G.D. Searle & Co. v. Novopharm Limited

G.D. Searle & Co. v. Novopharm Limited
Court (s) Database
Federal Court Decisions
Date
2007-01-24
Neutral citation
2007 FC 81
File numbers
T-1067-05
Notes
Reported Decision
Decision Content
Date: 20070124
Docket: T-1067-05
Citation: 2007 FC 81
Toronto, Ontario, January 24, 2007
PRESENT: The Honourable Mr. Justice Hughes
BETWEEN:
G.D. SEARLE & CO. AND PFIZER CANADA INC.
Applicants
and
NOVOPHARM LIMITED AND
THE MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT AND JUDGMENT
[1] This is an application to prohibit the Minister of Health from issuing a Notice of Compliance to the Respondent Novopharm Limited (Novopharm) which, if issued, would permit Novopharm to sell 100 mg and 200 mg capsules containing a medicine known as celecoxib in Canada. For the Reasons that follow I find that the application is to be dismissed with costs to the Respondent.
(1) The Proceedings
[2] These are proceedings commenced by the Applicants, G.D. Searle & Co. and Pfizer Canada Inc. (collectively “Searle”) under the provisions of the Patent Medicines (Notice of Compliance) Regulations, SOR/93-133 as amended (NOC Regulations).
[3] The proceedings were instituted by a Notice of Application filed June 21, 2005, therefore must be determined before June 21, 2007. The process, but not those proceedings, was commenced by a Notice of Allegation served by Novopharm on the Applicants on May 3, 2005. Those allegations were directed to two patents, Canadian Patent No. 2,177,576 (the ‘576 patent) and Canadian Patent No. 2,267,186 (the ‘186 patent). Novopharm alleged that several claims of those patents were irrelevant, several would not be infringed and several were invalid.
[4] The Applicants engaged some of these allegations in its Notice of Application filed with this Court as to both the ‘576 and the ‘186 patents. During the course of the proceedings including during argument at the hearing, a number of issues were withdrawn. The entirety of the ‘186 patent has been withdrawn as have all but claims 4 and 8 of the ‘576 patent. An allegation as to abandonment as to the whole of the ‘576 patent remained at issue.
The Issues
[5] The issues in Notice of Compliance proceedings must be stated in a particular way since they are governed in large measure not only by the Rules and practice of this Court, but more particularly by the NOC Regulations. In brief, section 4 of those Regulations permit a first party (Searle) to list certain types of patents on a list kept by the Minister of Health. Section 5 requires that a second party (Novopharm), who seeks a shortcut in obtaining approval to sell a drug in Canada by referencing materials the first party filed with the Minister, to serve a Notice on Searle alleging, inter alia, that the patents listed would not be infringed or are invalid providing a detailed statement of the legal and factual basis for such allegations.
[6] Section 6(1) of the NOC Regulations permit, but do not require, the person listing the patents (Searle) to file an application with the Court to prohibit the Minister from issuing a Notice of Compliance to the generic until the relevant patents expire. The Applicant is not required to challenge all of the allegations made by the generic, nor to engage all of the patents or claims of a patent addressed in the allegation. From within the Notice of Allegation, the Applicant may pick and choose that which it wishes to engage.
[7] Section 6(2) of the NOC Regulations is directed to the Court hearing the matter and states:
(2) “The Court shall make an Order (prohibiting the issue of an NOC) pursuant to subsection (1) in respect of a patent that is the subject of one or more allegations if it finds that none of the allegations is justified.
(2) Le tribunal rend une ordonnance en vertu du paragraphe (1) à l’égard du brevet visé par une ou plusieurs allégations si elle conclut qu’aucune des allégations n’est fondée.
[8] Thus the issue before the Court is whether, in respect of any allegation put in play, the allegation is justified.
Issues
[9] As previously discussed, one patent and several claims of the other have been withdrawn or abandoned. As a result, the following are the issues for determination in these proceedings:
1. Is the allegation that the application for the ‘576 patent was abandoned, justified?
2. Are any of the allegations that either or both of claims 4 and 8 of the ‘576 patent are invalid, justified, those allegations being, in brief:
i. Obviousness;
ii. Lack of utility; and
iii. Sufficiency.
[10] If Novopharm were to succeed on any of these issues 1 or 2(a), (b) or (c), this Court would be required to dismiss this application.
The ‘576 Patent
[11] The only patent now at issue is the ‘576 patent, Canadian Patent No. 2,177,576. The ‘576 patent is entitled “Substituted Pyrazolyl Benzenesulfonamedes for the Treatment of Inflammation” and names John J. Talley and twelve others as inventors.
[12] The application for that patent was filed in the Canadian Patent Office effective November 14, 1994, and, unless otherwise held to be invalid, the patent will expire twenty years from that date, November 14, 2014. The application and patent are to be governed by the relevant provisions of the Patent Act and Rules dealing with post October 1, 1989, and post October 1, 1996, applications and patents maturing therefrom. The patent application was laid open for public inspection on June 8, 1995. The patent was issued and granted to Searle on October 26, 1999.
[13] The patent claimed priority from two earlier applications filed in the United States Patent Office, one on November 30, 1993, the other on April 6, 1994. Neither application appears in the Record in these proceedings.
[14] In a general way it can be said that the patent deals with compounds that treat inflammation without troubling the gastric system. There have been steroidal compositions that treat inflammation and non-steroidal (NSAIDS) compositions that do so as well. Aspirin and ibuprofen are commonly known NSAIDS. The patent states that some NSAIDS are known to have side effects such as irritation or ulceration of the gastro-intestinal (GI) tract. An objective of the patent is to provide an anti-inflammatory compound with less harmful side effects. After some discussion, Counsel for the Applicants conceded that both the anti-inflammatory properties and lesser side effects were necessary to the utility of the claimed invention.
[15] A mechanism by which the desired effects were achieved is described in the patent as the COX (cyclooxygenase) theory. At one time it was believed that NSAIDS worked by inhibiting COX as produced in the body. Later, scientists believed that there was two cyclooxygenases in the body, COX I and COX II and that a compound that would selectively inhibit COX II but not COX I could result in the treatment of inflammation without appreciable unwanted side effects. The patent deals with such compounds. It is agreed by the parties that one such compound, given the name celecoxib, is that as claimed in claim 4. It is sold by the Applicants under the name CELEBREX.
[16] Turning to the patent in more detail, page 1 gives a brief introduction followed by statement by way of background:
Field of the Invention
This invention is in the field of anti-inflammatory pharmaceutical agents and specifically relates to compounds, compositions and methods for treating inflammation and inflammation-associated disorders, such as arthritis.
Background of the Invention
Prostaglandins play a major role in the inflammation process and the inhibition of prostaglandin production, especially production of PGG2, PGH2 and PGE2, has been a common target of anti-inflammatory drug discovery. However, common non-steroidal anti-inflammatory drugs (NSAIDS) that are active in reducing the prostaglandin-inducted pain and swelling associated with the inflammation process are also active in affecting other prostaglandin-regulated processes not associated with the inflammation process. Thus, use of high doses of most common NSAIDS can produce sever side effects, including life threatening ulcers, that limit their therapeutic potential. An alternative to NSAIDS is the use of corticosteroids, which have even more drastic side effects, especially when long term therapy is involved.
Previous NSAIDS have been found to prevent the production of prostaglandins by inhibiting enzymes in the human arachidonic acid/prostaglandin pathway, including the enzyme cyclooxygenase (COX). The recent discovery of an inducible enzyme associated with inflammation (named “cyclooxygenase II (COX II)” or “prostaglandin G/H synthase II”) provides a viable target of inhibition which more effectively reduces inflammation and produces fewer and less drastic side effects.
[17] Certain prior art is set out at pages 2 and following, the most relevant being the first, a patent to Matsuo, in which certain compounds there described become important later in these Reasons. It says:
Pyrazoles have been described for use in the treatment of inflammation. U.S. Patent No. 5,134,142 to Matsuo et al describes 1,5-diaryl pyrazoles, and specifically, 1-(4-fluorophenyl)-5-[4-(methylsulfonyl)phenyl]-3-trifluoromethyl pyrazole, as having anti-inflammatory activity.
[18] Commencing at page 4 the patent sets out general classes of compositions, followed by more restrictive and yet more restrictive classes of compounds, and lists many specific compounds of interest. It must be noted that while the discussion at page 4 commences with reference to a general formula, Formula I, it is only a more restricted class of compounds as defined by Formula II set out at page 22 that is the subject of the claims of the patent.
[19] The use of the compounds is set out at pages 7 and 8 of the patent.
Compounds of Formula I would be useful for, but not limited to,…
The compounds are useful as antiinflammatory (sic) agents, such as for the treatment of arthritis, with the additional benefit of having significantly less harmful side effects.
[20] The “preferable” way to measure the utility is described at page 8 with respect to the “selectivity” ratio at which COX II is selected over COX I by the compound:
The present invention preferably includes compounds which selectively inhibit cyclooxygenase II over cyclooxygenase I. Preferably, the compounds have a cyclooxygenase II Ic50 of less than about 0.2 μM, and also have a selectivity ration of cyclooxygenase II inhibition over cyclooxygenase I inhibition of at least 50, and more preferably of at least 100. Even more preferably, the compounds have a cyclooxygenase I IC50 of greater than about 1 μM, and more preferably of greater than 10 μM. Such preferred selectivity may indicate an ability to reduce the incidence of common NSAID-induced side effects.
[21] Example 2 of the patent at pages 72 and 73 is specific to celecoxib as claimed in claim 4.
[22] A biological evaluation of the compounds, including that of Example 2, commences at page 175 of the patent. Table XI at page 177 presents data as to inflammation inhibition provided by several of the compounds including that of Example 2. Table XII at pages 180 and 181 provides data as to COX I and COX II inhibition provided by the compounds including that of Example 2. Example 2 provides COX II inhibition at less than 0.1 while providing COX I inhibition at 15.0 thus giving a ratio of greater than 150 and well above the minimum desired range of 50 or 100 as discussed at page 8.
[23] The only claims that require consideration are claims 4 and 8 which read:
4. Compound of Claim 2 where the compound is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-y1]benzenesulfonamide, or a pharmaceutically-acceptable salt thereof.
[24] Claim 2 in turn refers to claim 1 and each simply claims a more general class of compounds which includes the compound of claim 4.
8. A pharmaceutical composition for treating inflammation or an inflammation –associated disorder comprising a therapeutically-effective amount of a compound and a pharmaceutically-acceptable carrier or diluent, said compound selected from compounds according to any of Claims 1-7.
[25] Counsel for the Applicants stated in argument that claim 8 was asserted only to the extent that it relied on claim 4.
Construction of Claims 4 and 8
[26] The Court must, before further consideration of a patent, construe the claims. Much law has been written as to claim construction which need not be repeated here as there is little controversy except as to one point raised by claim 8, which I will discuss.
[27] Claim 4 recites a single chemical compound and includes a pharmaceutically acceptable salt of the compound. That compound can simply be referred to as celecoxib. No use of that compound is stated in that claim but, as conceded by Counsel for the Applicants, the utility of that compound is set out in the specification as being the duality of treatment of inflammation and reduction of unwanted side effects such as ulcers of the gastrointestinal system. Celecoxib may be depicted as:
Celecoxib
[28] Claim 8 is directed to the use of a composition in the treatment of inflammation or an inflammation-associated disorder in which a therapeutically effective amount of celecoxib or other compounds as set out in “any of claims 1-7” is used.
[29] An issue arises as to the meaning of the words “any of claims 1-7”. Does this phrase include all compounds in those claims or is it simply a shorthand way of referring to each claim separately instead of having many claims, one referring to claim 1, the next to claim 2 and so forth. Section 27(5) of the Patent Act post October 1, 1996 (this patent was granted in 1999) provides:
“(5) For greater certainty, where a claim defines the subject matter of an invention in the alternative, each alternative is a separate claim for the purposes of sections 2, 28.1 to 28.3 and 78.3.”
“(5) Il est entendu que, pour l’application des articles 2, 28.1 à 28.3 et 78.3, si une revendication définit, par variantes, l’objet de l’invention, chacune d’elles constitue une revendication distincte.”
[30] A claim very similar in wording to claim 8 at issue here was considered by this Court, and ultimately the Supreme Court of Canada, in Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., (1978), 39 C.P.R. (2nd) 145 (SCC). In Consolboard claim 16 of the patent ‘565, 681 read “a consolidated structure as claimed in claims 7, 8 or 9 in which the tapered ends of the wafers are ragged”. Claims 8 and 9 were held to be invalid, only claim 7 was valid. The Federal Court and ultimately the Supreme Court held claim 10 to be valid “as far as it includes claim 7”.
[31] By way of contrast, this Court in Abbott Laboratories v. Canada, (2005), 45 C.P.R. (4th) 81, held to be invalid a claim where ingredients of a composition were “selected from a group consisting of (a number of individually named compounds)”. It was found on the evidence that some of those compounds did not have the requisite utility. I find the Abbott claims to be different from claim 8 at issue here. In Abbott the claim stated, in effect, that all members of the group were useful whereas at least some were found on the evidence not to be.
[32] Here, I construe claim 8, for purposes of these proceedings, to refer to claims 1 to 7 separately, thus can be construed to refer to claim 4 only. Claim 8 therefore is directed to the use of a drug containing an appropriate quantity of celecoxib for treatment of inflammation or an inflammation related disorder.
Who Has What Burden
[33] Notice of Compliance proceedings such as these do not follow the normal course expected of actions and applications before the Court. They are governed by the NOC Regulations and the Rules of this Court to the extent not otherwise provided in those Regulations. These proceedings are awkward and almost unfathomable to even the most experienced practitioner outside of the small group of those specializing in the area.
[34] The process begins not with a document filed with the court but a document prepared by a generic (second party) such as Novopharm called a Notice of Allegation served by the generic on the innovator (first party) who has listed patents with the Minister. Jurisprudence has developed to the point where it is established that this Notice must set out all bases upon which issues such as invalidity and infringement are raised. The Notice must include much detail as to the evidence, references and opinions upon which the generic rests its allegations together with substantial legal argument. Amendment is nearly impossible, a fresh document may in some circumstances, be delivered, but that has an effect of starting the process all over and giving the innovator an opportunity to establish a new two year stay on proceedings by the Minister each time a fresh Notice is delivered.
[35] The Notice of Allegation is then the “target” for the innovator, it may choose which of the allegations it wishes to challenge on the basis that they are not “justified”. The challenge by the innovator takes the form of a Notice of Application to the Court. The innovator (first party-Applicant) may select which of the allegations that it challenges and set that out clearly in the Notice. In addition, if the innovator wishes to raise a point that would otherwise surprise or “vex” the generic (see Pfizer Canada Inc. v. Apotex Inc., (2005), 43 C.P.R. (4th) 81 (FC) at paragraph 10) it must raise such point in its Notice of Application. The innovator at least has the advantage in that the Federal Courts Rules provide an opportunity, in appropriate circumstances, to amend the Notice of Application.
[36] Having filed the Notice of Application, the innovator, as Applicant, under the Federal Courts Rules, must file such evidence as it chooses to support its position that the allegations of the generic which it chose to challenge are not “justified”. Section 6(5) of the NOC Regulations provide that a generic may bring a motion to strike out the proceedings as abusive. If the Notice of Application and evidence fail to establish a case or is otherwise inappropriate, the proceedings or part thereof could be struck out (see Sanofi-Aventis v. Novopharm Limited, December 19, 2006, 2006 FC 1547).
[37] After the innovator (Applicant) has filed its evidence, the Rules of the Court require that the generic (Respondent) file its evidence. That evidence is directed to the challenges to the allegations set out in the Notice of Application and evidence of the innovator. A question arises as to whether the generic can, in whole or in part, simply rely on the allegations made in the Notice of Allegation as being themselves in evidence to the extent that the innovator’s evidence fails to address in sufficient fashion that which is alleged. While this matter has not been entirely settled, it would be imprudent for a generic not to support its allegations with appropriate factual and opinion evidence.
[38] Where the issues are directed to validity, there is a complication. The innovator can, in its Notice of Application, invoke the presumption of validity provided in the Patent Act, section 43(2) of the post October 1, 1996, version, to the effect that a patent is presumed valid “in the absence of any evidence to the contrary”. Having raised the presumption but being forced by the Rules to file evidence first to address the allegations of invalidity, an innovator should file evidence rebutting the allegations as to invalidity. The generic should then file its own evidence supporting its allegations and rebutting the evidence of the innovator.
[39] The question of burden of proof in NOC proceedings, where issues of validity are raised, was canvassed in Pfizer Canada Inc. v. Canada, (2006), 46 C.P.R. (4th) 481, at paragraphs 6 to 12, in Abbott Laboratories v. Apotex Inc., 2006 FC 1558, at paragraphs 85 to 94, and in Pfizer Canada Inc. v. Apotex Inc., 2007 FC 26, at paragraphs 5 to12. . The Respondent (generic) must put the invalidity allegations in play, the Applicant may respond by asserting the presumption of validity. Should the Applicant lead no evidence as to validity but the Respondent does lead some evidence, the Applicant would place itself at a serious disadvantage. Once the evidence is in, the Applicant bears the ultimate burden to establish that the allegations of invalidity are not justified.
The Meaning of “Justified”
[40] Section 6(2) of the NOC Regulations require a determination by the Court as to whether the Applicant has demonstrated that “none of those allegations is justified”.
[41] The meaning of the word “justified” or in the French language “fondée”, was considered by the Federal Court of Appeal in Genpharm Inc. v. Procter & Gamble Pharmaceuticals Canada Inc. (2004), 37 CPR (4th) 289 . It means the ordinary civil burden on a balance of probabilities.
History of the Development of Celecoxib
[42] Much of what is at issue in these proceedings turns on what was known to the Applicant, Searle, and various persons including Dr. Seibert and her group at Searle doing biological work , as well as what was done by or known to the inventors named in the patent (Talley et al), at relevant periods of time and what was disclosed by Searle to the public. This is to be measured against what the evidence shows would have been known to the ordinary person skilled in the art as of the relevant time.
[43] As will be discussed, there is a lack of evidence in many areas that are critical to this discussion. The Court must deal with the Record that it has.
[44] I will first deal with the scheme of the Patent Act as it pertains to the ‘576 patent, then with the nature of the evidence in the Record and then with the pertinent matters disclosed in that evidence.
Scheme of the Patent Act
[45] The Patent Act although it is cited as R.S.C. 1985, c. P-4, is actually divided into three parts, one part deals with applications filed before October 1, 1989, the second with applications filed after that date and before October 1, 1993, and the third with applications filed after October 1, 1996. To some extent, the patents resulting from those application will be affected by later versions of the Act even though the application was filed at a time period pertinent to an earlier version.
[46] The application for the ‘576 patent was filed with the Canadian Patent Office on an effective date of November 14, 1994, thus the version of the Patent Act for the period between October 1, 1993, and October 1, 1996, is pertinent. However the application continued to be prosecuted in the Canadian Patent Office after October 1, 1996. The patent was ultimately issued on October 26, 1999. Thus post October 1, 1996, provisions of the Patent Act will be pertinent as well. I will refer to these two version as pre October 1, 1996, and post October 1, 1996. The transitional provisions of the post October 1, 1996, version, section 78.4 and 78.5 provides as to how the transition, for purposes here, is managed:
78.4 Patent applications filed on or after October 1, 1989 - Applications for patents in Canada filed on or after October 1, 1989, but before October 1, 1996, shall be dealt with and disposed of in accordance with subsection 27(2) as it read immediately before October 1, 1996 and with the provisions of this Act as they read on October 1, 1996.
78.4 Régime applicable au traitement de certaines demandes - La présente loi dans sa version du 1er octobre 1996 de même que le paragraphe 27(2) dans sa version du 30 septembre 1996 s’appliquent aux demandes de brevet déposées le 1er octobre 1989 ou par la suite, mais avant le 1er octobre 1996.
78.5 Patents issued on or after October 1, 1989 - Any matter arising in respect of a patent issued on the basis of an application filed on or after October 1, 1989, but before October 1, 1996, shall be dealt with and disposed of in accordance with the provisions of this Act and with subsection 27(2) as it read immediately before October 1, 1996.
78.5 Régime applicable aux affaires relatives à certains brevets - La présente loi de même que le paragraphe 27(2) dans sa version du 30 septembre 1996 s’appliquent aux affaires relatives aux brevets délivrés au titre de demandes déposées le 1er octobre 1989 ou par la suite, mais avant le 1er octobre 1996.
[47] Section 27(2) as referred to in these provision, as it read in the pre October 1, 1996, version of the Act, dealt with a situation where a patent was previously granted to the applicant in another country before an application was filed in Canada. It said:
27(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 that 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 that 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 that inventor or his legal representative for patent for that invention in any other country.
27(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 sone 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 :
a) soit avant la délivrance d’un brevet à cet inventeur ou à son représentant légal couvrant cette même invention dans tout autre pays;
b) soit, 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 cette invention dans tout autre pays.
[48] There is a further complexity since the application for the ‘576 patent was filed in Canada under the provisions of the Patent Co-Operation Treaty (PCT). That treaty provides that a single application can be filed in an appropriate “receiving office” of one of the countries adhering to that Treaty and obtain a filing date pertinent to all, or a selected group of other of such countries, provided that the applicant enters the “national phase” of such other countries within an appropriate time period. Here the original “international” application was filed in the United States as a receiving office on November 14, 1994, and entered the national phase in Canada on May 28, 1996, (Applicant’s Record, Vol. 3, pg. 613). However, in accordance with the Treaty, the application is considered to have been filed in the Canadian Patent Office with an effective date of November 14, 1994.
[49] An “applicant” is defined in section 2 of both versions of the Patent Act as the inventor and legal representative of the inventor, such as an assignee. Thus the “applicant” is a person standing in the shoes of the inventor(s). Searle is the Applicant because it is the assignee of Talley et al., the named inventors and not otherwise.
[50] As of the Canadian filing date (November 14, 1994), both versions of the Patent Act (section 27(1)(c) and (d) pre October 1, 1996, and section 28.2(a) post October 1, 1996) provide that the invention should not have been previously disclosed in such a manner as to become available to the public before that date except that the applicant or person obtaining knowledge from the applicant has a twelve month grace period prior to that date as to disclosures.
[51] Section 28.3 of the post October 1, 1996, Act provides that an invention must not have been obvious as of the “claim date” having regard to information disclosed to the public prior to that date, except for information disclosed by the applicant or person gaining knowledge from the applicant, in which case a twelve month grace period prior to the Canadian filing date applies to such information.
[52] Sections 28.1 and 28.4 of the post October 1, 1996, Act provides that the “claim date” is the Canadian filing date unless there has been a proper assertion of one or more priority dates respecting applications filed in another “treaty or convention country disclosing the subject matter defined by the claims”. If such priority has been claimed, and such subject matter was disclosed before the Canadian filing date, then the priority date becomes the “claim date” for which obviousness may be tested, provided that it can be shown that the priority application disclosed the same invention as claimed in the ultimate patent as issued. Sections 27 and 28 of the pre October 1, 1996, Act are to the same effect, except that section 28 uses the word describe rather than disclose ,the meaning is the same for the purposes of the discussion here.
[53] On a different point, effective October 1, 1996, section 73 was added to the Patent Act requiring a “reply in good faith” to requisitions by a patent office examiner, payment of fees and other compliances, failing which an application would become abandoned subject to certain re-instatement opportunities. It reads:
73. Deemed abandonment of an application
(1) An application for a patent in Canada shall be deemed to be abandoned if the applicant does not
(a) reply in good faith to any requisition made by an examiner in connection with an examination, within six months after the requisition is made or within any shorter period established by the Commissioner;
(b) comply with a notice given pursuant to subsection 27(6);
(c) pay the fees payable under section 27.1, within the time provided by the regulations;
(d) make a request for examination or pay the prescribed fee under subsection 35(1) within the time provided by the regulations;
(e) comply with a notice given under subsection 35(2); or
(f) pay the prescribed fees stated to be payable in a notice of allowance of patent within six months after the date of the notice.
(2) Deemed abandonment in prescribed circumstances - An application shall also be deemed to be abandoned in any other circumstances that are prescribed.
(3) Reinstatement - An application deemed to be abandoned under this section shall be reinstated if the applicant
(a) makes a request for reinstatement to the Commissioner within the prescribed period;
(b) takes the action that should have been taken in order to avoid the abandonment; and
(c) pays the prescribed fee before the expiration of the prescribed period.
(4) Amendment and re-examination - An application that has been abandoned pursuant to paragraph (1)(f) and reinstated is subject to amendment and further examination.
(5) Original filing date - An application that is reinstated retains its original filing date.
73. Abandon (1) La demande de brevet est considérée comme abandonnée si le demandeur omet, selon le cas:
a) de répondre de bonne foi, dans le cadre d’un examen, à toute demande de l’examinateur, dans les six mois suivant cette demande ou dans le délai plus court déterminé par le commissaire;
b) de se conformer à l’avis mentionné au paragraphe 27(6);
c) de payer, dans le délai réglementaire, les taxes visées à l’article 27.1;
d) de présenter la requête visée au paragraphe 35(1) ou de payer la taxe réglementaire dans le délai réglementaire;
e) de se conformer à l’avis mentionné au paragraphe 35(2);
f) de payer les taxes réglementaires mentionnées dans l’avis d’acceptation de la demande de brevet dans les six mois suivant celui-ci.
(2) Idem - Elle est aussi considérée comme abandonnée dans les circonstances réglementaires.
(3) Rétablissement - Elle peut être rétablie si le demandeur :
a) présente au commissaire, dans le délai réglementaire, une requête à cet effet;
b) prend les mesures qui s’imposaient pour éviter l’abandon;
c) paie les taxes réglementaires avant l’expiration de la période réglementaire.
(4) Modification et réexamen - La demande abandonnée au titre de l’alinéa (1)f) et rétablie par la suite est sujette à modification et à nouvel examen.
(5) Date de dépôt originelle - La demande rétablie conserve sa date de dépôt.
Nature of the Evidence in the Record
[54] The evidence that is pertinent to the issues of obviousness and candor of disclosure consists of the following:
1. The ‘576 patent itself (Applicant’s Record Vol. 1, Tab 4, pp 25-221);
2. The file history of the application for the ‘576 patent as it exists in the records of the Canadian Patent Office (Applicant’s Record, Vols. 2 & 3, Tab A, pp 225-821). This Record includes, among other things, the application as originally filed in the Canadian Patent Office, Vol. 3, page 616-821. It must be noted that this is not either of the priority applications relied upon in the patent;
3. The affidavit of Dr. Karen Seibert, Vice-President of Discovery Research at Pfizer Inc., together with Exhibits A through J (Applicant’s Record, Vol. 5, Tabs 10 and A through J, pages 1110 – 1201). She is not a named inventor of the ‘576 patent;
4. Transcript of the cross-examination of Dr. Seibert and Exhibits 1, 2 and 3 thereto (Respondent’s Record, all of Vol. 14, page 4458-4635); and
5. The two priority applications relied upon by Searle in the 576 patent (Respondents Record Vol 4, pages 876-1128).
[55] It is important to note what is not in the Record.
1. Evidence from any inventor named in the ‘576 patent. Dr. Seibert in her cross-examination, pages (4500-4506, Respondent’s Record, Vol. 14) acknowledged that many of them are still alive and can be located;
2. The exhibits A to J of Dr. Seibert’s affidavits dealing with laboratory work at Searle, are severely redacted so that apparently only references to celecoxib and nothing else, are visible. Although she says in paragraph 8 of her affidavit (Applicant’s Record, Vol. 5, page 1113) that she reviewed the unredacted versions, in cross-examination (Vol. 14 of Respondent’s Record commencing at page 4547) she said the redactions were made by the “legal team” and that she did not compare the copies with the original notebooks. Therefore I have placed little reliance on these documents; and
3. No other person who would have direct knowledge as to what was happening at Searle at the relevant time, gave evidence.
Pertinent Matters Disclosed in Evidence
[56] From the evidence as presented in the Record as described above, I make the following findings:
1. Commencing in or before 1991, certain teams of scientists at Searle were investigating the potential use of compounds to treat inflammation that would selectively inhibit what became known as COX II as opposed to COX I, the theory being that such a compound would minimize gastrointestinal side effects experienced with other inflammation treating compounds. (Seibert affidavit, paragraphs 3 to 7, Applicant’s Record, pages 1112-1113);
2. Dr. Seibert headed up the biology team of those working on the COX II project. Dr. Peter Isakson was the overall team leader. (Seibert cross-examination, Respondent’s Record, page 4490). Dr. Seibert is not listed as an inventor of the ‘597 patent (cross-examination, Respondent’s Record, page 4506) nor is Dr. Isakson (patent cover page, Applicant’s Record, page 26);
3. Molecules identified in Figure 1 of Exhibit 1 to Dr. Seibert’s cross-examination as 1 (DuPont 697) and 2 (NS-398) became known to Dr. Seibert’s team in the 1992 time frame. (Seibert cross-examination, Respondent’s Record, 4506-4516). This cross-examination makes it clear that Dr. Seibert is not the chemist who developed the compounds, her task was to evaluate them from a biological standpoint. Her testimony does not reveal how knowledge of those compounds or their development came about;
4. Dr. Seibert’s group in this early 1990’s period were screening randomly a number of compounds including SC-58125, DuP 697 and NS-398 looking for appropriate compounds. They studied different constituents on the structure of those compounds to understand the structure-to-activity relationship. (Seibert cross-examination, Respondent’s Record, pages 4527-4531);
5. Sometime prior to October 1993, Dr. Seibert’s team was working on celecoxib and other compounds including SC-58125 in addition to DuP 697 and NS-398. (Seibert affidavit, Exhibits A et seq, Applicant’s Record, pages 1131 ff);
6. By November 1993, Dr. Seibert’s team had established, in vitro that celecoxib selectively inhibits COX-2 more than 250 times more than COX-1. (Seibert affidavit, Applicant’s Record, paragraph 24, page 1117);
7. November 30, 1993, the first priority application as claimed in the ‘597 patent, was filed in the United States (Respondents Record Vol 4 pages 1006-1128). As will be discussed later the compound now known as celecoxib is not specifically described nor is any biological data given as to that compound. No mention is made of COX 1 or COX 2;
8. By 1994 the approaches to be taken by scientists to assess gastric toxicity studies for such compounds was pretty well known. (Seibert cross-examination, Respondent’s Record, page 4534);
9. By February 14, 1994, Dr. Seibert’s team had determined, using a rat model, that celecoxib exhibited both anti-inflammatory and analgesic effects. (Seibert affidavit, Applicant’s Record, paragraph 61, page 1129);
10. April 6, 1994, the second priority application as claimed in the ‘597 patent was filed in the United States (Respondents Record Vol 4 pages 876-1004). Again no specific disclosure of celecoxib is made nor any biological data as to that compound give nor any mention as to COX 1 or COX 2;
11. By June 1994, Dr. Seibert’s team had determined that compound SC-58125 exhibited anti-inflammatory properties while not causing gastric toxicity (Seibert cross-examination, Respondent’s Record, pages 4530-4531);
12. At a meeting in June 1994, Dr. Siebert made a public disclosure that SC-58125 treated inflammation while not causing gastric toxicity. (Seibert cross-examination, Respondent’s Record, page 4531);
13. In August 1994, Dr. Seibert’s paper respecting SC-58125 was submitted to a peer review scientific publication for publication. That paper was published in the December 1994 issue of that publication. That paper disclosed that compound SC-58125 treated inflammation without exhibiting gastric side-effects. (Seibert cross-examination, Respondent’s Record, pages 4527-4534; copy of the published paper, Respondent’s Record, pages 4630-4634);
14. The compound SC-58125 is one of the compounds that comes within the scope of a patent granted to Matsuo, U.S. Patent 5,134,142 (the ‘142 patent) that is referenced at page 2 of the ‘576 patent. (Exhibit 3 to Seibert cross-examination, Respondent’s Record, page 1635; Moody Affidavit, paragraphs 107-109, Applicant’s Record, page 2258-2259; Knaus Affidavit, paragraphs 146-158, Applicant’s Record, pages 3733-3735);
15. The difference between the Matsuo ‘142 compound (SC-58125) and one of the Applicants compounds specifically disclosed in the ‘576 patent in Example 17 are illustrated in Exhibit 3 to Dr. Seibert’s cross-examination as follows:
Matsuo Compound Applicant's Compound
The difference is that in the upper left hand corner of the illustration, Matsuo has H3C whereas the Example 17 compound has H3N. This can be described as Matsuo having a methyl group on the sulphonyl (methylsulphonyl) and Example 17 having an amino group on the sulphonyl (aminosulphonyl). Methylsulphonyl is, chemically speaking, an isostere of aminosulfonyl. (Supuran cross-examination, Respondent’s Record, page 4993). The difference between the Matsuo compound and celecoxib is that celecoxib has an H3C at the lower left instead of an F as well as an aminosulponyl rather than a methylsulponyl; and
16. November 14, 1994, is the effective filing date in the Canadian Patent Office of the application for the ‘597 patent. (Applicant’s Recor