Date: 19990917
Docket: T-421-96
B E T W E E N :
GLAXO GROUP LIMITED and
GLAXO WELLCOME INC.
Applicants
- and -
THE MINISTER OF NATIONAL HEALTH AND WELFARE
and APOTEX INC.
Respondents
REASONS FOR JUDGMENT
(Rendered from the Bench at Ottawa, Ontario
Wednesday, March 25, 1998)
HUGESSEN J.
[1] These are prohibition proceedings brought pursuant to the Patented Medicines (Notice of Compliance) Regulations1.
[2] The patent in issue, and there is only one, contains claims with respect to a medicine. The patent is owned by the applicants and the claims are for the preparation of a particular crystalline form of ranitidine hydrochloride which is referred to and defined in the patent as form 2 ranitidine hydrochloride. The patent contains claims for processes for the preparation of the medicine but does not otherwise contain claims for the medicine itself or for the use of the medicine. It also does not claim ranitidine hydrochloride form 1.
[3] So the medicine is, as I say, ranitidine hydrochloride form 2. That substance, in its form 2, is claimed in the patent to be different from, and, in respects mentioned in the patent, superior to form 1.
[4] Apotex has filed with the Minister a notice of allegation. In its essential part that notice reads in these words:
| This patent has claims only for a particular form of ranitidine hydrochloride, which is known as form 2. We undertake that until expiry of this patent any 75 mg tablets made and sold by us will contain only form 1 ranitidiine hydrochloride and not form 2. |
(Applicants' application record, page 80)
[5] The applicants attack this notice of allegation both as to its form and as to its substance.
[6] As to the form, they take two points. The first, they say, is that the allegation does not refer specifically to a pending new drug submission before the Minister. In my view, that argument simply cannot prevail in the light of the judgment of the Court of Appeal in the case of Eli Lilly and Co.2 and the more recent judgment of the Trial Division in the case of Smithkline Beecham3 by Mr. Justice McKeown.
[7] The second argument as to form taken by the applicants is that the allegation which I have just read is no more than "a bare assertion of non-infringement" and, as such, is insufficient. I do not agree. The allegation is, in my view, a specific allegation of fact which is at the foundation of an assertion of non-infringement. The fact asserted is that form 1 and not form 2 will be used. The patent in suit is for a process for form 2 only.
[8] This brings me to the applicants' argument with respect to substance. The applicants have filed evidence in the form of an affidavit by a Dr. Ferguson who is an expert in these matters. The critical paragraph of that affidavit is paragraph 6 which reads:
| 6. Different crystalline forms for the same chemical substance are known as polymorphs. Known polymorphs of a given chemical compound may be interconverted by using appropriate solvents and reaction conditions. For example the 638 patent at page 9, examples 7 and 8, refers to the conversion of Form 1 ranitidine hydrochloride to Form 2 ranitidine hydrochloride. Similarly the Form 2 may be converted to the Form 1 ranitidine hydrochloride under appropriate solvents and reaction conditions. As a result, the fact that a product may only contain Form 1 ranitidine hydrochloride does not mean that Form 2 ranitidine hydrochloride as defined in the 638 patent was not employed in the process to make Form 1. |
(Applicants' application record, page 87)
[9] In my view, that evidence, which may be said to show a latent ambiguity in the allegation made by Apotex, does no more than raise a purely speculative or hypothetical possibility of infringement by Apotex. That is clearly not enough. I would, on that ground alone, be prepared to dismiss the application for prohibition.
[10] In this record, however, there is far more. I am quite satisfied that the evidence produced by Apotex, when fairly read, shows that Apotex has a contract for the supply of form 1 ranitidine hydrochloride from a supplier whose manufacturing process does not, at any stage, include form 2 ranitidine hydrochloride. That, in my view, is quite enough to require dismissal of the application.
[11] This brings me at last to what I have found to be by far the most interesting question raised by these proceedings. The applicants have asked in their proceedings that, if I should dismiss their prohibition application, as indeed I am about to, I should "confirm" pursuant to subsection 7(4) of the Regulations "that the thirty month period prescribed by paragraph 7(1)(e) continues until all appeals in the proceeding have been exhausted or all appeal periods have expired".
[12] A judge of this Court, very recently, and for the first time, has given a declaration of precisely this sort. I, of course, make no comment on that decision.
[13] Since that decision was rendered, however, there has been an important change in the legislation. On March 12 of this year, the relevant part of subsection 7(4) was changed. Formerly that subsection read in relevant part that "paragraph (1)(e) ceases to apply in respect of an application .... if the application is withdrawn or is finally dismissed by the Court". It was the word "finally" which led the judge of this Court to accede to the request that had been made to her. In the amended Regulations, which, as I say, came into force on the 12th of March of this year, that word "finally" has disappeared and subsection 7(4) now reads "paragraph 1(e) ceases to apply in respect of an application ... if the application ... is dismissed by the court hearing the application". The reference to "finally" has disappeared.
[14] The applicants urge upon me that the Patented Medicine (Notice of Compliance) Regulations are substantive law and that therefore all changes to those Regulations are likewise substantive. In support of that proposition, they cite the decision of the Court of Appeal in Merck v. Apotex4 and, in particular, this passage from the reasons of Robertson J.A.:
| In the instant case, we are not dealing with procedural regulations per se. The imposition of a criterion that a NOC cannot issue with respect to a patent-linked NDS is clearly a substantive change in the law and, hence, subject to the rule of statutory construction applicable to legislation purporting to affect vested rights. |
[at page 382]
[15] I, of course, accept that statement as a correct and binding statement of the law. However, in my view, it does no more than establish that the Regulations themselves deal with matters of substance. It does not say that everything in the Regulations is necessarily a matter of substance. More important still it does not say that everything in the Regulations deals with vested rights. In my view, it simply cannot be asserted that the applicants had a vested right on March 12, 1998, that, in the event of the dismissal of their prohibition application on March 25, 1998, the statutory stay imposed upon the Minister would nonetheless continue in force until the expiry of the appeal periods. Furthermore, there is nothing retrospective whatever about the provision that I have to deal with. It speaks to future events. On March 12, the applicants' prohibition proceedings had not been dismissed. Today, they will be dismissed. The provision on the Regulations triggers its effect as and from this day. It is neither retrospective nor retroactive in its application. Paragraph 7(1)(e) accordingly ceases to apply today.
[16] I propose to enter an order accordingly.
"James K. Hugessen"
Judge
__________________1 SOR/93-133, 12 March 1993 as amended by SOR/98-166, 12 March, 1998
2 Eli Lilly & Company et al v. Apotex Inc. et al (September 29, 1997), A-339-97, (F.C.A.) [unreported]
3 Smithkline Beecham Pharma Inc. et al v. The Minister of Health and Welfare et al, (November 24, 1997), T-2528-96 (F.C.T.D.) [unreported]
4 Apotex Inc. v. Canada (Attorney-General), 51 C.P.R. (3d) 339 (F.C.A.)