Date: 19990316
Docket: T-2431-98
Ottawa, Ontario, the 16th day of March 1999
PRESENT: THE HONOURABLE MADAME JUSTICE SHARLOW
BETWEEN:
HOFFMANN-LA ROCHE LIMITED and
SYNTEX (U.S.A.) INC.,
Applicants/
Responding Parties,
- and -
THE MINISTER OF NATIONAL HEALTH
AND WELFARE,
Respondent/
Responding Party,
- and -
PHARMASCIENCE INC.,
Respondent/
Moving Party.
ORDER
The motion to dismiss the application is granted and the prohibition application is dismissed. Pharmascience is entitled to costs on a solicitor and client basis.
Karen R. Sharlow
Judge
Date: 19990316
Docket: T-2431-98
BETWEEN:
HOFFMANN-LA ROCHE LIMITED and
SYNTEX (U.S.A.) INC.,
Applicants/
Responding Parties,
- and -
THE MINISTER OF NATIONAL HEALTH
AND WELFARE,
Respondent/
Responding Party,
- and -
PHARMASCIENCE INC.,
Respondent/
Moving Party.
REASONS FOR ORDER
SHARLOW J.
[1] This is a motion by Pharmascience Inc. under subsection 6(5) of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations") to strike out a prohibition application filed on December 24, 1998 by Hoffmann-La Roche Limited and Syntex (U.S.A.) Inc. (referred to collectively as "Hoffmann"). Pharmascience has also applied for costs on a solicitor and client basis.
[2] Pharmascience cannot succeed unless it is plain and obvious that Hoffmann's prohibition application is futile.[1]
[3] In the prohibition application, Hoffmann seeks an order pursuant to subsection 6(1) of the Regulations prohibiting issuance of a notice of compliance to Pharmascience in respect of the medicine ticlopidine hydrochloride, including ticlopidine hydrochloride tablets 250 mg, until the expiration of Canadian patent number 1,176,170 (the "170 patent").
[4] Hoffmann's prohibition application was in response to a notice of allegation dated November 20, 1998 relating to the 170 patent that Hoffmann received from Pharmascience. The notice of allegation was contained in a letter reading as follows:
Subject: Notice of Allegation
pms - Ticlopidine 250 mg tablets
Pursuant to Section 5(1) of the "Patented Medicines (Notice of Compliance) Regulations" we are hereby serving you with our "Notice of Allegation" for the above mentioned product. Pharmascience alleges that "no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by the person of the drug for which the submission for the Notice of Compliance is filed".
The attached statement describes the legal and factual basis for the allegation.
The attached statement reads as follows:
RE: pms - Ticlopidine 250 mg tablets
This is a Notice of Allegation pursuant to section 5(3) (b) of the Patented Medicine[s] (Notice of Compliance) Regulations.
With respect to Canadian Patent 1,176,170 listed in your Form IV Patent List for tablets containing 250 mg of the medicine Ticlopidine Hydrochloride, we allege that no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by us of the product pms - Ticlopidine tablets containing 250 mg of Ticlopidine Hydrochloride.
The legal and factual basis of the aforesaid allegation is as follows:
Canadian patent 1,176,170 relates to the stabilization of a pharmaceutical compositions [sic] containing acid salts of thieno-pyridine derivatives. The stabilization is achieved using a pharmaceutically acceptable, non-volatile organic acid, particularly citric acid. More specifically all claims relate to pharmaceutical compositions comprising at least one pharmaceutically acceptable, non-volatile organic acid which is ascorbic acid, benzoic acid, cinnamic acid, citric acid, fumaric acid, glycolic acid, mandelic acid, malic acid, malonic acid or tartaric acid.
A qualitative description of the pharmaceutical composition for pms - Ticlopidine 250 mg tablets is provided as Annex 1. Since the pharmaceutical composition for pms - Ticlopidine 250 mg tablets contains no non-volatile organic acids, and more specifically, no ascorbic acid, benzoic acid, cinnamic acid, citric acid, fumaric acid, glycolic acid, manolic acid, malic acid, malenic acid or tartaric acid, there will be no infringement on any of the claims of Canadian Patent 1,176,170.
Annex 1 reads as follows:
ANNEX 1
pms - Ticlopidine 250 mg tablets
Quantitative Composition
INGREDIENTS
Ticlopidine Hydrochloride
Butylated Hydroxyanisole
Microcrystalline Cellulose
Starch
Povidone
Stearic Acid
Magnesium Strearate
Opadry
I hereby certify that the qualitative composition for pms - Ticlopidine 250 mg tablets described above is true and accurate
Signed at St-Laurent, Quebec this 20 th day of November, 1998
[Signature]
Dr. L.G. Neirinok, Ph.D.
Vice President, Scientific Affairs
[1] Hoffmann raises several arguments in its prohibition application, the principal ones being that Pharmascience did not provide a detailed statement of legal and factual basis as required by the Regulations and, that in any event, the allegation of non-infringement is not justified.[2]
[2] Pharmascience argues that Hoffmann's prohibition application is futile because on four other occasions, on facts indistinguishable from the facts of this case, Hoffmann has sought to prohibit issuance of a notice of compliance to a generic manufacturer with respect to a medicine that was alleged not to infringe the 170 patent, and has failed each time. In three of those cases the prohibition application proceeded to hearing, and the application failed because the notice of allegation described a product that could not possibly infringe the 170 patent, given its language and literal interpretation. In the fourth, Hoffmann's prohibition application was dismissed pursuant to paragraph 6(5)(b) of the Regulations as an abuse of process. The cases are summarized below.
(a) The Nu-Pharm case.[3] This case dealt with an application by Hoffmann to prohibit the Minister from issuing a notice of compliance to Nu-Pharm with respect to "Ticlopidine Hydrochloride Tablets 50 mg." The detailed statement relating to the notice of allegation said, among other things:
[...] the claims of [the 170 patent] are limited to compositions (dosage forms) containing an acid selected from ascorbic acid, benzoic acid, cinnamic acid, citric acid, fumaric acid, glycolic acid, mandelic acid, malic acid, malonic acid and tartaric acid. Nu-Pharm's ticlopidine hydrochloride tablets will not contain any of the said acids [...].
Reed J. held that because Nu-Pharm's product did not contain any of the acids listed in the 170 patent, there could be no infringement and therefore there was no basis for an order prohibiting the Minister from issuing a notice of compliance to Nu-Pharm. She noted that the jurisprudence had established that the facts asserted in a notice of allegation are to be taken as true until disproved,[4] and the allegation not been disproved. The Federal Court of Appeal agreed.
(b) The Apotex case.[5] This case involved an application by Hoffmann that was substantially the same as the first one except that the generic manufacturer was Apotex, which sought a notice of compliance for "ticlopidine hydrochloride tablets 250 mg." In support of its application for prohibition in the Apotex case, Hoffmann introduced what it said was evidence of infringement. As no such evidence had been before Reed J., Hoffmann argued that the two cases were distinguishable. Jerome A.C.J. did not agree. He said (at page 467):
[...] a proceeding pursuant to the Regulations should not be a full-blown examination into patent infringement but was designed to allow the Minister to issue a Notice of Compliance once it had been established that, based on a literal interpretation of the patent, no infringement would occur. Given that the notice of allegation at issue in the case at bar is identical to that which was considered in the above two cases, this motion must also be dismissed.
(c) The Genpharm case.[6] This case involved the same patent and a similar notice of allegation, this time by Genpharm in respect of "Ticlopidine tablets" in specified strengths. Hoffmann raised the same arguments as before and also argued that the Minister had no jurisdiction to issue a notice of compliance because Genpharm had not filed a new drug submission until after the notice of allegation was served. Both arguments were rejected.
On the first point, Muldoon J. held that the prior decisions established the sufficiency of that information to justify a conclusion of non-infringement. On the second point, Muldoon J. noted that the new drug submission had in fact been filed before the hearing, and the jurisprudence had established that it does not matter whether the submission is filed before or after service of the notice of allegation.[7]
Hoffmann also adduced evidence intended to prove that Genpharm's product would be an infringement because it contained stearic acid, which is an organic acid. Muldoon J. rejected this argument. First, he said that stearic acid is not one of the organic acids that is listed in the 170 patent, and on the basis of the interpretation of the 170 patent adopted by the Federal Court of Appeal in the Nu-Pharm case, the use of stearic acid could not amount to infringement. In any event, the evidence was that the stearic acid in Genpharm's product was used as a lubricant, a use that did not come within the relevant claim in the 170 patent. Muldoon J. dismissed the application for prohibition, awarding costs of $10,000 inclusive of disbursements.
(d) The Pro Doc case.[8] This case involved an application by Hoffmann that again was substantially the same as the first one except that the generic manufacturer was Pro Doc, which sought a notice of compliance for "Ticlopidine Hydrochloride Tablets 250 mg for oral administration." Pro Doc made an application under paragraph 6(5)(b) of the Regulations to dismiss Hoffmann's application. Hoffmann sought to distinguish its application from the other cases by adducing the affidavit of a patent attorney and chemist skilled in the art of the 170 patent, who opined that the 170 patent was not intended to limit the invention to the listed acids. Rothstein J. (as he then was) said that the arguments presented in the affidavit had been considered and rejected by the Federal Court of Appeal in the Nu-Pharm case. He allowed the application of Pro Doc, saying (at paragraph 14):
In view of the prior decisions involving Nu-Pharm and Apotex and the fact that the evidence filed by the applicants in this application adds nothing new to assist in the construction of the relevant words of the patent, the issue in this litigation is the exact same issue as in the Nu-Pharm and Apotex cases. The applications for prohibition are the same, the patent at issue is the same, and the notice of allegations are virtually identical. This litigation is an abuse of the process in that it attempts to retry the same issue which has already been determined in three separate proceedings against the applicants.
Rothstein J. awarded costs of $7,000 inclusive of disbursements.
[3] I have been told that the Apotex, Genpharm and Pro Doc decisions are under appeal.
[4] All of these cases turn on the literal interpretation of the 170 patent first adopted by Reed J. and accepted by the Federal Court of Appeal in the Nu-Pharm case. I am bound to adopt the same interpretation. The inescapable result of that interpretation is that the 170 patent cannot be infringed by a medicine that does not use ascorbic acid, benzoic acid, cinnamic acid, citric acid, fumaric acid, glycolic acid, mandelic acid, malic acid, malonic acid, or tartaric acid.
[5] It follows that where a party proposes to manufacture a medicine that contains none of those acids and files a notice of allegation saying so, a patent holder cannot possibly succeed in an application to prohibit the issuance of a notice of compliance on the basis that the notice of allegation is not sufficiently detailed, or that the allegation of non-infringement is not justified.
In this case Hoffmann makes three additional arguments, which are considered below.
Mode of administration
[6] Hoffmann argues that the notice of allegation is deficient in that it fails to describe the dosage form, including the mode of administration, as required by the Regulations,[9] and Hoffmann should be permitted to proceed with its prohibition application on that basis.
I see no merit in this argument. If the interpretation of the 170 patent as previously adopted this Court is correct, then a drug that does not contain one of the listed acids cannot possibly infringe the patent regardless of dosage or mode of administration.
Time of filing of new drug submission
[7] Pharmascience's allegation comes under subparagraph 5(1)(b)(iv) of the Regulations, and therefore section 5(3)(c) of the Regulations applies, which means that Pharmascience should have filed a new drug submission before or at the same time as it made the non-infringement allegation. Hoffmann argues that it should be entitled to pursue its prohibition application on the basis of Pharmascience's failure to file its submission at the correct time.
[8] The premise underlying this argument is that the 1998 amendment to the Regulations adding paragraph 5(3)(c) effectively reverses the jurisprudence that makes the timing of the submission irrelevant, as long as it is filed before the hearing.[10] For the reasons that follow, I have concluded that this premise is incorrect.
[9] The relevant part of section 5 of the Regulations, as amended in 1998, reads as follows:
(3) where a person makes an allegation pursuant to paragraph 1(b) [...] the person shall
[...]
(c) if the allegation is under subparagraph (1)(b)(iv),
(i) serve on the first person a notice of allegation relating to the submission filed under subsection (1) at the time that the person files the submission or at any time thereafter [...].
[10] Before proceeding with an analysis of paragraph 5(3)(c), it is necessary to consider the factual basis for the argument. The notice of allegation dated November 20, 1998 refers to the "drug for which the submission of the notice of compliance is filed." Pharmascience argues that this statement should be taken as an assertion that Pharmascience filed a submission on or before November 20, 1998, and that assertion should be taken as true because there is no evidence to the contrary.[11]
[11] Taking into account only Pharmascience's notice of allegation and the other November 20, 1998 documents received by Hoffmann (as described above), I am left with doubt as to whether Pharmascience filed a new drug submission on or before the date the notice of allegation was received by Hoffmann. The question, therefore, is how that gap affects the present application, if at all.
[12] Hoffmann argues, in essence, that even though the drug Pharmascience proposes to manufacture cannot possibly infringe the 170 patent, Hoffmann's prohibition application should proceed to hearing because Pharmascience may have failed to file its new drug submission on or before the date on which Hoffmann received the notice of allegation, and if so, Hoffmann may be able to persuade this Court to prohibit the issuance of a notice of compliance to Pharmascience because of that procedural failure, regardless of the non-infringement.
[13] Although the Regulations contemplate that the new drug submission will precede or be contemporaneous with the notice of allegation, that sequence of events is not expressed as a condition for the granting of a notice of compliance. Nor is a patent holder necessarily prejudiced by the failure of a generic manufacture to take the steps in the correct order. Under other amendments to the Regulations made at the same time as the enactment of section 5(3)(c), the patent holder may seek disclosure of the drug submission, and also may seek an extension of the statutory stay if the generic manufacturer has failed to reasonably cooperate in expediting a prohibition application.
[14] I was referred to the Regulatory Impact Analysis Statement relating to the 1998 amendments,[12] and in particular to this comment:[13]
The following improvements to the NOC [Notice of Compliance] Regulations are enacted:
[...]
No premature NOA [Notice of Allegation]: An NOA relating to non-infringement may only be served on a patentee by a generic manufacturer when or after it has filed a submission for an NOC with the Minister of Health.
[15] This was only one of a number of objectives referred to in the Regulatory Impact Analysis Statement. The changes to the Regulations were also said to be aimed at "reinforcing the balance between providing a mechanism for the effective enforcement of patent rights and ensuring that generic drug products enter the market as soon as possible."[14] Another objective of the amendments was to "reduce unnecessary litigation and streamline the litigation process."[15]
[16] To interpret section 5(3)(c) of the Regulations as suggested by Hoffmann would accord with the "no premature NOA" objective, but would tend to defeat the other objectives referred to above, at least in the circumstances of this case.
[17] I have concluded, given the history of the Regulations and the manner in which they have been applied by this Court,[16] and the established interpretation of the 170 patent, that this Court would not prohibit the issuance of a notice of compliance to Pharmascience in this case, even if it is proved that Pharmascience failed to take the procedural steps in the correct sequence.
Right to disclosure
[18] Hoffmann argues that it would be unfair to halt its prohibition application at this stage because it will be deprived of its right to seek disclosure of the new drug submission as permitted by section 6(7) of the Regulations, and thus its right to test the truth of the facts stated in the notice of allegation. Hoffmann has made no application under that provision since receiving the notice of allegation in November of 1998, over three months before the hearing of this application.
[19] It appears that a similar argument was made in the Pro Doc case, one of the four cases referred to above dealing with the 170 patent, but that did not dissuade Rothstein J. from dismissing the prohibition application in that case as an abuse of process. Citing the decision of the Federal Court of Appeal in the Nu-Pharm case (the first of the four 170 patent cases), he noted that the statements in a notice of allegation are intended to be accurate, and prohibition proceedings are not a substitute for infringement proceedings. He said (at paragraph 10):
Certainly, if Pro Doc's ticlopidine hydrochloride reaches the market, the applicants will have an opportunity to analyze it. If it were shown to contain one of the acids listed in claim 1, contrary to Pro Doc's notice of allegation, the consequences for Pro Doc could be very serious indeed.
[20] I have concluded that the same can be said of this case. The fact that the 1998 amendments to the Regulations provide expressly for certain disclosures that formerly were permitted only on an ad hoc basis does not put Hoffmann in any different position with respect to the notice of allegation of Pharmascience than it was with respect to the notices of allegation of Nu-Pharm, Apotex, Genpharm or Pro Doc.
Conclusion
[21] The motion to dismiss the application is granted and the prohibition application is dismissed. Pharmascience is entitled to costs on a solicitor and client basis.
Karen R. Sharlow
Judge
FEDERAL COURT OF CANADA TRIAL DIVISION NAMES OF SOLICITORS AND SOLICITORS ON THE RECORD
COURT FILE No.: T-2431-98
STYLE OF CAUSE: Hoffman-La Roche Limited and Syntex (U.S.A.) Inc.
v. Minister of National Health and Welfare and Pharmascience Inc.
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: March 1, 1999
REASONS FOR ORDER OF THE HONOURABLE MADAME JUSTICE SHARLOW DATED MARCH 16, 1999
APPEARANCES:
J. Sheldon Hamilton for the Applicants
No one appearing for the Respondent (Minister)
Warren N. Sprigingsfor the Respondent (Pharmascience)
SOLICITORS OF RECORD:
Smart & Biggar
Toronto, Ontario for the Applicants
Morris Rosenberg, Deputy Attorney
General of Canada, Ottawa, Ontario for the Respondent (Minister)
Hitchman & Sprigings
Toronto, Ontariofor the Respondent (Pharmascience)
[1]Hunt v. Carey Canada Inc., [1990] 2 S.C.R. 959 at 980; David Creaghan v. Canada, [1972] F.C. 732 (F.C.T.D.); Bayer Inc. v. Apotex Inc., (16 December 1998), T-420-98 (F.C.T.D.).
[2]There was also an argument as to service of the notice of allegation. That argument was abandoned at the hearing of the motion before me and I will make no further reference to it.
[3]Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1996), 67 C.P.R. (3d) 484 (F.C.T.D.), affirmed (1996), 70 C.P.R. (3d) 206 (F.C.A.), leave to appeal to S.C.C. refused, [1996] S.C.C.A. No. 626 (QL)
[4]Merck Frosst Canada Inc. v. Canada (Minister of National Health & Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.), leave to appeal to S.C.C. refused, [1994] S.C.C.A. no. 330 (QL).
[5]Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1997), 79 C.P.R. (3d) 464 (F.C.T.D.)
[6]Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare), (22 December 1998), T-2730-97 (F.C.T.D.).
[7]Eli Lilly and Company v. Apotex Inc. (29 September 1997), A-339-97 (F.C.A.), leave to appeal to the S.C.C. refused, [1997] S.C.C.A. no. 528 (QL).
[8]Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare), (19 November 1998), T-1363-98 (F.C.T.D.).
[9] This is not a point that was raised in its application for prohibition or in any material filed in this Court until the day before the hearing.
[10]Eli Lilly and Company v. Apotex (supra, note 7). Section 5(3)(c) was not in force when the notices of allegation in the other four cases involving the 170 patent were filed.
[11] Pharmascience also filed affidavits in the present motion that are said to support the truth of that assertion. My view is that those affidavits cannot fairly be read as proof of the date of filing of the submission.
[16]I refer particularly to the cases in which this Court has declined to let procedural missteps govern over the substance of the issue to be determined: Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (26 January 1999), T-970-98 (F.C.T.D.), Pfizer Canada Inc. v. Nu-Pharm Inc. (16 October 1998), T-1713-95 (F.C.T.D.), Eli Lilly and Company v. Apotex Inc., supra, Note 7.