Date: 20040325
Docket: T-1035-02, T-1133-02, T-1847-02
Citation: 2004 FC 465
BETWEEN:
ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Applicants
and
THE MINISTER OF HEALTH and PHARMASCIENCE INC.
and
THE MINISTER OF HEALTH and APOTEX INC.
and
THE MINISTER OF HEALTH and RATIOPHARM,
A DIVISION OF RATIOPHARM INC.
Respondents
(Re: Order dated January 29, 2004)
Introduction
[1] This case concerns the listing of Canadian Letters Patent No. 2,261,732 (the "732 Patent"). It is a product by process patent for the drug Biaxin which contains the antibiotic clarithromycin. The respondent corporations (the "Respondents") moved, pursuant to subsection 6(5) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended SOR/98-166; SOR/99-379 (the "PM (NOC) Regulations"), to dismiss applications by the applicants for orders prohibiting the Minister of Health from issuing notices of compliance pursuant to subsection 6(1) of the PM(NOC) Regulations, on the basis that the 732 Patent was not eligible for listing on the Patent List.
[2] Abbott Laboratories Limited is a Canadian corporation ("Abbott Canada"). Abbott Laboratories is its American parent and the owner of the 732 Patent. The Respondents are manufacturers of generic drugs.
The Facts
[3] Initially, Biaxin was used to treat respiratory ailments. Later, it was discovered that Biaxin could be used in triple therapy with a second antibiotic and a Proton Pump Inhibitor (a "PPI") to eradicate gastrointestinal infections caused by a type of bacteria known as Heliobacter pylori ("H. pylori").
Biaxin for respiratory infection
[4] In December of 1989 Abbott Canada filed an new drug submission (an "NDS") for the drug Biaxin in 250 mg tablets to treat respiratory infection. An notice of compliance (an "NOC") was issued in 1992. Thereafter, in April of 1993, Abbott Canada filed a supplementary new drug submission (an "SNDS") for Biaxin in 500 mg tablets for respiratory ailments and an NOC was issued.
Biaxin in dual therapy for H. pylori
[5] In February of 1995, Abbott Canada filed an SNDS seeking approval for the use of Biaxin in the eradication of H. pylori in dual therapy with the PPI omeprazole. An NOC was issued.
Biaxin in triple therapy for H. pylori
[6] In December of 1996, Abbott Canada filed an SNDS seeking approval for triple therapy involving Biaxin, amoxicillin (a second antibiotic) and the PPI omeprazole. This submission was supported by 14 volumes of clinical data. The NOC was issued in 1998.
[7] TAP Pharmaceuticals Inc. ("TAP") is a corporation owned by Abbott Laboratories (the US company) and another unrelated company. TAP manufactures the PPI lansoprazole which is marketed as Prevacid.
[8] On February 27, 1997, Abbott Canada, acting on behalf of TAP, filed an SNDS seeking Health Canada's approval for a triple therapy treatment for the eradication of H. pylori. The drugs involved were the antibiotics Biaxin and amoxicillin and TAP's PPI lansoprazole. This submission was supported by 166 volumes of clinical and scientific data. An NOC was issued to TAP on April 7, 1998, (the "TAP NOC").
[9] In July of 1997, the application for the 732 Patent for Biaxin was filed.
[10] On April 8, of 1998, Abbott Canada filed an NDS, on behalf of TAP, seeking Health Canada's approval for a blister package (the "HP PAC") which contained the same drugs covered by the TAP NOC. An NOC was issued to TAP on July 20, 1998 and Abbott Canada sold the HP PAC on TAP's behalf in this country.
[11] Abbott Canada knew that certain benefit formularies would not reimburse patients for prescriptions for the HP PAC but would cover the cost of the three drugs in the HP PAC if they were prescribed separately.
SNDS 055754
[12] Accordingly, on April 8, 1998, Abbott Canada also filed SNDS 055754 which sought approval for a revision of its product monograph for Biaxin (the "Revision") to include a reference to the product monograph on TAP's HP PAC. The Revision read as follows:
For additional information on the use of Biaxin in triple therapy for the treatment of H pylori infection and active duodenal occurrence refer to the HP PAC product monograph.
This SNDS made reference to the 166 volumes of clinical and scientific data which had supported the SNDS for the TAP NOC. An NOC was issued for the Revision on July 20, 1998. In practical terms, the Revision allowed Abbott Canada to market Biaxin outside the HP PAC as a component of triple therapy with amoxicillin and the PPI lansoprazole.
[13] In July of 2001, the 732 Patent was granted and, within thirty days, Abbott Canada submitted it for listing with SNDS 055754.
[14] In February of 2002, the 732 Patent was listed and it remains listed today.
[15] During submissions, the parties agreed:
(a) That the submission of an SNDS is a submission for an NOC which may, in some circumstances, support the filing of a patent list under section 4 of the PM (NOC) Regulations.
(b) That an SNDS that is trivial or is submitted in bad faith (such as one that deals only with a name change or one that is filed only to defeat the timing provisions in section 4 of the PM(NOC) Regulations) will not support the filing of a patent list.
(c) That, if SNDS No. 055754 was eligible to support the filing of the 732 Patent List, Abbott met the timing requirements in section 4 of the PM(NOC) Regulations in that the 732 Patent List accompanied SNDS No. 055754 and was submitted within 30 days of the granting of the 732 Patent.
The Issues
[16] Against this background, the question is whether, in the circumstances of this case, SNDS 055754 is eligible to support the filing of the 732 Patent List. The Respondents say that SNDS 055754 is trivial because it does not relate to a change in the drug or to a new use or indication for the drug and submit that this position is supported by the fact that Biaxin's drug identification number did not change. They also submit that SNDS 055754 is merely a labelling revision. The Applicants, on the other hand, submits that SNDS 055754 is substantive. It says that Health Canada required it to file SNDS 055754, that it was supported by extensive research and that it dealt with a new use for Biaxin in triple therapy with amoxicillin and lansoprazole for which Abbott Canada had no prior regulatory approval.
Conclusions
[17] I accept Abbott Canada's submission that, once it decided to market Biaxin in Canada for use in triple therapy with amoxicillin and lansoprazole, it was required to file an SNDS. I have also concluded that there is no evidence that SNDS 055754 was filed to circumvent the provisions of section 4 of the PM (NOC) Regulations. The motivation appears to have been the desire to exploit a market for Biaxin that was not available to TAP's HP PAC. Abbott's filing of the 732 Patent List with the SNDS, in these circumstances, was bona fide.
[18] However, I have not been persuaded that the use of Biaxin in triple therapy with amoxicillin and lansoprazole for the eradication of H. pylori was a new indication when SNDS 055754 was filed on April 8, 1998 as Abbott has claimed. This indication was approved by Health Canada one day earlier when it issued the TAP NOC on April 7, 1998.
[19] In support of its submission about the new indication, Abbott Canada noted that Health Canada required Abbott Canada to include the Revision in three places in the Biaxin product monograph and that one location (at page 6) was found under the general heading "Indication and Clinical Use". This is accurate, but a closer reading of the text discloses that each time the Revision appears (see also pages 26 and 63) it is directly under a heading dealing with the eradication of H. pylori. There is no discussion of a new indication.
[20] In these circumstances, it is my view that the approval of SNDS 055754 meant that, instead of using TAP's HP PAC, a patient could take the same drugs in the same tablets in the same dosages for the same indication from three separate packages. For this reason, I have concluded that, from the point of view of the drug and the consumer, SNDS 055754 lacked substance and was, therefore, not eligible to support the filing of the 732 Patent List.
"Sandra J. Simpson"
JUDGE
Ottawa, Ontario
March 25, 2004
FEDERAL COURT
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-1035-02, T-1133-02, T-1847-02
STYLE OF CAUSE: ABBOTT LABORATORIES ET AL
Applicants
and
THE MINISTER OF HEALTH ET AL
Respondents
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: May 5 and 6, 2003
REASONS FOR ORDER : Honourable Madam Justice Simpson
DATED: March 25, 2004
APPEARANCES:
Mr. William H. Richardson
For the Applicants
Mr. Steven G. Mason
For the Applicants
Mr. Andrew Reddon
For the Applicants
Ms. Carol Hitchman
For the Respondents
Ms. Lilly Sormaz
For the Respondents
SOLICITORS OF RECORD:
McCarthy Tétrault LLP
Toronto, Ontario
For the Applicants
HITCHMAN & SPRIGINGS
Toronto, Ontario
For the Respondent (Pharmascience Inc.)
Deputy Attorney General of Canada
Federal Department of Justice
For the Respondent (The Minister of Health)