Toronto, Ontario, February 16, 2006
PRESENT: Madam Prothonotary Milczynski
BETWEEN:
LABORATOIRES FOURNIER S.A.
Applicants
and
THE MINISTER OF HEALTH and
CIPHER PHARMACEUTICALS LIMITED
Respondents
REASONS FOR ORDER AND ORDER
Nature of Motion
[1] This is a motion brought by Cipher pursuant to subsection 6(5)(b) of the PMNOC Regulations:
ss.6 (5) In a proceeding in respect of an application under subsection (1), the court may, on the motion of a second person, dismiss the application,
(b) on the ground that the application is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process.
[2] Cipher argues, among other things, that the doctrines of res judicata and issue estoppel apply to this application, and that there is no basis for the Court to exercise its discretion to permit the proceeding to continue to a hearing on its merits. For the reasons below, I so find and dismiss the application in its entirety.
Background
[3] The Applicants in this proceeding, Fournier Pharma Inc., and Laboratoires Fournier S.A. (the "Applicants" or "Fournier") seek an order prohibiting the Minister of Health from issuing a Notice of Compliance ("NOC") to Cipher for its 100 and 160 mg fenofibrate capsules (the "Cipher capsules") until the expiry of Canadian Patent No. 2,372,576 (the "576 Patent"). Cipher filed an Abbreviated New Drug Submission ("ANDS") seeking a NOC for these capsules, and served the Applicants with its Notice of Allegation ("NOA"), alleging that the Cipher capsules would not infringe the claims of the 576 Patent.
[4] As part of its legal and factual bases for this allegation of non-infringement, Cipher stated that the decision of this court in respect of Canadian Patent No. 2,219,475 (the "475 Patent") was equally applicable to the 576 Patent. That decision, released on December 14, 2004 by Justice Layden-Stevenson (and affirmed by the Federal Court of Appeal on October 11, 2005), identified the proper construction of the 475 Patent, and its essential elements. In that regard, the essential elements of the patent and factual issues were, whether the 100 and 160 mg fenofibrate Cipher capsules:
(i) were an immediate release fenofibrate composition;
(ii) contained fenofibrate in a micronized form; and
(iii) contained at least one layer of micronized fenofibrate on an inert hydrosoluble carrier.
[5] Justice Layden-Stevenson found that the Cipher capsules were not immediate release fenofribrate compositions. This was sufficient for her to determine that the allegation of non-infringement was justified, because to infringe the relevant claims, the Cipher capsules needed to contain all of the above three elements. However, she went on to find that the Cipher capsules also did not contain either of the remaining two essential elements as well.
[6] The Federal Court of Appeal expressly upheld the finding that the Applicants had failed to establish that Cipher's capsules contain fenofibrate in micronized form. This was sufficient to dispose of the appeal, and the Court did not find it necessary to enter into an analysis of the two other issues of whether the Cipher capsules were an immediate release fenofibrate composition, or contained at least one layer of micronized fenofibrate on an inert hydrosoluble carrier.
[7] Even though Cipher was successful in the 475 Patent proceeding, and received approval from Health Canada for the Cipher capsules, Cipher did not receive its NOC for the capsules because of the listing of the 576 Patent on the Patent Register in March of 2004. The 576 Patent is a divisional of the 475 Patent. The two patents share identical titles, identical priority dates and application dates, identical inventorship and identical ownership.
[8] The 576 Patent describes the identical subject matter as the 475 Patent. The drawings of the two patents are identical, and the disclosures of the two patents are identical but for seven words on page 8, lines 19 and 20 of the 576 Patent (additional wording: "more specifically 10 to 75% by weight").
[9] The claims of the 475 Patent and the 576 Patent do differ. The layered structure of the 475 Patent (inert dydrosoluble carrier covered with at least one layer of micronized fenofibrate and hydrophilic polymer) is not stated to be required in the 576 Patent claims. Also, all claims of the 576 Patent require a stated dissolution profile, while this dissolution profile appears only in some of the claims of the 475 Patent.
[10] Nonetheless, there is no dispute between Fournier and Cipher that the claims of the 576 Patent and the 475 Patent both require the following identical essential elements:
(a) an inert hydrosoluble carrier;
(b) micronized fenofibrate; and
(c) an immediate release composition.
These are the very same elements that Justice Layden-Stevenson found not to be present in the Cipher capsules in the context of the 475 Patent litigation.
[11] Thus, by letter dated January 11, 2005, Cipher served a NOA addressing the 576 Patent, containing allegations of non-infringement that are virtually identical to the NOA Cipher delivered in respect of the 475 Patent. Cipher alleges that Claims 1 to 28 of the 576 Patent would not be infringed by the making, constructing, using or selling of the Cipher capsules - which are the same capsules addressed in the 475 Patent proceeding - because those capsules:
(i) do not contain an inert hydrosoluble carrier;
(ii) do not contain or use fenofibrate in micronized form; and
(iii) are not immediate release compositions within the meaning of the 576 Patent and do not meet the claimed dissolution profile.
[12] Despite Cipher's allegations of non-infringement and assertion that the issues raised in the NOA concerning 576 Patent were already decided by the 475 Patent decision, Fournier commenced this proceeding seeking an order prohibiting the Minister from issuing a NOC to Cipher until after the expiry of the 576 Patent, on the grounds that the Cipher capsules do contain the three essential elements noted above.
Issue Estoppel
[13] The doctrine of issue estoppel prevents a person from re-litigating a legal issue already decided in a previous proceeding between the same parties. As set out by Justice Binnie in Danyluk v. Ainsworth Technologies Inc., [2001] 2 S.C.R.:
The law rightly seeks a finality to litigation. To advance that objective, it requires litigants to put their best foot forward to establish the truth of their allegations when first called upon to do so. A litigant, to use the vernacular, is only entitled to one bite at the cherry....An issue, once decided, should not generally be re-litigated to the benefit of the losing party and the harassment of the winner. A person should only be vexed once in the same cause. Duplicative litigation, potential inconsistent results, undue costs, and inconclusive proceedings are to be avoided.
Finality is thus a compelling consideration and judicial decisions should generally be conclusive of the issues decided unless and until reversed on appeal. However, estoppel is a doctrine of public policy that is designed to advance the interests of justice.
[14] Taking into account the issues in this proceeding concerning the 576 Patent and those already decided in the 475 Patent, it is clear that the three preconditions for issue estoppel have been met: there has been a disposition of the legal issues relating to the essential elements of the 475 Patent which are the same in the 576 Patent; that disposition of the legal issues is final; and the parties to the 475 Patent proceeding are the same as the parties to this proceeding in respect of the 576 Patent.
[15] Those conclusions do not, however, end the inquiry or are dispositive of this motion to dismiss the application. Issue estoppel is an equitable doctrine. The Court must decide whether to refuse to apply estoppel as a matter of discretion, in order to prevent an injustice. In exercising this discretion, the court must review the facts and surrounding circumstances of each case, and ask whether there is something in the facts of the particular case, so as to yield the usual operation of the doctrine of issue estoppel to work an injustice.
[16] In the case at hand, the Applicants submit that the Court should have the benefit of new evidence that was not before the Court in the 475 Patent proceeding. The Applicants refer to scientific papers and documentation. However, this material predates the 475 Patent proceeding and there is insufficient evidence on this motion as to why this scientific evidence was not available or submitted in that application.
[17] The Applicants also refer to test results of a drug: "Lipirex". Lipirex is not a Cipher product, but the Applicants submit that, with insignificant differences, it is the same drug or product as the Cipher capsules. Because the Applicants do not have samples of the Cipher capsules, they seek to rely on the results of the Lipirex testing as evidence, in a surrogate fashion, of infringement of the 576 Patent by the Cipher capsules. However, whatever the relevance or admissibility of such testing might be, this too is not "new" evidence. Evidence relating to Lipirex testing for the same purposes was sought to be filed by way of reply evidence in the 476 Patent proceeding. Leave was denied by Order of Prothonotary Lafrenière, and upheld on appeal by Justice von Finckenstein.
[18] Fournier has already fully litigated the issues that are at the heart of this application in the 475 Patent Proceeding. The matters of immediate release, inert hydrosoluble carrier and micronized fenofibrate have all been determined. The fact that the Applicants seek to rely on some evidence that was not in the 475 Patent proceeding does not, in this case, justify re-litigating those same issues. Fournier has had its bite of the cherry, and I do not find that the circumstances warrant re-litigation of the issues or that denial of such re-hearing constitutes an injustice.
[19] Accordingly, I find that, having had the matters in issue determined in the 475 Patent proceeding (claims construction, essential elements and non-infringement), it is plain and obvious that this application is clearly bereft of any possibility of success. In light of this finding, it is unnecessary to address Cipher's alternative arguments or relief, and also unnecessary to address Fournier's arguments that the NOA was deficient on other grounds.
ORDER
THIS COURT ORDERS that
1. The application is hereby dismissed.
2. The parties may make submissions as to costs of the application and of this motion, in writing, within twenty days of the date of this Order.
"Martha Milczynski"
FEDERAL COURT
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-350-05
STYLE OF CAUSE: FOURNIER PHARMA INC. and LABORATOIRES FOURNIER S.A.
Applicants
and
THE MINISTER OF HEALTH and CIPHER PHARMACEUTICALS LIMITED
Respondents
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: FEBRUARY 9, 2006
REASONS FOR ORDER
APPEARANCES:
| David M. Reive Angela Furlanetto |
|
|
Shonagh McVean Paul Thomas |
|
SOLICITORS OF RECORD:
| DIMOCK STRATTON LLP Toronto, Ontario |
|
|
GILBERT'S LLP Toronto, Ontario |
|