Date: 20030307
Docket: T-2216-00
Neutral citation: 2003 FCT 286
OTTAWA, ONTARIO, THIS 7TH DAY OF MARCH, 2003
PRESENT: THE HONOURABLE MADAM JUSTICE HENEGHAN
BETWEEN:
JANSSEN-ORTHO INC.
Applicant
and
THE MINISTER OF HEALTH and
THE ATTORNEY GENERAL OF CANADA
Respondents
INTRODUCTION
[1] Janssen-Ortho Inc. ("Applicant") seeks judicial review of the decision by the Minister of Health ("Minister") to remove Canadian Patent 1,245,983 (the " '983 patent") from the Patent Register relative to DURAGESIC fentanyl patch formulation.
FACTS
[2] The Applicant is a manufacturer of pharmaceutical products. On December 20, 1991, it was granted a Notice of Compliance by the Minister for 2.5 mg, 5.0 mg, 7.5 mg and 10.0 mg/DURAGESIC fentanyl transdermal system. On or about April 1, 1993, the Applicant submitted Form IV patent lists to the Minister listing the '983 patent relative to DURAGESIC fentanyl. Subsequently, the Minister included the '983 patent on the Patent Register for 2.5 mg, 5.0 mg, 7.5 mg and 10.0 mg/DURAGESIC fentanyl transdermal system and the '983 patent has since remained on the Patent Register.
[3] The DURAGESIC fentanyl patches are a combination of the active medicinal ingredient fentanyl and inactive ingredients. They are analgesics that are commonly used to alleviate chronic cancer pain. The DURAGESIC patches consist of several layers, including a drug reservoir which contains the medicine fentanyl. Patches are administered by attaching the adhesive portion of the patch to the recipient's skin. The patch is designed to administer the drug continuously through the skin into the bloodstream to relieve pain.
THE '983 PATENT
[4] The '983 Patent is entitled "Transdermal Administration of Fentanyl and Device Therefor". It relates to a new transdermal dosage form of fentanyl that achieves a constant rate of administration of the drug over a long period of time. It is useful in treating pain in persons afflicted with terminal cancer.
[5] The '983 Patent contains 65 claims, all of which are directed to a "medical device", "transdermal system" or "device" designed for the transdermal administration of fentanyl or its analgetically effective derivative. The '983 Patent does not contain claims for the medicine fentanyl itself or for the use of fentanyl.
[6] The '983 Patent was added to the Patent Register in 1993.
[7] On March 12, 1998, the Patented Medicines (Notice of Compliance) Regulations, SOR 193-133, as amended by SOR/98-66, s. 3 (the "Regulations") were amended. The amendments expressly confirmed the Minister's authority to audit the patent list, including the removal of ineligible patents from the Patent Register. In 1998, the Minister undertook a complete audit of the Patent Register and in the context of this audit, decided that the '983 Patent did not comply with the Regulations and should be removed from the Patent Register.
[8] By letter dated March 3, 2000, the Applicant was advised that the '983 Patent would be removed, subject to any written representations to be received from the Applicant. In this letter, written by Marilyn Schwartz, Acting Chief, Submission and Information Policy Division, the reason for the decision to remove the '983 Patent from the Patent Register was that the patent was identified as a medical device patent and, consequently, pursuant to the Federal Court of Appeal's decision in Glaxo Group Ltd. v. Novopharm Ltd. (1999), 87 C.P.R. (3d) 525 (F.C.A.), this patent was ineligible for inclusion on the Patent Register since that Register did not extend to medical devices.
[9] By letter dated March 31, 2000, the Applicant made submissions to the Minister opposing the proposed delisting of the '983 Patent.
[10] These representations were rejected by the Minister by letter dated November 2, 2000. On November 24, 2000, the Applicant commenced this application for judicial review relative to the Minister's decision. By Order dated December 20, 2000, that decision was stayed pending the disposition of this application.
ISSUE
[11] The sole issue raised in this application is whether the Minister erred in deciding that the '983 Patent is ineligible for inclusion on the Patent Register.
APPLICANT'S SUBMISSIONS
[12] The Applicant argues that the claim to a pharmaceutical formulation combining active ingredients with non-medicinal ingredients, for an intended therapeutic effect is a "claim for the medicine itself" within the meaning of sections 2 and 4 of the Regulations.
[13] Relying on Hoffmann-La Roche Limited v. Canada (Minister of National Health and Welfare) (1995), 62 C.P.R. (3d) 58 (F.C.T.D.), the Applicant argues that the Minister applied a definition of medicine that is narrower than the commonly understood meaning, as discussed in that case.
[14] The Applicant says that the purpose of the Regulations is to protect infringement and argues that this purpose is not promoted by prohibiting the listing of patents containing claims to formulations of an active medicinal ingredient, together with other materials.
[15] The Applicant says that the '983 Patent claims are not to a medical device, but that a person skilled in the art would know that the patent refers to a patch.
[16] Furthermore, the Applicant says that the DURAGESIC fentanyl patches have always been treated as drug products and not as medical devices.
[17] Next, the Applicant submits that the Minister's decision to delist the '983 Patent is inconsistent with other government decisions. In particular, the policy on Drug/Medical Device, Combination Products (the "1997 Policy") introduced in 1997, states that combination products need only file one type of submission for approval. Such approval would either be for a drug, under the Food and Drugs Regulations, C.R.C., c. 870 or as a device, under the Medical Devices Regulations SOR 198-282. The Applicant was never required to seek approval of DURAGESIC as a medical device.
[18] The Applicant further argues that it is inconsistent for its product to be subject to the regulations of a drug, such as price control, yet be considered a medical device by the Minister under the Regulations and consequently, precluded from the benefit of those Regulations.
[19] The Applicant distinguishes the facts in the present case from those in Glaxo Group Limited v. Novopharm Limited (1999), 87 C.P.R. (3d) 525 (F.C.A.). In that case, an inhaler that was used to administer medicine was found to be a medical device. However, in the case of the '983 Patent, the device which holds the medicine remains with the patient during administration.
[20] Finally, the Applicant draws an analogy to creams and tablets, by submitting that the DURAGESIC fentanyl formulation works like a topical cream that adheres to the skin to allow the active ingredient to enter the bloodstream.
RESPONDENTS' SUBMISSIONS
[21] The Respondents rely on Glaxo, supra, as authority for the distinction between medicine and devices that administer medicine. The Respondents argue that the claims in the '983 Patent do not speak to the medicine fentanyl or its use, but rather to a device that administers fentanyl or its deratives to patients.
[22] The Respondents say that Hoffmann-La Roche, supra, is distinguishable from the present case, on the facts. In that case, the issue dealt with a nasal spray in which the medicine was found to be in the formulation of the active and inactive ingredients. In the present case, the Respondents argue that the DURAGESIC patch is distinct and separate from the medicine component and cannot be considered a formulation.
[23] As for the argument that there is an inconsistency in the manner in which the government treats the Patent, the Respondents argue that whether the DURAGESIC patches are regulated under the Food and Drugs Regulations is an extraneous matter that should not be considered when interpreting a patent.
ANALYSIS
[24] The present application involves consideration of the Regulations. The terms "claim for the medicine itself", "claim for the use of the medicine" and "medicine" are defined in section 2 of the Regulations as follows:
| ... "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; |
|
... « 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. |
|
"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. |
| ... "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. |
[25] Sections 3(1) and 4(2)(b) of the Regulations are also relevant and provide as follows:
| 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. |
|
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.
|
| 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; ... |
|
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; ... |
[26] The first question for consideration is whether the DURAGESIC patches are medicine.
[27] There has been judicial consideration of what constitutes a "medicine" in the context of the Regulations. In Hoffmann-La Roche, supra, at issue was a nasal spray which was composed of an active ingredient and several inactive ingredients designed to assist the delivery of the medicine to the affected area. The Court found the definition of "medicine" includes compositions of active and inactive ingredients.
[28] At the trial level of Glaxo Group Ltd. v. Novopharm Ltd. (1998), 79 C.P.R. (3d) 488 (F.C.T.D.), Tremblay-Lamer, J., considered the question of whether "medicine" can be extended to encompass devices used to administer active substances to patients. The qualifying feature, according to that case, is whether the inactive ingredients are physically mixed with the medicine and whether they are ingested in the body as a single composition. The Court adopted the interpretation of "medicine" from Hoffmann-La Roche, supra, and further stated at pages 492-493:
...The contentious issue is whether the definition of "medicine" can be extended to encompass substances which are nothing more than devices used to administer active substances to patients, but which are not ingested into the body. The Applicants insist that the fact that the inactive ingredient is not ingested by the patient is immaterial. So long as its function is to deliver the active ingredient to the patient, it complies with the reasoning of Hoffmann-La Roche.
In my opinion, the Applicants' interpretation of Hoffmann-La Roche is incorrect. The case specifically deals with compositions of active and inactive ingredients, such as coatings and inert carriers, which are physically mixed together and which are ingested into the body as a single composition. It was obviously not intended to include a mechanical device as an inactive ingredient.
...
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.
[29] This interpretation was upheld, although the disposition was reversed on other grounds, by the Federal Court of Appeal in Glaxo, supra. There, the Court stated at page 527:
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 medicaments 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.
[30] I am not persuaded by the Applicant's argument that DURAGESIC patches work like a topical cream. While the patch does contain an adhesive that binds to the skin, other components of the patch cannot be ingested into the body. In particular, the release membrane, the drug reservoir and the backing cannot be considered "medicine"according to Hoffmann-La Roche, supra and Glaxo, supra. In my opinion, the patch is not a medicine and the case parallels the circumstances in Glaxo where the inhaler was found not to be a medicine.
i) Do the words of the patent indicate that DURAGESIC patches are medicine?
[31] Page 1 of the '983 Patent reads as follows:
This invention relates to the administration of fentanyl for analgetic purposes and more particularly to a method and device for administering fentanyl to a subject through intact skin over an extended period of time at a substantially constant rate.
[32] Throughout the '983 Patent, the DURAGESIC patches are referred to as a "device", "medical device" or "transdermal system". The Applicant argues that a person skilled in the art reading the '983 Patent would be aware that the "device" referred to is indeed a patch.
[33] In my opinion, a person skilled in the art would identify the '983 Patent as describing a patch, but this does not mean that such a patch falls within the definition of "medicine" for the purposes of the Regulations.
[34] A similar fact situation was before this Court in Novartis Pharmaceuticals Canada Inc. v. Canada (Minister of Health), [2002] F.C.J. No. 1387 (T.D.)(QL), where the patented item under consideration was a patch which released estrogen and progestin through the skin for relief of menopausal symptoms and for the prevention of osteoporosis. Justice MacKay stated for the Court as follows at paragraph 17:
The '021 patent was issued in relation to a "therapeutic system for the transdermal combined administration of oestrogens and gestagens", that is, in relation to a system for the administration of substances, not in relation to the substances themselves. It follows, in my view, that the subject matter of the '021 patent is not analogous to the subject matter of the '963 patent found to be within the NOC Regulations in Hoffman-La Roche (which related to a "composition" of substances in a container). Rather, it is analogous to the subject matter of the '917 patent held by this Court not to be for patent within those Regulations in Glaxo (which patent related to a "device for administering medicaments"). The '021 patent, which relates to a system for the administration fo medicine, does not contain a claim for the medicine itself, or the use of the medicine, as required by subparagraph 4(2)(a) [sic. (b)] of the Regulations.
[35] None of the 65 claims in the '983 Patent are for the medicine fentanyl itself or for the use of fentanyl. Consequently, the Patent does not fall within section 4(2)(b) of the Regulations which provides that a patent list submitted in respect of a drug must set out any Canadian Patent that contains a claim for the medicine itself or a claim for the use of the medicine. As DURAGESIC patches do not fall into the definition of medicine and since the '983 Patent does not make any claims to fentanyl or the use of fentanyl, the '983 Patent is not eligible to be included in the patent list.
ii) The Drug/Medical Device Combination Products Policy
[36] The1997 Policy established a processing system for approval of combination products. This Policy defines "combination products" in the following terms:
... a therapeutic product that combines a drug component and a device component (which by themselves would be classified as a drug or a device), such that the distinctive nature of the drug component and device component is integrated in a singular product.
[37] The Applicant submits that it is inconsistent for DURAGESIC patches to be governed by the Food and Drugs Act without being eligible to have the benefit of the Regulations. Furthermore, the Applicant says that the DURAGESIC patch has consistently been governed by the Food and Drugs Regulations.
[38] While this is a valid concern of the Applicant, the Policy itself recognizes that there will be gaps in the current regulatory schemes for drugs and devices. The Policy provides, in part, as follows:
Ultimately, it will be necessary to amend the Food and Drugs Act and/or the Food and Drugs Regulations and/or the Medical Device Regulations to provide an appropriate regulatory framework for new and emerging therapeutic products that are difficult to define under current frameworks, including combination products.
[39] However, in my opinion, it is not appropriate for the Court to stretch the definition of "medicine" as provided in the Regulations in order to comply with a policy document. Furthermore, this policy document has no bearing on the interpretation of the '983 Patent. The construction of a patent is a matter of law; see Whirlpool Corp. v. Camco Inc. (2000), 9 C.P.R. (4th) 129 (S.C.C.).
[40] The '983 Patent does not contain a claim for the medicine itself or a claim for the use of the medicine, as anticipated by section 4(2)(b) of the Regulations. Whether the subject of the patent is governed by the Food and Drugs Act or the Medical Device Regulations is irrelevant to the interpretation of the '983 Patent. As stated by this Court in Novartis, supra, at paragraphs 18 and 19:
The applicant submits that the Minister erred by concluding that the patch in question is a "device", despite the fact that it is regulated as a drug under the Food and Drug Regulations. The applicant notes that s. 2 of the Food and Drugs Act defines a "device" as an article used, inter alia, in the treatment of a disease, which is not a drug.
In my view, the regime set out in the Food and Drugs Act and the accompanying Food and Drug Regulations is distinct from, and serves a different purpose than, the regime set out in the Patented Medicines (Notice of Compliance) Regulations. The difference between these two regimes in relation to other considerations was recognized by the Federal Court of Appeal in Merck Frosst & Co. v. Canada (Minister of Health) (2001), 12 C.P.R. (4th) 383.
[41] The purpose of the Patent Act, R.S.C. 1985, c. P-4 and the Regulations is to protect patented inventions and medicines. The Applicant says that this purpose is offended by the decision of the Minister to delist the '983 Patent. I do not accept this argument Justice Binnie for the minority of the Supreme Court of Canada in Harvard College v. Canada (Commissioner of Patents), [2002] S.C.J. No. 77, while acknowledging that a patent protects its owner from the unauthorized use of an invention for a limited time, stated at paragraph 64 , "A patent does not exempt the owner from any relevant regulation or prohibition."
[42] For the reasons given above, I conclude that the '983 Patent is not a medicine within the meaning of the Regulations. Since it is not a medicine, it does not meet the requirements for inclusion on the register, having regard to the definition in section 2 of the Regulations and section 4(2)(b) of the Regulations. Whether or not the Minister erred in using the term "device" to refer to the patch is not determinative in this case. Once again, I refer to this Court's ruling in Novartis, supra, where Justice MacKay summarized the main point for consideration as follows at paragraph 20:
In any event, whether the Minister erred in referring to the patch in question as a "device" is not in issue before me. Here the issue is whether he erred in concluding it was not provided for in a patent subject to registration on the register under the NOC Regulations. Reference to the patch as a device was not the basis on which the Minister concluded the patch was not registrable under the NOC Regulations.
[43] Consequently, the decision to delist the Patent does not offend the principles of patent law. The '983 Patent remains valid and enforceable throughout its life notwithstanding the decision to delist, as do the patents related to the drug fentanyl itself. The Applicant is entitled to benefits from the Regulations with respect to the patent associated with the drug components of the DURAGESIC patch, but may not do so for products that are not a "medicine" within the meaning of those Regulations.
[44] In the result, the application for judicial review is dismissed with costs to the Respondents.
ORDER
The application for judicial review is dismissed, with costs to the Respondents.
"E. Heneghan"
J.F.C.C.
FEDERAL COURT OF CANADA
TRIAL DIVISION
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-2216-00
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: September 9, 2002
REASONS FOR ORDER AND
ORDER: The Honourable Madam Justice Heneghan
APPEARANCES:
Anthony Creber
Jennifer Wilke FOR APPLICANT
Marie Crowley FOR RESPONDENT
SOLICITORS OF RECORD:
Gowling Lafleur Henderson FOR APPLICANT
Morris Rosenberg
Deputy Attorney General of Canada FOR RESPONDENT