T-155-02
2003 FCT 583
Procter & Gamble Pharmaceuticals Canada, Inc. and The Procter & Gamble Company (Applicants)
v.
The Minister of Health and Genpharm Inc. (Respondents)
Indexed as: Procter & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health) (T.D.)
Trial Division, Gauthier J.--Toronto, February 3; Ottawa, May 12, 2003.
Patents -- Practice -- Motion to dismiss application on basis patent should not have been listed on patent register because (i) out of time, (ii) surrendered patent ineligible -- Standard to be applied to motions under Patented Medicines (Notice of Compliance) Regulations, s. 6(5) not determined -- Reissued patents subject to Regulations, s. 4(4) time requirement -- Difference between grant and issuance of patent -- Motion dismissed as not plain, obvious patent not eligible for inclusion on register.
Procter & Gamble Pharmaceuticals Canada, Inc. and the Procter & Gamble Company (Procter) successfully applied for an order prohibiting the Minister from issuing a notice of compliance to Genpharm Inc. until after the expiration of Procter's Canadian Patent 1338376 (376 patent) (for a new use of its drug etidronate disodium). In this context, Genpharm brought this motion, pursuant to subsection 6(5) of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations), to dismiss the notice of application of Procter on the basis that the 376 patent should not have been listed on the patent register because it was allegedly registered outside of the period specified in subsection 4(4) of the NOC Regulations and because the patent (702) which was surrendered on the reissue of the 376 patent was also not eligible for listing on the patent register. (The 376 patent included the original claims of the 702 patent as well as additional claims for the use of a bone resorption inhibiting polyphosphonate, such as etidronate disodium, for the treatment and prevention of osteoporosis.) Later, Procter filed an amendment of a patent list to include the 376 patent on the patent register instead of the 702 patent.
Held, the motion should be dismissed.
Whether or not the restrictive standard enunciated in the Supreme Court of Canada case of Hunt v. Carey Canada Inc. should apply to motions to dismiss under subsection 6(5) was not determined in the present case because the same conclusion would have been arrived at in any event.
According to the Regulatory Impact Analysis Statement for the 1998 amendments to the NOC Regulations, subsection 3(1) thereof confirmed the authority of the Minister of Health to remove ineligible patents from the patent list. That provision confers the right to delete anything that does not meet the requirements set out in section 4 as a whole, including subsection 4(4) (time within which to submit a patent list or an amendment to an existing patent list). Based on subsection 47(1) of the Patent Act, which deals with "reissue", and on the wording of subsection 4(4) of the NOC Regulations, the latter provision did apply to the 376 patent.
The 376 patent clearly claimed the use of a medicine, and as such would be eligible for inclusion in the patent register. Subsection 47(2) of the Patent Act cannot be construed as exempting any portion of the 376 patent from the requirements of subsection 4(4) of the NOC Regulations and a determination with respect to the kit claims (the original claims of the 702 patent) is irrelevant. The purpose of subsection 47(2) is to give a retroactive effect to the claims in the newly issued patent which are identical to those of the surrendered patent. Such retroactivity was not intended to and cannot cure a failure to follow a mandatory procedure applicable in the context of an administrative scheme developed in parallel to the right to institute actions.
The question of whether the 376 patent was registered more than 30 days after its date of issue, in accordance with subsection 4(4), raises the question of the meaning of the terms "issuance" and "date of issue". (The 376 patent was granted on June 11, 1996, but was not physically issued until June 18, 1996, and Procter filed the amendment to the patent list to include the 376 patent on the register on July 17, 1996). The Minister of Health accepted that the 376 patent had been registered within the required period and included it in the patent register. The wording of section 43 of the Patent Act indicates that there is a difference between the grant of the patent and its issuance. On the facts, it was not clear when the Patent Office seal was affixed to the 376 patent, but it was clear that, because of a clerical error, this did not take place on June 11, 1996. On this motion, there was no need to determine whether the 376 patent was properly included in the register; it had only to be decided if Genpharm had established that it was not eligible for registration. On the basis of the evidence presented, it was not plain and obvious that the 376 patent was not eligible for inclusion on the register.
Even if the restrictive standard of Hunt was not applied, Genpharm did not establish that the 376 patent was not registered within 30 days of the date of issuance.
statutes and regulations judicially
considered
Patent Act, R.S.C., 1985, c. P-4, ss. 43 (as am. by S.C. 1993, c. 15, s. 42), 47(1),(2).
| Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 3(1) (as am. by SOR/98-166, s. 2), (4) (as am. idem), 4(2) (as am. idem, s. 3), (4) (as am. idem), (6) (as am. idem), (7) (as am. idem), 5 (as am. idem, s. 4; 99-379, s. 2), 6(1) (as am. by SOR/98-166, s. 5), (5) (as enacted idem). |
cases judicially considered
considered:
Bayer Inc. v. Apotex Inc. (1998), 85 C.P.R. (3d) 334 (F.C.T.D.); Hunt v. Carey Canada Inc., [1990] 2 S.C.R. 959; (1990), 74 D.L.R. (4th) 321; [1990] 6 W.W.R. 385; 49 B.C.L.R. (2d) 273; 4 C.C.L.T. (2d) 1; 43 C.P.C. (2d) 105; 117 N.R. 321.
referred to:
Procter & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health), [2003] 1 F.C. 402; (2002), 216 D.L.R. (4th) 376; 20 C.P.R. (4th) 1; 291 N.R. 339 (C.A.); leave to appeal to S.C.C. dismissed, [2002] S.C.C.A. No. 407.
MOTION to dismiss a notice of application for an order prohibiting the Minister of Health from issuing a notice of compliance to Genpharm Inc. until after the expiration of Procter's Canadian Patent 1338376. Motion dismissed.
appearances:
Ronald E. Dimock and Angela M. Furlanetto for applicant.
Eric Peterson for respondent Minister of Health.
Roger T. Hughes, Q.C. and Kamleh J. Nicola for respondent Genpharm.
solicitors of record:
Dimock Stratton Clarizio LLP, Toronto, for applicant.
Deputy Attorney General of Canada for respondent Minister of Health.
Sim Hughes, Ashton & MacKay LLP, Toronto, for respondent Genpharm.
The following are the reasons for order and order rendered in English by
[1]Gauthier J.: The applicants Procter & Gamble Pharmaceuticals Canada, Inc. and The Procter & Gamble Company (Procter) and Genpharm Inc. (Genpharm) have litigated over the same patent, Canadian Patent No. 1338376 (the 376 patent) under the Patented Medicines (Notice of Compliance Regulations, [SOR/93-133, as amended by] SOR/98-166(the NOC Regulations) since October 1999 in three separate proceedings. The first two resulted in orders of prohibition which were affirmed by the Federal Court of Appeal [[2003] 1 F.C. 402]. Motions for permission to appeal the Supreme Court were filed in September 2002 and have yet to be heard.*
[2]The present proceeding, the third one, was initiated in January 2002. The parties have exchanged affidavit evidence and conducted several cross-examinations and the matter has been set to be heard on December 2 and 3, 2003.
* Editor's Note: Applications for leave to appeal were dismissed March 27, 2003 ([2003] S.C.C.A. No. 407).
[3]It is in that context, that Genpharm brings this motion to dismiss the notice of application of Procter on the basis that the 376 patent should not have been listed on the patent register. Genpharm alleges that (i) the 376 patent was registered outside of the period specified by subsection 4(4) [as am. by SOR/98-166, s. 3] of the NOC Regulations and that (ii) the Canadian Patent No. 1282702 (the 702 patent) which was surrendered on the reissue of the 376 patent was also not eligible for listing on the patent register as it did not include claims to a medicine or the use of a medicine.
[4]To understand the second ground advanced by Genpharm, it is relevant to note that the original patent listed by Procter for its etidronate disodium drug Didrocal was the 702 patent issued on April 9, 1991. The notice of compliance for the Didrocal was issued on July 19, 1995. The 702 patent was listed shortly thereafter on the patent register.
[5]Procter filed an application for a reissue on June 4, 1995, and in accordance with subsection 47(1) of the Patent Act, R.S.C., 1985, c. P-4, the 702 patent was definitely surrendered when the 376 patent was issued to replace it.
[6]The 376 patent included the original claims of the 702 patent which the parties have referred to as the "kit claims" as well as additional claims for the use of a bone resorption inhibiting polyphosphonate (such as etidronate disodium) for the treatment and prevention of osteoporosis.
[7]On July 17, 1996, Procter filed an amendment to a patent list (Form IV) to include the 376 patent on the patent register instead of the 702 patent.
[8]The three proceedings between the parties have all taken place after the 376 patent was included on the patent register.
[9]Before addressing the main issues raised by Genpharm's motion, it is also important to note that there has been no decision made pursuant to paragraph 6(5)(a) of the NOC Regulations since the provision was added in 1998 [DORS/98-166, s. 5] and the parties disagree on the standard or test to be applied in assessing the merits of this motion.
[10]Subsection 6(5) of the NOC Regulations reads as follows:
6. (1) . . .
(5) In a proceeding in respect of an application under subsection (1), the court may, on the motion of a second person, dismiss the application
(a) if the court is satisfied that the patents at issue are not eligible for inclusion on the register or are irrelevant to the dosage form, strength and route of administration of the drug for which the second person has filed a submission for a notice of compliance; or
(b) on the ground that the application is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process.
[11]In Bayer Inc. v. Apotex Inc. (1998), 85 C.P.R. (3d) 334 (F.C.T.D.), Justice Joyal on a motion to dismiss under paragraph 6(5)(b) of the NOC Regulations held that such a motion should be granted only where the notice of application is clearly improper and bereft of any possibility of success. He agreed with the arguments presented to him that paragraph 6(5)(b) simply gives the Court explicit jurisdiction to consider motions to dismiss where earlier the Court had to rely on its own rules to do so. Thus, the restrictive standard enunciated in Hunt v. Carey Canada Inc., [1990] 2 S.C.R. 959, at page 980, should apply.
[12]Procter argues that the reasoning adopted in Bayer applies when dealing with a motion under paragraph 6(5)(a) while Genpharm submits that the purpose of this provision is to get rid of groundless notices of application and there is thus no reason to adopt such a restrictive approach.
[13]The parties said little more to support their respective position.
[14]The administrative scheme set out in sections 5 [as am. by SOR/98-166, s. 4; 99-379, s. 2] and 6 of the NOC Regulations is intended to apply only where a notice of compliance is filed in respect of a drug that can be compared with another drug for which a patent was properly included in a patent list on the Register. Thus, a motion to strike a notice of application filed under subsection 6(1) [as am. by SOR/98-166, s. 5] based on the fact that the only patent currently on the Register should not be there, is or is akin to a motion to strike out the proceeding on the basis that there is no reasonable cause of action.
[15]It is settled law that if this interpretation is correct, the restrictive standard set out in Hunt, supra, should apply. Genpharm would thus have to prove that it is plain and obvious that the 376 patent was not eligible for inclusion in the Register.
[16]In this particular case, as noted by Procter, Genpharm did not raise the issue that the 376 patent was not properly included in the Register because of late filing, in its notice of allegation. Genpharm may therefore be precluded from raising this issue at the December hearing.
[17]Genpharm did not challenge the decision of the Minister to include the 376 patent on the Register.
[18]In the circumstances, it may well be that the issue of whether or not this patent was registered after the period provided for in subsection 4(4) will not be adjudged otherwise than on the current motion. The parties did not address this issue.
[19]That being said with respect to the restrictive standard to be applied generally to motions under paragraph 6(5)(a), this finding will not be determinative in the present case because the Court would have reached the same conclusion even if it had not applied it. I shall now turn to the substantive issues.
[20]Considering the written and oral arguments presented by the parties, the Court will need to review the following questions:
(i) Is subsection 4(4) a criteria for the eligibility referred to in paragraph 6(5)(a)?
(ii) Does subsection 4(4) apply to the 376 patent?
(iii) Does the 376 patent or the 702 patent include claims to a medicine or use of a medicine?
(iv) Was the 376 patent registered more than 30 days after its date of issue?
(v) If so, is Genpharm estopped from raising this argument?
| (i) Is subsection 4(4) a criteria for the eligibility referred to in paragraph 6(5)(a) of the NOC Regulations? |
[21]Procter submits that a patent is not eligible for inclusion in the Register only if it does not meet the requirements set out in paragraph 4(2)(b) [as am. idem, s. 3] of the NOC Regulations and that the requirements set out in subsection 4(4) are not relevant on a motion made pursuant to paragraph 6(5)(a).
[22]The expression "not eligible for inclusion on the register" found in 6(5)(a) is not defined and is used only in one other provision of the NOC Regulations. However, subsection 4(7) [as am. idem] which requires the person submitting a patent list to certify that the patents set out in the said list are eligible for inclusion on the Register, does little to explain the concept of "eligibility".
[23]This concept appears to have been introduced by the amendments to the NOC Regulations of March 12, 1998, SOR/98-166. The Regulatory Impact Analysis Statement indicates that one of the amendments is to "expressly confirm the authority of the Minister of Health to audit the patent list and to refuse to add or to remove ineligible patents from the patent list" (motion record, at page 11).
[24]The 1998 amendments added a new subsection 3(1) [as am. idem, s. 2] which states:
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.
[25]The Court agrees with Genpharm that this is the provision intended to enable the Minister to audit and delete patents which were ineligible and that it does confer the right to delete anything that does not meet the requirements set out in section 4 as a whole, including subsection 4(4). This means, for example, that if a patent does not have a filing date that precedes the date of filing of a submission for a notice of compliance, it would not be eligible for inclusion in the register. In that same manner, if a patent issued more than 30 days before its registration, it would not be eligible for registration.
| (ii) Does subsection 4(4) apply to the 376 patent |
[26]According to Procter, a reissued patent should be dealt with pursuant to subsection 4(6) [as am. idem, s. 3] of the NOC Regulations which refers to the updating of the patent list and does not fix any timeline to do so if one does not seek to add a patent. Subsection 4(6) reads as follows:
4. (1) . . .
(6) A person who submits a patent list must keep the list up to date but may not add a patent to an existing patent list except in accordance with subsection (4).
[27]This provision would definitely apply to changes in the information provided under paragraph 4(2)(c) [as am. idem] or 4(2)(e) [as am. idem] of the NOC Regulations.
[28]The Court agrees with Procter that it did not add a patent to its patent list for Didrocal as it deleted at the same time the 702 patent. This was a substitution not an addition. But the Court cannot agree that because the last portion of subsection 4(6) does not apply, it automatically means that subsection 4(4) will not apply to the 376 patent.
[29]Subsection 4(4) states:
4. (1) . . .
(4) A first person may, after the date of filing of a submission for a notice of compliance and within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date that precedes the date of filing of the submission, submit a patent list, or an amendment to an existing patent list, that includes the information referred to in subsection (2). [My emphasis.]
[30]Procter argues that the words "a patent that was issued" cannot or should not apply to the 376 patent because it is a reissued patent. It submits no authorities or detailed arguments to support this view. It adds in its written submissions that the Form IV (amendment to a patent list) used to register the 376 patent was not an original patent list submission for a new invention thus it can not be governed by the strict timelines of subsection 4(4).
[31]On the other hand, Genpharm submits that the words used in the NOC Regulations should be given the same meaning as in the Patent Act, the legislation under which these Regulations were adopted.
[32]Subsection 47(1) of the Patent Act dealing with "reissue" clearly states that "the Commissioner may, on the surrender of the patent . . ., cause a new patent, in accordance with an amended description and specification made by the patentee, to be issued to him for the same invention for the then unexpired terms for which the original patent was granted" [emphasis added].
[33]The Court also notes that subsection 4(4) expressly states that one can submit a patent list or an amendment to an existing patent list, thus, the argument with respect to the use of a Form IV is not valid.
[34]The Court finds that subsection 4(4) applies to the 376 patent.
| (iii) Does the 376 or 702 patents include claims to a medicine or the use of a medicine. |
[35]The 376 patent clearly claims the use of a medicine (see claims 17 to 37) and as such would be eligible for inclusion in the patent register.
[36]The Court will not deal with the question of whether or not the 702 patent claimed a medicine or the use of a medicine. As mentioned, this patent has not been in the patent register since 1996 and it is not the subject of the current notice of application of Procter. The 702 patent has been surrendered. It does not exist anymore and cannot be revived.
[37]The parties appeared to agree at the hearing that the Court must look at the "kit claims" in the 376 patent and decide whether they cover a medicine or the use of a medicine because of the effect of subsection 47(2) of the Patent Act. The said provision states:
47. (1) . . .
(2) The surrender referred to in subsection (1) takes effect only on the issue of the new patent, and the new patent and the amended description and specification have the same effect in law, on the trial of any action thereafter commenced for any cause subsequently accruing, as if the amended description and specification had been originally filed in their corrected form before the issue of the original patent, but, in so far as the claims of the original and reissued patents are identical, the surrender does not affect any action pending at the time of reissue or abate any cause of action then existing, and the reissued patent to the extent that its claims are identical with the original patent constitutes a continuation thereof and has effect continuously from the date of the original patent.
[38]The purpose of this subsection is to give a retroactive effect to the claims in the newly issued patent (i.e. 376 patent) which are identical to the claims of the surrendered patent (702 patent). But clearly, this applies only with respect to any action pending at the time of the reissue or with respect to any cause of action then existing.
[39]Such retroactivity was not intended and cannot in the Court's opinion cure a failure to follow a mandatory procedure applicable in the context of an administrative scheme developed in parallel to the right to institute actions albeit for infringement or any other cause of action arising under the Patent Act or at common law.
[40]Therefore, the Court holds that subsection 47(2) of the Patent Act cannot be construed as exempting any portion of the 376 patent from the requirements of subsection 4(4) of the NOC Regulations and a determination with respect to the kit claims is irrelevant.
| (iv) Was the 376 patent registered more than 30 days after its date of issue? |
[41]The parties did not present any authority or detailed argument on the meaning of the terms "issuance" and "date of issue" in subsection 4(4). The Court notes that these terms are not defined in the Patent Act or the NOC Regulations. However, section 43 [as am. by S.C. 1993, c. 15, s. 42] of the Patent Act specifies that:
43. (1) Subject to section 46, every patent granted under this Act shall be issued under the seal of the Patent Office, and shall bear on its face the filing date of the application for the patent, the date on which the application became open to public inspection under section 10, the date on which the patent is granted and issued and any prescribed information.
(2) After the patent is issued, it shall, in the absence of any evidence to the contrary, be valid and avail the patentee and the legal representatives of the patentee for the term mentioned in section 44 or 45, whichever is applicable.
[42]Genpharm relies on the date on which the patent is said to have been granted and issued on the face of the 376 patent, i.e. June 11, 1996. It also referred to an answer given during the examination of Mr. Andrew McCleanaghan who filed an affidavit in support of the notice of application of Procter in March 2002, to the effect that the 376 patent was granted on June 11, 1996 (see questions 63 and 64). It argues that this evidence is sufficient to meet its burden of proof.
[43]Procter submits that although the 376 patent was granted on June 11, 1996, it was not physically issued until June 18, 1996, and that by filing their Form IV on July 17, 1996, they were within the 30 days provided for at subsection 4(4).
[44]In their letter dated July 17 to the Bureau of Pharmaceutical Assessment, they fully disclosed this fact. They also enclosed with their said letter, copy of a letter from the Patent Office confirming that a printing problem delayed the physical issuance of the patents granted on June 11, 1996. This letter from the Patent Office dated June 27, 1996, states:
Mr. Anthony McDonough has recently been appointed Commissioner of Patents. Therefore, new patent granted certificates had to be printed. Due to printing delays, June 11, 1996, patents were mailed out on June 18, 1996. We are sorry for any inconvenience this delay may have caused.
[45]The Minister of Health accepted that the 376 patent had been registered within the required period and included it in the patent register. As mentioned, this decision has not been challenged by Genpharm.
[46]Although the Minister of Health is named as a respondent and was served with the motion record, he has not filed any submissions. Thus, the Court does not know if, using the power granted to him under subsection 3(4) (as am. by SOR/98-166, s. 2] of the NOC Regulations, he consulted with officers and employees of the Patent Office to get any further information in that respect.
[47]From the wording of section 43 above, one can reasonably conclude that there is a difference between the grant of the patent and its issuance. One can also understand that either these two acts are performed on the same day or the date appearing on the face of the patent will be the date when the patent, after having been granted, has been issued by the Commissioner of Patents under the seal of the Patent Office.
[48]It is not clear when the patent certificates bearing the name of the new Patent Commissioner were actually delivered to the Patent Office or when the Patent Office seal was affixed to the 376 patent. But what is clear is that this did not take place on June 11, 1996. It appears that there was a clerical error admitted to by the Patent Office.
[49]On this motion, the Court does not need to determine whether the 376 patent was properly included in the patent register, it only needs to decide if Genpharm has established that it was not eligible for registration.
[50]Therefore, the Court does not need to determine exactly when the 376 patent was issued and this is as well for, as mentioned, many factual elements are missing in that respect.
[51]The Court does find that on the basis of the evidence presented, it is not plain and obvious that the 376 patent was not eligible for inclusion on the register.
[52]Even if the Court did not apply the restrictive standard of Hunt, supra, it would not be satisfied that Genpharm has established that the 376 patent was not registered within 30 days of its date of issuance.
[53]In effect, there are only two definite dates before the Court, that is (i) the date of the grant and (ii) the date on which the patent was mailed out to Procter. As mentioned, in this case the first date is not relevant and the 376 patent was registered less than 30 days from the second date.
[54]In the circumstances, it is not necessary to decide if Genpharm is estopped from raising this issue.
[55]The motion is dismissed with costs.
| THIS COURT ORDERS that: |
| 1. The motion is dismissed with costs. |