use of these patches. The Applicant relies particularly on claims 44 and 45 of the patent:

44. A use of an ovulation inhibiting amount of 17-deacetyl norgestimate an estrogen for preventing ovulation in a woman where in the 17-deacetyl norgestimate and the estrogen are co-administered transdermally to the woman from a matrix comprising a mixture of 17-deacetyl norgestimate, and estrogen in a pressure sensitive adhesive comprising at least one of the silicone and polyisobutylene.

45. The use of Claim 44 where the estrogen is ethinyl estradiol.

[10]            The relevant Health Canada officials took the view that the patent relates to a system or method for administering a medicine, and does not contain a claim to the medicine in EVRA, being the combination of norelgestromin and ethinyl estradiol, or to its use. Accordingly, by letter dated March 25, 2003, Janssen-Ortho Inc. was informed that, subject to any written representations it may wish to make, the patents would not be considered eligible for inclusion on the Patent Register.

[11]            The reasons for coming to that conclusion are set out in the following paragraphs of the March 25, 2003 letter:

In accordance with the judgment of the Federal Court of Appeal in Glaxo Group Ltd. v. Novopharm Ltd. (1999), 87 C.P.R.(3^nd) 525, leave to appeal to the Supreme Court of Canada refused [1999] S.C.C.A. No. 391, the Patented Medicines (Notice of Compliance) Regulations do not extend to devices. Therefore, any patents solely containing claims for mechanical devices for the administration of a drug are ineligible for inclusion on the Patent Register.

Patent 2,22,133 (the '133 patent) is entitled "Transdermal Patch and Method for Administering 17-Deacetyl Norgestimate Alone or in Combination with an Estrogen" and contains 51 claims. Claims 1 through 38 are directed towards a transdermal patch for preventing ovulation in a woman comprising a backing layer and a non-acrylate containing matrix layer which contains a mixture of 17-deacetyl norgestimate, lauryl acetate and a pressure sensitive adhesive. Claims 39 through 51 are directed towards the use of the above noted transdermal patch.

There is no claim to the medicine norelgestromin/ethinyl estradiol or the use of the medicine in the '133 patent, and therefore it is not eligible for addition to the Patent Register. Pursuant to the authority vested in the Minister of health by subsection 3(1) of the Regulations, the above patent will not be added to the Patent Register for the above product, subject to any written representations.

[12]            Janssen-Ortho Inc. submitted representations. At Janssen-Ortho's request, no final decision was taken until after the Federal Court of Appeal released its decision in Janssen-Ortho Inc. v. Canada (Minister of Health), [2004] F.C.J. No. 242 (QL). Ultimately, by letter dated April 5, 2004, the Minister confirmed that the patent would not be listed on the Patent Register.

[13]            The relevant portion of that letter reads as follows:

As you know, the Therapeutic Products Directorate ("TPD") had previously agreed to reserve making a final decision in this matter until the Federal Court of Appeal had released its decision in Janssen-Ortho Inc. v. Canada (Minister of Health). I note that the Court of Appeal has now upheld the decision of the Trial division in this matter. As a result, the Therapeutic Products Directorate maintains the points it had previously set out in correspondence dated November 6, 2003, regarding the eligibility of Canadian Patent No. 2,222,133 (the "133 patent") for listing on the Patent Register.

The supplemental representations you have provided deal only with the "use claims" set out in claims 39 to 51 of the '133 patent. In your view, the reasoning of the Court of Appeal in Janssen-Ortho and Novartis Pharmaceuticals Canada Inc. v. Canada (Minister of Health), does not apply to the use claims of the '133 patent. You characterize these claims as claims for the use of an active ingredient and inactive ingredients, such that they would be eligible for listing by virtue of the reasoning in Hoffman-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1995) 67 C.P.R.(3d) 25.

With respect, the TPD does not agree with this position. In the view of the TPD, the claims you rely upon describe the use of a medicine wherein the medicine is administered transdermally from a matrix having a specific composition. In other words, the claims describe the use of a transdermal patch. The Janssen-Ortho and Novartis cases have made it clear that patents with claims to a transdermal patch for the administration of a medicine are not eligible for listing on the Patent Register. In the view of the TPD, the reasoning of the Court of Appeal in these decisions can be relied upon for the conclusion that claims within a patent for the use of a transdermal patch are likewise insufficient to support a listing on the Patent Register.

Consequently, for these reasons and those set out in the TPD's previous correspondence, the TPD remains of the view that the '133 patent does not contain a claim to the medicine norelgestromin/ethinyl estradiol as required by section 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations. Therefore, pursuant to subsection 3(1) of the Regulations, the '133 patent will not be added to the Patent Register.

[14]            Janssen-Ortho commenced the within application by Notice of Application dated May 5, 2004, seeking an Order quashing the decision of the Minister refusing to add the '133 Patent to the Patent Registar in respect of EVRA norelgestromin/ethinyl estradiol.

ISSUE

[15]            The only question in this application is whether the patent at issue meets the requirements of section 4 of the Patented Medicines (Notice of Compliance) Regulations SOR/93-133 (Regulations). To determine that issue, it is necessary to decide whether the patent contains a claim for either the medicine norelgestromin/ethinyl estradiol or its use.

THE LEGISLATIVE FRAMEWORK

[16]            Under the Regulations, the Minister maintains a register of certain patents. Essentially, if a person has both (1) a Notice of Compliance for a drug and (2) patent rights for the medicine contained in that drug, the person may apply to the Minister to have the patent for the medicine included on the register in connection with the drug. (The Regulations make a clear distinction between a "drug" and a "medicine", which is simply that a drug contains a medicine.)

[17]      The requirement that the patent contain a claim for the medicine that is contained in the drug is particularly set out in paragraph 4(2)(b).

[18]            The terms "medicine", "claim for the medicine itself", and "claim for the use of the medicine" are individually defined.

SUBMISSIONS OF THE PARTIES

[19]            The applicant argues that the '133 patent contains claims to the use of two medicines, 17-d-Ngm, and ethinyl estradiol. The applicant says the Minister construed the '133 patent in a manner inconsistent with the evidence of a person skilled in the art, and contrary to the law of claim construction. The applicant submits that the Claims, properly construed, are claims to the use of the medicines. The applicant argues that the '133 patent should be included on the Patent Register.

[20]            The respondent says that the patent does not contain a claim to the medicines, or a claim to the use of the medicines. The respondent argues that the patent is for a delivery system, and this Court has said, more than once, that a delivery system patent will not be added to the patent register. The respondent submits that Claims 44 and 45, the two contested claims, do not contain a claim to the medicines themselves, nor do they contain a claim to the use of the medicine.

ANALYSIS

[21]            It is settled law that the standard of review of the Minister's decision is correctness (Ely Lilly Canada Inc. v. Canada (2003), 300 N.R. 76 (FCA)). The Court is in as good a position to decide whether a given patent satisfies the prescribed requirements as the Minister. Given that context, the Court's conclusion must result from a fresh appraisal, made on the basis of the legislation, the contents of the patent, and the jurisprudence.

[22]               The principles of patent construction have been enunciated by the Supreme Court of Canada in Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067 and in Free World Trust v. Électro-Santé Inc., [2000] 2 S.C.R. 1024. In the first of these two cases, Justice Binnie quoted approvingly the following description of purposive construction by Lord Diplock's in Catnic Components Ltd. v. Hill and Smith Ltd., [1982] R.P.C. 183, at pp. 242-243:

My Lords, a patent specification is a unilateral statement by the patentee, in words of his own choosing, addressed to those likely to have a practical interest in the subject matter of his invention (i.e. "skilled in the art"), by which he informs them what he claims to be the essential features of the new product or process for which the letters patent grant him a monopoly. It is those novel features only that he claims to be essential that constitute the so-called "pith and marrow" of the claim. A patent specification should be given a purposive construction rather than a purely literal one derived from applying to it the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge. The question in each case is: whether persons with practical knowledge and experience of the kind of work in which the invention was intended to be used, would understand that strict compliance with a particular descriptive word or phrase appearing in a claim was intended by the patentee to be an essential requirement of the invention so that any variant would fall outside the monopoly claimed, even though it could have no material effect upon the way the invention worked.

[23]            Justice Binnie elaborated furthermore in the Free World Trust case, wherein the following propositions can be extracted:

-             The key to purposive construction is the identification of the essential elements of the invention. Construction of a patent is a question of law for the Court. However, it should be undertaken with the knowledge of a person skilled in the art, to the extent that such knowledge is revealed by expert evidence at trial;

-              Non-essential elements may be substituted or omitted without having a material effect on the structure or operation of the invention as described in the claim, while essential elements must be present in order for the device to work as contemplated and claimed by the inventor;

-              A person skilled in the art is "a hypothetical person possessing the ordinary skill and knowledge of the particular art to which the invention relates, and a mind willing to understand a specification that is addressed to him. This hypothetical person has sometimes been equated with the 'reasonable man' used as a standard in negligence cases. He is assumed to be a man who is going to try to achieve success and not one who is looking for difficulties or seeking failure" (Fox, H.G., The Canadian Patent Law and Practice Relating to Letters Patent for Inventions, 4^th ed., Toronto, Carswell, 1969, at p. 184);

-               The claims are to be read in an informed and purposive way to permit fairness and predictability and to define the limits of the monopoly. "Ingenuity of the patent lies not in the identification of the desired result but in teaching one particular means to achieve it. The claims cannot be stretched to allow the patentee to monopolize anything that achieves the desired result" (para. 32).

[24]            One last point needs be made before we undertake the analysis required to determine whether the '133 patent should be included on the Patent Register. The ultimate legal question underlying this assessment, of course, is whether the patent contains a claim for the medicine or the use of the medicine. It is trite law that a Court does not simply endorse the opinion of an expert on the ultimate legal question. This is particularly so where claim construction is at issue: a patent is at law an "enactment", and a Court would certainly not abdicate to a scientific expert the proper construction of a statute. The person skilled in the art may certainly provide assistance to the Court, but the construction of a patent must "in the final analysis" be examined by the Court and no one else.

[25]            A careful examination of the parties' written and oral submissions reveal that they come to a different construction of the '133 Patent, and particularly of its Claim 44 and 45, essentially because they focus on different part of these claims. The Applicant, relying on the expert evidence of his witness, Dr. McGinity, puts the emphasis on the first part of the claim to conclude that its subject matter is the use of two medicines, namely 17-deacetyl norgestimate and ethinyl estradiol. For that reason, they are of the view that the two medicines are literally "a substance intended or capable of being used for the diagnosis, treatment, medication or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof", and that claim 44 is therefore a claim for the use of the medicine for preventing ovulation.

[26]            The respondent, on the other hand, focus on the second part of Claim 44, "wherein the 17-deacetyl norgestimate and the estrogen are co-administered transdermally to the woman from a matrix comprising a mixture of 17-deacetyl norgestimate, an estrogen and a pressure sensitive adhesive comprising at least one of a silicone and polyisobutylene". According to the respondent, the invention is the insight that the medicine can be administered transdermally from a matrix consisting of the medicine, a pressure-sensitive adhesive, etc. In other words, and using a purposive construction, a product containing the medicine and used to prevent ovulation will fall within the scope of the claims if and only if it uses the described transdermal patch. The pith and substance of the invention is not the medicine or its use, but the delivery or administration of the medicine via a transdermal patch.

[27]            This is the heart of the debate. If one was to rely exclusively on the language of claim 44, both of these interpretations could prima facie hold true. But a careful reading of the invention's disclosure sheds some light on the proper construction to be given to this claim. First of all, the title of the patent reads: "Transdermal patch and method for administering 17-deacetyl norgestimate alone or in combination with an estrogen".

[28]            Secondly, the description of the patent found in the disclosure states: "This invention relates to transdermal drug delivery. More particularly, it concerns patches and methods for transdermally administering 17-deacetyl norgestimate either alone or in combination with an estrogen, particularly ethinyl estradiol". The same focus on the delivering of the medicine is found on page 2 of the disclosure, which we will reproduce here for ease of reference:

Accordingly, one aspect of this invention is a transdermal patch for preventing ovulation in a woman comprising: a backing layer; and a matrix layer underlying the backing layer, the matrix layer comprising a mixture of 17-d-Ngm and a pressure sensitive adhesive and being adapted to be in diffusional communication with the skin of the woman and to administer an ovulation-inhibiting amount of 17-d-Ngm to said skin.

Another aspect of the invention is a transdermal patch for administering 17-d-Ngm and estrogen to a woman, the patch comprising: a backing layer: and a matrix layer underlying the backing layer, the matrix layer comprising a mixture of 17-d-Ngm, an estrogen, and a pressure sensitive adhesive, and being adapted to be in diffusional communication with the skin of the woman and to co-administer an ovulation-inhibiting amount of said 17-d-Ngm and estrogen to the woman through the skin. These patches are also can (sic) be used to provide hormone replacement therapy."

[29]            Finally, it is also worth noting that the medicine and its use to prevent ovulation is, in the invention's disclosure (at p. 1), admitted to be already known. This is one more confirmation that the invention is the method of delivering the medicine to the skin, continuously and for an extended period of time (typically for 1 to 7 days). Accordingly, EVRA is just another form of hormonal contraceptive; indeed, the information to the patient mentions that it is associated with the same risks and benefits as the birth control pills (Application Record, p. 95).

[30]            If that is the proper construction of claims 44 and 45, the Applicant cannot succeed in its application. The Courts have repeatedly recognized that a patent construed as claiming a device used to administer a substance does not constitute a claim for the medicine itself or for the use of that medicine. In Glaxo Group Ltd. v. Novopharm Ltd. (1998), 87 C.P.R.(3d) 525, for example, the Federal Court of Appeal decided that a patent claiming an inhaler used to administer a medicament to patients did not contain claims to the medicine itself or the use of that medicine.

[31]            That decision was considered in another ruling of the Court of Appeal dealing specifically with transdermal patches. In Novartis Pharmaceuticals Canada Inc. v. Canada (Minister of Health) (2003), 28 C.P.R.(4^th) 1, the Court reiterated that the appropriate test is whether the invention is the medicine or administers the medicine: "Accordingly, 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." (par. 18). That decision was subsequently followed by the Court of Appeal in Janssen-Ortho Inc., supra, and by this Court in Pfizer Canada Inc. v. Canada (A.G.), [2004] F.C.J. No. 438.

[32]            The Applicant, relying on Hoffmann-LaRoche Ltd. v. Canada (Minister of Health) (1995), 62 C.P.R.(3d) 58 (F.C.), has argued that a claim to the medicine includes a formulation claim which combines active ingredients with inactive ingredients. But this argument must be rejected, because the patches claimed in the '133 Patent are not formulations. The layers of the patches are not mixed with the medicine. Rather, they are discrete and separate components, and only the17-deacetyl norgestimate and the estrogen are administered to the patient; the other layers of the patches are never administered.

[33]            The Applicant, relying on the wording of s. 4(2)(b) of the PMNOC Regulations ("¼claim for the medicine itself or a claim for the use of the medicine¼), contends that the conditions for listing a patent containing a claim to the use of the medicine are not as restrictive as the law relating to the propriety of listing patents containing claims to the medicine itself. To quote from the Applicant factum:

Where the pharmaceutical formulation is contained in a dosage from such as a transdermal patch, the argument exists that a patent containing only such claim may not be listable on the Patent Register in light of certain jurisprudence. However, a narrow restriction relating to the medicine itself does not extend to use claims which only need be a claim to the use of the medicine. As a result, the foregoing jurisprudence cannot be applied to the case at hand where the issue relates to a claim to the use of the medicine and not a claim to the medicine itself.     

[34]            This argument is untenable. First of all, nothing turns on the use of the word "itself" in s. 4(2)(b) of the PMNOC Regulations. It is only meant to distinguish between the medicine as originally used when first developed, and the subsequent use that can be made of this same medicine. As for the proposition that the jurisprudence dealing with medicines is irrelevant when the use of medicines is involved, it is clearly wrong. The relevant case law, supra paras 29-31, clearly states that a claim relating to a method or a device to deliver a medicine cannot be constructed as a claim to the medicine itself, or as a claim to the use of the medicine.

[35]            The Applicant further argues that if the Minister's construction of Claim 44 was adopted, the scope of Claims 41 and 44 would be the same. Claim 41 reads as follows:

41. Use of the transdermal patch as defined in claim 31 to prevent ovulation.

Claim 31, on the other hand, states:

31. A transdermal patch comprising:

A backing layer; and

A non-acrylate containing matrix layer underlying the backing layer, the matrix layer comprising a mixture of 17-deacetyl norgestimate, crosslinked polyvinyl pyrrolidone, and a pressure sensitive adhesive consisting essentially of polyisobutylene and an aliphatic resin tackifier, wherein the matrix is adapted to be in diffusional communication with skin to transdermally administer a therapeutically effective amount of 17-deacetyl norgestimate for 7 consecutive days.

[36]            According to the Applicant, one of the canons of construction to be followed is that each claim, if possible, must be given a distinct meaning. To avoid giving the same meaning to claims 41 and 44, one must then necessarily construct Claim 41 as claiming the use of the transdermal patch to prevent ovulation, while claim 44 would be a claim to the use of the medicines to prevent ovulation in a formulation that includes a patch.

[37]            But for the reasons already given in paragraph 31, the patches claimed in the '133 Patent are not formulations. The better way to reconcile claims 41 and 44 is to look at claim 41 (and the underlying claim 31) as a more specific description of the matrix found in claim 44. There is nothing wrong with two claims being essentially the same, where one is essentially more detailed than the other.

[38]            Finally, the Applicant is of the view that an interpretation leading to the prevention of patent infringement is to be preferred to one that does not, considering that the intent of the PMNOC Regulations was to help preventing patent infringement. In preventing a patent from being listed on the Patent Register, the Minister would not even allow the possibility of meeting the objective of the Regulations in preventing patent infringement.

[39]            Clearly, this argument has its limits, as it begs the question to be answered. The Government's intention in adopting the PMNOC Regulations was "to balance effective patent enforcement over new and innovative drugs with the timely market entry of their lower priced generic competitors" (Regulatory Impact Analysis Statement, in the proposed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, Canada Gazette Part I, December 11, 2004, page 3718). The protection given to the patents by these Regulations is part of an overall scheme designed to balance two competing interests. As a result, any interpretation that leads to the prevention of patent infringement should not automatically be preferred to one that does not.

[40]            If a patent does not make it to the Register put in place by the PMNOC Regulations, it is still protected by all the remedies provided under the Patent Act. In particular, the owner of such a patent could still claim damages for infringement under the Patent Act. It is only those extraordinary remedies provided by the Regulations that the Applicant will not be able to claim with respect to the '133 patent.   

[41]            As a result, I come to the conclusion that the Minister was correct in refusing to include the patent on the Register. The application for judicial review of a decision of the Minister of Health dated April 5, 2004, wherein the Minister refused to add to the Patent Register Canadian Letters Patent 2,222,133, in relation to Janssen's EVRA norelgestromin/ethinyl estradiol transdermal system, is therefore dismissed with costs.

                                                                                                                        (s) "Yves de Montigny"             

Judge

                                                             FEDERAL COURT

                            NAMES OF COUNSEL AND SOLICITORS OF RECORD

DOCKET:                                          T-881-04

STYLE OF CAUSE:                          JANSSEN-ORTHO INC. v.

THE MINISTER OF HEALTH and THE ATTORNEY GENERAL OF CANADA

PLACE OF HEARING:                    OTTAWA, ONTARIO

DATE OF HEARING:                      FEBRUARY 14, 2005

REASONS FOR ORDER :             de MONTIGNY, J.

DATED:                                             May 30, 2005

APPEARANCES:

JAMES MILLS                                                                        FOR THE APPLICANT

CHANTAL SAUNDERS                                                        

F.B. (RICK) WOYIWADA                                                      FOR THE RESPONDENTS

SOLICITORS OF RECORD:

GOWLING LAFLEUR HENDERSON LLP                            FOR THE APPLICANT

OTTAWA, ON                                                                       

MR. JOHN H. SIMS, Q.C.                                                      FOR THE RESPONDENTS

DEPUTY ATTORNEY GENERAL

OF CANADA