Apotex Inc. v. Sanofi-Aventis

Apotex Inc. v. Sanofi-Aventis
Court (s) Database
Federal Court Decisions
Date
2011-12-06
Neutral citation
2011 FC 1486
File numbers
T-644-09
Decision Content
Federal Court
Cour fédérale
Date: 20111206
Dockets: T-644-09
T-933-09
Citation: 2011 FC 1486
Ottawa, Ontario, December 6, 2011
PRESENT: The Honourable Mr. Justice Boivin
Docket: T-644-09
BETWEEN:
APOTEX INC.
Plaintiff
and
SANOFI-AVENTIS
Defendant
Docket: T-933-09
BETWEEN:
SANOFI-AVENTIS AND
BRISTOL-MYERS SQUIBB SANOFI
PHARMACEUTICALS HOLDINGS PARTNERSHIP
Plaintiffs
and
APOTEX INC.
APOTEX PHARMACHEM INC.
AND SIGNA SA de CV
Defendants
PUBLIC REASONS FOR JUDGMENT
Heard: April 18, 19, 20, 21, 26, 27, 28, 29,
May 3, 4, 5, 9, 10, 11,
May 16, 17, 18, 19, 24, 25, 30, 31,
June 1, 13, 14, 15, 2011
I Introduction
A. Preliminary Observations
[1] This case concerns the drug clopidogrel bisulfate, sold in Canada under the brand name Plavix and commercialized as an anticoagulant that inhibits platelet aggregation activity in the blood. Plavix is the subject of Canadian Patent No. 1,336,777 (the ‘777 Patent) issued on August 22, 1995.
[2] The ‘777 Patent is a selection patent held by Sanofi-Aventis.[1] At the heart of this case lies the issue of the validity of the ‘777 Patent. Sanofi submits that the ‘777 Patent is valid and that it has been infringed by Apotex[2] who manufactures and sells generic clopidogrel. Apotex, on the other hand, submits that the ‘777 Patent is invalid and that there has accordingly been no infringement.
[3] The application leading to the ‘777 Patent was filed in Canada on February 2, 1988. The Court observes at the outset that pursuant to s 78.1-78.2 of the current Patent Act, RSC 1985, c P-4, as amended, patent applications, such as the one at issue, filed before October 1, 1989 are to be dealt with under the provisions of the Patent Act as they read immediately before that date. Thus, references in these Reasons to the Patent Act (referred to as the Patent Act or the Act), unless specifically noted otherwise, will be to the Act as it stood immediately prior to October 1, 1989.
[4] The Court further notes that this proceeding in fact consists of a consolidation of two actions. First, there is the impeachment action undertaken by Apotex (T-644-09) and, second, there is the infringement action undertaken by Sanofi (T-933-09). The procedural background in which each of these actions was initiated is summarized next.
B. Procedural Background
[5] On March 10, 2003, Apotex served upon Sanofi a Notice of Allegation (NOA) under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (PMNOC Regulations) for the purpose of obtaining a Notice of Compliance (NOC) from the Minister of Health, pursuant to section C.08.004 of the Food and Drug Regulations, CRC 1978, c 870. As part of its NOA, Apotex alleged that its manufacture and sale of generic clopidogrel bisulfate tablets would not infringe any valid claim in the ‘777 Patent.
[6] In response, Sanofi sought an order prohibiting the Minister of Health from issuing a NOC to Apotex in respect of generic clopidogrel bisulfate tablets until the expiry of the ‘777 Patent.
[7] By Order dated March 21, 2005, Justice Shore of the Federal Court granted Sanofi’s application. As a result of this Order, the ‘777 Patent prevented Apotex from coming to market with its generic clopidogrel bisulfate tablets in Canada. The Federal Court of Appeal and the Supreme Court of Canada upheld this Order. Apotex accordingly did not obtain a NOC from the Minister of Health.
[8] Following the Order dated March 21, 2005, and related court challenges, the two present actions, now consolidated, were commenced as follows: Apotex’ impeachment action dated April 22, 2009 (T-644-09); and Sanofi’s infringement action dated June 8, 2009 (T-933-09).
[9] In summary, Apotex’ impeachment action seeks a declaration that the claims of the ‘777 Patent are invalid, void and of no force and effect. Apotex alleges the following grounds of invalidity:
§ inutility;
§ lack of demonstrated utility/lack of sound prediction;
§ obviousness;
§ lack of novelty/anticipation;
§ double patenting.
Apotex further seeks a declaration of non-infringement with respect to its generic clopidogrel products.
[10] Conversely, Sanofi’s infringement action seeks a declaration that Apotex has infringed the ‘777 Patent by manufacturing clopidogrel – containing products in Canada for export to other countries, including the United States and that, as a result, Sanofi is entitled to injunctive relief and an accounting of profits or damages.[3]
[11] Apotex’ impeachment action and Sanofi’s infringement action were briefed as follows:
Impeachment Action
1. Apotex Statement of Claim dated April 22, 2009;
2. Apotex Amended Statement of Claim dated May 27, 2009;
3. Sanofi Statement of Defence dated June 8, 2009; and
4. Apotex Reply dated June 18, 2009.
Infringement Action
1. Sanofi Statement of Claim dated June 8, 2009;
2. Apotex Second Amended Statement of Defence and Counterclaim dated December 14, 2010;
3. Statement of Particulars dated December 2, 2010 to the Amended Statement of Defence and Counterclaim of Apotex;
4. Statement of Particulars dated December 16, 2010 bis;
5. Sanofi Reply and Defence to Counterclaim dated January 31, 2010;
6. Statement of Particulars dated April 8, 2010 in Reply to Defence to Counterclaim of Sanofi; and
7. Apotex Amended Reply to Defence to Counterclaim dated April 15, 2011.
[12] On or about July 15, 2009, Sanofi filed a motion to consolidate the impeachment and infringement actions in order for them to be heard together. Apotex indicated its opposition to consolidation in its Statement of Defence and Counterclaim and stated that the infringement action should be stayed. By Order dated November 2, 2009, Prothonotary Tabib, acting as the Case Management Judge, ordered consolidation. She further ordered bifurcation of the damages issues.
[13] Both actions were accordingly heard together in a trial that commenced on April 18, 2011. During the twenty-six (26)-day trial, a total of twenty-three (23) experts and fact witnesses appeared before the Court. A brief overview of the experts and fact witnesses’ testimony is included in Appendix A.
[14] The key questions to be addressed in this proceeding are as follows:
A) Does Sanofi have standing to bring its infringement action?
B) Has Apotex infringed the ‘777 Patent?
C) Is the ‘777 Patent valid?
[15] As explained in these Reasons, the Court has concluded that:
A) Sanofi has standing to bring its infringement action;
B) The ‘777 Patent was infringed by Apotex; and
C) The ‘777 Patent is invalid.
[16] As a result, Apotex’ impeachment action is allowed and Sanofi’s infringement action is dismissed.
II Table of Contents
[17] To assist the reader, the Court has compiled a Table of Contents for these Reasons with page numbers for each heading.
Table of Contents Paragraph
I Introduction
2
A Preliminary Observations ............................................................................
1
B Procedural Background ..............................................................................
5
II The Table of Contents
Table of Contents .............................................................................................
17
III NOC Proceedings
NOC Proceedings ..............................................................................................
18
IV Standing
29
A The Parties’ Submissions ............................................................................
29
(1) The Position of Apotex ....................................................................
29
(2) The Position of Sanofi ......................................................................
30
B Subsection 55.1 of the Patent Act – General Principles ...............................
33
C The BMS/Sanofi Partnership Agreements ....................................................
40
D The Evidence before the Court ....................................................................
47
E Conclusion on Standing ...............................................................................
57
V Claims Constrution
A General Principles .......................................................................................
58
B The Hypothetical Person of Ordinary Skill in the Art (POSITA) ...................
64
C The Patent Specification ..............................................................................
81
D The Claims at Issue .....................................................................................
95
E Claims 1, 3, 10 and 11 ................................................................................
96
F The Limitations of Claims 6 to 9 ..................................................................
102
G What is the Meaning of “Medicine of the Invention”? ...................................
108
H Page 21 of the ‘777 Patent .........................................................................
119
I The Invention described in the ‘777 Patent ...................................................
133
J The Construction of the Promise of the Patent ..............................................
141
(1) General Principles ..............................................................................
141
(2) Summary of Expert Evidence .............................................................
147
(3) What Is the Promise of the ‘777 Patent? ..............................................
158
K Summary on Claims Construction ...............................................................
182
VI Infringement – Background
184
A Introduction ...............................................................................................
184
B General Principles .......................................................................................
185
C Summary of Sanofi’s Case on Infringement .................................................
194
D The Evidence before the Court ...................................................................
198
(1) Product Claims: Claims 1, 3, 10 and 11 .............................................
211
(2) Process Claims: Claims 6-9 ...............................................................
214
E Potential Exemption from Liability ...............................................................
232
(1) Apotex’ Alleged Experimental Use ....................................................
233
F Apotex’ Defences to Infringement ...............................................................
239
(1) The Limitation Period ........................................................................
240
(2) The Settlement Agreements and Estoppel Defence .............................
259
G Conclusion .................................................................................................
293
VII Validity
294
A Overbreadth ...............................................................................................
295
B Sufficiency ..................................................................................................
303
C Anticipation ................................................................................................
306
(1) General Principles ................................................................................
306
(2) The Posters and the Abstracts .............................................................
312
(3) The ‘875 Patent ..................................................................................
323
(4) The Conclusion in Anticipation .............................................................
330
D Double Patenting ........................................................................................
331
E Utility ..........................................................................................................
336
(1) The Lack of Utility ...............................................................................
336
(2) The Demonstrated Utility .....................................................................
339
(3) The Utility – Sound Prediction .............................................................
358
(a) The Promise of the ‘777 Patent ...................................................
358
(b) The Prediction ............................................................................
363
(i) What is the Utility? ..............................................................
363
(ii) The Promise of the Patent ...................................................
367
(iii) Prima Facie Reasonable Inference of Utility .......................
401
(c) Factual Basis ..............................................................................
404
(i) Summary of Chronology .....................................................
404
(ii) Important Events in Factual Basis ........................................
441
(iii) Draw-Backs in Factual Basis................................................
468
(iv) Conclusion on Factual Basis.................................................
483
(d) Sound Line of Reasoning ............................................................
489
(i) Stereochemistry ..................................................................
492
(ii) Toxicology ..........................................................................
502
(iii) Haematology .......................................................................
507
(iv) Pharmacology .....................................................................
518
(v) Previous Work on Thienopyridine Compounds .....................
543
(vi) Extrapolation from Animals to Humans ................................
556
(vii) Conclusion on Line of Reasoning .........................................
562
(e) Disclosure ..................................................................................
564
(i) Quid Pro Quo – Principles .................................................
564
(ii) Factual Basis ......................................................................
569
(iii) Insufficient Disclosure – Essential Elements of Factual Basis Missing .............................................................................
571
(a) No Reference to Work Done on Ticlopidine .............
574
(b) No Reference to PCR 4099 .....................................
575
(c) No Reference to Multiple Animal Models used and Knowledge of Convulsions .......................................
578
(d) No Recognition of Importance of Metabolism ...........
580
(4) Conclusion on Disclosure ...................................................................
584
F Conclusion on Sound Prediction ..................................................................
585
VIII Obviousness
A General Principles .......................................................................................
587
B Date of Invention .........................................................................................
591
C Common General Knowledge .....................................................................
601
(1) The State of the Art of Science ...........................................................
605
(2) The ‘875 Patent .................................................................................
608
(3) The Abstracts and Posters at the July 1985 Conference in San Diego and the June 1986 Conference in Jerusalem ...............................................
615
(4) The 1987 FDA Manufacturing Guidelines ...........................................
629
(5) The Ariens Article ..............................................................................
639
(6) PCR 4099 .........................................................................................
645
D Test for Obviousness ...................................................................................
648
(1) Identify the Notional “Person Skilled in the Art” ................................
649
(2) Identify the Relevant Common General Knowledge of that Person......
650
(3) Identify the Inventive Concept of the Claim in Question or if that Cannot Readily be Done, Construe It ...........................................................
653
(4) Identify what, if any, differences exist between the matter cited as forming part of the “State of the Art” and the inventive concept of the claim or the claim as construed .........................................................
654
(5) Viewed without any knowledge of the alleged Invention as claimed, do those differences constitute steps which would have been obvious to the Person Skilled in the Art or do they require any degree of invention? .
657
E “Obvious to Try” Considerations .................................................................
658
(1) Is it more or less self-evident that what is being tried ought to work? Are there a finite number of identified predictable solutions known to Persons of Ordinary Skill in the Art? ................................................
663
(a) Methods to Separate ................................................................
664
(i) What is the “Pasteur Method”? .........................................
667
(ii) Would the Person of Ordinary Skill in the Art turn to this Chiral HPLC? .................................................................
678
(iii) Conclusion on Method to obtain Separation ......................
687
(b) Methods to Obtain Salt Formation ............................................
694
(c) Conclusion: “Ought to Work” ...................................................
707
(2) What is the extent, nature and amount of effort required to achieve the Invention? Are Routine Trials carried out or is the Experimentation prolonged and arduous, such that the trials would not be considered routine? ...........................................................................................
709
(a) What is “Routine” in separating the enantiomers of PCR 4099 and obtaining the salts? ...........................................................
709
(3) Is There a Motive provided in the Prior Art to find the Solution the Patent addresses? ............................................................................
721
(a) The Motivation to separate: “the Mumblings”of the mid-1980’s
722
Event 1: The Thalidomide Disaster ..............................................
725
Event 2: The 1985 Japanese Guidelines .......................................
727
Event 3: Dr. Kumkumian’s 1986 Speech .....................................
729
Event 4: The 1987 FDA Guidelines Document and the Stereoisomer’s Committee ............................................
733
Event 5: The 1989 Nature Article and the Pressure for New Drugs
735
Event 6: Joint Venture Partner asking about Data on Enantiomer...
738
Event 7: The 1992 FDA Policy In Force .....................................
741
(b) Summary ...............................................................................
743
(c) Conclusion “Motivation” .........................................................
750
(4) Actual Course of Conduct that Culminated in Invention ....................
752
(5) Conclusion on Obviousness .............................................................
783
IX Overall Conclusions
Conclusion ..................................................................................................
785
III NOC Proceedings
[18] As noted earlier, the parties’ dispute regarding the ‘777 Patent was the subject of a NOC proceeding. Given the circumstances, the Court considers it apposite to provide a brief overview of these NOC proceedings.
[19] Essentially, NOC proceedings consist of a summary procedure for assessing the validity of a Canadian patent. Such proceedings are initiated by way of application to the Federal Court of Canada (Sanofi-Synthelabo Canada Inc. v Apotex Inc., 2005 FC 390, 39 CPR (4th) 202). In particular, there is no viva voce testimony from witnesses, and the evidence is accordingly limited to a documentary record. Significantly, the PMNOC Regulations do not allow any determinative findings on the validity of the patent per se; the only conclusion to be drawn in the context of NOC proceedings is whether the allegations of patent invalidity are “justified” or “not justified”.
[20] Furthermore, the PMNOC Regulations do not displace the right of a patent holder to bring an action for infringement, an interested person to challenge the validity of a patent in an action for impeachment (Pharmacia Inc. v Canada (Minister of National Health & Welfare) (1994), [1995] 1 FC 588, 58 CPR (3d) 209 (FCA) at 217; Bristol-Myers Squibb Co. v Canada (Attorney General), 2005 SCC 26, 39 CPR (4th) 449 at paras 11-12).
[21] As part of the NOC proceedings initiated by Apotex, it was alleged by Apotex that a NOC should be issued because generic clopidogrel bisulfate did not infringe the ‘777 Patent. In particular, Apotex maintained that the ‘777 Patent was invalid on grounds of obviousness, anticipation and double patenting.
[22] As noted earlier, Apotex was not successful in obtaining a NOC. Justice Shore, the Applications Judge, rejected all three (3) of Apotex’ allegations of invalidity on the basis that these allegations were not justified.
[23] Apotex appealed the decision of Justice Shore and, on December 22, 2006, the Federal Court of Appeal upheld this decision and accordingly dismissed Apotex’ appeal (Sanofi-Synthelabo Canada Inc. v Apotex Inc., 2006 FCA 421, 59 CPR (4th) 46).
[24] Justice Noël, writing for a unanimous Federal Court of Appeal, concluded that Apotex had not shown, on a balance of probabilities, that Justice Shore had committed any reviewable errors in arriving at the conclusions on obviousness, anticipation and double patenting.
[25] Thereafter, Apotex appealed to the Supreme Court of Canada. On November 6, 2008, in Apotex v Sanofi-Synthelabo Canada Inc., 2008 SCC 61, 69 CPR (4th) 251 (SCC Plavix), the Supreme Court of Canada, in a unanimous judgment written by Justice Rothstein, dismissed Apotex’ appeal, again on the issues of obviousness, anticipation and double patenting. In its judgment, the Supreme Court of Canada modified the legal tests for the law of obviousness and anticipation. A review of the relevant legal principles will be considered later in this decision.
[26] In the context of the present case, Sanofi relied extensively on the decision of the Supreme Court of Canada in the NOC proceedings. However, the NOC proceedings and the fact conclusions they may have yielded are of limited assistance when, as here, the evidence adduced and the issues differ considerably from those presented in the course of the NOC proceedings. Indeed, unlike the NOC proceedings, the present impeachment and infringement actions, at trial, involved viva voce testimony from nine (9) experts and fourteen (14) fact witnesses. Furthermore, these experts and fact witnesses were heard on a broader range of issues than those considered as part of the NOC proceedings. In particular, many were heard on the issue of sound prediction which, as seen later, is a central question before the Court. Yet the issue of sound prediction was not addressed as part of the NOC proceedings and there was accordingly no evidenciary record on that issue.
[27] On the issues of obviousness and anticipation, it is equally clear that the evidentiary record before the Federal Court of Canada, the Federal Court of Appeal, and the Supreme Court of Canada differed significantly from the record before the Court. Thus, whilst the Court recognizes that the legal principles and the questions of law decided by the Supreme Court of Canada in the NOC proceedings must necessarily be followed, the Court is not, however, bound by the factual findings made in the context of the NOC proceedings because the evidence is not necessarily the same. Hence, the NOC proceedings, whilst instructive, are not fact-determinative. As further noted by the Federal Court of Appeal, “factual findings are derived from the evidence that is before the court in the particular proceeding” and it is “incumbent upon the judge to arrive at his findings on the basis of the evidence that was before him” (Ratiopharm Inc. v Pfizer Ltd., 2010 FCA 204, 87 CPR (4th) 185, at paras 25 and 26).
[28] It follows that NOC proceedings do not constitute res judicata (Ratiopharm Inc. v Pfizer Ltd., 2009 FC 711, 76 CPR (4th) 241, at para 18; Eli Lilly Canada Inc. v Novopharm Ltd., 2009 FC 235, 73 CPR (4th) 253). To put it another way, NOC proceedings are not the gospel.
IV Standing
A. The Parties’ Submissions
(1) The Position of Apotex
[29] Apotex submits that one of the plaintiffs in this case, namely Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership (the Partnership), has no standing to bring the present action to the extent it relates to any acts of infringement alleged to have taken place prior to June 12, 2007, the date on which the Amendment to Clopidogrel Intellectual Property License and Supply Agreement (the Amended IP Agreement) was entered into between Sanofi and the Partnership. It is Apotex’ position that the Partnership had no explicit licence prior to the Amended IP Agreement and that, furthermore, such an amendment cannot be applied to confer rights retroactively. Apotex argues that the Partnership is not the active entity that carries on in the foreign jurisdictions at issue and Apotex also argues that the Partnership does not operate in Canada. This, according to Apotex, bars the Partnership from seeking recovery in the form of damages in the circumstances.
(2) The Position of Sanofi
[30] In response, Sanofi asserts that, on the basis of its ‘777 Patent, there can be no question that it has standing to sue for infringement and obtain a remedy. As for the Partnership, Sanofi submits that it is an exclusive licensee under the ‘777 Patent and that the Partnership consequently has standing to sue for infringement and obtain a remedy as described in ss 55(1) of the Patent Act.
[31] More particularly, Sanofi argues that the Partnership is a “person claiming under” a patentee as stated in ss 55(1) of the Patent Act because the Partnership is assessing a right under the ‘777 Patent and that can be traced right back to the patentee. According to Sanofi, exclusive and non-exclusive licensees, implied or oral, qualify as a “person claiming under” under a patentee (Jay-Lor, below).
[32] In this regard, Sanofi emphasizes that the Partnership has been given an explicit right to use and exploit the subject matter of the ‘777 Patent and clopidogrel bisulfate.
B. Subsection 55(1) of the Patent Act – General Principles
[33] The term “patentee” is defined in s 2 of the Patent Act to mean “the person for the time being entitled to the benefit of a patent”. Because the patentee has monopoly over his patented invention, he may on this basis assign, licence or give a right to use his patent either exclusively or non-exclusively, in whole or in part. Significantly, ss 55(1) of the Patent Act provides a damages remedy and hence standing to claim damages not only to the patentee but also to “all persons claiming under the patentee”. Subsection 55(1) provides as follows:
55. (1) A person who infringes a patent is liable to the patentee and to all persons claiming under him for all damages sustained by the patentee or by any such person, by reason of the infringement.
55. (1) Quiconque viole un brevet est responsable, envers le breveté et envers toute personne se réclamant du breveté, de tous dommages-intérêts que cette violation a fait subir au breveté ou à cette autre personne.
[34] The question of who qualifies as a person claiming under a patentee pursuant to ss 55(1) of the Patent Act has been analyzed numerous times by Canadian courts. In the 1972 case, American Cyanamid Company v Novopharm Limited, [1972] FC 739 (FCA), the Federal Court of Canada enlarged the meaning of “persons claiming under” when it held that a non-exclusive licensee of a patent is a person claiming under the patentee within the meaning of ss 55(1) of the Patent Act.
[35] Along the same lines, in Armstrong Cork Canada Ltd. v Domco Industries Ltd., [1982] 1 SCR 907, 66 CPR (2d) 46, at p 912, the Supreme Court of Canada adopted the comments of Fry L.J. at p 470, in Heap v Hartley, (1889) 42 Ch D 461:
[…] An exclusive license is only a license in one sense; that is to say, the true nature of an exclusive license is this. It is a leave to do a thing, and a contract not to give leave to anybody else to do the same thing. But it confers like any other license, no interest or property in the thing. […]
[36] Another leading case in this regard is Signalisation de Montréal Inc. v Services de Béton Universels Ltée (FCA), [1993] 1 FC 341, 46 CPR (3d) 199, where the Federal Court of Appeal analyzed the issue of the rights of someone other than the patentee to maintain an action for infringement. In so doing, the Federal Court of Appeal considerably enlarged the pool of “persons claiming under the patentee”. It held at pp 210-211 that:
[…] 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 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 that the source of that right may be traced back to the patentee. […]
[37] More recently, Justice Snider in the case of Laboratoires Servier v Apotex Inc., 2008 FC 825, 67 CPR (4th) 241, at para 77, found that “[t]he ability of a party to claim under a patentee does not necessarily require the existence of an express licence”. She added that “[w]here no express licence exists, each case will be determined on its facts to determine whether an implied licence or other right exists that gives rise to a claim “under the patentee”.
[38] In addition, Justice Snider in Servier, above, at para 70, provided the following guidance:
[70] The test for who qualifies as a person claiming under a patentee is not simply whether the patentee has consented to the person being joined as a plaintiff in an action; nor is it enough to demonstrate that two parties are related. In each case, the facts must demonstrate a credible and legally sufficient basis for claiming under a patentee
(Jay-Lor International Inc. v. Penta Farm Systems Ltd., (2007), 59 C.P.R. (4th) 228 at paras 31, 36 (F.C.) [Jay-Lor]).
[Emphasis added]
[39] In light of these principles, the Court now turns to the BMS/Sanofi Partnership Agreements entered into between Sanofi and the Partnership.
C. The BMS/Sanofi Partnership Agreements
[40] The Partnership arose from the discovery of clopidogrel and irbesartan, two promising drugs. Because Sanofi had very little presence in the United States and Canada, it turned to Bristol-Myers Squibb (BMS) to create a partnership in order to commercialize the compounds on a worldwide basis. Sanofi and BMS accordingly entered into a Development Agreement in 1993, as well as a series of subsequent agreements including a Partnership Agreement, an Alliance Support Agreement (Territory A and B), a Product Know-How Licence Agreement and a Clopidogrel Intellectual Property License and Supply Agreement, all of which are dated January 1, 1997.
[41] In 2007, the parties decided to revise the initial Clopidogrel Intellectual Property License and Supply Agreement they had signed in 1997. This revised agreement was meant to address the needs of the alliance as the products were moving closer to commercialization and it included revisions to […] of the initial agreement listing the patent at issue. Thus, an Amendment to Clopidogrel Intellectual Property License and Supply Agreement was signed on December 6, 2007.
[42] The Court observes that contractual arrangements regarding the Partnership were structured around two territories, commonly referred to as Territory A and B. Territory B covers the United States, Canada, Mexico, South America, Australia and New Zealand, whereas Territory A includes Europe, Africa, the Middle East and Asia. Two territory partnerships were accordingly formed in order to manage central expenses, such as marketing, research and development and royalties, and to supply the finished product to the individual countries. At the country level, agreements either to co-promote or to co-market were also put in place.
[43] The Court further notes that the Product Know-How Licence Agreement confers rights to either party in the Partnership with regards to all technical data, information, material and other know-how that relates to the formulation of the products that are developed under the Development Agreement.
[44] As for the Clopidogrel Intellectual Property License and Supply Agreement (1997) as well as the Amended Agreement (2007), it grants an exclusive licence to the Partnership in the following terms:
[…] [omitted] .
[45] [omitted] .
[46] Against this background, the Court now turns to the evidence put before it in connection with the rights conferred to the Partnership.
D. The Evidence before the Court
[47] During the trial, Dr. Thierry Saugier, Vice-President Alliance and Partnership at Sanofi-Aventis, was called by Sanofi to testify as to the standing of the Partnership. Dr. Saugier testified that, since April 2006, he has managed group of alliances for Sanofi-Aventis, including the alliance referred to the Territory B Partnership and the Territory A Partnership.
[48] In particular, Dr. Saugier testified that, in order to structure the alliance, Sanofi granted an exclusive licence for clopidogrel to the Partnership, as can be seen in the Partnership Agreements which are still in effect today. The various agreements produced into evidence indeed support Dr. Saugier’s oral testimony as to the rights granted thereunder.
[49] [omitted]:
Q. [omitted]?
A. [omitted].
Q. [omitted]?
A. [omitted].
Q. [omitted]?
A. [omitted].
Q. [omitted]?
A. [omitted].
[50] [omitted]:
Q. [omitted]?
A. [omitted].
Q. [omitted]?
A. [omitted].
Q. [omitted]?
A. [omitted].
Q. [omitted]?
A. [omitted].
Q. [omitted]?
A. [omitted].
Q. [omitted]?
A. [omitted].
Q. [omitted]?
A. [omitted].
Q. [omitted]?
A. [omitted].
[51] [omitted].
[52] [omitted].
[53] [omitted].
[54] [omitted]:
[omitted].
[55] The Court believes that such a list could not, on a practical point of view, be amended each time a development occurred in connection with products under research or in a process of a patent application. The terms and scope of the agreement at issue are such that […] must be interpreted to encompass newly developed compounds. To conclude otherwise would fly in the face of the very purpose of the Partnership Agreements, which was to allow the Partnership to carry out all activities related to the development, manufacturing, sourcing and commercialization of clopidogrel in the specified territory known as Territory B, would otherwise be defeated.
[56] Finally, the Court recalls that counsel for Apotex questioned Dr. Saugier in connection with the absence of manufacturing facilities, employees and registered place of business in Canada in order to demonstrate the lack of standing. In light of the breadth of the Partnership Agreements, the Court finds this line of questioning to be of no assistance for the purposes of the standing issue.
E. Conclusion on Standing
[57] In sum, considering the broad meaning of “persons claiming under” a patentee as referred to under ss 55(1) of the Patent Act, and based on the Court’s review of the Partnership Agreements and the testimony given in that regard, the Court finds that the Partnership has a “credible and legally sufficient basis” for claiming under a patentee in the circumstances. Indeed, the evidence clearly shows that the Partnership was granted an exclusive licence for clopidogrel products through the various Agreements as of 1997. It follows that the Partnership has standing to bring the action at issue for any infringement that it alleges to have occurred prior to December 6, 2007.
V Claims Construction
A. General Principles
[58] In a patent case such as the one at issue, the Court must first construe the claims of the patent in accordance with the principles of claims construction established by the caselaw (Whirlpool Corp. v Camco Inc., 2000 SCC 67, 9 CPR (4th) 129; Novopharm Ltd. v Janssen-Ortho Inc., 2007 FCA 217, 59 CPR (4th) 116; Canada (Attorney General) v Amazon.com, Inc., 2011 FCA 328, [2011] FCJ No 1621).
[59] The Court observes that claims construction is a question of law and must be addressed with a purposive approach in order “to achieve fairness and predictability and to define the limits of the monopoly” (Dimplex North America Ltd. v CFM Corp., 2006 FC 586, 54 CPR (4th) 435, at para 49, aff'd 2007 FCA 278, 60 CPR (4th) 277). In so doing, the Court is required to read the patent claims with “a mind willing to understand” (Whirlpool, above).
[60] Conceptually, the claims construction analysis focuses on what a hypothetical person of ordinary skill in the art (POSITA) would have understood the patent to claim (Whirlpool, above, at paras 45, 53). This, in turn, requires that the Court first determine the requisite skills and expertise for the POSITA (Aventis Pharma Inc. v Apotex Inc., 2005 FC 1283, 43 CPR (4th) 161; Apotex Inc. v Syntex Pharmaceuticals International Ltd, [1999] FCJ No 548, 166 FTR 161, at para 38, (QL) (FCTD)).
[61] Furthermore, as the patent should be read as a whole, the claims should be read in light of the description in the specification, assisted by experts as to the meaning of technical terms used therein (Shire Biochem Inc. v Canada (Minister of Health), 2008 FC 538, 328 FTR 123, at para 22; Whirlpool, above, at para 45).
[62] The Court further recalls that, because the ‘777 Patent was issued under the old Patent Act, all claims are to be construed as of the date the patent was granted and issued (Pfizer Canada Inc. v Canada (Minister of Health), 2005 FC 1725, 285 FTR 1, at para 36). In the case of the ‘777 Patent, the relevant date is August 22, 1995.
[63] With these general principles of claims construction in mind, the Court now turns to its assessment of the POSITA.
B. The Hypothetical Person of Ordinary Skill in the Art (POSITA)
[64] In assessing the hypothetical POSITA, the Court must define the person or group to whom the ‘777 Patent is addressed. This person is obviously not a real person. As explained by Justice Hughes in Merck & Co v Pharmascience Inc., 2010 FC 510, 85 CPR (4th) 179, at para 42: “[T]hat person is to be unimaginative, but that does not mean that the person is slow-witted or graduated (if at all) at the bottom of the class. Nor is the person the gold medalist who graduated at the top of the class. That person is the average person in the group. Just as a “reasonable man” is expected to be reasonable, the POSITA is expected to possess the ordinary skill in the art”.
[65] The Supreme Court of Canada considered such a person in Whirlpool, above, at para 74, where Justice Binnie for the Court wrote that the POSITA refers to the hypothetical “ordinary worker” who is reasonably diligent in keeping up with advances in the field to which the patent relates.
[66] In Merck & Co v Pharmascience Inc., above, at para 35, Justice Hughes further referred to submissions made by the Canadian Group of AIPPI (Association internationale pour la Protection de la Propriété intellectuelle) and to a summary under Canadian law as to what a POSITA is understood to be:
35. …
Q.213