Reports.fja.gc.ca

Apotex Inc. (Appellant) (Respondent)
AB Hassle, AstraZeneca AB and AstraZeneca Canada Inc. (Respondents) (Applicants)
The Minister of Health (Respondent)(Respondent)
INDEXED AS: AB HASSLE v. APOTEX INC. (F.C.A.) Federal Court of Appeal, Décary, Evans and Sharlow JJ.A.—Toronto, November 24, 2005; Ottawa, February 10,2006.
Patents — Practice — Appeal from Federal Court order prohibiting Minister of Health from issuing notice ofcompliance to Apotex Inc. in respect of 10 mg, 20 mg omeprazole magnesium tablets until after expiration ofCanadian Patent No. 1292693 (N693 patent) in 2008 — Present case involving same parties, same proposed genericproduct of Apotex, construction of same claim of same patent, etc. as in prior proceeding — Apotex claimingmaking new non-infringement allegation in present case — Federal Court’s conclusion notice of allegationinsufficient to raise new non-infringement allegation reasonable on record — Federal Court also not erring whenfinding Apotex could have raised invalidity allegations in previous proceeding — In patent proceedings, abuse ofprocess may be argued by “first person” (as defined in Patented Medicines (Notice of Compliance Regulations))when “second person” (as defined in NOC Regulations) submitting second or subsequent notice of allegationrelating to same proposed product, same patent — However, no abuse of process if second notice of allegation basedon new facts, newly discovered process, change in law — Even if second or subsequent notice of allegationconsidered abuse of process, Federal Court nevertheless having discretion to determine application for prohibitionorder on merits — Federal Court of Appeal will not interfere with exercise of judge’s discretion unless error of lawor principle made or discretion not judicially exercised — Record in present case disclosing no such error.
This was an appeal from a Federal Court order, made under the Patented Medicines (Notice of Compliance)Regulations (NOC Regulations) prohibiting the Minister of Health from issuing a notice of compliance to ApotexInc. in respect of 10 mg and 20 mg omeprazole magnesium tablets until after the expiration of Canadian Patent No.
1292693 (N693 patent) in 2008. The Federal Court granted the prohibition order because (1) the non-infringementallegation made by Apotex was identical to a non-infringement allegation it had raised in a prior proceeding (ABHassle 2003) that resulted in a prohibition order and (2) because Apotex’ allegations of invalidity were not made inthe prior proceeding. This case and AB Hassle 2003 involved the same parties, the same proposed generic product ofApotex, the same comparison product of AstraZeneca, and the construction of the same words of the same claim ofthe same patent. The non-infringement allegation Apotex made in AB Hassle 2003 was based on a construction ofparagraph (b) of claim 1 of the N693 patent. In AB Hassle 2003, the Federal Court found Apotex’ allegation not to besufficient, with the result that the application for a notice of prohibition was granted. The Federal Court of Appealdoubted that the allegation was deficient, but confirmed the prohibition order because it was premised on anincorrect construction of paragraph (b) of claim 1 of the N693 patent. The notice of allegation in this case containedsubstantially the same non-infringement allegation that was the subject of AB Hassle 2003, as well as, according toApotex, a new non-infringement allegation. The main issue was whether Apotex could and should have raised theinvalidity allegations in AB Hassle 2003 and whether in the particular circumstances of this case, its attempt to raisethese invalidity allegations for the first time should be barred on the basis of the doctrine of abuse of process.
Held, the appeal should be dismissed.
This appeal raised a number of questions about the scope of the doctrine of abuse of process in proceedings underthe NOC Regulations. These are summary proceedings, intended to facilitate a relatively quick determination by theFederal Court of certain issues of patent construction, infringement and validity, but only for the limited purpose ofmaking (or declining to make) an order prohibiting the Minister of Health from approving the sale in Canada of anew generic drug for which approval is sought on the basis of a comparison to an existing product whose producerhas certain patent rights. A generic drug producer who wishes to market its produce before the expiry of a particularpatent must file a “notice of allegation” and a “detailed statement” explaining why the product will not infringe thepatent, or why the patent is invalid. To obtain a prohibition order, the patent holder must satisfy the Federal Court,on a balance of probabilities, that the generic manufacturer’s allegations are not justified. The notice of allegationand detailed statement must address all relevant patent claims and must contain enough information to allow the“first person” (as defined in the NOC Regulations) to make an informed decision as to whether to respond to thenotice of allegation by commencing an application for a prohibition order. A notice of allegation that meets thesetests is said to be “sufficient”. A “second person” (as defined in the NOC Regulations) cannot, in response to a firstperson’s application for prohibition, present evidence and argument relating to an issue that is outside the scope ofthe notice of allegation and detailed statement.
The determination of the sufficiency of an allegation is a question of mixed law and fact. The Federal Court foundthat the notice of allegation was not sufficient to raise the new non-infringement allegation. This conclusion wasreasonably open to the Court on the record and there was no error of any kind justifying a departure from the Court’sinterpretation of the notice of allegation. Therefore, the only non-infringement allegation properly raised in this casewas the same point as the one raised in AB Hassle 2003, and that allegation was found not to be justified. There wasno basis for reaching a different conclusion in this case with respect to the same non-infringement allegation.
Most of Apotex’ invalidity allegations turned on the point of patent construction that was finally accepted in ABHassle 2003. In certain situations, the Federal Court of Appeal has permitted a second person to make a series ofdistinct allegations so that a first person might be forced to consider commencing a new prohibition proceeding tochallenge each one. Moreover, in certain circumstances, a second person may submit more than one notice ofallegation in relation to a certain patent in respect of the same proposed generic product. However, if a secondperson submits a second or subsequent notice of allegation relating to the same proposed product and the samepatent, the first person may commence prohibition proceedings and argue that the second or subsequent notice ofallegation is an abuse of process. Similarly, if a prohibition order was previously denied, the second person mayargue that a second application for a prohibition order is an abuse of process.
It is possible that there would be no abuse of process if, for example, the second notice of allegation is based on newfacts, a newly discovered process, a change in the law or a situation that limits the scope or application of an existingprohibition order. Even if it is determined that a second or subsequent notice of allegation is an abuse of process, theFederal Court nevertheless has the discretion to determine the application for a prohibition order on its merits. TheFederal Court made no error of law in finding that Apotex could have raised its invalidity allegations in the previousproceedings and therefore that issue estoppel, or alternatively abuse of process, applied. The Federal Court ofAppeal will not interfere with the exercise of a judge’s discretion unless there is an error of law or principle or afailure to exercise the discretion judicially. The record in this case disclosed no such error.
Proceedings under the NOC Regulations cannot result in decisions that are conclusive for all purposes on questionsof validity and infringement. Parties to proceedings under the NOC Regulations can obtain a full trial on such issuesby commencing an action under section 60 of the Patent Act to impeach the patent. Therefore, Apotex, whoremained of the view that the N693 patent is invalid, was not without a possible remedy.
Federal Courts Rules, SOR/98-106, rr. 1 (as am. by SOR/2004-283, s. 2), 397.
Patent Act, R.S.C., 1985, c. P-4, s. 60.
Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 2 “first person”, “second person” AB Hassle v. Apotex Inc. (2003), 29 C.P.R. (4th) 23; 312 N.R. 288; 2003 FCA 409; affg (2002), 21 C.P.R. (4th) 173;223 F.T.R. 43; 2002 FCT 931; leave to appeal to S.C.C. refused [2004] 1 S.C.R. v; Gillette Safety Razor Co. v.
Anglo American Trading Co. (1913), 30 R.P.C. 465 (H.L.).
Bayer AG v. Canada (Minister of National Health and Welfare) (1993), 51 C.P.R. (3d) 329; 163 N.R. 183 (F.C.A.);AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272; 256 N.R. 172 (F.C.A.);SmithKline Beecham Inc. v. Apotex Inc. (2001), 10 C.P.R. (4th) 338; 267 N.R. 101 (F.C.A.); AstraZeneca AB v.
Apotex Inc. (2005), 335 N.R. 1; 2005 FCA 183; Housen v. Nikolaisen, [2002] 2 S.C.R. 235; (2002), 211 D.L.R. (4th)577; [2002] 7 W.W.R. 1; 219 Sask. R. 1; 10 C.C.L.T. (3d) 157; 30 M.P.L.R. (3d) 1; 286 N.R. 1; 2002 SCC 33;Parke-Davis Division v. Canada (Minister of Health), [2003] 2 F.C. 514; (2002), 22 C.P.R. (4th) 417; 296 N.R. 279;2004 FCA 5; Apotex Inc. v. Canada (Attorney General), [2000] 4 F.C. 264; (2000), 188 D.L.R. (4th) 145; 24 Admin.
L.R. (3d) 279; 6 C.P.R. (4th) 165; 255 N.R. 319 (C.A.); leave to appeal to S.C.C. refused [2001] 1 S.C.R. v; ApotexInc. v. Canada (Minister of National Health and Welfare) (1997), 153 D.L.R. (4th) 68; 76 C.P.R. (3d) 1; 219 N.R.
151 (C.A.); leave to appeal to S.C.C. refused [1998] 1 S.C.R. viii; Elders Grain Co. v. Ralph Misener (The), [2005]3 F.C.R. 367; (2005), 334 N.R. 1; 2005 FCA 139; Apotex Inc. v. Syntex Pharmaceuticals International Ltd. (1999), 1C.P.R. (4th) 22; 166 F.T.R. 161 (F.C.T.D.); Hoffmann-La Roche Ltd. v. Canada (Minister of National Health andWelfare) (1999), 167 F.T.R. 111 (F.C.T.D.).
APPEAL from a Federal Court order ([2005] 4 F.C.R. 229; (2005), 38 C.P.R. (4th) 216; 271 F.T.R. 30; 2005 FC234) made under the Patented Medicines (Notice of Compliance) Regulations prohibiting the Minister of Healthfrom issuing a notice of compliance to Apotex Inc. in respect of 10 mg and 20 mg omeprazole magnesium tabletsuntil after the expiration of Canadian Patent No. 1292693 in 2008. Appeal dismissed.
Harry B. Radomski and Andrew R. Brodkin for appellant (respondent).
Gunars A. Gaikis and Yoon Kang for respondent (applicant) AB Hassle.
No one appearing for respondent (respondent) Minister of Health.
Goodmans LLP, Toronto, for appellant (respondent).
Smart & Biggar, Toronto, for respondent (applicant) AB Hassle.
Deputy Attorney General of Canada for respondent (respondent) Minister of Health.
The following are the reasons for judgment rendered in English by SHARLOW J.A.: Apotex Inc. is appealing the order of the Federal Court dated February 24, 2005, made on the application of AB Hassle, AstraZeneca AB and AstraZeneca Canada Inc. (collectively, AstraZeneca) under thePatented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the “NOC Regulations”). That orderprohibits the Minister of Health from issuing a notice of compliance to Apotex Inc. in respect of 10 mg and 20 mgomeprazole magnesium tablets until after the expiration of Canadian Patent No. 1292693 (the N693 patent) in 2008.
The reasons for that order are reported as AB Hassle v. Apotex Inc., [2005] 4 F.C.R. 229.
This appeal raises a number of questions about the scope of the doctrine of abuse of process in proceedings under the NOC Regulations. These are summary proceedings, intended to facilitate a relatively quick determinationby the Federal Court of certain issues of patent construction, infringement and validity, but only for the limitedpurpose of making (or declining to make) an order prohibiting the Minister of Health from approving the sale inCanada of a new generic drug for which approval is sought on the basis of a comparison to an existing productwhose producer has certain patent rights. If the generic drug producer wishes its product to be marketed before theexpiry of a particular patent, the NOC Regulations require a “notice of allegation” and a “detailed statement”explaining why the product will not infringe the patent, or why the patent is invalid. To obtain a prohibition order,the patent holder must satisfy the Federal Court, on a balance of probabilities, that the generic manufacturer’sallegations are not justified.
In this case, the Judge granted the prohibition order because (1) the non-infringement allegation made by Apotex was identical to a non-infringement allegation it had raised in a prior proceeding that resulted in a prohibitionorder, and (2) the allegations of invalidity made by Apotex were not made in the prior proceeding, but thoseallegations are not to be considered in this case because of the doctrine of issue estoppel, or alternatively the doctrineof abuse of process.
It has been recognized by this Court that a notice of allegation, together with the detailed statement of the factual and legal basis of the allegations stated in the notice, plays a critical role in defining the issues to bedetermined in proceedings under the NOC Regulations. The notice of allegation and detailed statement must addressall relevant patent claims, and must contain enough information to allow the “first person” (as defined in the NOCRegulations [section 2]) to make an informed decision as to whether to respond to the notice of allegation bycommencing an application for a prohibition order. A notice of allegation that meets these tests is said to be“sufficient”. The corollary is that a “second person” (as defined in the NOC Regulations [section 2 (as am. bySOR/99-379, s. 1)]) cannot, in response to a first person’s application for prohibition, present evidence and argumentrelating to an issue that is outside the scope of the notice of allegation and detailed statement. The jurisprudence onsufficiency arises from a line of cases that includes Bayer AG v. Canada (Minister of National Health and Welfare)(1993), 51 C.P.R. (3d) 329 (F.C.A.), at paragraph 15; AB Hassle v. Canada (Minister of National Health andWelfare) (2000), 7 C.P.R. (4th) 272 (F.C.A.), at paragraph 21; SmithKline Beecham Inc. v. Apotex Inc. (2001), 10C.P.R. (4th) 338 (F.C.A.), at paragraph 27; and AstraZeneca AB v. Apotex Inc. (2005), 335 N.R. 1 (F.C.A.), atparagraph 12.
There is no doubt that Apotex provided enough information for AstraZeneca to frame an application for a prohibition order. The argument of AstraZeneca as to the sufficiency of the notice of allegation raises a debate aboutthe scope of the notice of allegation and detailed statement. AstraZeneca argues that the notice of allegation anddetailed statement raise only one point of patent construction, the very point that was determined against Apotex inAB Hassle v. Apotex Inc. (2003), 29 C.P.R. (4th) 23 (F.C.A.); confirming (2002), 21 C.P.R. (4th) 173 (F.C.T.D.),leave to appeal to the Supreme Court of Canada dismissed March 25, 2004, [2003] S.C.C.A. No. 173. I will refer tothat case as “AB Hassle 2003”.
Apotex argues that its notice of allegation and detailed statement should be interpreted as raising a point of patent construction that is new (that is, a point that was not raised in AB Hassle 2003). In support of that argument,Apotex argues that AstraZeneca discerned that new point of patent construction because it led evidence relevant tothat point and addressed that point in its submissions in the Federal Court. AstraZeneca says that its evidence andsubmissions in the Federal Court are intended to address only the point of patent construction that was considered inAB Hassle 2003.
To put this debate into its proper context, it is necessary to consider AB Hassle 2003 in some detail. This case and AB Hassle 2003 involve the same parties, the same proposed generic product of Apotex, the same comparisonproduct of AstraZeneca, and the construction of the same words of the same claim of the same patent. The focus ofAB Hassle 2003 is paragraph (b) of claim 1 of the N693 patent. Claim 1 reads as follows: 1. An oral pharmaceutical preparation comprising: (a) a core region comprising an effective amount of materialselected from the group consisting of omeprazole plus an alkaline reacting compound, an alkaline omeprazole saltplus an alkaline reacting compound and an alkaline omeprazole salt alone; (b) an inert subcoating which is soluble orrapidly 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 layerdisposed on said subcoating comprising an enteric coating. In these reasons, I use the terms “medicinal core” to refer to the core described in paragraph (a) of claim 1, “subcoating” to refer to the subcoating described in paragraph (b) of claim 1, and “enteric coating” to refer to theouter layer described in paragraph (c) of claim 1.
In AB Hassle 2003, Apotex made only one allegation, which was a non-infringement allegation. That allegation reads as follows (appeal book, Vol. 1, page 319): The claims of these patents cover compositions comprising a core containing a medicine, an inert subcoating, and anouter 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 coreswithout any subcoating between the cores and the enteric coating. Our tablets will not infringe, by reason [sic] therebeing no subcoating between the cores and the enteric coating.
In the decision of the Federal Court in AB Hassle 2003, this allegation was found not to be sufficient, with the result that the Federal Court granted the application for a notice of prohibition. On appeal Rothstein J.A., writing forthe Court, doubted that the allegation was deficient, but confirmed the prohibition order on the basis that thenon-infringement allegation could not be justified because it was premised on an incorrect construction of paragraph(b) of claim 1 of the N693 patent.
The non-infringement allegation made by Apotex in AB Hassle 2003 was based on a particular construction of paragraph (b) of claim 1 of the N693 patent. Apotex construed that part of claim 1 as referring to a layer ofmaterial that is applied to the medicinal core and covered with the enteric coating. In other words, Apotex argued inAB Hassle 2003 that the meaning of “subcoating” in paragraph (b) of claim 1 of the N693 patent must mean asubcoating placed on the core by design and not any material created in situ by a chemical reaction that occurs whenan enteric coating is applied directly to a medicinal core.
The proposed Apotex product in AB Hassle 2003 (and in this case) is said to consist of an enteric coating applied directly to the medicinal core. The evidence is that a chemical reaction occurs where the two meet, resultingin a layer of material between the medicinal core and the enteric coating that would fulfil the function of thesubcoating referred to in paragraph (b) of claim 1 of the N693 patent but, according to the construction proposed byApotex, would not meet the description of the subcoating in paragraph (b).
Rothstein J.A., writing for this Court in AB Hassle 2003, did not accept the construction of paragraph (b) of claim 1 of the N693 patent proposed by Apotex. He construed the relevant part of the claim as follows at paragraphs21-24 of his reasons: Because claim 1 is clearly a product claim and not a process claim, I construe the term “disposed on said coreregion” as describing the structure of the finished pharmaceutical preparation. The term, in the context of a productclaim, describes the location of the subcoating and not the process by which it was formed.
If, as I construe it, claim 1 describes a finished product, nothing in the disclosure detracts from the interpretation thatthe inert subcoating need not be formed by any particular process or formation. In the finished product, a subcoatingapplied to the core or a subcoating formed in situ would separate the core from the enteric coating. That thedisclosure provides that the core and enteric coating must be separated “during the coating process” might help toconstrue an ambiguous process claim. But I do not see those words as having any application to a claim that clearlydescribes a finished product. Similarly, the other references in the disclosure relied upon by Apotex describe oneprocess for making the pharmaceutical preparation—sequentially applying the subcoating to the core and then theenteric coating to the subcoating. But nothing in claim 1 purports to place a process limitation on the finishedpharmaceutical preparation.
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 indiscoloura-tion and the eventual degradation of the core. However, the patent goes on to teach that this storagestability problem can be solved by adding sufficient alkaline reacting constituents to the core. A subcoating is onlyneeded 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 entericcoating from coming into contact during the manufacturing process so long as a subcoating exists in the finalproduct.
I conclude that patent claim 1 describes a pharmaceutical preparation which, in its finished product form, contains asubcoating or separating layer between the core and enteric coating, however the subcoating or separating layer isformed.
This conclusion is germane to this case because this case involves a similar, if not identical, non- infringement allegation. The key portions of the non-infringement allegation in this case read as follows (appealbook, Vol. 1, pages 190-193): With respect to . . . [claim 1] . . ., we allege that no claim for the medicine itself and no claim for the use of themedicine would be infringed by the making, constructing, using or selling by us of the said tablets.
The N693 Patent, entitled “Pharmaceutical Preparation Containing Omeprazole”, relates to a pharmaceuticalpreparation containing omeprazole or its alkaline salts intended for oral use and to the use of these preparations inthe treatment of gastrointestinal diseases.
The essence of the alleged invention in the N693 Patent is the development of a formulation which purports to solvethe problem of the prior art formulations which consisted of an alkaline core containing omeprazole or an alkalinesalt of omeprazole, and an enteric coating disposed on the core that led to degradation. The alleged solution to theproblem is asserted in the patent to be the separation from contact of the core and the enteric coating by applicationof a subcoating within the meaning of the patent.
Each of the claims in issue of the N693 Patent contain among its essential elements, the following essential elements: within the formulation core region a selection from the group consisting of: (a) omeprazole plus an alkaline reacting compound; (b) an alkaline omeprazole salt plus an alkaline reacting compound; or (ii) 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 polymericfilm-forming compounds; and (iii) an outer layer disposed on said subcoating comprising an enteric coating.
In light of the foregoing, and in light of the very clear discussion within the disclosure, the “subcoating” in part (ii)above cannot mean material comprising a reaction product resulting from a reaction between the core material andthe enteric coating when the core is brought into contact with the enteric coating. The reaction product is preciselywhat the disclosure and the patent are directed not to having formed and hence it is not a subcoating within themeaning of “subcoating” of the patent. It is clearly not what the patent is directed to or what the inventors intended.
The patent and the inventors intended the subcoating to be distinct material placed between the core and the entericcoating so as to avoid their coming into contact.
Furthermore, the claims in issue of the patent cannot be construed to include within their scope those formulationswhich are referred to in the disclosure of the N693 Patent as being within the prior art. More particularly,formulations comprising a core with an enteric coating disposed on the core which were prepared by directapplication of the enteric coating onto a core containing omeprazole and an alkaline reacting compound, or analkaline salt of omeprazole optionally including an alkaline reacting compound, cannot be construed as falling withinthe scope of the claims of the N693 Patent, otherwise, the patent would be invalid as failing to claim something whichis new, because it would have within its scope that which is old.
Finally, the claims in issue of the patent cannot be construed to include within their scope those formulations whichare disclosed within the disclosure of the N693 Patent as examples of formulations which were used for comparisonpurposes, and were thus disclaimed from being within the scope of the claimed invention, against those formulationswhich were described as being examples of the alleged claimed invention of the N693 Patent for the purpose ofdemonstrating the benefits of the alleged inventive formulations.
Each of the claims in issue of the N693 Patent is dependent on claim 1.
We allege that we will not infringe any of the claims in issue of the N693 Patent since we will not infringe claim 1.
Claim 1 will not be infringed since our formulation will not contain a “subcoating”, as discussed above, within themeaning of the N693 Patent. Our product will contain a core with an enteric coating disposed on the core. Informulating our product, we will bring into contact the outer enteric coating with the core and will not place asubcoating within the meaning of the patent between the core and the enteric coating, so that our formulation willconsist of only components (i) and (iii), not component (ii).
In addition, given that what we are manufacturing is that which is taught in the prior art, then there clearly cannot beany infringement.
More particularly, our formulation of magnesium omeprazole tablets is taught in European Patent Application No.
124,495, published on November 7, 1984, wherein at pages 5 to 8 and at Example 12 of this Application,formulations containing a base addition salt of omeprazole (including magnesium omeprazole) are disclosed.
Included within the aforemen-tioned disclosure are references to enteric coated tablet formulations wherein thetablets are coated with an enteric coating which protects the active compound from degradation. Our formulation isin accordance with the aforementioned teachings of European Patent Application No. 124,495.
Should you assert that any of the claims in issue of the N693 Patent are infringed, we allege that the claims are invalidbased upon what has become known in Canadian law as the Gillette Defence, as discussed below.
The “Gillette Defence”, so named because it was recognized in Gillette Safety Razor Co. v. Anglo American Trading Co. (1913), 30 R.P.C. 465 (H.L.), as a defence to a claim of infringement, is made out when it is establishedthat the alleged infringing product is based on the teachings of a prior patent. In this case, the particulars of theGillette Defence are to be understood on the basis of the following explanation, which appears at the beginning ofthe allegations of invalidity in the notice of allegation (appeal book, Vol. 1, page 194): As noted above, we assert that the meaning of “subcoating” within the N693 Patent; is a subcoating which consists ofmaterial placed there by design and not any material created in situ. If you assert that any of the claims of the N693Patent are infringed by our formulation by reason of the fact that our formulation allegedly contains a “subcoating”which is formed in situ between the core and the enteric coating, and said “subcoating” is within the meaning of theclaims of the N693 Patent, then we allege that the claims must be invalid in accordance with the principles set out inthe decision of the House of Lords in Gillette Safety Razor Company v. Anglo American Trading Company Ltd.,(1913) R.P.C. 465, and the decision of J.K. Smit & Sons, Inc. v. Richard S. McClintock, [1940] S.C.R. 279.
Our formulation is within the prior art as disclosed by the teachings of European Patent Application No. 124,495,published on November 7, 1984, as discussed above. Further, the use of such a formulation to treat gastrointestinaldisease is also in accordance with the teachings disclosed within European Patent Application No. 124,495.
If our formulation contains a “subcoating” within the meaning of the N693 Patent, then the enteric coatedformulations disclosed within European Patent Application No. 124,495 would also contain such a “subcoating” andthus any allegedly infringed claims must be invalid.
The notice of allegation in this case contains, in substance, the same non-infringement allegation that was the subject of AB Hassle 2003, although that allegation is described in greater detail in the notice of allegation in thiscase. Apotex argues that it also contains a new non-infringement allegation, which I summarize as follows: (1) Ifparagraph (b) of claim 1 of the N693 patent is properly construed, a product is within the scope of that claim only if ithas a subcoating that is inert, continuous and comprised of polymeric film-forming compounds. (2) In the proposedApotex product, the layer of material between the medicinal core and the outer coating lacks those characteristics.
(3) Because those characteristics are not present, the Apotex product cannot be within the scope of paragraph (b) ofclaim 1 of the N693 patent. AstraZeneca argues that the notice of allegation and detailed statement do not raise thisnew non-infringement allegation, or at least do not raise it with sufficient clarity to meet the “sufficiency” test.
The determination of the sufficiency of an allegation is a question of mixed law and fact. The standard of appellate review is palpable and overriding error, except to the extent that a question of law can be extricated fromthe conclusion, on which case that question of law must be determined correctly: Housen v. Nikolaisen, [2002] 2S.C.R. 235; see also paragraph 9 of AstraZeneca AB v. Apotex Inc. The Judge discussed in detail the competing arguments on the sufficiency debate (see her reasons for judgment at paragraphs 17-54). The Judge refers in her reasons to all of the relevant material, including the materialfiled by AstraZeneca that, in the view of Apotex, established that AstraZeneca understood that Apotex was raising anew point of patent construction, and that AstraZeneca addressed or attempted to address that new point in thematerial filed in support of its application for prohibition. In the end, the Judge accepted the submission ofAstraZeneca that the notice of allegation was not sufficient to raise the new issue.
In my view, the Judge’s conclusion on this point was reasonably open to her on the record. Having reviewed the same material that she did, and the arguments of counsel, I can find no error of law or any other error that wouldjustify adopting an interpretation of the notice of allegation that departs from the Judge’s interpretation. This groundof appeal must fail.
It follows that the only non-infringement allegation properly raised in this case was the same point as that raised in AB Hassle 2003. The non-infringement allegation in that case was held not to be justified because it waspremised on an incorrect construction of the patent. There is no basis for reaching a different conclusion in this casewith respect to the same non- infringement allegation.
I turn now to the invalidity allegations. There are a number of them. Most turn on the point of patent construction that was finally accepted in AB Hassle 2003. For example, Apotex asserts that if paragraph (b) of claim1 of the N693 patent is construed to include a subcoating formed in situ between the medicinal core and the entericcoating (as determined in AB Hassle 2003), then the claim is invalid because (a) such a subcoating is disclosed in theprior art (refer to the comments above relating to the Gillette Defence), (b) the claim is invalid for anticipationbecause of the prior art, (c) the disclosure is insufficient and ambiguous because it does not disclose how to achievea successful formulation with an in situ subcoating, and (d) the claims are obvious, based on the prior art. Otherallegations of invalidity do not appear to be related to the patent construction issue that was the subject of AB Hassle2003. For the purposes of this appeal it is not necessary to summarize them.
The principal issue in this case is whether Apotex could and should have raised the invalidity allegations in AB Hassle 2003 and whether, in the particular circumstances of this case, its attempt to raise these invalidityallegations for the first time in this case should be barred on the basis of the doctrines of issue estoppel, res judicataor abuse of process. In my view, this issue is best resolved on the basis of abuse of process alone. For that reason, Ido not propose to discuss issue estoppel or res judicata.
In certain situations, this Court has permitted a second person to make a series of distinct allegations, so that a first person might be forced to consider commencing a new prohibition proceeding to challenge each one. Forexample, if a first person’s product is the subject of a patent list with more than one patent, a second person maysubmit a separate notice of allegation with respect to each patent, potentially resulting in a separate prohibitionproceeding for each patent: Parke-Davis Division v. Canada (Minister of Health), [2003] 2 F.C. 514 (C.A.), atparagraph 67.
It has also been recognized that, in certain circumstances, a second person may submit more than one notice of allegation in relation to a certain patent in respect of the same proposed generic product: see Apotex Inc. v.
Canada (Attorney General), [2000] 4 F.C. 264 (C.A.), per Evans J.A., at paragraph 44 (leave to appeal to S.C.C.
refused, [2001] 1 S.C.R. v); Apotex Inc. v. Canada (Minister of National Health and Welfare) (1997), 153 D.L.R.
(4th) 68 (F.C.A.) (leave to appeal to S.C.C. refused, [1998] 1 S.C.R. viii). However, if a second person submits asecond or subsequent notice of allegation relating to the same proposed product and the same patent, the first personmay commence prohibition proceedings and argue that the second or subsequent notice of allegation is an abuse ofprocess. Similarly, the second person may argue (if a prohibition order was previously denied), that a secondapplication for a prohibition order is an abuse of process.
It would be fruitless to attempt an exhaustive list of situations in which a second or subsequent notice of allegation would not be an abuse of process. However, by way of example, it may be that there would be no abuse ofprocess if the second notice of allegation is based on new facts, a newly discovered process, a change in the law, asituation that limits the scope or application of an existing prohibition order, or a new and definitive decision as tothe validity or construction of the patent. Even if it is determined that a second or subsequent notice of allegation isan abuse of process, the Federal Court nevertheless has the discretion to determine the application for a prohibitionorder on its merits: Apotex Inc. v. Canada (Attorney General), per Evans J.A., at paragraphs 46-47.
The Judge in this case found that Apotex could have raised its invalidity allegations in the previous proceedings, from which she concluded that issue estoppel, or alternatively abuse of process, applies. In my view,the Judge made no error of law in reaching that conclusion. The Judge went on to consider whether she shouldnevertheless exercise her discretion to hear the invalidity arguments, and concluded that she should not. In thatregard, she considered a number of issues, which are discussed comprehensively in her reasons at paragraphs 82-90(with respect to issue estoppel) and paragraphs 91-98 (with respect to abuse of process).
This Court will not interfere with the exercise of a judge’s discretion unless there is an error of law or principle, or a failure to exercise the discretion judicially: Elders Grain Co. v. Ralph Misener (The), [2005] 3 F.C.R.
367 (F.C.A.), at paragraph 13. The record in this case discloses no such error.
It is apparent that Apotex disagrees with the point of patent construction adopted in AB Hassle 2003, and remains of the view that the N693 patent is invalid. If so, Apotex is not without a possible remedy. It is wellestablished that proceedings under the NOC Regulations cannot result in decisions that are conclusive for allpurposes on questions of validity and infringement. It is open to parties to proceedings under the NOC Regulationsto obtain a full trial on such issues by commencing an action under the Patent Act [R.S.C., 1985, c. P-4].
For example, if a patent holder applies unsuc-cessfully for a prohibition order under the NOC Regulations in response to a non-infringement allegation, but still believes that the product will infringe its patent once it is broughtto market, the patent holder retains the right to sue for damages for infringement. Similarly, in this case Apotex maybring an action under section 60 of the Patent Act to impeach the N693 patent: Apotex Inc. v. Syntex PharmaceuticalsInternational Ltd. (1999), 1 C.P.R. (4th) 22 (F.C.T.D.). If such an action were to result in a declaration that the N693patent is invalid, then either the prohibition order in AB Hassle 2003 would cease to have any effect, or theprohibition order could be set aside under Rule 397 of the Federal Courts Rules, SOR/98-106 [r. 1 (as am. bySOR/2004-283, s. 2)]: see Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1999),167 F.T.R. 111 (F.C.T.D.), at paragraphs 14-16.
For these reasons, I would dismiss this appeal with costs.

Source: http://reports.fja.gc.ca/eng/2006/2006fca51.pdf