Biogen Canada Inc. v. Pharmascience Inc.

Biogen Canada Inc. v. Pharmascience Inc.
Court (s) Database
Federal Court of Appeal Decisions
Date
2022-08-08
Neutral citation
2022 FCA 143
File numbers
A-145-20, A-146-20
Notes
A correction was made on February 14th, 2024.
Decision Content
Date: 20220808
Dockets: A-145-20
A-146-20
Citation: 2022 FCA 143
CORAM:
GAUTHIER J.A.
GLEASON J.A.
RIVOALEN J.A.
Docket: A-145-20
BETWEEN:
BIOGEN CANADA INC., BIOGEN INTERNATIONAL GMBH and ACORDA THERAPEUTICS INC.
Appellants
and
PHARMASCIENCE INC.
Respondent
Docket: A-146-20
AND BETWEEN:
BIOGEN CANADA INC., BIOGEN INTERNATIONAL GMBH and ACORDA THERAPEUTICS INC.
Appellants
and
TARO PHARMACEUTICALS INC.
Respondent
Heard by online video conference hosted by the Registry on February 22, 2022.
Judgment delivered at Ottawa, Ontario, on August 8, 2022.
PUBLIC REASONS FOR JUDGMENT BY:
GAUTHIER J.A.
CONCURRED IN BY:
GLEASON J.A. RIVOALEN J.A.
Date: 20220808
Dockets: A-145-20
A-146-20
Citation: 2022 FCA 143
CORAM:
GAUTHIER J.A.
GLEASON J.A.
RIVOALEN J.A.
Docket:A-145-20
BETWEEN:
BIOGEN CANADA INC., BIOGEN INTERNATIONAL GMBH and ACORDA THERAPEUTICS INC.
Appellants
and
PHARMASCIENCE INC.
Respondent
Docket:A-146-20
AND BETWEEN:
BIOGEN CANADA INC., BIOGEN INTERNATIONAL GMBH and ACORDA THERAPEUTICS INC.
Appellants
and
TARO PHARMACEUTICALS INC.
Respondent
PUBLIC REASONS FOR JUDGMENT
This is a public version of confidential reasons for judgment issued to the parties. The two are identical, there being no confidential information disclosed in the confidential reasons.
GAUTHIER J.A.
[1] The appellants appeal from the decision of the Federal Court (per Manson J., 2020 FC 621) (the “FC Decision”). In its decision, the Federal Court dismissed the appellants’ two patent infringement actions (in T-1163-18 and T-220-19) instituted pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 (the Regulations). The Federal Court concurrently heard both actions on issues of validity based on the same allegations and evidence along with the issue of infringement with respect to Taro Pharmaceutical Inc. (Taro), whose non-infringement claim was dependent on the validity issues. The FC Decision relates to the validity of Canadian patent number 2,562,277 (the 277 Patent) and Taro’s alleged infringement of the 277 Patent in Court file T-1163-18. The infringement portion of the action against Pharmascience Inc. (Pharmascience) in T-220-19 was to be scheduled later, if necessary.
[2] The Federal Court concluded that a key document in this litigation anticipated four claims of the 277 Patent and that all of the asserted claims were invalid for obviousness. Having concluded that the invalidity of the asserted claims was the only ground on which Taro relied as a basis for non-infringement in its Notice of Allegation (NOA) and Statement of Defence, the Federal Court did not address infringement further in its decision. This is the subject of a cross-appeal by Taro.
[3] Although there are some unusual facts in this matter, none of the issues raised before us involves any new questions of law. The main issue is whether, when applying the law, the Federal Court failed to adopt the perspective of a person skilled in the art (POSITA) when it construed the patent and reviewed the prior art. A subsidiary issue is whether the Federal Court should have dismissed the attack on the validity of the 277 Patent because the only expert evidence presented by the respondent was inadmissible and, thus, the respondents could not have met their burden of proof.
[4] For the reasons set out below, I have concluded that this appeal and the cross-appeal should be dismissed.
I. Background [5] For ease of reading, I will provide a background about the patent at issue, the parties and the main witnesses whose evidence I will be discussing.
[6] The 277 Patent is entitled “Methods of Using Sustained Release Aminopyridine Compositions”. Although the 277 Patent contains 112 claims, the parties limited the issues before the Federal Court to independent claims 17, 18, 31, 32, and dependent claims 19, 21, 23, 24, 26, 28, 33, 35, 37, 38, 40, 42. All the claims in this patent deal with the use of a composition of sustained release (SR) 4-aminopyridine (4-AP), also known as fampridine, to treat multiple sclerosis (MS) or the making of a medicament composed of such composition for such use (i.e., a Swiss-type claim).
[7] The description of the 277 Patent refers to some embodiments of the invention as being methods for selecting individuals based on responsiveness to a treatment, and deals at length with what is referred to as Example 5, which resulted from a post hoc analysis. However, it is no longer disputed that such methods including the post hoc responders analysis described in Example 5 are not part of the invention claimed in the 277 Patent. More will be said about this later on.
[8] The 277 Patent is owned by Acorda Therapeutics Inc. (Acorda), a Delaware corporation that is one of the appellants in this proceeding. The President and CEO of Acorda, Dr. Cohen, is one of the inventors named in the 277 Patent. He was a factual witness before the Federal Court (FC Decision at paras. 27-43). Acorda licences the 277 Patent to Biogen International GmbH (a Swiss corporation), who in turn authorized Biogen Canada to use and sell the invention claimed in the 277 Patent. Unless otherwise indicated, these entities are referred to collectively in these reasons as Biogen. Biogen Canada is an Ontario corporation related to Biogen International; it is a first person within the meaning of subsections 4(1) and 6(1) of the Regulations. It markets and sells FAMPYRA® in Canada, a sustained released (SR) composition of fampridine.
[9] The respondents, Taro and Pharmascience, are generic pharmaceutical companies incorporated under the laws of Ontario. They were seeking access to the Canadian market with their own fampridine SR products. Both parties sent an NOA, pursuant to subsection 5(3) of the Regulations, before the appellants commenced their actions in accordance with the Regulations.
[10] Dr. Oh, a staff neurologist at St-Michaels Hospital and a scientist at the Keenan Research Center for Biomedical Science in Toronto, was qualified to give expert opinion evidence on various issues listed at paragraph 47 of the FC Decision. She gave evidence on the POSITA’s common general knowledge and infringement of the 277 Patent by Taro based on her understanding of the asserted claims.
[11] Dr. Thomas Leist is the Chief of Clinical Neuroimmunology Division and Director of the Comprehensive Multiple Sclerosis Center at Thomas Jefferson University in Philadelphia, Pennsylvania. He gave evidence on the scientific background of MS, claim construction, state of the art and the POSITA’s common general knowledge as of April 2004, anticipation and obviousness. He responded to Dr. Ebers’ opinions on anticipation and obviousness. He was qualified by consent to give expert opinion evidence on the matters listed in paragraph 57 of the FC Decision.
[12] Dr. George Ebers is an emeritus professor at the Nuffield Department of Clinical Neurology at the University of Oxford. The description of his activities during the relevant period from 1997 to 1999, and to present are outlined in the FC Decision at paragraphs 62 to 64. He was qualified by consent to give expert opinion on matters set out in paragraph 65 of the FC Decision. He was the only expert presented by the respondents to deal with issues of claim construction, anticipation and obviousness.
II. The Federal Court Decision [13] The Federal Court defined the POSITA to whom the 277 Patent is addressed as follows:
[84] Having considered the expert testimony on the composite POSITA, I find that the 277 Patent is directed to a POSITA team with expertise in the treatment of MS, design and analysis of MS clinical trials, and pharmaceutical formulations. Further, the POSITA understands basic pharmacokinetic parameters and biostatistics. No expert pharmacokineticists or biostatisticians were put forward as witnesses for claim construction, so I accept that the skilled MS clinician/neurologist would have sufficient expertise in these areas to understand and interpret the 277 Patent.
[14] The Federal Court then described in some detail what was commonly known about MS by the POSITA. To avoid repetition, I will provide more detail about these findings later on in these reasons (see paras. 61-70 below). I will simply say here that such findings are not challenged by either party, and they were also properly grounded in the evidence before the Federal Court (FC Decision at paras. 8-17; 86-91).
[15] Turning to claim construction, the Federal Court started by reviewing the main terms requiring construction in the asserted claims, all of which are reproduced in Appendix A to the FC Decision. It is apparent from a review of the FC Decision that the Federal Court considered the description of the 277 Patent, the CGK, at least some of the expert evidence, and the actual language of the claims in reaching its conclusion on claim construction.
[16] The Federal Court found that the several terms in the claims in suit required construction. These included, among others, the terms “improving walking”, “a subject with MS in need thereof”, “for a time period of at least two weeks” and “unit dose of 10 milligrams of the 4‑aminopyridine twice daily”. At paragraph 94 of its decision, the Federal Court held that the POSITA would have understood these terms at the relevant date as follows:
Improving walking includes improving some aspect of walking, such as endurance, step strength, or walking speed. The improvement must be quantitatively measured, and given the variability of symptoms and the prevalence of placebo effect in MS treatment, the quantitative improvement must be statistically significant.
A subject with MS in need thereof refers to MS patients who experience some form of walking disability. This is necessarily a subset of all MS patients, as patients with little to no disability (e.g. EDSS scores 0 – 2) are not in need of improvement walking, and patients who are immobilized (e.g. EDSS scores 8 – 9) are no longer able to walk, and will not benefit from treatment to improve walking. Therefore, a subject with MS in need of treatment is a subject with an EDSS score of approximately 3.5 to 7.
For a time period of at least two weeks means the fampridine SR is used for at least two weeks, at a fixed dose of 10 mg bid.
Unit dose of 10 milligrams of the 4-aminopyridine twice daily means the dose amount is 10 mg twice daily, or 10 mg bid.
[17] In so holding, the Federal Court expressly rejected Dr. Leist’s opinion that improved walking would be understood as including not only a quantitative improvement, but also as requiring as an essential element, a qualitative one based on a subjective perception of improvement by the MS patient (FC Decision at para. 95). The Federal Court also disagreed with Biogen’s argument that a further claim limitation is included in some of the asserted claims based on Dr. Leist’s opinion that “for a time period of at least two weeks” requires that the improvement in walking be consistently improved during at least two weeks. In the Federal Court’s view, the plain claim language merely required use of 10 mg bid fampridine SR over the entire two-week period (FC Decision at para. 97).
[18] The Federal Court also construed the expression CavSS based on the evidence of Dr. Ebers as meaning average plasma concentration at steady state (FC Decision at para. 100). This term required construction in respect of dependent claims 19, 24, 33, and 38.
[19] With respect to dependent claims 21, 26, 35 and 40, which introduce a further limitation in respect of “mean Tmax” in a range 2 to 5 hours after administration, the Federal Court used the definition of Tmax found in the disclosure (also referred to as the description); that is, the “time to maximum plasma concentration” (FC Decision at para. 101).
[20] There is no need to refer here to all the elements of each asserted claim. Rather, I will simply reproduce the summary of the essential elements as described in paragraphs 109, 110 and 111 of the FC Decision:
[109] In summary, the essential elements of claims 17 and 18 are:
i. Use of a fampridine SR composition (or use of a fampridine SR composition in the manufacture of a medicament)
ii. For improving walking in a statistically significant way
iii. In a subject with MS who experiences some form of walking disability
iv. For a time period of at least two weeks
v. At a unit dose of 10 mg bid.
[110] The remaining Asserted Claims incorporate one or more of the following essential elements:
i. Increasing walking speed in a statistically significant way (claims 31 and 32)
ii. The fampridine SR composition exhibits a CavSS of 15 ng/mL to 35 ng/mL (claims 19, 24, 33, and 38)
iii. The fampridine SR composition provides a mean Tmax in the range of 2-5 hours after administration (claims 21, 26, 35, and 40)
iv. The fampridine SR composition is in a form for administration every 12 hours (claims 23, 28, 37, and 42).
[111] As noted, the asserted dependent claims also depend from earlier unasserted claims that do not include the element “for a time period of at least two weeks,” and/or specify a broader mean Tmax range of 1 to 6 hours or 2 to 6 hours after administration.
[21] I understand that the two expressions “statistically significant way” and “in a subject with MS who experiences some form of walking disability” in subparagraphs 109(ii) and (iii) above are meant to be read together with the findings set out in paragraph 94 of the FC Decision (as reproduced in paragraph 16 above).
[22] The Federal Court then addressed the validity attacks after noting that the 277 Patent is presumed to be valid, and that the defendant bears the burden of establishing each ground of invalidity on the balance of probabilities (FC Decision at para. 112).
[23] After identifying the cut-off dates for citable prior art, the Federal Court first dealt with anticipation (FC Decision at paras. 114-147). Prior to trial, the parties provided the Federal Court with a joint statement of issues, where Taro asserted that it would rely only on the Acorda S-1 document with respect to anticipation. The Federal Court refused Taro’s request in closing submissions to admit the Goodman Abstracts and Goodman Poster for the purposes of anticipation after it argued it had excluded these documents in error. There is no need to go into great detail about this finding here, given that I have come to the conclusion that this appeal can be determined without addressing this point.
[24] It is still useful to say a few words at this point about Acorda S-1, because it is referred to later in the FC Decision when dealing with obviousness. Acorda S-1 is a public financial document filed by Acorda with the US Securities and Exchange Commission (SEC) issued in the Fall of 2003. In this document, Acorda summarises its clinical studies respecting the use of fampridine SR, including studies referred to as MS-F201, which was completed in 2001, and MS-F202, initiated in early 2003, with results anticipated by the end of March 2004. These studies were conducted by Acorda in cooperation with Elan, an Irish pharmaceutical company that then owned at least one patent on fampridine (SR) for use in MS treatment cited by the experts (see also Patent Number 5,580,580, AB Vol. 2, at p. 490). Elan also supplied the SR composition to Acorda for the trials. It is worth reproducing paragraphs 123 to 125 of the FC Decision, which deal with this document in the context of its anticipation analysis:
[123] As stated in the Acorda S-1, MS-F201 was designed to determine the optimal dose level of fampridine SR and to evaluate possible ways to measure the effect of the drug, including motor strength, timed walking, and self-reported fatigue. Subjects with MS received fampridine SR in doses increasing from 10 mg to 40 mg bid over eight weeks of treatment. The results are described as follows:
The clinical trial demonstrated that doses up to 25 mg twice a day were well tolerated, and were associated with statistically significant improvements in walking speed and leg muscle strength. Most of the improvement in strength and walking speed was apparent within the first three weeks of the Fampridine-SR treatment, at doses from 10 to 25 mg twice a day.
[124] The Acorda S-1 describes MS-F202 as a clinical trial designed to compare doses of 10, 15, and 20 mg bid, and to assess their relative safety and efficacy over a 12-week treatment period, with a primary endpoint of improvement in average walking speed using the Timed 25 Foot Walk.
[125] From these descriptions of MS-F201 and MS-F202, the POSITA would derive the following information:
• Elan was supplying the fampridine SR composition;
• Doses of up to 25 mg bid were associated with statistically significant improvements in walking speed and leg muscle strength;
• Most of the improvement seen in the eight week MS-F201 trial was apparent at doses from 10 to 25 mg bid, and 9 of 25 subjects had improved walking speeds of more than 20% from baseline;
• The ongoing MS-F202 trial was comparing three fixed doses of 10, 15, and 20 mg bid over a treatment period of 12 weeks.
[25] Because the appellants argue that the Federal Court did not adopt the mantle of the POSITA, it is also worth reproducing paragraph 130 of the FC Decision:
[130] The POSITA is taken to be trying to understand what the authors of the Acorda S-1 meant, reading the document for the purpose of understanding (Sanofi at para 25). While the evidence establishes that the POSITA would approach small studies such as the MS-F201 with a healthy dose of skepticism, there is no question that the POSITA would understand the reported MS-F201 results and the design and implementation of the MS-F202 study.
[26] Although I will not deal with anticipation , the Federal Court made a few comments under enablement that are relevant to its analysis of obviousness in that they include factual findings that pertain to both enablement and obviousness. In this regard, I believe it is both fair and necessary to read the Federal Court’s reasons holistically (see also para. 191 of the FC Decision).
[27] For purposes of assessing enablement, the POSITA is taken to be willing to conduct routine trial and error experiments to get an invention to work. To do so, they may consider the entirety of the prior art reference (here the Acorda S-1) and may use their common general knowledge to supplement the teachings in the prior art reference (Apotex Inc v. Sanofi-Synthelabo Canada Inc, 2008 SCC 61 (Sanofi) at para 37). At paragraphs 144 and 145 of its decision, the Federal Court explained why, in its view, the POSITA would have been able to get the invention to work, despite the fact that, by applying only the pre-defined endpoints, the MS-F202 study would fail (one of the unusual facts in this matter). More particularly, the Federal Court found that the POSITA would also have been aware of the prevalence of post hoc analyses and the possibility of conducting so-called “n-of-1” trials to sequentially dose those patients with placebo and drug treatments to compare individual patients against themselves. In the Federal Court’s view, using their common general knowledge, the POSITA would be able to routinely identify a subgroup of subjects who experienced a statistically significant increase in walking speed when taking 10 mg bid of fampridine SR.
[28] Finally, the Federal Court dealt with obviousness at paragraphs 148 to 201 of its decision. First, it correctly identified the obviousness framework laid out by the Supreme Court in Sanofi, and noted that it is appropriate to apply the “obvious to try” test in this case (which is not disputed). Then, it reviewed the state of the art at the relevant date (FC Decision at paras. 152-171) before identifying the inventive concept (FC Decision at paras. 172-176). This enabled the Federal Court to then address the difference between the state of the art and the inventive concept at paragraphs 177 to 179.
[29] At this stage, it is important to reproduce paragraphs 169 and 170 of the FC Decision that are at the heart of the appellants’ argument that the Federal Court failed to read the prior art through the eyes of a POSITA.
[169] For the reasons given in the Expert Witnesses section above, the Court gives very little weight to Drs. Leist and Ebers’ expert opinion evidence on obviousness, particularly as to how the POSITA would interpret and understand the prior art. This leaves the Court in the somewhat unusual position of interpreting the prior art through the eyes of the POSITA, while rejecting much of the expert evidence given at trial by both parties’ expert neurologists.
[170] The Court accepts the conclusions made by Dr. Goodman, an undisputedly respected MS researcher, in his poster and abstracts. While the evidence of Drs. Leist and Ebers at trial shows that MS researchers, particularly those with a long history in the field, are highly skeptical of new treatments that are not backed by double-blind, placebo-controlled studies, the prior art should be approached by a motivated POSITA with a mind willing to understand, not one myopically focused on seeking out failure. As stated by Justice Hughes with respect to prior disclosures in the anticipation context, prior art should be given the same, purposive interpretation as the claims at issue (Shire Biochem Inc v Canada (Health), 2008 FC 538 at paras 64-65; see also Sanofi at para 25).
[30] In paragraphs 181 to 199 of the decision, the Federal Court addressed the question of whether the differences it had identified would require any degree of inventiveness and dealt with the main arguments presented by the parties. It is in this section that the Federal Court considered the inventors’ course of action (FC Decision at paras. 190-191)—a factor that, according to the appellants, the Federal Court did not give sufficient weight to.
[31] It is also in this section that the Federal Court reiterated that the post hoc responder analysis discussed in Example 5 of the 277 Patent and certain parts of the description are not part of the claimed invention or the inventive concept, contrary to the position taken by Dr. Leist (see also para. 195 of the FC Decision). It also commented on the impact of the divisional application filed by Acorda in response to a Patent Office unity of invention objection. Originally, Acorda had included many method claims in its application to cover the responder analysis referred to in the description portion of the application (in particular see 277 Patent at paras. 0019-0020 at Example 5 and the various paragraphs referring to it or explaining it, such as paras. 0078-0079). The material dealing with such methods in the description was necessary to support the claims that were later removed and included in the divisional application.
[32] At paragraph 200 of its decision, the Federal Court concluded as follows in respect of obviousness:
[200] To conclude, all Asserted Claims of the 277 Patent are invalid for obviousness. As of April 2004, the POSITA would have routinely bridged the gap between the state of the art and the inventive concept of the Asserted Claims. The POSITA would have understood that 10 mg bid dosing of fampridine SR was therapeutically effective to improve walking and increase walking speed for at least some patients with MS, and would have routinely verified this understanding by studying fixed doses of 10 mg bid fampridine SR. Specifying dosing every 12 hours, rather than twice a day, is not inventive. The claimed pharmacokinetic parameters— CavSS and Tmax —are inherent properties of the Elan formulation when administered at doses of 10 mg bid. Because it was not inventive to use doses of 10 mg bid, it was not inventive to claim the resulting plasma concentrations, which were known in the art.
[33] There is no need to discuss the Federal Court’s finding under “Methods of Medical Treatment” as this was not an issue raised before us.
III. Issues and standards of review [34] This appeal attracts the usual appellate standards of review set out in Housen v. Nikolaisen, 2002 SCC 33. However, the parties disagree as to the characterization of the questions raised by the appellants, and therefore as to the standard that would apply to them.
[35] In their memorandum, the appellants frame the issues as follows:
Did the Federal Court err in declaring the asserted claims to be invalid by failing to adopt the perspective of the POSITA when assessing the 277 Patent and the prior art for obviousness and anticipation?
Did the Federal Court err in failing to adopt a perspective of the POSITA in construing the claimed terms “improving walking” and “increasing walking speed”?
Did the Federal Court err in failing to find that the respondents failed to meet their evidentiary burden to prove that the 277 Patent is invalid?
[36] It is undisputed that in the absence of an extricable error of law, a trier of fact’s conclusions with respect to obviousness and anticipation are reviewed on the standard of palpable and overriding error. The appellants claim that there is an extricable error of law here. I note again, however, that the appellants do not dispute the applicable general principles of law and tests expressly stated by the Federal Court. Both parties recognized that the trial judge, who was an intellectual property (IP) practitioner before he became a leading Federal Court Judge in IP matters, was particularly well acquainted with them.
[37] Given that the issue here is really about an alleged misapplication of the principles rather than the principles themselves, an appellate court should normally intervene only where there is a palpable and overriding error. In that respect, the appellants maintain that if this characterization applies here, they have met their burden in any event.
[38] With respect to the construction of the claim terms referred to above, it is undisputed that the construction of the patent is a matter of law, subject to the correctness standard. That said, there is also no dispute that in respect of the appreciation of the expert evidence on how a POSITA would understand specific terms, the trier of fact is entitled to deference and the standard of palpable and overriding error applies (ABB Technology AG v. Hyundai Heavy Industries Co., Ltd., 2015 FCA 181 at paras 22-23).
[39] Considering that this Court is tasked with construing the language of the claims as a matter of law, it becomes irrelevant to determine whether, as also argued by the appellants; the Federal Court may have erred by considering validity and infringement in its purposive construction analysis at paragraph 96. I do not share the appellants’ literal interpretation of this paragraph. As I mentioned in Apotex Inc. v. Astrazeneca Canada Inc., 2017 FCA 9 (Astrazeneca) at paragraph 43, one must be particularly careful when assessing the submissions that a Court has paid lip service to the well-established principles it clearly meant to apply. This is an often-raised argument. As posited in Astrazeneca, are we to assume that because Justice Binnie discussed claims construction in the section of his reasons entitled infringement in Whirlpool Corp. v. Camco Inc., 2000 SCC 67, (Whirlpool), he was misapplying the rules he had just set out in that very case?
[40] Turning to the third question, the appellants argue that the Federal Court made an extricable error of law by determining the issue of admissibility without a motion and detailed arguments on the issue. They say that the report of Dr. Ebers should have been held inadmissible and thus the validity attacks should have been dismissed as the respondents did not meet their burden of proof. They also argued that in any event, having decided to give no weight to the evidence of this expert witness, the Federal Court had to dismiss those attacks. I do not agree that according no weight to evidence is the same as according little weight to much of the evidence. This Court will not intervene in this respect in the absence of a palpable and overriding error.
[41] Because the issue of admissibility of Dr. Ebers’ report can have an impact on all the issues in this appeal, I will deal with it first. I will then address the issue of claim construction followed by the two issues concerning obviousness, which, as will be seen, affects the validity of all the asserted claims. It is therefore not necessary to deal with anticipation of four of the claims to determine this appeal.
[42] Taro’s cross-appeal also not need to be addressed in light of my conclusion in respect of the issues raised by the appellants.
IV. Analysis [43] A few preliminary remarks are warranted. As already mentioned, this case, in my view, was particularly difficult in that it involved many unusual features, albeit not unique ones. I will refer only to a few here. First, the 277 Patent’s description includes a substantial amount of information that is no longer directed at a subject matter claimed. This can easily lead astray expert witnesses who are not particularly familiar with patent law. Second, MS is not a typical disease because of the constant fluctuation of its symptoms, and the fact that only a portion of the individual patients in need of the subject matter claimed will effectively respond to the active ingredient (fampridine SR). This portion of patients cannot be ascertained prospectively, and it is not disputed that the claims as written are not referring only to the so-called “responders” in the description. Third, for various reasons, the expert evidence on both sides could not be given much weight and certainly not as much weight as the parties, particularly the appellants, would have liked.
[44] These factors and others contributed to this decision being factually complex. In circumstances like these, this Court must be very careful in not imposing its own view of the weight to be given to the evidence. This is simply not our role.
A. The Admissibility of Dr. Ebers’ Evidence [45] The appellants argue that the Federal Court erred by not declaring the whole of Dr. Ebers’ report inadmissible. As mentioned, the appellants add that had it done so, the Federal Court would have had no choice but to dismiss the validity attacks by the respondents.
[46] The objection to the admissibility of this evidence is based on the fact that the section entitled “State of the art” in Dr. Ebers’ report consisted mostly of paragraphs found in Taro’s NOA dated May 3, 2018, a document he had never reviewed. As mentioned by the respondents during the trial, these are limited to quoting various extracts from the relevant prior art. There is no issue that all these papers were well-known to Dr. Ebers. In fact, the Federal Court noted that this witness dedicated much of his life to studying and documenting MS and treatments for the disease (FC Decision at para. 67).
[47] I agree with the appellants that an appellant is free to contest in the context of an appeal on the merits a trier of fact’s finding made during the course of a trial in respect of admissibility of evidence. But this does not mean that such a right can be used as an ambush to preclude the opposing party from their right to present their case. There is a minimum duty of due diligence on a party who wishes to bring an admissibility objection to ensure that it is squarely made and properly determined, especially when it intends to have this objection reviewed on appeal.
[48] There is also a minimum level of diligence that a court can expect from a party, especially a sophisticated one like the appellants, who is represented by experienced counsel, as to the timing of such an objection. Admissibility of evidence from a party’s sole expert can have a real prejudicial impact on the said party’s rights and the way that party’s counsel will conduct their cross-examination of other experts and construct their case.
[49] The Supreme Court of Canada has emphasized that admissibility of expert evidence should be scrutinized when the expert evidence is presented for acceptance to the Court so as to enable the trier of fact to exercise its role as a gatekeeper (see R. v. J.-L.J., 2000 SCC 51 at para. 28). To ensure this, the Federal Courts Rules S.O.R./98-106 (the Rules) provide that objections as to admissibility must be raised in writing and as soon as possible in the proceeding (see Rule 52.5). In this case, at the trial management conference, the trial judge expressly directed that all preliminary issues and motions be brought to his attention before February 26, 2020. These normally would include any remaining objections to the experts and their reports.
[50] Here, the duplication contained in Dr. Ebers’ report, on which the appellants’ argument rests, should have been clearly evident to them as soon as they received his report, which also included his Code of Conduct for Expert Witnesses certificate mandated by the Federal Courts Rules outlining his obligations as an expert witness. By the time the appellants mentioned their concerns to the Federal Court on the second day of their cross-examination of Dr. Ebers, they had spent some time preparing a document, highlighting in yellow all the duplicated paragraphs in the report and NOA.
[51] At the hearing before us, the appellants claimed that it was not evident to them that this duplication was a problem because they had wrongly assumed that Dr. Ebers was involved in the drafting of Taro’s NOA. They learned of their error in the course of Dr. Ebers’ cross-examination after he had been qualified as an expert. However, a simple inquiry with opposing counsel would have revealed if there was a need to contest the issue by way of a motion as was directed by the Federal Court during the trial management conference for this action.
[52] Instead, the appellants’ counsel came prepared to cross-examine Dr. Ebers with respect to this assumption (AB Vol. 32, at p. 9342-9343 of the transcript). Furthermore, after the first day of cross‑examination, they had time to consider bringing a motion to challenge the admissibility of the report before the trial resumed the next day. Instead of doing so they had a minimal exchange with Justice Manson:
MR. JUSTICE MANSON: Well, the fact it's there and the fact if you put that question to him, he is going to say whatever he says, and at the end of the day you're going to -- you are going to tell me it's verbatim what was in the Notice of Allegation, and then your point is made, I mean. And I will take whatever weight and whatever I want to give to that in terms of your question about impartiality. I get your point.
MR.
(Ebers cross, AB Vol. 32, Tab 79, p. 9383)
….
MR. NORMAN: And this goes to admissibility as well. So I'm not sure if you want us to do a motion beforehand or not.
MR. JUSTICE MANSON: It's not going to go to admissibility. It's going to go to weight.
MR. NORMAN: Okay.
(Ebers cross, AB Vol. 32, Tab 79, p. 9385)
[53] According to the appellants, they considered this exchange to be a final ruling on the admissibility of the report. The respondents submit that the appellants in fact simply chose to abandon the point. As noted, by the time the appellants decided to raise the issue, Dr. Ebers had not only been admitted on consent as an expert but his report also had been accepted into the evidentiary record. When the matter was raised, Dr. Ebers was under cross-examination (and was about two thirds of the way through the second day of questioning) on quite a few issues and a lot of the prior art on which the appellants now rely to argue that the Federal Court did not adopt the mantle of the POSITA. That portion of their cross-examination also clearly indicates that Dr. Ebers was very knowledgeable and well informed about the literature dealing with MS and all clinical trials and studies relating thereto.
[54] During their closing arguments before the Federal Court (AB Vol. 33, at p. 9804), the appellants took the position that Dr. Ebers’ report should be given little weight. I reproduce this passage because it indicates that they also appear to have made another strategic decision.
… So we submit that the Ebers’ report should be given little weight. But what does it mean?
And I want to be fair to my friends. We do not take issue with paragraphs 1 to 94. That’s the section Justice Manson, right before the state of the art section. We have a concern with duplication. That’s not to say that we agree with it. … But we are not suggesting that 1 to 94 was improperly tainted based on what we have. … So we suggest that little weight or extreme caution should be used in reviewing the state of the art section of Dr. Ebers’ report and the portion thereof. And one of the consequence of this … is that it caused Dr. Ebers’ report to become a product of hindsight.
[55] This, in effect, is what the Federal Court ended up doing as it gave little weight to much of the evidence of Dr. Ebers in respect of the prior art and obviousness. But it did accept and refer to some of his evidence in respect of the common general knowledge (CGK) and claim construction (contained in paragraphs 1-94 of his report). In such circumstances, should this Court now intervene because the appellants argue that it was an error of law not to dismiss the report on the basis that it was not impartial based on the principles set out by the Supreme Court in White Burgess Langille Inman v. Abbott and Haliburton Co., 2015 SCC 23 (White Burgess), a Supreme Court of Canada case that the Federal Court considered and referred to in its decision in order to issue a general warning to the IP bar regarding an expert witness’ duty of impartiality and independence owed to the Court? I think not.
[56] First, I do not consider the exchange referred to above as a final decision on admissibility. Asking whether one should bring a motion is not the same as asking for a ruling on one’s objection. When counsel have an issue with impartiality or independence, it is incumbent upon them at that point to clearly raise an objection and present their argument. A trier of fact should not be presumed to have made a final decision on an objection when it did not even have the opportunity to review the NOA or hear submissions on the objection.
[57] Second, I am satisfied that the Federal Court was alert and alive to the principles enunciated in White Burgess despite the appellants’ position in their closing submissions. It did note that the duplication raised an issue about this expert’s report impartiality, and it is implicit from paragraphs 70-71 of its reasons that, in this case, the Federal Court did not find it appropriate to strike out the report on that basis. There is no an error of law in this finding; the Federal Court exercised its gatekeeping role as best as it could in the particular circumstances. I also have not been persuaded that it made a palpable and overriding error in not striking out the report considering the type of information that was copied in its proper context.
[58] There was no doubt that the Federal Court was satisfied that Dr. Ebers was entirely aware of all the prior art listed before referring to it in his report. The part of the report that mirrors the NOA essentially consists of citations of various passages from documents attached to his report. It would not have made a meaningful difference if he had acknowledged in his report that the passages he cited were those reproduced in the NOA because he was satisfied that they were relevant. He certainly said so during his testimony. There are paragraphs in this section of the report that were clearly added to reflect Dr. Ebers’ personal knowledge, see for example paragraphs 159-165. Thus, t