Astrazeneca AB v. Apotex Inc.

Astrazeneca AB v. Apotex Inc.
Court (s) Database
Federal Court Decisions
Date
2007-06-28
Neutral citation
2007 FC 688
File numbers
T-985-05
Decision Content
Date: 20070628
Docket: T-985-05
Citation: 2007 FC 688
Ottawa, Ontario, June 28, 2007
PRESENT: The Honourable Mr. Justice Barnes
BETWEEN:
ASTRAZENECA AB,
AB HASSLE and
ASTRAZENECA CANADA INC.
Applicant(s)
and
APOTEX INC. and
THE MINISTER OF HEALTH
Respondent(s)
REASONS FOR JUDGMENT AND JUDGMENT
[1] This is an application by Astrazeneca AB, AB Hassle and Astrazeneca Canada Inc. seeking an order of prohibition under the provisions of the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 to prevent the Respondent, the Minister of Health (Minister), from issuing a Notice of Compliance (NOC) to the Respondent, Apotex Inc. (Apotex), for the production of omeprazole for use in a combination therapy to treat Helicobacter pylori (Hp) infections. As can be seen from the following citations, this proceeding is one of a long line of Canadian cases which have considered omeprazole patents: see, for example, AB Hassle v. Apotex Inc. (2006), 47 C.P.R. (4th) 329, 2006 FCA 51 aff’g (2005), 38 C.P.R. (4th) 216 (F.C.); AstraZeneca AB v. Apotex Inc. (2006), 46 C.P.R. (4th) 418, 2006 FC 7; AstraZeneca Canada Inc. Apotex Inc. (2005), 40 C.P.R. (4th) 449, 2005 FCA 216 aff’g (2004), 34 C.P.R. (4th) 450, 2004 FC 647; AstraZeneca Canada Inc. v. Canada (Minister of Health) (2005), 40 C.P.R. (4th) 353, 2005 FCA 189 rev’g (2004), 36 C.P.R. (4th) 519, 2004 FC 1277 rev’d (2006), 52 C.P.R. (4th) 145, 2006 SCC 49; AstraZeneca AB v. Apotex (2005), 335 N.R. 1, 2005 FCA 183 aff’g (2004), 33 C.P.R. (4th) 125, 2004 FC 44; AstraZeneca Canada Inc. v. Canada (Minister of Health) (2005), 38 C.P.R. (4th) 212, 2005 FCA 58 aff’g (2004), 36 C.P.R. (4th) 141, 2004 FC 1278 leave to appeal to S.C.C. refused [2005] S.C.C.A. No. 255; AB Hassle v. Apotex Inc. (2003), 29 C.P.R. (4th) 23, 312 N.R. 288 (F.C.A.) aff’g (2002), 223 F.T.R. 43, 21 C.P.R. (4th) 173 (F.C.), leave to appeal to S.C.C. refused March 25, 2004, S.C.C. Bulletin, 2004, page 471; AB Hassle v. Canada (Minister of Health and Welfare) (2002), 22 C.P.R. (4th) 1, 2002 FCA 421 aff’g (2001), 16 C.P.R. (4th) 21, 2001 FCT 1264 leave to appeal to S.C.C. refused [2002] S.C.C.A. No. 531.
[2] The Applicants (collectively referred to hereafter as Astrazeneca) are the owners of Canadian Patents 2,025,668 (’668) and 2,133,762 (’762). This proceeding was commenced by Astrazeneca in response to a Notice of Allegation (NOA) from Apotex dated February 8, 2005. Apotex’s NOA alleged both non-infringement and invalidity with the respect to the ’668 and ’762 patents. Its position is summarized in the following passages from its Memorandum of Fact and Law:
5. Apotex has already obtained an NOC to market and sell its Apo-omeprazole capsules for non-Hp indications, namely, to treat ulcers by simply suppressing gastric acid and therefore heal the ulcer, rather than killing the bacteria that cause the ulcer. Apotex now seeks approval to sell its omeprazole capsules as part of the triple therapy regimen currently approved by Health Canada for the eradication of Hp. This triple therapy regimen consists of a combination of the acid suppressant omeprazole and two antibiotics, namely, clarithromycin and either amoxicillin or metronidazole. Omeprazole alone is approved by Health Canada to treat an ulcer (by healing the ulcer), but is not approved as a single therapy to eradicate the bacteria.
6. Apotex filed a Notice of Allegation (“NOA”) dated February 8, 2005, in which Apotex alleged that, with respect to the ’668 Patent, its Apo-omeprazole capsules will not infringe any of its claims, since its capsules will not be marketed or include an indication for the eradication of Hp by the use of omeprazole alone as a single drug therapy (rather than as a multiple drug therapy). The NOA further alleged invalidity of the ’668 Patent on the basis of anticipation, inutility, no sound basis to predict and ambiguity. With respect to the ’762 Patent, Apotex alleged that its Apo-omeprazole capsules will not infringe certain claims thereof since Apotex’s triple therapy regimen includes the use of omeprazole as an acid suppressant, clarithromycin as an acid degradable antibacterial, and an antibacterial compound that is other than an acid degradable antibacterial compound, namely, amoxicillin or metronidazole. Further, the Apotex NOA alleged invalidity of the ’762 Patent on the bases of anticipation, ambiguity, obviousness, inutility, lack of sound prediction and on the basis of subsection 53(1) of the Patent Act. In response, Astra initiated the within proceeding.
Issues
[3] The parties have raised numerous issues of construction and validity but in view of my findings that the ’668 Patent is invalid on the ground of anticipation and that the ’762 Patent is
invalid on the grounds of anticipation and obviousness it is unnecessary to deal with several additional allegations of invalidity raised by Apotex. The issues which I have resolved are the following:
1. Is Apotex precluded from challenging the subject patents on the ground of abuse of process?
2. What are the appropriate burdens of proof resting upon the parties and have they been met?
3. Should the ’668 Patent be construed as proposing the use of omeprazole as a single or multiple drug therapy?
4. Was the ’668 Patent anticipated by prior art teachings and to what extent are those teachings citable?
5. How should the term “bioavailability” be construed in the ’762 Patent?
6. Was the ’762 Patent anticipated by prior art teachings and to what extent are those teachings citable?
7. Is the ’762 Patent invalid for obviousness?
8. Is the ’762 Patent eligible for inclusion on the Patent Register?
9. Costs?
Analysis
Abuse of Process
[4] As a preliminary matter, Astrazeneca contends that its application for an order of prohibition should be allowed because Apotex’s prior judicial conduct constitutes an abuse of process which precludes any right to challenge the subject patents. It is, accordingly, necessary to deal with this issue before dealing with the substantive issues of non-infringement and invalidity.
[5] Astrazeneca’s argument is based on the prior history of litigation between these parties regarding the same patents that are the subject of this application. Astrazeneca argues that Apotex should not be permitted to litigate new issues of non-infringement and invalidity in this proceeding which it could have raised in those earlier proceedings. It says that the substantive issues raised by this application are necessarily bound up in the prior allegation of non-infringement and, by implication, the failure by Apotex in the earlier proceedings to mount a comprehensive challenge to the subject patents constitutes an acceptance of their validity.
[6] While there are certainly situations where subsequent litigation or re-litigation in this type of proceeding may be an abuse of process, that principle does not arise in the circumstances of this case. Indeed, there is nothing about the conduct of Apotex in the advancement of its legal interests either in this proceeding or in the earlier proceedings which can be fairly impugned.
[7] In the two earlier proceedings, Apotex alleged only that it would not infringe either of Astrazeneca’s patents because Apotex would not market or sell its omeprazole product to treat Hp infections or as part of a combination treatment regimen: see AB Hassle v. Canada (Minister of National Welfare) (2001), 16 C.P.R. (4th) 21 (F.C.T.D.) aff’d (2002), 22 C. P. R. (4th) 1 (F.C.A.) (AB Hassle #1) and AstraZeneca AB v. Apotex Inc. (2003), 33 C.P.R. (4th) 97 (F.C.) (AstraZeneca AB). At that earlier point, Apotex was content to enter the market in a limited way solely for the provision of omeprazole as an anti-acid therapy – that being an old and permitted use for the medicine. Apotex did not attempt to challenge the validity of either patent or to mount an argument of non-infringement based on contested points of patent construction. Instead, it simply advised Astrazeneca that what it intended to do would not infringe either of its patents. Astrazeneca then opposed the issuance of a NOC to Apotex based on an argument that infringement by third parties would necessarily occur if Apotex entered the omeprazole market even in a limited and ostensibly permissible way. In an appeal from the decision in AB Hassle #1 Justice Edgar Sexton upheld the finding of non-infringement of the ’668 Patent. He also noted the limited scope of that patent and Apotex’s narrow claim to the use of omeprazole in the following passages at paras. 6 and 7:
[6] Omeprazole was a known or existing compound. The patent held by Hassle only relates to the new use of omeprazole. Therefore, the '668 patent only reserves exclusive rights to omeprazole that are somehow related to the treatment of Campylobacter infections; it does not contain any claims for the compound omeprazole itself.
[7] The Appellants received Apotex' Notice of Allegation ("NOA") in a letter dated October 4, 1999. The NOA stated in part:
With respect to patent 2025668, we allege that no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by us of capsules for oral administration containing omeprazole in strengths 10 mg, 20 mg, and 40 mg.
The legal and factual basis for the aforesaid allegation is as follows:
The claims of this patent relate to the use and treatment of Campylobacter infections. Our product will not be made, used or sold for the treatment of Campylobacter infections and, more particularly, we are not seeking approval for such use and no such use will be included in our product monograph.
The Court went on to hold that, absent inducement, the likelihood of third party downstream patent infringement (by patients, physicians and pharmacists) was not a legal basis for claiming infringement by Apotex of a new use patent. Such a claim, the Court held, would allow the patent holder to control not only the new uses for an old, unprotected compound but also the compound itself (see para. 57).
[8] The same result was obtained in AstraZeneca AB, above, where the subject of the proceeding was the ’762 Patent and where AstraZeneca similarly challenged Apotex’s allegation of non-infringement. In finding for Apotex, Justice John O’Keefe defined the issue before him as follows:
[74] AstraZeneca can only succeed on the facts of this case, if the references to concomitant use, increases in bioavailability and the other impugned product monograph references (pp. 16 and 17) establish that Apotex is seeking approval to make use of Apo-Omeprazole concomitantly with antibiotic substances to increase bioavailability, that is to use Apo-Omeprazole with an antibiotic such as clarithromycin to achieve better treatment.
[9] Justice O’Keefe then concluded by finding that the use sought to be approved by Apotex was limited to the old approved use for reducing gastric acid secretion and, in the result, AstraZeneca had failed to establish infringement of the ’762 Patent.
[10] When considered in the context of the above judicial history, Astrazeneca’s complaint about abuse of process is incongruous. Its arguments that Apotex was “lying in the weeds” and had, by serving a new NOA, “conveniently” retracted its earlier position of non-infringement are also unmeritorious.
[11] There is nothing inherently objectionable about a generic manufacturer attempting to move into the market with a product that is no longer protected by a patent. Apotex was entitled to limit the scope of its allegations to an issue of non-infringement so long as it was prepared to accept the commercial trade-off of gaining only a partial entry to the marketplace for omeprazole. The other obvious disadvantage to Apotex by adopting a two-stage approach for the use of omeprazole is that it subjected itself to the burden of two separate statutory stays for the issuance of a NOC.
[12] The complaint by Astrazeneca that Apotex’s incremental challenge to its patents is somewhat wasteful of judicial resources ignores the fact that Astrazeneca was the unsuccessful instigator of the previous litigation. Astrazeneca had the option of allowing a NOC to be issued to Apotex for its limited use claim. By not getting out of the way, Astrazeneca obtained the benefit of a 2-year, and arguably unjustified, stay of the issuance of a NOC to Apotex. That may well have been an acceptable litigation strategy but Astrazeneca cannot then use its own unmeritorious challenge as the foundation for an abuse of process argument alleging juridical inefficiency.
[13] This is not a situation where Apotex was attempting to split its case around an issue of patent validity or to avoid some earlier unfavourable judicial disposition by bringing new allegations forward. There are situations where a party is expected to put its best and strongest case forward in the first instance and where subsequent litigation will not be permitted. A good example of this can be found in AB Hassle et al. v. Apotex Inc. et al. (2005), 38 C.P.R. (4th) 216, [2005] 4 F.C.R. 229, 271 F.T.R. 30, 137 A.C.W.S. (3d) 613, 2005 FC 234, aff’d (2006), 47 C.P.R. (4th) 329 (AB Hassle #2) - a decision heavily relied upon here by Astrazeneca. The circumstances there, however, were markedly distinct from the facts of this case. There, Apotex was attempting to re-litigate a point which had been determined in an earlier proceeding. Justice Carolyn Layden-Stevenson described the nature of the problem before her as follows:
[80] It seems to me that Apotex's submission begs the question. It did, in the previous proceeding, allege non-infringement. Thus, it put the issue of "infringement" into play. It does not advance any explanation for its failure to put its best foot forward in the previous proceeding. To accept its submission, in my view, is tantamount to allowing it to split its case. It enables Apotex to test the waters on the construction of the patent and then, if unsuccessful (as it was), to [page244] recast its case and get a second bite at the cherry. While I would not go so far as to say (using the words of Mr. Justice Evans in P & G, supra) that Apotex has hidden in the weeds, holding back a defence for use in subsequent litigation, it certainly put all its eggs in one basket. This omission is not of a procedural or technical nature; it is substantive. Apotex has not persuaded me that the conditions for issue estoppel have not been met regarding the issue of "infringement".
Justice Layden-Stevenson went on to say that by limiting its allegations in the first proceeding, Apotex was implicitly accepting the validity of the patent and was, therefore, estopped from subsequently asserting invalidity.
[14] On appeal, Justice Karen Sharlow upheld the abuse of process finding but did so with a caveat that it was justified “in the particular circumstances of this case”. The Court went on to observe that there will be situations where a generic manufacturer will be allowed to submit more than one NOA in relation to a certain patent in respect to the same generic product (see para. 24) and some examples were noted (see para. 25).
[15] In the recent decision in Pharmascience v. Abbott, 2007 FCA 140, aff’g [2006] F.C.J. No. 492, 2006 FC 341, the Federal Court of Appeal closely examined many of the previous authorities which had considered issue estoppel and abuse of process in the context of multiple NOA proceedings. There the Court upheld the decision of Justice O’Keefe where he had applied issue estoppel to bar the generic manufacturer from advancing a second NOA which brought forward new allegations of patent invalidity. On appeal, Justice Sexton held that multiple NOA’s from the generic manufacturer concerning the same product and alleging invalidity of a particular patent will generally not be permitted even where different grounds are advanced for establishing invalidity (see para. 41). However, the Court also recognized that there is a valid distinction to be made between cases which raise validity issues and those which allege only non-infringement. For example, in the context of a non-infringement NOA, the generic is entitled to raise new allegations based on new formulations of its proposed product. The Court summed up the distinction in the following passage at para. 47:
…As has already been explained, the situation of NOAs directed to non-infringement is distinguishable from the situation of NOAs directed to invalidity. Because infringement is a factual circumstance that varies depending on the formulation of the drug made by the generic and the process used by the generic for making the drug, among other things, multiple non-infringement NOAs may be permitted. Multiple NOAs alleging invalidity, on the other hand, will rarely be acceptable.
[Emphasis added]
[16] A case which is more closely comparable to this one is Aventis v. Apotex (2005), 44 C.P.R. (4th) 108, 2005 FC 1504. There, too, Apotex had initially alleged in a NOA that it would not infringe the subject patent. The only argument of invalidity made in the first proceeding was raised on a conditional basis in response to an anticipated counter-argument on a point of claim construction. That invalidity issue was not pursued by either party. When Apotex served a second NOA raising issues of invalidity due to anticipation, obviousness and double patenting, it was met with an abuse of process argument based on the conclusion reached in AB Hassle #2, above. While Justice Danièle Tremblay-Lamer observed that multiple challenges to a patent may not enhance the efficiency of the judicial system, she found that the regulatory scheme contemplates a sequential approach provided that the underlying legal and factual bases were separate and distinct (see para. 41). She also declined to accept that a generic challenger would be deemed to have accepted the validity of a patent by not putting validity in issue in the context of an earlier proceeding which raised only the issue of non-infringement (see para. 39). She rejected the abuse of process argument, in part, for the following reasons:
[47] Thus, Apotex was entitled to serve the second NOA because the second allegation is separate and distinct from the first one. While the first dealt with non-infringement, the second alleges that the patents are invalid based on anticipation, obviousness and double-patenting. The issue of invalidity of the '457 patent is therefore properly before this Court and does not give rise to the doctrine of abuse of process.
While some of Justice Tremblay-Lamer’s comments in Aventis, above, have been called into question by the Federal Court of Appeal decision in Pharmascience v. Abbott, above, her recognition of a distinction between proceedings which are limited to issues of non-infringement and those which raise issues of validity was accepted by the Federal Court of Appeal in the following passage at para. 48:
[48] In addition, Pharmascience points to Aventis Pharma Inc. v. Apotex Inc., 2005 FC 1504, in which Tremblay-Lamer J. refused to find a second NOA alleging invalidity of a patent to be an abuse of process on that basis that a previous NOA alleging non-infringement had proceeded to a decision. That case is of no assistance here, however, where both NOAs alleged invalidity.
[17] I accept Justice Tremblay-Lamer’s conclusion that a generic challenger should not be deemed to accept the validity of a patent by not putting that issue in play in the first instance, particularly where infringement is the only issue raised. In appropriate cases the abuse of process or issue estoppel doctrines are sufficient to deal with the problem without resorting to an evidentiary presumption of this sort.
[18] Here, Apotex had a legitimate basis for limiting its initial allegations to a single issue of non-infringement. Presumably its commercial interest at that time was limited to a partial entry to the market and the subsequent litigation with Astrazeneca was joined on that basis. Such an approach did not prejudice Astrazeneca’s competing commercial interests because it continued to enjoy a monopoly for the uses of omeprazole which were arguably protected by its new use patents. It has since had the benefit of a second statutory stay to prevent the issuance of a NOC to Apotex as a consequence of this proceeding. It has also offered no evidence of actual prejudice to its legal or commercial interests and, in the absence of established harm, its abuse of process argument must fail: see Merck & Co. v. Apotex Inc. (2003), 25 C.P.R. (4th) 289, 2003 FCA 234 at para. 79.
Burden of Proof
[19] The parties spent considerable time debating the finer points of the burden of proof in this proceeding and each of them was able to marshal considerable authority in support of its position. Suffice it to say that the ultimate burden in this proceeding clearly rests upon Astrazeneca to disprove Apotex’s allegation of invalidity on a balance of probabilities and it has failed to meet that burden. Although there continues to be some controversy around the intermediate burden resting on the second party challenger (see Abbott Laboratories et al. v. The Minister of Health and Apotex Inc., 2007 FCA 153 at paras. 9 and 10 and Pfizer Canada Inc. et al. v. The Minister of Health and Apotex Inc., 2007 FCA 209, at paras. 109 and 110), I am satisfied that Apotex led sufficient evidence to rebut the presumption of validity on a balance of probabilities and that Astrazeneca, in turn, has failed to meet its burden of showing that the Apotex allegations of invalidity are unjustified.
The ’668 Patent Claims
[20] The ’668 Patent is titled “Use of Omeprazole as an Antimicrobial Agent”. It claimed to be a new use patent based on the inventors’ discovery that omeprazole had antimicrobial activity and could, therefore, be used effectively in the treatment of Hp. Omeprazole had been previously used in the treatment of ulcers caused by Hp but only because of its known anti-acid or antisecretory effects and it was understood that it was not a cure.
[21] The ’668 Patent contains the following three claims:
(a) Use of omeprazole or a pharmaceutically acceptable salt thereof for the manufacture of a medicament for the treatment of Campylobacter [ie. Hp] infections.
(b) Use of omeprazole or a pharmaceutically acceptable salt thereof for the treatment of Campylobacter infections.
(c) A pharmaceutical preparation for use in the treatment of Campylobacter infections wherein the active ingredient is omeprazole or a pharmaceutically acceptable salt thereof.
Construction of the ’668 Patent
[22] It is agreed by the parties that the ’668 Patent must be construed as of its publication date on August 19, 1990. There is also no obvious disagreement about the general principles of patent construction, including the point that a patent must be construed before any issues of invalidity are addressed. With respect to all of the construction issues arising in this proceeding, I have applied the principles expressed by the Supreme Court of Canada in Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, 2000 SCC 67, and in Free World Trust v. Électro Santé Inc., [2000] S.C.J. No. 67, 2000 SCC 66, which are fairly summarized by Justice Layden-Stevenson in Wyeth-Ayerst Canada Inc. v. Faulding (Canada) Inc. [2002] F.C.J. No. 1263, 2002 FCT 969 at paras. 30-34:
30 Claims construction is antecedent to consideration of both validity and infringement issues. Claims construction is a matter of law. Whether the [respondent's] activities fall within the scope of the monopoly is a question of fact. It is the claims that define the monopoly: Whirlpool Corp. v. Camco Inc. (2000), 9 C.P.R. (4th) 129 (S.C.C.).
31 The Patent Act requires the letters patent granting a patent monopoly to include a specification which sets out a correct and full disclosure of the invention. The disclosure is followed by a claim or claims stating 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. It is the invention thus claimed to which the patentee receives the exclusive right, privilege and liberty of exploitation: Free World Trust v. Électro Santé Inc. (2000), 9 C.P.R. (4th) 168 (S.C.C.).
32 The disclosure is the quid provided by an inventor in exchange for the quo of a monopoly on the exploitation of the invention. It is important to know what is prohibited and where it is safe to go while the patent is still in existence. The public notice function is performed by the claims that conclude the specification. 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: Whirlpool Corp., supra.
33 There is a high economic cost attached to uncertainty and it is the proper policy of patent law to keep it to a minimum. Predictability is achieved by tying the patentee to its claims; fairness is achieved by interpreting those claims in an informed and purposive way. A purely literal application of the text of the claims would allow a person skilled in the art to make minor and inconsequential variations and appropriate the substance of the invention with a copycat while staying just outside of the monopoly. A broader interpretation risks conferring on the patentee the benefit of inventions that he had not in fact made but which could be deemed with hindsight to be equivalent to what in fact was invented. This would be unfair to the public and unfair to competitors: Free World Trust, supra.
34 In Free World Trust, supra, Binnie J. identified the principles to be applied to resolve the tension between "literal infringement" and "substantive infringement" to achieve a fair and predictable result. The principles are:
(a) The Patent Act promotes adherence to the language of the claims.
(b) Adherence to the language of the claims in turn promotes both fairness and predictability.
(c) The claims language must, however, be read in an informed and purposive way.
(d) The language of the claims thus construed defines the monopoly. There is no recourse to such vague notions as the "spirit of the invention" to expand it further.
(e) The claims language will, on a purposive construction, show that some elements of the claimed invention are essential while other are non essential.
(f) There is no infringement if an essential element is different or omitted. There may still be infringement, however, if non essential elements are substituted or omitted.
[23] One of the construction issues raised by the parties is whether the ’668 Patent should be read as relating to the use of omeprazole as a form of monotherapy to treat Hp or as a combination therapy to be used in conjunction with antibiotics.
[24] Apotex alleged in its NOA that the ’668 Patent should be construed as though it claimed only the use of omeprazole as a single drug therapy for the treatment of Hp infections. It then asserted that its proposed use of omeprazole would be in combination with antimicrobial medicines and, as such, there would be no infringement of any of the claims of the ’668 Patent. If Apotex is correct on this issue, the resolution of its invalidity arguments becomes unnecessary.
[25] It is clear enough that the Patent claims referenced above say nothing explicit about the use of omeprazole either as a single drug therapy or as a constituent part of a combination therapy program involving other medicines. Apotex says that, in the absence of any reference to the use of omeprazole in combination with other medicines, it should be assumed that what was intended by the inventors was the use of omeprazole alone to treat Hp infections. It says that this construction is supported by the language of the claims including the reference in claim 3 to “a pharmaceutical preparation for the use in the treatment of [Hp] infections wherein the active ingredient is [omeprazole]”. If the claims were intended to cover the use of omeprazole in combination with other “active” medicaments, presumably the claims would have said so and, in the absence of clarity, the claims should be narrowly construed.
[26] Apotex also relies upon the language of the patent disclosure which it says clarifies what the inventors intended. It points to references which seem to indicate that the inventors were claiming the use of omeprazole alone to treat Hp infections. Those references include assertions that omeprazole is particularly efficacious in the treatment of Hp infections and was “surprisingly” found to have “excellent antimicrobial activity”. The only reference to other medications is a statement that commonly used antibiotics have been found to have “insufficient effect” in treating Hp infections. Apotex says that these statements are testimonials to the utility of omeprazole to treat Hp infections as a new gold standard or “wonder drug” for monotherapy use.
[27] Apotex also relies upon several references in the disclosure to pharmaceutical preparations and dosages which contain no reference to the use of other active medicines in association with omeprazole, but only to inert substances.
[28] On this issue, Astrazeneca relied upon the evidence of Dr. Richard Hunt, a professor of medicine at McMaster University in Hamilton, Ontario. He has taught gastroenterology at McMaster since 1982. Dr. Hunt expressed the view that because the ’668 Patent contains no limitations on the use of omeprazole either alone or in combination with other medicines, it should be read without any limitation. In other words, all that the patent was claiming was that omeprazole had a beneficial antibacterial effect. According to Dr. Hunt, a person skilled in the art would know that omeprazole would need to be administered as part of a combination therapy because single drug therapy had been shown to be ineffective in most cases for eradicating Hp infections. Notwithstanding the promises contained in the patent disclosure of the supposed excellent antibacterial properties of omeprazole, it would still be seen as an adjunct to effective treatment and not, on its own, as a cure.
[29] Apotex relied upon the evidence given by Dr. David Graham, a professor of medicine and molecular virology and microbiology at Baylor College of Medicine in Houston, Texas. Dr. Graham appears to agree with Dr. Hunt that omeprazole would not have been viewed in 1990 as being efficacious as a stand-alone treatment for Hp. In his affidavit at para. 30, he stated:
30. Additionally, as at August 10, 1990, the skilled reader would be aware that one would not obtain “substantially the same result” when comparing omeprazole therapy to the multiple drug therapy. As stated above, omeprazole therapy was disclosed in the Unge Abstract as producing only transient reduction with no eradication, and my aforesaid 1989 publication entitled In Vivo Susceptibility of Campylobacter pylori (Exhibit F) disclosed H. pylori infection as being not susceptible to omeprazole. In contrast, the prior art taught that multiple drug therapy consisting of omeprazole and amoxicillin would result in eradication of the infection in some patients. As discussed further below, eradication of the infection was (and still is) viewed as being the only relevant outcome when treating H. pylori infection. As such, the skilled person would have understood that the use of a multiple drug therapy would have had a material change in the way the claimed invention worked.
The above passage seems to indicate that although omeprazole might suppress the Hp bacteria, it was unlikely to eradicate the infection. Nevertheless, Dr. Graham stated elsewhere in his affidavit that the “skilled reader would understand the patent to be teaching that omeprazole was sufficient on its own to eradicate Hp”. That statement not only seems to exceed the scope of Apotex’s NOA which accepted that the term “treatment” in the ’668 Patent could include a reduction in the level of infection, but it also contradicts what was known about omeprazole at the time.
[30] The idea that treatment with omeprazole was known to be unlikely to eradicate Hp teaches away from a construction of the patent that limits its scope to single use therapy. In my view, the skilled person construing a pharmaceutical patent must bring to bear the accepted wisdom in the scientific art supported by the application of commercial commonsense. This point is made by the English Court of Appeal in Ranbaxy v. Warner, [2006] EWCA Civ 876 at paras. 19-21, in the following passages:
[19] I do not accept this. Overshadowing everything is the fact that the skilled reader would know that the R,R-enantiomer was the form which had all or by far the preponderance of the pharmaceutical activity. He would expect the patentee to know that too. And he would know that the patent claim was drafted by someone who knew what its function was - to 'demarcate the invention' (per Lord Hoffmann in Kirin at p 185). There simply is no rational basis for supposing that the patentee would want to exclude the pure enantiomer which he would have known was the substance which really mattered.
[20] Mr Waugh's suggestions as to why the patentee would want to limit the monopoly to the racemate simply do not stand up - they are merely reasons why he would want to cover the racemate too. True it is that 'a patent may, for one reason or another, claim less than it teaches or enables' (per Lord Hoffmann at p 186) but that is not a reason for interpreting the claim in the context of the patent in a way that no rational patentee would have intended.
[21] Lord Diplock said in the Antaios case [1985] AC 191, 201:
'I take this opportunity of re-stating that if detailed and semantic analysis of words in a commercial contract is going to lead to a conclusion that flouts business commonsense, it must be made to yield to business commonsense'
Lord Hoffmann made it clear in Kirin at 31 that this applies equally to the construction of patent claims. It applies here.
[31] In this case, the better view was expressed by Dr. Hunt where he testified that the expectation of a skilled practitioner would be that effective Hp treatment would require the use of omeprazole in combination with other drugs and not on its own. This point was given both in his testimony and in his affidavit where he stated:
23. The term “antimicrobial” would have been understood by a skilled person to refer to inhibitory activity against the bacterium, either bacteriostatic (inhibiting growth) or bacteriocidal (killing). “Antimicrobial agent” would thus have been understood to include an agent capable of inhibiting or retarding the growth or multiplication of the bacterium. Therefore, I agree with Apotex’ understanding that the term “treatment” as used in the ‘668 patent claims includes reduction of infections.
24. I do not agree with Apotex, however that the claims are limited to either single drug or multiple drug therapy. As discussed above, the invention is predicated on the finding that omeprazole is useful as an antibacterial agent. Provided omeprazole is so used, alone or as part of multiple drug therapy directed to treating H. pylori infection, the skilled person would understand that use to be use of omeprazole in an antibacterial treatment of H. pylori. Further, the skilled person, as of August 10, 1990, having reviewed the entirety of the patent would also understand that the patent does not preclude the use of omeprazole in combination with another active ingredient, such as an antibiotic, to treat H. pylori. To the contrary, in this infection, it was understood from early experience that multiple drug therapy was necessary to achieve a higher eradication rate. For example, bismuth, metronidazole and tetracycline, three antibacterial agents, were used as a combination therapy for treating H. pylori.
[32] There is no doubt that the problem of construing the ’668 Patent presented by this case could have been avoided by one or two simple clarifying phrases. Nevertheless, it is open to being construed and I accept the position advanced by Astrazeneca, that is, that the patent is not limited to the use of omeprazole as a single drug therapy. It contemplates a use for omeprazole as an antibacterial agent in the treatment of Hp infections whether used in combination with other medicines or not. It is the intended use of the medicine as an antibacterial agent that is advanced by the patent and not whether it will be used alone or in combination. The fact that the patent disclosure statements indicated that omeprazole was found to be highly efficacious in the treatment of Hp does not lead logically to a conclusion that the invention was intended to be limited to monotherapy use. I accept, as well, that the patent does not promise eradication and should not construed as though it does.
[33] On this point, I also find support in the decision by Justice Konrad von Finckenstein in Abbott Laboratories Ltd. v. Canada (Minister of Health), [2006] F.C.J. No. 1766, 2006 FC 1411, where a markedly similar issue of patent construction was raised and resolved as follows:
25 As to point b) I see nothing in either claim that imports a limitation that Lansoprazole has to be used alone. We know from Whirlpool, supra as quoted in Biovail, supra that:
The claim portion of the patent specification takes precedence over the disclosure portion in the sense that the disclosure is read to understand what was meant by a word in the claims "but not to enlarge or contract the scope of the claim as written and thus understood" (Whirlpool, paragraph 52 [61]).
26 Thus, even if there was a limitation implicit or explicit in the disclosure, it could not be imported into the claims. Drugs often are not administered in a pure state but mixed with an excipient or other drugs and the use of such drugs would be highly restricted if the mention of a use of a drug would be read as implying it has to be used alone. Unless the use claimed specifically employs such words as "alone" or "not in conjunction with other compounds" it would be improper to read such a limitation into the claim….
To the extent that Apotex’s allegation of inutility was premised on its construction that the patent promised eradication of Hp as a result of the stand-alone use of omeprazole, that argument, too, must fail.
The ’668 Patent - Anticipation
[34] On the issue of anticipation, I would adopt the test described by Justice Roger Hughes in Janssen-Ortho Inc. v. Novopharm Ltd., [2006] F.C.J. No. 1535, 2006 FC 1234, where he applied the Supreme Court of Canada decision in Free World Trust, above, as follows:
105 The Supreme Court of Canada in Free World Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024, 2000 SCC 66 outlined the test for anticipation is in Canada. The Court said at paragraph 26:
... The legal question is whether the Solov'eva article contains sufficient information to enable a person of ordinary skill and knowledge in the field to understand, without access to the two patents, "the nature of the invention and carry it into practical use without the aid of inventive genius but purely by mechanical skill" ... In other words, was the information given by Solov'eva for [the] purpose of practical utility, equal to that given in the patents in suit"?: ... as was memorably put in General Tire & Rubber Co. v. Firestone Tyre & Rubber Co., [1972] R.P.C. 457 (C.A.) at p. 486:
A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.
The test for anticipation is difficult to meet:
One must, in effect, be a