Toronto, Ontario, January 25, 2006
PRESENT: MADAM PROTHONOTARY MILCZYNSKI
BETWEEN:
ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
and
THE MINISTER OF HEALTH and PHARMASCIENCE INC.
Respondents
Issue and Summary
[1] Pharmascience has brought this motion pursuant to Rule 312 of the Federal Courts Rules.
Pharmascience seeks leave of the Court to file the affidavit of its proposed expert, Dr. Christopher T. Rhodes sworn September 29, 2005, which affidavit adopts the affidavit of Dr. Joseph B. Schwartz sworn May 16, 2005. Dr. Schwartz was Pharmascience's expert, but is unavailable for cross-examination due to serious illness. Pharmascience thus seeks to substitute Dr. Rhodes for Dr. Schwartz, and have Dr. Rhodes adopt the previously sworn affidavit as his own, be made available for cross-examination, and not serve and file any further evidence. For reasons below, leave is denied and the motion is dismissed, with leave, however to Pharmascience to seek further leave to file a replacement affidavit of an alternate expert in substitution for Dr. Schwartz.
Nature of the Proceeding
[2] Pharmascience served on the Applicants, Abbott Laboratories' and Abbott Laboratories Limited's ("Abbott"), its Notice of Allegation ("NOA") dated November 11, 2004. The NOA was in respect of Pharmascience's abbreviated new drug submission, regarding its 250 and 500 mg. clarithromycin tablets, which made reference to Abbott's 250 and 500 mg. clarithromycin tablets sold under the brand name Biaxin BID. Among other things, the NOA alleged that the patent listed in respect of Biaxin BID (the "614 Patent"), was invalid on the grounds of obviousness.
[3] In response, on December 23, 2004, Abbott commenced this notice of application under subsection 6(1) of the Patent Medicines (Notice of Compliance) Regulations (the "Regulations") for an order prohibiting the Minster of Health from issuing a notice of compliance to Pharmascience for its clarithromycin tablets.
[4] In addition to this proceeding, Pharmascience had also delivered an earlier NOA to Abbott regarding the same clarithromycin tablets and Biaxin BID, alleging Pharmascience's tablets did not infringe the 614 Patent. In response, Abbott commenced an application under subsection 6(1) of the Regulations, which is Court File No. T-10-04.
[5] Court File No. T-10-04 and the within proceeding are to be heard together.
[6] Evidence has been filed in this application by both Abbott and Pharmascience. Abbott filed its evidence in chief comprised of the affidavits of Dr. Stephen Byrn, Dr. Gordon L. Amidon, Ms. Sonia Attwell and Ms. Barbara Cole, all of whom have been cross-examined. Pharmascience filed its responding evidence comprised of the affidavits of Chris Gleave and Dr. Peter Rue, who have been cross-examined, and that of Dr. Schwartz, who cannot be cross-examined.
[7] As noted above, Pharmascience seeks to replace Dr. Schwartz with Dr. Rhodes. Abbott does not, in the circumstances, object to another expert adopting Dr. Schwartz's affidavit, but opposes Dr. Rhodes being that other expert, on the grounds that:
· Dr. Rhodes received confidential Abbott information relating to the issues that are in dispute in this proceeding;
· Dr. Rhodes received confidential Abbott information relating to similar issues in dispute in litigation in the United States;
· Dr. Rhodes was retained as an expert for Abbott in the U.S. proceeding; and
· Abbott would suffer prejudice if Dr. Rhodes is permitted to replace Dr. Schwartz.
Dr. Rhodes and the basis of Abbott's Objection
[8] Prior to receiving Pharmascience's NOA alleging the 614 Patent was invalid, (but after it received the Pharmascience NOA alleging non-infringement), Abbott received an NOA from another generic drug manufacturer, ratiopharm. In its NOA, ratiopharm alleged that it would not infringe the 614 Patent and that the 614 Patent was invalid because of obviousness. In response to ratiopharm's NOA, Abbott commenced an application under subsection 6(1) of the Regulations, which is Court File No. T-428-04, (the "ratiopharm proceeding").
[9] All of the allegations regarding invalidity of the 614 Patent and obviousness, including prior art references that are contained in the ratiopharm NOA are contained, with virtually identical wording, in the Pharmascience NOA.
[10] Abbott's counsel contacted Dr. Rhodes to determine whether he would assist Abbott in the ratiopharm proceeding. In his affidavit sworn, November 4, 2005, Mr. Marcus Klee, of counsel for Abbott, describes his discussions with Dr. Rhodes. Mr. Klee was not cross-examined on his affidavit and his evidence goes unchallenged. Mr. Klee states that he spoke to Dr. Rhodes and that at the outset of the telephone conversation, he advised Dr. Rhodes that the communications on the call were to be kept in strict confidence. They discussed:
· ratiopharm's allegations of invalidity of the patent on the basis of obviousness (which as noted above, are the same as that made by Pharmascience in its subsequent NOA);
· other matters and issues raised in the ratiopharm of Allegation;
· portions of the 614 Patent that Mr. Klee read out to Dr. Rhodes; and
· Abbott's legal theory of the case and litigation strategy.
[11] Mr. Klee and Dr. Rhodes also discussed the terms of Dr. Rhodes' retainer, fees and a confidentiality agreement. Dr. Rhodes signed the agreement, but also advised Mr. Klee in a voice mail that given his involvement in another case, on the "other side" of Abbott, he understood if there would be some difficulty or conflict in his participation for Abbott in the ratiopharm proceeding. Mr. Klee and Dr. Rhodes did not have any further discussions.
[12] In addition to being contacted in respect of the ratiopharm proceeding, Dr. Rhodes has had involvement on behalf of Abbott in proceedings in the United States. Abbott filed the affidavit of its U.S. counsel, Ted Dane, sworn November 4, 2005, setting out Dr. Rhodes' involvement in litigation relating to the extended release formulation of clarithromycin. Mr. Dane was also not cross-examined on his affidavit. He states that Dr. Rhodes not only participated in discussions concerning the matters in issue in that particular proceeding, but was also privy to confidential discussions regarding a whole host of issues surrounding clarithromycin, including confidential legal strategy to deal with the issues of claim construction, infringement and invalidity. Among the validity issues Mr. Danes states he discussed with Dr. Rhodes, was Abbott's potential defences to whether the U.S. clarithromycin patents were obvious.
[13] Abbott retained Dr. Rhodes for the U.S. case; and Dr. Rhodes executed a consultancy agreement, and an undertaking by which he agreed not to use any confidential information for any purposes other than for that proceeding.
[14] With respect to prejudice, Abbott also submits that it might have conducted its cross-examinations differently, given that a textbook edited by Dr. Rhodes was put to various deponents.
[15] For his part, Dr. Rhodes admits to not having the best recollection, and did not take notes of his discussions with respect to the ratiopharm proceeding and his retainer. He states in his affidavit that he did not receive or retain a copy of the 614 Patent or other documents or confidential information, but does not mention the telephone discussion with Mr. Klee. He also admits that he signed a retainer and confidentiality agreement for the ratiopharm proceeding, and in respect of the proceedings in the United States, and that neither agreement has been terminated.
[16] Pharmascience did not file any evidence other than the affidavit of Dr. Rhodes on this motion, and in particular, did not file any evidence addressing the number or availability of qualified experts to take the place of Dr. Schwartz, or evidence that the task of replacing Dr. Schwartz would be onerous or difficult without Dr. Rhodes. On the contrary, at the hearing of the motion, counsel for Pharmascience conceded that there were a number of other qualified experts. Rather than explore these other options and accommodate Abbott's objection, however, Pharmascience insists in this motion upon Dr. Rhodes.
Rule 312
[17] Pharmascience brings this motion pursuant to Rule 312 of the Federal Courts Rules, where with leave of the Court, a party may file additional affidavits to those provided for in Rules 306 and 307. Leave may be granted where the evidence will serve the interests of justice, assist the Court, and not cause prejudice to the other side. Further, in considering whether leave should be granted, the Court must consider the overall fairness of the request made by the moving party and whatever objections are raised by a responding party.
[18] While the disqualification of a proposed expert is not strictly the matter in issue on this motion, the considerations should be the same. The grounds upon which Abbott objects to Dr. Rhodes' substitution for Dr. Schwartz concern the former's conflict arising out of his receipt of confidential Abbott information and the resulting risk of prejudice to Abbott. Abbott submits that if Dr. Rhodes had been put forward as Pharmascience's expert initially, a motion would have been brought to have him disqualified.
[19] The proper approach to determine whether or not to an expert should be disqualified must consider the facts and surrounding circumstances of each case and:
· whether the expert knew he or she was receiving confidential information, with the expectation that the information would be maintained in confidence;
· the nature of the confidential information;
· the risk of the confidential information being disclosed;
· the risk of prejudice arising to either the party challenging the expert or to the party seeking to retain the challenged expert; and
· the interests of justice and public confidence in the judicial process.
[20] Accordingly, the principles require that the Court balance the interests of the party seeking to retain an expert witness and the party seeking to protect its confidential information. In that regard, counsel for Pharmascience raises the danger of expert witnesses being contacted simply to deprive an opposing party of their expertise. This danger was eloquently described by Lord Denning in Harmony Shipping Co SA v. Davis et al, [1979] 3 All ER 177 (C.A.):
If an expert could have his hands tied by being instructed by one side, it would be very easy for a rich client to consult each of the acknowledged experts in the field. Each expert might give an opinion adverse to the rich man, yet the rich man could say to each, "Your mouth is closed and you cannot give evidence in court against me"..... Does that mean that the other side is debarred from getting the help of any expert evidence because all the experts have been taken up by the other side? The answer is clearly No.... There is no property in an expert witness as to the fact he has observed and his own independent opinion of them. There being no such property in a witness, it is the duty of a witness to come to court and give his evidence in so far as he is directed by the judge to do so.
[21] In Labee v. Peters, [1996] A.J. No.809 (Alta. Q.B.), after reviewing a number of authorities, the Court set out the principles:
1. There is no property in a witness.
2. Even though a party has retained an expert and communicated privileged information to the expert, the expert may still be asked for an opinion by an opposing party and may call that expert at trial.
3. The expert may not, however, be questioned concerning any privileged material he received from the opposing solicitor nor shall he disclose any opinion he has given to the opposing counsel.
[22] This presents the difficulty in Dr. Rhodes's case. The evidence of both Mr. Klee and Mr. Dane is that Dr. Rhodes received sensitive and highly confidential Abbott information relating to Abbott's defence and litigation strategy and was involved in confidential discussions regarding these strategies with Abbott's counsel. These defences and strategies were with respect to the issues in the ratiopharm proceeding which are identical to those in this case - ratiopharm's allegations of invalidity of the patent on the basis of "obviousness". In the United States, where Dr. Rhodes' involvement with Abbott was over a longer period of time, there were discussions regarding Abbott's legal strategy dealing with claim construction, infringement and invalidity, including Abbott's potential defences to whether the U.S. clarithromycin patents were "obvious". Dr. Rhodes was advised from the outset that these discussions were confidential. By his own evidence, however, Dr. Rhodes cannot recall very much of the substance of these discussions. He signed agreements, nonetheless, to maintain the confidentiality of these discussions, both in Canada and in respect of the proceedings in the United States.
[23] The absence of recollection may also create a greater problem than clarity of memory. As acknowledged in Burgess (Litigation Guardian of) v. Wu (2003), 68 O.R. (3d)710 (S.C.), at p.729, it would be an impossible task to enforce a rule which permitted a person who had received confidential information to act for an opposing party if they said they did not remember the information. How would the court know or verify the lack of memory? At what stage of the proceeding? There is a risk also that the forgotten information could, in any event, have influence or be inadvertently disclosed.
[24] Finally, I note that there is no issue in this case that Abbott has set upon a deliberate course of action to tie up qualified experts so as to make them unavailable to Pharmascience in this proceeding. There is also no issue that Pharmascience is unable to find or retain other qualified experts. Counsel for Pharmascience readily acknowledged that Dr. Rhodes is not the only expert as qualified as Dr. Schwartz, and that there are other individuals Pharmascience may retain.
[25] Consequently, I find that Dr. Rhodes was advised at the time he engaged in discussions with Abbott's counsel in Canada about the ratiopharm proceeding that he was in receipt of confidential information, and that similarly he knew he received confidential information in the context of proceedings in the United States. Dr. Rhodes agreed, in writing, to keep this information confidential. The nature of the information Dr. Rhodes received both in Canada and in the United States was confidential solitictor-client information regarding litigation strategy and legal defences to claims of invalidity of the Abbott's patent on the grounds of "obviousness" - the very issue in this proceeding involving Pharmascience. There is a risk that this information may be disclosed or otherwise utilized by Dr. Rhodes in this proceeding given his lack of recollection. Finally, weighing the risk of prejudice as between the parties, given that there is no evidence that Pharmascience is in any way prevented or hampered in preparing its case without Dr. Rhodes, and there is prejudice to Abbott in the event confidential information is disclosed, the motion must be dismissed.
ORDER
THIS COURT ORDERS that
1. The motion is dismissed with leave to Pharmascience to seek further leave pursuant to Rule 312 of the Federal Courts Rules to file an affidavit that adopts that of Dr. Schwartz.
2. In the event the parties cannot agree as to costs of this motion, they may file written submissions regarding costs, no longer than three pages in length, within twenty days of the date of this Order.
"Martha Milczynski"
FEDERAL COURT
Names of Counsel and Solicitors of Record
DOCKET: T-2267-04
STYLE OF CAUSE: ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Applicants
and
THE MINISTER OF HEALTH and PHARMASCIENCE INC.
Respondents
DATE OF HEARING: November 17, 2005
PLACE OF HEARING: Toronto, Ontario
REASONS FOR ORDER
AND ORDER BY: Milczynski P.
APPEARANCES BY:
Steven Mason
Aaron Swachuk For the Applicants
Carol Hitchman
Mala Joshi For the Respondent
SOLICITORS OF RECORD:
McCarthy Tétrault
Barristers and Solicitors
Toronto, Ontario For the Applicants
Hitchman & Sprigings
Barrristers and Solicitors
Toronto, Ontario For the Respondent