Date: 20031103
Docket: A-563-02
Citation: 2003 FCA 409
CORAM: DÉCARY J.A.
LINDEN J.A.
ROTHSTEIN J.A.
BETWEEN:
APOTEX INC.
Appellant
(Respondent)
and
AB HASSLE, ASTRAZENECA AB and
ASTRAZENECA CANADA INC.
Respondents
(Applicants)
and
THE MINISTER OF HEALTH
Respondent
(Respondent)
Heard at Ottawa, Ontario, on October 15, 2003.
Judgment delivered at Ottawa, Ontario, on November 3, 2003.
REASONS FOR JUDGMENT BY: ROTHSTEIN J.A.
CONCURRED IN BY: DÉCARY J.A.
LINDEN J.A.
Date: 20031103
Docket: A-563-02
Citation: 2003 FCA 409
CORAM: DÉCARY J.A.
LINDEN J.A.
ROTHSTEIN J.A.
BETWEEN:
APOTEX INC.
Appellant
(Respondent)
and
AB HASSLE, ASTRAZENECA AB and
ASTRAZENECA CANADA INC.
Respondents
(Applicants)
and
THE MINISTER OF HEALTH
Respondent
(Respondent)
REASONS FOR JUDGMENT
ROTHSTEIN J.A.
ISSUES
[1] This is an appeal from a decision of the Trial Division (as it then was) rendered under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended. The motions judge granted the Application for Prohibition of AB Hassle, AstraZeneca AB and AstraZeneca Canada Inc. (Astra), prohibiting the Minister of Health from issuing a Notice of Compliance for Apotex's product, Apo-Omeprazole tablets. Apotex raises two issues on this appeal:
1. whether the motions judge erred by failing to construe the relevant patents and whether the relevant patents, properly construed, claim a formulation in which the inert subcoating consists of material comprised of reacted portions of the core and the enteric coating resulting from direct contact between the core and enteric coating; and
2. whether the motions judge erred by finding that Apotex's Notice of Allegation was deficient and non-compliant with the Regulations.
[2] Apotex must succeed on both issues in order to have this Court set aside the Order of Prohibition issued by the motions judge.
FACTS
[3] The medicine at issue is a pharmaceutical preparation for the treatment of gastric and duodenal ulcers. The active medicinal ingredient is either omeprazole or omeprazole magnesium. Astra's trade name for its product is Losec. There are three similar patents covering related product formulations, but for purposes of this appeal, the parties are agreed that it is only necessary to have regard to one patent - patent number 1,292,693 (the 693 Patent).
[4] I take the following description of the circumstances of the invention from the 693 Patent disclosure. To be effective, the omeprazole must be released in the small intestine and not in the stomach. In order to prevent the omeprazole from being degraded by acidic gastric juices in the stomach, an enteric coating covering the omeprazole core is required. The enteric coating dissolves in the neutral to alkaline environment found in the small intestine after allowing the omeprazole to pass through the stomach unaltered.
[5] However, if a conventional enteric coating is applied directly to the omeprazole core, the omeprazole rapidly decomposes, with the result that the pharmaceutical preparation (or, in everyday language for purposes of this case, a tablet) becomes badly discoloured and loses omeprazole content with the passage of time. This problem of storage stability can be addressed by including alkaline reacting constituents in the omeprazole core. However, when a tablet containing an alkaline core which is in direct contact with the enteric coating is ingested, some of the gastric juice in the stomach diffuses through the enteric coating into the omeprazole core during the time the tablet resides in the stomach before it is emptied into the small intestine. The gastric juice causes parts of the omeprazole core to dissolve which, in turn, interfere with and eventually dissolve the enteric coating.
[6] The object of the invention disclosed in the relevant patents is to provide an enteric coated tablet of omeprazole which is resistant to dissolution in the stomach. This is obtained by having an inert subcoating between the omeprazole core and the enteric outer coating.
[7] The relevant product claim in the 693 Patent provides:
1. An oral pharmaceutical preparation comprising:
(a) a core region comprising an effective amount of a material selected from the group consisting of omeprazole plus an alkaline reacting compound, an alkaline omeprazole salt plus an alkaline reacting compound and an alkaline omeprazole salt alone;
(b) an inert subcoating which is soluble or rapidly disintegrating in water disposed on said core region, said subcoating comprising one or more layers of materials selected from among tablet excipients and polymeric film-forming compounds; and
(c) an outer layer disposed on said subcoating comprising an enteric coating.
[8] In its Notice of Allegation, Apotex advises Astra that it has filed with the Minister of Health a new drug submission for Apo-Omeprazole tablets. Apotex alleges that no claim for the medicine in the 693 Patent would be infringed by Apotex making, constructing, using or selling its tablets.
[9] Apotex then explains why, in its view, its tablets do not fall within the scope of the claims in the 693 Patent and why the tablets would not infringe the 693 Patent:
The claims of these patents cover compositions comprising a core containing a medicine, an inert subcoating, and an outer enteric coating. Our tablets will not fall within the scope of the claims of these patents.
More specifically, our tablets comprise cores containing the drug, and an enteric coating applied directly to the cores without any subcoating between the cores and the enteric coating. Our tablets will not infringe, by reason there being no subcoating between the cores and the enteric coating.
[10] As a result of reviewing Apotex's Notice of Allegation, Astra filed its Application for Prohibition. The motions judge, by Order dated September 4, 2002, granted the Application for Prohibition prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex. This is an appeal from that decision.
APOTEX'S POSITION
[11] Apotex says the motions judge failed to construe the 693 Patent. Although Apotex concedes that the motions judge correctly stated the first principle of patent infringement analysis - that the relevant patent claims must first be construed, Apotex says he failed to apply this principle and did not construe the relevant patent claim. Apotex says the motions judge instead proceeded to consider patent infringement, a step he could not reach without first determining the scope of the relevant patent claim. Apotex also says the motions judge erred in finding its Notice of Allegation to be inadequate.
DECISION OF THE MOTIONS JUDGE
[12] Although the motions judge reviewed the expert and other evidence in some detail, he did not expressly make any finding with respect to the construction of the relevant patent claim or whether there would be infringement by Apotex. Rather, he found that Apotex's Notice of Allegation was deficient and, on that basis alone, allowed the Application for Prohibition. The motions judge was not satisfied that Apotex had addressed the relevant patent claim in its Notice of Allegation.
ANALYSIS
Construction of Patent Claim 1
[13] Claim construction is a matter of law (Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067 at paragraph 76). This Court must, therefore, determine the correct construction of claim 1 (Housen v. Nikolaisen, [2002] 2 S.C.R. 235 at paragraphs 8-9).
[14] There is no issue about paragraphs (a) and (c) of claim 1. It is paragraph (b) that is in controversy. Apotex says that paragraph (b) does not cover inert material formed between the core and enteric outer layer in situ from reaction between certain components of the core and the enteric outer layer. Rather, Apotex submits that paragraph (b) only covers a subcoating which is applied to the core and which is then covered by the enteric outer layer.
[15] In support of this interpretation of paragraph (b), Apotex relies upon certain paragraphs of the patent disclosure. Apotex says that the patent disclosure excerpts upon which it relies indicate that the scope of the invention described in patent claim 1 only covers a product in respect of which the intermediate subcoating is applied to the core before the outer enteric coating is applied to the subcoating. Apotex says that the description of the product requires the core and the enteric coating to never come into contact with each other. Rather, it says the core and enteric coating must be separated during the coating process, as well as during storage. The excerpts relied upon by Apotex are:
Outline of the invention
Cores containing omeprazole mixed with alkaline compounds or an alkaline salt of omeprazole optionally mixed with an alkaline compound or coated with two or more layers, whereby the first layer/layers is/are soluble in water o [sic] rapidly disintegrating in water and consist(s) of non-acidic, otherwise inert pharmaceutically acceptable substances. This/these first layer/layers separates/separate the alkaline core material from the outer layer, which is an enteric coating (page 4).
Separating layer
The omeprazole containing alkaline reacting cores must be separated from the enteric coating polymer(s) containing free carboxyl groups, which otherwise cause degradation/discolouration of omeprazole during the coating process or during storage (page 6).
Enteric coating layer
The enteric coating layer is applied onto the sub-coated cores by conventional coating techniques such as, for instance, pan coating or fluidized bed coating using solutions of polymers in water and/or suitable organic solvents or by using latex suspensions of said polymers (page 7).
The cores are coated with an inert reacting water soluble or in water rapidly disintegrating coating, optionally containing a pH-buffering substance, which separates the alkaline cores from the enteric coating.... the subcoated dosage form is finally coated with an enteric coating rendering the dosage form insoluble in acid media, but rapidly disintegrating/dissolving in neutral to alkaline media such as, for instance the liquids present in the proximal part of the small intestine, the site where dissolution is wanted.
...
Process
A process for the manufacturer [sic] of the oral dosage form represents a further aspect of the invention. After the forming of the cores the cores are first coated with the separating layer and then with the enteric coating layer. The coating is carried out as described above (pages 8 and 9).
[Emphasis added]
Apotex further argues that of all the examples shown in the patent, none disclose a subcoating formed in situ from the reaction of components in the core and enteric coating.
[16] I have some difficulty with Apotex's reliance on the patent disclosure. In this case, patent claim 1, as a product claim, appears to be clear and in such a case, it is not appropriate to look to the disclosure to construe the claim and, in particular, to vary the scope or ambit of the claim (Dableh v. Ontario Hydro, [1996] 3 F.C. 751 at paragraph 30 (C.A.)). I will, therefore, first construe claim 1 itself. However, since Apotex largely rested its case on the patent disclosure, I will then deal with Apotex's argument based on the disclosure.
[17] Claim 1 describes an "oral pharmaceutical preparation" or, in every day language, a tablet. The tablet is described as having a core region, an inert subcoating and an outer layer or enteric coating. Claim 1 does not purport to place any limitations on the inert subcoating. It does not say that the inert subcoating must be created in any particular manner.
[18] Claim 1 does provide that the inert subcoating is to be "disposed on said core region". Apotex says this must mean that the core is coated with the subcoating or that the subcoating is placed on or applied to the core. Apotex says this is not just a process limitation but a limitation on the product which would exclude a tablet whose inert separating layer was formed in situ by the reaction of certain materials in the core and enteric coating.
[19] The evidence of Dr. Rees, expert for Astra, was that the term "disposed on said core region" should be construed to describe the need to have a subcoating located between the core and the enteric coating in the finished preparation. The evidence of Apotex's experts, Dr. Niebergall and Dr. Schnaare, was that, since the purpose of the inert subcoating was to avoid any reaction between the enteric coating and the medicinal core, the product of a reaction between the enteric coating and the core could never be a subcoating within the meaning of the patent. Dr. Niebergall further stated that a reaction between the enteric coating and the core could never produce a continuous subcoating at least 10 μm thick, which he believed the patent required.
[20] In respect of the required thickness of the subcoating, it appears that Dr. Neibergall misread the disclosure. The disclosure indicates that the thickness of the separating layer cannot be less than 2 μm, although a greater thickness is preferable. His evidence does not say that a 2 μm thickness could not be formed in situ.
[21] I would give greater weight to Dr. Rees's evidence. Because claim 1 is clearly a product claim and not a process claim, I construe the term "disposed on said core region" as describing the structure of the finished pharmaceutical preparation. The term, in the context of a product claim, describes the location of the subcoating and not the process by which it was formed.
[22] If, as I construe it, claim 1 describes a finished product, nothing in the disclosure detracts from the interpretation that the inert subcoating need not be formed by any particular process or formation. In the finished product, a subcoating applied to the core or a subcoating formed in situ would separate the core from the enteric coating. That the disclosure provides that the core and enteric coating must be separated "during the coating process" might help to construe an ambiguous process claim. But I do not see those words as having any application to a claim that clearly describes a finished product. Similarly, the other references in the disclosure relied upon by Apotex describe one process for making the pharmaceutical preparation - sequentially applying the subcoating to the core and then the enteric coating to the subcoating. But nothing in claim 1 purports to place a process limitation on the finished pharmaceutical preparation.
[23] Apotex argues that such a construction is inconsistent with the disclosure because the very problem the invention was designed to solve is that direct contact between the omeprazole core and the enteric coating results in discolouration and the eventual degradation of the core. However, the patent goes on to teach that this storage stability problem can be solved by adding sufficient alkaline reacting constituents to the core. A subcoating is only needed to prevent the premature dissolution in the stomach of the enteric coating of tablets with an alkaline core. That problem only occurs when the tablet is ingested and thus claim 1 does not preclude the core and the enteric coating from coming into contact during the manufacturing process so long as a subcoating exists in the final product.
[24] I conclude that patent claim 1 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.
Adequacy of the Notice of Allegation
[25] In finding the Notice of Allegation inadequate in this case, the motions judge relied on the decision of this Court in Genpharm Inc. v. The Minister of Health and Procter & Gamble Pharmaceuticals (Canada) Inc., 2002 FCA 290 at paragraphs 22 to 25. In Genpharm, the Notice of Allegation failed to address relevant patent claims. In this case, the Notice of Allegation does address the relevant patent claim.
[26] The point to be made is that the adequacy of the Notice of Allegation must be decided on the facts of each case, and in particular, the wording of the Notice of Allegation. Although I entertain some doubt that the Notice of Allegation in this case was inadequate, it will not be necessary to decide that issue because of my determination with respect to the construction of claim 1 in the 693 Patent.
CONCLUSION
[27] Apotex conceded that if claim 1 was construed, as it now has been by this Court, as disclosing a tablet which contains a subcoating or separating layer between the core and enteric coating in its finished product form, however the subcoating or separating layer is formed, its appeal must fail. Therefore, it is not necessary for me to address the issue of infringement.
[28] The appeal should be dismissed with costs.
"Marshall Rothstein"
J.A.
"I agree
Robert Décary J.A."
"I agree
A.M. Linden"
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-563-02
STYLE OF CAUSE: Apotex Inc. v. AB Hassle, AstraZeneca AB et al.
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: October 15, 2003
REASONS FOR JUDGMENT
BY: ROTHSTEIN J.A.
CONCURRED IN BY: DÉCARY J.A.
LINDEN J.A.
DATED: November 3, 2003
APPEARANCES:
Mr. Harry Radomski
Mr. Andrew Brodkin FOR THE APPELLANT
Mr. Gunar Gaikis FOR THE RESPONDENTS, AB HASSLE, ASTRAZENECA AB and ASTRAZENECE CANADA INC.
SOLICITORS OF RECORD:
Goodmans LLP
Toronto, Ontario FOR THE APPELLANT
Smart & Biggar
Toronto, Ontario FOR THE RESPONDENTS, AB HASSLE, ASTRAZENECA AB and ASTRAZENECA CANADA INC.
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