2021 FC, 2021 FC 1456

Date: 20211221 Docket: T-419-20 Citation: 2021 FC 1456 Toronto, Ontario, December 21, 2021 PRESENT: The Honourable Madam Justice Furlanetto BETWEEN: MERCK SHARPE & DOHME CORP., AND MERCK CANADA INC. Plaintiffs and PHARMASCIENCE INC. Defendant ORDER AND REASONS [ 1 ] This is a motion for reply evidence relating to an action under section 6(1) of the Patented Medicines (Notice of Compliance) Regulations , SOR/93-133 [ PMNOC Regulations ]. The sole patent that remains at issue is Canadian Patent No. 2,529,400 [400 Patent], which is listed on the Patent Register in association with JANUVIA® (sitagliptin).

The issues for trial include obviousness and insufficiency of disclosure. [ 2 ] The Defendant Pharmascience Inc. [PMS] seeks leave to file the following three reply expert reports from experts who provided reports in chief: the reply report of Dr. Vassil I. Elitzin [Elitzin Reply]; the reply report of Dr. Changquan Calvin Sun [Sun Reply]; and the reply report of Dr. James E. Foley [Foley Reply]. The reports seek to reply to responding evidence filed by the Plaintiffs’ experts: Dr. James Wuest [Wuest Report]; Dr. Jerry Atwood [Atwood Report]; Dr. Martyn C. Davies [Davies Report]; Dr. William R.

Roush [Roush Report]; and Dr. Richard Z. Lewanczuk [Lewanczuk Report]. [ 3 ] The principles governing the admissibility of reply evidence are not in dispute and can be summarized as follows: 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; and 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 trial judge’s discretion. (Janssen Inc v Teva Canada Limited , 2019 FC 1309 [Janssen] at para 16 , citing Halford v Seed Hawk Inc. , 2003 FCT 141 at para 15 ) [ 4 ] The purpose of reply evidence is to respond to issues arising from the opposing party’s evidence that were not raised in the plaintiff’s case in chief ( Janssen at para 13). Reply evidence is not a vehicle to bolster a party’s evidence.

A party is required to put their best foot forward at first instance and should not be allowed to make up for their failure to do so in a reply. Mere disagreement with statements made by another witness is not proper subject matter for reply evidence and can be addressed by cross-examination ( Janssen at para 17). Similarly, a party cannot split its case by adducing evidence on reply that is merely confirmatory of its case in chief ( Amgen Canada Inc v Apotex Inc , 2016 FCA 121 at para 12 ).

The general rule against case-splitting applies to promote the goals of trial fairness and efficiency, by ensuring that the responding party knows the case it has to meet and avoids an endless alternation between the parties in adducing evidence ( Bauer Hockey Limited v Sport Maska Inc , 2020 FC 212 [ Bauer ] at para 13 ). [ 5 ] The Court will also consider whether the proposed reply: will serve the interests of justice; will assist the Court to adjudicate an issue on the merits; will not cause serious prejudice to the other side; and, was available and/or could not be anticipated as being relevant at an earlier stage of the proceeding ( Swist v Meg Energy Corp , 2020 FC 759 [ Swist ] at para 10 , citing Merck-Frosst-Schering Pharma GP v Canada (Minister of Health) , 2009 FC 914 at para 10 ).

The Court has discretion to weigh these factors on a case-by-case basis (see for example, Bauer at paragraph 29 ). [ 6 ] PMS asserts that much of its proposed reply is seeking to address the position that the act of selecting sitagliptin from the world of dipeptidyl peptidase – IV [DP-IV] inhibitors is the starting point of the obviousness analysis for the 400 Patent. It contends that this was only made known through the Plaintiffs’ responding expert reports. It argues that the proposed reply reports are narrowly focussed and set out important points of difference that deal with the

interpretation of scientific issues, which will be of assistance to the Court. It contends that identification of these points of difference cannot be effectively achieved through cross-examination. [ 7 ] The Plaintiffs assert that the opposed portions of the reply evidence contain mere statements of disagreement, critiques of critiques, or re-address issues and repeat opinions given by the experts in chief. The Plaintiffs take issue with the assertion that there were unanticipated positions or documents presented.

They assert that the reply reports are prejudicial because they constitute case splitting. [ 8 ] As set out further below, I find some of the opposed paragraphs to be appropriate reply while other paragraphs are not.

A. Elitzin Reply [ 9 ] The Plaintiffs consent to paragraphs 1-5, 22-24 and 30-41 of the proposed Elitzin Reply with paragraphs 6-20 and 25-29 remaining in dispute. [ 10 ] Paragraphs 6-9 seek to reply to paragraphs 30 and 88 of the Wuest Report in which Dr. Wuest opines that a medicinal chemist would be included in the definition of the person of ordinary skill in the art [POSITA]. PMS asserts that this opinion was unanticipated because it did not expect Dr. Wuest to include the selection of a DP-IV inhibitor as the starting point for his obviousness analysis.

PMS contends that the selection of sitagliptin as a DP-IV inhibitor is not the focus of the 400 Patent, but rather the subject matter of another of Merck’s patents – Canadian Patent No. 2,450,740 [740 Patent]. PMS asserts that it is necessary for the Court to have positive evidence on this issue so that it understands why this is not the starting point, rather than relying solely on negative evidence that may be obtained through cross-examination. [ 11 ] The Plaintiffs assert that paragraphs 6-9 provide mere statements of disagreement with the opinions of Dr.

Wuest and that allowing these paragraphs would amount to improper case splitting. The Plaintiffs rely on the decision in Paid Search Engine Tools v Google , 2021 FC 587 [ Paid Search Engine ] at paragraphs 20-26 as support for their position. In Paid Search Engine , the Court did not permit certain reply evidence which sought to respond to an opinion on the qualifications of the POSITA on the basis that it amounted to a disagreement amongst experts that could be dealt with in cross-examination or in argument. [ 12 ] In this case, I arrive at a similar conclusion. Dr.

Elitzin has already substantively addressed the qualifications of the POSITA in his expert report in chief as well as his views on the teachings of the 400 Patent. He has already opined that sitagliptin was a known DP-IV inhibitor that was disclosed in WO 498. As set out below, in Dr. Elitzin’s description of the WO 498 Patent, he provides his view that the 400 Patent presumes that the POSITA has chosen to investigate sitagliptin. In my view, reply paragraphs 6-9 are simply an extension of these earlier opinions: 122. Other compounds are set out in the WO 498 Patent.

The reason the 400 Patent explores sitagliptin, as opposed to any of those other compounds, is not explained. In fact, not a single comparison even appears in the 400 Patent between sitagliptin and another compound from the WO 498 Patent. The 400 Patent presumes that the PSA has chosen to investigate sitagliptin and draw its comparisons to the prior disclosure of sitagliptin in the WO 498 Patent. Those are the comparisons to which the 400 Patent is directed. [ 13 ] While Dr.

Elitzin does not expressly state in his report in chief that the POSITA does not include a medicinal chemist, this is understood by the omission of a medicinal chemist from Dr. Elitzin’s definition. It is understood that his definition of the POSITA arises from his opinion on the teachings of the 400 Patent. The specific comments now proposed reiterate earlier views and amount to statements of disagreement with Dr. Wuest’s opinion.

The comments made in paragraphs 6-9 can effectively be dealt with on cross- examination and in argument, and the objection to these paragraphs will stand. [ 14 ] With the exception of paragraph 110 of the Atwood Report (which I understand from the Defendant’s written submissions should be a reference to paragraph 110 of the Wuest Report instead), paragraphs 10-19 of the proposed Elitzin Reply do not identify specific paragraphs from which it seeks to respond, instead referring generally to statements made by Drs.

Wuest, Atwood and Davies that the disclosure of the free base and hydrochloride salt of sitagliptin in prior art document WO 498 would have dissuaded further research. PMS argues that this opinion is unexpected and that the Court would benefit from Dr. Elitzin’s views as to why the free base and hydrochloride salt are the starting point for the analysis and not the end point. The Plaintiffs assert that the subject paragraphs are repetitious of opinions given in chief, providing additional support and offering critiques of critiques.

As the POSITA’s proposed course of action was known to be in issue, the Plaintiffs assert that the subject paragraphs also amount to case splitting and an attempt to supplement the evidence. I agree. [ 15 ] WO 498 and the prior disclosure of the free base and hydrochloride salt of sitagliptin were discussed in Dr. Elitzin’s expert report in chief and identified as the starting point for the 400 Patent. Dr. Elitzin comments extensively on the steps a POSITA would take during drug development, including with salt screening and how this would be applied by the POSITA who has knowledge of WO 498. Dr.

Elitzin specifically addresses the formation and consideration of phosphate salts. [ 16 ] The subject-matter of paragraphs 10-19 cover this same ground and are extensions of opinions already given or statements of disagreement with the asserted opinion of the Plaintiffs’ experts. Indeed, proposed paragraph 17, for example, expressly states that it is a disagreement with the Plaintiffs’ expert. To allow Dr. Elitzin’s further comments on hydrochloride salts and phosphate salts would in my opinion, be impermissible case splitting. These matters can be addressed through cross-examination of Dr.

Wuest. [ 17 ] Paragraphs 20-21 of the Elitzin Reply seek to respond to paragraphs 114-116 of Dr. Wuest’s report and his comments that WO 498 " “teaches away” " from the process of claim 19 of the 400 Patent. It is undisputed that WO 498 and claim 19 were already extensively discussed in Dr. Elitzin’s expert report in chief. In my view, the comments proposed to be introduced are statements of disagreement and are not proper reply. [ 18 ] At paragraphs 25-29 of the proposed Elitzin Reply, Dr. Elitzin refers to a new patent application, WO 2012/147092 [WO 092], introduced by Dr. Atwood in his report. Dr.

Elitzin does not seek to provide comments on WO 092, rather he seeks to introduce an International Report on Patentability for the corresponding PCT application to WO 092 [the Report] and to highlight certain statements made by the Examiner in the Report on the common general knowledge, the lack of an inventive step of the claims of the PCT application, and as to WO 498 being the closest prior art. [ 19 ] PMS asserts that the introduction of WO 092 opened the door to the admissibility of the Report and any criticism of Dr. Elitzin’s comments can be dealt with on cross-examination.

The Plaintiffs assert that the commentary made by Dr. Elitzin is not responsive to Dr. Atwood’s opinion, is not relevant to the 400 Patent or the issues in this proceeding, and would not be of assistance to the Court. They further assert that the reliance on the Examiner’s comments in the Report is hearsay and constitutes oath-helping.

[ 20 ] I agree that the introduction of WO 092 cannot be used as a springboard for Dr. Elitzin to introduce documents that are not relevant to the proceeding. The Court must consider the relevance of the proposed reply to the issues in dispute and whether the admission of the reply will unduly complicate the proceedings. In this case, I do not see how the comments of an Examiner during prosecution of an unrelated foreign application made some nine years after the relevant date for obviousness could be relevant to the issues in dispute. Dr.

Elitzin seems to be seeking to introduce the statements from the Report as confirmation of his opinions. I fail to see how these comments, which are made after the relevant date, could achieve this purpose. In my view, the Report has little if any relevance and its introduction through Dr. Elitzin’s report would unnecessarily complicate the proceeding. [ 21 ] I note that PMS asserts that it will be seeking to file a certified copy of the WO 092 application, which presumably will include the Report.

The comments made here are not intended to be a finding on the admissibility of that certified copy of which no arguments are before me. B. The Proposed Sun Reply [ 22 ] The Plaintiffs consent to paragraphs 1-4, 25, and the first three sentences of paragraph 26 of the proposed Sun Reply, with paragraphs 5-24 and the last three sentences of paragraph 26 remaining in dispute. All paragraphs in dispute seek to reply to the Davies Report. [ 23 ] Paragraphs 5-19 seek to reply to paragraphs 24-26, 42-55, 64-72, 75 and 81 of the Davies Report in which Dr.

Davies relies on the Biopharmaceutics Classification System [BCS System] to support his opinion that sitagliptin dihydrogenphosphate monohydrate is " “highly soluble” " . In Dr. Sun’s report in chief he relied on the USP classification system to arrive at his opinion that sitagliptin dihydrogenphosphate monohydrate is a " “soluble” " drug. Dr. Sun suggests that reliance on the BCS System is unexpected as it is not mentioned in the 400 Patent.

The Plaintiffs assert that the BCS System has always been in play as it was referenced in the Remington text referred to in the notice of allegation served by PMS. [ 24 ] While it may be that Remington refers to the BCS System somewhere in its lengthy text, this does not in my view constitute putting the BCS System in play. I agree with PMS, Dr. Sun was not required to anticipate every document that might be cited by Dr. Davies when he provided his opinion in chief, particularly where it was not referred to in the pleadings or expressly identified in the patent in issue. In my view, the comments proposed by Dr.

Sun at paragraphs 7, 8 (first sentence), 9-15 and 17 on the BCS System are appropriate reply as they relate to a reference that was not previously discussed and which I accept was not anticipated by Dr. Sun. The comments made are relevant to the issues in dispute and are of assistance to the Court. I do not consider there to be any prejudice in allowing these paragraphs into the reply and any critique on this commentary can be addressed through cross-examination of Dr. Sun. I will maintain the objection, however, to paragraphs 5, 6, 8 (second sentence), 16, 18 and 19, which in my view is not appropriate reply.

Paragraphs 5, 6 and 8 (second sentence) merely recite Dr. Sun’s disagreement with Dr. Davies’ overall opinion and paragraphs 16, 18 and 19 extend beyond comments on the document and delve into subject-matter that can be addressed on cross-examination or in argument. [ 25 ] Paragraphs 20-24 of the proposed Sun Report seek to reply to two statements made by Dr. Davies. First, his statement that the skilled formulator would prefer to avoid hydrates because hydrates are typically less soluble than anhydrous forms and have slower dissolution rates.

Second, his related opinion at paragraph 80 that the most stable form of a drug typically has the lowest dissolution rate and that the POSITA would be surprised to find both high stability and high solubility in a sitagliptin dihydrogenphosphate monohydrate salt form. PMS asserts that Dr. Davies’ opinion was unexpected and was not previously addressed by Dr. Sun. It asserts that paragraphs 20-24 of the Sun Reply provide important technical information that will assist the Court in assessing this opinion.

The Plaintiffs assert that opinions on the common general knowledge of hydrates and on the solubility of the compounds covered by the 400 Patent were already discussed in Dr. Elitzin’s expert report in chief and as Dr. Sun was asked to comment on Dr. Elitzin’s report, were accepted by Dr. Sun without further comment. They assert that allowing further evidence now would be improper case splitting and that it is a further level of disagreement that should not be permitted. [ 26 ] I do not consider the paragraphs now proposed to be repetitive of earlier evidence given by Drs. Elitzin and Dr.

Sun and do not consider this to be an example of case splitting. Proposed reply paragraphs 20-24 are properly responsive to Dr. Davies’ evidence and provide important critiques on the opinion given, which are of assistance to the Court. In my view, these paragraphs are not prejudicial and can be challenged through cross-examination. They are appropriate reply and should be allowed. [ 27 ] Paragraph 26 of the Sun Reply clarifies a misinterpretation made by Dr. Davies of Dr. Sun’s comments on example 7 of WO 498. The Plaintiffs do not object to the first three sentences of this paragraph.

However, they assert that the last three sentences extend beyond clarification and seek to expand on Dr. Sun’s

interpretation of the 400 Patent and the starting point for the obviousness analysis. [ 28 ] As held in Bristol-Myers Squibb Canada Co v Pharamscience Inc , 2020 FC 897 [ BMS ] at paragraph 21 , an expert may clarify and restate some of their initial evidence in reply if the purpose for doing so is to clarify a mischaracterization of their evidence. [ 29 ] In my view, the last three sentences are a further explanation of the clarification Dr. Sun is seeking to make, and of the third sentence of paragraph 26.

As the Plaintiffs do not object to the third sentence of this paragraph, I see no basis or prejudice to the Plaintiffs allowing the last three sentences. C. The Proposed Foley Reply [ 30 ] The Plaintiffs consent to paragraphs 1-5 and 12-16 of the proposed Foley Reply with paragraphs 6-11 and 17-21 remaining in dispute. [ 31 ] PMS grouped paragraphs 6-11 of the Foley Reply with the last three sentences of paragraph 26 of the Sun Reply in its argument. Like paragraph 26 in the proposed Sun Reply, paragraphs 6-11 of the proposed Foley Reply seek to clarify a perceived mischaracterization of Dr.

Foley’s opinion which appears in the Roush Report. While the Plaintiffs assert that paragraphs 6-11 extend

beyond the clarification intended, in my view these paragraphs seek to explain the basis for the opinion given in Dr. Foley’s report in chief and why Dr. Roush has mischaracterized that opinion. I consider this to be appropriate reply on the principle set out in BMS . [ 32 ] Paragraphs 17-21 of the Foley Reply refer to paragraph 132 of the Lewanczuk Report and paragraph 134 of the Roush Report. PMS asserts that paragraphs 17-21 seek to correct a mischaracterization of Dr. Foley’s evidence made by Drs. Lewanczuk and Roush.

The Plaintiffs argue that these paragraphs go beyond a correction to the mischaracterization. [ 33 ] In my view, paragraphs 17-19 adequately addresses the proposed mischaracterization from Drs. Lewanczuk and Roush, but paragraph 20 extends beyond that clarification and Dr. Foley’s original opinion to restate the separate opinion that salt and polymorph screening was routine. The objection to paragraphs 20 and 21 will thus be maintained. D.

Proposal for Oral Sur-reply [ 34 ] The Plaintiffs submitted that if any of the objected to paragraphs were allowed, they should be permitted to respond to such reply evidence in their experts’ oral testimony. They refer to the decision in Bristol-Myers Squibb Canada Co v Apotex Inc , 2019 FC 1379 [ Apotex ] at paragraph 13 as support for their position. [ 35 ] I do not read Apotex as authority for the order requested by the Plaintiffs. In Apotex , a motion to introduce sur-reply evidence had been made and the Court was determining its admissibility.

I have no such motion for sur-reply evidence before me nor do I have any indication as to the further evidence that is proposed by the Plaintiffs’ experts. The Plaintiffs’ request cannot be properly entertained. E. Costs [ 36 ] As the outcome of the motion was of divided success, there shall be no award as to costs. ORDER IN T-419-20 THIS COURT ORDERS that : 1 . The Defendant is granted leave to serve and file the reply expert reports of Dr. Elitzin, Dr. Sun and Dr. Foley with the following paragraphs included: a . Dr. Elitzen: paragraphs 1-5, 22-24 and 30-41; b . Dr.

Sun: paragraphs 1-4, 7, 8(first sentence), 9-15, 17, 20-26 c . Dr. Foley: paragraphs 1-19 2 . There shall be no award as to costs. "Angela Furlanetto" Judge FEDERAL COURT SOLICITORS OF RECORD DOCKET: T-419-20 STYLE OF CAUSE: MERCK SHARPE & DOHME CORP., AND MERCK CANADA INC v PHARMASCIENCE INC. PLACE OF HEARING: heard by videoconference DATE OF HEARING: November 29, 2021 ORDER AND REASONS: FURLANETTO J.

DATED: DECember 21, 2021 APPEARANCES : David Tait James Holtom Sanjay Mendis For The Plaintiffs Kavita Ramamoorthy Kerry Andrusiak For The Defendant SOLICITORS OF RECORD : McCarthy Tétrault LLP Barristers and Solicitors Toronto, Ontario For The Plaintiffs Fineberg Ramamoothy LLP Barristers and Solicitors Toronto, Ontario For The Defendant