Bayer Inc. v. Canada (Minister of National Health and Welfare), docket T-1596-95

Date: 19980720

Docket: T-1596-95

BETWEEN:

     BAYER INC. AND BAYER AG

     Applicants

     - and -

     THE MINISTER OF NATIONAL HEALTH

     AND WELFARE and APOTEX INC.

     Respondents

     REASONS FOR ORDER

LUTFY J.:

[1]      On July 28, 1995, the applicants Bayer Inc. and Bayer AG filed an originating notice of motion seeking an order prohibiting the Minister of National Health and Welfare from issuing a Notice of Compliance to the respondent Apotex Inc. in respect of the medicine ciprofloxacin hydrochloride, including the medicine ciprofloxacin hydrochloride tablets 100 mg, 250 mg, 500 mg and 750 mg, until after the expiration of Canadian Patent No. 1,322,334. This application is made pursuant to the Patented Medicines (Notice of Compliance) Regulations.¹

[2]      This originating notice of motion is in response to a notice of allegation sent by Apotex on June 12, 1995 which alleges the invalidity of the 3334 patent:

Re: CIPROFLOXACIN HYDROCHLORIDE TABLETS 100 MG, 250 MG, 500 MG AND 750 MG.

This is a Notice of Allegation pursuant to Section 5(3)(b) of the Patent Medicines (Notice of Compliance) Regulations.

We allege that patent 1,322,334 is not valid. The factual and legal basis is as follows.

Patent 1,322,334 discloses no invention beyond what is claimed in patent 1,218,067. More particularly, there is nothing further inventive in mixing ciprofloxacin hydrochloride with a pharmaceutically acceptable diluent or carrier to make a composition or the use of such composition.

[3]      The Canadian Letters Patent No. 1,218,067 referred to in the Apotex notice of allegation and the 3334 patent were both issued to Bayer for ciprofloxacin hydrochloride. The 3067 patent contains process and product by process claims for the compound ciprofloxacin hydrochloride. The 3334 patent contains claims to a composition comprising the compound "as an active ingredient".

[4]      The Apotex notice of allegation of June 12, 1995 is the third of five such notices it has sent concerning ciprofloxacin hydrochloride. The four other notices of allegation issued by Apotex and the corresponding applications for prohibition orders have been described in Bayer's amended originating of motion:

9. The first notice of allegation compelled a proceeding, T-1192-93, which resulted in an order of MacKay J., dated 22 November 1995, prohibiting the Minister from issuing an NOC to Apotex in respect of ciprofloxacin hydrochloride until after the expiration of Canadian Patent No. 1,218,067 ("067").

10. The second notice of allegation compelled a proceeding, T-468-95, which resulted in an order of MacKay J., dated 22 November 1995, prohibiting the Minister from issuing an NOC to Apotex in respect of ciprofloxacin hydrochloride tablets ("ciprofloxacin tablets") until after the expiration of the 334 patent.

11. The fourth notice of allegation was dated 24 November 1995 and has compelled a fourth proceeding under the Regulations, T-35-96, commenced by the Applicants on 8 January 1996, in respect of ciprofloxacin tablets and the 067 and 334 patents.

12. The fifth notice of allegation was dated 26 January 1996, and has compelled a fifth proceeding under the Regulations, T-591-96, commenced by the Applicants on 11 March 1996, in respect of ciprofloxacin tablets and the 067 and 334 patents.

In a sixth proceeding,² Bayer issued a statement of claim against Apotex under court file no. T-2645-95 seeking the following declaratory relief:

(a)      a declaration that Bayer AG was entitled to obtain Canadian Patents 1,218,067 and 1,322,334 and was not in breach of S.28 of the Patent Act R.S. 1970, c. P-4 by reason of the issue of Chilean Patent 32,861 or otherwise;

(b)      a declaration that during the pendency of the prohibition orders granted by this Court in proceedings T-1192-93 and T-468-95, the Minister of National Health and Welfare may not issue a Notice of Compliance to Apotex for the medicine ciprofloxacin hydrochloride, notwithstanding any Notice of Allegation subsequently filed by Apotex Inc.;

(c)      an order prohibiting the Minister of National Health and Welfare from issuing a Notice of Compliance to Apotex in respect of the medicine ciprofloxacin hydrochloride until the expiry of Patents 1,218,067 and 1,322,334; ...

[5]      In the first notice of allegation, Apotex alleged that with respect to patent 3067 no claim for the medicine itself and no claim for the use of the medicine would be infringed by Apotex making, using or selling ciprofloxacin hydrochloride tablets. The reasons for order of MacKay J. granting the prohibition sought by Bayer are reported³ and Apotex is pursuing its appeal of this order under court file no. A-787-95.

[6]      Concerning the second notice of allegation, the issue was whether a claim for a pharmaceutical composition is a "claim for the medicine itself" as defined in section 2 of the Patented Medicines (Notice of Compliance) Regulations. That issue was resolved affirmatively by the Court of Appeal in Nu-Pharm Inc. v. Hoffmann-La Roche Ltd.⁴ and Apotex has since discontinued its appeal under court file no. A-788-95 from the second order of MacKay J. of November 22, 1995⁵ which prohibited the issuance of a Notice of Compliance to Apotex until after the expiration of patent 3334. Bayer no longer relies on the issue of res judicata concerning this prohibition order of MacKay J. and the third Apotex notice of allegation which is the subject matter of this proceeding. It is now settled that "... successive allegations are possible and each one must be treated independently provided it is separate and distinct from the others ...",⁶ even where the allegation has been made after the issuance of a prohibition order.

[7]      The fourth and fifth notices of allegation of Apotex allege the invalidity of the 3067 and 3334 patents on grounds that appear to bring into play sections 27, 28 and 29 of the Patent Act .⁷

[8]      Concerning the third notice of allegation of Apotex and the application for a prohibition order in this proceeding, Bayer's substantive position is that the Apotex allegation of the invalidity of patent 3334 is not justified. As a preliminary issue, however, Bayer characterizes this third notice of allegation as an abuse of process.

Abuse of process

[9]      The bringing of more than one notice of allegation before the Court, provided it is separate and distinct from the others, cannot be seen as an abuse of process.⁸

[10]      Bayer states that the third notice of allegation is an abuse of process for at least two principal reasons. Firstly, in the context of five notices of allegation, the statement of claim, the prohibition order concerning the 3334 patent which is now a final decision and the lack of significant progress in the appeal from the prohibition order concerning the 3667 patent, this notice of allegation is an abuse.⁹ Secondly, the eventual adjudication of the applications for prohibition orders concerning the fourth and fifth notices of allegation and the statement of claim render this proceeding moot and a waste of effort for all concerned.¹⁰

[11]      The first notice of allegation concerned the 3067 patent. The notice of allegation which caused this proceeding is referred to as the third notice of allegation, although it is only the second one concerning the 3334 patent. This third notice of allegation was issued some months prior to the second prohibition order of MacKay J. No one suggests that this notice of allegation is not "separate and distinct" from the first one concerning the 3334 patent. Bayer has suggested, however, that the allegations in the second and third notices should have been combined in a single notice of allegation and that the failure by Apotex to do so constitutes abuse of process. A similar argument was rejected in AB Hassle v. Canada (Minister of National Health and Welfare¹¹ although the issue there was cast in terms of "res judicata in its broad application". I know of no authority which requires that separate and distinct allegations be made in the same notice although it may well be time efficient, particularly for "the second person", to proceed precisely in that manner. I am fully satisfied, on the basis of the Court of Appeal decision in Eli Lilly & Co. v. Apotex Inc.¹² that there could have been no serious suggestion of abuse of process at the time this notice of allegation issued.

[12]      Bayer suggests that subsequent proceedings can form the basis of an abuse of process challenge to an earlier one.¹³ Even if Bayer were correct, and I have serious doubts in this regard, there is no evidence in this proceeding concerning the substantive issues in the applications concerning the fourth and fifth notices of allegation and the statement of claim. A cursory review of the fourth and fifth notices of allegation and Bayer's statement of claim, with no other evidence, is not a sufficient basis upon which to determine in a serious way that this proceeding is moot. Similarly, the simple assertion by Bayer's counsel in argument that this proceeding is moot in the context of the others does not establish an abuse of process. Mootness is one thing, abuse of process is another.

[13]      If the proceedings concerning the third, fourth and fifth notices of allegation were so related as to make this proceeding moot, it may have been open to one or both of the parties for reasons of efficiency or otherwise to take up the suggestion of Strayer J.A. in Bayer AG v. Canada (Minister of National Health and Welfare),¹⁴ an interlocutory ruling made in the first of these related proceedings:

It might well be more convenient, and more economical of the time of the court and the time and money of clients, if all notices of allegation filed by a given "second person" with respect to the same medicine could be dealt with in the same prohibition proceeding or at least at the same time. With a modicum of cooperation and good sense of the parties a trial judge might in an appropriate case order the evidence and argument of all such matters to be dealt with in this fashion.

[14]      In my view, the third notice of allegation was not an abuse of process when it was issued or at the time of the hearing.

The allegation of the invalidity of patent 3334

[15]      The 3334 patent is a division from a parent application relating to ciprofloxacin hydrochloride as embodied in the 3067 patent. The substantive issue in this application is whether Bayer has discharged its burden in establishing that the Apotex allegation of invalidity of the 3334 patent is not justified. A statutory presumption, for example, may assist Bayer and "have the effect of displacing the burden of proof".¹⁵

i)      The evidence of the parties

[16]      Bayer relies on the statutory presumption of validity in section 43 of the Patent Act.¹⁶ The Bayer deponents produced the 3334 patent, the patent lists in respect of the medicine ciprofloxacin hydrochloride, the Apotex notice of allegation of June 12, 1995 (the third notice of allegation) and a Dedication to the Public filed with the Commissioner of Patents which purports to limit the term for the duration of the 3334 patent to the term of the 3067 patent which issued some eighty months earlier.¹⁷

[17]      The opening words of the abstract of the 3334 patent state:

A pharmaceutical composition comprising as an active ingredient a pharmaceutically effective amount of a 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-piperazino-quinoline-3-carboxylic acid of formula I ...

Further on, the 3334 patent states:

This application is a divisional from the third of three divisional applications all of which are divided out of parent application serial number 409,435, filed on August 13, 1982. The third divisional application was filed on May 5th, 1986 with application number 508,336.

...

The invention of the parent application relates to processes for preparing certain new 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-piperazinoquinoline-3-carboxylic acids which are compounds of formula I.

The invention of this application relates to compositions of certain of the compounds of formula I defined above and below in which R represents hydrogen or ethyl and to the use of such compositions in feed additives and as antibacterial agents.

This divisional application was filed on October 26, 1990 and the '334 patent issued on September 21, 1993.

[18]      It is also useful to set out the terms of the Dedication to the Public signed on behalf of Bayer AG on October 9, 1995 and filed in the Patent Office on October 17, 1995:

DEDICATION TO THE PUBLIC

Whereas Bayer Aktiengesellschaft ("Bayer"), of Leverkusen, Federal Republic of Germany, is the owner of Canadian Patent No. 1,322,334 granted and issued on September 21, 1993, for an invention entitled 1-CYCLOPROPYL-6-FLUORO-1,4-DIHYDRO-4-OXO-7-PIPERAZINO-QUINOLINE-3-CARBOXYLIC ACID-CONTAINING COMPOSITIONS AND USES THEREOF.

And Whereas Canadian Patent No. 1,322,334 was granted and issued from an application which was a divisional from the third of three divisional applications all of which where divided out of parent application serial number 409,435, filed on August 13, 1982, the latter having been granted and issued on February 17, 1987, as Canadian Patent No. 1,218,067, entitled 1-CYCLOPROPYL-6-FLUORO-1,4-DIHYDRO-4-OXO-7-PIPERAZINO-QUINOLINE-3-CARBOXYLIC ACIDS, A PROCESS FOR THEIR PREPARATION AND ANTIBACTERIAL AGENTS CONTAINING THESE COMPOUNDS.

And Whereas Bayer does not intend to have an exclusive property or privilege in the embodiments of the invention described and claimed in Canadian Patent No. 1,322,334 beyond the statutory term limited for the duration of Canadian patent No. 1,218,067.

Now Therefore Bayer hereby irrevocably dedicates Canadian Patent No. 1,322,334 to the public domain, this dedication to be effective as of the date the statutory term limited for the duration of Canadian Patent No. 1,218,067 expires ("expiry date"). Be it therefore known that after the expiry date, Canadian Patent No. 1,322,334, and all rights arising under Canadian Patent No. 1,322,334, will be hereby completely, entirely and irrevocably abandoned and all such rights will be hereby dedicated to public use in Canada to the full extent of such rights, and the Commissioner of Patents is hereby authorized to make such publication of this fact as he may deem desirable.

There is no evidence to explain the filing of this document several weeks subsequent to the commencement of this proceeding. In its memorandum of law, Bayer states, however, that the Dedication to the Public is a complete answer to any harm suggested by Apotex in connection with the 3334 patent because of its expiration on the same day as the 3067 patent expires. In oral representations, Bayer suggested that the Dedication to the Public may have been filed with the Patent Office for reasons other than this proceeding.¹⁸

[19]      The evidence of Apotex is from its president. He is both the author of its notice of allegation and the deponent of the one affidavit filed by Apotex. For ease of reference, it is useful to repeat the factual and the legal basis asserted by Apotex in support of its allegation of the invalidity of the 3334 patent:

Patent 1,322,334 discloses no invention beyond what is claimed in patent 1,218,067. More particularly, there is nothing further inventive in mixing ciprofloxacin hydrochloride with a pharmaceutically acceptable diluent or carrier to make a composition of the use of such composition.

The portions of the Apotex affidavit which complement its notice of allegation state:

17. The 3334 Patent is titled 1-Cyclopropyl-6-Fluoro-1,4-dihydro-4-Oxo-7-Piperazino-Quinoline-3-Carboxylic acid - Containing Compositions and Uses Thereof.

18. The 3334 Patent is a result of a division to a parent application related to compounds including the compounds, ciprofloxacin hydrochloride. The 3334 Patent at issue in the present proceeding claims pharmaceutical compositions containing an effective amount of, among other things, ciprofloxacin hydrochloride, together with pharmaceutically acceptable carriers of various types to form various types of pharmaceutical compositions for use in a specified manner.

19. The only use for ciprofloxacin hydrochloride is a medicine, that is, compounded into a pharmaceutical formulation for use in the treatment of human or animal disease. As such, this use is the utility of the ciprofloxacin hydrochloride contained in the parent application. Therefore, the inclusion of claims to compositions of ciprofloxacin hydrochloride and their use in the 3334 Patent does not constitute any invention over and above that disclosed in the parent application. Rather, the 3334 Patent represents an attempt to double patent the invention contained in the parent application.

20. Typically, the exercise of standard pharmaceutical formulations art will lead to an appropriate combination of inactive ingredients mixed with one or more active ingredients to create an effective pharmaceutical composition. The particular combinations and choices are well known to pharmaceutical formulators.

21. Except in the case of a very few hard to formulate active ingredients, of which ciprofloxacin hydrochloride is not one, no inventive ingenuity is ordinarily required to enable a formulator to take an active ingredient and include it in a pharmaceutically acceptable dosage form.

22. The 3334 Patent claims compositions of ciprofloxacin hydrochloride. However, the invention disclosed in the 3334 Patent does not describe or solve problems of formulating the ciprofloxacin hydrochloride. It is my experience that ciprofloxacin hydrochloride is easily formulated into dosage forms without the need of a separate invention. As a result, the 3334 Patent does not disclose any invention.

[20]      Bayer does not contest the assertions in paragraph 19 of the Apotex affidavit that the only use for ciprofloxacin hydrochloride is a medicine, when compounded into a pharmaceutical formulation, for the treatment of human or animal disease and that this is the utility "contained in the parent application". From this accepted assertion, I conclude that the Apotex deponent had knowledge of the parent application.

[21]      The Apotex deponent also stated that "the inclusion of claims to compositions of ciprofloxacin hydrochloride and their use in the 3334 patent does not constitute any invention over and above that disclosed in the parent application". Again, in the absence of any cross-examination concerning this assertion or of any other evidence, one can conclude that the Apotex deponent was able to make this statement because of his knowledge of the parent application. While Bayer's counsel did not unequivocally agree with this assertion, Bayer does not dispute the lack of any separate inventiveness in the 3334 patent over and above the invention in the 3067 patent.¹⁹ Bayer's position is that, as a divisional patent, "... the 3334 patent is entitled to rely on the same invention, the same inventive idea or genius ..."²⁰ of the parent 3067 patent.

[22]      Neither party filed the 3067 patent. Bayer strongly urged that there is no evidence in this proceeding as to the contents of the 3067 patent. In my view, however, the relevant extracts of the 3334 patent, the notice of allegation, the Dedication to the Public and the Apotex affidavit establish, if there was any doubt on the issue, that both patents concern the same compound ciprofloxacin hydrochloride. Bayer also acknowledges that the parent application was subject to subsection 41(1) of the Patent Act .²¹ From this, one can only conclude that the claims in the 3067 patent are compound by process. The first claim in the 3334 patent is for a composition comprising as an active ingredient a pharmaceutically effective amount of ciprofloxacin hydrochloride with a pharmaceutically acceptable diluent or carrier. I have not understood what information may be contained in the 3067 patent, not otherwise disclosed in the parties' evidence, which is necessary from Apotex' point of view to support its allegation of invalidity. This is particularly so in view of Bayer's acknowledgment of no new inventiveness in the 3334 patent other than that in the compound itself.²² The issue here is the validity of the composition claims in the 3334 patent, not the process-dependent compound claims in the 3067 patent.

ii)      Analysis of the parties' positions

[23]      Counsel referred to six cases²³ concerning the validity of non-inventive composition claims, three of which were with respect to medicinal products. Only inventions relating to substances intended for food and medicine were subject to the then existing section 41 of the Patent Act. This distinction among the cases is directly related to the different interpretations by counsel in the application of the true ratio decidendi in these six cases.

[24]      The history of subsection 41(1) was set out by my colleague MacKay J. in his thoughtful analysis and review of these six cases in Merck & Co. v. Apotex Inc.:²⁴

Under s. 39(1) of the Act (formerly s. 41(1) and so referred to in the jurisprudence relied upon by Apotex), substances prepared by chemical processes and intended for food or medicine could not be claimed as an invention except when prepared or produced by the methods or processes of manufacture also particularly described and claimed. In a short-hand way the regime was described as one where, in the case of medicines produced by chemical process, there could be no claim to an invention in the product except when it resulted from a claimed process. That regime ended in 1987 with amendment to the Act, which provided this exceptional basis for claiming a patent would be applicable, but only for a period of four years from the date of amendment, and then only in relation to inventions relating to naturally occurring substances prepared or produced by microbiological processes and intended for food or medicine (R.S.C. 1985, c. 33 (3rd Supp.) (or S.C. 1987, c. 41), s. 14). Thus, after 1987, a claim to a medical product produced by a chemical process, may be valid, as any other chemical product, without also claiming the chemical process for its production.25

[25]      The application for the '334 patent was filed after the revocation of subsection 41(1). For Bayer, this is important because of its view that the case law relied upon by Apotex is based upon subsection 41(1) and is therefore not directly applicable to this proceeding. For Apotex, the case law regarding the validity of pharmaceutical composition claims remained the same both when subsection 41(1) was in force and after its revocation. In the view of Apotex, therefore, the outcome of this application should not be affected in any manner by subsection 41(1) or its revocation.

[26]      In Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning,²⁶ the Supreme Court of Canada declared unpatentable the claims in a divisional application concerning anti-diabetic compositions containing sulphonyl urea. A parent and nine other divisional applications had previously issued pursuant to subsection 41(1) of the Patent Act concerning different processes for producing sulphonyl urea. In this newest divisional application, another patent was being sought for the same medicine in a diluted form, mixed with some inert substance ("an orally ingestible pharmaceutically acceptable carrier") to enable the marketable conception of the medicine. Counsel for both Bayer and Apotex agreed that the facts in Farbwerke Hoechst were on all fours with the circumstances in the present case:

In this case, the addition of an inert carrier, which is a common expedient to increase bulk, and so facilitate measurement and administration, is nothing more than dilution and does not result in a further invention over and above that of the medicinal itself. If a patent subsists for the new medicinal substance, a separate patent cannot subsist for that substance merely diluted.

...

The mixing of a patented chemical substance with a carrier is not new and it is not the result of inventive ingenuity. It is, of course, a substance, as the learned President has found, but it is still a substance identical in all respects except dilution with a substance produced by a chemical process and for which a patent has been granted under s. 41(1) of the Patent Act.

The decision under appeal is of extreme practical significance. It gives effect to form rather than substance. The claim to a pharmaceutical composition with which the present appeal is concerned is free from the limitations imposed by s. 41(1) and a person who obtained a patent in this way could assert such claims against anyone using the pharmaceutically active ingredient constituting the substance of the invention regardless of the process whereby it was produced.

...

In this case there is no question of a second invention involving the discovery of a new and particular carrier which imparts a special, new, and unexpected character to the compositions. To permit the claiming of a medicine mixed with a carrier in per se form, rather than in process-dependent form, would mean that all new medicines could be claimed free of the restrictions of Section 41 in the only practical form in which they may be used. This, of course, would defeat the whole purpose of the Section.27

Of the six cases reviewed by counsel, Farbwerke Hoechst is the only one which is both a divisional application and one concerning a medicinal composition and therefore subject to section 41. The two other cases²⁸ concerning medicines were not divisional applications.

[27]      For Bayer, the only ratio in Farbwerke Hoechst is that a medicinal composition cannot circumvent the restriction in subsection 41(1) of the Patent Act requiring the claim to be in a process dependent form. In my view, the decision stands for two separate and distinct propositions, only the second of which is directly linked to subsection 41(1). Firstly, the dilution of an original compound with no inventive ingenuity cannot support a second patent. Secondly, to do so would fly in the face of the policy subsumed in subsection 41(1). In Shell Oil Co. v. Commissioner of Patents²⁹, the Supreme Court of Canada quoted the above extracts from Farbwerke Hoechst and summarized its interpretation of that case as follows:

... the applicant was asking for a patent on a medicine in respect of which it already had a patent; only this time it was seeking to patent it in a diluted form. [The Court] held that the addition of an inert carrier to the original compound was nothing more than dilution and did not result in a further invention over and above that of the compound itself.30

This interpretation of Farbwerke Hoechst by the Supreme Court is of significance because section 41(1) was not in issue in Shell Oil Co. which did not deal with substances intended for food or medicine.

[28]      In Shell Oil Co., the Supreme Court of Canada reiterates the principle that in the absence of any inventive ingenuity other than in the original patent, there is no invention in the composition:

... no inventive ingenuity is involved in mixing a compound with a carrier. Accordingly, if the compound is patented, there is no invention in the composition. That proposition, in my view, makes eminent good sense whether the substance is covered by s. 41 or not ... 31

This statement by Madam Justice Wilson reinforces my view concerning the interpretation to be given to the Farbwerke Hoechst line of cases. Regardless of whether the compound is a medicine or not or, in other words, regardless of whether s. 41 is in play or not, there must be inventive ingenuity other than that in the compound itself if a separate patent is to issue for the composition. In Shell Oil, claims for a composition based on a novel use of the old compound or on new compounds were allowed.

[29]      In Merck & Co. v. Apotex Inc.,³² the Court of Appeal considered the validity of composition claims with no inventive ingenuity within the same patent as the claims for the compound. After noting the Supreme Court's two reasons for disallowing the composition claims in the divisional application in Farbwerke Hoechst, MacGuigan J.A. summarized that decision in these words:

However, in effect, this was another case establishing that, once a patent has been granted in respect of an invention, another patent will not be assured for something that is inherent in the same invention.33

From this, I conclude that as recently as its decision in Merck & Co., the Court of Appeal interpreted Farbwerke Hoechst as applying regardless of section 41. After reviewing the cases that followed Farbwerke Hoechst, Justice MacGuigan stated:

At least after Shell Oil, it must be clear that the earlier cases do not stand for the proposition that a composition claim cannot survive with a compound claim, on the ground that it involves no inventive ingenuity. As long as there is no separate invention in the compositions, there is no rule that claims to compounds and claims to compositions including them cannot be combined in a single patent.

Indeed, quite the contrary is the case. Within a single patent a variety of aspects of an invention may be claimed. It has thus been longstanding practice to permit different kinds of claims in the same patent.34

[30]      In summary, I am satisfied that the facts and the result in Farbwerke Hoechst are directly applicable to this case. In Farbwerke Hoechst, the Commissioner of Patents rejected the composition claims because their essential inventive feature "resides in the medicinally active chemical compound, and not in the fact that this compound is associated with a carrier".³⁵ The facts in this case are no different. The Commissioner concluded that the composition claims in the divisional applications failed to reveal anything "not taught or clearly implied" in compound claims.³⁶ Accordingly, he rejected the composition claims and his decision was eventually confirmed by the Supreme Court of Canada. The subsequent judgments in this line of cases are consistent with the outcome in Farbwerke Hoechst. I see no reason to distinguish that result from the proper outcome in this case.

[31]      Bayer does not concede that this interpretation of Farbwerke Hoechst necessarily defeats its position. Bayer relies on the practice of the Patent Office in applying the then existing Patent Rules 58 through 60:³⁷

     Division

58. An application that claims a product and a process for making the product shall not, for that reason only, be deemed to claim more than one invention.

59. An application that describes and claims a process and an apparatus specially adapted to carry out the process shall not, for that reason only, be deemed to be directed to more than one invention.

60. Subject to sections 58 and 59, an application that does not contain a claim broader in its scope than any other claim in the application shall be deemed to be directed to more than one invention.

     Division

58. Une demande qui revendique un produit et un procédé de fabrication de tel produit n'est pas censée, pour ce motif seulement, revendiquer plus d'une invention.

59. Une demande qui décrit et revendique un procédé et un appareil adapté spécialement à la mise en oeuvre de ce procédé, n'est pas censée, pour ce motif seulement, viser plus d'une invention.

60. Sous réserve des articles 58 et 59, une demande qui ne renferme pas une revendication de plus grande portée que toutes ses autres revendications, est censée viser plus d'une invention.

[32]      Bayer's argument concerning Patent Rules 58-60 is set out in its memorandum:

64. The 913 application (which issued as the 334 patent), as a divisional application, could only be accorded divisional status if the invention defined in the claims in the resulting 334 patent were in the 435 application (which issued as the 067 patent). At the date of filing the 435 application, August 13, 1982, Patent Rule 60 "deemed" an application to be directed to more than one invention where the application did not contain a claim broader in its scope than any other claim in the application. This reflects the concept of "unity of invention" required by the Patent Office at the time and applied in respect of the requirement that an applicant file divisional applications.

65. An application that contained claims to (a) a process for preparing a novel compound; (b) a novel compound in process dependent form; (c) a composition containing the novel compound with a carrier; and (d) the use of the composition, would have been deemed to be directed to more than one invention by operation of Rules 58-60, thereby requiring the filing of divisional applications. The Patent Office routinely applied these rules to require applicants to file divisional applications in respect of different embodiments when there was no unity of invention.

Rules 58, 59 and 60

66. Subject matter disclosed in a parent application is not prior art for the purposes of considering the inventiveness of the subject matter claimed in a divisional application of the parent.

Patent Act, s. 38(3)

67. Bayer, the applicant in the 435 application was required by the Patent Office to file a number of divisional applications as is apparent from the disclosure of the 334 patent. It is also clear that claims of the type in the 334 patent, were lawfully patentable at the date thereof.

[33]      As I understand Bayer's position, the '334 patent which issued in response to the divisional application no. 615,913 was the proper result of the Patent Office practice at the time concerning Rule 60 when that provision was in force. If Bayer is correct, the practice would have the effect of extending the period of the statutory grant with respect to the '334 patent composition claims, for which there is no inventive ingenuity other than that in the compound claims in the '067 patent. Such a result would be inconsistent with the purpose and intent of the Patent Act and, in my view, with the teachings in Farbwerke Hoechst. Rule 60 and the principle of unity of invention, relevant to the issue of the infringement of a broad claim by one or more dependent claims, cannot be used to extend the patentee's monopoly rights. This would create a serious anomaly in the law. It cannot be that it resides with the patentee, and only if it so chooses, to correct this anomaly simply through its voluntary filing of the Dedication to the Public.

[34]      In Farbwerke Hoechst, although the Commissioner had under review a divisional application for composition claims whose sole inventive feature was in the medicinal compound which was the subject matter of the parent application, he rejected all the composition claims without reference to Rules 58-60 or their application by the Patent Office.³⁸ These rules were in force since 1948. The Commissioner's decision in Farbwerke Hoechst was in 1960. One would have thought that the practice relied upon by Bayer in support of its position in this case would have been equally applicable in Farbwerke Hoechst. There is no evidence that the Patent Office practice relied upon by Bayer was introduced subsequent to the Farbwerke Hoechst decision. There is no evidence that subsection 41(1) or its amendments in 1987 directly affected this administrative practice. In the end, the Patent Act as interpreted by judicial pronouncements must prevail over administrative practice.

[35]      Bayer's reliance on the administrative practice of the Patent Office is not supported with evidence. The parties chose not to file the '067 patent. There is no evidence to establish that the divisional application for the '334 patent was forced or directed by the Commissioner. There is no evidence to explain why the application for the '334 patent was filed only in 1990. There is no information upon which to conclude that the administrative practice of the Patent Office or any other factual circumstance warrants an outcome inconsistent with the Farbwerke Hoechst line of cases.

[36]      In conclusion, the statutory presumption of a patent's validity applies "in the absence of any evidence to the contrary."³⁹ In this case, the limited evidence of the parties and Bayer's acknowledgement establish that the composition claims disclose no inventive ingenuity over and above that of the compound claims. This evidence, when assessed in the light of Farbwerke Hoechst, is sufficient to rebut the presumption of validity in section 43 of the Patent Act, at least for the purpose of this summary proceeding⁴⁰.

[37]      On the basis of the record in this summary proceeding, I conclude that Bayer has failed to establish that the Apotex allegation of invalidity of the '334 patent is not justified. Accordingly, this application for a prohibition order will be dismissed. As this hearing was completed prior to the coming into force of the recent amendments to the Patented Medicines (Notice of Compliance) Regulations, I have concluded that there will be no order as to costs.

     A. Lutfy

    

                                         Judge

Ottawa, Ontario

July 20, 1998

__________________

     ¹      SOR/93-133.

     ²      The amended originating notice of motion was filed on October 31, 1996, some months after Bayer's application in this proceeding was perfected. Neither the four other notices of allegation nor the statement of claim were filed in this proceeding but counsel for both parties were advised that the Court reviewed copies of these documents from the Court files which, upon request of one of the parties, were available during the first two days of this hearing. Neither party objected to my reviewing the documents in question which counsel referred to during that portion of the oral argument concerning abuse of process.

     ³      (1996), 65 C.P.R. (3d) 203 (F.C.T.D.).

     ⁴      (1995) 67 C.P.R. (3d) 25 (F.C.A.), affirming (1995) 62 C.P.R. (3d) 58 (F.C.T.D.).

     ⁵      (1996), 65 C.P.R. (3d) 200 (F.C.T.D.).

     ⁶      Eli Lilly & Co. v. Apotex Inc. (1997), 76 C.P.R. (3d) 1 (F.C.A.) at 10. Leave to appeal to the Supreme Court of Canada dismissed on January 8, 1998, court file no. 26259.

     ⁷      R.S.C. 1970, c. P-4.

     ⁸      Supra, note 6 at p. 10.

     ⁹      Transcript of October 21, 1997 at p. 137.

     ¹⁰      Transcript of January 23, 1998 at p. 41.

     ¹¹      (1997), 71 C.P.R. (3d) 129 (F.C.T.D.) at 145.

     ¹²      Supra, note 6.

     ¹³      In my view, the statements of Muldoon J. in Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1997), 74 C.P.R. (3d) 131 (F.C.T.D.) at 149, upon which Bayer relies, that the assessment of the allegations of non-infringing activity is to be made on the basis of the status "at the time of the hearing" do not necessarily apply in the determination of abuse of process.

     ¹⁴      (1995), 60 C.P.R. (3d) 129 (F.C.A.) at 134.

     ¹⁵      Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1995), 55 C.P.R. (3d) 302 (F.C.A.) at 319.

     ¹⁶      R.S.C. 1985, c. P-4. According to section 43, every patent shall for the term of its duration, "... in the absence of any evidence to the contrary, be valid ..." ("Il est par la suite, sauf preuve contraire, valide ...").

     ¹⁷      Bayer also produced the transcript of its very short cross-examination of the Apotex deponent. Nothing in this proceeding turns on the 21 questions of that cross-examination which focusses on the deponent's qualifications in pharmaceutical formulation and that he has personally formulated ciprofloxacin hydrochloride.

     ¹⁸      Transcript of January 23, 1998 at p. 137.

     ¹⁹      Transcript of January 23, 1998, p. 74.

     ²⁰      Transcript of October 21, 1997, p. 98.

     ²¹      Supra, note 7. Subsection 41(1), which later became subsection 39(1), stated:

In the case of inventions relating to substances prepared or produced by chemical processes and intended for food or medicine, the specification shall not include claims for the substance itself, except when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents.

Lorsqu'il s'agit d'inventions portant sur des substances préparées ou produites par des procédés chimiques et destinées à l'alimentation ou à la médication, le mémoire descriptif ne peut comprendre les revendications pour la substance même, sauf lorsque la substance est préparée ou produite par les modes ou procédés de fabrication décrits en détail et revendiqués, ou par leurs équivalents chimiques manifestes.

Dr. Harold G. Fox, The Canadian Law and Practice relating to Letters Patent for Inventions, 4th ed. (Toronto: Carswell, 1969), pp. 46-7, wrote:
     The reason for the section is that it was designed to prevent the appropriation by a patentee of certain substances in such a way as to preclude other explorers in the same field form devising improvements in the preparation or the quality of the substances in question.
     When such a substance is claimed it must be claimed by reference to a claim for the process by which it is produced and that process claim must be valid. [Footnotes omitted.]

     ²²      See the transcript of January 23, 1998 at pp. 70-74 for Bayer's response to the relevance of the knowledge of the claims in the 3067 patent in the adjudication of this application.

     ²³      Rohm & Haas Co. v. Commissioner of Patents (1959), 30 C.P.R. 113 (Ex. Ct.); [1964] S.C.R. 49">Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning v. Commissioner of Patents [1964] S.C.R. 49, 41 C.P.R. 9, rev'g (1962), 39 C.P.R. 105 (Ex. Ct.); [1974] S.C.R. 1336">Sandoz Patents Ltd. v. Gilcross Ltd., [1974] S.C.R. 1336, 8 C.P.R. (2d) 210; Agripat S.A. v. [1964] S.C.R. 49">Commissioner of Patents (1977) 52 C.P.R. (2d) 229 (F.C.A.); [1982] 2 S.C.R. 536">Shell Oil Co. v. Commissioner of Patents, [1982] 2 S.C.R. 536, 67 C.P.R. (2d) 1; and Apotex Inc. v. Merck & Co. Inc., [1995] 2 F.C. 723 (F.C.A.), 60 C.P.R. (3d) 356.

     ²⁴      (1994), 59 C.P.R. (3d) 133 (F.C.T.D.) at pp. 166 and ff., rev'd on other grounds, (1995), 60 C.P.R. (3d) 356 (F.C.A.).

     ²⁵      Ibid., at pp. 166-7. See also, supra, footnote 21.

     ²⁶      Supra, note 23.

     ²⁷      Ibid, pp. 53-55 (S.C.R.); pp. 13-16 (C.P.R.).

     ²⁸      [1974] S.C.R. 1336">Sandoz Patents Ltd., supra, note 23 and Apotex Inc. supra, note 23.

     ²⁹      Supra, note 23.

     ³⁰      Ibid., at p. 539-40 (S.C.R.), p. 4 (C.P.R.). The Court, in referring to Farbwerke Hoechst and Sandoz, added that "... the inventive ingenuity lay in the compounds only and there was no further invention involved in their mere dilution with an inert carrier" (at p. 544 (S.C.R.), p. 7 (C.P.R.)).

     ³¹      Supra, note 23 at p. 552 (S.C.R.), p. 13 (C.P.R.).

     ³²      Supra,note 23.

     ³³      Ibid. at p. 751 (F.C.), p. 379 (C.P.R.).

     ³⁴      Ibid. at p. 756 (F.C.), p. 382 (C.P.R.).

     ³⁵      The Commissioner's decision is set out in the reasons for judgment of the Supreme Court of Canada in Farbwerke Hoechst, supra, at pp. 54-5 (S.C.R.) and pp. 14-16 (C.P.R.).

     ³⁶      Ibid.

     ³⁷      Patent Rules, C.R.C., 1978, c. 1250. There are only minor changes between the 1978 version of Rules 58-60 and the original text which came into force on June 1, 1948 (P.C. 1948-2637). Rules 58 and 59 were revoked on September 21, 1989 (P.C. 1989-1782, SOR/89-452, s. 7). Rule 60 was revoked on May 25, 1984 (P.C. 1984-1749, SOR/84-398, s. 1).

     ³⁸      Supra, note 35.

     ³⁹      Supra, note 16.

     ⁴⁰      See Diversified Products Corp. v. Tye-Sil Corp. (1991), 35 C.P.R. (3d) 350 (F.C.A.) at 359.