Date: 19981103
Docket: T-35-96
BETWEEN:
BAYER AG and BAYER INC.
Applicants
and
APOTEX INC. and THE MINISTER OF NATIONAL
HEALTH AND WELFARE
Respondents
REASONS FOR JUDGMENT
GIBSON J.:
[1] On the 8th of January, 1996, the applicants Bayer AG ("Bayer Germany") and Bayer Inc. ("Bayer Canada"), (collectively "Bayer"), filed an Originating Notice of Motion seeking an order prohibiting the Minister of National Health and Welfare (the "Minister") from issuing a Notice of Compliance to the respondent Apotex Inc. ("Apotex") 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 patents Nos. 1, 218,067 (the "067 patent") and 1,322,334 (the "334 patent"), (collectively "the Canadian patents").
[2] The Notice of Motion filed the 8th of January, 1996 was filed in response to a notice of allegation sent by Apotex on the 24th of November, 1995 alleging with respect to the medicine ciprofloxacin hydrochloride ("ciprofloxacin") that:
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With respect to those applicable claims under the Regulations, namely claims to the medicine itself and claims to the use of the medicine, there was no entitlement to the grant of patents 1,269,067 and 1,322,334, and hence, at least to that extent, such patents are invalid. Any other claims, even if valid are not relevant for the purposes of the Regulations.1 |
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[3] By further Originating Notice of Motion filed the 11th of March, 1996 and amended the 28th of May, 1996, Bayer sought an order prohibiting the Minister:
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...from responding to or acting in respect to the Notice of Allegation of Apotex Inc. ...dated November 24, 1995 and purportedly amended on November 27, 1995 and in respect of Canadian Patent No. 1,218,067... and Canadian Patent No. 1,322,334... from issuing a Notice of Compliance... for the medicine ciprofloxacin hydrochloride, including ciprofloxacin hydrochloride tablets 100mg, 250mg, 500 mg, and 750 mg by reason of a previous Order of Prohibition in Court File No. T-1192-93, respecting the "067 Patent and a previous Order of Prohibition in Court File No. T-468-95 respecting the "334 Patent ... |
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and other relief.
[4] As reflected in the relief sought in the later Notice of Motion, these Originating Notices of Motion were not the first filed by Bayer against the Minister and Apotex in respect of the medicine ciprofloxacin. They were in fact the fourth and fifth such Motions, all responsive to notices of allegations by Apotex. The first two applications were heard together by my colleague MacKay J. who held in favour of Bayer.2 The third was heard by my colleague Lutfy J. who found in favour of Apotex.3 These applications, that is to say the fourth and fifth applications, were, like the first and second, heard together. The argument proceeded almost entirely on the basis of material submitted on Court file T-591-96. These reasons have been written to apply with respect to both applications and copies of the reasons will be filed on both files together with separate orders.
[5] Bayer Germany is the owner of the 067 and the 334 patents. The 067 patent contains process and product by process claims for the compound ciprofloxacin hydrochloride. The 334 patent contains claims to a composition comprising ciprofloxacin hydrochloride "as an active ingredient". Bayer Canada is a licensee of Bayer Germany in respect of both patents. It sells ciprofloxacin as a medicine in Canada under Notices of Compliance granted by the Minister.
[6] Apotex is a "generic drug company", that is to say a manufacturer and marketer of drugs in Canada which, in the words of Mr. Justice Nadon in Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare)"Market[s] a drug without having to independently established the safety and effectiveness of the drug.4 It seeks a Notice of Compliance from the Minister to so enable it to market ciprofloxacin.
[7] The Minister, now the Minister of Health, is the Minister charged with the responsibility to administer the Regulations. No material filed on behalf of the Minister was before me. Further, the Minister was not represented before me.
[8] The following facts were essentially not in dispute.
[9] Ciprofloxacin is a drug which is used as an antibiotic. It is marketed by Bayer under the trade mark CIPROTM. Ciprofloxacin belongs to the class of compounds known as quinolines. The structure for ciprofloxacin, also known as 7-chloro- 1-propyl-6-fluoro-1, 4 -dihydro- 4- oxo-quinoline- 3-carboxylic acid, is:
[10] Bayer Germany filed in a number of countries what counsel for Bayer described as "two families of patents." While counsel for Apotex took exception to the description of the patent applications as two distinct families, he acknowledged that the table which follows discloses the patent applications relevant to this matter and the actual filing dates in respect of each of them.
| Germany Chile Spain Canada |
Family I
Actual Filing
| Dates Sept.3,1980 Aug. 12, 1991 Sept.2,1981 No |
Family II
Actual Filing
| Dates Oct. 29, 1981 No Oct. 28, 1982 Aug. 13, 1982 |
The patent application filed in Germany on September 3, 1980 did not result in the issue of a patent. The three applications described as being within the "family I" category were agreed by counsel to be virtually identical and to be described in their titles as being in respect of "naphiradines" a class of compounds broader than " quinolines" though, once again, it was acknowledged by counsel that ciprofloxacin was within the genus of compounds, a very wide genus, disclosed and claimed in Claim I of the "family I" applications.
[11] Both of the Canadian patents derived from the application in the "family II" class identified in the above diagram with an actual filing date in Canada of October 28, 1982. A "priority date" of October 29, 1981, the date of filing of the Germany II application, was claimed in respect of that application. Bayer alleges that the purpose of subsection 29(1) of the Patent Act5 (the "Act") was to implement in Canadian law the priority date provisions of the Paris Convention.6 More specifically, Bayer asks the court to take note of the parallels between subsection 29(1) of the Act and articles 4A(1) and 4B of the Paris Convention.7
[12] The 067 Canadian patent is based directly on the October 28, 1982 "family II" application. That application, at the request of the Canadian Patent Office, was divided into three further applications since the Canadian Patent Office took the position that there were four different inventions covered by the application. One of the three divisional applications matured into the 334 patent.
[13] As indicated earlier, the 067 patent is directed to the preparation of four quinolines including ciprofloxacin. The 334 patent is directed to the pharmaceutical composition of two of those same quinolines, including ciprofloxacin.
[14] For ease of reference, I have identified seven issues argued before me, five of which I will deal with as preliminary issues and two of which I describe as substantive issues. The seven issues are the following:
| ii) Fraud on the Patent Office; |
| iv) The breadth of the applicants" reply memorandum; and |
| v) Credibility of expert witnesses. |
| i) The interpretive interrelationship to be given to subsections 28(2) and 29(1) of the Patent Act and the appropriate priority date for the application for the Canadian patents; and |
| ii) Whether the inventions disclosed in the Canadian patents are the same as that disclosed in the family I application filed in Germany and that claimed in the Chile and Spain family I patents, or the "same invention" issue. |
| 5. POSITIONS OF THE PARTIES, ANALYSIS AND FINDINGS |
[1] Bayer relies on the statutory presumption of validity in section 47 of the Act which provides that every patent shall, for the term of its duration, "...be prima facie valid..." .
[2] In Hoffmann-Laroche Ltd. v. Canada (Minister of National Health and Welfare)8, Mr. Justice Stone wrote:
....
2. The initiator of a section 6 proceeding [a proceeding such as these], being the person having the carriage of the litigation, bears "the initial burden of proof" which is a difficult burden because "it must be to disprove some or all of the allegations in the notice of allegation which, if left unchallenged, would have allowed the Minister to issue a notice of compliance". ...
3. This burden, known in a civil case as either the "persuasive burden" or the "legal burden", is the burden of establishing a case to the civil standard of proof. By contrast, the "evidential burden" consists of the burden of putting an issue in play and means that a party has the responsibility to ensure that there is sufficient evidence of the existence or non-existence of a fact or an issue on the record to pass the threshold for that particular fact or issue. ... [citations omitted]
[3] Here, against the foregoing principles, the initial "persuasive" or "legal" burden of proof falls on Bayer to establish that Bayer Germany was entitled to the grant of the Canadian patents and that, contrary to the allegations made by Apotex, the patents are not invalid. Bayer is entitled to rely on the presumption of validity earlier referred to. Regarding both entitlement and validity, the issue here put in play by Apotex" notices of allegations is the novelty of the inventions disclosed by the Canadian patents. By adducing in evidence the Chilean patent and the Spanish patent supported by expert evidence to which I will refer later to the effect that those patents claim the inventions of the Canadian patents, Apotex has, I conclude, adduced "sufficient evidence of the existence ... of an issue on the record to pass the threshold for that particular... issue".
[4] Thus, the "initial burden of proof" is restored and lies upon Bayer.
| ii) Fraud on the Patent Office |
[5] Subsection 55(1) of the Act provides, among other things, that a patent is void if "any material allegation in the petition of the applicant in respect of [the] patent is untrue".
[6] Counsel for Apotex urges that the failure on the part of Bayer to disclose in the petition leading to the issue of the Canadian patents the existence of: the German patent application filed the 3rd of September, 1980; the Chilean application filed the 12th of August, 1981; the Chilean patent conceded as early as the 16th of March, 1982; the Spanish application filed the 2nd of September, 1981; and the Spanish patent granted on the 29th of April, 1982, all referred to earlier in these reasons and comprising what Bayer describes as the "family I" patents, amounted to an untrue material allegation in the petition leading to the issue of the Canadian patents.
[7] In Rothmans, Benson & Hedges Inc. v. Imperial Tobacco Ltd./Ltée9 Mr. Justice Rouleau wrote:
Under the first ground of invalidity provided for in s. 53(1)[the ground of invalidity alleged here], it is necessary to establish that an allegation made in the petition is untrue and that the allegation is material.
[8] Thus, for Apotex to succeed on this ground, it must establish that: first, an allegation is made in the petition; second, the allegation is untrue; and third, the allegation is material. On the facts of this matter, no allegation with respect to the German application, the Chilean application or patent or the Spanish application or patent is made on the face of the petition giving rise to the Canadian patents. A failure to disclose is certainly not an explicit allegation. Nor can it be said that a failure to disclose is an implicit allegation that there is nothing to disclose that would thus invoke the first ground of invalidity provided for in subsection 55(1). If Parliament had intended that the first ground of invalidity extend, not only to untrue and material allegations, but also to material non-disclosures, it could easily have done so. It did not.
[9] In the result, I conclude that Apotex cannot succeed on this ground. I find that the Canadian patents are not void by reason of any untrue material allegation in the petition giving rise to them. No fraud on the Patent Office has been established.
[10] Earlier in these reasons, I noted that the notices of allegations giving rise to these applications are the fourth and fifth notices of allegations made by Apotex in respect of ciprofloxacin. Bayer alleges that the fifth notice of allegation is essentially the same as, and not separate and distinct from, the fourth notice of allegation. The fifth notice of allegation arises, it is alleged, under the same provision of the Act, that is to say subsection 28(2). It involves the same parties, the same medicine, the same Canadian patents and relies in part on the same foreign patent, the Chilean patent. It merely adds the Spanish patent and the German patent application comprised in the "family I" referred to earlier. Bayer alleges that, through the exercise of reasonable diligence, the references to the Spanish patent and the German patent application could reasonably have been included in the fourth notice of allegation.
[11] In Bayer Inc. and Bayer AG v. the Minister of National Health and Welfare and Apotex Inc.,10 Mr. Justice Lutfy wrote:
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.
For this proposition, Mr. Justice Lutfy cites Apotex Inc. v. Canada (Minister of National Health and Welfare)11 where Mr. Justice Marceau wrote:
I agree with the views expressed in the numerous Trial Division decisions referred to by the motions judge to the effect that successive allegations are possible and each one must be treated independently provided it is separate and distinct from the others and its bringing before the Court cannot be seen as an abuse of process.
[12] Mr. Justice Lutfy, who was dealing with the third notice of allegation brought by Apotex in respect of ciprofloxacin, noted:
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 by AB Hassle v. Canada (Minister of National Health and Welfare) 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. [citation omitted]
[13] The issue, then, is not whether multiple notices of allegations in respect of the same medicine and brought by the same "second person" constitute an abuse of process but rather whether each of those notices of allegations is separate and distinct from each of the others.
If they are not, there may be an abuse of process.
[14] I am satisfied that the fifth notice of allegation is not "separate and distinct" from the fourth. It alleges no new grounds of invalidity or non-infringement with respect to the Canadian patents or either of them. Rather, it simply provides new evidence or support for the fourth notice of allegation, the new evidence being the existence and nature of the Spanish patent and the first German patent application. The latter was disclosed in the application giving rise to the Canadian patents. The former was closely interrelated with the German application and the Chilean patent.
[15] In Hoffman-Laroche Ltd. v. Canada (Minister of National Health and Welfare)12, Mr. Justice Stone, in summarizing the "core guidance" provided by earlier decisions in matters of this nature wrote:
7. Where a second person fails to file notices of allegation or adequate notices of allegation they "must assume their own risk when it comes to attacks on the adequacy of such allegations once prohibition proceedings are commenced". ...
8. The requirement in paragraph 5(3)(a) of the Regulations that a second person provide a detailed statement "seems intended... [to make] the patentee... fully aware of the grounds on which the applicant seeks issuance of a NOC [that will not lead to infringement of the patent] before the patentee decides whether or not to apply to a court for a determination. Such disclosure would define the issues at a very early stage. (emphasis added, citations omitted]
[16] No satisfactory explanation was provided in evidence to support the failure to discover and rely upon the German application and the Spanish patent in the fourth notice of allegation. In an affidavit sworn the 31st of May, 1996 and filed on Court file T-591-96, Dr. Bernard Sherman, the Chairman and Chief Directing Officer of Apotex simply attests:
In the course of preparing our materials in response to the prohibition application commenced as Court File No. T-35-96, we discovered further facts which we believe support our allegation that the "067 patent and the "334 patent were not valid. That further information was set out in a letter dated January 26, 1996 which I transmitted to Miles Canada Inc., [apparently a predecessor of Bayer Canada]... .13
[17] No satisfactory explanation was provided as to why the "further facts" were only discovered during the course of preparing materials in response to the originating notice of motion filed on Court File No. T-35-96.
[18] In the letter of January 26, 1996 referred to by Dr. Sherman, a request was made that the further information simply be added to the fourth notice of allegation and thus dealt with in the fourth proceeding which had already been commenced. Bayer declined to accept that request. I am satisfied, against the 7th and 8th principles quoted above from Hoffman-Laroche, that it was entitled to do so. Where a "second person" finds its notice of allegation to be incomplete and an application has already been instituted arising out of that notice of allegation, if no satisfactory explanation for the failure to put all of the facts forward in the notice of allegation is provided, I cannot conclude that any obligation arises on the "first person".
[19] I find that the fifth notice of allegation provided by Apotex to Bayer is not separate and distinct from the fourth notice of allegation. In the result, I am satisfied that it constitutes an abuse of process, not of the process of this Court since it is not a document in a proceeding in this Court other than as evidence, but rather of the regulatory scheme established by the Regulations.14 By reason of that abuse of process, the result in the proceeding on file T-591-96 will follow the result in the proceeding on file T-35-96. I will rely upon material filed on file T-591-96 only to the extent that it in any way refers to the patent application in Chile and the resulting patent. Material relating to the patent application in Germany, Germany I, and to the patent application in Spain and the resulting patent will be disregarded.15
| iv) The Breadth of the Applicants" Reply Memorandum |
[20] On or about the 8th of September, 1998, with the hearing of these two applications scheduled to commence slightly less than a month later, counsel for Bayer filed a reply memorandum of fact and law extending on file T-591-96 to some 146 paragraphs and listing some 43 new authorities, including a significant number of American authorities to which reference will be made later.15 Counsel for Apotex urged that his client was substantially prejudiced by the nature and extent of the reply argument and his inability to reply in writing. He referred me to Vrabek v. R.16 where Mr. Justice Linden wrote by reference to Rule 1608 of the former Federal Court Rules17:
This Rule [which provided for the filing and service of a supplementary application record in response to a respondent"s application record] does not authorize additional legal argument to be filed, but rather is meant to permit a party to file additional factual evidence to meet the Respondent"s case, if thought to be advisable.
[21] There can be no question but that the reply memorandum filed on behalf of Bayer includes extensive "additional legal argument".
[22] While counsel for Apotex took no objection to the filing of a reply memorandum per se, he did object to the scope of legal argument included in the memorandum and in particular to the reference to extensive jurisprudence, not previously cited on behalf of either Bayer or Apotex.
[23] In all of the circumstances, I indicated to counsel toward the close of the hearing that, while I would make reference to the reply memorandum in reaching my decision, I would be guided by the words of Mr. Justice Linden in respect of certain aspects of the memorandum and authorities cited therein. These reasons have been prepared in a manner consistent with my indication to counsel. No further relief was requested on behalf of Apotex and no further relief is provided.
| v) Credibility of Expert Witnesses |
[24] Counsel for Bayer and for Apotex each expressed concerns regarding the utility of the expert evidence tendered by the other side. In light of my earlier findings, the following takes no account of concerns regarding expert evidence as to the issuance of the Spanish patent.
[25] There can be no question but that the expert witness on behalf of Bayer with respect to the issuance of the Chilean patent overstated his qualifications. The result of that overstatement must be regarded as reflecting on the credibility and competence of that witness. My concerns in that regard are taken into account in the portion of these reasons that follows.
[26] That being said, based on the arguments presented to me, and subject to what is said above, I otherwise reject the concerns. I find no reason to discount the weight to be given to such evidence.
| i) The interpretive interrelationship to be given to subsections 28(2) and 29 (1) of the Act and the appropriate priority date for the Canadian patents. |
[27] At all relevant times for the purpose of these applications, subsections 28(2) and subsection 29(1) of the Act read as follows:
| (2) Any inventor or legal representative of an inventor who applies in Canada for a patent for an invention for which application for patent has been made in any other country by such inventor or his legal representative before the filing of the application in Canada is not entitled to obtain in Canada a patent for that invention unless his application in Canada is filed, either
a) before issue of any patent to such inventor or his legal representative for the same invention in any other country, or
b) if a patent has issued in any other country, within twelve months after the filing of the first application by such inventor or his legal representative for patent for such invention in any other country.
...
29.(1) An application for a patent for an invention filed in Canada by any person entitled to protection under the terms of any treaty or convention relating to patents to which Canada is a party who has, or whose agent or other legal representative has, previously regularly filed an application for a patent for the same invention in any other country that by treaty, convention or law affords similar privilege to citizens of Canada, has the same force and effect as the same application would have if filed in Canada on the date on which the application for patent for the same invention was first filed in such other country, if the application in this country is filed within twelve months from the earliest date on which any such application was filed in such other country or from the 13th day of June 1923.
|
2) Un inventeur ou représentant légal d"un inventeur, qui a fait une demande de brevet au Canada pour une invention à l"égard de laquelle une demande de brevet a été faite dans tout autre pays par cet inventeur ou par son représentant légal avant le dépôt de sa demande au Canada, n"a pas le droit d"obtenir au Canada un brevet couvrant cette invention sauf si sa demande au Canada est déposée , soit
a) avant la délivrance de quelque brevet à cet inventeur ou à son représentant légal couvrant cette même invention dans tout autre pays, soit,
b) si un brevet a été délivré dans un autre pays, dans un délai de douze mois à compter du dépôt de la première demande, par cet inventeur ou son représentant légal, d"un brevet pour une inventin dans tout autre pays.
...
29.(1) Une demande de brevet d"invention, déposée au Canada par quelque personne ayant le droit d"être protégée aux termes d"un traité ou d"une convention se rapportant aux brevets et auquel ou à laquelle le Canada est partie, qui a, elle-même our par son agent ou autre représentant légal, antérieurement déposée de façon régulière une demande de brevet couvrant le même invention dans un autre pays qui, par traité, convention ou législation, procure un privilège similaire aux citoyens du Canada, a la même vigueur et le même effet qu"aurait la même demande si elle avait été déposée au Canada à la date où la demande de brevet pour la même invention a été en premier lieu déposée dans cet autre pays, si la demande au Canada est déposée dans un délai de douze mois à compter de la date la plus éloignée à laquelle une telle demande a été déposée dans cet autre pays, ou à compter du 13 juin 1923.
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[28] It was not in dispute before me that the application giving rise to the Canadian patents was filed on the 13th of August, 1982. Similarly, it was not in dispute before me that Bayer filed its application in Chile for a "family I" patent on the 12th of August, 1981. Therefore, if the Chilean patent can be said to be for the "same invention" as disclosed and claimed in the Canadian patents or either of them, and more will be said about that later in these reasons, application was made in Chile more than one year before the filing of the application in Canada.
[29] Similarly, it was not in dispute that the Chilean patent was "conceded" or, in the terms which the evidence discloses were in use at the relevant time in Chile, was "issued", before the filing of the application in Canada.
[30] The first element of this issue then, postponing for the moment the issue of "same invention", is whether the conceding or "issuing" of the Chilean patent on either the 16th of March or the 27th of May, 1982 constituted an issuing of that patent for the purposes of paragraphs 28(2)(a) and (b) of the Act quoted above.
[31] Counsel for Bayer urged that before a patent can be said to have issued within the meaning of subsection 28(2) of the Act, the following criteria must be satisfied:
| first, the public must have been given some notice of the grant of the patent, as by the laying open to inspection of the patent, its publication, or publication of notice of the issue of the patent in an official journal; |
| second, the public must be able to inspect the specification of the patent and copy it; and |
| third, the application must have reached a stage in its prosecution such that the owner is able to enforce his or her rights to the invention. |
Evidence before me on behalf of Bayer indicates that this is the interpretation given to the word "issue" in subsection 28(2) by the Canadian Patent Office. For the reasons that follow, I am satisfied that the evidence before me substantiates this proposition.
[32] Against this tripartite test, the evidence before me fails to support the proposition that the Chilean patent was "issued" before the filing of the application in Canada that gave rise to the Canadian patents. At the very least, the Chilean patent could not be said to have been open to the public for inspection and copying of the specification before the filing in Canada.
[33] Counsel for Apotex urges that to interpret the word "issue" in subsection 28(2) as counsel for Bayer proposes would be to distort the ordinary meaning of the word and that I should not do so. I cannot agree. In the context of the Act , the concept of issue is, in my view, entirely consistent with the degree of openness urged on behalf of Bayer.
[34] As indicated earlier, the interpretation of the word "issue" in subsection 28(2) that is urged on behalf of Bayer would appear to be consistent with Canadian Patent Office practice as reflected in the Manual of Patent Office Practice that was in force at the relevant time.18 In turn, the Manual is supported in this regard by a paper entitled "Points of Practice in the Canadian Patent Office" and an article entitled "The Statutory Bar with a Foreign Accent".19
[35] While neither the Manual of Patent Office Practice nor the paper and article just referred to are binding on me, I find them persuasive and, in the absence of persuasive evidence that would favour a different interpretation, I adopt the interpretation of "issue" in the context of subsection 28(2) set out therein and urged on behalf of Bayer .
[36] In The Friends of the West Country Association v. The Minister of Fisheries and Oceans and the Director, Marine Programs, Canadian Coast Guard,20 I wrote with respect to the Canadian Environmental Assessment Act Responsible Authorities" Guide, a document not dissimilar in character to the Manual of Patent Office Practice:
The Guide, of course, does not have the force of law. It is not binding on responsible authorities, nor is it binding on, or enforceable by, this Court. That being said, I find the quoted portions apt to the circumstances before me and entirely consistent with the CEAA [the Act there subject to interpretation] and the position enunciated by Mr. Justice Iacobucci on behalf of the Supreme Court. ... I am satisfied that the quoted portions reflect the principles enunciated in the preamble to the CEAA, the purposes enunciated in section 4 thereof, and the principles enunciated by Mr. Justice LaForest in Friends of the Oldman River Society v. Canada (Minister of Transport), ... . While the CEAA is, in general terms, administered under the authority of the Minister of the Environment, responsible authorities may be found in any department or agency of the Government of Canada and beyond that Government. It therefore makes eminent sense that such a guide was published to achieve some degree of uniformity in the application of the CEAA, and its pronouncements should therefore be treated both by responsible authorities and Courts with a reasonable degree of deference as an interpretive tool, to the extent that they are not inconsistent with law. [citations omitted]
[37] Much the same can be said here. The Act falls to be interpreted, used and applied by a broad range of individuals. As with the CEAA, the Canadian Environmental Assessment Act,21 it makes eminent sense that a document such as the Manual of Patent Office Practice was published to achieve a degree of uniformity in the interpretation of the Patent Act and the pronouncements of the Manual should therefore be treated with a reasonable degree of deference as an interpretive tool, to the extent that they are not inconsistent with law.
[38] I find the interpretation of the word "issue" in subsection 28(2) of the Act that is urged on behalf of Bayer and supported in the Manual, not to be inconsistent with law.
[39] I conclude on the evidence before me that, for the purposes of subsection of 28(2) of the Act, the Chilean patent had not "issued" when the application giving rise to the Canadian patents was filed.
[40] Thus, I conclude that the "foreign patent bar" provided by subsection 28(2) of the Act does not apply to disentitle Bayer from obtaining the Canadian patents.
[41] Counsel for Bayer argued, in the alternative, that subsection 29(1) applies to provide Bayer with a priority filing date or "effective" filing date of October 29, 1991, the actual filing date of the German "family II" patent application. In light of my conclusion regarding the interpretation of subsection 28(2) of the Act , it is not necessary that I consider this question. However, in very brief summary, were I to do so, I am satisfied that subsection 28(2) and subsection 29(1) should be read together in such a way that the references to "filing" of an application in Canada in subsection 28(2) are not simply to the actual filing but to any effective or priority filing date to which the applicant is entitled by virtue of subsection 29(1). On the facts of this matter, such an interpretation would entitle Bayer, in the application of subsection 28(2) with respect to the patent application giving rise to the Canadian patents, to the benefit of a priority filing date of October 29, 1981. On such an interpretation, a fortiori , the foreign patent bar provided by subsection 28(2) would not apply to the filing by Bayer of the application giving rise to the Canadian patents.
[42] Counsel for Apotex referred me to Bayer AG and Miles Inc. v. Barr Laboratories Inc., a decision of the United States District Court, Southern District of New York22 where senior DJ Knapp reached a different conclusion as to the interrelationship between the equivalent of subsections 28(2) and 29(1) of the Act in United States law. Judge Knapp wrote:
Bayer"s motion [for partial summary judgment striking a particular defence] relies entirely on the assumption that "the date of the application for a patent in this country" and the date of "filing of the application in the United States" under " 102 (d) [the equivalent of subsection 28(2) of the Act] includes the benefit of a 35 U.S.C. " 119 [the equivalent of subsection 29(1) of the Act] foreign priority date. We believe that " 119 and " 102(d) deal with unrelated concepts and that these two provisions cannot be read together. It is clear that " 119 was intended to preserve the priority of a foreign applicant"s invention against novelty defeating references,... . However , there is no authority indicating that " 102(d) is a novelty or priority provision.
In addition, by referring to a foreign application that was filed more than twelve months before the date of the filing of an application in the United States, " 102(d) preserves " 119's one-year grace period in which to file counterpart applications in other member countries. As noted by Barr, allowing " 119 to modify " 102(d) would give foreign applicants two years within which to file counterpart applications in the United States. In light of the policy behind " 102(d) -- the encouragement of prompt filing of U.S. applications after filing abroad -- this result would seem unreasonable.
[43] Based upon the argument of counsel before me, I am satisfied that the "policy considerations" referred to in the foregoing quotation are not directly applicable in Canada and that therefore the reasoning of Senior DJ Knapp is here inapplicable. In the result, I am not prepared to rely on the American decision, arising in very parallel litigation involving the compound ciprofloxacin, to overcome my conclusion as to the appropriate interpretation of subsections 28(2) and 29(1) of the Act .
[44] Given my findings to this point, the issue of whether the Canadian patents and the Chilean patent are for the same invention, thus potentially invoking the foreign patent bar under subsection 28(2) of the Act, is moot since I have determined that the foreign patent bar, on the basis of the Chilean patent, does not apply with respect to the Canadian patents. That being said, I will nonetheless turn briefly to the issue of "same invention".
[45] The "invention" protected by a patent is defined by the claims of the patent. In Minerals Separation North American Corporation v. Noranda Mines, Limited23, President Thorson wrote:
Section 14.(1) also requires that the specification shall end with a claim or claims stating distinctly the things or combinations which the applicant regards as new and in which he claims an exclusive property and privilege. By his claims the inventor puts fences around the fields of his monopoly and warns the public against trespassing on his property. His fences must be clearly placed in order to give the necessary warning and he must not fence in any property that is not his own. The terms of a claim must be free from avoidable ambiguity or obscurity and must not be flexible; they must be clear and precise so that the public will be able to know not only where it must not trespass but also where it may safely go.
[46] The foregoing general statement is not, in my opinion, in any sense in conflict with later case law which provides, in appropriate circumstances, for reference to the specification of a patent. In Nekoosa Packaging Corp v. AMCA International Ltd.,24 Mr. Justice Robertson wrote:
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After Beecham and Johnson, this court had a further opportunity to elaborate on the law. In TRW Inc. v. Walbar of Canada Inc. ... Stone J. offered a concise analysis of certain accepted canons of patent construction: |
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If a patentee defines and limits with precision, in language which is plain and unambiguous, what it is he claims to have invented, the courts are not "to restrict or expand or qualify" the scope of an invention by reference to the body of the specification: ... . This does not mean, however, that claims are never to be construed in the light of the rest of the specification. It means that such resort is limited to assisting in comprehending the meaning in which words or expressions contained in the claims are used: ... . However, reliance on "stray phrases" in the disclosure for such assistance is not permitted: ... . Nor may the disclosure be used to change a claim from one subject-matter into a claim for another subject-matter..., or to make the words of a claim "say things which in fact it does not say at all":... .
In my opinion, the cases decided after Beecham place it in proper perspective and clear the way for us to recognize the Supreme Court"s approach to the proper construction of a patent.
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In Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd...., Dickson J. (as he then was), speaking for the court, stated: |
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We must look to the whole of the disclosure and the claims to ascertain the nature of the invention and methods of its performance ... , being neither benevolent nor harsh, but rather seeking a construction which is reasonable and fair to both patentee and public. There is no occasion for being too astute or technical in the matter of objections to either title or specification for, as Duff C.J.C. said, ... "where the language of the specification, upon a reasonable view of it, can be so read as to afford the inventor protection for that which he has actually in good faith invented, the Court, as a rule, will endeavour to give effect to that construction". Sir George Jessel spoke to like effect at a much earlier date... . He said the patent should be approached "with a judicial anxiety to support a really useful invention".
As Hayhurst, ... cautions...: "Terms must be read in context and it is therefore unsafe in many instances to conclude that a term is plain and unambiguous without a careful review of the specification ...". [citations omitted]
[47] For the purposes of this matter, I adopt the words of President Thorson from the Minerals Separation case, as quoted above, as recently placed in context by Robertson J. A. in Nekoosa.
[48] I turn then to the claims, first of the Chilean patent and then of the Canadian patents placed in the context of their related disclosures, where appropriate.
[49] The Chilean patent describes and claims a process of preparing a genus compound of Formula I and the genus compound of Formula I prepared by such process.
The genus compound reflects a significant number of variables with the result that it encompasses millions of compounds. Those compounds are of three broad classes: 1,6 naphthyridines; 1,8 naphthyridines; and quinolines, one of which is acknowledged to be ciprofloxacin.
[50] The process in the Chilean patent which is the subject of the patent claims is the reaction of a compound of Formula II with a compound of Formula III to form a compound of Formula I. None of the seven claims of the Chilean patent include the process for making a compound of Formula II.
[51] Claim 1 of the Chilean patent is a claim to a process for the preparation of compounds of general Formula I by reacting a compound of Formula II with a compound of Formula III. Claim 2 is a claim to the compounds of genus Formula I as prepared by the process of claim 1. Claim 3 is a claim to ciprofloxacin, one of the compounds of genus formula I, as prepared by the process of claim 1.
[52] The claims of the 067 Canadian patent, as supported by the disclosure, are not directed to a genus compound, but rather are limited to claims directed to four selected quinolines, labelled Formula I, including ciprofloxacin, and a process involving several distinct steps, only the last of which is a reaction of a compound of Formula II with a compound of Formula III to produce a compound Formula I, being one of the four selected quinolines.
[53] The 067 Canadian patent claims a novel process for making the compound of Formula II which process is termed the malonic ester synthesis process (the "MES process").
[54] The MES process is not described, referred to, or claimed in the Chilean patent. Bayer alleges that the MES process was not known prior to filing of the application leading to the 067 Canadian patent and its priority document, the Germany II patent application.
[55] At least claims 6, 7, 9 by 6, 12, 13 and 14 by 12 in the 067 Canadian patent refer to one or more steps of the MES process. Those claims include a process for making ciprofloxacin, one of the Formula I compounds, using the MES process to form compounds of Formula II, a precursor of ciprofloxacin, a compound of Formula I. None of the steps, save the final step of reacting a compound of Formula II with a compound of Formula III is claimed or disclosed in the Chilean patent.
[56] As indicated earlier in these reasons, the 334 Canadian patent issued from a divisional application of the application giving rise to the 067 Canadian patent and contains substantially the same disclosure as the 067 Canadian patent. The 334 Canadian patent is directed to and claims, among other things, pharmaceutical compositions which contain two specific quinolines, one of which is ciprofloxacin, and the use of those pharmaceutical compositions to combat bacterial disease.
[57] The Chilean patent contains no claim which is the same or similar to the claims of the 334 Canadian patent. In fact, the Chilean patent contains no claim to a pharmaceutical composition or to the use of a pharmaceutical composition.
[58] Against the foregoing brief description of the claims as supported by the disclosures in the Chilean patent and the Canadian patents, I conclude that the Chilean patent is not for the same invention as the invention claimed in either of the Canadian patents.
[59] Counsel for Apotex urges that I should reach a different conclusion based upon the fact that the final step in the Chilean patent, reacting of a compound of a Formula II with a compound of Formula III to produce a compound of Formula I which might be ciprofloxacin, is indeed the same as the final step claimed in the 067 Canadian patent of which the 334 Canadian patent is nothing more than a divisional. I decline to take such a narrow view of the claims of the 067 Canadian patent. As indicated earlier, the Chilean patent discloses and claims no process for making the precursor of ciprofloxacin that is a compound of Formula II, either by the MES process or by any other process. In that regard alone, the invention claimed by the 067 Canadian patent is a different invention than that claimed in the Chilean patent.
[60] Based on the foregoing analysis and findings, an order will go on each of files T-35-96 and T-591-96 prohibiting the Minister of Health from issuing a notice of compliance to Apotex for the medicine ciprofloxacin hydrochloride, including ciprofloxacin hydrochloride tablets 100 mg, 250 mg, 500 mg and 750 mg, until after the expiration of the Canadian patents.
[61] At the close of the hearing, by agreement with counsel, I undertook to reserve the question of costs to be dealt with following the issuance of these reasons and the related orders. It was agreed that the question of costs would be the subject of written submissions unless counsel for any party requests that the issue be dealt with by teleconference or brief resumed hearing. Assuming that costs will be dealt with by written submissions, I rely upon counsel to provide their submissions on an expeditious basis.
___________________________
Judge
Ottawa, Ontario
November 3, 1998
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1 The reference to "the Regulations" is to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 which will be referred to in these reasons as "the Regulations". The Regulations were amended by SOR/98-166, effective the 12th of March, 1998. The Regulations as amended will be referred to in these reasons as the "amended Regulations".
2 See (1995), 65 C.P.R. (3d) 203; Notice of Appeal filed, November 30, 1995, File No. A-787-95; and (1995), 65 C.P.R. (3d) 200; Notice of Appeal filed, November 30, 1995, File No. A-788-95; Discontinued, December 4, 1997.
3 See [1998] F.C.J. No. 1035 (Q.L.). Notice of Appeal filed, September 17, 1998, File No. A-518-98.
4 (1997), 74 C.P.R.(3d) 307 at 314 (F.C.T.D.) Notice of Appeal filed 11 July, 1997 to the Federal Court of Appeal: A-502-97.
5 R.S.C. 1985, c. P-4. While amended since, it was not in dispute before me that this version of the Act was for all relevant purposes, the form of the Act in force at the time of filing of the application giving rise to the Canadian patents and therefore the relevant version of the Act for the purposes of this matter.
6 The International Convention for the Protection of Industrial Property signed in Paris, March 20, 1883.
7 Articles 4A(1) and 4B of the Paris Convention read in part as follows:
A(1). Any person who has duly filed an application for a patent ... in one of the countries of the Union, shall enjoy, for the purpose of filing in the other countries, a right of Priority during the period hereinafter stated. ...
B. Consequently, any subsequent filing in any of the other countries of the Union before the expiration of the periods referred to above shall not be invalidated by reason of any acts accomplished in the interval, in particular, another filing, the publication or exploitation of the invention, ... .
8 (1996), 70 C.P.R. (3d) 206 at 210-11 (F.C.A.).
9 (1991), 35 C.P.R. (3d) 417 at 428 (F.C.T.D.). Affirmed, (1993), 47 C.P.R. (3d) 188 (F.C.A.).
10 Supra, note 3.
11 (1997), 76 C.P.R. (3d) 1 at 10 (F.C.A.) Leave to appeal to the Supreme Court of Canada dismissed on January 8, 1998. Court file No. 26259.
12 Supra, note 6.
13 Application record of the applicants, Volume 3, Tab 13, paragraph 27.
14 For the converse of the abuse I find here, that is, an abuse of the process of this Court by a "first person" rather than of the regulatory scheme by a "second person", see subsection 6(5) of the amended Regulations where a remedy to the like effect of that I propose here is provided in favour of "second persons".
See: Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) 207 (F.C.A.) where, at page 209, Mr. Justice Stone wrote:
It seems to us that while a notice of allegation does play an important role in the ultimate outcome of litigation of this nature, it is not a document by which the judicial review application may be launched under s.6 of the regulations. That document was put in as a piece of evidence by the appellants; it originated with the application filed before the Minister. Because it is not a document that was filed with the court but with the Minister, in our view the notice of allegation is beyond the reach of the court"s jurisdiction in a judicial review proceeding. That being so, the court, in our opinion, lacks jurisdiction to strike out the notice of allegation. See also Schering Canada Inc. v. Nu Pharm Inc. (1996), 68 C.P.R. (3d) 332 (F.C.T.D.) Where Mr. Justice Muldoon wrote:
Although the notice of allegations is not a strikable Court document, it is nevertheless a document having legal effect in contemplation of the law of Canada. The Schering applicants here have given plain notice of seeking the following declaration relief: 2. an order declaring that the Notice of Allegation dated June 22, 1995, provided by the Respondent Nu-Pharm Inc. allegedly in compliance with Section 5(3)(b) of the Regulations with respect to 10mg tablets and 1mg/ml oral liquid syrup of the drug known as loratadine and 5mg loratadine/120 mg pseudoephedrine tablets is void, of no effect and was not provided in compliance with the said Regulations. This relief should be granted ex debito justiciae and for the better administration of the laws of Canada. While the response I have adopted to the abuse of process that I have found is not the same as that adopted by Mr. Justice Muldoon or as the relief requested by Bayer, I am satisfied that the result is substantially the same.
15 The reply memorandum of fact and law on file T-35-96 consists of 124 paragraphs and cites 39 authorities.
16 [1997] 2 C.T.C. 261 (F.C.A.).
17 C.R.C. 1978, c. 663 (as amended).
18 See Exhibit I to the affidavit of Robert E. Mitchell affirmed the 8th of January, 1996; tab 5 M1, Volume 2, Application record of the applicant, Court File No. T-591/96.
19 Exhibits K and J respectively to the Mitchell affidavit referred to in footnote 16, supra .
20 [1998] F.C.J. No. 976. Notice of Appeal filed 25 Sept. 1998, Court file no. A-550-98.
21 R.S.C. 1985, c. C-15.2 (as amended)
22 92 Civ. 0381 (WK), June 2, 1996
23 [1947] Ex. C.R. 306 at 352.
24 (1994), 56 C.P.R. (3d) 470 at 481-2 (F.C.A.).
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