AstraZeneca Canada Inc. v. Apotex inc.

AstraZeneca Canada Inc. v. Apotex inc.
Court (s) Database
Federal Court Decisions
Date
2014-07-02
Neutral citation
2014 FC 638
File numbers
T-1668-10
Decision Content
Date: 20140702
Docket: T-1668-10
Citation: 2014 FC 638
Ottawa, Ontario, July 2, 2014
PRESENT: The Honourable Mr. Justice Rennie
BETWEEN:
ASTRAZENECA CANADA INC., ASTRAZENECA AKTIEBOLAG and ASTRAZENECA UK LIMITED
Plaintiffs
(Defendants by Counterclaim)
and
APOTEX INC. and
APOTEX PHARMACHEM INC.
Defendants
(Plaintiffs by Counterclaim)
JUDGMENT AND REASONS
TABLE OF CONTENTS
Paragraph
I. Overview
1
II. Preliminary Issues
7
A. Standing of AstraZeneca Canada
8
B. Preclusion from Contesting Invalidity
25
(1) Relationship Between NOC Proceedings and an Action for Infringement
25
(2) Issue Estoppel
32
(3) Abuse of Process
38
III. Interpretation (Construction)
49
A. The Skilled Person
51
B. The Common General Knowledge
54
C. Claims Construction
65
(1) The Analytical Approach to Claims Construction
65
(2) Construction of the ‘653 Patent’s Claims
72
IV. Utility
83
A. Legal Principles Regarding the Promise of the Patent
85
B. The Utility Experts
91
C. The Promise of the ‘653 Patent
95
(1) Preliminary Issue: The “Promise” of Stability Against Racemization
96
(2) Common Ground Regarding All Three Points
101
(3) Does the ‘653 Patent Promise Stability Against Enzyme-Mediated Racemization?
106
(4) Does the ‘653 Patent Promise an Improved Therapeutic Profile such as a Lower Degree of Interindividual Variation?
113
(5) Additional Grounds for Rejecting AstraZeneca’s Proposed Promise
127
D. Demonstration and Sound Prediction of Utility
134
(1) The Evidence Regarding Demonstration and Sound Prediction of Utility
135
(2) The Law on Demonstration and Sound Prediction of Utility
137
(a) Differentiating Demonstrated and Soundly Predicted Utility
137
(b) The Meaning of Proper Disclosure
139
(c) Application of the Law on Demonstration and Sound Prediction of Utility to the Promise of the ‘653 Patent
162
(i) Demonstration and Sound Prediction of Use as a Proton Pump Inhibitor
162
(ii) Demonstration and Sound Prediction of Stability Against Racemization
167
(iii) Demonstration of the Full Promise of an Improved Therapeutic Profile
191
(iv) Sound Prediction of the Full Promise of an Improved Therapeutic Profile
193
(v) Demonstration of the Truncated Promise of Improved Properties
196
(vi) Sound Prediction of the Truncated Promise of Improved Properties
199
E. Summary of Utility Analysis
214
V. The Difference Between Novelty and Obviousness
219
VI. Novelty
223
A. Prior Disclosure
225
(1) The Law of Prior Disclosure
225
(2) No Prior Disclosure of 99.8% Enantiomeric Excess
230
B. Enablement
238
(1) The Law of Enablement
238
(2) The Evidence Regarding Enablement
241
(3) No Enablement of 99.8% Enantiomeric Excess
245
VII. Obviousness
259
A. Step 2: The Inventive Concept of the Claims in Question
264
(1) The Meaning of the Inventive Concept
265
(2) The Inventive Concept of the ‘653 Patent
270
B. Step 3: Differences Between the State of the Art and the Inventive Concept
276
C. Step 4: Inventive Step from State of the Art to the Inventive Concept
286
(1) The Law Governing Obviousness
287
(a) The Merged Obviousness and Obvious to Try Inquiries
287
(b) Obvious to Try and Obviousness Factors
289
(c) The Threshold to be Met to Satisfy the Obvious to Try and Obviousness Inquiries
295
(2) Application of the Law Governing Obviousness to the ‘653 Patent
298
(a) The Non-Inventive Step from the State of the Art to Specific Salts and the (-) Enantiomer of Omeprazole
300
(b) The Inventive Step from the State of the Art to a Specified Optical Purity of 99.8%ee
306
(i) Motivation to Separate the Enantiomers of Omeprazole
307
(ii) Climate in the Field
316
(iii) Effort Required
329
(iv) Actual Courts of Conduct Leading to Invention
337
(v) Commercial/Clinical Success
342
D. Conclusion on Obviousness
365
VIII. Conclusion
367
I. Overview [1] This action for impeachment of the 2,139,653 patent (the ‘653 patent) and counter-claim for infringement pertains to a compound known as esomeprazole. Esomeprazole is a proton pump inhibitor (PPI), which is used in the reduction of gastric acid, reflux esophagitis and related maladies. They are known, collectively, as GERD. Esomeprazole is sold in Canada as Nexium, in 20 and 40 mg strength tablets. It has proven to be a very successful drug for the plaintiff AstraZeneca Aktiebolag.
[2] Apotex Inc. sought to sell a generic version of esomeprazole. Accordingly, it applied to the Minister of Health for a Notice of Compliance (NOC) allowing it to do so. In response, AstraZeneca brought an application for prohibition under the Patented Medicines (Notice of Compliance) Regulations (SOR/93-133) (PMNOC Regulations) prohibiting the Minister from issuing an NOC to Apotex. On June 30, 2010, Justice Roger Hughes, in AstraZeneca Canada Inc v Apotex Inc, 2010 FC 714 [Nexium NOC], dismissed the application for prohibition. Apotex subsequently commenced to sell its generic version of esomeprazole, precipitating these proceedings.
[3] The validity of the ‘653 patent ultimately turns on its proper interpretation, as informed by the following statement:
It is desirable to obtain compounds with improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile such as a lower degree of interindividual variation. The present invention provides such compounds, which are novel salts of single enantiomers of omeprazole (emphasis added)
[4] AstraZeneca contends that this is a mere statement of a hoped for advantage or a goal that the compound may have an “improved therapeutic profile,” and not a promise of such. In particular, AstraZeneca contends that the use of the word “will” in the patent supports its characterization of an “improved therapeutic profile” as merely a goal. “Will,” in AstraZeneca’s submission, is prospective, and simply indicative of only a hope or expectation. I will address this analysis in greater detail below – I promise. Suffice to say, AstraZeneca seeks to circumvent the ordinary meaning of “will” and a plain reading of the phrase by truncating it – effectively reading out the phrase “which will give an improved therapeutic profile such as a lower degree of individual variation.” This interpretation is not consistent with the governing principles of patent utility nor is it consistent with how the patent would be read by a skilled person.
[5] Apotex, in response, contends that a plain reading of the patent makes an explicit promise of an improved therapeutic profile. In support of this position, Apotex relies on received principles underlying the interpretation of the promise of the patent in the context of utility. Accordingly, the ‘653 patent promises an improved therapeutic profile – a promise that it fails to keep.
[6] For the reasons that follow, AstraZeneca’s action for infringement is dismissed, and Apotex’s counter-claim for a declaration of invalidity is granted.
II. Preliminary Issues [7] Prior to interpreting the ‘653 patent and assessing its validity two preliminary issues merit discussion, namely, Apotex’s view that AstraZeneca Canada lacks standing and secondly that AstraZeneca Canada and AstraZeneca Aktiebolag should be precluded, in this trial, from re-litigating the validity of its patent in the prior NOC proceeding.
A. Standing of AstraZeneca Canada [8] The first preliminary issue is the standing of AstraZeneca Canada. Under section 55(1) of the Patent Act, RSC, 1985, c P-4, a patent-infringer is liable to “the patentee [in this case, AstraZeneca Aktiebolag] and to all persons claiming under the patentee.” As a consequence, the standing of AstraZeneca Canada turns on whether or not it qualifies as a person “claiming under” AstraZeneca Aktiebolag.
[9] Apotex contends that AstraZeneca Canada lacks standing. In particular, Apotex asserts that neither the Further Amended Statement of Claim nor the evidence support a finding that AstraZeneca Canada is a person claiming under AstraZeneca Aktiebolag. In support of this assertion, Apotex notes, correctly, that there is no express license agreement between AstraZeneca Aktiebolag and AstraZeneca Canada.
[10] In my view, AstraZeneca Canada has standing. More specifically, AstraZeneca Canada qualifies as a person claiming under the patentee because there is an implied license between AstraZeneca and AstraZeneca Canada regarding the sale of Nexium. However, prior to elaborating on this finding, it is important to note the factual background underlying Apotex’s surprisingly technical standing defence against its alleged infringement.
[11] That factual background overwhelmingly supports AstraZeneca Canada’s standing in this case. AstraZeneca Canada has sold Nexium in Canada for the last 13 years. During those 13 years, AstraZeneca Aktiebolag has supplied AstraZeneca Canada with either bulk tablets or pre-packaged Nexium except for two brief interruptions in supply where AstraZeneca UK was a substitute supplier for approximately 3-6 months. In turn, AstraZeneca Canada sold Nexium in Canadian markets, as its name suggests, throughout those 13 years. Now, both AstraZeneca Canada and AstraZeneca Aktiebolag are joined before this court seeking recovery for AstraZeneca Canada’s losses caused by Apotex’s alleged infringement in the Canadian market. For Apotex to claim that there was no implied license, no right whatsoever, arising from a common understanding between AstraZeneca Canada and AstraZeneca Aktiebolag that AstraZeneca Canada was entitled to sell Nexium in Canada, strains credulity. Presumably, Apotex is of the opinion that AstraZeneca Aktiebolag supplied AstraZeneca Canada with pre-packaged Nexium for some purpose other than its sale – perhaps, for the profitable venture of storing unsold pharmaceuticals. In this regard, Justice Rothstein’s remarks in Apotex Inc v Wellcome Foundation Ltd, [2001] 1 FC 495 (FCA) at para 99 are on point:
It is perhaps not uncalled for to observe that this is not a case in which the alleged licensee is alone in advancing its claim for patent infringement. Here, the patentee is also before the Court as a co-plaintiff supporting the claim of GWI. It is difficult to conceive of what more is necessary to prove the existence of a licence than to have the licensor and licensee both attesting to the validity of the licence. Where both the patentee and the person claiming under the patentee are before the Court, are affiliated as being owned by the same parent and have an identity of interest in the litigation--with the patentee supporting the person claiming under the patentee--it is, to say the least, surprising that technical questions of status to sue would be advanced as a defence to infringement.
[12] On that basis alone, Apotex’s standing defence rests on a weak foundation. Regardless, I will proceed to the merits of the standing issue.
[13] The substance of Apotex’s argument relates to amendments to the pleadings of the Statement of Claim which, admittedly, result in partial ambiguity with respect to the various relationships amongst the AstraZeneca corporations. I described those amendments in an earlier ruling (Astrazeneca v Apotex, T-1668-10, Reasons for Ruling, November 15, 2013). Relevant to the issue of standing, those amendments re-characterized the relationships between AstraZeneca Aktiebolag, AstraZeneca UK, and AstraZeneca Canada.
[14] The Further Amended Statement of Claim, at paragraph 5, state that AstraZeneca Aktiebolag is the exclusive holder of the intellectual property rights to Nexium:
By reason of the grant of the patents, AstraZeneca AB has, in Canada, the exclusive right, privilege and liberty of making, constructing, importing, exporting, using, offering for sale and selling to others to be used, the invention claimed in the patents.
[15] This exclusive right is confirmed in the Distribution Agreement between AstraZeneca Aktiebolag and AstraZeneca Canada which authorizes AstraZeneca Canada, as a distributor of Nexium, to formulate and package Nexium. However, the Further Amended Statement of Claim, surprisingly, do not allege that AstraZeneca Canada has permission, express or implied, to sell Nexium. In particular, paragraph 6(a) does not allege that permission:
AstraZeneca UK with the agreement of AstraZeneca AB can sell, and has sold, is a licensee of the patentee AstraZeneca AB in respect of the patents and has sold and continues to sell NEXIUM brand tablets containing (-)-omeprazole magnesium trihydrate to AstraZeneca Canada who in turn distributes and sells the NEXIUM brand tablets in Canada. (emphasis as in original).
[16] It is from this omission of AstraZeneca Canada’s right to sell Nexium that Apotex grounds its defence that AstraZeneca Canada lacks standing.
[17] This lacunae in the claim is compounded by the absence of a plea of a licence, express or implied, between AstraZeneca Canada and AstraZeneca Aktiebolag. Rather, the pleadings make the bald statement that they are “related companies,” In Apotex’s submission, the pleadings only support that AstraZeneca Aktiebolag alone has the exclusive right to the invention claimed in the patent.
[18] The sole pleading of material fact in support of AstraZeneca Canada’s standing is that AstraZeneca Canada sells and distributes Nexium. Arguably, the Court is left to infer, from this, that a right traceable to the patentee arises from the sale alone.
[19] For their part, AstraZeneca Aktiebolag and AstraZeneca Canada urge the Court to take a broad view of section 55(1) of the Patent Act and the phrase “persons claiming under the patent.” They also rely on evidence of the relationship between AstraZeneca Aktiebolag and AstraZeneca Canada with respect to Nexium, and urge a finding of an implied licence from AstraZeneca Aktiebolag to AstraZeneca Canada to sell Nexium in Canada, and thus, a right of AstraZeneca Canada to claim under the patentee. As stated earlier, both the evidence, and common sense, support such a finding.
[20] The starting point in this analysis is the decision of the Federal Court of Appeal in Signalisation de Montréal Inc v Services de Béton Universels Ltée, [1993] 1 FC 341 (FCA). In that decision, Justice Hugessen wrote, at paragraph 24:
In my view, a person “claiming under” the patentee is a person who derives his rights to use the patented invention, at whatever degree, from the patentee. The right to use an invention is one of the monopoly to which is conferred by a patent. When a breach of that right is asserted by a person who can trace his title in a direct line back to the patentee that person is “claiming under the patentee”. It matters not by what technical means the acquisition of the right to use may have taken place. It may be a straightforward assignment or a licence. It may, as I have indicated, be a sale of an article embodying the invention. It may also be a lease thereof. What matters is that the claimant asserts a right in the monopoly and the source of that right may be traced back to the patentee (emphasis added)
[21] In a more recent articulation of the test under section 55(1), Justice Judith Snider examined whether the “right to use” the product could be traced back to the patent holder and affirmed that Canadian jurisprudence has provided a broad interpretation of “persons claiming under” the patentee which can include the exclusive licensee, the non-exclusive licensee, the purchaser of a patented article, and sales agents (Jay-Lor International Inc v Penta Farm Systems Ltd, 2007 FC 358 at para 34).
[22] The inquiry as to whether the right to use can be traced back to the patentee is highly fact-dependent. In Apotex’s favour, there is no express licence between AstraZeneca Canada and AstraZeneca Aktiebolag. However, the existence of an express licence is not determinative of whether a right may be traced back to the patentee. On the other side, in AstraZeneca’s favour, it has sold Nexium for 13 years, though, as Apotex points out, it too sells esomeprazole. Accordingly, the sale of a product alone is similarly not determinative of whether a right may be traced back to the patentee – there must be something more.
[23] In this case, there is something more. Indeed, a number of facts support the finding that AstraZeneca Canada’s right of use can be traced back to AstraZeneca Aktiebolag:
1. AstraZeneca Canada and AstraZeneca Aktiebolag are both indirect subsidiaries of a common parent, AstraZeneca PLC, located in Sweden;
2. AstraZeneca Aktiebolag, the owner of the ‘653 patent, is the principal source of supply to AstraZeneca Canada and globally;
3. AstraZeneca Canada sought and obtained regulatory approval to sell Nexium in Canada. The information in support of the regulatory filing derived from AstraZeneca Aktiebolag – the holder of the master regulatory file for Nexium;
4. AstraZeneca Canada and AstraZeneca Aktiebolag entered into a Formulation, Packaging and Distribution Agreement (Distribution Agreement) in December 2000. In the Distribution Agreement, AstraZeneca Canada is defined as the “Distributor,” and is granted non-exclusive rights to the “Products” which are defined to include Nexium. This agreement addresses intellectual property rights in articles 24.1 and 24.2:
24 INTELLECTUAL PROPERTY RIGHTS
24.1 All intellectual property rights relating to the Products shall remain the property of ASTRAZENECA at all times. The Distributor shall not acquire any intellectual property rights relating to the Products and shall only have permission to use such rights granted to the Distributor under this Agreement.
24.2 The Distributor will inform ASTRAZENECA of any infringement or suspected infringement of any of ASTRAZENECA’s intellectual property rights in the Market which comes to the notice of the Distributor. ASTRAZENECA will take all reasonable steps, at its own expense, to prosecute infringers. The Distributor will give ASTRAZENECA all reasonable assistance in such prosecution [emphasis added].
5. From 2001-2008 AstraZeneca Canada packaged Nexium which it received from AstraZeneca Aktiebolag in bulk tablets, prior to sale in Canada. In 2008, AstraZeneca Canada’s packaging facility in Mississauga was closed. The letter agreement between AstraZeneca Canada and AstraZeneca Aktiebolag dated December 12, 2007 stated that after closure, Nexium would be supplied by AstraZeneca Aktiebolag to AstraZeneca Canada in finished packaged form, and that AstraZeneca Canada would continue to act as the distributor. Accordingly, after 2008, AstraZeneca Canada received pre-packaged Nexium from AstraZeneca Aktiebolag for sale in Canada. Thus, AstraZeneca Canada has always received its supply of Nexium (pre-packaged or in bulk) from AstraZeneca Aktiebolag, except for a three month period in 2001 and a six month period in 2012, during which AstraZeneca UK was the source of supply.
6. According to the evidence of Ms. Elaine Campbell, CEO of AstraZeneca Canada, AstraZeneca Canada has obtained the consent of AstraZeneca Aktiebolag to file Form IV patent lists under the PMNOC Regulations;
7. Ms. Campbell testified that all of AstraZeneca Canada’s legal costs in respect of this litigation were being paid by AstraZeneca Aktiebolag.
[24] When assessed against this factual landscape, AstraZeneca Canada’s right to use the patent may be traced back to AstraZeneca Aktiebolag, the patentee. All rights of use of Nexium by AstraZeneca Canada are derivative, by an implied agreement, from AstraZeneca Aktiebolag. While there is no express licence and no plea of licence, the conduct of the parties is consistent with a finding of an implied licence granted by AstraZeneca Aktiebolag. The Distribution Agreement grants AstraZeneca Canada permission to use AstraZeneca Aktiebolag’s intellectual property rights “insofar as is necessary to exercise the rights granted” under the Distribution Agreement. These rights include the right to sell Nexium and the obligation to assist AstraZeneca Aktiebolag in the civil prosecution of possible infringement by others. Commencement of an infringement action by AstraZeneca Canada falls within a reasonable interpretation of sections 24.1 and 24.2, and implicit to that is an acknowledgment of a right to recover damages on behalf of the patentee for infringement. Consequently, AstraZeneca Canada is a person claiming under the patentee as required by section 55(2) of the Patent Act and has standing in this trial.
B. Preclusion from Contesting Invalidity (1) Relationship between NOC Proceedings and an Action for Infringement [25] The parties advance diametrically opposed positions with respect to the legal effect of the decision of Justice Hughes in the prior NOC proceeding addressing the same patent (the Nexium NOC). AstraZeneca contends that the decision is neither binding nor instructive. Further, it says that if the Court does consider it, the decision is wrong and should not be followed.
[26] Apotex contends that the Nexium NOC must have some meaningful legal effect or consequence, otherwise the NOC proceedings provide an empty remedy. In support, Apotex contends that the doctrines of issue estoppel and abuse of process preclude AstraZeneca from re-litigating the same issues in this proceeding as were previously determined in the NOC proceeding. In the alternative, it says that comity requires that the reasoning and result reached by a judge of this Court ought to be followed.
[27] The distinctions between the PMNOC proceedings and patent infringement proceedings are well known. They differ in form (an application as opposed to a trial) and in remedy (prohibition as opposed to declarations, damages, or an accounting of profits). It is settled law that decisions taken in the NOC proceedings are not binding on infringement actions or to declare a patent invalid. NOC proceedings were never intended to be a surrogate for a trial on infringement. In consequence, a plea of res judicata will be struck:
This Court has been very clear on the fact that section 6 proceedings are not adjudicative of the rights of the patentee. In Merck Frosst Canada, supra at 319, Hugessen J.A. rejected the notion that prohibition proceedings could be assimilated to an action of any kind:
The proceedings are not an action and their object is solely to prohibit the issuance of a notice of compliance under the Food and Drug Regulations. Manifestly, they do not constitute "an action for infringement of a patent.
In these circumstances, it is idle to suggest that any decision that this Court makes in these appeals could be used to attack collaterally a judgment in an infringement action (Pfizer Canada Inc v Apotex Inc, (2001) 11 CPR (4th) 245 at para 25).
[28] In Apotex Inc v Pfizer Ireland Pharmaceuticals, 2011 FCA 77 at paras 19 and 24 [Apotex sildenafil], the Court of Appeal observed that there are nonetheless circumstances where the interrelationship between the two proceedings can give rise to a remedy in estoppel, and it is on these passages that Apotex predicates its argument that AstraZeneca should be precluded from pursuing this action:
Even where a later proceeding involves issues quite different from an earlier proceeding, it may be open to a judge to apply the doctrines of issue estoppel or abuse of process in the later proceeding to prevent a party from relitigating certain factual and legal issues decided in the earlier proceeding: Danyluk v. Ainsworth Technologies Inc., 2001 SCC 44 (CanLII), [2001] 2 S.C.R. 460, 2001 SCC 44 [Danyluk] (involving issue estoppel) and Toronto (City) v. Canadian Union of Public Employees (C.U.P.E.), Local 79, 2003 SCC 63 (CanLII), [2003] 3 S.C.R. 77, 2003 SCC 63 [C.U.P.E.] (involving abuse of process). Danyluk and C.U.P.E. both emphasize that these bars against relitigation are discretionary and that the discretion must be exercised taking into account a wide variety of circumstances.
[…]
This court has repeatedly said that NOC proceedings are quite different from subsequent infringement or impeachment actions. In my view, there is scope for applying the bars of issue estoppel and abuse of process in the later proceedings to prevent the relitigation of subsidiary factual and legal issues in order to preserve judicial resources, promote the integrity of the justice system, prevent inconsistent findings, and prevent abuse. The difference between the NOC proceeding and later proceedings is an important consideration for the judge in the later proceedings, along with all of the other discretionary considerations discussed in Danyluk and C.U.P.E. Simply put, Danyluk and C.U.P.E. can apply in proceedings such as these.
[29] There is support for Apotex’s argument, both in the legal policy objectives served by the doctrines of issue estoppel and abuse of process, and as well in the Regulatory Impact Analysis Statement (RIAS) which accompanies the 1998 amendments to the PMNOC Regulations.
[30] While a defence of res judicata will be struck, the doctrines of issue estoppel and abuse of process remain open for consideration in the discretion of the trial judge. Thus, the re-litigation of an issue decided against a party in an NOC proceeding “is generally not permissible” (Apotex sildenafil, at para 22). Justice Sexton gave one example where he could foresee the application of issue estoppel or abuse of process at paragraph 26:
Specific applications of the principles in Danyluk and C.U.P.E. should await later cases. But, for clarity, I offer one illustration. If a witness gives exactly the same evidence in both proceedings, and the judge found the witness not to be credible in the NOC proceedings, it may be open to the trial judge in the action to bar relitigation of the witness’s credibility through issue estoppel or abuse of process. On the other hand, if the witness gives different or additional evidence at the action, the trial judge may be justified in reconsidering the witness’s credibility. There may of course be other considerations as well. Obviously, this is a discretionary matter. Suffice to say, the facts that will inform the discretion are not known in a pleadings motion.
[31] The application of these principles in any particular case is discretionary and informed by the factual context, to which I now turn.
(2) Issue Estoppel [32] There is, in this case, a significant overlap between the issues and the evidence led in the two proceedings. Justice Hughes found the allegation of invalidity based on lack of sound prediction and obviousness to be justified (Nexium NOC, at paras 94 and 137). Sound prediction and obviousness are again in issue in this trial. Apotex contends that AstraZeneca should not be able to re-litigate the same issues, with the same evidence, before another judge of this Court.
[33] Apotex contends that all of the criteria to engage issue estoppel are at play here: the same parties, the decision which creates the estoppel is final, and the same question has been decided. However, as the Court of Appeal emphasized, the doctrine depends on similarity in the substance of the evidence, whether it is contested, and the Court’s assessment of its weight and credibility. The fact that the same witnesses testified in respect of the same issues does not alone dispose of the matter.
[34] Five of AstraZeneca’s key witnesses in the NOC proceeding also gave evidence at trial. However, the scope of their evidence at trial, in the form of expert reports, reply reports, sur-reply reports, was broader. Additionally, the form of giving evidence, viva voce, distinguishes the nature of the evidence. The issues in respect of which the experts testified were not constrained by the Notice of Allegation. There was much new evidence, and some key witnesses, whose evidence may have informed the appreciation of the testimony of other witnesses, did not testify.
[35] I note, in particular, the extensive use at trial of prior testimony to impeach the evidence of witnesses. This exercise of confronting witnesses with apparent inconsistencies provided this Court with an appreciation of the evidence and witnesses which was unavailable to Justice Hughes. Importantly, credibility was not critical to Justice Hughes’ assessment of the evidence. Accordingly, this is not a case, as envisioned by Justice Sexton, where a party seeks to re-coup before one judge credibility lost before another.
[36] Put otherwise, while Apotex focuses on the similarities, they are overshadowed by the differences. Though many cards in the deck are the same, they have been shuffled, considerably. Additionally, witnesses and the evidence they give take their colour, in part, from the Court’s appreciation of other witnesses. Dr. Bernard Kohl, one of the inventors behind a key piece of prior art in this case, gave evidence in the NOC proceeding, but not in this action. As will be seen, in some cases my conclusions as to the expert opinion evidence have been affected by my observations of their demeanour in court. To conclude the issue estoppel analysis, the evidentiary record was not shown to be sufficiently similar and therefore the doctrine does not apply.
[37] It is in the context of this guidance that I have considered the decision of Justice Hughes. It is informative and instructive, but it remains a decision taken in a different context on a similar, but nonetheless different, record. Given the clear language of the Court of Appeal in Apotex sildenafil to the effect that the NOC decision does not make validity and infringement res judicata, I have reached my own conclusions based on a different evidentiary record.
(3) Abuse of Process [38] Apotex has a second bow in its quiver. It contends that AstraZeneca has adopted positions in this infringement action that are inconsistent with the positions it adopted in the NOC proceeding, thus engaging the doctrine of abuse of process (Toronto (City) v CUPE, Local 79, 2003 SCC 63, [2003] 3 SCR 77). In CUPE, the Supreme Court of Canada observed, at paragraph 52, that “relitigation carries serious detrimental effects and should be avoided unless the circumstances dictate that relitigation is necessary to enhance the credibility and the effectiveness of the adjudicative process as a whole”. In this case, Apotex argues that AstraZeneca abusively adopted new and contradictory views with respect to two issues: (1) the promise of the patent (relevant to utility) and (2) the motivation to separate the enantiomers of omeprazole (relevant to obviousness). Though these are new and contradictory views, for the reasons that follow, I do not consider them abusive and worthy of precluding AstraZeneca from advancing its arguments.
[39] First, Apotex contends that AstraZeneca has modified its position in respect of the promise of the patent. In the NOC proceeding, AstraZeneca took the position that there was no promise of utility in the ‘653 patent specification. At paragraph 85 of his decision, Justice Hughes wrote:
Nowhere in the patent, whether in the Examples or otherwise, is any information given to the person skilled in the art as to whether, in fact, the highly pure esomeprazole salt does give an improved therapeutic profile such as a lower degree of interindividual variation. There is no evidence from any witness to say that there is anything in the disclosure of the ‘653 patent that would inform a person skilled in the art that the purified esomeprazole salt fulfills this promise. Counsel for AstraZeneca argued that all that was required was that an alternative to racemic omeprazole be provided not whether it is an improvement. This argument ignores the promise of the patent as set out in the portion recited above at page 1 that the resulting product would provide “an improved therapeutic profile” (emphasis in original)
[40] In contrast, before this Court, AstraZeneca argues that the patent promises improved properties.
[41] I do not see the promise advanced by AstraZeneca in this case to be such a change in position that it could be considered abusive. Admittedly, it is a variation of AstraZeneca’s position, presumably in response to the decision of Justice Hughes in which that position was rejected. However, the promise of the patent is ultimately a legal question about which a party may strategically tailor their arguments through multiple proceedings. AstraZeneca’s shift from no promise to a minor promise, while still a shift, is not abusive, but rather, an argument that has strategically evolved in the course of multiple proceedings. Moreover, it is a shift with respect to a question of law informed by expert testimony, the substance of which has changed between the NOC proceeding and this infringement trial. Finally, as I discuss below, I ultimately accept Apotex’s version of the promise of the patent over AstraZeneca’s version, thus resulting in the ‘653’s invalidity for lack of utility. As a consequence, abusive or otherwise, AstraZeneca’s change of heart does not alter the outcome or reasoning of this decision.
[42] Apotex is correct to say that the promise of the patent was an issue before Justice Hughes and now before this Court and that the administration of justice is not enhanced by having differing interpretations on an identical legal issue between the same parties. However, as I described earlier, it is also a legal issue informed by expert testimony, the substance of which is different between the NOC proceedings and this infringement action. As a consequence, while a patent’s promise does not vary depending on the day it is litigated, the evidence before the court charged with interpreting that promise may vary, and did vary in this case. If anything, to rely on all of Justice Hughes legal conclusions in the NOC proceeding after several months of litigation and expert testimony in this infringement trial would be the gravest error.
[43] Second, AstraZeneca now disputes, in this infringement trial, that a person of ordinary skill in the art (the skilled person) would be motivated to separate the enantiomers of omeprazole – a point which it conceded before Justice Hughes in the NOC proceeding. At paragraph 132 of the Nexium NOC, Justice Hughes wrote:
There was no serious argument raised by AstraZeneca that a person could and would be sufficiently motivated to make a salt of the esomeprazole enantiomer.
[44] Further, at paragraph 43 of the Nexium NOC, Justice Hughes wrote:
AstraZeneca, in argument, put forward a portion of Dr. Caldwell’s affidavit, an Apotex expert, and agreed with that portion as far as it went. I refer to paragraphs 114 and 115 (Record, page 5616), noting that the acronym PPI stands for “proton pump inhibitor”, the proton pump being that which is found in the stomach that produces acid:
114. Omeprazole was a blockbuster PPI – By May 1993, it was common knowledge that omeprazole was a very successful drug that was useful to treat conditions that required the inhibition of gastric acid secretion in humans. This fact was described in many sources available to skilled persons including Lindberg et. al., “Omeprazole: The first Proton Pump Inhibitor.”
115. Skilled persons were motivated to resolve omeprazole to its enantiomers and study their respective properties – Omeprazole was a drug that was known to be racemic. It was also known that both of its enantiomers were active as PPIs. It was also known that the two enantiomers of omeprazole might be metabolized differently.
[45] By contrast, in this action, AstraZeneca took the position that there would be no motivation to investigate differences in the activity of the single enantiomers, no motivation to investigate toxicity, and no motivation to assess pharmacokinetic differences (or, at least, a very limited motivation to investigate these issues).
[46] I consider this change of position to be more problematic than AstraZeneca’s change of position with respect to the promise of the patent. In particular, a changed view on the question of motivation is problematic because it relates to a question of fact with respect to the actual motivations facing research scientists in the early 1990s, rather than a question of law such as the promise of the patent (though I recognize that the question of motivation centers on the motivations of a legal creation: the skilled person).
[47] That being said, the focus of this Court is not on the conduct of AstraZeneca, but on truth and fact finding. Put otherwise, the focus of this Court, regardless of AstraZeneca’s adoption of inconsistent positions, remains on the evidence before it. Save in egregious cases, which this is not, relevant and otherwise compelling expert evidence should not be excluded by reason of the conduct of the party who called the witness. While I do ultimately agree with AstraZeneca’s position and find that the skilled person was not motivated to investigate the enantiomers of omeprazole, that is because I prioritized weighing the most credible and compelling evidence before me (in the interest of truth-seeking) over disciplining the parties for their inconsistent positions between the NOC proceeding and this trial. AstraZeneca’s inconsistent positions speaks to its own integrity, not that of its witnesses, and Dr. Armstrong’s compelling analysis of the incentives and barriers facing the skilled person in 1993 displayed, as I discuss below, that a limited motivation existed to investigate the enantiomers of omeprazole at that time. In that sense, AstraZeneca’s “relitigation” of the motivation question was, in the phrasing of CUPE, “necessary to enhance the credibility and the effectiveness of the adjudicative process” (at para 52).
[48] Additionally, I note that motivation is only one of many factors considered in the obviousness analysis, the majority of which, motivation aside, favour AstraZeneca’s position on obviousness. I also note that, in any event, the ‘653 patent is ultimately invalidated for lack of utility, rendering the patent’s validity with respect to obviousness insufficient to save its overall validity.
III. Interpretation (Construction) [49] Having addressed the preliminary issues in this case, I turn to the interpretation and assessment of the validity of the ‘653 patent.
[50] Before addressing the grounds of invalidity, three interpretive aides must be established: (1) identifying the skilled person, (2) identifying the skilled person’s common general knowledge, and (3) interpreting (i.e. constructing) the claims of the patent from the perspective of that skilled person.
A. The Skilled Person [51] The skilled person is a notional person used by the courts to ensure that patents are read in an “informed” way. For the purpose of patent law, and as a reflection of reality, patents are notionally addressed to a skilled person rather than an ordinary member of the public. The skilled person is “deemed to be unimaginative and uninventive, but at the same time is understood to have an ordinary level of competence and knowledge incidental to the field to which the patent relates and to be reasonably diligent in keeping up with advances.” Additionally, the skilled person can come from a single discipline, or reflect a combination of multiple disciplines, depending on the nature of the patent: Merck & Co v Pharmascience Inc, 2010 FC 510 at paras 34-40 [Merck finasteride].
[52] The parties substantially agreed on the characteristics of the skilled person. The skilled person of the ‘653 patent is a composite of:
• An organic or medicinal chemist;
• A pharmacologist;
• A pharmaceutical formulator; and
• A physician familiar with the pharmaceutical treatment of excess gastric acid secretion and related diseases.
[53] This composite skilled person (who is really a combination of skilled persons, or a skilled team), embodies the science incidental to the ‘653 patent. Throughout the trial, both parties advanced witnesses who described how their specific expertise related to a proper reading of the ‘653 patent in light