2022 FC, 2022 FC 1734

Date: 20221214 Docket: T-1007-20 Citation: 2022 FC 1734 Ottawa, Ontario, December 14, 2022 PRESENT: Madam Justice Pallotta BETWEEN: MEDEXUS PHARMACEUTICALS INC., MEDEXUS INC. AND MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH Plaintiffs (Defendants by Counterclaim) and ACCORD HEALTHCARE INC. AND INTAS PHARMACEUTICALS LTD. Defendants (Plaintiffs by Counterclaim) ORDER AND REASONS [ 1 ] The defendants, Accord Healthcare Inc and Intas Pharmaceuticals Ltd, seek leave to file an October 2022 expert report of Dr.

Peter Rue as proposed reply evidence (Rue Reply) in a patent action scheduled for trial commencing January 9, 2023. They submit the Rue Reply is proper and admissible reply evidence because it responds to a new and unexpected literature reference, put forward for the first time in a September 2022 expert report of Dr. Patrick J.

Sinko (Sinko Report) that was tendered on behalf of the plaintiffs. [ 2 ] In the underlying action, the plaintiffs allege that the defendants’ pre-filled syringe products containing methotrexate infringe certain claims of Canadian Patent No 2,659,662 (662 Patent), including claims 3 and 20. The defendants allege these claims are invalid.

They seek leave to file the Rue Reply to support one of their asserted grounds of invalidity, namely that the claim language " “wherein the methotrexate is present at a concentration of about 50 mg/ml” " renders claims 3 and 20 ambiguous as to the methotrexate concentrations falling within their scope.

The parties’ expert witnesses disagree on whether " “about” " is ambiguous from the perspective of a person of ordinary skill in the field to which the 662 Patent relates, at the material time. [ 3 ] The defendants bear the burden of establishing invalidity, and their proposed evidence in chief includes an opinion of Dr. Rue as set out in his June 2022 report (Rue Report).

The Rue Report opines that the skilled person would be unable to give meaning to the term " “about 50 mg/ml” " in relation to methotrexate concentrations, and therefore would have no precise understanding of the boundary for the term in claims 3 and 20 of the 662 Patent. In response, the plaintiffs rely on the Sinko Report, which opines that the skilled person would understand the term " “about” " , and claims 3 and 20 are not ambiguous.

The Sinko Report further states that, to the extent the skilled person would need to seek clarification of the scope of " “about” " , they would simply look to a reference text such as the United States Pharmacopeia (USP) to confirm the appropriate range. The 2006 edition of the USP defines " “about” " as indicating a quantity within 10% of the specified weight or volume. [ 4 ] The defendants argue they should be permitted to reply to Dr. Sinko’s further points by way of the Rue Reply.

They submit the Rue Reply offers the Court important scientific context that explains how the USP would be understood by the skilled person. It is a short, focused, six-page report addressing a point that could not have been anticipated and addressed in chief because the USP was not previously in issue—the USP was not pleaded, asserted as prior art, cited in the 662 Patent, or mentioned in any previous expert report.

The defendants submit that if the Rue Reply is admitted, minimal trial time will be needed to address this additional evidence and there will be no prejudice to the plaintiffs that cannot be compensated in costs. [ 5 ] The plaintiffs argue the Rue Reply is improper as it does not meet the narrow circumstances for admitting reply evidence. They state the defendants and Dr. Rue were required to put their best foot forward with their evidence in chief, and now seek to split their case and bolster the Rue Report under the guise of reply evidence. According to the plaintiffs, the defendants have mischaracterized Dr.

Sinko’s evidence responding to the allegation that certain claims are invalid for ambiguity, and the Sinko Report does not raise a new issue requiring reply. Dr. Sinko disagrees with Dr. Rue’s conclusion on ambiguity even without reference to outside sources, and Dr. Sinko did not raise a new issue by explaining why the skilled person would understand " “about” " and providing an example of a scientific text that defines the term. Dr. Sinko’s evidence simply shows that Dr.

Rue is wrong when he says a skilled formulator would not understand the meaning of " “about” " and there is no scientific definition of " “about” " . In addition, the plaintiffs argue the defendants failed to establish that the issues addressed in the Rue Reply could not have been anticipated—the Rue Reply does not state the issues were unanticipated, and the defendants have not provided other evidence to meet this requirement. Finally, the plaintiffs submit they will be prejudiced by the admission of the Rue Reply because it would allow the defendants to introduce evidence to contradict Dr.

Sinko’s opinion, without having to put the evidence to him on cross-examination and give him a chance to explain. [ 6 ] The parties agree that the core principles governing the admissibility of reply evidence are set out in Halford v Seed Hawk Inc , 2003 FCT 141 at paragraphs 15-16 [ Halford ]: 1 . Evidence which is simply confirmatory of evidence already before the Court is not to be allowed.

2 . Evidence which is directed to a matter raised for the first time in cross-examination and which ought to have been part of the plaintiff’s case in chief is not to be allowed.Any other new matter relevant to a matter in issue, and not simply for the purpose of contradicting a defence witness, may be allowed. 3 . Evidence which is simply a rebuttal of evidence led as part of the defence case and which could have been led in chief is not to be admitted. 4 .

Evidence which is excluded because it should have been led as part of the plaintiff’s case in chief will be examined to determine if it should be admitted in the exercise of the Court’s discretion. [ 7 ] The principles in Halford apply to reply expert reports in patent cases: Janssen Inc v Teva Canada Ltd , 2019 FC 1309 at paras 16-17 , citing Dow Chemical Co v NOVA Chemicals Corp , 2014 FC 844 at paras 5-8 of

Schedule A; see also T-Rex Property AB v Pattison Outdoor Advertising Limited Partnership , 2022 FC 1008 at para 34 . [ 8 ] Reply evidence should not be allowed to spread beyond what is needed to achieve its purpose.

Rules limiting the scope of reply evidence foster the goals of trial fairness and efficiency by ensuring that the defendant knows the case to meet, and by avoiding an endless alternation in adducing evidence: Bauer Hockey Ltd v Sports Maska Inc dba CCM Hockey , 2020 FC 212 at para 13 [ Bauer ], citing Amgen Canada Inc v Apotex Inc , 2016 FCA 121 at para 12 . [ 9 ] For the reasons below, I find that paragraphs 5, 9, the second sentence of paragraph 12, paragraphs 13-15 (together with the associated footnotes, and schedules A-F), the second and third sentences of paragraph 23, and paragraphs 24-25 of the Rue Reply are inadmissible, as they are not proper reply.

Apart from those paragraphs, the Rue Reply is proper reply evidence. [ 10 ] The plaintiffs rely on Bauer at paragraph 21 to argue that the defendants cannot meet their burden without evidence that Dr. Rue could not have anticipated the issues he addressed in reply, and the motion should be dismissed on this basis alone. However, the Court in Bauer did not reject reply evidence on this basis. The Court examined the evidence of the opposing party’s expert and found it was " “entirely foreseeable” " .

The reply evidence was found to be improper because it sought to reinforce evidence given in chief, or to introduce evidence that was not responding to unanticipated evidence. The Court added that, contrary to the usual practice with respect to reply reports, the expert tendering proposed reply evidence did not state which opinions, if any, he could not have anticipated: Bauer at paras 21-22 . I would note that the Rue Reply is not silent in this regard, as Dr. Rue states it is " “surprising” " that Dr.

Sinko would refer to the passage from the USP. [ 11 ] The Court must determine whether reply evidence could have been anticipated based on an objective analysis; an expert’s assertion that he or she could not have anticipated an approach or argument may be of marginal value: Merck-Frosst v Canada (Health) , 2009 FC 914 at paras 17-18 [ Merck-Frosst ], citing Astrazeneca Canada Inc et al v Novopharm Limited et al , 2009 FC 902 . The defendants’ failure to file evidence attesting that they or Dr. Rue did not anticipate Dr. Sinko’s points is not fatal to this motion. [ 12 ] The plaintiffs submit that Dr.

Sinko’s evidence about the USP was in direct response to an issue that Dr. Rue raised, and furthermore, it was not Dr. Sinko’s primary opinion on ambiguity. According to the plaintiffs, allowing a right of reply every time an expert refers to a new literature reference would give rise to an endless cycle. [ 13 ] While I accept that the defendants would have expected a response to Dr. Rue’s opinion that there is no specific scientific meaning of the word " “about” " , I find the defendants could not have reasonably anticipated Dr.

Sinko’s opinion that the skilled person would rely upon the USP to construe the 662 Patent claims, and in particular, to clarify the scope of the term " “about” " in claims 3 and 20. I do not make this finding merely because Dr. Sinko relies on a new reference; however, Dr. Sinko’s reliance on a reference the defendants say was not pleaded, asserted as prior art, identified as part of the skilled person’s common general knowledge, cited in the 662 Patent, or mentioned in any previous expert report, is a relevant consideration.

I am satisfied that the admitted parts of the Rue Reply respond to an issue that could not have been reasonably anticipated, even if Dr. Sinko’s opinion is offered as a secondary or alternative opinion. [ 14 ] In any event, the Court has discretion to admit evidence that may not be the proper subject of reply, and may consider factors such as whether admitting the further evidence would serve the interests of justice, assist the Court in making a determination on the merits, or cause substantial prejudice to the other party: Solvay Pharma Inc v Apotex Inc , 2007 FC 913 at paras 9-12 .

The Court may weigh the relevant factors differently on a case-by-case basis: Ibid . Requiring an expert to address every possible anticipated issue can be burdensome and inefficient: Merck Sharp & Dohme Corp v Wyeth LLC , 2020 FC 1087 at para 21 ; Merck-Frosst at para 30 . Admitting Dr.

Rue’s reply opinion on whether the skilled person would reference the USP would be in the interests of justice, and it would assist the Court in making a determination on the merits. [ 15 ] I am not persuaded by the plaintiffs’ argument that admitting the evidence fails to advance the interests of justice because it " “denies the Court Dr. Sinko’s response to the challenges to his evidence” " .

In essence, this is a complaint about which party’s expert will have the last word, which is not the purpose of reply. [ 16 ] The plaintiffs also argue they will be significantly prejudiced because admitting reply allows the defendants to avoid putting contradictory evidence to Dr. Sinko on cross-examination, depriving him of the chance to explain. As I understand this argument, it is that the plaintiffs will be prejudiced because the contradictory evidence is already admitted, and the rule in Brown v Dunn does not apply.

The rule in Brown v Dunn is a principle of fairness that applies when a party intends to impeach the credibility of a witness by adducing evidence that contradicts their testimony. I fail to see how the reply evidence seeks to impeach Dr. Sinko’s credibility with contradictory evidence—if anything, it is Dr. Sinko who has introduced the USP to show that Dr. Rue is wrong. Dr.

Sinko had the opportunity to explain his position on the USP reference introduced in the Sinko Report. [ 17 ] I agree with the plaintiffs that the Rue Reply is not short, when considered relative to the paragraphs that were devoted to ambiguity in the Rue Report in chief. However, the Rue Reply only responds to Dr. Sinko’s opinion on ambiguity, and does not address any other issues in the Sinko Report. Provided that the Rue Reply is limited to addressing the USP issue, I agree with the defendants that this issue is focussed and would take minimal trial time.

In my view, any prejudice to the plaintiffs does not outbalance the discretionary factors that favour the admission of this limited reply evidence.

[ 18 ] I find that paragraphs 4, 10, 11, the first sentence of paragraph 12, paragraphs 16-22 and the first sentence of paragraph 23 of the Rue Reply address the USP issue. In my view, they are proper reply evidence. These paragraphs provide Dr. Rue’s opinion on the scientific context for the term " “about” " as used in the USP, from the perspective of the skilled person, and explain why the skilled person would not rely on the USP to confirm the appropriate concentration range for " “about 50 mg/ml” " in claims 3 and 20 of the 662 Patent. Paragraphs 1-3 of the Rue Reply provide the instructions followed by Dr.

Rue, his agreement to be bound by the Code of Conduct for Expert Witnesses , and a reference to Dr. Rue’s qualifications and experience found in the Rue Report. Similarly, paragraphs 6-8 state information and instructions Dr. Rue was given and assumptions he was asked to make.

Paragraphs 1-3 and 6-8 are admissible as they provide necessary context for the substantive opinion contained in the paragraphs noted above, which I have found to be proper reply. [ 19 ] Paragraphs 5, 9, the second sentence of paragraph 12, paragraphs 13-15, the second and third sentences of paragraph 23, and paragraphs 24-25 of the Rue Reply do not meet the requirements for admissibility. Furthermore, I am not satisfied these paragraphs should be admitted pursuant to the Court’s residual discretion.

As the footnotes and schedules to the Rue Reply relate to inadmissible paragraphs, they are also inadmissible. [ 20 ] Paragraphs 5 and 9 of the Rue Reply constitute general statements of disagreement with Dr. Sinko’s opinion and his construction of the term " “about” " . Disagreements may be explored during cross-examination or highlighted in argument: Bauer at para 16 .

These paragraphs are not proper reply. [ 21 ] The second sentence of paragraph 12 and paragraphs 13-15 of the Rue Reply go beyond the USP issue to provide additional evidence of reference texts that lack a definition for " “about” " , or that have a different definition than the USP, all in support of Dr. Rue’s opinion that there is no precise definition of " “about” " . The defendants argue that aside from one reference, the other texts were referenced in the Rue Report.

In my view, this does not change the fact that reply evidence should not spread beyond what is needed to achieve its limited purpose: Bauer at para 13 . The second and third sentences of paragraph 23 relate to Dr. Rue’s opinion on the skilled person’s understanding of " “about 50 mg/ml” " in the context of the 662 Patent. In my view, all of these paragraphs are confirmatory of or supplemental to the evidence about the skilled person’s common general knowledge and

interpretation of claim terms provided the Rue Report in chief, and they are not proper reply evidence. [ 22 ] The evidence in paragraphs 24-25 of the Rue Reply do not respond to the USP issue. Paragraph 24 provides Dr. Rue’s opinion on the ambiguity of the term " “about” " with reference to a concentration range of +/- 10%. While I appreciate that " “within 10%” " is the range indicated in the USP, the opinion provided in paragraph 24 addresses the inventor’s use of finite concentration ranges in the 662 Patent. Dr.

Rue opines that the inventor’s use of finite concentration ranges in other claims of the 662 Patent indicate that the inventor did not intend the word " “about” " to denote a range of +/- 10% (that is, a finite concentration range) in claims 3 and 20. In paragraph 25, Dr. Rue seeks to counter Dr. Sinko’s statements pointing out that " “state of the art” " documents Dr. Rue relied on in chief, including an allegedly anticipatory patent, use the term " “about” " to describe a concentration range.

In my view, paragraphs 24-25 of the Rue Reply supplement points of claim construction and alleged ambiguity that were addressed or could have been addressed in the Rue Report. Paragraphs 24-25 are not proper reply. [ 23 ] Each party has requested costs if successful. In view of the divided success, I decline to make an award of costs of the motion. ORDER in T-1007-20 THIS COURT ORDERS that : 1 . The defendants are granted leave to file the proposed Rue Reply, limited to paragraphs 1-4, 6-8, 10-11, the first sentence of paragraph 12, paragraphs 16-22 and the first sentence of paragraph 23. 2 .

No costs are awarded. "Christine M. Pallotta" Judge FEDERAL COURT SOLICITORS OF RECORD DOCKET: T-1007-20 STYLE OF CAUSE: MEDEXUS PHARMACEUTICALS INC., MEDEXUS INC. AND MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH v ACCORD HEALTHCARE INC. AND INTAS PHARMACEUTICALS LTD. PLACE OF HEARING: Toronto, Ontario

DATE OF HEARING: November 22, 2022 ORDER AND REASONS: PALLOTTA J. DATED: December 14, 2022 APPEARANCES : Sean Jackson Dylan Churchill For The Plaintiffs (DEFENDANTS BY COUNTERCLAIM) Justin Kearsley-Ho Nisha Anand For The Defendants (PLAINTIFFS BY COUNTERCLAIM) SOLICITORS OF RECORD : Blakes Cassels & Graydon LLP Barristers and Solicitors Toronto, Ontario For The Plaintiffs (DEFENDANTS BY COUNTERCLAIM) Gilbert's LLP Barristers and Solicitors Toronto, Ontario For The Defendants (PLAINTIFFS BY COUNTERCLAIM)