Astrazeneca AB v. Apotex Inc.

Astrazeneca AB v. Apotex Inc.
Court (s) Database
Federal Court Decisions
Date
2006-01-18
Neutral citation
2006 FC 7
File numbers
T-766-03
Decision Content
Date: 20060118
Docket: T-766-03
Citation: 2006 FC 7
BETWEEN:
ASTRAZENECA AB and ASTRAZENECA CANADA INC.
Applicants
and
APOTEX INC. and THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER
[Confidential Reasons for Order issued on January 4, 2006]
LAYDEN-STEVENSON J.
[1] Are the applicants, AstraZeneca AB and AstraZeneca Canada Inc. (collectively Astra), entitled to an order prohibiting the Minister of Health (the Minister) from issuing a notice of compliance (NOC) to the respondent, Apotex Inc. (Apotex), with respect to 10mg and 20 mg magnesium omeprazole tablets until after the expiration of Canadian Letters Patent No. 2,186,037 (the '037 patent)? I conclude that the answer is "no".
BACKGROUND
[2] The '037 patent is listed by AstraZeneca Canada Inc. on the Patent Register in respect of omeprazole (which includes magnesium omeprazole) tablets 10 mg and 20 mg (manufactured as LOSEC) and used to treat gastric and duodenal ulcers. AstraZeneca AB is the owner of the patent. On March 25, 2003, pursuant to the provisions of the Patented Medicines (Notice of Compliance Regulations (the Regulations), Apotex informed Astra that Apotex had filed with the Minister a submission for a NOC for magnesium omeprazole tablets for oral administration in strengths of 10 mg and 20 mg. Apotex alleges non-infringement and invalidity of the '037 patent. Astra, by notice of application dated May 13, 2003, seeks a declaration that the Apotex letter of March 25th is not a NOA and Detailed Statement as contemplated by the Regulations and an order prohibiting the Minister from issuing a NOC to Apotex in respect of its 10 and 20 mg magnesium omeprazole tablets until after the expiration of the '037 patent. The Minister administers the Regulations and did not file submissions or participate in the hearing of this application.
THE PATENT
[3] The application that resulted in the '037 patent was filed on February 9, 1996, and claims a priority filing date of February 9, 1995. It was published on August 15, 1996, and the patent issued on April 16, 2002. The patent refers to new pharmaceutical formulations, comprising acid labile heterocyclic compounds with gastric inhibitory effect, referred to in the patent as proton pump inhibitors.
[4] The disclosure reveals that proton pump inhibitors are susceptible to degradation/ transformation in acidic reacting and neutral media. The proton pump inhibitor (PPI) in an oral solid dosage form must be protected from contact with the acidic reacting gastric juice and the active substance must be transferred in intact form to that part of the gastrointestinal tract where pH (the measure of degree of acidity or alkalinity of a substance in water measured on a scale of 1-14 with 7 being neutral) is less acidic, neutral, or alkaline and where rapid absorption of the pharmaceutically active substance (the PPI) can occur. A pharmaceutical dosage form of these proton pump inhibitors is best protected from contact with acidic gastric juice by an enteric coating layer. The disclosure states that there must be a separating layer between the enteric coating and the ingredients in the tablet's core. The '037 patent purports to provide a new pharmaceutical formulation and process for the manufacture of such tablets, namely, the separating layer is formed in situ (formed as the result of a reaction between the enteric coating polymer and the tablet's core). An in situ separating layer can be contrasted with a separating layer that is put in place as a distinct step in the manufacturing process. The '037 patent purports to simplify the manufacturing process by removing the additional step, that being the application of a layer.
[5] The patent has 61 claims. Claim 1 and its dependent claims 2 through 22 and 27 to 29 are claims for the medicine or for the use of the medicine. Claim 1 and claims 2 to 19, 21, 22 and 27 to 29, which depend from claim 1, include an omeprazole dosage form within their scope. Claims 30 to 56 are process claims. Claims 57 to 59 are claims to the use of the pharmaceutical dosage form defined in any one of claims 1 to 29. Claim 60 is a claim to a commercial package comprising the pharmaceutical dosage form defined in any one of claims 1 to 29. Claim 61 is a claim to an oral pharmaceutical dosage form prepared by a process defined in any one of claims 30 to 56. The parties agree, for all intents and purposes, that it is claim 1 of the '037 patent that is relevant and, at the hearing, only claim 1 was addressed. Claim 1 describes an oral pharmaceutical dosage form in the following terms:
1. An oral pharmaceutical dosage form comprising:
(a) a core material that contains a proton pump inhibitor and an alkaline
reacting compound;
(b) an enteric coating layer comprising an enteric coating polymer; and
(c) a water soluble separating layer that is formed in situ as a water soluble
salt between the core material and the enteric coating layer by a reaction
between the enteric coating polymer and the alkaline reacting compound.
THE NATURE OF THE PROCEEDING
[6] As earlier noted, this proceeding is brought under the Regulations, the history and scheme of which are well known. Briefly, when a second person (usually a generic manufacturer) seeks marketing approval (a NOC) for a drug, by comparing its drug to the drug of a first person (an innovator) for the purpose of demonstrating bioequivalence, the generic will be required to address patents listed on the patent register by a first person. The generic or second person may do so by making an allegation of invalidity, non-infringement, or both. The issues of validity and non-infringement between the innovator and the generic originate with a NOA served on the first person by the second person setting out the second person's allegations, including a statement of the legal and factual basis for the allegation. Following receipt of a NOA, a first person may apply to the court for an order prohibiting the Minister from issuing a NOC until after the expiration of one or more of the patents. If the Court finds that none of the generic's allegations is justified, the Court shall grant an order of prohibition.
[7] Apotex, the generic drug producer or second person, under section 5 of the Regulations, provided its NOA to Astra regarding the '037 patent that Astra has listed under the provisions of section 4 of the Regulations. Astra's application, in response to the Apotex NOA, is brought under section 6 of the Regulations.
[8] Section 6 proceedings are not to be likened to actions for determining validity or infringement. They are proceedings in judicial review, to be held expeditiously, aimed at determining whether the Minister is free to issue the requested NOC. Their scope is confined to administrative purposes: Apotex Inc. v. Canada(Minister of National Health and Welfare) (1997), 76 C.P.R. (3d) 1 (F.C.A.). The determination must turn on whether there are allegations by the second person sufficiently substantiated to support a conclusion for administrative purposes (the issue of a NOC) that an applicant's patent would not be infringed if the second person's product is put on the market: Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) 209 (F.C.A.).
[9] The Regulations allow a Court to determine summarily, on the basis of the evidence adduced, whether the allegations are justified. If a full trial of validity or infringement issues is required, this can be obtained in the usual way by commencing an action: Pfizer Canada Inc. v. Apotex Inc. (2001), 11 C.P.R. (4th) 245 (F.C.A.); SmithKline Beecham Pharma Inc. v. Apotex Inc. (2001), 14 C.P.R. (4th) 76 (F.C.T.D.) aff'd. (2002), 21 C.P.R. (4th) 129 (F.C.A.); Novartis A.G. v. Apotex Inc. (2002), 22 C.P.R. (4th) 450 (F.C.A.). By merely commencing the proceeding, the applicant obtains what is tantamount to an interlocutory injunction without having satisfied any of the criteria a court would require before enjoining issuance of a NOC: Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [1998] 2 S.C.R. 193; Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General) (2001), 11 C.P.R. (4th) 539 (F.C.A.). The statutory stay in this proceeding has been extended to February 11, 2006.
PRELIMINARY MATTERS
[10] There are grounds delineated in the NOA that were not pursued at the hearing. Specifically, Apotex did not advance its argument in relation to Canadian Patent No. 2,166,794 (the '794 patent) nor did it maintain its position that the '037 patent was ineligible for listing. Astra did not formally abandon its request for a declaration that Apotex's letter of March 25, 2003 "is not a Notice of Allegation and Detailed Statement as contemplated by the Regulations", but it made no submissions, written or oral, in this regard. Astra withdrew its argument of judicial estoppel in relation to the issue of anticipation. Consequently, I will not be dealing with these matters and no further reference will be made to them.
[11] Astra argued, both in its written submission and in oral argument, but did not plead, reliance on the doctrine of issue estoppel. After hearing from both parties, I invited Astra to consider (prior to its reply) whether it wished to abandon its position. It did not. I will therefore address this question.
[12] Astra argues that Apotex is estopped from relitigating certain factual matters in respect of its tablet formulation. It claims that the three requirements for issue estoppel, as set out by the Supreme Court of Canada in Danyluk v. Ainsworth Technologies, [2001] 2 S.C.R. 460 at 476, are met in this case. First, it points to the decision of the Federal Court of Appeal in AB Hassle v. Apotex Inc. (2003), 29 C.P.R. (4th) 23 (F.C.A.) and asserts that certain facts fundamental to the conclusion that Apotex's tablet infringes claim 1 of Canadian Patent No. 1,292,693 (the '693 patent) have been implicitly determined by the Court of Appeal. Astra contends that, in Apotex's appeal (premised on the construction of claim 1), Apotex accepted that its tablets would infringe if the subcoating of claim 1 of the '693 patent covers material between the core and enteric outer layer formed in situ from a reaction between components of the core and the enteric coating outer layer. The Court rejected Apotex's construction arguments and concluded that claim 1 of the '693 patent describes "a pharmaceutical preparation which, in its finished product form, contains a subcoating or separating layer between the core and enteric coating, however the subcoating or separating layer is formed".
[13] The second and third requirements have also been met, according to Astra, because the Court of Appeal decision is a final decision and the parties there included Astra and Apotex. Accordingly, issue estoppel applies and bars Apotex from disputing that its tablets have a separating layer that is sufficiently thick and complete to function to provide the requisite stability for the tablet and the layer cannot be comprised primarily of omeprazole or degraded omeprazole (as argued by Apotex's expert Dr. Cima). Since Apotex is precluded from relitigating the question of the nature of its tablets relevant to infringement of claim 1 of the '693 patent and since the completeness and thickness of the separating layer/subcoat are features common to claim 1 of both the '693 and '037 patents, Astra says that this is dispositive of Apotex's allegation of non-infringement herein.
[14] At the hearing, Astra expanded on its written arguments, stating that the same parties and the same tablets are involved. The only distinguishing factor is that a different patent is at issue. Astra notes that the purpose behind issue estoppel is to protect a party from being vexed more than once in relation to the same matter. The doctrine exists to preclude multiplicity of litigation and favours finality.
[15] Pointing to this Court's reasons in AB Hassle v. Apotex Inc. (2005), 38 C.P.R. (4th) 216 (F.C.), Astra says that this matter deals with factual matters that were either raised or could have been raised in the context of the '693 patent and that the Court of Appeal's decision has effectively determined the matter. Apotex led evidence before the applications judge with respect to the '693 patent, in relation to matters of continuity and thickness of the subcoating. The Apotex NOA was found to be inadequate. But, the same evidentiary record was in existence when the case went on appeal. It was the Court of Appeal that provided the basis for Astra to argue issue estoppel because, although it was not convinced that there was a deficiency in the Apotex NOA, the Court upheld the order of prohibition.
[16] Relying on Amgen Inc. v. Genetics Institute Inc. 40 USPQ2d, a decision of the United States Court of Appeals Federal Circuit, Astra says that the doctrine can be applied to different patents. In sum, Astra contends that it "shouldn't mean that we should duke it out again, because it's the same tablets, the same parties. Different patent doesn't matter."
[17] In relation to not having pleaded its reliance on the doctrine, Astra insists that this is a "technical point" and that to deny Astra its opportunity to rely on issue estoppel is to prefer form over substance. Jurisprudence that precludes an argument because it has not been pleaded deals with "true judicial review" and this is "not true judicial review, we're creating a record, and so it's really distinguishable". Moreover, Astra couldn't have raised this issue at the time the matter was initiated because the Court of Appeal decision was not available. Astra claims that this is a point of law and is not a matter of evidence. The intervening decision of the Court of Appeal has changed the law. Apotex is not prejudiced because the matter was raised in Astra's memorandum of law and Apotex has had its opportunity to respond.
[18] I reject Astra's argument that the requirement in Rule 301(e) can be characterized as a technical argument that elevates form over substance. The rule mandates that an application is to be commenced by a notice of application that must set out a complete and concise statement of the grounds intended to be argued. I also reject the submission that the jurisprudence does not evince the application of the rule to proceedings brought under the Regulations. In this respect, I refer specifically to Pharmacia Inc. et al. v. Minister of National Health and Welfare et al. (1995), 60 C.P.R. (3d) 328 (F.C.T.D.) at pp. 339, 340 aff'd. (1995), 64 C.P.R. (3d) 450 (F.C.A.) at paragraph 1. See also: Bayer AG et al. v. Apotex Inc. et al. (2003), 29 C.P.R. (4th) 143 (F.C.) and Pfizer Canada Inc. and Pfizer Inc. v. Apotex Inc. and the Minister of Health, 2005 FC 1421.
[19] If the intervening decision of the Court of Appeal crystallized Astra's issue estoppel argument, as alleged, Astra could have utilized Rule 75 which provides that the Court may on motion, at any time, allow a party to amend a document, on such terms as will protect the rights of all parties. Rule 75 applies to all proceedings. An application is a proceeding (see: Rules 61 and 300). Indeed, Astra was aware of Rule 75 for it utilized it in Court File No. T-1747-00, a matter that concerned the same tablets and the same parties, in its application for an order of prohibition under the Regulations. As for the timing, as Mr. Radomski notes, the Federal Court of Appeal's decision was issued on November 3, 2003. The evidence in this matter was far from complete at that time. Dr. Lindquist's (Astra's expert witness) second affidavit was not sworn until April 15, 2004. Apotex filed four affidavits after that date and Dr. Lindquist's third affidavit was not sworn until September 24, 2004. At no point, did Astra seek to amend its notice of application.
[20] It appears rather anomalous that Astra should point to what Apotex did or ought to have done in relation to the '693 patent and, in the same breath, request that I ignore its own failure to have regard to the Rules and the requirements contained therein.
[21] I note that the United States authority, relied upon by Astra, dealt with two patents where the specifications were identical. One patent was a continuation of the other and the subject matter was the same. That is not the situation here. The "invention" of the '693 patent is different than that disclosed in the '037 patent. Claim 1 of the '693 patent is not the same as Claim 1 in the '037 patent. The question regarding the allegation of non-infringement of the '037 patent has not been determined.
[22] For the foregoing reasons, I conclude that it is not open to Astra to advance issue estoppel, for the first time, in its memorandum of fact and law. Even if it were otherwise, it would not be open to it to expand on the contents of its memorandum during the course of its oral argument. Finally, there has been no previous determination in relation to the '037 patent.
THE BURDEN OF PROOF
[23] After hearing argument relating to the burden of proof, I articulated my understanding of the law as set out in a plethora of authorities beginning with Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.) and culminating with Genpharm Inc. v. Procter & Gamble Pharmaceuticals Canada, Inc. et al. (2004), 37 C.P.R. (4th) 289 (F.C.A.). Counsel for both parties were satisfied that I had accurately summarized the law. Succinctly stated, the respondent Apotex's allegations of non-infringement are presumed to be true and the applicant Astra bears the legal burden of establishing, on a balance of probabilities, that none of Apotex's allegations are justified. In relation to validity, Astra may rely on the presumption of validity and Apotex must then meet an evidentiary burden to rebut the presumption. The legal burden remains with Astra throughout.
THE WITNESSES
[24] Astra relies on the evidence of the following witnesses:
(1) Mr. Peder Oxhammar, Senior Legal Counsel in GI Patent Litigation at AstraZeneca AB in Sweden, swore an affidavit on June 23, 2003, stating that Astra had no knowledge or access to knowledge regarding the contents or existence of the new drug submission (NDS) referred to by Apotex in its NOA. He is not being put forward as an expert and he was not cross-examined.
(2) Ms. Karen Burke, Vice-President of Regulatory Affairs at AstraZeneca Canada Inc., swore an affidavit on June 24, 2003, stating that Astra received Apotex's NOA and that Astra had no knowledge of the NDS referred to by Apotex in that NOA. She is not being put forward as an expert and she was not cross-examined.
(3) Ms. Jacinta M. De Abreu, a law clerk in the Toronto offices of Smart & Biggar (Astra's solicitors), swore an affidavit on June 27, 2003, wherein she provided a copy of Apotex's memorandum of fact and law in Court File No. T-1747-00.
(4) Dr. Jörgen Lindquist, a research scientist specializing in analytical chemistry and an employee of AstraZeneca AB, holds a Ph.D. in analytical chemistry from the University of Uppsala in Sweden. Until 1975, he was an associate professor of analytical chemistry at that university. He affirmed an affidavit on June 24, 2003, stating that he could determine whether an in situ separating layer existed in the Apotex tablets if he were to be provided with samples. He affirmed a second affidavit on April 15, 2004 (Lindquist 2) describing analytical tests he performed on samples of the Apotex tablets sent to him in order to determine the existence and composition of an in situ separating layer. He affirmed a third affidavit on September 24, 2004 (Lindquist 3) responding to the affidavits of Drs. Cima and Sodhi. Dr. Lindquist was cross-examined.
(5) Dr. John Elvan Rees, a former professor of pharmacy practice and pharmaceutics, holds a Ph.D. from the School of Pharmacy, University of London, for research on tablet manufacture. He has published extensively on pharmaceutical formulation, including articles on film-coating. He is an expert in pharmaceutical formulation including the coating of these formulations. He is currently a pharmaceutical industry consultant for matters relating to medicine design, pharmaceutical technology, and pharmacy practice research. He swore an affidavit on June 26, 2003, wherein he provided evidence with regard to the construction of the '037 patent and the validity of its claims. Dr. Rees was cross-examined.
[25] Apotex relies on the evidence of the following individuals:
(1) Dr. Harold B. Hopfenberg is the Camille Dreyfus Professor of Chemical Engineering and Director Emeritus of the Kenan Institute for Engineering, Technology and Science at North Carolina State University. He holds a Ph.D. in chemical engineering from the Massachusetts Institute of Technology. He has conducted research on surface, colloid and polymer science with a special emphasis on transport phenomena in coatings, membranes and films applied to pharmaceutical formulations and controlled drug delivery systems for human and veterinary medicine. He has served on a number of editorial advisory boards for scientific journals. He swore an affidavit on August 21, 2003, wherein he provided his opinion with regard to the construction of the '037 patent and the validity of its claims. He was cross-examined.
(2) Dr. Michael J. Cima, a professor of materials science and engineering at the Massachusetts Institute of Technology (MIT), holds a Ph.D. in chemical engineering from the University of California at Berkeley. He was elected a fellow of the American Ceramics Society in 1997 and was recently awarded the Sumitomo Industries Chair at MIT. His research interests include: powder processing; ceramics processing; drying; novel powder forming methods; slurry and ink formulation; pharmaceutical formulation; ceramic thin films; and ceramics manufacturing. He swore his first affidavit on August 22, 2003 and described his conclusions regarding tests that he conducted on samples of the Apotex tablets. He swore a second affidavit on July 19, 2004, responding to Lindquist 2. Dr. Cima was cross-examined.
(3) Mr. Francis Ng-Chen-Hin is employed in the office of Ivor M. Hughes, counsel to Apotex. He is not being offered as an expert. On August 25, 2003, he swore his first affidavit and stated that he forwarded documents to Drs. Signorio and Hopfenberg. His second affidavit, sworn July 19, 2004, described the contents of a delivery he received from Apotex and states that he forwarded the contents onto Dr. Sodhi. He was cross-examined.
(4) Dr. Bernard Sherman is the Chair of Apotex and is intimately involved with the development of Apotex's omeprazole magnesium tablets. He is not being put forward as an expert. In his affidavit, affirmed on August 25, 2003, he testified that he provided samples of tablets and documents to Ivor Hughes. In a second affidavit, affirmed July 14, 2004, he stated that he supplied samples of ingredients contained in the enteric coating of the Apotex tablets. Dr. Sherman was cross-examined.
(5) Dr. Charles A. Signorio is the President of Emerson Resources and C.S. Associates, companies that provide consulting services to the pharmaceutical industry on issues of coating formulations. He holds a Ph.D. in organic chemistry from the University of Pennsylvania and, for 30 years, he was employed by Colorcon Inc., one of the leading companies specializing in pharmaceutical coatings. He is the holder of 17 patents, the majority of which relate to pharmaceutical coatings. On August 25, 2003, he swore an affidavit in which he provided evidence regarding the construction of the '037 patent and deposed that he prepared slides and samples for testing. Dr. Signorio was cross-examined.
(6) Mr. Samuel Tekie, a professional engineer and a scientific technical researcher at the firm of Apotex's counsel, is not offered as an expert. In an affidavit sworn on August 25, 2003, he provided evidence regarding a literature search he conducted that resulted in the compilation of the documents listed within a number of Canadian and United States patents relevant to this matter. He was cross-examined.
(7) Ms. Nicole Roth, an employee of Goodmans LLP (solicitors for Apotex), swore an affidavit on August 25, 2003 and exhibited documents that were filed in Court File No. T-1747-00, including an affidavit sworn by Dr. Rees on October 20, 2000 and written representations made by Apotex dated November 6, 2000. She was not cross-examined.
(8) Dr. Rana N.S. Sodhi is the Director of Scientific Operations for Surface Interface Ontario, a laboratory established within the Department of Chemical Engineering and Applied Chemistry at the University of Toronto. Dr. Sodhi holds a Ph.D. in electron microscopy from the University of British Columbia and is an expert in the application of surface analytical techniques to a wide variety of different materials including polymers, pharmaceuticals, metals, ceramics and semi-conductors. On July 19, 2004, he swore an affidavit responding to Lindquist 2. Dr. Sodhi was cross-examined.
ISSUES
[26] The issues and the subsidiary issues flowing from those issues, as identified in the memoranda of fact and law, can be framed as follows:
(1) Has Astra established that Apotex's allegation of non-infringement is not justified?
(a) Do the Apotex tablets contain an alkaline reacting compound (ARC)?
(b) Do the Apotex tablets contain an in situ separating layer or subcoating?
(2) Has Apotex led evidence that is sufficient to displace the statutory presumption of validity and if so, has Astra established that Apotex's allegation of invalidity is not justified?
(a) Gillette Defence
(b) Anticipation
(c) Double Patenting
(d) Insufficiency of Specification and Ambiguity
(e) Insufficiency of Specification and Inutility
INFRINGEMENT
[27] Apotex's complete NOA is attached to these reasons as Schedule "A". The pertinent provisions in relation to claim 1 are set out below.
Claim 1 will not be infringed since our formulation will not contain an
alkaline reacting compound, as discussed above, within the meaning of
the '037 Patent.
Additionally, our product will contain a core material, which does not
contain an alkaline reacting compound, together with an enteric coating
disposed on the core material. Accordingly, claim 1 will not be infringed
since our formulation will not contain a water soluble separating layer,
because claim 1 requires that the water soluble separating layer be formed
in situ as a water soluble salt by a reaction between the enteric coating
polymer and the alkaline reacting compound. This cannot occur in our
product since it will not have an alkaline reacting compound.
Thirdly, as discussed above, the water soluble separating layer within
the meaning of claim 1 must completely coat the core material and be
of sufficient thickness which would allow it to function as a separating
layer which provides the requisite stability required for an oral dosage
formulation of a proton pump inhibitor which comprises a separating
or subcoating layer between the enteric coating and the core material.
Any material formed between our core material and the enteric coating
layer will not completely coat the core material and be of sufficient
thickness as to allow it to function as aforesaid.
Do the Apotex tablets contain an ARC?
[28] Before turning to the arguments of the parties, since this issue turns on the construction of claim 1, it is useful, again, to reproduce that claim.
1. An oral pharmaceutical dosage form comprising:
(a) a core material that contains a proton pump inhibitor and an alkaline
reacting compound;
(b) an enteric coating layer comprising an enteric coating polymer; and
(c) a water soluble separating layer that is formed in situ as a water soluble
salt between the core material and the enteric coating layer by a reaction
between the enteric coating polymer and the alkaline reacting compound.
[29] The first paragraph from the excerpt of Apotex's NOA reproduced above makes reference to a previous discussion in the NOA. The gravamen of that discussion is as follows:
The disclosure of the '037 patent makes it very clear that the phrase "proton pump inhibitor" includes both omeprazole and its base addition salt, such as magnesium omeprazole. The disclosure also makes clear that the phrase "alkaline reacting compound" cannot mean any substance which is a proton pump inhibitor. For example, omeprazole or magnesium omeprazole is not an "alkaline reacting compound" within the meaning of the patent.
Additionally, the phrase "alkaline reacting compound" cannot mean any constituent or excipient whose function in the formulation is other than as an "alkaline reacting compound". For instance, substances in the formulation which function as a lubricant, dye or disintegrant cannot be an "alkaline reacting compound".
[30] There is some, but not much, common ground. There is no debate that the proton pump inhibitor (PPI) includes both omeprazole and its base addition salts such as magnesium omeprazole. Thus, magnesium omeprazole is a PPI. There is also no dispute that the magnesium salt of omeprazole is alkaline. The crux of the argument between the parties is Apotex's assertion that the alkaline reacting compound (ARC) in Claim 1(a) cannot mean any substance that is a PPI and Astra's view to the contrary. The evidence that is pertinent to this issue is comprised of the affidavits and cross-examinations of Dr. Rees (for Astra) and Drs. Hopfenberg and Signorio (for Apotex).
The Arguments
[31] Astra submits that Apotex's construction of the '037 patent is incorrect. Astra maintains that the PPI can also be used to fulfill the role of the ARC. When read in its ordinary and grammatical context, claim 1 does not preclude the PPI and the ARC from being the same substance. The disclosure of the '037 patent contains a clear definition for the term "alkaline reacting compound" and, according to Astra, it was accepted by Apotex's witnesses that magnesium omeprazole can act as an ARC. Since the '037 patent imposes no other requirement or limitation in defining ARC (other than "a substance in the position to form a water soluble salt with an enteric coating polymer"), Astra alleges that Apotex's argument is tantamount to asking the Court to read in additional requirements that are not present on a fair reading of the claim. Specifically, Astra contends that the Apotex construction requires the addition of words in claim 1(a) to say "core material that contains a proton pump inhibitor and an alkaline reacting compound which must be different from the proton pump inhibitor".
[32] Astra asserts that it is well-known and common formulation practice that some ingredients are designed to serve more than one purpose and it is desirable, whenever feasible, to use as few ingredients as possible in a formulation in the interests of keeping it as simple as possible. Astra adds that the '037 patent provides no teaching to the effect that the ARC cannot be an excipient or constituent that serves more than one function.
[33] Moreover, notes Astra, Apotex's construction relies extensively upon examples in the disclosure when the disclosure specifically states that the scope of the invention is not limited by examples. Additionally, Dr. Signorio relied heavily (in cross-examination) on the patent's abstract. Subsection 79(1) of the Patent Rules, SOR/96-423 provides that the abstract "cannot be taken into account for the purpose of interpreting the scope of protection sought or obtained" in the patent.
[34] Apotex argues that the grammatical structure of claim 1, namely the use of the conjunctive word "and" makes it clear to an ordinary person skilled in the art that the PPI and the ARC are two separate components. To accept Astra's construction requires the insertion of a further definition regarding the PPI, specifically the insertion of the words "a proton pump inhibitor including an alkaline reacting compound", "a proton pump inhibitor without an alkaline reacting compound plus an alkaline reacting compound" or both.
[35] Also, says Apotex, component (c) of claim 1, which requires an in situ separating layer formed from a "reaction between the core material and the enteric coating layer by a reaction between the enteric coating layer and the ARC" supports the Apotex construction. Various references in the disclosure, which refer to the PPI "mixed with" the ARC also indicate that the ARC and PPI are distinct ingredients (affidavits of Drs. Hopfenberg and Signorio: applicant's record, volume 2, tab 7, pp. 197 and 199-201 and volume 3, tab 11, pp. 670-672).
[36] Further, the disclosure of the '037 patent teaches that it is the ARC that is involved in a reaction with the enteric coating polymer to form an in situ separating layer, the purpose of which is to protect the active medicinal ingredient (in this case the magnesium omeprazole) from degradation. Thus, Apotex asserts, to use the PPI (the active medicinal ingredient) as a reactant in a chemical reaction with the enteric coating polymer is antithetical to the intended purpose of the separating layer (affidavit of Dr. Hopfenberg, applicant's record, volume 2, tab 7, p. 204).
Analysis
[37] As noted, the determination of this issue turns on the construction of claim 1. One of the most recent pronouncements of the Federal Court of Appeal on the issue of claims construction is contained in Novartis Pharmaceuticals Canada Inc. v. RhoxalPharma Inc. (2005), 38 C.P.R. (4th) 193 (F.C.A.). Madam Justice Desjardins, for the majority[1], discusses the question at paragraphs 45 through 52 as follows:
¶ 45 Expert evidence, although essential to the construction of a claim, does not govern the construction of a claim. Claims construction is a question of law for the judge who is even entitled to adopt a construction of the claims that differs from that put forward by the parties (Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, 9 C.P.R. (4th) 129, 194 D.L.R. (4th) 193, at para. 61 (Whirlpool); Canamould Extrusions Ltd. v. Driangle Inc. (2004), 237 D.L.R. [page207] (4th) 157, 30 C.P.R. (4th) 129 (F.C.A.), at para. 3, per Stone J.A.; Nekoosa Packaging Corp. v. AMCA International Ltd. (1994), 172 N.R. 387, 56 C.P.R. (3d) 470 (F.C.A.), at paras. 12, 13 and 14, per Robertson J.A.).
¶ 46 Whirlpool in particular (see also Free World Trust v. Electro Santé Inc., [2000] 2 S.C.R. 1024, 9 C.P.R. (4th) 168, 194 D.L.R. (4th) 232, at paras. 28 and 44) teaches us the principles of patent claims construction.
¶ 47 At para. 42 and 43 of Whirlpool, Binnie J. states:
[42] The content of a patent specification is regulated by s. 34 of the Patent Act. The first part is a "disclosure" in which the patentee must describe the invention "with sufficiently complete and accurate details as will enable a workman, skilled in the art to which the invention relates, to construct or use that invention when the period of the monopoly has expired": Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504, at p. 517. The disclosure is the quid provided by the inventor in exchange for the quo of a 17-year (now 20-year) monopoly on the exploitation of the invention. The monopoly is enforceable by an array of statutory and equitable remedies and it is therefore important for the public to know what is prohibited and where they may safely go while the patent is still in existence. The public notice function is performed by the claims that conclude the specification and must state "distinctly and in explicit terms the things or combinations that the applicant regards as new and in which he claims an exclusive property or privilege" (s. 34(2))". An inventor is not obliged to claim a monopoly on everything new, ingenious and useful disclosed in the specification. The usual rule is that what is not claimed is considered disclaimed.
[43] The first step in a patent suit is therefore to construe the claims. ... [My emphasis.]
¶ 48 Binnie J. confirmed that the purposive approach developed in Catnic Components Ltd. v. Hill and Smith Ltd., [1982] R.P.C. 183 (H.L.), and adopted by this Court in Eli Lilly & Co. v. O'Hara Manufacturing Ltd. (1989), 26 C.P.R. (3d) 1 (F.C.A.), was the proper approach to claims construction.
¶ 49 "The key to a purposive construction ....", Binnie J. wrote at para. 45, "... 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".
¶ 50 Binnie J. wrote further at para. 49(e) that when a patent is issued, it is an enactment within the definition of "regulation" in subsection 2(1) of the Interpretation Act, R.S.C. 1985, c. I-21, and, [page208] as such, according to section 12 of the Interpretation Act, it must be given an interpretation "as best ensures the attainment of its objects".
¶ 51 Binnie J. rejected the dictionary approach. He wrote that we must look at the whole of the specification (including the disclosure and the claims) "to ascertain the nature of the invention" (see para. 52 of Whirlpool).
¶ 52 He further added, at para. 53:
¶ ...53 However, the patent specification is not addressed to grammarians, etymologists or to the public generally, but to skilled individuals sufficiently versed in the art to which the patent relates to enable them on a technical level to appreciate the nature and description of the invention: H. G. Fox, The Canadian Law and Practice Relating to Letters Patent for Inventions (4th ed. 1969), at p. 185. The court, writes Dr. Fox, at p. 203, must place itself in the position of some person acquainted with the surrounding circumstances as to the state of the art and the manufacture at the time, and making itself acquainted with the technical meaning in that art or manufacture that any particular word or words may have. [My emphasis.]
[38] However, the patent's disclosure cannot be used to impose limitations on the claims where no such limitations exist on a fair reading: Dableh v. Ontario Hydro (1996), 68 C.P.R. (3d) 129 (F.C.A.). Here, claim 1 provides that the product is comprised of three elements:
(a) a core;
(b) an enteric coating layer; and
(c) a water soluble separating layer between the core material and the enteric coating layer.
[39] Each of these elements has limitations. In the case of (a), the core must contain a PPI and an ARC. For (b), the enteric coating layer is comprised of an enteric coating polymer. Element (c) contains the most significant limitation in that it is not just any water soluble separating layer between the core and the enteric coating. It is a water soluble separating layer that is formed in situ as a water soluble salt between the core material and the enteric coating layer by a reaction between the enteric coating polymer and the alkaline reacting compound. Thus, there is a process limitation contained in claim 1. The meaning that is ascribed to the ARC is of significant import.
[40] Astra claims that a skilled formulator would interpret magnesium omeprazole as including both a PPI and ARC. Thus, without further ado, magnesium omeprazole is a core material that contains a PPI and an ARC within the meaning of claim 1(a) of the '037 patent. With respect, I do not think that it is that simple.
[41] Astra's argument, while referring to the skilled person, does not point to any evidence, other than that derived on cross-examination, to support its statement. Evidence obtained during cross-examination must be examined in the context in which it was given to ensure that the specific "admissions" being relied upon do, in fact, constitute statements of the nature for which they are b