Teva Canada Innovation v. Apotex Inc.

Teva Canada Innovation v. Apotex Inc.
Court (s) Database
Federal Court Decisions
Date
2014-12-19
Neutral citation
2014 FC 1070
File numbers
T-22-13
Decision Content
Date: 20141219
Docket: T-22-13
Citation: 2014 FC 1070
Ottawa, Ontario, December 19, 2014
PRESENT: The Honourable Madam Justice Gleason
BETWEEN:
TEVA CANADA INNOVATION AND TEVA PHARMACEUTICAL INDUSTRIES LTD.
Applicants
and
APOTEX INC. AND THE MINISTER OF HEALTH
Respondents
PUBLIC JUDGMENT AND REASONS
(Confidential version of Judgment and Reasons issued November 12, 2014)
[1] The applicants, Teva Canada Innovation and Teva Pharmaceutical Industries Ltd. [collectively, Teva], seek an order pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 [the PMNOC Regulations] to prohibit the Minister of Health [the Minister] from issuing a Notice of Compliance [NOC] to the respondent, Apotex Inc. [Apotex], for approval to sell a generic version of rasagiline, a drug used in the treatment of Parkinson’s disease.
[2] Teva markets rasagiline under the brand name AZILECT in two forms, 0.5 mg and 1.0 mg rasagiline mesylate tablets. It owns two Canadian patents in relation to rasagiline that are listed on the Patent Register established under subsection 3(2) of the PMNOC Regulations: Canadian Patent 2,232,310 [the 310 Patent] and Canadian Patent 2,174,449. Only the 310 Patent is at issue in this proceeding. It was published on April 10, 1997 (but claims a priority date to September 20, 1995, due to an earlier filing in Israel). The 310 Patent was granted on January 8, 2008 and will expire on September 18, 2016.
[3] Apotex filed an Abbreviated New Drug Submission with the Minister seeking NOCs for 0.5 and 1.0 mg rasagiline mesylate tablets branded as APO-Rasagiline [the Apotex Products]. On November 20, 2012, Apotex served Teva with a Notice of Allegation [NOA] with respect to the 310 Patent and 0.5 and 1.0 mg rasagiline tablets in which it asserted that the Apotex Products would not infringe the 310 Patent and that the 310 Patent was invalid.
[4] Teva initiated this prohibition proceeding on January 4, 2013. It asserts only Claims 2 and 31 of the 310 Patent against Apotex and says that the Apotex Products infringe these Claims and that the 310 Patent is valid. Teva thus requests that the Minister be prohibited from issuing NOCs for the Apotex Products until the 310 Patent expires.
[5] As the Minister has not yet issued an NOC to Apotex, it seeks to have details of its formulation redacted in the public version of these Reasons to protect its commercial interests. I believe it appropriate to redact those details of the Aptoex formulation that are not essential to understanding these Reasons. However, these details will be revealed in Apotex’ Product monographs if it is granted an NOC and markets the Apotex Products. Accordingly, if and when the Minister issues an NOC to Apotex for the Apotex Products, Apotex shall advise the Court within 48 hours of receipt of the NOC and the redactions shall be removed from the public version of these Reasons.
I. Overview [6] The 310 Patent is entitled “Stable Compositions Containing [Rasagiline]” and discloses that the stability of rasagiline formulations can be significantly improved by the addition of large amounts of “pentahydric or hexahydric alcohols”. The specification refers to three of these alcohols as being “typically” used in making the invention to which the 310 Patent pertains, namely, mannitol, sorbitol and xylitol. The examples contained in the 310 Patent disclose test results for stability studies conducted with mannitol, sorbitol and xylitol. No test results are reported in the 310 Patent for any other alcohol nor is any other alcohol coming within the class of pentahydric or hexahydric alcohols mentioned in the 310 Patent.
[7] Claims 2 and 31 of the 310 Patent are composition claims and extend to compositions that include at least 60% by weight of a pentahydric or hexahydric alcohol. Claims 2 and 31 of the 310 Patent are dependent on Claim 1. The three Claims provide as follows:
1. A pharmaceutical composition in tablet form comprising an amount of R(+)-N-propargyl-1-aminoindan or a pharmaceutically acceptable salt thereof, and at least one alcohol selected from the group consisting of pentahydric and hexahydric alcohols.
2. The pharmaceutical composition of claim 1, wherein said at least one alcohol comprises at least 60% by weight of the total composition.
31. The pharmaceutical composition of claim 2, wherein the composition comprises 1.56 mg of the pharmaceutically acceptable salt of R(+)-N-propargyl-1-aminoindan.
[8] The Apotex Products contain more than 60% weight of an alcohol that is commonly called [ ] .
[9] The sole issue that arises with respect to infringement of the 310 Patent by Apotex in this application is whether [ ] is a “pentahydric” or “hexahydric alcohol”. Teva’s expert witnesses opine that it is; Apotex’ experts opine the opposite.
[10] For the reasons detailed below, I prefer the evidence tendered by Apotex and accordingly have concluded that [ ] is not a pentahydric or hexahydric alcohol. I have thus determined that Apotex’ non-infringement allegation is justified and that this application for prohibition will be dismissed, with costs.
II. The Experts [11] Teva filed evidence from three experts, Dr. Jerry Atwood, Dr. Steven Byrn and Dr. Norman Weiner.
[12] Dr. Atwood is Professor and Chairman of the Department of Chemistry at the University of Missouri-Columbia. He holds a B.S. degree in Chemistry and Mathematics and a Ph.D. in Chemistry. He has published hundreds of articles and has consulted widely for industry in the fields of pharmaceutical chemistry and polymer chemistry, including in relation to the formulation of pharmaceuticals. He has given expert evidence previously in several proceedings, almost always on behalf of patentees. His mandate was to provide an opinion related to patent construction and infringement.
[13] Dr. Byrn is a Professor of Medicinal Chemistry at Purdue University, where he was the Head of the Department of Industrial and Physical Pharmacy. He has published over 160 articles and is the past Chair of the FDA Pharmaceutical Sciences Advisory Committee and the U.S. Pharmacopeia Chemistry 5 Expert Committee. He has consulted widely for pharmaceutical companies and has given evidence on many occasions previously, likewise virtually always for patentees. His mandate was to provide an opinion related to construction and infringement.
[14] Dr. Weiner is an Emeritus Professor of Pharmacy at the University of Michigan. He has over 45 years experience in the pharmaceutical field, particularly in pharmaceutical chemistry and drug delivery systems. He has authored or co-authored more than 170 publications and has consulted for many companies regarding physical and chemical stability of raw materials and solid dosage forms. His mandate was to provide an opinion relating to construction, infringement, and invalidity (insufficiency, ambiguity, obviousness and utility).
[15] Apotex filed evidence from two experts, Dr. Harold Hopfenberg and Dr. Anthony Palmieri.
[16] Dr. Hopfenberg is a Professor Emeritus of Chemical Engineering and Biomedical Engineering and Director Emeritus of the Kenan Institute for Engineering, Technology & Science at North Carolina State University. He has an S.B., an S.M. and a Ph.D. in Chemical Engineering. He has consulted in industry and has served on the editorial boards of various journals. His mandate was to provide an opinion related to patent construction, utility, obviousness, ambiguity, insufficiency, and infringement.
[17] Dr. Palmieri is a registered pharmacist and a faculty member at the Department of Pharmaceutics at the University of Florida, College of Pharmacy. He has a Ph.D. in Pharmaceutics and has worked at the university’s Office of Technology Licensing. He has authored over 80 publications and has served on the steering committee for the Handbook of Pharmaceutical Excipients. He has consulted for pharmaceutical companies and has previously provided evidence on behalf of both innovator and generic companies. His mandate was to provide an opinion related to construction, utility, obviousness, and infringement.
III. The Matters the Parties and their Experts Agree On [18] In reviewing the facts relevant to the issue of whether the Apotex Products infringe the 310 Patent, I commence by reviewing the relevant factual matters that are not in dispute.
[19] In this regard, the parties and their experts concur that alcohols are organic compounds that have at least one hydroxyl group (i.e. a group comprised of an oxygen and hydrogen atom, represented by the formula -OH) and no other carbon-oxygen functional group with a higher order of precedence in the chemical nomenclature system (see in this regard the Affidavit of Anthony Palmieri III, sworn November 19, 2013 [Palmieri affidavit] at para 67 Applicant’s Record [AR], p 1810; Affidavit of Dr. Harold Hopfenberg sworn November 19, 2013 [Hopfenberg affidavit] at para 30 AR, p 1499; Affidavit of Dr. Jerry Atwood sworn August 16, 2013 [Atwood affidavit] at paras 26 and 27 AR, p 57; Affidavit of Dr. Stephen Byrn sworn August 19, 2013 [Byrn affidavit] at paras 21-22 AR, p 210; Affidavit of Dr. Norman Weiner sworn August 19, 2013 [Weiner affidavit] at paras 22-23 AR, p 274).
[20] There also is no dispute that the term “pentahydric” refers to five hydroxyl, or “-OH” groups, and that the term “hexahydric” refers to six hydroxyl groups (Palmieri affidavit at para 68 AR, pp 1810-1811; Hopfenberg affidavit at paras 30 and 49, AR, pp 1499 and 1505; Atwood affidavit at para 22 AR, p 56; Byrn affidavit at para 20 AR, p 210; Weiner affidavit at para 22 AR, p 274).
[21] It is likewise undisputed that mannitol, sorbitol and xylitol are simple, straight chain sugar alcohols that contain five (in the case of xylitol) or six hydroxyl groups (in the case of mannitol and sorbitol) (Palmieri affidavit at para 69 AR, p 1811; Hopfenberg affidavit at paras 31- 32, AR, pp 1499-1500; Atwood affidavit at para 23 AR, p 56; Byrn affidavit at para 22 AR, pp 210-211).
[22] The parties likewise agree that the chemical formulae and molecular structures of mannitol, sorbitol and xylitol are as follows (Palmieri affidavit at para 189 AR, p 1851; Hopfenberg affidavit at para 31 AR, p 1500; Byrn affidavit at para 25 AR, p 213; Weiner affidavit at para 25 AR, p 275):
Mannitol
C6H14O6
Sorbitol
C6H14O6
Xylitol
C5H12O5
[23] The parties further agree that [ ] is an alcohol that[ [ ] It is similarly undisputed that the chemical formula for [ ] is [ ]
(See in this regard Palmieri affidavit at para 168 and 189 AR, pp 1843 and 1850-1851; Hopfenberg affidavit at para 60, AR, p 1509; Byrn affidavit at paras 24-26 AR, pp 212-213; Weiner affidavit at paras 24-25 AR, p 275, as corrected by cross-examination at Questions 192 and 193 AR, p 2567).
[24] As is apparent from the foregoing, the [ ].
[25] There is also no dispute that [ ] is now a relatively commonly-used pharmaceutical excipient. However, it was not as commonly-used by pharmaceutical formulators in April 1997, the date the 310 Patent was published.
[26] Finally, the parties and their experts are in substantial agreement regarding the attributes of the notional skilled person, from whose vantage point the 310 Patent is to be construed. They concur in this regard that the skilled person is a pharmaceutical formulator with practical experience. This person would have a master’s, doctoral or, perhaps, a bachelor’s degree in chemical engineering, organic chemistry, pharmacy, pharmaceutics, pharmaceutical chemistry, medicinal chemistry, or a related field and experience working as a formulator. Moreover it is not disputed that the skilled person would not necessarily be an expert in chemical nomenclature, but the parties agree that he or she would have learned about naming conventions applied by chemists in undergraduate chemistry courses (see in this regard: Palmieri affidavit at paras 25 and 57 AR, pp 1800-1801 and 1808; Hopfenberg affidavit at paras 17 and 27, AR, pp 1495 and 1498-1499; Atwood affidavit at para 11 AR, p 53; Byrn affidavit at para 15 AR, p 209; Weiner affidavit at para 21 AR, p 274; Teva memorandum at para 37 AR, p 2813; Apotex memorandum at para 37; Respondent’s Memorandum [RM], para 26).
IV. The Points in Dispute [27] I turn now to the points in dispute. The parties diverge on several points, but only one of them is material to the infringement issue, namely, what is meant by the terms “pentahydric and hexahydric alcohols”.
[28] Teva asserts that a skilled person would understand these terms to include any alcohol molecule that contains five or six hydroxyl groups or any alcohol molecule that contains an alcohol moiety (i.e. an identifiable portion of a molecule) that contains five or six hydroxyl groups. Teva thus says that [ ] is a [ ] alcohol because there are [ ] hydroxyl groups on the alcohol moiety [ ]. In other words, Teva and its experts contend that for purposes of classifying the type of alcohol that [ ] is, the skilled person would count only the [ ] hydroxyl groups on the alcohol moiety of the molecules [ ].
[29] Apotex and its experts, on the other hand, assert that the skilled person would understand pentahydric and hexahydric alcohols to include only those alcohols comprised of molecules that contain a total of five or six hydroxyl groups. They thus contend that the skilled person would count all the hydroxyl groups in a molecule for purposes of classifying it and, accordingly, that the skilled person would understand [ ] is not pentahydric [or hexahydric] alcohol. They therefore say that the Apotex Products do not infringe the 310 Patent as they do not contain a pentahydric or hexahydric alcohol.
V. Principles Applicable to Claims Construction [30] In assessing the parties’ respective positions on this issue, the first step to be undertaken is the construction of the relevant Claims in the 310 Patent. The case law teaches in this regard that construing the claims in a patent is the necessary first step in an infringement analysis as the claims define the invention and the limits of the monopoly conferred by a patent (see e.g. Whirlpool Corp v Camco Inc., 2000 SCC 67, [2000] 2 SCR 1067 at para 43 [Whirlpool]; Free World Trust v Electro Sante Inc., 2000 SCC 66, [2000] 2 SCR 1024 at para 31 [Free World Trust]; Pfizer Canada Inc. v Canada (Minister of Health), 2005 FC 1725, 144 ACWS (3d) 938 [Pfizer 1] at para 10; Novo Nordisk Canada Inc. v Cobalt Pharmaceuticals Inc., 2010 FC 746, 86 CPR (4th) 161 at para 89; Alcon Canada Inc. v Cobalt Pharmaceuticals Company, 2014 FC 149, 117 CPR (4th) 323 [Alcon v Cobalt] at para 18).
[31] The principles of claims construction are well-settled and were laid out by the Supreme Court in Whirlpool and Free World Trust. There, the Court indicated that patent claims are to be construed in an informed and purposive manner, with the claims being read in the context of the patent as a whole through the eyes of a person of ordinary skill in the art (or skilled person). Justice Hughes aptly summarized these principles in Pfizer 1 at paras 32-53. He restated those principles in Hughes & Woodley, Patents, 2nd ed, looseleaf (Canada: LexisNexis Canada Inc, 2005-2014) at 310-11 [Hughes & Woodley] as follows:
(1) Who construes the claim?
The Court construes the claims, not an expert witness.
(2) When are the claims construed?
At the outset, before deciding issues of infringement and validity.
(3) As of what date are the claims construed?
As of the date of publication, except for patents issuing from applications filed before October 1, 1989, in which case it is the date of issue and grant.
(4) What are the criteria for construction?
The claim must be given a purposive construction. It is an objective exercise as to what a person skilled in the art would have understood the inventor to mean.
(5) What resources may be used for construction?
The claim is to be read in the context of the rest of the specification, assisted by an expert witness, in order to understand the context of the invention described and the particular meaning of terms used in the patent. The expert is not to displace the Court in the role of the person who is to interpret the claims.
(6) Through whose eyes is the construction made?
Through the eyes of the ordinary person skilled in the art. An ordinary person is one who operates on the basis of common knowledge in the trade, possessing ordinary skills and without any special “in house” knowledge.
(7) What is to be made of the resulting construction?
The literal meaning of the claim may be expanded or limited. There may be a self-inflicted wound committed by the inventor in drafting the claim.
(8) A finding of ambiguity is to be avoided if at all possible.
[32] Here, as noted, the sole construction issue that is relevant to infringement is how the terms “pentahydric alcohol” and “hexahydric alcohol” are to be construed as Claims 2 and 31 of the 310 Patent include compositions including at least 60% by weight of such alcohols.
VI. The Experts’ Evidence on Construction [33] Turning first to Teva’s experts, their evidence establishes that, prior to formulating their opinions on construction, each was given a copy of Apotex’ NOA and portions of Apotex’ ANDS by counsel for Teva. Thus, before they formulated their opinions on construction, each Teva expert was aware that the Apotex Products contained [ ] and that the party who wished to retain them took the position that the Apotex Products infringed the 310 Patent.
[34] Their affidavits moreover reveal that the Teva experts undertook the construction of the terms “pentahydric or hexahydric alcohols” with [ ], the allegedly infringing substance, in mind.
[35] More specifically, Dr. Atwood offers in his affidavit a definition of the terms “pentahydric” and “hexahydric” and an explanation for what constitutes an “alcohol” but does not specifically say what the skilled person would understand the terms, when used together, to mean, except with reference to [ ].
[36] He states as follows in this regard:
22. “Penta” and “hexa” refer to five and six, respectively.
[…]
26. The term “alcohol” generally refers to an organic molecule having at least one hydroxyl (-OH) group, although the term “alcohol” is also generally used to refer to the hydroxyl group itself.
[37] Then, after discussing nomenclature and sugar alcohols generally, he states as follows:
29. In addition to mannitol, sorbitol and xylitol (the polyols exemplified in the 310 Patent), other sugar alcohols have been approved for use in the food and pharmaceutical industries. [ ] is classified as a sugar alcohol. It is a [ ].
30. The skilled person would understand that although glucose contains five hydroxyl groups [ ] glucose is not considered to be an “alcohol” or “polyol” because it also contains an aldehyde group. This is a simple matter of nomenclature taught in undergraduate organic chemistry classes. However, because [ ] is considered to be an “alcohol” that contains a [ ] the skilled person would clearly understand [ ] to be included within the group of pentahydric and hexahydric alcohols contained in the 310 Patent.
[38] Drs. Byrn and Weiner’s affidavits (which are very similar to each other on the construction point) offer a more fulsome construction for the terms “pentahydric”, “hexahydric” and “alcohol”, but also tie their construction of these terms in the 310 Patent to [ ].
[39] Dr. Byrn says as follows:
20. “Pentahydric” would be understood to refer to five hydroxyl 9-OH) groups. “Hexahydric” would be understood to refer to six hydroxyl groups.
21. The term “alcohol” would be understood to be an organic compound having at least one hydroxyl group on the alcohol moiety or alcohol molecule but which does not contain carbon-oxygen functional groups such as carboxylic acids, aldehydes, or ketones.
[40] He then goes on to discuss [ ] and concludes as follows on the issue of construction of the terms used in the 310 Patent:
28. A skilled person would understand that when a compound contains a polyhydric moiety and a sugar moiety, determining whether it is a pentahydric or hexahydric alcohol is done on the basis of the number of hydroxyl groups on the polyhydric moiety. The skilled person would not include the –OH groups attached to the glucose moiety in determining the class of polyhydric alcohol to which it belongs.
29. [ ].
[41] Similar reasoning and language are contained in paras 21 to 26 of Dr. Weiner’s affidavit.
[42] On cross-examination, all three Teva experts confirmed that they reviewed portions of Apotex’ ANDS and NOA and were aware that the Apotex Products contained [ ] before they formulated their opinions on construction (Atwood affidavit at para 7 AR, p 51-52, Cross-examination Questions 314-317 AR, p 2253; Byrn affidavit at para 11 AR, p 208; Byrn Cross-examination Questions 221 and 321 AR, pp 2467, 2468 and 2473; Weiner affidavit at para 10 AR, p 271, Cross-examination Questions 117-120 AR, pp 2562-2563).
[43] Apotex’ experts, on the other hand, were never given a copy of the Apotex NOA and were given portions of the Apotex ANDS only after they had formulated their opinions on construction. This is made clear in their affidavits.
[44] Dr. Hopfenberg says as follows at paras 10 to 13 of his affidavit:
10. Mr. Richard Naiberg of Goodmans LLP, counsel for Apotex Inc. (“Apotex”), provided me with a copy of Canadian Letters Patent No. 2,232,310 (“310 Patent”, a copy of which is attached as Exhibit 2), and the documents referenced in the 310 Patent, as follows: GB 1,003,686 (“GB 686”, a copy of which is attached as Exhibit 3) and WO 95/11016 (“WO 016”, a copy of which is attached as Exhibit 4).
11. Mr. Naiberg then asked me to:
(a) Examine the 310 Patent and state my opinion as to:
(i) Who is the person of ordinary skill in the art to whom the 310 Patent is addressed?
(ii) How would the person of ordinary skill in the art at April 10, 1997 understand the disclosure of the 310 Patent and claims 2 and 31 thereof? And
(iii) Would the person of ordinary skill in the art understand the 310 Patent to promise any specific useful property or properties for its subject matter, and if so identify it or them.
(b) Provide some background information about the subject matter of the 310 Patent, as would have been known to the person of ordinary skill in the art as of April 10, 1997.
12. After forming my opinions with respect to these matters, I was provided with a copy of what I am advised by Mr. Naiberg is an excerpt from Apotex’s Abbreviated New Drug Submission (“ANDS excerpt”, a copy of which is attached as Exhibit 5) for Apo-rasagiline.
13. I was asked by counsel to review the ANDS excerpt and answer the following question: Is Apo-rasagiline a pharmaceutical composition that falls within the scope of claim 2 and/or claim 31 of the 310 Patent?
[45] Likewise, Dr. Palmieri deposes as follows at paras 19 to 21 of his affidavit:
19. Counsel provided me with copies of the following documents:
a) Canadian Letters Patent No. 2,232,310 (the “310 patent”), a copy of which is attached as Exhibit “C” and
b) The documents cited in the 310 patent, namely GB 1,003,686 (“GB686”) and WO 95/11016 (“WO11016”), copies of which are attached as Exhibits “D” and “E”, respectively.
20. Counsel then asked me to provide my opinion on the following questions:
a) Who is the “skilled person” to whom the 310 patent is addressed?
b) What would the skilled person understand the 310 patent to be describing as of April 10, 1997?
c) What would the skilled person understand claims 2 and 31 of the 310 patent to cover as of April 10, 1997?
d) What, if anything, would the skilled person understand the 310 patent to be promising in respect of the utility of its subject matter?
e) If the 310 patent promised any specific utility, was this utility demonstrated prior to September 18, 1996?
f) If the 310 patent promised any specific utility, did the inventors have and disclose in the patent a factual basis and line of reasoning for a sound prediction of this promised utility?
g) Do claims 2 and 31 of the 310 patent cover compositions that do not have the promised utility, if any?
h) Do claims 2 and 31 of the 310 patent include compositions that were not indicated to have been invented or disclosed in the patent?
i) What would the skilled person understand by the term “stable” as it was used in the 310 patent?
j) Does the 310 patent teach the skilled person how to prepare compositions that meet the promised utility, if any?
k) Are there any differences between the inventive concept of each of claims 2 and 31 of the 310 patent and the common general knowledge/state of the art as of September 20, 1995 that the person to whom the 310 patent is addressed, without viewing the 310 patent, would have needed to exercise inventive ingenuity to overcome?
21. After providing my opinion on these questions, counsel provided me with a copy of portions of Apotex’s Abbreviated New Drug Submissions (“ANDS”) for its Apo-Rasagiline product, which are attached to my affidavit as Exhibit “F”. Counsel asked me to provide my opinion as to whether the Apo-Rasagiline product falls within claims 2 and/or 31 of the 310 patent?
[46] Thus, neither of the Apotex experts was aware that [ ] was contained in the Apotex Products when they formulated their opinions on how to construe the terms in the 310 Patent.
[47] Their opinions on construction, not surprisingly, make no reference to [ ]. Dr. Hopfenberg offers the following as to how he believes the skilled person would interpret the terms “pentahydric and hexahydric alcohols” in the 310 Patent:
30. An alcohol is an organic compound having at least one hydroxyl (-OH) group. Alcohols may contain more than one –OH group, in which case they are known as polyhydroxyl or polyhydric alcohols or polyols. Polyhydric alcohols may also be identified more specifically according to the number of hydroxyl (-OH) groups in the molecule. Polyhydric alcohols with five –OH groups are called pentahydric alcohols; those alcohols with six –OH groups are called hexahydric alcohols.
[…]
49. As discussed above, the person of ordinary skill in the art understands the term “pentahydric or hexahydric alcohols” to be a polyhydric alcohol having five or six –OH groups, respectively. Since the inventors specifically reference and exemplify those polyhydric alcohols that have five or six hydroxyl groups and no others, the person of ordinary skill in the art would not understand claim 1 (or claims 2 or 31) to include any polyhydric alcohols have a greater than six or less than give hydroxyl groups.
50. The person of ordinary skill in the art would assume that the specification of the pentahydric and hexahydric alcohols was intentional and that polyhydric alcohols with more than six or less than five hydroxyl groups would not function in the same way to achieve the same improved stability as promised for pentahydric or hexahydric alcohols. Thus, the skilled person understands that no other polyhydric alcohol can be substituted for a pentahydric or hexahydric alcohol in the formulations of claim 1 of the 310 Patent.
[48] Dr. Palmieri, for his part, says as follows:
67. An alcohol is a molecule that contains a carbon atom to which is attached a hydroxyl (-OH) group, namely an oxygen atom (O) attached to a hydrogen atom (H). The hydroxyl group (-OH) is the functional group that defines the compound as an alcohol.
68. The term “pentahydric” would refer to an alcohol having 5 hydroxyl (-OH) groups and the term “hexahydric” would refer to an alcohol having 6 hydroxyl (-OH) groups. “Typically” says the patent, “the alcohol used in accordance with the invention is a member selected from the group of mannitol, xylitol and sorbitol.
69. The skilled formulator would understand that mannitol, xylitol and sorbitol are each closely-related, simple, straight chain alcohols that share similar properties and uses in formulations.
70. Mannitol, sorbitol and xylitol have very similar structures. Mannitol and Sorbitol each consist of a chain of 6 carbon atoms with a single hydroxyl group (-OH) on each carbon atom and have the [same] chemical formula and the same molecular weight (182.17 g/mol). Xylitol has 5 carbon atoms with a hydroxyl group (-OH) on each carbon atom with a somewhat lesser molecular weight (152.15 g/mol).
[…]
126. The term pentahydric or hexahydric alcohol has the meaning ascribed to this term above. The skilled formulator would understand the phrase “comprising at least 60% by weight of the total composition” to mean that the weight of the at least one pentahydric or hexahydric alcohol makes up about 60% of the total tablet. For example, if the total tablet weight is 100 mg, then the weight of the pentahydric or hexahydric must be at least about 60 mg.
[49] Both Apotex experts were provided with the Apotex ANDS for purposes of formulating their opinions on infringement. Drs. Hopfenberg and Palmieri offer the opinion that [ ] is not a pentahydric or hexahydric alcohol because it contains [ ] hydroxyls, all of which must be counted for purposes of classification. They both also offer critiques of the views expressed by the Teva experts.
[50] In this regard, Dr. Hopfenberg points out a disagreement between the Teva experts. He notes that Dr. Atwood offered a different interpretation from Drs. Byrn and Weiner, and tied his construction to the number of carbon atoms in the molecule or moiety as opposed to the number of hydroxyls. Dr. Hopfenberg expresses the view that this is an error. It appears that Dr. Hopfenberg is correct in this assertion as all the other experts for both sides concur that the relevant atoms for purposes of classifying something as a pentahydric or hexahydric alcohol are the hydrogen and oxygen atoms that comprise the hydroxyl groups. Indeed, Teva did not seek to defend Dr. Atwood’s reference to carbon as being correct.
[51] Dr. Hopfenberg also offers in his affidavit an extract from the International Union of Pure and Applied Chemistry (IUPAC) Compendium of Chemical Terminology to counter the construction offered by Teva’s experts. He states as follows at paras 65 to 68 of his affidavit:
65. However, Dr. Weiner’s description overlooks the important distinction between a molecule and a moiety. The person of ordinary skill in the art understands that an alcohol is a complete molecule and a moiety is part of a molecule.
66. The IUPAC defines “moiety” as follows:4
In physical organic chemistry moiety is generally used to signify part of a molecule, e.g. in an ester R1COOR2 the alcohol moiety is R2O. The term should not be used for a small fragment of a molecule. [emphasis added]
67. This statement, from the IUPAC “Gold Book”, indicates that a molecule containing a moiety that is a remnant of an alcohol (because a hydrogen atom is “subsumed” in the formation of the ester) is not understood to be an alcohol. Rather, the molecule is understood to be an ester.
68. The person of ordinary skill in the art reading the 310 Patent would understand that the claim terms “pentahydric alcohol” and “hexahydric” alcohol” refer unequivocally to entire, individual molecules, and not to a selected “part of a molecule” that contains a pentahydric or hexahydric moiety.
[52] The other Apotex expert, Dr. Palmieri, makes reference in his affidavit to two patents for other substances in support of his view that [ ] is not a pentahydric or hexahydric alcohol.
[53] The first of these is U.S. Patent 3,234,151 [the U.S. 151 Patent], issued in February 1966 for products produced from lactositol, [ ] The 151 Patent states that lactositol is the “trivial or common name of the nonahydric alcohol obtained by the reduction of lactose under nonhydrolyzing conditions. Its proper chemical name is 4-O-β-D-galactosyl-D-glucitol” [emphasis added] (Exhibit “M” to the Palmieri affidavit, Applicant’s Application Record, AR, p 2168).
[54] In his affidavit, Dr. Palmieri provides the chemical structure for lactositol as follows:
[55] The other patent to which Dr. Palmieri refers in his affidavit is U.S. Patent 6,204,300 [the U.S. 300 Patent]. It was issued on March 20, 2001 and filed on January 29, 1999 (with a foreign priority date of February 6, 1998). The U.S. 300 Patent pertains to low resistance urethane foam, which is made in part from a polyol (or alcohol with multiple hydroxyl groups). The 300 Patent describes the alcohols that may be used to make the invention in the following terms:
The alcohol that may be used as the initiator includes monohydric or polyhydric alcohol including monohydric alcohol such as methanol or ethanol; dihydric alcohol such as ethylene glycol and propylene glycol; trihydric alcohol such as glycerine and trimethylol-propane; tetrahydric alcohol such as pentaerythritol; hexahydric alcohol such as sorbitol; and octahydric alcohol such as saccharose. (Exhibit N to Palmieri affidavit AR, p 2195)
[emphasis added]
[56] In his affidavit, Dr. Palmieri provides the chemical structure for saccharose as follows:
[57] Dr. Palmieri opines that because lactositol and saccharose [ ] contain alcohol groups but are classified based on the total number of hydroxyls in the molecule, [ ] cannot be a pentahydric or hexahydric alcohol. He opines that, just as is done with lactositol and saccharose, one must count all the hydroxyl groups in [ ] for classification purposes. When one does this, according to Dr. Palmieri, one must conclude that [ ] is a [ ] and not a pentahydric or hexahydric alcohol.
[58] Dr. Palmieri also makes another point in his affidavit, saying that the skilled formulator would appreciate that [ ] is quite different in structure from mannitol, sorbitol and xylitol as it contains a greater number of reactive hydroxyl groups. He therefore offers the view that [ ] would not be seen by the skilled person as coming within the group of pentahydric or hexahydric alcohols because there is no reason to believe that [ ] would function the same way as the alcohols named in the 310 Patent. He buttresses this argument with reference to the entries for [ ] in the 2006 edition of the Handbook of Pharmaceutical Excipients, R.C. Rowe, P.J. Sheskey, S.C. Owen, ed, 5th ed (Chicago: Pharmaceutical Press, 2006) [the Handbook], noting that [ ] was not contained in earlier edition of the Handbook and that the 2006 extract does not list sorbitol, mannitol or xylitol as substances related to [ ].
VII. Teva’s Objection to Additional Evidence Offered by Dr. Palmieri [59] Teva argues that the U.S. 151 and 300 Patents as well as the [ ] extract from the 2006 version of the Handbook, and all references to them in Dr. Palmieri’s affidavit, are inadmissible because they were not mentioned in Apotex’ NOA. It submits that the case law of this Court and of the Federal Court of Appeal establishes that a respondent in this sort of application cannot rely on any fact, document or argument that was not disclosed in its NOA, relying in this regard on AB Hassle v Canada (Minister of National Health and Welfare) (2000), 7 CPR (4th) 272, [2000] FCJ No 855 at paras 21-24; Bayer Inc v Cobalt Pharmaceuticals Co, 2013 FC 1061, 121 CPR (4th) 14 [Bayer] at paras 34-37; Alcon Canada Inc v Apotex Inc, 2014 FC 791, [2014] FCJ No 952 at paras 75 and 94-95; Alcon v Cobalt at paras 14 and 135; Merck & Co. v Pharmascience Inc., 2010 FC 510, 85 CPR (4th) 179 [Merck v Pharmascience] at para 96; Pfizer v Canada, 2008 FC 500, 167 ACWS (3d) 984 [Amlodipine] at para 88; and Bristol-Myers Squibb Canada Co. v Mylan Pharmaceuticals ULC, 2012 FC 1142, 107 CPR (4th) 75 at para 63. As the U.S. 151 and 300 Patents and the extract from the 2006 version of the Handbook were not mentioned in Apotex’ NOA, Teva says they should be struck from the record and ought not to be considered by me.
[60] Not surprisingly, Apotex disagrees. While recognizing that the case law and subsection 5(3)(a) of the PMNOC Regulations do require a party to disclose all facts and arguments it intends to rely on in its NOA, Apotex argues that an exception to this requirement has been recognised in those situations where a respondent is replying to arguments made by the applicant in their evidence. It points in this regard to the decisions in AstraZeneca AB v Apotex Inc., 2005 FCA 183, 39 CPR (4th) 289 [Omeprazole 1]; Pfizer v Novopharm, 2005 FCA 270, 141 ACWS (3d) 636 [Pfizer 2]; Fournier Pharma Inc. v Canada, 2004 FC 1718, 136 ACWS (3d) 349 [Fournier]; Merck v Alcon, [2000] FCJ No 785, 8 CPR (4th) 87 [Merck Frosst]; and AstraZeneca AB v Apotex Inc., 2004 FC 313, 33 CPR (4th) 97 [Omeprazole 2], where respondents were allowed to file materials to address unanticipated arguments made by the applicants or their experts. Apotex says that it is merely countering Teva’s position that [ ] is a pentahydric alcohol, which is characterized as a “fantastical argument” and not something that it could have anticipated. Apotex thus asserts that its situation is on all fours with those in Omeprazole 1, Pfizer 2, Fournier, Merck Frosst, and Omeprazole 2 and therefore says that the disputed documents are properly before me.
[61] I disagree with Apotex, and in spite of the colourful language used by its counsel to describe Teva’s position, do not believe Teva’s arguments were unanticipated. In this regard, the 310 Patent claims an invention centred on the alleged stabilizing properties of pentahydric or hexahydric alcohols when combined with rasagiline. Apotex asserted in its NOA that its Products did not infringe the 310 Patent, and when it made this assertion knew that its Products contained [ ]. It therefore was asserting that [ ] is not a pentahydric or hexahydric alcohol. Apotex staked this position out in its NOA where it stated:
No claim of the 310 Patent will be infringed by the making, constructing, using or selling of APO-Rasagiline tablets since APO-Rasagiline tablets will not contain an alcohol selected from the group consisting of pentahydric and hexahydric alcohols. More specifically, APO-Rasagiline tablets will not contain mannitol, xylitol and sorbitol or any other pentahydric and hexahydric alcohol, as these terms would be understood by a person skilled in the art of the 310 Patent. (AR, p 1150)
[62] Thus, Apotex’ case, from the inception, involved the assertion that [ ] is not classified as a pentahydric or hexahydric alcohol. The defence of Teva to the opposite effect is one that Apotex clearly had to anticipate as it is only if [ ] is such an alcohol that the 310 Patent would be infringed.
[63] The disputed documents are directed toward proving that [ ] should not be classified as a pentahydric or hexahydric alcohol. This is precisely the position that Apotex advanced in its NOA. It therefore follows that the disputed documents ought to have been disclosed in the NOA: they are material evidence in support of an issue that Apotex was well aware of when it drafted its NOA.
[64] As Teva correctly notes, the case law recognizes that by virtue of subsection 5(3)(a) of the PMNOC Regulations, a party seeking an NOC through the filing of an ANDS must disclose in its NOA the material facts, arguments and documents it intends to rely on so as to allow the patentee the opportunity to make an informed decision as to whether to seek a prohibition order. Because commencing such a proceeding may expose the patentee to damages under section 8 of the PMNOC Regulations, both this Court and the Federal Court of Appeal have held that a respondent in an application such as this cannot seek to rely on material documents that were not disclosed in its NOA, in circumstances where it possessed sufficient information when it filed the NOA to know that the documents would be relevant to its position.
[65] For example, in Bayer, Justice Hughes stated at paras 34-37:
It