Shire Canada Inc. v. Apotex Inc.

Shire Canada Inc. v. Apotex Inc.
Court (s) Database
Federal Court Decisions
Date
2016-04-07
Neutral citation
2016 FC 382
File numbers
T-1392-14
Notes
A correction was made on June 7, 2016
Decision Content
Date: 20160407
Docket: T-1392-14
Citation: 2016 FC 382
Toronto, Ontario, April 7, 2016
PRESENT: The Honourable Mr. Justice Locke
BETWEEN:
SHIRE CANADA INC.
Applicant
and
APOTEX INC. AND THE MINISTER OF HEALTH
Respondents
and
SHIRE LLC
Respondent/Patentee
JUDGMENT AND REASONS
Table of Contents
I. Overview.. 3
II. The 090 Patent 4
III. Apotex’s Product 9
IV. Summary of the Issues in Dispute and Burden of Proof. 10
A. Issues in Dispute. 10
B. Burden of Proof. 13
V. The Witnesses. 14
A. Blinding of Expert Witnesses. 15
B. Shire’s Expert Witnesses. 18
(1) Roland Bodmeier 18
(2) James McGough. 18
(3) James Polli 19
C. Shire’s Fact Witnesses. 20
(1) Beth Burnside. 20
(2) Erin McIntomny. 21
D. Apotex’s Expert Witnesses. 21
(1) Mario González. 21
(2) Ping Lee. 22
E. Apotex’s Fact Witness. 23
(1) Duane Terrill 23
VI. Claim Construction. 23
A. Applicable Law.. 24
B. Person Skilled in the Art 28
C. Analysis. 29
(1) Claim 22. 29
(2) Claim 31. 33
(3) Claim 32. 53
(4) Claim 43. 54
(5) Claim 46. 55
VII. Non-Infringement 55
A. Applicable Law.. 55
B. Analysis. 56
(1) Claim 22. 58
(2) Claim 31. 59
(3) Claim 32. 61
(4) Claim 43. 62
(5) Claim 46. 62
C. Conclusion on Infringement 63
VIII. Invalidity Issues. 63
IX. Claims Not Relevant to the Regulations. 63
X. Conclusion. 63
I. Overview [1] This is an application by Shire Canada Inc. (Shire) under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 [the Regulations], for an Order prohibiting the Minister of Health (the Minister) from issuing a notice of compliance (NOC) to Apotex Inc. (Apotex) in connection with its 5, 10, 15, 20, 25 and 30 mg extended release capsules of mixed amphetamine salts (MAS) until after the expiry of Canadian Patent No. 2,348,090 (the 090 Patent).
[2] The patented composition is for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
[3] Apotex filed an Abbreviated New Drug Submission (ANDS) with the Minister seeking an NOC for approval to sell its capsules, which would be marketed under the name APO-AMPHETAMINE MIXED SALTS XR (Apotex’s product). Because the 090 Patent is listed against Shire’s ADDERALL XR product on the patent register maintained by the Minister under sections 3 and 4 of the Regulations, Apotex had to address the 090 Patent under section 5 of the Regulations before it could obtain its NOC.
[4] By letter to Shire dated April 24, 2014, Apotex served a notice of allegation (NOA) alleging that the 090 Patent is invalid, that it will not be infringed by Apotex’s product, and that certain claims of the 090 Patent are not relevant under the Regulations and hence need not be addressed by Apotex.
[5] In response to Apotex’s NOA, Shire commenced the present application on June 9, 2014, by filing a notice of application asserting that Apotex’s allegations are not justified.
[6] The scope of issues in dispute in relation to the 090 Patent has since been narrowed. The claims in issue have been limited to five, being claims 22, 31, 32, 43 and 46. Apotex maintains its allegations that (i) none of these claims will be infringed by its product, (ii) in the event that the claims in issue are construed as Shire argues, they are invalid for overbreadth, ambiguity, insufficiency and lack of utility, and (iii) none of the claims in issue is relevant under the Regulations because Shire’s ADDERALL XR product does not fall within the scope of said claims.
[7] For the reasons that follow, I have concluded that Apotex’s allegations of non-infringement of the claims in issue are justified. Accordingly, the present application will be dismissed and the requested prohibition order will not be granted. Because Apotex’s invalidity allegations apply only if the claims in issue are construed so as to encompass Apotex’s product, it is not necessary to address these allegations. It is also not necessary to address Apotex’s allegation that the claims in issue are not relevant under the Regulations.
II. The 090 Patent [8] The 090 Patent has a filing date of October 20, 1999, and is based on a priority application that was filed in Germany on October 21, 1998. It was published on April 27, 2000, and is to expire on October 20, 2019. It names eight inventors: Beth A. Burnside, Xiaodi Guo, Kimberly Fiske, Richard A. Couch, Donald J. Treacy, Rong-Kun Chang, Charlotte M. McGuinness and Edward M. Rudnic. The registered owner of the 090 Patent is Shire LLC. The applicant in the present proceeding, Shire, is a licensee of the 090 Patent.
[9] The 090 Patent is entitled “Oral Pulsed Dose Drug Delivery System”. It describes and claims a system for treating ADHD. ADHD is a psychiatric disorder characterized as a persistent pattern of inattention and/or hyperactive/impulsive symptoms that are out of the typical range for a person’s developmental level. It is common in children and adolescents (affecting 3-5% of school-age children), but is also known in some adults.
[10] Prior to the 090 Patent, favoured treatments for ADHD required at least two separate doses during the day, generally one at home in the morning and one around lunch time, usually at school. There were several disadvantages to the need for a second dose. Firstly, it would often require involving school staff to keep and then administer the second dose. This was administratively heavy, because the drugs in question are stimulants that are subject to heightened regulatory control. It also risked missed doses, as well as a loss of confidentiality and resulting stigma. Moreover, there were concerns about increased risk of diversion or misuse of these controlled drugs.
[11] Because of the problems associated with the second daily dose, there were efforts to develop a formulation that would be effective for the treatment of ADHD by means of a single daily dose. A common approach to permit reduced frequency of dosing is to develop a formulation that releases medication gradually so as to maintain a steady level in the blood plasma over an extended period. However, it was already known, though it was not clear why, that this approach did not work for medications known in the treatment of ADHD.
[12] It had been observed that one ADHD medication, methylphenidate, had the best effect in the period between the beginning of drug absorption and the time of maximum blood plasma concentration (Tmax). It was not clear why this was the case, but it was later theorized that, once the methylphenidate reached its maximum blood plasma concentration (Cmax), the patient acquired an acute tolerance, being a rapidly-developing decline in pharmacological effect called tachyphylaxis.
[13] Another ADHD medication known prior to the 090 Patent was MAS (mixed amphetamine salts) taken twice a day. It was known as ADDERALL. Amphetamine is a racemate, which means that it is composed of equal amounts of two stereoisomers (also known as enantiomers). These enantiomers have the same chemical composition but in a different arrangement; they differ from one another only in that the orientation of the atoms is in mirror image. The enantiomers of amphetamine are called dextroamphetamine (d-amphetamine) and levoamphetamine (l-amphetamine).
[14] The 090 Patent describes an approach whereby multiple pulsed doses of MAS are delivered by means of a single administration comprising a first (immediate) pulse, which is released to the blood without delay at the time the medication is taken, and a second (delayed) pulse, which is released after a predetermined time. This is intended to mimic the effect in the body of the twice daily dosing that was already known to be effective. Figure 1 of the 090 Patent shows a target plasma level profile based on the twice daily dosing.
[15] The 090 Patent describes a number of examples that illustrate the claimed invention. Example 1 is an immediate release formulation of MAS which are fully dissolved in the body within 15 minutes. Examples 2, 3 and 4 are delayed release formulations of the same MAS with different enteric coatings. Enteric coatings are designed to delay dissolution and release of active pharmaceutical ingredients until they reach the intestines. The best results are obtained in a formulation that combines Examples 1 and 2 in a hard gelatin capsule. This provides an immediate release dose and a delayed release dose in a single administration. Figure 7 of the 090 Patent shows a plasma profile that is said to be typical of results obtained from this formulation in a human study. The profile of Figure 7 (as well as Figure 8, which concerns a formulation combining Examples 1 and 3) is described in the 090 Patent as being “similar to the desired target plasma level profile shown in Figure 1.”
[16] Of the five claims that remain in issue, claims 22, 31 and 32 are independent, and claims 43 and 46 are dependent. The text of these claims is reproduced here:
22. An oral pharmaceutical composition for delivery of one or more amphetamine base salts comprising an immediate release dosage form containing a first dosage amount of said one or more salts effective to treat Attention Deficit Hyperactivity Disorder (ADHD) in a human patient, and a second dosage form containing a second dosage amount of said one or more salts effective to treat ADHD in a human patient which has a release onset lag time sufficient that the plasma concentration/time curve of said composition has substantially the same shape as that of Figure 7, adjusted proportionally for said first and second dosage amounts.
31. An oral pharmaceutical composition for delivery of dosage amounts of one or more amphetamine base salts sufficient to provide an Attention Deficit Hyperactivity Disorder (ADHD) effective plasma level in said patient for at least 8 hours without further administration of amphetamine base salts and which has a plasma concentration/time curve which is substantially the same as that of Figure 7, adjusted proportionally for said dosage amounts.
32. An oral pharmaceutical composition for delivery of one or more amphetamine base salts comprising an immediate release dosage form containing a first dosage amount of said one or more salts effective to treat Attention Deficit Hyperactivity Disorder (ADHD) in a human patient, and a second dosage form containing a second dosage amount of said one or more salts effective to treat ADHD in a human patient, wherein the plasma concentration/time profile of said composition is substantially the same as that of Figure 7, adjusted proportionally for said first and second dosage amounts.
43. The pharmaceutical composition of any one of claims 14 to 41, wherein said amphetamine base salts are a mixture of dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate and amphetamine sulfate.
46. The pharmaceutical composition of any one of claims 22 to 45 sufficient to maintain an effective level of amphetamine base salts in the patient over the course of at least 8 hours without further administration of amphetamine base salts.
[17] Each of the independent claims in issue defines an oral pharmaceutical composition for delivery of one or more amphetamine base salts sufficient to treat ADHD, and refers to the plasma profile of Figure 7.
[18] Though the key characteristics of Figure 7 and the essential elements of the claims are discussed in detail below in the Claim Construction section, it is useful at this stage to note briefly some of these features.
[19] Claims 22 and 32 each define both “an immediate release dosage form containing a first dosage amount” and “a second dosage form containing a second dosage amount.” Claim 22 specifies that the second dosage amount “has a release onset lag time”. Claim 32 does not. Claim 31 does not specify first and second dosage forms respectively containing first and second dosage amounts, and instead defines simply “dosage amounts”.
[20] With regard to Figure 7, claim 22 specifies that the plasma concentration/time curve of the claimed composition should be “substantially the same shape as that of Figure 7”, whereas claims 31 and 32 specifies that it should be “substantially the same as that of Figure 7”, without the word “shape”.
III. Apotex’s Product [21] In this decision, I refer often to Apotex’s product and issues of infringement in the present, despite the fact that the product is not yet on the market. This is done to simplify the grammar.
[22] The parties are in general agreement as to the qualities of Apotex’s product. They disagree however on how those qualities should be characterized for the purposes of the 090 Patent.
[23] Apotex’s product is a hard gelatin capsule filled with two, four, six, eight, ten or twelve tablets depending on the dosage amount. Each tablet is a uniform monolithic matrix in which MAS and excipients are dispersed in an enteric polymer (methacrylic acid and ethyl acrylate). Apotex’s product employs an enteric polymer of the kind described in the 090 Patent, but as a matrix rather than as a coating.
[24] Apotex’s product does not achieve its extended-release characteristics by a combination of coated (delayed release) and uncoated (immediate release) tablets as in Shire’s ADDERALL XR product and as described for the key embodiments in the 090 Patent. Rather, Apotex’s product achieves its extended-release characteristics first by a mechanism of diffusion (while the tablets are in the stomach), and later by a mechanism of diffusion and erosion (once the tablets have entered the intestines). In the low pH environment of the stomach, the enteric matrix remains intact and some of the MAS are dissolved gradually. The higher pH environment of the intestines will begin the erosion of the enteric matrix, thus facilitating further and faster dissolution of the MAS.
[25] The MAS in Apotex’s product are the same as those defined in claim 43, except that Apotex uses anhydrous amphetamine aspartate instead of amphetamine aspartate monohydrate. This distinction is addressed later in the Claim Construction section.
IV. Summary of the Issues in Dispute and Burden of Proof A. Issues in Dispute [26] In respect of claim 22, Apotex alleges non-infringement on the basis that its product does not comprise a first, immediate release dosage form and a second dosage form which has a release onset lag time, and further that its product does not contain an immediate release dosage form at all.
[27] It is notable that, for reasons that were not explained, Apotex has not alleged non-infringement of claim 22 on the basis that its product does not result in a plasma concentration/time curve that is substantially the same shape as that of Figure 7. Accordingly, this feature need not be discussed in relation to claim 22.
[28] In respect of claim 31, Apotex alleges non-infringement on the basis that its product does not have a plasma concentration/time curve that is substantially the same as that of Figure 7. Apotex also asserts that its product does not have more than one dosage amount.
[29] In respect of claim 32, Apotex alleges non-infringement on the basis that its product is not comprised of first and second dosage forms, is not comprised of an immediate release dosage form, and does not have a plasma concentration/time profile that is substantially the same as that of Figure 7.
[30] In respect of claim 43, Apotex cites the dependency of this claim on claims that are not infringed, and further alleges non-infringement on the basis that its product will not contain amphetamine aspartate monohydrate.
[31] In respect of claim 46, Apotex cites the dependency of this claim on claims that are not infringed.
[32] Apotex also maintains, in the alternative, that if the claims in issue are construed broadly enough to encompass Apotex’s product, then those claims are invalid for overbreadth, ambiguity and insufficiency. Further, Apotex maintains (again in the alternative) that claim 31 is invalid for lack of utility.
[33] The essence of Apotex’s alternative invalidity allegations is as follows. If the claims in issue encompass a uniform monolithic formulation like Apotex’s, then they are invalid for:
a) overbreadth, because they encompass any composition that achieves the desired result of providing a plasma profile effective to treat ADHD for at least eight hours (even a sustained release formulation of the type that the 090 Patent indicates it is avoiding), and hence they encompass more than was invented or disclosed in the 090 Patent;
b) ambiguity, because they do not permit a person to determine whether a formulation falls within or outside the scope of the claims without reliance on bioequivalence data, which varies from person to person;
c) insufficiency, because the 090 Patent does not describe how to make the invention using a uniform monolithic matrix so as to permit a person skilled in the art to use the invention referring only to the patent; and
d) in respect of claim 31 only, lack of utility, because the claim encompasses a uniform monolithic matrix embodiment that was neither demonstrated to have utility before the filing date of the 090 Patent, nor met the requirements of the doctrine of sound prediction.
[34] Apotex also maintains that the claims in issue are not relevant under the Regulations because Shire’s ADDERALL XR product does not fall within the scope of said claims.
[35] As indicated above, because of my conclusions concerning Apotex’s non-infringement allegations, it is not necessary for me to address either the alternative invalidity allegations or the assertion that the claims in issue are not relevant under the Regulations.
B. Burden of Proof [36] The burden of proof in the context of an application under the Regulations is somewhat complicated and counterintuitive. It warrants some discussion.
[37] I addressed this issue in my decision in Leo Pharma Inc v Teva Canada Limited, 2015 FC 1237 at paras 62-64, and neither party in the present application argued that my analysis there was flawed. I reproduce it here and rely upon it:
[62] The general principle in an application is that the applicant bears the onus of proof. This applies in the present application, even on issues of patent validity.
[63] Because subsection 43(2) of the Patent Act, RSC 1985, c P-4 [the Patent Act], creates a presumption that a patent is valid, the jurisprudence has held that, once the existence of the patent has been established, the onus shifts to the respondent [Apotex, here] who then has the burden of putting its allegations of invalidity “into play”: Pharmascience Inc v Canada (Health), 2014 FCA 133 at para 32 [Pharmascience]. This can be done by adducing evidence which is “not clearly incapable of establishing its allegations of invalidity”: Pfizer Canada Inc v Canada (Health), 2007 FCA 209 at para 109. The respondent’s burden in this respect has also been characterized as the requirement to “lead sufficient evidence to give its allegations ‘an air of reality’.” The standard of proof here is lower than a balance of probabilities: Pharmascience at para 33; Pfizer Canada Inc v Apotex Inc, 2007 FC 971 at para 51, aff’d 2009 FCA 8 [Pfizer]. However, the respondent’s onus cannot be satisfied by the mere fact of detailing its allegations in its NOA: Pharmascience at para 36.
[64] Once the respondent has properly put its invalidity allegations into play, the onus shifts back to the applicant [Shire, here] to establish, on a balance of probabilities, that those allegations are not justified.
[38] The burden of proof is simpler with regard to infringement issues. The applicant bears the burden of proving on a balance of probabilities that the respondent’s non-infringement allegations are unjustified. There is no evidentiary burden on the respondent. Its allegation of non-infringement is “in play” by virtue of the NOA: Bristol-Myers Squibb v Teva Canada Limited, 2015 FCA 3 at para 11. Statements in an NOA with regard to allegations of non-infringement are presumed to be true: Eli Lilly Canada Inc v Mylan Pharmaceuticals ULC, 2015 FC 178 at para 81.
[39] That said, the applicant has no burden to meet any non-infringement arguments that have not been asserted in the NOA: Apotex Inc v Pfizer Canada Inc, 2014 FCA 250 at para 92.
V. The Witnesses [40] The record in this application includes the evidence of eight witnesses. Shire had five witnesses (three experts and two fact witnesses) and Apotex had three witnesses (two experts and one fact witness). The witnesses and their respective testimony are each described briefly below.
[41] As often happens in patent cases, the parties’ experts disagree on key questions of claim construction. I discuss in these reasons some of these opinions that I found the most compelling. Where I have remained silent on an expert’s opinion on an issue, it should be understood that I have read and considered that opinion but have not felt it necessary to discuss it in these reasons.
A. Blinding of Expert Witnesses [42] Apotex argues with considerable energy that the evidence of its expert witnesses should be favoured over the evidence of Shire’s experts because Apotex blinded its experts to certain unnecessary facts when seeking their opinions, whereas Shire did not. Apotex’s experts never saw the NOA and were never told Apotex’s legal position. Apotex’s experts were essentially asked to provide a series of mini-opinions. They were asked to construe the claims of the 090 Patent without information about Apotex’s product. They were given information about Apotex’s product only once they were asked to give their opinion on issues of patent infringement. They were subsequently asked to opine on issues of patent validity and then to comment on the opinions expressed by Shire’s experts.
[43] Apotex argues that, since claim construction should precede analysis of issues like patent infringement and validity, exposing experts to information about the allegedly infringing product or the relevant prior art could improperly taint their analysis on claim construction. One way to avoid this problem is by seeking the expert’s opinion without first alerting the expert to the conclusion the party wants by sharing such unnecessary information. Apotex expresses the concern that the unblinded expert’s analysis risks becoming results-oriented. Apotex argues that Shire’s experts’ opinions should be discounted for precisely this reason. In support of its position, Apotex cites Teva Canada Innovation v Apotex Inc, 2014 FC 1070 at paras 94-96; AstraZeneca Canada Inc v Apotex Inc, 2014 FC 638 at para 321 [AstraZeneca]; Takeda Canada Inc v Canada (Health), 2015 FC 570 at para 29; and Allergan Inc v Apotex Inc, 2016 FC 344 at para 13.
[44] For its part, Shire argues that blinding of experts is not a requirement and there is no principle of law whereby testimony of blinded experts must be favoured over that of unblinded experts. Shire argues that I should consider the opinions of the experts (and whether they seem to be well-supported or are tortured) rather than focusing on the information to which they had been exposed before forming those opinions: Eli Lilly Canada Inc v Apotex Inc, 2015 FC 875 at para 166 [Eli Lilly].
[45] I agree to some extent with both parties. In some situations, the fact that an expert witness was unaware of the features of an allegedly-infringing product when they formed their opinion on claim construction may be helpful in deciding the weight to be placed on that expert’s opinion. However, I agree with Shire that favouring the evidence of experts who have been blinded has not been raised to the level of a legal principle that must be applied in all cases, and is merely persuasive (AstraZeneca at para 322; Eli Lilly at para 166). I am mainly interested in the substance of an expert’s opinion and the reasoning that led to that opinion. If it is well-reasoned, there may be no reason for concern about whether the witness was blinded to certain facts when giving the opinion. A concern may arise where the expert’s opinion seems tortured or less well-reasoned.
[46] I am also conscious that the blinding of witnesses is no guarantee that the expert evidence before the Court is reliable. It would not be difficult (though it would be expensive) for an unscrupulous party to seek opinions from a number of experts, keeping them all blind to unnecessary information. If one of those many experts provided the opinion that the party sought and all of the others concluded otherwise, the party would be able to retain the outlier and present him or her as a blinded (and therefore reliable) witness.
[47] In the present case, I did not find the blinding of expert witnesses to be determinative. I agree with Apotex’s experts on some issues and with Shire’s experts on others. I have indicated below some of my reasons for preferring the experts of one side over the other.
[48] As a complement to its arguments that the testimony of Shire’s experts was less reliable, Apotex also noted that Dr. Bodmeier appears frequently as an expert witness, and cited criticism of his testimony in Janssen Inc v Teva Canada Limited, 2015 FC 184 [Janssen] and in Eli Lilly Canada Inc v Apotex Inc, 2015 FC 1016. However, Shire pointed to positive consideration of Dr. Bodmeier’s expert testimony just a month after Janssen in AstraZeneca Canada Inc v Apotex Inc, 2015 FC 322, which was decided by the same judge as presided in Janssen. Shire also cited other decisions commenting positively on Dr. Bodmeier’s expert testimony. In the end, I remain of the view that I am mainly interested in the substance of each expert’s opinion and the reasoning that led to that opinion.
B. Shire’s Expert Witnesses (1) Roland Bodmeier [49] Dr. Bodmeier obtained his PhD in Pharmaceutics in 1986 from the University of Texas at Austin. He is currently a Full Professor of Pharmaceutical Technology at the College of Pharmacy at the Free University of Berlin, Germany. In addition to being a professor, he provides consulting services to the pharmaceutical industry regarding the formulation and characterization of drug dosage forms. He has also founded two pharmaceutical firms.
[50] In his affidavit, Dr. Bodmeier describes the 090 Patent and the inventive concept. He then construes the claims in issue, and proceeds to address Apotex’s allegations of non-infringement, disagreeing with all of them. In relation to Apotex’s allegations of invalidity, Dr. Bodmeier opines that the claims of the 090 Patent are not broader than the invention disclosed, that the language of the claims can be clearly understood and the claims are therefore not ambiguous, that the patent sufficiently describes how to make the invention, and that the promised utility of the patent was demonstrated by Figure 7.
(2) James McGough [51] Dr. McGough is a psychiatrist with specific expertise in child and adolescent psychiatry. He received his MD from the Duke University School of Medicine in 1986. He is currently a Professor of Clinical Psychiatry, Step V in the Division of Child and Adolescent Psychiatry at the University of California, Los Angeles. The treatment of ADHD is one of his principle research interests, which is reflected in his many publications and presentations on this topic. From 1999-2002, he used grants from Shire to perform studies of Adderall XR in both children and adults with ADHD.
[52] In his affidavit, Dr. McGough presents his interpretation of the 090 Patent, defining terms such as “immediate release dosage form”, and noting what he considers to be the important characteristics of the Figure 7 blood plasma concentration/time curve. He then discusses the nature of ADHD and its treatment. Finally, Dr. McGough addresses Apotex’s allegations of invalidity, concluding that the 090 Patent has sufficient disclosure, that the inventors both demonstrated and soundly predicted utility, and that the claims are neither overbroad, nor ambiguous.
(3) James Polli [53] Dr. Polli’s expertise lies in pharmacokinetics and pharmacodynamics. He is a professor at the University of Maryland School of Pharmacy, where he holds the Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics. He completed his Doctorate of Pharmacy in Pharmaceutics in 1993 at the University of Michigan College of Pharmacy. He has published widely in his field, edited a number of peer-reviewed pharmaceutical journals, and been part of various boards and committees in the area of pharmaceutics.
[54] In his affidavit, Dr. Polli provides a primer on some of the science behind the 090 Patent, such as the pharmacokinetic characteristics of plasma concentration/time profiles. He provides his interpretation of the disputed claims of the 090 Patent, discussing in particular his understanding as a pharmacokineticist of Figure 7. Dr. Polli subsequently addresses Apotex’s allegations of non-infringement, asserting that the plasma concentration/time curve of Apotex’s product is substantially the same as that illustrated by Figure 7, and therefore it infringes the disputed claims. Dr. Polli also addresses whether the disputed claims of the ‘090 Patent are relevant under the Regulations, opining that Shire’s ADDERALL XR product produces a plasma concentration/time curve that is substantially the same that of Figure 7. Finally, Dr. Polli addresses Apotex’s allegations of insufficiency, overbreadth, ambiguity, and inutility, concluding that they are groundless.
C. Shire’s Fact Witnesses (1) Beth Burnside [55] Dr. Burnside is the lead inventor on the 090 Patent. She earned her Ph.D. in Physical Organic Chemistry from Drexel University in 1987. She has worked at a number of pharmaceutical corporations; most recently, at QRxPharma, Inc., where she is the Senior Vice President of Quality Assurance. She was employed by Shire between 1997 and 2002, her final position there being Vice President of Advanced Drug Delivery.
[56] In her affidavit, Dr. Burnside provides background on the treatment of ADHD, and on the development of Shire’s ADDERALL XR product.
(2) Erin McIntomny [57] Ms. McIntomny is a law clerk at Gowlings, solicitors for the Applicant. She provides documents related to the litigation, namely portions of Apotex’s Abbreviated New Drug Submissions.
D. Apotex’s Expert Witnesses (1) Mario González [58] Dr. González is President and CEO of P’Kinetics International, Inc., a pharmacokinetics and biopharmaceutics consulting company. He is also an Adjunct Professor with the College of Pharmacy at the University of Florida. He received his Ph.D. in Pharmacokinetics from the University of California, San Francisco, in 1975. Dr. González’ expertise in pharmacokinetics is demonstrated by his many publications and speaking engagements in this area.
[59] In his affidavit, Dr. González describes his understanding of the 090 Patent and construes the claims in issue. He then opines on whether the essential elements of those claims are embodied in Apotex’s product, concluding that the plasma concentration profiles provided by Apotex’s product do not meet the essential characteristics of Figure 7. Dr. González then addresses the issue of whether the claims in issue are relevant under the Regulations, and comments on the affidavits of Drs. Burnside, Polli and Bodmeier.
(2) Ping Lee [60] Dr. Lee is familiar with all aspects of the drug development process. He received his Ph.D. in Physical Chemistry from Michigan State University in 1975, and subsequently worked in pharmaceutical research and development and in drug delivery for several major pharmaceutical companies, most recently as the Senior Director of Pharmaceutical R&D at Schering-Plough Research Institute. Currently, he is a Professor in Pharmaceutics and Drug Delivery at the Leslie Dan Faculty of Pharmacy, University of Toronto. He has published many peer-reviewed articles, presented at many conferences, and is a named inventor of 40 patents.
[61] In his affidavit, Dr. Lee provides background information concerning the 090 Patent and explains how a skilled person would understand terms used in the disputed claims thereof. He then opines on whether all of the essential elements of any claims of the ‘090 Patent are found in Apotex’s product, concluding that since Apotex’s product uses a formulation design and drug release method different from what is contemplated in the claims, it does not infringe the 090 Patent. Dr. Lee also comments on whether the ‘090 Patent contains sufficient disclosure, whether the inventors demonstrated the promised utility of certain claims or had a basis for a sound prediction of such utility. Finally, Dr. Lee comments on the affidavits of Drs. Bodmeier, Polli, and McGough.
E. Apotex’s Fact Witness (1) Duane Terrill [62] Mr. Terrill is Associate Director, Regulatory Affairs, for Apotex. He indicates in his affidavit that in this capacity, he oversaw the preparation and filing of Apotex’s ANDS in respect of its product. Mr. Terrill reviews the portions of Apotex’s ANDS that were provided to the applicant, and confirms their source.
VI. Claim Construction [63] Claim construction refers to the exercise of interpreting the words of the claims in a patent. It is the claims which define the patentee’s exclusive rights. In this case, as in many, the dispute turns largely on claim construction.
[64] As stated above, the parties do not disagree greatly on the nature of Apotex’s product. Moreover, the words of the claims are in writing and therefore (in theory, at least) easily ascertainable. The focus of the parties’ dispute is with regard to (i) the proper understanding of those claims (claim construction), and (ii) whether Apotex’s product falls within the scope of the claims in issue, properly construed. The exercise of claim construction in this case is particularly challenging because the claims in issue refer to Figure 7 which is not words but a diagram of a curve.
A. Applicable Law [65] Claim construction is antecedent to consideration of both validity and infringement issues: Whirlpool Corp v Camco Inc, 2000 SCC 67 at para 43 [Whirlpool]. That said, the Court is not to construe a claim without knowing where the disputes between the parties lie (where the metaphorical shoe pinches): Shire Biochem Inc v Canada (Health), 2008 FC 538 at para 22; Sanofi-Aventis Canada v Apotex Inc, 2009 FC 676 at para 82.
[66] The same claim construction applies for all issues, including infringement and validity issues: Whirlpool at para 49(b).
[67] A patent is not addressed to an ordinary member of the public, but to a worker skilled in the art described as:
[A] hypothetical person possessing the ordinary skill and knowledge of the particular art to which the invention relates, and a mind willing to understand a specification that is addressed to him. This hypothetical person has sometimes been equated with the “reasonable man” used as a standard in negligence cases. He is assumed to be a man who is going to try to achieve success and not one who is looking for difficulties or seeking failure.
[Free World Trust v Électro Santé Inc, 2000 SCC 66 at para 44 [Free World Trust], quoting Fox, Harold G. The Canadian Law and Practice Relating to Letters Patent for Inventions, 4th ed., Toronto: Carswell, 1969 at 184]
[68] The person skilled in the art may also be a team of people: Pfizer Canada Inc v Pharmascience Inc, 2013 FC 120 at para 28; General Tire & Rubber Company v Firestone Tyre and Rubber Company Limited, [1972] RPC 457 (Eng CA) at 482.
[69] As stated in the UK House of Lords decision in Catnic Components Ltd v Hill & Smith Ltd, [1982] RPC 183 at 242-243 [Catnic], and quoted in Whirlpool at para 44:
A patent specification should be given a purposive construction rather than a purely literal one derived from applying to it the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge. The question in each case is: whether persons with practical knowledge and experience of the kind of work in which the invention was intended to be used, would understand that strict compliance with a particular descriptive word or phrase appearing in a claim was intended by the patentee to be an essential requirement of the invention so that any variant would fall outside the monopoly claimed, even though it could have no material effect upon the way the invention worked.
[Emphasis in original]
[70] The key to purposive construction is therefore the identification by the Court, with the assistance of the skilled reader, of the particular words or phrases in the claims that describe what the inventor considered to be the “essential” elements of his invention: Whirlpool at para 45. For an element to be considered non-essential and thus substitutable, it must be shown either (i) that on a purposive construction of the words of the claim it was clearly not intended to be essential, or (ii) that at the date of publication of the patent, the skilled addressees would have appreciated that a particular element could be substituted without affecting the working of the invention, i.e., had the skilled worker at that time been told of both the element specified in the claim and the variant and “asked whether the variant would obviously work in the same way”, the answer would be yes: Free World Trust at para 55.
[71] The Supreme Court of Canada (SCC) in Free World Trust tied its method of determining the essentiality of a claim element to the questions posed in the UK decision in Improver v Remington, [1990] FSR 181 [Improver], which distilled the test provided in Catnic:
(i) Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim. If no: --
(ii) Would this (i.e.: that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art? If no, the variant is outside the claim. If yes: --
(iii) Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim.
[72] It should also be noted that identification of elements of claims as essential or non-essential is to be made based on the patent specification and without resort to extrinsic evidence: Free World Trust at paras 61 and following.
[73] As stated in Consolboard Inc v MacMillan Bloedel (Saskatchewan) Ltd, [1981] 1 SCR 504 at 520:
We must look to the whole of the disclosure and the claims to ascertain the nature of the invention and methods of its performance, (Noranda Mines Limited v. Minerals Separation North American Corporation [[1950] S.C.R. 36]), being neither benevolent nor harsh, but rather seeking a construction which is reasonable and fair to both patentee and public. There is no occasion for being too astute or technical in the matter of objections to either title or specification for, as Duff C.J.C. said, giving the judgment of the Court in Western Electric Company, Incorporated, and Northern Electric Company v. Baldwin International Radio of Canada [[1934] S.C.R. 570], at p. 574, “where the language of the specification, upon a reasonable view of it, can be so read as to afford the inventor protection for that which he has actually in good faith invented, the court, as a rule, will endeavour to give effect to that construction”. Sir George Jessel spoke to like effect at a much earlier date in Hinks & Son v. Safety Lighting Company [(1876), 4 Ch. D. 607]. He said the patent should be approached “with a judicial anxiety to support a really useful invention”.
[74] In construing the claims of a patent, recourse to the disclosure portion of the specification is (1) permissible to assist in understanding the terms u