Bristol-Myers Squibb Canada Co. v. Apotex Inc.

Bristol-Myers Squibb Canada Co. v. Apotex Inc.
Court (s) Database
Federal Court Decisions
Date
2009-02-10
Neutral citation
2009 FC 137
File numbers
T-891-07
Notes
Digest
Decision Content
Date: 20090210
Docket: T-891-07
Citation: 2009 FC 137
Toronto, Ontario, February 10, 2009
PRESENT: The Honourable Mr. Justice Hughes
BETWEEN:
BRISTOL-MYERS SQUIBB CANADA CO. and
BRISTOL-MYERS SQUIBB COMPANY
Applicants
and
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT AND JUDGMENT
[1] This is an application brought under the provisions of the Patented Medicines (Notice of Compliance) Regulations SOR/93-133, as amended (NOC Regulations) in which the Applicants Bristol-Myers Squibb Canada Co. et al. seek to restrain the Respondent Apotex Inc. from obtaining a Notice of Compliance from the Respondent Minister of Health to sell a generic version of a drug containing cefepime dihydrochloride monohydrate (which the parties refer to as CDM) until the expiry of Canadian Patent No. 1,298,288 (’288 patent). For the reasons that follow, I find that the application is dismissed with costs to Apotex Inc.
THE PARTIES
[2] The Applicants are Bristol-Myers Squibb Canada Co. (BMS Canada) which company is, as agreed by counsel for the parties at the hearing, the holder of a Notice of Compliance from the Minister for the drug in question. BMS Canada is known as a “first person” in the scheme of the NOC Regulations. The second Applicant Bristol-Myers Squibb Company (BMS US) is the owner of the ’288 patent at issue and presumably is corporately related to BMS Canada. Collectively the Applicants will be referred to as BMS or the Applicants.
[3] The Respondent Apotex Inc. is a generic drug company, known as a “second person” in the scheme of the NOC Regulations. It will be referred to as Apotex. The Respondent, Minister of Health, herein referred to as the Minister, is charged with issuing Notices of Compliance to permit the sale and distribution of certain drugs in Canada and is charged with certain duties under the NOC Regulations. The Minister was not represented in these proceedings although served with the appropriate documents.
THE DRUG
[4] The drug in question is generally known as cefepime dihydrochloride monohydrate (CDM). It is a crystalline dihydrochloride monohydrate acid addition salt of 7-[α-(2-aminothiazol-4-yl)-α-(Z)- methoximinoacetamido]-3-[(1-methyl-pyrrolidinio)methyl]-3-cephem-4-carboxylate. It is an antibiotic.
[5] CDM is a member of a class of beta-lactam antibiotics known as cephalosporins. It is a complex molecule. Such molecules are known to possess an electrical charge + or – at certain locations. Those molecules which exist in a form in which the totality of such electrical charges around the molecule is zero are considered to be neutral or in the language of the patent are a zwitterion or are said to be zwitteric. BMS acknowledges that the zwitterion form of the cefepime molecule is prior art to the patent at issue having been disclosed for instance in a previous patent, Canadian Patent No 1,213,882 (the ‘882 patent).
[6] BMS Canada has received a Notice of Compliance from the Minister to market this drug in Canada which it does under the brand name MAXIPIME.
THE PROCEEDINGS
[7] Apotex wishes to receive a Notice of Compliance from the Minister to market a generic version of this drug in Canada. Apotex has availed itself of procedures to abbreviate its submissions to the Minister by referencing BMS Canada’s Notice of Compliance. Thus Apotex must comply with the provisions of the NOC Regulations. In that regard, Apotex served BMS Canada with a Notice of Allegation dated April 2, 2007 alleging that each of the claims of the ’288 patent is invalid. In response, the Applicants commenced this application to prohibit the Minister from issuing a Notice of Compliance to Apotex until the expiry of the ’288 patent.
THE ’288 PATENT
[8] Canadian Patent 1,298,288 (the ’288 Patent) was issued and granted to BMS US on March 31, 1992. The application for the patent was filed in the Canadian Patent Office on January 18, 1989. Since this date of application precedes the date of the substantial revisions of the Patent Act, R.S.C. 1985, c. P-4 on October 1, 1989, consideration of the ’288 patent and the validity of its claims is to be decided having regard to the pre-October 1, 1989 or “old” version of the Patent Act.
[9] The application for the ’288 Patent claims priority from an application filed on January 19, 1988 in the United States Patent Office as number 144,899. The ’288 Patent endures for the term of 17 years from the date of its grant that is, until March 31, 2009. This application was launched by the Applicants by filing a Notice of Application on May 23, 2007, thus under the provisions of the NOC Regulations, this application must be determined by May 23, 2009. I inquired of the parties as to whether they were content simply to await the expiry of the ’288 Patent since the expiry date predates by about two months the date set by the NOC Regulations for determination of this application. Apotex was not content to wait citing a number of reasons in its correspondence with the Court such as a right to claim damages and possible early entry into the market. This application has proceeded to a hearing and this determination.
[10] On May 22, 2008, the day before the Applicants filed the Notice of Application in these proceedings, BMS US as patentee filed with the Canadian Patent Office a document known as a disclaimer. That disclaimer was directed to claims 1 and 2 of the ’288 Patent and stated, in part:
4. The patentee disclaims the entirety of claim 1 with the exception of the following:
1. Substantially pure temperature stable crystalline dihydrochloride hydrate acid addition salt 7-[α-(2-aminothiazol-4-yl)-α-(Z)- methoximinoacetamido]-3-[(1-methyl-pyrrolidinio) methyl]-3-cephem-4-carboxylate containing from 2.5% to 7.0% by weight of water.
5. The patentee disclaims the entirety of claim 2 with the exception of the following:
2. Substantially pure temperature stable crystalline dihydrochloride monohydrate acid addition salt 7-[α-(2-aminothiazol-4-yl)-α-(Z)- methoximinoacetamido]-3-[(1-methyl-pyrrolidinio) methyl]-3-cephem-4-carboxylate containing from 2.5% to 4.1% by weight of water.
[11] Prior to May 22, 2008, the date of filing of the disclaimer, claims 1 and 2 had read:
1. Temperature stable crystalline dihydrochloride hydrate acid addition salt of 7-[α-(2-aminothiazol-4-yl)-α-(Z)- methoximinoacetamido]-3-[(1-methyl-pyrrolidinio)methyl]-3-cephem-4-carboxylate containing from 2.5% to 7.0% by weight of water.
2. Temperature stable crystalline dihydrochloride monohydrate acid addition salt of 7-[α-(2-aminothiazol-4-yl)-α-(Z)- methoximinoacetamido]-3-[(1-methyl-pyrrolidinio)methyl]-3-cephem-4-carboxylate containing from 2.5% to 4.1% by weight of water.
[12] In effect, the disclaimer adds the words “Substantially pure” before the rest of the wording of each claims 1 and 2. No change in wording was made to any other claim.
[13] Claim 3 of the ’288 Patent which was not the subject of the disclaimer reads and has always read as follows:
3. Temperature stable crystalline dihydrochlioride monohydrate acid addition salt 7-[α-(2-aminothiazol-4-yl)-α-(Z)- methoximinoacetamido]-3-[(1-methyl-pyrrolidinio) methyl]-3-cephem-4-carboxylate having the following X— ray powder diffraction pattern
X-RAY POWDER DIFFRACTION
Dihydrochloride Monohydrate
d I/Io (%)
10.21 100
8.62 13
6.78 23
6.28 9
5.84 9
5.12 4
5.01 9
4.95 5
4.74 38
4.62 4
4.50 4
4.44 4
4.26 32
4.10 4
3.95 33
3.90 28
3.78 39
3.64 5
3.59 13
3.48 10
3.39 15
3.32 10
3.21 10
3.11 10
3.04 5
2.99 13
2.93 15
2.76 5
2.63 10
2.51 10
2.43 5
2.38 7
[14] Claim 4 claims a physical mixture of what is set out in claim 3 together with L (+) lysine. Claim 5, the last claim, claims a physical mixture of what is set out in claim 3 together with L(+) arginine.
[15] In proceedings such as this the Applicants do not need to take issue with every challenge to validity made by a second person such as Apotex in respect of every claim. In the present proceedings, the Applicants have, in argument, restricted themselves to challenges raised in respect of claims 2 and 3 only. Therefore, the Court need not be concerned with challenges to the validity of any of claims 1, 4 or 5. No issue of infringement of any claim has been raised by Apotex in its Notice of Allegation.
WITNESSES
[16] Evidence in these proceedings has taken the usual form of affidavits, exhibits to affidavits, transcripts of cross-examination and exhibits identified in cross-examination.
[17] The Applicants put forward in evidence the affidavits of the following witnesses in chief:
· Dr. Stephen R. Byrn, professor of chemistry, Purdue University, West Lafayette, Indiana. He gave evidence as to the chemistry involved in this proceeding.
· Dr. Paul A. Bartlett, professor of chemistry, emeritus, University of California, Berkley, California. He gave evidence as to the chemistry involved in this proceeding.
· Mr. Kevin Murphy, Canadian and United States registered patent agent, partner of Ogilvy Renault LLP, Montreal, Quebec. He gave evidence respecting the file history of the ’288 patent and Patent Office practices.
[18] In reply, pursuant to an Order of Prothonotary Tabib, the Applicants filed the following affidavits:
· Reply affidavit of Dr. Stephen R. Byrn
· Reply affidavit of Dr. Paul A. Bartlett
· Mr. Scott Brown, patent litigation counsel for the Applicant BMS US. He gave evidence as to the disclaimer involved in the ’288 patent.
[19] Each of Byrn, Bartlett and Murphy were put forward as an expert witness. No challenge has been made to their claim to be experts. Brown was put forward as a fact witness. Each one of Byrn, Bartlett, Murphy and Brown were cross-examined by counsel for Apotex.
[20] Apotex put forward in evidence the affidavits of the following witnesses:
· Antigone Dialinou, a Certified Translator of the Greek and English languages. She translated into English a Greek Patent 862055 (the ‘055 patent) and the application for that patent. She was not cross-examined. The accuracy of these translations was not challenged.
· Jenny L. Gerster, a chemist employed by an Apotex related company who carried out experiments said to replicate certain examples in the prior art.
· Nadia K. Corelli-Rennie a chemist employed by an Apotex related company who carried out certain experiments intended to replicate certain examples given in the prior art.
· Dr. Robert A. McClelland, professor of chemistry emeritus, University of Toronto. He gave evidence as to the chemistry involved in this proceeding.
· Dr. Robert S. Langer, professor of chemistry, Massachusetts Institute of Technology, Boston Massachusetts. He gave evidence as to the chemistry involved in this proceeding.
· Mr. Douglas N. Deeth, Canadian lawyer and Patent Agent. He gave evidence as to patent application procedures and the application for the ’288 patent and disclaimer.
· Dr. Michael J. Cima, Professor Massachusetts Institute of Technology, material science relating to pharmaceuticals. He gave evidence respecting the testing conducted by Gerster and Corelli-Rennie.
· Ms. Kimberly Kreider, employee in the firm of Apotex’s co-counsel. She attached to her affidavit copies of a number of documents identified in Apotex’s Notice of Allegation. No challenge was raised as to the authenticity of these documents.
[21] Each of McClelland, Langer, Deeth and Cima were offered as expert witnesses. No challenge was made to their claim to be experts. Each of them was cross-examined by counsel for the Applicants. The other Apotex witnesses were offered as fact witnesses and were not cross-examined.
ISSUES
[22] There is only one main issue in this proceeding. That issue is whether the allegation made by Apotex that the claims of the ’288 patent are not valid are justified having regard to the provisions of the NOC Regulations particularly sections 5(1)(b)(iii) and 6(2). If such allegation is not justified, then the Court shall make an order prohibiting the Minister from issuing an NOC to Apotex until the expiry of that patent.
[23] The particular arguments raised as to invalidity are simplified by the Applicants’ reliance only on claims 2 and 3 of the ’288 patent but are complicated by the filing of a disclaimer by one of the Applicants with the Patent Office the day before they instituted these proceedings. That disclaimer directly affects claim 2 but not claim 3.
[24] Apotex raised a number of grounds for arguing invalidity of claims 2 and 3 and, in argument at the hearing dropped two grounds. First it dropped any assertion that section 53 of the Patent Act which deals false and misleading statements, was violated by the patentee BMS US. Second it dropped any argument as to inutility. Further one of the arguments as to ambiguity dealing with crystals was abandoned by Apotex but it maintained arguments as to ambiguity of the words substantially pure.
[25] Having regard to the written and oral submissions the arguments as to invalidity of claims 2 and 3 of the ’288 patent are:
1. Effect of the disclaimer;
2. Anticipation
3. Obviousness
4. Double Patenting
5. Selection Patents
6. Ambiguity-substantially pure
[26] Before consideration of these matters, the Court is required to place a construction upon claims 2 and 3. Further, the Court must determine where the burden of proof lies in respect of these matters. Lastly, the Court must consider who is the person skilled in the art to whom the patent is addressed.
[27] A preliminary matter was raised by the Court which is the issue of mootness. It will be considered first.
MOOTNESS
[28] The Court is asked by the Applicants to grant an Order prohibiting the Minister from issuing a Notice of Compliance to Apotex until the expiry of the ’288 patent. That patent will expire March 31, 2009 which is just over two months after the hearing of this matter has been held. The NOC Regulations provide in section 7(1)(e) that this proceeding should be determined within 24 months from the date it was instituted, that is, by May 23, 2009. Thus the ’288 patent will expire before the last date upon which this Court should determine this matter in which case there could be no Order for prohibition since the patent would have expired.
[29] The question of mootness was considered by the Supreme Court of Canada in Borowski v. Canada (Attorney General), [1989] 1 S.C.R. 342 where it was held that, as an aspect of general policy or practice, a court may decline to decide a case which raises merely a hypothetical or abstract question and where the decision of the court will not have the effect of resolving some controversy which affects or may affect the rights of the parties. Sopinka J. of the Court wrote at paragraph 15:
15 The doctrine of mootness is an aspect of a general policy or practice that a court may decline to decide a case which raises merely a hypothetical or abstract question. The general principle applies when the decision of the court will not have the effect of resolving some controversy which affects or may affect the rights of the parties. If the decision of the court will have no practical effect on such rights, the court will decline to decide the case. This essential ingredient must be present not only when the action or proceeding is commenced but at the time when the court is called upon to reach a decision. Accordingly if, subsequent to the initiation of the action or proceeding, events occur which affect the relationship of the parties so that no present live controversy exists which affects the rights of the parties, the case is said to be moot. The general policy or practice is enforced in moot cases unless the court exercises its discretion to depart from its policy or practice. The relevant factors relating to the exercise of the court's discretion are discussed hereinafter.
[30] In the present case, Apotex argues that, even if the patent expires, a holding that its allegation as to invalidity was justified would entitle it to make a claim for relief under section 8 of the NOC Regulations. Further, it argues, a decision could be made before the patent expires which, if favourable, could permit its early entry into the market even if for only a few days. There is, however, no evidence in the record to indicate whether or not Apotex is in fact ready, before the patent expires, to enter the market or whether it is in a position to make a viable claim under section 8 of the Regulations.
[31] I am guided by the decision of the Federal Court of Appeal in Apotex Inc. v. Bayer AG (2004), 32 C.P.R. (4th) 449 where a motion was brought to dismiss an appeal in NOC proceedings for mootness on the basis that the patent at issue had expired and the generic had been issued its Notice of Compliance. The Court, at paragraph 5, was satisfied that the appeal was moot in that the live controversy between the parties had ceased to exist. However, the Court found that there remained what it described as “collateral consequences” such as the possibility of proceedings brought by the generic for relief under section 8 of the NOC Regulations. Rothstein JA. (as he then was) for the Court wrote at paragraph 14:
14 There is no indication in section 8 that the reversal on appeal must occur prior to expiry of the patent at issue or the issuance of a Notice of Compliance to the generic. Nor is there any rationale for such a requirement. If a generic manufacturer has been wrongly excluded from the market during the lifetime of a patent, the fact that an appeal is decided after the patent expires should have no bearing on the generic's entitlement to damages. In my respectful opinion, it would be inconsistent with the object of the current Regulations to deprive a generic manufacturer of the opportunity to avail itself of section 8 of the Regulations merely because a patent has expired or a Notice of Compliance has issued. The liability referred to in section 8 arises from the period prior to the expiry of the patent or issuance of the Notice of Compliance to the generic and the mere fact that the appeal is decided after that date has no bearing on the application of section 8.
[32] I will, in the circumstances, make a determination of the issues, notwithstanding a concern as to mootness. I do so because it was the Court, not a party, who raised the issue of mootness, thus the parties were deprived of an opportunity to lead evidence one way or the other, as to whether there exists a live controversy. It may be in future cases where a patent has or is about to expire during the course of proceedings such as this, that there would be a proper record upon which the issue of mootness could be addressed.
BURDEN OF PROOF
[33] The issue is one of validity of two claims of the ‘288 patent. No issue as to infringement has been raised.
[34] Counsel for the Applicants agreed during the oral hearing that the burden of proof as to validity in NOC proceedings is as I expressed at paragraphs 57 and 58 of Abbott Laboratories v. Canada (Minister of Health), 2008 FC 1359:
57 This is a proceeding brought under the provisions of section 6 of the PMNOC Regulations for a determination of several issues including whether Sandoz's allegations that claim 5 of the '527 patent is "not valid" is "justified". The use of the term "not valid" comes from section 5(b)(iii) of the PMNOC Regulations and, as the Supreme Court of Canada (Rothstein J. for the Court) wrote in Apotex Inc. v. Sanofi-Synthelabo Canada Inc., [2008] S.C.J. No. 63, 2008 SCC 61 (Sanofi) at paragraph 17, the inquiry parallels what would otherwise be a defence to an infringement action as referred to in section 59 of the Patent Act.
58 The Patent Act, section 43(2), in the case of a post October 1, 1996 patent such as the '527 patent here, provides that a patent shall, in the absence of evidence to the contrary, be valid. In Pfizer Canada Inc. v. Canada (Minister of Health), [2008] F.C.J. No. 3, 2008 FC 11, I reviewed the recent authorities, including two from the Federal Court of Appeal, on the question as to who had the burden of proof as to validity particularly in NOC proceedings such as this, and concluded that a patentee such as Abbott may rely on the presumption of validity however, if the attacking party, Sandoz, has lead reliable evidence, then the Court must weight all the evidence on the usual civil burden of proof, if the matter was then seen to be evenly balanced, the attack on validity fails. At paragraph 33 of that decision, I wrote:
33 If the matter were an ordinary action for, say, infringement of a patent where validity is put in issue, the party challenging validity bears the burden such that, it must put in evidence to support the allegation of invalidity. The patentee may rely on the presumption but only to the extent that the attacking party must lead some reliable evidence to support its allegation. At the end of the day, the Court must weigh the evidence on the usual civil burden of proof (Tye-Sil Corp. Ltd. v. Diversified Products Corp. (1991), 35 C.P.R. (3d) 350 at 357-359 (F.C.A.)). Only if the Court finds the evidence to be "evenly balanced" (a rare event) would the question of burden arises in an ordinary case the party attacking validity, bearing the burden, would fail.
Counsel for Apotex agreed that this was a proper statement of the law.
PERSON SKILLED IN THE ART
[35] A patent, as well as prior art, is to be considered from the viewpoint of a person skilled in the art. There is no controversy as to who is such a person in this case as Applicants’ counsel has agreed that Apotex has correctly characterized such a person through the evidence of one of its expert witnesses, Dr. McClelland, at paragraph 9 of his affidavit:
9. The ’288 Patent is thus addressed to chemists, medicinal chemists, chemical engineers, formulators and pharmaceutical chemists. Such an individual (or group of individuals) has a university degree in one of these areas. This individual (or group of individuals) will also have several years experience in the pharmaceutical industry or in a pharmaceutically related area. In respect of such an individual (or group of individuals), if such an individual (or group of individuals) had only an undergraduate degree, then such an individual (or group of individuals) would have more experience in the pharmaceutical industry or in a pharmaceutically related area. That experience would take the form of chemical synthesis, the preparation of crystalline solids such as salts by crystallization/recrystallization, the preparation of solvates including hydrates, the characterization of such crystalline solids, salts and hydrates by techniques such as infrared spectroscopy and X-ray powder diffraction, and the study of the stability of compounds intended for use of pharmaceuticals.
[36] No particular controversy arises in these proceedings in respect of this characterization of such a person skilled in the art.
CONSTRUCTION OF CLAIMS 2 AND 3
[37] The Supreme Court of Canada has instructed that the Court must first construe the claims at issue before moving to consideration of issues such as validity and infringement of those claims, the purpose in doing so is to identify what it is in the claims that the inventor considered to be essential. This construction is to be conducted in a purposive manner so as to endeavour to be fair to both the patentee and the public per Binnie J. for the Court in Whirlpool Inc. v. Camco Inc., [2000] 2 S.C.R. 1067 at paragraphs 42 to 50. I repeat part of paragraphs 43 and 45:
43 The first step in a patent suit is therefore to construe the claims. Claims construction is antecedent to consideration of both validity and infringement issues. The appellants' argument is that these two inquiries -- validity and infringement -- are distinct, and that if the principles of "purposive construction" derived from Catnic are to be adopted at all, they should properly be confined to infringement issues only. The principle of "purposive construction", they say, has no role to play in the determination of validity, and its misapplication is fatal to the judgment under appeal.
…
45 The key to purposive construction is therefore the identification by the court, with the assistance of the skilled reader, of the particular words or phrases in the claims that describe what the inventor considered to be the "essential" elements of his invention.
[38] The ’288 patent is governed by the provisions of the old Patent Act, thus is to be construed by the Court as of the date of its grant, March 31, 1992, through the eyes of a person skilled in the art, assisted if needed by expert evidence as to the meaning of certain terms and the knowledge that a person skilled in the art would have had as of trial date. As Sharlow JA. for the Federal Court of Appeal wrote at paragraph 4 of Novopharm Limited v. Janssen-Ortho Inc., (2007), 59 C.P.R. (4th) 116, 2007 FCA 217 respecting an old Patent Act patent:
4 In any case in which the validity or infringement of a patent claim is in issue, it is necessary to construe the claim: Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067 at paragraph 43. The relevant date for the construction of the 080 patent is the date of its issuance, June 23, 1992. The patent must be understood as being addressed to a person skilled in the art, taking into consideration the knowledge that such a person is expected to possess on that date. The construction of a patent claim is a task for the Court and must be based on the whole of the disclosure and the claim, assisted by expert evidence as to the meaning of certain terms and the knowledge that a person skilled in the art is expected to possess on the relevant date.
[39] Claims 2 and 3 are to be construed. Since claim 2 was the subject of a disclaimer, its form both before and after the disclaimer should be considered. I repeat claim 2:
Before disclaimer:
2. Temperature stable crystalline dihydrochloride monohydrate acid addition salt 7-[α-(2-aminothiazol-4-yl)-α-(Z)- methoximinoacetamido]-3-[(1-methyl-pyrrolidinio) methyl]-3-cephem-4-carboxylate containing from 2.5% to 4.1% by weight of water.
After disclaimer:
2. Substantially pure temperature stable crystalline dihydrochloride monohydrate acid addition salt 7-[α-(2-aminothiazol-4-yl)-α-(Z)- methoximinoacetamido]-3-[(1-methyl-pyrrolidinio) methyl]-3-cephem-4-carboxylate containing from 2.5% to 4.1% by weight of water.
[40] Claim 3 is unaffected by the disclaimer and I repeat it:
3. Temperature stable crystalline dihydrochlioride monohydrate acid addition salt of 7-[α-(2-aminothiazol-4-yl)-α-(Z)- methoximinoacetamido]-3-[(1-methyl-pyrrolidinio) methyl]-3-cephem-4-carboxylate having the following X— ray powder diffraction pattern
X-RAY POWDER DIFFRACTION
Dihydrochloride Monohydrate
d I/Io (%)
10.21 100
8.62 13
6.78 23
6.28 9
5.84 9
5.12 4
5.01 9
4.95 5
4.74 38
4.62 4
4.50 4
4.44 4
4.26 32
4.10 4
3.95 33
3.90 28
3.78 39
3.64 5
3.59 13
3.48 10
3.39 15
3.32 10
3.21 10
3.11 10
3.04 5
2.99 13
2.93 15
2.76 5
2.63 10
2.51 10
2.43 5
2.38 7
EFFECT OF THE DISCLAIMER
[41] I pause in the consideration of construction for consideration of the effect of the disclaimer filed by the Applicants the day before they instituted this proceeding. Section 48 of the old Patent Act (a provision continued in the later versions of the Act) provides in subsection 48(1)(a) that whenever a patentee determines that by any mistake, accident or inadvertence, and without any wilful intent to defraud or mislead the public, the patentee has made his specification too broad, claiming more than that of which he invented, he may disclaim the parts which he does not claim to hold. Subsection 48(4) says that a disclaimer does not affect a pending action unless there has been unreasonable delay or neglect. Subsection 48(6) says that, after the disclaimer has been filed, the patent as it is then intended to be read is deemed to be valid.
[42] A patent which claims more than what was invented or disclosed can be found to be invalid for being overly broad. As Nadon JA. for the Federal Court of Appeal wrote at paragraph 115 of Pfizer Canada Inc. v. Canada (Minister of Health), (2007), 60 C.P.R. (4th) 81, 2007 FCA 209:
115 It is now settled law that a patent which claims more than what was invented or disclosed can be found invalid for being overly broad. As explained in Lovell Manufacturing Co. and Maxwell Ltd. v. Beatty Brothers Ltd. (1962), 41 C.P.R. 18 (Ex. Ct.) at p. 66:
The other attack was that the claims were too wide and that they claimed more than had been invented. This repeats the central them to which I have referred, namely, the contention that all that had been invented were the specific wringer constructions described in the specification and that unless the claims were limited in their application to inventions of the said specific constructions they were too wide and, therefore, invalid. There is a simple answer to the contention, If the claims read fairly on what has been disclosed and illustrated in the specification and drawings, as they do, they are not wider than the invention. The specific wringer constructions described in the specification are simply embodiments or illustrations of the invention. The claims embrace them and might well embrace similar other embodiments or illustrations. There is nothing in any of the specifications that would limit the claims to one of the specific wringer constructions or to all of them.
[43] Thus a claim which is overly broad in a patent that has not yet been adjudged to be invalid may be saved from a finding of invalidity by a Court if a disclaimer is filed but only if filed in a timely way.
[44] In the present case, a disclaimer was filed by one of the Applicants BMS US as it is the patentee. The document as submitted to the Patent Office on May 22, 2007 says:
1. The patentee at Patent No. 1,298,288, granted on March 31, 1992 for an invention entitled “Cephalosporin Salts and Injectable Compositions”, has, by mistake, accident or inadvertence, and without any wilful intent to defraud or mislead to public made the specification too broad, claiming more than that of which the patentee or the person through whom the patentee claims was the first inventor.
2. The name and complete address of the patentee is Bristol-Myers Squibb Company, 345 Park Avenue New York, NY 10154, United States of America.
3. Due to inadvertence, accident or mistake, some claims in the application issued in a broader scope than the applicant was entitled. Accordingly, Claims 1 and 2 will be partially disclaimed to limit the scope of the claims.
4. The patentee disclaims the entirety of claim 1 with the exception of the following:
1. Substantially pure temperature stable crystalline dihydrochloride hydrate acid addition salt 7-[α-(2-aminothiazol-4-yl)-α-(Z)- methoximinoacetamido]-3-[(1-methyl-pyrrolidinio) methyl]-3-cephem-4-carboxylate containing from 2.5% to 7.0% by weight of water.
5. The patentee disclaims the entirety of claim 2 with the exception of the following:
2. Substantially pure temperature stable crystalline dihydrochloride monohydrate acid addition salt 7-[α-(2-aminothiazol-4-yl)-α-(Z)-methoximinoacetamido]-3-[(1-methyl-pyrrolidinio) methyl]-3-cephem-4-carboxylate containing from 2.5% to 4.1% by weight of water.
[45] This is a public document, filed with the Patent Office, affecting claims 1 and 2 of the ’288 patent which states in unequivocal terms that the patentee “made the specification too broad, claiming more than that…of which it was the first inventor” and the claims were “broader in scope” than what was intended. The document is a clear admission by the patentee that the original claims were too broad. Thus, if a Court were to have considered only the original claims prior to the filing of the disclaimer, they could have been declared to be invalid for overbreadth.
[46] The Applicants submitted in these proceedings, but not with the Patent Office, the affidavit of Brown, who is not one of the inventors and not the attorney who drafted or prosecuted the original application, but who is a current in-house lawyer with BMS US. On cross-examination, he stated that the disclaimer was, in effect, only precautionary. He testified that once the Applicants received Apotex’s Notice of Allegation, it was thought prudent to clear up any doubt as to the scope of claims 1 and 2. Even though he thought the original claims to be limited to substantially pure product, it was believed prudent by the Applicants to clear up any doubt by filing a disclaimer.
[47] I cannot accept this argument. The Applicants filed a document with the Patent Office, intending it to be acted upon by that Office and knowing that it would be seen and relied upon by the public. That document clearly and unequivocally says that the patentee made the original claims too broad. Private reservations of in-house counsel or litigation tactics cannot allow the Applicants to resile from those public statements.
[48] Given those statements, what is the effect of the disclaimer? These proceedings are not an “action” as spoken of in subsection 48(4) of the Patent Act, supra. These proceedings are not the kind in which the Court may expunge a patent or claims for invalidity. In these proceedings under the NOC Regulations all that a Court may do is determine whether the allegations made, in this case by Apotex in its Notice of Allegation, are justified.
[49] The Commissioner of Patents has no discretion to exercise upon a disclaimer as filed, it must be accepted as is. However the patentee must accept the possibilities afforded by litigation as to the effect of such disclaimer. This is what the Federal Court of Appeal held in Distrimedic Inc. v. Richards Packaging Inc. (2008), 66 C.P.R. (4th) 1 (FCA) per Letourneau JA. at paragraphs 9 and 12:
9 Indeed, not only is there no mention of such power in the provision, the Act, and more specifically section 48, as well as the Rules, provide no administrative and procedural framework to properly and effectively allow a substantive consideration of the contents of a disclaimer. This is in contrast with numerous other situations where an administrative structure is provided and authority is given to the Commissioner or delegate to act: see for example section 35 (request for examination), Rule 30 (procedural guarantees), section 65 and ff. (abuse of rights under patents).
…
12 Finally, if the Commissioner does not possess the power to refuse to record a disclaimer, as is presently the case, the appellant recognizes that it suffers no loss of rights and no prejudice other than having the trouble and bearing the cost of litigating the effect of the disclaimer. Once the possibility of recording a disclaimer is given to a patentee, possible litigation as to the effect of the disclaimer is something inherent to the very fact that a disclaimer is made and sought to be recorded.
[50] The Privy Council on appeal from the Supreme Court of Canada in Canadian Celanese Ltd. v. B.V.D. Co. Ltd., [1939] 2 D.L.R. 289 dealt with a situation where the Supreme Court held in its Reasons delivered before formal Judgment was entered, that the claims of a patent were too broad and hence the claims were invalid. Before judgment was entered the patentee filed a disclaimer limiting the scope of the claims, then sought a rehearing by the Supreme Court on the basis that the reformulated claims overcame the objections raised by the Court, hence validity was preserved. The Supreme Court refused to rehear the matter. The patentee appealed to the Privy Council which dismissed the appeal. The Privy Council in its advice to His Majesty said that, in making the amendments by way of disclaimer, the patentee had accepted that the findings of the Supreme Court were valid and it was not open to appeal against those findings. At page 294 of its advice, the Privy Council wrote:
The disclaimer is an unconditional disclaimer; it must necessarily be unconditional. The statute does not contemplate or authorize a contingent disclaimer. As soon as the disclaimer was filed and recorded in the office of the Commissioner, it as made part of the Patent; the only existing Claims are the Claims as amended by virtue of the disclaimer, and the only invention protected by the Letters Patent is the invention a description whereof is contained in the Specification as so amended. In these circumstances the present Appellants, having filed a disclaimer for the purpose of changing the construction which the Supreme Court had declared to be the true construction of the original Claims, must be taken to have finally accepted that construction as being the true construction of those claims; and it is not open to them to appeal successfully against the Court’s declaration of that construction.
[51] In the present case, Apotex served its Notice of Allegation on April 2, 2007; the Applicants filed their disclaimer on May 22, 2007 and instituted these proceedings the next day, May 23, 2007. Section 6(2) of the NOC Regulations requires that this Court make a determination as to whether Apotex’s allegations as to invalidity are justified.
[52] Justice Stone in the Federal Court of Appeal has held that a Notice of Allegation is a document beyond the reach of a Court’s jurisdiction. The Court cannot strike such a document as it is not a document filed with the Court. In Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) 207 (FCA) he wrote at paragraph 6:
6 It seems to us that while a notice of allegation does play an important role in the ultimate outcome of litigation of this nature, is not a document by which the judicial review application may be launched under section 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.
[53] In AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (FCA) Stone JA. held that the Notice of Allegation “casts a long shadow” and NOC proceeding as it serves to frame the issues. At paragraph 20 he wrote:
20 While it is true that the detailed statement is not filed in a section 6 proceeding, it nevertheless casts a long shadow over that proceeding. Indeed, it is upon the content of that statement that the patentee must decide whether or not to commence a section 6 proceeding and to assess its chances of success or failure. In this sense the allegation and detailed statement assist in an important way in framing the issues and facts to be determined in the section 6 proceedings for in seeking prohibition the patentee is obliged to show that, contrary to what is stated in the detailed statement, the patentee's patent right will be infringed if an NOC for the drug is issued prior to the expiration of the listed patent.
[54] Therefore the Court must consider the various possibilities since the Court cannot amend a Notice of Allegation. If the patentee disclaimed certain claims but did not commence proceedings in the court, the generic would get its Notice of Compliance as soon as the 45 day period provide by subsection 7(1)(d) of the NOC Regulations. If the patentee commenced proceedings and the generic did not defend, the patentee would get judgment prohibiting the generic from receiving a Notice of Compliance until the patent expired. If a generic wishes to attack the validity of the claims as reformulated by the disclaimer, it cannot revise its Notice of Application since proceedings,