Ottawa, Ontario, this 7th day of June, 2005
PRESENT: THE HONOURABLE MADAM JUSTICE SNIDER
BETWEEN:
Applicant
MAYNE PHARMA (CANADA) INC.
THE MINISTER OF HEALTH
AVENTIS PHARMA DEUTSCHLAND GMBH
Respondents
An Application under section 55.2(4) of the Patent Act and
section 6 of the Patented Medicines (Notice of Compliance) Regulations
REASONS FOR ORDER
SNIDER J.
[1] Hoffmann-LaRoche Limited (the "Applicant" or "Roche") manufactures and sells the medicine ceftriaxone disodium under the brand name ROCEPHIN. Cefriaxone is within the scope of a number of claims in Canadian patent 1,259,606 (the " '606 patent"), held by Aventis Pharma Deutschland GMBH ("Aventis"). This medicine is a broad spectrum antibiotic used for treating bacterial respiratory infections. Roche's production of this drug is subject to a licence agreement with Aventis.
[2] Mayne Pharma (Canada) Inc.("Mayne") has applied to the Minister of Health (the "Minister") for a Notice of Compliance which would allow it to market tablets of ceftriaxone disodium. On May 28, 2003, Mayne served Roche with a Notice of Allegation ("NOA") indicating that, while ROCEPHIN was the drug against which its version of this medicine would be compared, no claim for the medicine and no claim for the use of the medicine would be infringed by the making, constructing, using or selling of the drug.
[3] In this application, commenced by Notice of Application dated July 17, 2003, Roche seeks an Order, in accordance with subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations"), prohibiting the Minister from issuing Notices of Compliance under section C.08.004 of the Food and Drug Regulations to Mayne in connection with ceftriaxone disodium until after the expiry of the '606 patent. The '606 patent will expire in September 2006.
[4] Aventis, successor in title to Hoechst Aktiengesellschaft ("Hoechst"), is the owner of the '606 patent and is joined as a party to these proceedings in accordance with subsection 6(4) of the Regulations. However, Aventis adopts the representations of Roche and did not make separate oral or written submissions. The Minister did not participate in this application.
ISSUES
[5] The overarching issue in an application of this nature is whether the allegation of non-infringement made by the second person in this case Mayne, is justified. In determining the answer to this question, the following issues arise in this application:
1. Is the allegation of non-infringement justified, on the basis that claims 45, 64 and 65 of the '606 patent are limited to the processes set out in claims 1 and 2 of the '606 patent?
2. Is the allegation of non-infringement of claims 5, 6 and 44 (claims to the product-by-process or its obvious chemical equivalent) justified on the basis that the process disclosed by Mayne is not an obvious chemical equivalent of the claimed processes?
[6] Mayne must be successful on both of these issues. If claims 45, 64 and 65 or any of them are not limited by the processes set out in claims 1 and 2, they would be product per se claims, with the result that Mayne's allegation of non-infringement cannot be justified. Only if these claims are construed to include the processes described in claims 1 and 2 will it be possible for Mayne to succeed overall. Even then, Mayne must also be justified in alleging that its process does not infringe claims 5, 6 and 44 which claims the medicine when prepared by the process set out in other claims of the patent or "an obvious chemical equivalent thereof".
[7] Mayne is not alleging invalidity of the '606 patent.
THE '606 PATENT
[8] A brief history of the '606 patent is useful to the analysis that follows. The '606 patent was filed in Canada on March 31, 1978 by Hoechst. Due to conflict being declared between the Hoechst application and a number of other applications, issuance of the patent did not occur until September 19, 1989. The '606 patent will expire in September 2006.
[9] At the time of filing of the application, subsection 41(1) of the Patent Act, R.S.C. 1970 prohibited Hoechst from filing a claim for the medicine ceftriaxone disodium as a product; it could only file a claim for the product as made by certain described processes. The Patent Act was amended in November 1987 and this restriction removed, thereby allowing compound per se claims for medicinal interventions (An Act to Amend the Patent Act and to Provide for Certain Matters in Relation Thereto, R.S.C. 1985, Ch. 33 (3rd Supp.), section 14, assented to Nov. 19th 1987).
[10] On February 17, 1988, Hoechst submitted an amendment to the Patent Office adding claims 45 to 64. In the letter accompanying the amendments, Hoechst advised the Commissioner of patents that:
New claims 45 to 64 are submitted to add product per se protection in view of the amendments to subsection 41(1) of the Patent Act. New claim 65 is submitted to add a pharmaceutical composition claim in view of the decisions of the Supreme Court of Canada and the Patent Appeal Board in the recent Shell cases.
[11] This history is set out in the prosecution file history available from the Canadian Intellectual Property Office for the '606 patent. The extent to which I can use this information to assist in the construction of the '606 patent was the subject of some dispute and is discussed later in these reasons beginning at paragraph 47.
ANALYSIS
The burden of proof
[12] It is well-established that, in a proceeding under subsection 6(2) of the Regulations, the first person - in this case, Roche - has the burden of proving that, on a balance of probabilities, the NOA is not justified (Merck Frosst Canada Inc. et al v. Canada (Minister of National Health and Welfare) et al (1994), 55 C.P.R. (3d) 302, at 319 (F.C.A.); GlaxoSmithKline Inc. et al v. Canada (Minister of Health) et al, 2003 FC 899 (F.C.T.D.); Hoffmann-La Roche Ltd. et al v. Canada(Minister of National Health and Welfare) (1996), 70 C.P.R. (3d) 206 (F.C.A.)).
Are claims 45, 64 and 65 product subject to the limitations and restrictions set out in claims 1 and 2?
[13] As taught by the Supreme Court of Canada in Camco Inc. et al v. Whirlpool Corporation et al, [2000] 2 S.C.R. 1067, (2000) 9 C.P.R. (4th) 129, at para. 43 (referred to as "Camco"), before considering the issue of infringement, this Court has a duty to construe the claims in question.
[14] The parties agree that claims 5, 6, 44, 45, 64 and 65 all include the compound ceftriaxone disodium within their scope. There is no dispute that claims 5, 6 and 44 are product-by-process claims. However, the crux of the dispute on this issue is whether claims 45, 64 and 65 are product per se claims or whether they are limited by reference to claims 1 and 2 to the particular processes set out in those claims. This question can only be answered after a careful construction of the claims in question. Only after construing the claim can I turn to the question of whether Mayne's allegation of non-infringement is justified. As assistance to the reader, a copy of claim 1 is attached as Appendix A to these reasons. Claim 2, for purposes of these reasons, is similar in structure to claim 1 and is not reproduced.
[15] There are many statements in the jurisprudence that outline how I am to approach the task of claim construction. All the parties agree that the claims must be construed in a "purposive" way. Generally speaking, Justice Binnie, in Camco, at para. 45 described the key to purposive construction as "identification, with the assistance of the skilled reader, of the particular words or phrases in the claim that describe what the inventor considered to be the "essential" elements of his invention." In the case of the first issue before me, the challenge is not so much one of identifying essential elements but one of interpreting the words and phrases used. Some of the principles that are, in my view, relevant to this first issue are the following:
· The context and use to which words are being put must not be ignored (Camco, at para. 49(d));
· Close attention must be paid to the purpose and intent of the author (Camco, at para. 49(c));
· "Where the language of the specification, upon a reasonable view of it, can be 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" (Camco, at para. 49(g), citing Justice Dickson in Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd. (1981), 56 C.P.R. (2d) 145 (S.C.C.), at pp. 520-21, citing Western Electric Company Incorporated, and Northern Electric Company v. Baldwin International Radio of Canada [1934] S.C.R. 570, at p. 574).
[16] At the end of the day, it is a matter for the Court to construe the relevant claims. However, I must carry out this important task through eyes educated by a person skilled in the art.
[17] The three claims of the lengthy '606 patent in question for this first issue are as follows:
· Claim 45 is a claim to "A cepham derivative of the general formula I as defined in claim 1".
· Claim 64 is to a "cepham derivative of the general formula I as defined in claim 2".
· Claim 65 is a claim to a "pharmaceutical composition containing compounds of the formula I as defined in claim 1, or a pharmaceutically acceptable salt thereof, in admixture with one or more pharmaceutically acceptable auxiliaries, carriers, diluents or excipients, for use in the treatment of microbial infections".
[18] The appropriate interpretation of the phrase "of the general formula I as defined in claim 1" (or claim 2, as applicable) is the challenge that I face. Looking just at claim 45, should I read this phrase as meaning that all of claim 1, including the process, defines claim 45 and limits claim 45 to a cepham derivative made by the process set out in claim 1? That is the meaning that Mayne argues I should adopt. Or, should I regard general formula I as not including the process? This is what Roche urges. Given the nature of my task in this case, I will begin by reviewing what the experts had to say on this critical question.
Mr. Kevin Murphy
[19] Roche provided the affidavit evidence of Mr. Kevin Murphy, a patent agent with Ogilvy Renault. He holds a science degree from the University of Southampton. His area of specialization as a patent agent included chemical, pharmaceutical, material sciences and other related patent areas. He was asked to review the NOA in this application and, particularly, those allegations relating to claims 45, 64 and 65 of the '606 patent. In his affidavit, Mr. Murphy states:
In reading the description of formula I at claim 1 and at claim 2, ceftriaxone and its disodium salt are covered by the language of claims 45 and 64. There are no process limitations contained in either of claim 45 or claim 64.
. . .
A plain reading of claims 45, 64 and 65 of the '606 Patent shows that those claims are product per se claims and demonstrates that there are no process limitations to these claims. [emphasis added]
[20] Mr. Murphy was not challenged on these statements in cross-examination.
[21] While Mr. Murphy does not have the same level of scientific expertise in these matters as other affiants, he has been a patent agent for over 30 years and, as such, has extensive experience in the interpretation of patents. Even though his testimony is written from the perspective of a patent agent, rather than a chemist, I believe it should be given considerable weight, particularly where Mayne chose not to question him on this aspect of his affidavit.
Dr. James Wuest
[22] Roche submitted two affidavits by Dr. James Wuest. Dr. Wuest holds a doctorate in chemistry and is a Professor of Chemistry conducting research, in particular, with respect to the synthesis, structure, function and properties of organic compounds. For purposes of his first affidavit, he was asked to review the claims of the '606 patent and, for the second affidavit, to reply to the affidavit of Dr. Durst. Only his first affidavit is relevant to the first issue before me.
[23] Dr. Wuest begins his first affidavit by noting that there are three types of claims in the '606 patent:
· process claims (e.g. claim 1);
· compound claims where the compounds are made by a particular process or its obvious chemical equivalents (e.g. claim 5); and
· claims for compounds per se, that is claims for compounds that do not depend on the process used to make the compounds, namely claims 45, 64 and 65.
[24] During cross-examination, he affirmed this characterization of the claims of the '606 patent.
Professor Ronald H. Kluger
[25] Mayne put forward Professor Ronald H. Kluger as an expert. He holds a doctorate in organic chemistry. His research focuses on the design, synthesis and reactive patterns of chemicals that interact with biological molecules. In preparation for his affidavit, he studied the '606 patent and claims to be "very familiar with the type of chemical process involved, my own research group having published papers relating to similar types of reactions." Professor Kluger was asked by counsel for Mayne to consider the following:
· Whether the process used by Mayne, as disclosed in its NOA, is within the scope of the process disclosed and claimed in the '606 patent; and
· Whether the Mayne process is an "obvious chemical equivalent" of the processor processes claimed in the '606 patent.
[26] Thus, Professor Kluger does not address the question of whether certain of the claims in the '606 patent are claims for the compound per se. He does, however, refer to claims 1 and 2 as claims for the process of making compounds of the general formula 1 and describes claim 44 of the patent as a product-by-process claim.
[27] During cross-examination, Professor Kluger was questioned on his understanding of the parts of claim 2. He consistently stated that he saw the entire claims 1 and 2 as an "entity". However, when questioned on the words of claim 2, he had the following to say:
Q148. Let's look at claim 2, then. Maybe that will help us. Where does the process information or the process -- where is the process set out in claim 2 in contrast to the compound made by that process?
A. I'm not aware of the -- it says that there is a process disclosed but it doesn't say what the process is.
Q149. Isn't it set out on page 296 in the last quarter of that page starting with the words 'in which'?
A. The last quarter of the page. Where are we? You're asking me to -- okay, page 296, just tell me where.
Q150. Just before the letter (a) on the left-hand side it starts 'in which'.
A. I'm on 296. It is at the top, middle or bottom.
Q 151. The last quarter of the page.
A. "...'in which (a) a lactam of the general formula...is reacted with a reactive derivative
of a carboxylic acid of the general formula III.' That's the process.
Q152. The words that appear after the words "in which" are the process?
A. They're the process as described in this, "wherein the radical R2 is as defined above,
and R1 is an amino-protective group known in peptide chemistry, or" and it goes on.
Q153. And that goes all the way through to the first line of page 298?
A. Where claim 3 does begin.
[28] As I understand this exchange, Professor Kluger acknowledges that claim 2 (and, by analogy, claim 1) has two components with the second part of the claim, commencing after the words "in which", defining the process.
Professor Tony Durst
[29] Mayne also put forward the affidavit of Professor Tony Durst, who holds a doctorate in chemistry. He was asked to review the '606 patent and, in particular, to determine whether the process used by Mayne as disclosed in the NOA is within the scope of the process disclosed and claimed in the '606 patent. He was also asked to consider whether the Mayne process is an "obvious chemical equivalent" of the process or processes claimed in the '606 patent. Finally, although he was not directly requested to do so, he did opine on whether claims 45, 64 and 65 were product claims. His views on this issue are as follows:
. . . defining the cephem derivative in claim 45 by referring to process claim 1 incorporates all of the limitations of that definition found in claim 1, including the requirement that in reaction 1(a), (which is the only method in the claim for reacting the two reactants of formula II and formula III), the substituent R1 cannot be hydrogen, but must be an amino protective group.
[30] Professor Durst made similar statements with respect to claims 64 and 65. In other words, his view is that claims 45, 64 and 65 all incorporate the restrictions and limitations of claim 1 or claim 2, as applicable.
[31] During cross-examination on his affidavit, Dr. Durst was asked to dissect claim 2.
Q51. Going back to the sheet I gave you before with claim 44, the first line, as written
here reads: 'A cephem derivative of the general formula I as defined in claim 2?'
A. Yes.
Q52. Can you identify the portion of claim 2 that relates to those words in claim 44?
A. I will have to go back to find out where it starts again. . . .
Q53. And there is also a formula I set out there - a diagram.
A. There is a formula I set out, of course, and in that formula I there are a number of
variables: A, R3, and R2 , and there are definitions given for those three, and then
there are definitions given for the substituent that is used -- Within A there are
variations. So A can be modified. It is not a simple atom, it can be CH2Y, and then
they define Y in a number of ways.
Q54. There are a number of alternatives of what A can be?
A. That's right. As I say, they define A in a variety of ways.
Q55. So the portion of claim 2 that relates to the cephem derivative of general formula I
starts at about the middle of page 295 ---
A. And goes all the way down to the end, just in front of the comma, 'in which'.
[emphasis added]
[32] In other words, Professor Durst acknowledges that the first part of claim 2 relates to the product, that being a cephem derivative.
Analysis
[33] As instructed, I must review the claims in issue, with the assistance of the experts, to resolve this problem of interpretation. As between claims 1 and 2, the language used to describe the possible substituents is not identical. Thus, while the general structures appear to be the same, the definition of "A" in claim 2 is of a narrower scope than the definition of "A" in claim 1. Nevertheless, ceftriaxone is included within either definition of "A". Thus, since the two claims are similar, I will focus on claim 1. The text of the claim begins with a claim to a process for the preparation of a cephem derivative of a general formula I. The chemical formula follows in the text.
[34] Directly following the chemical formula, the claim defines the symbols of R2, R3, A, and R5 used in the formula. Next, in the claim, a series of claimed substituents for certain of the symbols are set out following, in each case, the words "or wherein". For example, the first definition is of R5 and is set out as:
a 5- or 6-membered heterocycle which is thiazolyl . . . or is such a heterocycle which is partially or completely hydrogenated,
which may have, as a substitute:
a 5- or 6-membered heterocycle which is condensed with a 5- or 6-membered aromatic ring, said 5- or 6-membered heterocycle containing from 1 to 4 hetero atoms selected from the group consisting of oxygen, sulphur, nitrogen, and oxidized nitrogen or is such a 5- or 6-membered heterocycle which is partially or completely hydrogenated
[35] Up until the words "in which" on the third page of the claim, the claim uses words that describe the product. More specifically, this section of the claim states that R2 "is hydrogen", that R5 "is a 5- or 6-membered heterocycle", that Y "is pyridinium", A may not be 5-amino-1, 3, 4-thiadiazol-2-yl-thiomethyl . . .", etc.
[36] With the words "in which", the claim seems to change tracks. Now the claim states that "a lactam . . . is reacted with a reactive derivative . . ."; that "a cepham compound of the general formula IV . . . is reacted with a compound . . ."; that "a resulting salt is converted into the free carboxylic acid and the product can be esterified . . ."; that "a resulting ester is saponified . . .". On a
simple reading of the words used by the inventor, the steps described in this second part of the claim tell the reader how to make the product claimed in the first part of the claim.
[37] This separation of claims 1 and 2 into a "product" component and a "process" component was acknowledged by Professor Kruger and Professor Durst, as described in the cross-examination extracts set out above.
[38] In my view, claim 1 must be broken down into two parts; the first being a description of the product and the second being the process by which the product is made. Stripped down to its essential components, claim 1 is a claim to a process that responds to three questions.
1. What does the process make? It makes a cepham derivative.
2. Which particular cepham derivative does it make? It makes one that looks like the general formula I.
3. How is this particular cepham derivative to be made? It is to be made in the manner or by one of the two processes described after the words "in which" on page 3 of the claim.
[39] With this mind, I return to claim 45 which is a claim to "a cepham derivative of the general formula I as defined in claim 1". In my view, the proper construction of claim 45 is that it refers only to the compounds that are within claim 1. Otherwise, to capture both concepts included in claim1, I would have to read into claim 45 the words "and made by the process described in", such that it would be a claim to "a cepham derivative of the general formula I as defined in and made by the process described in claim 1". It follows that claim 45 is a claim to the product. It does not include the process described in claim 1, but only the description of a particular cepham derivative.
[40] The same reasoning applies to claim 64. It does not include the process component of claim 2 and is a claim to the product only. Formula I in claim 2 differs from that set out in claim 1. Thus, claims 45 and 64 claim different compounds, both of which include ceftriaxone disodium within their scope. A similar construction can be applied to claim 65.
[41] The construction of claims 45, 64 and 65 as product claims was endorsed by Dr. Wuest and Mr. Murphy, experts retained for Roche. On this point, they were not cross-examined. While Professor Durst opined, in his affidavit for Mayne, that these claims incorporate the restrictions and limitations of claim 1 or claim 2, as applicable, I prefer the views of Dr. Wuest and Mr. Murphy. Both Professor Durst and Professor Kruger accepted that the process claims 1 and 2 can be read as two separate components - the product component and, after the words "in which", a process component. Once it is established that claims 1 and 2 can be construed as two separate parts, the meaning that logically follows for claims 45, 64 and 65 is that they are product claims and not-product-by-process claims; and they are not, as asserted by Professor Durst, subject to the limitations set out in claim 1 or claim 2. When read with this in mind, the words "of the general formula I as defined in claim 1" (or claim 2, as applicable) refer only to the "product" of first portion of claim 1 (or claim 2). Thus, claims 45, 64 and 65 do not contain the limitations and restrictions described in the process contained in the second part of claim 1 or claim 2, as applicable.
[42] In addition, an interpretation of claim 45 as a product per se claim gives distinct meanings to each claim in a series of claims within the '606 patent. Claim 1 is a claim to a process. Claim 5 is a claim to:
A cephem derivative of the general formula I as defined in claim 1, whenever obtained according to a process as claimed in claim I or by an obvious chemical equivalent thereof.
[43] Finally, claim 45 is a claim to the product alone. Thus, there is a pattern of "process, product-by-process and product". This pattern is repeated in claims 2, 44 and 64. With a construction of claim 45 as a product claim, each patent has an effective and distinct meaning and is consistent with the words of Harold G. Fox in The Canadian Law and Practice Relating to Letters Patent for Inventions, 4th ed., 1969, at p. 219:
Each part of the specification must be effectively construed and, if it is at all possible, each claim must be construed independently of the others and be given an effective and distinct meaning. The court will not be inclined to construe two claims in a specification as identical, for if one claim bears the same meaning as another it does not bear an effective meaning. [emphasis added]
[44] Mayne argues that dividing claim 1 into two parts requires that I stop reading in the middle of a sentence where the words "in which" appear. Mayne points out that the words are in the middle of a line without even a comma separating them from the balance of the passage. I agree that the claim is not as clearly set out as it could be; the single sentence claim runs on for 3½ pages with commas randomly sprinkled throughout. I do not think anything turns on the lack of a comma. Indeed, in claim 2, which parallels the structure of claim 1, the words "in which" are proceeded by a comma. Fortunately, claim construction does not turn on the number of grammatical anomalies. If a purposive reading of the words leads to an identification of separate parts within the claim, it should not matter that the divisions are visually or grammatically poorly laid out.
[45] Mayne submits that claim 45 could have been drafted in a way that did not refer to claim 1, for example, by including a version of formula I in claim 45 itself. I assume that Mayne is arguing that I should draw a negative inference from this failure. However, I note that making reference to other claims to incorporate parts of a previous claim into a new claim has been acceptable practice with the Canadian Patent Office since at least 1979. Section 8.03 of the Manual of Patent Office Practice that was in effect at the time of the filing of the amendment to include claims 45, 64 and 65 provides that:
Claims are also permitted to refer to other claims or parts of claims of the same or other class in order to avoid repeating lengthy definitions already given and to simplify claiming ...
[46] Given that the definition of formula I in claim 1 runs to over two pages and over a page in claim 2, it is understandable why the patent applicant did not feel the need to repeat it in claim 45.
[47] In my analysis for the construction of the claims in question, I have not taken into account the history of the amendments to the Patent Act and, subsequent to those statutory changes, the amendment to the application for the '606 patent. Although Roche attempted to assert that this history was not being put forward as an attempt to have me take into account the "file wrapper" for this patent, there appears to be no other reason to consider the amendments and why they were made. Generally, persecution history is irrelevant "for the purpose of defining the monopoly" (Free World Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024, at para. 66). Nor have I considered the arguments of Mayne relating to how Roche, in 1992, presented its position for purposes of Compulsory Licence J2324-39(4)-1013. (The compulsory licence provisions of the Patent Act were repealed in 1993.) As stated by Justice Binnie in Free World, at para. 66:
In my view, those references to the inventor's intention refer to an objective manifestation of that intent in the patent claims, as interpreted by the person skilled in the art, and do not contemplate extrinsic evidence such as statements or admissions made in the course of patent prosecution. To allow such extrinsic evidence for the purpose of defining the monopoly would undermine the public notice function of the claims, and increase uncertainty as well as fuelling the already overheated engines of patent litigation. The current emphasis on purposive construction, which keeps the focus on the language of the claims, seems also to be inconsistent with opening the pandora's box of file wrapper estoppel.
[48] In conclusion on this point, focusing on the language of the claims and consistent with the skilled readers who have assisted with my task, I construe claims 45, 64 and 65 to cover ceftriaxone with no limitations or restrictions on the process used to obtain the medicine. This, in my view, is a reasonable view of the language of the claims that affords the inventor protection for what he invented - that being the medicine cefriaxone disodium. Stated simply, claims 45, 64 and 65 are product per se claims.
Is the allegation of non-infringement of claims 45,64 and 65 justified?
[49] Having construed the claim, I turn to Mayne's allegation that its drug will not infringe claims 45, 64 and 65. Mayne's drug is ceftriaxone disodium. Each of claims 45, 64 and 65 are claims to the product ceftriaxone. Consequently, Roche has satisfied me, on a balance of probabilities, that Mayne's allegation of non-infringement is not justified.
CONCLUSION
[50] Given my conclusion that Mayne's allegation of non-infringement of claims 45, 64 and 65 is not justified, there is no need for me to consider the second issue of whether the process disclosed by Mayne is an obvious chemical equivalent of the claimed process. Roche's application will be allowed and the Minister prohibited from issuing a Notice of Compliance until the expiry of the '606 patent.
COSTS
[51] Roche has been successful in its application and will have its costs against Mayne throughout. At the commencement of the hearing, I obtained submissions from counsel regarding the issue of costs. Roche seeks costs assessed on Column IV of Tariff B, rather than the more usual Column III, on the basis that the NOA raised a number of issues that did not need to be addressed. Aventis is not seeking any costs.
[52] Although the NOA raised at least one issue (double patenting) that did not, ultimately, come into play, I do not believe that this is a reason to depart from the more usual assessment on Column III. However, the issues raised were complex and, thus, warrant a somewhat higher assessment of costs than is usual.
[53] Having considered the submissions of counsel and the pertinent factors set out in Rule 400(3), in the exercise of my discretion, I will award costs to Roche to be assessed at the upper end of column III of Tariff B, with second counsel allowed.
"Judith A. Snider"
______________________________
Judge
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-1268-03
STYLE OF CAUSE: HOFFMANN-LAROCHE LIMITED
v. MAYNE PHARMA (CANADA) INC. ET AL
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: April 4, 2005
REASONS FOR ORDER
AND ORDER: The Honourable Madam Justice Snider
APPEARANCES:
Mr. Anthony Greber FOR APPLICANT
Mr. Jay Zakaib
Mr. Douglas Deeth FOR RESPONDENT MAYNE PHARMA
Ms. Abigail Brown
Mr. Sheldon Hamilton FOR RESPONDENT AVENTIS PHARMA
SOLICITORS OF RECORD:
Gowling Lafleur Henderson LLP FOR APPLICANT
Ottawa, Ontario
Deeth Williams Wall LLP FOR RESPONDENT MAYNE PHARMA
Toronto, Ontario
Smart & Biggar FOR RESPONDENT AVENTIS PHARMA
Toronto, Ontario