Fournier Pharma Inc. v. Canada (Health)

Fournier Pharma Inc. v. Canada (Health)
Court (s) Database
Federal Court Decisions
Date
2012-07-05
Neutral citation
2012 FC 741
File numbers
T-991-10
Decision Content
Date: 20120705
Docket: T-991-10
Citation: 2012 FC 741
Ottawa, Ontario, July 5, 2012
PRESENT: The Honourable Mr. Justice Zinn
BETWEEN:
FOURNIER PHARMA INC. and
LABORATOIRES FOURNIER S.A.
Applicants
and
THE MINISTER OF HEALTH and
SANDOZ CANADA INC.
Respondents
*PUBLIC REASONS FOR JUDGMENT AND JUDGMENT
(Confidential Reasons for Judgment and Judgment released June 15, 2012)
Notice of Compliance proceedings “should not be likened to actions for determining validity or infringement but are of the nature of proceedings in judicial review, to be held expeditiously, whose aim is to determine whether the Minister is free to issue the notice of compliance requested:” Apotex Inc v Canada (Minister of National Health and Welfare), [1997] FCJ No 1251 (FCA), at para 6.
I would add that because the scope of the proceeding is confined to administrative purposes only and not a final determination that may be made following a trial, it is reasonable for the Court to expect that the parties will focus their submissions, both written and oral, on the one or two or three serious, credible issues in dispute. These proceedings ought not to be seen as an occasion for parties to throw everything at the applications judge in order to see what might “stick.”
Reasons are issuing contemporaneously in two related applications: T-991-10, Judgment 2012 FC 741, and T-1184-10, Judgment 2012 FC 740. Both deal with the drug fenofibrate; however, each involves a different patent. Both were brought into play as a result of Sandoz Canada Inc. seeking permission to market its fenofibrate composition in Canada. The result in one application is not determinative of the other, although some substantive and procedural issues are common to both.
A Table of Contents follows.
TABLE OF CONTENTS
PARA.
OVERVIEW....................................................................................................................... 1
The Proceeding and Its Background.................................................................... 1
Burden of Proof.................................................................................................... 8
The Drug and the ‘576 Patent.............................................................................. 9
The ‘576 Patent................................................................................................... 12
THE EVIDENCE.............................................................................................................. 14
Person of Ordinary Skill in the Art (POSITA)................................................... 16
Expert Evidence Filed By Fournier.................................................................... 18
Dr. Fernando Muzzio (On Infringement)............................................... 18
Dr. Fernando Muzzio (On Validity)....................................................... 25
Dr. Elizabeth Vadas................................................................................ 31
Expert Evidence Filed by Sandoz...................................................................... 34
Dr. Joseph Bogardus .............................................................................. 34
Dr. Eugene Cooper ................................................................................ 39
Dr. David Fairhurst ................................................................................ 43
Additional Expert Evidence............................................................................... 46
Challenges to the Opinions of the Experts......................................................... 52
THE INTERPRETATION OF THE ‘576 PATENT........................................................ 61
Particle Size........................................................................................................ 63
Adherence........................................................................................................... 69
Co-Micronized.................................................................................................... 79
INFRINGEMENT............................................................................................................ 83
ANTICIPATION.............................................................................................................. 94
OBVIOUSNESS............................................................................................................. 100
OVERBREADTH........................................................................................................... 112
UTILITY………............................................................................................................. 123
SOUND PREDICTION................................................................................................. 138
INSUFFICIENCY OF DISCLOSURE ….……………………………………………….140
AMBIGUITY….............................................................................................................. 141
CONCLUSION.............................................................................................................. 143
OVERVIEW
The Proceeding and its Background
[1] Fournier Pharma Inc. markets LIPIDIL EZ in 48 mg and 145 mg tablets. The active pharmaceutical drug in LIPIDIL EZ is fenofibrate which reduces LDL (bad) cholesterol and increases HDL (good) cholesterol in patients.
[2] Sandoz Canada Inc. (Sandoz) has sought approval from the Minister of Health (Minister) to market Sandoz Fenofibrate E (the Sandoz Tablet), its generic version of LIPIDIL EZ. In its Abbreviated New Drug Submission (ANDS) filed with the Minister, Sandoz referenced LIPIDIL EZ “for the purpose of demonstrating bioequivalence or bioavailability characteristics” of the Sandoz Tablet. Three patents are listed on the register in respect of LIPIDIL EZ: Canadian Patent 2,219,475 (the ‘475 Patent), Canadian Patent 2,372,576 (the ‘576 Patent), and Canadian Patent 2,487,054 (the ‘054 Patent). Laboratoires Fournier S.A. is the owner of the ‘576 Patent. The ‘576 Patent is in the French language. It has been translated and the parties used the English translation that forms part of the record. The title of the ‘576 Patent is Pharmaceutical Composition of Fenofibrate Presenting a High Biodisponsibility and its Preparation Process. The applicants will be collective referred to as “Fournier” in these Reasons.
[3] The Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended (PMNOC Regulations) provide that the person seeking a Notice of Compliance (NOC) (Sandoz in this case), referred to in the legislation as the “second person,” must serve a Notice of Allegation (NOA) on the person who filed the new drug submission which it references in its ANDS (Fournier Pharma Inc. in this case), referred to in the legislation as the “first person.”
[4] Three separate applications were commenced in this Court each seeking an order, pursuant to subsection 6(1) of the PMNOC Regulations, prohibiting the Minister from issuing a NOC to Sandoz in connection with the Sandoz Tablets until after the expiration of the relevant Canadian patents. These applications, and the patents at issue are as follows:
a. Court File T-991-10 filed June 24, 2010, in relation to the ‘576 Patent;
b. Court File T-1054-10 filed June 30, 2010, in relation to the ‘475 Patent; and
c. Court File T-1184-10 filed July 22, 2010, in relation to the ‘054 Patent.
[5] Court File T-1054-10 was discontinued on January 25, 2012. The application in Court File T-1184-10 was heard the week commencing March 26, 2012, and that in Court File T-991-10 was heard the following week. Each application was heard separately; however, as noted below, an Order was issued prior to the hearings directing that some of the evidence filed in one proceeding could be referenced by the parties in the other proceeding.
[6] Unless Fournier is granted an order of prohibition, the Minister is prohibited from issuing a NOC to Sandoz until twenty-four (24) months after this proceeding commenced, i.e. until June 24, 2012, unless prior to that date the Court declares that the ‘576 Patent is invalid or if one of the other conditions in paragraph 7(2)(b) of the PMNOC Regulations apply.
[7] Sandoz alleges that the Sandoz Tablet does not infringe the ‘576 Patent because the size of the fenofibrate particles in the Sandoz Tablet does not fall within the particle size set out in the claims of the ‘576 Patent, which Sandoz submits is a particle size greater than 1 µm and less than 20 µm. It further submits that to the extent of any infringement, the ‘576 Patent is invalid.
Burden of Proof
[8] Subsection 43(2) of the Patent Act, RSC 1985, c P-4 provides that an issued patent is presumed to be valid “in the absence of any evidence to the contrary.” In a proceeding under the PMNOC Regulations if there is evidence in the record that, if accepted, is capable of establishing the invalidity of the patent, then the burden is on the applicant to establish on a balance of probabilities (the civil standard) that the allegations of invalidity are not justified: Abbott Laboratories v Canada (Minister of Health), 2007 FCA 153. Such evidence is in the record in this proceeding; accordingly, the issue for the Court is whether Fournier has proved on the balance of probabilities that all of the allegations raised by Sandoz are not justified.
The Drug and the ‘576 Patent
[9] Fenofibrate is known to reduce bad cholesterol in the blood and the risk of a heart attack; however, fenofibrate comes with two central problems. First, it is almost insoluble in water. As a result, the patient must take large doses if an effective quantity of fenofibrate is to make its way into the blood stream. The ‘567 Patent is directed to the problem of dissolution and bioavailability of fenofibrate. Second, the pharmacokinetics (the absorption and distribution) of fenofibrate vary on whether the patient takes it in a fed or a fasted state. It is better absorbed when taken in a fed state and particularly when taken with fatty foods. Dr. Mayersohn described as “diabolical” the fact that the patient is instructed to take fenofibrate with fatty food when the patient, on a low cholesterol diet, is otherwise instructed to avoid fatty food. The ‘054 Patent is directed to the problem of bioequivalence in the fed and fasted state.
[10] The disclosure of the ‘576 Patent describes its object as follows:
The present invention has as its object a novel pharmaceutical composition presenting a high bioavailability through improved dissolution, and a method for its preparation.
[11] The ‘576 Patent contains both formulation claims (claims 1-28) and process claims (claims 29-30). Fournier is not asserting the process claims in this application.
The ‘576 Patent
[12] Fournier asserts that the Sandoz Tablet infringes two separate sets of claims, labelled by the parties as Claim 27A and Claim 27B. Claim 27A is claim 27 when read with claims 1-6, 14-16, 19, 21, 23, and 24. Claim 27B is claim 27 when read with claims 1-6, 14-16, 19, and 21-24. The relevant claims from the ‘576 Patent are reproduced in Appendix A.
[13] Fournier, in its Memorandum of Fact and Law, describes these two sets of claims, which I reproduce with slight amendment, as follows:
Claim 27A
(a) An immediate release fenofibrate composition;
(b) in the form of a tablet;
(c) comprising an inert hydrosoluble carrier that is lactose having an individual particle size comprised between 100 and 400 microns;
(d) and fenofibrate in a micronized form having a particle size less than or equal to10 μm;
(e) wherein the fenofibrate represents from 20% to 45% by weight;
(f) further comprising a hydrophilic polymer chosen from polyvinylpyrrolidone, poly (vinyl alcohol), hydroxypropylcellulose, hydroxymethylcellulose, hydroxypropylmethylcellulose, gelatin and their mixtures;
(g) further comprising a surfactant that is sodium lauryl sulfate which represents from 0.1 to 3% by weight; and
(h) having a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia in a dissolution medium constituted by water with 2% by weight of polysorbate 80 or 0.025 M sodium lauryl sulfate.
Claim 27B
Claim 27B has all of the elements of Claim 27A with the additional limitation of claim 22, which requires that the fenofibrate and the surfactant are co-micronized.
THE EVIDENCE
[14] The filing of evidence was partially reversed: Fournier filed its evidence on infringement and its factual evidence on invalidity first. Sandoz then filed all of its evidence on the application and Fournier then filed its responding expert evidence on invalidity.
[15] Fournier filed two affidavits sworn by its proposed expert, Dr. Fernando Muzzio: the first dealing with the issue of infringement and the second dealing with the issues relating to invalidity. It also filed an affidavit by sworn by its proposed expert Dr. Elizabeth Vadas relating to invalidity. Sandoz filed affidavits sworn by its proposed experts: Dr. Joseph Bogardus, Dr. Eugene Cooper, and Dr. David Fairhurst. It also filed affidavits from Alexandra Blin-Rogierie and Valerie Baubet speaking to dissolution testing done on Lipanthyl 200M, Catherine Herry speaking to dissolution testing done on compositions allegedly covered by the ‘576 Patent, and Vincent Cailly-Dufestel speaking to the fenofibrate particle size in the Sandoz Tablet. It also filed an affidavit of Deborah Zak, a law clerk, attaching as exhibits the prior art referenced by Sandoz in its NOA together with various other documents.
Person of Ordinary Skill in the Art (POSITA)
[16] The identification of the POSITA identifies the person or group of persons to whom the patent is addressed. Because the patent is addressed to the POSITA, that person may assist the Court which will have no or little familiarity with the subject matter of the patent. However, that assistance is limited as was observed by Justice Hughes in Merck & Co v Pharamscience Inc, 2010 FC 510, at para 70:
Experts may assist in two ways; first they may inform the Court as to the knowledge that a person skilled in the art would have had at the relevant time, so as to bring that knowledge to bear reading both the description and the claims; second, an expert may assist in explaining any technical terms not within the experience expected of a Court.
[17] Fournier’s expert, Dr. Fernando Muzzio, attests that the POSITA “would have a PhD in pharmaceutics along with 1-3 years of experience in the area of formulation of pharmaceutical products. Alternatively, the POSITA could have a Masters degree in pharmaceutics with 5-7 years of experience in the area of formulation of pharmaceutical products.” That description of the relevant POISTA does not vary significantly from that offered by Sandoz’s experts and I accept it as a statement of the qualifications of the POSITA. It is the same description accepted to be the POSITA in T-1184-10.
Expert Evidence Filed By Fournier
Dr. Fernando Muzzio (On Infringement)
[18] Dr. Muzzio has a B.Sc. in Chemical Engineering from the University of Mar del Plata, Argentina and a Ph.D. from the University of Massachusetts in Chemical Engineering. He is a Professor II of Chemical Engineering at Rutgers University and teaches a course called Pharmaceutical Unit Operations which includes lectures on size reduction of particles and milling. He directs a staff of approximately 130 persons at the National Science Foundation Engineering Research Center (NSFERC) where he oversees projects relating, in part, to nanoparticle stabilization of pharmaceutical products. As part of NSFERC’s industrial mentor program, he interacts and collaborates closely with an additional 120 representatives. He is also the director of the National Science Engineering and Research training program in Nanopharmaceutical Engineering at Rutgers University. Additionally, he teaches courses for industry and regulatory agencies such as the U.S. Food and Drug Administration and he has authored approximately 200 peer-reviewed scientific papers and book chapters on subjects which include powder mixing fundamentals and mixing and segregation in tumbling blenders.
[19] In Dr. Muzzio’s affidavit on infringement, he says that Sandoz’s allegation that the Sandoz Tablet would not infringe any claims of the ‘576 Patent is incorrect. Sandoz’s allegation of non-infringement of claim 1, the only independent claim, is based on Sandoz’s claim that the Sandoz Tablets do not contain fenofibrate in a micronized form in which all, or substantially all, have a particle size less than or equal to about 20 µm and greater than 1 µm.
[20] Dr. Muzzio disagrees with Sandoz’s view that the POSITA would read a lower limit on the particle size of fenofibrate into the ‘576 Patent. In his view, the POSITA would understand that the composition of claim 1 must include, but is not limited to, fenofibrate with a particle size less than or equal to about 20 µm. He says that if there was a lower limit to be read into the ‘576 Patent, it would be 0.1 µm; not 1 µm. Anything above 0.1 µm in 1998 was measured in microns and he says that in 1998 he was even not familiar with the use of the term “nano-milling” used by Sandoz.
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[23] Dr. Muzzio notes that Sandoz’s only allegation that it does not infringe claim 22 is that the fenofibrate in their tablets is not co-micronized. He disagrees with that assertion [ …]
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Dr. Fernando Muzzio (On Validity)
[25] Dr. Muzzio provides an overview of the ‘576 Patent and opines that the inventive concept is that “the dissolution profile claimed in the ‘576 Patent can be achieved by the claimed fenofibrate compositions where micronized fenofibrate is adhered to the inert hydrosoluble carrier and can be prepared by spray coating as described in the ‘576 Patent or other methods known to the POSITA.”
[26] Dr. Muzzio disagrees with Dr. Bogardus that the promised utility is a superior dissolution profile and bioavailability to Lipanthyl 200M, the prior art. First, he says that the POSITA would understand the “improvement” stated in the ‘576 Patent relates to the claimed dissolution profile and not any particular Lipanthyl formulation. He explains that the POSITA would know that commercially available products like Lipanthyl 200M could change over time in such a way as to affect its dissolution profile. Second, he gives the following four reasons to explain that the POSITA would not understand improved bioavailability to be a promise:
(a) The claims as drafted refer to a specific dissolution profile and include a testing protocol for measuring dissolution; the claims do not include any reference to bioavailability.
(b) The inventors describe as an aspect of their invention the claimed dissolution profile, as claimed, without reference to bioavailability.
(c) The inventors state that an “object” of the invention is “high bioavailability through improved dissolution.” There is no promise of improved bioavailability over every Lipanthyl 200M formulation.
(d) As with the dissolution profile, the POSITA would know that commercially available products like Lipanthyl 200M can and often do change over time in such a way as to affect its pharmacokinetic profile, including its bioavailability. As such, it would be illogical to suggest that the inventors were purporting to promise improved bioavailability over any Lipanthyl 200M formulation knowing as they must have – just as the POSITA would know – that such formulations can change [footnotes omitted].
[27] Dr. Muzzio opines that none of the ten documents listed as anticipatory disclose all of the elements of Claim 27A or Claim 27B. He says that none of the documents disclose adhering fenofibrate to the inert hydrosoluble carrier as described in the ‘576 Patent. In addition, they do not disclose formulating fenofibrate by spraying it onto a hydrosoluble carrier and they do not disclose fenofibrate in the range of 20% to 45% by weight. Finally, he explains that the only document that refers to co-micronization of a surfactant with fenofibrate does not disclose adherence.
[28] Responding to the allegations of obviousness, Dr. Muzzio attests the inventive concept, as he has described it, would not have been self-evident to the POSITA prior to conducting the work needed to achieve the invention. Specifically, he attests that the POSITA would not have known that the dissolution profile claimed in Claim 27A and Claim 27B could be achieved by “adhering the fenofibrate to an inert hydrosoluble carrier.”
[29] As to inutility, Dr. Muzzio asserts that there are no experiments proving that the tablets described in Claim 27A and Claim 27B do not achieve the dissolution profile claimed. He asserts that the inventors do not promise improved bioavailability but says that it is demonstrated when working the ‘576 Patent.
[30] He also says that the invention does not lack sound prediction. He states that the POSITA would have predicted that the tablets claimed in the ‘576 Patent would achieve the stated dissolution profile. The claims are not broader than the invention made or disclosed and that no undue experimentation would be required to carry out the invention.
Dr. Elizabeth Vadas
[31] Dr. Vadas earned her Ph.D. in Physical Chemistry from McGill University where she was also a Postdoctoral Fellow in biochemistry. She worked at Merck & Co., Inc. for over 20 years where she was the Executive Director, Pharmaceutical Research & Development. In 2002, she started her own consulting firm. A key focus of her career has been on pharmacokinetic properties and improving the bioavailability of poorly water soluble drugs by improving the dissolution characteristics of a formulation.
[32] After reviewing the ‘576 Patent, Dr. Vadas explains that the compositions tested in Examples 1 and 2 demonstrate an improved dissolution rate compared to LIPANTHYL 200 M. She says that when Example 3 is included, the inventors also demonstrated improved bioavailability in comparison to LIPANTHYL 200 M and Secalip 100. She does not share Dr. Bogardus’ view that the inventors could not soundly predict what they claimed. In her opinion, the ‘576 Patent is based on a sound line of reasoning.
[33] Dr. Vadas states that none of the Ethypharm reports referenced by Dr. Bogardus achieves the dissolution or improved bioavailability in Claims 27A or 27B.
Expert Evidence Filed By Sandoz
Dr. Joseph Bogardus
[34] For over 30 years, Dr. Bogardus has been involved in the pharmaceutical industry and in consultancy relating to the design and evaluation of drug products. He obtained his B.Sc. from the University of Kentucky and his Masters and Ph.D. in Pharmaceutical Chemistry from the University of Kansas.
[35] Dr. Bogardus, based on the common general knowledge in 1997, states that the POSITA would understand that the inventors of the ‘576 Patent were promising an improved dissolution profile and bioavailability over that provided by Lipanthyl 200 M, the existing composition. He reviews the claims and highlights that claims 1 and 2 cover a very broad dissolution profile. He explains that any dissolution profile that is faster than the claimed profile would be covered by the ‘576 Patent.
[36] It is his opinion that the claimed compositions do not provide the promised dissolution profile and bioavailability. He references two Ethypharm reports wherein a composition he says is claimed by the ‘576 Patent did not achieve the dissolution profile. In addition, he says that the promised utility is not predictable because: (1) the range of polymers covered is too broad; (2) there is no indication of the amount of polymers required in the composition; (3) the process for preparing the polymers is not explained; and (4) the dissolution profiles cover too large of a range. Furthermore, he says that practicing the claimed invention would require undue experimentation because the scope of the claims is too broad.
[37] Dr. Bogardus compares prior publications with the elements of the ‘576 Patent and provides his opinion that this prior art would have provided the POSITA with sufficient information to prepare pharmaceutical compositions covered by the claims of the ‘576 Patent. In his opinion, the differences between the prior art and the ‘576 Patent would have been obvious.
[38] Dr. Bogardus disagrees with Dr. Muzzio that the inventors did not intend to place a lower limit to the particle size of the micronized fenofibrate. He says that if they did not intend for there to be a lower limit, they would not have used the term “micronized.” He emphasizes that Sandoz does not “co-micronize” the fenofibrate found in their tablets. Rather, he says that the fenofibrate in the Sandoz Tablets is micronized before it is mixed with the surfactant.
Dr. Eugene R. Cooper
[39] Dr. Cooper obtained his Bachelors in Physics, Chemistry and Mathematics from Austin College. He received his Ph.D. in Physical and Theoretical Chemistry from Iowa State University. He has worked on various research and development projects and is now a consultant to the pharmaceutical industry on matters of general drug delivery.
[40] Dr. Cooper says that the POSITA would understand the term “micronized form” found in the ‘576 Patent to mean fenofibrate particles with a D50 between 3 µm and about 20 µm. He says that the inventors of the ‘576 Patent gave no explanation as to how the boundary for the dissolution profile in claim 1 was selected. In his opinion, the POSITA would understand that the dissolution profile in claim 1 was marginally better than the dissolution profile of the prior art, Lipanthyl 200 M.
[41] Dr. Cooper reviews patent European Patent 256,993 (EP ‘993 Patent), US Patent 5,145,684 (US ‘684 Patent), US Patent 5,510,118 (US ‘118 Patent), US Patent 4,721,709 (US ‘709 Patent), and US Patent 4,895,726 (US ‘726 Patent) and says that each individually would have provided the POSITA with sufficient information to make a composition covered by the claims of the ‘576 Patent.
[42] It is his view that the only difference between the common general knowledge and the ‘576 Patent was the “marginally” better dissolution profile and this, he says, was not inventive.
Dr. David Fairhurst
[43] Dr. Fairhurst holds an emeritus position as Corporate Research Fellow at Particle Sciences Inc. For 50 years he was involved in the theory and practical application of colloid and surface chemistry and dispersion/emulsion technologies. He has a B.Sc. in Applied Chemistry and a Ph.D. in Physical Chemistry from Liverpool Polytechnic.
[44] Dr. Fairhurst explains that the POSITA “would have understood the phrase ‘fenofibrate in a micronized form’ as used in the claims of the ‘576 Patent to refer to fenofibrate in which substantially all of the fenofibrate had a particle size greater than 1 micron (i.e. a mean particle size of a few microns or more).” He also says that the POSITA would not consider the claims of the ‘576 Patent to cover a formulation that has relatively few micronized particles since that would not provide the benefit of the invention.
[45] Dr. Fairhurst reviews Dr. Muzzio’s statement that “even today the term ‘micronized’ is not used to imply a lower size limit of one micro, and it never has been.” He notes that the brochure used by Dr. Muzzio to support his statement only shows one example where the size of the particles is reduced to below 1 µm. Also, admitting that the efficiency of the “jet-milling” process used in the brochure has improved over the past 15 years, Dr. Fairhurst cites an article from 1996 in which “jet-milling” could only reduce the particle size to “a few microns.”
Additional Expert Evidence
[46] One issue of material significance in this application is the particle size of the fenofibrate particles in the Sandoz Tablet. It is also an issue of material significance in T-1184-10. Days prior to the hearing of these applications, Fournier brought a motion seeking an order allowing the cross-referencing of certain affidavits and cross-examination transcripts as between Court Files T-1184-10 and T-991-10, on the basis that the evidence filed in these two applications by Sandoz relating to particle size was contradictory and that the interests of justice demanded that all of this evidence be before the applications judge in both matters.
[47] Sandoz resisted the motions, in part, on the basis that there is no conflict in the evidence, and in part of the basis that it would suffer prejudice because it has not had an opportunity to file expert evidence to assist the Court is assessing whether there truly is a conflict in the evidence.
[48] The motion was granted on the basis that:
[T]he interests of justice in having all of the relevant evidence before the Court and avoiding the possibility of conflicting findings of fact outweigh any prejudice of the sort Sandoz asserts it will suffer. Further, it is not clear that expert evidence of the type it says it would file is necessary or helpful to the Court in assessing what are statements of fact by the various expert witnesses.
[49] The issue as to whether there was any actual conflict in the evidence was to be determined as part of the decision on the merits of each application, if necessary.
[50] The portions of the Order relevant to this application are paragraphs 5 and 6 which read as follows:
5. The portions of the affidavit of Dr. Muzzio dated February 23, 2011 in T-1184-10 on particle size, as well as the portions of his cross-examination transcript relating to particle size, is incorporated into the Record of T-991-10.
6. The portions of the affidavits of Drs. LeClair, Serajuddin, and Ruddy and Christoph Heinemann, sworn June 16, 2012 in T-1184-10 on particle size, as well as the portions of their cross-examination transcripts relating to particle size, are incorporated into the Record of T-991-10.
[51] The evidence set out in these documents and the relevance, if any, in this application is discussed below.
Challenges to the Opinions of the Experts
[52] Both Fournier and Sandoz complained about the expert(s) proposed by the other and made representations as to whether that evidence ought to be accepted and, if so, the weight it ought to be given.
[53] Fournier, at paragraphs 6 and 7 of its Memorandum of Fact and Law, asked the Court to approach with caution the evidence of the experts put forward by Sandoz:
Sandoz’s experts did not have the benefit of proper legal instruction and gave conflicting testimony on important issues. Fourier has serious problems with their qualifications and evidence and submit that they should be given little weight. A few of the issues include:
a) Dr. Bogardus has never worked on the formulations of fenofibrate, on conducting bioavailability studies, or expertise to opine on micronization.
b) When impeached on question of bioavailability, Dr. Cooper attempted unreasonably to cling to his opinions despite clear concession by his co-expert, Dr. Bogardus.
c) Dr. Fairhurst has no experience in making oral dosage forms.
In addition, Sandoz thwarted Fournier’s ability to conduct any meaningful cross-examination on these affidavits [references omitted].
[54] Sandoz, for its part, at paragraphs 12 and 13 of its Memorandum of Fact and Law, challenges the evidence of Fournier’s experts, Dr. Vadas and Dr. Muzzio:
Dr. Vadas’ evidence in-chief should be afforded little weight. Counsel for Fournier repeatedly objected to relevant lines of cross-examination. In addition, she readily assumed the role of an advocate for Fournier. For example, she personally attacked Dr. Henry as “either very stupid or dishonest.”
Sandoz vigorously challenges the qualifications and expertise of Dr. Muzzio. The evidence establishes that he does not have the qualifications to meet his own definition of an [Ordinary Skilled Worker] at the relevant date. In addition, he is not an expert in bioavailability. Dr. Muzzio assumed the role of advocate for Fournier. He did not provide direct or comprehensible answers to simple questions and gave nonsensical responses in an attempt to avoid clear contradictions in his evidence. Sandoz was unable to complete Dr. Muzzio’s cross-examination and his evidence in-chief should be given little or no weight [references omitted].
[55] Shortly before this application was heard, Sandoz brought a motion to strike from the Application Record in this proceeding the affidavits of Dr. Muzzio on the ground that he was unresponsive and long winded, and because the respondent had been prevented from completing the cross-examination, despite having additional time. I dismissed that motion and provided the following short endorsement setting out my reasons for so doing:
I accept that Dr. Muzzio’s responses to the questions asked were neither brief nor direct. He was, as was suggested by counsel, a difficult witness. However, that was known prior to the Order of the Prothonotary, which ultimately issued on consent, required that he re-attend for an additional three hours and which contained the proviso that if the cross-examination was not then completed, “counsel will have regard to the time required for the witness to provide answers having regard to the nature and scope of the question posed in determining whether or not additional time will be provided to complete the cross-examination.”
It is clear from the Order that counsel for Sandoz accepted the possibility that the cross-examination would not be completed even after three hours. I do not find, on the balance of probabilities, that the applicants’ refusal to permit additional time for cross-examination was a decision made in bad faith or capriciously. I do not find that the refusal was contrary to the Order of the Prothonotary. While it might have been argued at the time that Sandoz did not have a full three hours of active cross-examination due to the breaks taken, that was not raised by counsel at the time nor afterwards and it is unfair that it be raised now at the eleventh hour when counsel for the applicants is not in a position to ameliorate that breach, if there was one.
[56] I find inappropriate and unfair the submission that Dr. Vadas, an expert put forward by Fournier, was an advocate for the position being advanced by Fournier. I have reviewed the transcript of her cross-examination. Her evidence certainly supported the position of Fournier and not that of Sandoz and she was most certainly firm in maintaining her opinion. That does not make her an advocate for the party whose position her evidence supports. Further, she provided an affidavit as required by Rule 52.2 of the Federal Courts Rules attesting that she had read and agreed to be bound by the Code of Conduct for Expert Witnesses. Paragraphs one and two of that Code provides as follows:
1. An expert witness named to provide a report for use as evidence, or to testify in a proceeding, has an overriding duty to assist the Court impartially on matters relevant to his or her area of expertise.
2. This duty overrides any duty to a party to the proceeding, including the person retaining the expert witness. An expert is to be independent and objective. An expert is not an advocate for a party. [emphasis added]
[57] For these reasons, I reject the submissions that her evidence ought to be given little weight because she was an advocate for the party putting her forward. Her evidence, like all evidence, must be weighed and considered within the context of the case as a whole, the other evidence, and the submissions made by the parties.
[58] All but one of the other complaints raised by the parties go to the weight to be given the testimony of the expert.
[59] There is merit to the submission of Sandoz that Dr. Muzzio does not have the credentials of the POSITA by his own definition. He does not profess to have these credentials; rather, in his affidavit sworn February 21, 2011, he states with respect to the POSITA: “I have worked with many individuals with these credentials and can speak to their knowledge, their understanding of this area of science and their capabilities.” Some of the evidence of Dr. Muzzio might best be described as “scientific hearsay” insofar as it is the evidence of a scientific witness without the required education offering an opinion on what scientists with the relevant education would understand a patent that is directed to them to mean. Taken to the extreme, it is akin to a physicist saying that he has worked with biologists and chemists and therefore can speak to their understanding of a document that is directed to biologists or chemists. The evidence of that physicist, in my view, should be given little weight.
[60] The situation of Dr. Muzzio is not quite akin to the extreme example offered. Dr. Muzzio does have an education and expertise that is relevant to the extent that I am not prepared to simply strike his affidavit. For example, as a chemical engineer, he is able to speak to the meaning of some of the terms used in the ‘576 Patent and assist the Court in understanding basic chemistry and formulations relevant to the invention. However, whenever his evidence is in conflict with that of the experts put forward by Sandoz, or is not supported by another expert or scientific evidence on a matter properly within the role of an expert, I prefer their evidence as Fournier made no challenge to their credentials or the fact that they were experts and met the definition of the POSITA.
THE INTERPRETATION OF THE ‘576 PATENT
[61] What is the invention captured by the ‘576 Patent? The Supreme Court in Whirlpool Corp v Camco Inc, 2000 SCC 67, at para 45, has instructed that patent claims are to be purposively interpreted, the key to which is “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.” Claims construction is a question of law: Bristol-Myers Squibb Co v Apotex Inc, 2007 FCA 379, at para 27. The purposive approach to construction ought to be used when construing the patent as a whole. The aim is to determine the inventor’s view as to what it is that he or she has invented and how that invention is to be made or the process described followed; how the invention is to be used or the result obtained from the invented process; and what the invention does.
[62] The parties are in disagreement about three aspects of the claims and their construction:
a. Whether the phrase “having a particle size less than or equal to about 20 µm” in claim 1 means the particle has a minimum as well as a maximum particle size;
b. Whether the phrase “an immediate release fenofibrate composition comprising an inert hydrosoluble carrier and fenofibrate in a micronized form” in claim 1 means that the fenofibrate is adhered to the inert hydrosoluble carrier; and
c. Whether “co-micronized” in claim 22 means that the fenofibrate and the surfactant are micronized together or whether it means that they are micronized by themselves and not together.
Particle Size
[63] Two construction issues must be decided regarding particle size. The first relates to the meaning of “in micronized form” and the second relates to the meaning of a “composition …having a particle size less than or equal to.”
[64] Fournier submits that properly construed, the ‘576 Patent places an upper limit on the size of the fenofibrate particles of “about 20 µm” but no lower limit. Sandoz submits that “[i]n 1997/1998, the term “micronized” would have been understood to refer to the process of reducing the par