Toronto, Ontario, October 6, 2005
PRESENT: MADAM PROTHONOTARY MILCZYNSKI
APPLICATION UNDER Section 55.2 of the Patent Act, Section 6 of the Patented Medicines (Notice of Compliance) Regulations, am. by the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, (the "Regulations")
BETWEEN:
ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Applicants
and
THE MINISTER OF HEALTH and RATIOPHARM,
A DIVISION OF RATIOPHARM INC.
Respondents
REASONS FOR ORDER AND ORDER
[1] This is a motion brought by the Applicants in writing pursuant to Rules 151, 152 and 369 of the Federal Courts Rules, for an Order to provide for the protection and maintenance of confidentiality of certain documents, information and transcripts to be produced by the parties during the course of this proceeding. While the protective and confidentiality order sought on this motion was on consent, I am not satisfied that the order should issue on either the grounds provided or in the form of the proposed draft order.
[2] The proceeding concerns the Applicants' Canadian Letters Patent Numbers 2,419,729 (the "729 Patent") and 2,471,102 (the "102 Patent"). The 729 Patent issued with 13 claims: Claims 1 to 8 concern processes for the production of Form I, its use as an antibiotic and Form I when made by those processes. Claims 9 to 13 pertain to Form II produced from Form I when prepared by the processes of claims 1 to 5 and by heating. The invention disclosed in the 102 Patent relates to a compound, 6-O-methylerthromycin A Form I or II, containing one or more impurities.
[3] By Notice of Application issued on May 27, 2005, the Applicants initiated this proceeding (the "Prohibition Proceeding") under the Regulations to prohibit the Minister from issuing a Notice of Compliance ("NOC") to ratiopharm for 250 mg or 500 mg Clarithromycin tablets until after the expiry of the Applicants' 729 and 102 Patents. The Prohibition Proceeding was filed in response to ratiopharm's Notice of Allegation dated April 8, 2005 (the "NOA"), in which ratiopharm alleges that the 729 and 102 Patents are invalid and that no claims of the Abbott Patents would be infringed by the making, constructing, using or selling by ratiopharm of its proposed Clarithromycin.
[4] The Applicants submit that to properly prosecute this proceeding, they must evaluate ratiopharm's allegations of non-infringement. To assist the Court with relevant and necessary evidence, the Applicants advise that they expect to lead expert evidence involving a comparison of the material and process used by ratiopharm with the material and process claimed in the 729 and 102 Patents and that to conduct such comparison, ratiopharm will need to disclose specific and detailed information.
[5] The Notice of Motion indicates that this information may include ratiopharm's confidential process, parts of its abbreviated new drug submissions ("ANDS") and parts of the drug master file ("DMF") from ratiopharm's supplier. The Notice of Motion also indicates that all of the parties have consented to the granting of an order, in the form attached, protecting and maintaining the confidentiality of certain documents, information, and transcripts to be produced by the parties during the course of the proceeding. In that regard, the draft order provides that Confidential Information shall be filed with the Court in sealed envelopes. Access is restricted to certain designated persons, including the Court's registry personnel, the parties' in-house and outside counsel, up to five experts for each party, and employees of the parties or their related companies on a "need to know" basis. "Confidential Information" is defined as:
...any document, thing, information or evidence designated by either Party as confidential in accordance with the procedure described herein. Confidential Information may include, without limitation, documents, things, information or evidence produced or disclosed, as the case may be, at any examination, motion, hearing or pursuant to any provision of the Federal Court Rules, 1998, which contains non-public and confidential or proprietary information, whether personal or business related, except information not identified as confidential;
"Confidential Information" shall not include:
(i) information which was lawfully and without legal restriction in the possession of an individual or Party other than through disclosure in this proceeding pursuant to this Order;
(ii) information derived independently of disclosure in this proceeding;
(iii) information which any individual or Party or its counsel lawfully and without legal restriction obtained from a person having the right to disclose such information; or
(iv) information which is or becomes part of the public domain not as a result of any unauthorized act or omission on the part of a recipient of designated Confidential Information pursuant to this Order.
[6] With respect to such arrangements or agreements, parties can agree, and the Court may issue an order regarding non-disclosure as it relates to documents and information exchanged during production and discovery. This type of protective order is an extension of the implied undertaking rule. Seeking an order to seal documents filed with the Court from public access, however, is a different matter. A confidentiality order pursuant to Rule 151 of the Federal Courts Rules is an extraordinary measure, even if the granting of such orders is more common in this type of case than in other cases. The Court must be satisfied in every case where a confidentiality order is sought that it is appropriate and necessary that such order should issue. To make such determination, the Court must know what information or documents are to be subject to the order. Further, based on the test enunciated by the Supreme Court of Canada in Sierra Club of Canada v. Canada (Minister of Finance), [2002] 2 S.C.R. 522 the interest to be protected must be identified and must be weighed against the public interest in open judicial proceedings. According to Sierra Club, a confidentiality order should only be granted when it is necessary to prevent a serious risk to an important interest, including a commercial interest, and considering whether the salutary benefits of the order, including the right of the litigants to a fair trial, outweigh its effects on the public interest in open courts. The standard or test for obtaining a confidentiality order under Rule 151 of the Federal Courts Rules is a high one.
[7] With respect to the first part of the test, the risk must be real and substantial. It must be well grounded in the evidence and pose a serious threat to the commercial interest in question. The "important commercial interest" in question is not an interest that is particular or specific to the party requesting the confidentiality order, it must be the general commercial interest of protecting confidential information. In the case of Sierra Club, the Supreme Court held it was necessary to maintain the confidentiality of the information in issue - it had been accumulated with the reasonable expectation that it would be confidential, it was always treated as confidential, and the party seeking the order satisfied the court that its proprietary, commercial interest would be harmed in the absence of such order. There were also no reasonable alternatives to the confidentiality order, expungement or the creation of summaries was ruled to be inadequate.
[8] With respect to this motion, while there may be a public interest in protecting some proprietary and commercially sensitive information of generic drug manufacturers and the information that may disclosed in proceedings under the Regulations, this interest does not give rise to a blanket confidentiality order. A confidentiality order also cannot be issued without the Sierra Club test being applied and without the Court weighing or balancing the private and public interests.
[9] The test has not been met in this case. There is no evidence as to the nature of the information or identification of what documents are sought to be sealed. There is no evidence as to why any material should be sealed and kept from public access or open court proceedings upon filing with the Court.
[10] In short, the documents that are to be subject to a confidentiality order must be clearly identified, the order must not be overly broad or simply provide for blanket confidentiality for anything the parties wish themselves to designate at any stage of the proceeding, and the motion for such order must be supported by evidence regarding the risk or harm if there is public access to the information, such that the Court may consider in determining whether to exercise its discretion in the manner requested.
ORDER
THIS COURT ORDERS thatthe motion is dismissed, without prejudice to any party seeking to file a further motion for a protective order, or for a confidentiality order pursuant to Rule 151 of the Federal Courts Rules.
"Martha Milczynski"
PROTHONOTARY
FEDERAL COURT
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-915-05
STYLE OF CAUSE: ABBOTT LABORATORIES and ABBOTT
LABORATORIES LIMITED
Applicants
and
THE MINISTER OF HEALTH and RATIOPHARM,
A DIVISION OF RATIOPHARM INC.
Respondents
CONSIDERED AT TORONTO, ONTARIOPURSUANT TO RULE 369
REASONS FOR ORDER
AND ORDER BY: MILCZYNSKI P.
DATED: OCTOBER 6, 2005
WRITTEN REPRESENTATIONS BY:
William H. Richardson
Marcus Klee FOR THE APPLICANTS
F.B. (Rick) Woyiwada FOR THE RESPONDENT, MINISTER OF HEALTH
J. Bradley White FOR THE RESPONDENT, RATIOPHARM
SOLICITORS OF RECORD:
McCarthy Tétrault LLP
Toronto, Ontario FOR THE APPLICANTS
John H. Sims Q.C.
Deputy Attorney General of Canada FOR THE RESPONDENT, MINISTER OF HEALTH
Osler, Hoskin & Harcourt LLP
Ottawa, Ontario FOR THE RESPONDENT, RATIOPHARM