Pfizer Research And Development Co. v. Lilly Icos LLC

Pfizer Research And Development Co. v. Lilly Icos LLC Court (s) Database Federal Court Decisions Date 2003-06-17 Neutral citation 2003 FCT 753 File numbers T-2082-02 Decision Content Date: 20030617 Docket: T-2082-02 Citation: 2003 FCT 753 Ottawa, Ontario, this 17th day of June 2003 Present: The Honourable Madam Justice Heneghan BETWEEN: PFIZER RESEARCH AND DEVELOPMENT CO. N.V./S.A. and PFIZER CANADA INC. Plaintiffs and LILLY ICOS LLC and ELI LILLY CANADA INC. Defendants REASONS FOR ORDER AND ORDER INTRODUCTION [1] Lilly ICOS LLC and Eli Lilly Canada Inc. (the "Defendants") seek an order pursuant to the Federal Court Rules, 1998, SOR/98-106, striking out the Amended Statement of Claim issued by Pfizer Research and Development Co. N.V./S.A. and Pfizer Canada Inc. (the "Plaintiffs"). Alternatively, the Defendants seek to strike parts of the Amended Statement of Claim and in the further alternative they seek particulars as to certain allegations or threats made in the Amended Statement of Claim. BACKGROUND FACTS TO THIS MOTION [2] The Defendant Lilly ICOS LLC is a body corporate pursuant to the laws of Delaware, United States of America. The Defendant Lilly ICOS LLC is a joint venture formed by ICOS Corporation and Eli Lilly and Co., the parent company of the Defendant Eli Lilly Canada Inc. The Defendant Eli Lilly Canada Inc. is a body corporate pursuant to the laws of Canada and is engaged in the production, marketing, distribution and sales of pharmaceuticals in Canada. [3] The Plaintiff Pfizer Research and Development Co. N.V./S.A. is the owner and patentee of Canadian Patent No. 2,163,446 (the "Patent"). Pfizer Canada Inc. is a licensee under the Patent and claims as a licensee, pursuant to the Patent Act, R.S.C. 1985, c. P-4. [4] The Patent is for an invention for the treatment of male erectile dysfunction. The Plaintiffs, by Notice of Disclaimer filed in the Canadian Patent Office on December 11, 2002, disclaimed a number of claims of the Patent in their entirety and made a limited disclaimer relative to other claims, including claims 25 and 26. The Plaintiffs assert claims 25 and 26 of the Patent. As disclaimed, claim 25 relates to the use of an effective amount of a selective CGMP-specific PDEv inhibitor, or a pharmaceutically acceptable salt thereof, or a pharmaceutical composition containing either entity for the oral treatment of erectile dysfunction in men. [5] Claim 26, as disclaimed, relates to the use of an effective amount of a selective cGMP-specific PDEv inhibitor, or a pharmaceutically acceptable salt thereof, or a pharmaceutical composition containing either entity, for the manufacture of a medicament for the curative or prophylactic oral treatment of erectile dysfunction in men. [6] The Plaintiffs allege, in their Amended Statement of Claim dated March 19, 2003, that the Defendants are threatening to imminently import, market and sell in Canada, for the oral treatment of male erectile dysfunction, a pharmaceutical composition containing tadalafil, which is a cGMP PDEv inhibitor that selectively inhibits cGMP-specific PDEv. The Plaintiffs say that the Defendants are now seeking regulatory approval in Canada to market and sell this pharmaceutical composition and that the approval will issue, in Canada, during the third quarter of 2003. [7] The Plaintiffs refer, in the Amended Statement of Claim, to an existing action in this Court, cause T-341-02, in which the Defendants are attempting to impeach the Patent. [8] The Plaintiffs now allege, in their Amended Statement of Claim, that the Defendants will act immediately, upon receipt of the necessary regulatory approval, to begin to "import, make, distribute, promote and sell" a pharmaceutical composition containing an effective amount of tadalafil for the oral treatment of male erectile dysfunction. They allege that such activity will constitute infringement of Claims 25 and 26 of the Patent. [9] The Plaintiffs claim that they will suffer damage from the infringing activities of the Plaintiffs and seek the following relief: a) A declaration that the defendants infringe or threaten to infringe Canadian Patent No. 2,163,446; b) An interim, interlocutory and permanent injunction restraining the defendants, their respective officers, directors, employees, agents, servants, and all those over whom they exercise control or act in concert with, from: i) Selling, offering for sale, distributing, testing, importing to or exporting from Canada, or inducing others to use, the defendants' tadalafil pharmaceutical composition; ii) Selling, offering for sale, distributing, testing, importing to Canada, by any means compounds or compositions that infringe Claims 25 or 26 of Canadian Patent No. 2,163,446; iii) Inducing, facilitating, instructing or procuring any individual in Canada to use as a medicament any compound or composition that infringes Claims 25 or 26 of Canadian Patent No. 2,163,446; c) An order requiring the defendants to deliver up to the plaintiffs or destroy under supervision of this Court, any and all compounds or compositions in the possession, care, custody or control of the defendants or for which the defendants have title, in Canada that infringe Claim 25 or 26 of Canadian Patent No. 2,163,446, whether said compounds or compositions are in bulk or dosage form or otherwise, as well as any and all packaging and marketing and promotional material associated therewith; d) Damages, or in the alternative, profits, as the plaintiffs may elect following discovery thereon. The amount being claimed, exclusive of interest and costs, exceeds $50,000 and the action is not proceeding by way of simplified action; ... THE CURRENT MOTION TO STRIKE [10] The Defendants, who have not filed a Statement of Defence, now bring this Notice of Motion to strike the Plaintiffs' Amended Statement of Claim, in whole or in part. The Defendants claim that the Plaintiffs have failed to meet the test for bringing a quia timet action and that this action is premised on the issuance of regulatory approval in Canada to the Defendants. The Defendants say that this is a matter which is beyond the knowledge and control of the Plaintiffs since it requires action by the government. Accordingly, the Plaintiffs' allegations concerning the issuance of that approval and subsequent actions by the Defendants are wholly based on speculation and are premature. [11] Furthermore, the Defendants argue that the relief sought by the Plaintiffs is too broad, particularly in respect of an order for delivery-up of the Defendants' products. The Defendants characterize this relief as ancillary to injunctive relief and say that it is inappropriate and premature. [12] The Plaintiffs argue that their action is properly taken at this time and that the Amended Statement of Claim is a proper pleading that can withstand the Defendants' attack. The Plaintiffs rely on the long-established rule that a pleading is to be based on facts, not evidence, and argue that they have adduced sufficient facts, which if true, demonstrate sufficient immediacy to justify quia timet relief. [13] The Plaintiffs argue that it is not necessary for them to plead the exact date when regulatory approval will issue to the Defendants. They also argue that they are not required to demonstrate any control over the regulatory approval process. In brief, they submit that it is enough to show that regulatory approval will likely issue from the Canadian public authorities within the next few months and to argue that, upon receipt of that approval, the Defendants will act in a manner that will damage the legal interests of the Plaintiffs in the Patent. [14] The Plaintiffs dispute the Defendants' submission that the relief sought is too broad. They say that Claims 25 and 26 of the Patent provide broad, field of use claims and that the Defendants' imminent intended activities will infringe those claims. The Plaintiffs argue that their action is brought on a timely basis and the Amended Statement of Claim is properly pleaded, having regard to the issues raised concerning proposed use of the subject of the Patent. [15] The Plaintiffs argue that the issue of the Defendants' use of a pharmaceutical composition containing tadalafil for the treatment of male erectile dysfunction is presumably a justiciable issue and relies on the decision of the Supreme Court of Canada in Shell Oil Company v. Canada (Commissioner of Patents), [1982] 2 S.C.R. 536. [16] The Plaintiffs submit that the prayer for relief is not too broad, in light of the pending infringement by the Defendants. The Plaintiffs say that the relief sought here is similar to that granted by this Court in the issuance of Anton Pillar orders. [17] Finally, the Plaintiffs argue that the fact of non-particularized threats is not really an issue. The issue arising from the Amended Statement of Claim is imminent unauthorized and infringing use of certain material by the Defendants, contrary to the patent rights granted to the Plaintiffs. ANALYSIS [18] This motion to strike is brought pursuant to Rules 174 and 221(1)(a) and (f) of the Federal Court Rules, 1998. Rule 221(1)(a) and (f) is critical and provides as follows: 221. (1) On motion, the Court may, at any time, order that a pleading, or anything contained therein, be struck out, with or without leave to amend, on the ground that it (a) discloses no reasonable cause of action or defence, as the case may be, ... (f) is otherwise an abuse of the process of the Court, and may order the action be dismissed or judgment entered accordingly. 221. (1) À tout moment, la Cour peut, sur requête, ordonner la radiation de tout ou partie d'un acte de procédure, avec ou sans autorisation de le modifier, au motif, selon le cas : a) qu'il ne révèle aucune cause d'action ou de défense valable; ... f) qu'il constitue autrement un abus de procédure. Elle peut aussi ordonner que l'action soit rejetée ou qu'un jugement soit enregistré en conséquence. [19] An attack on a pleading that is based on Rule 221(1)(a) is to proceed on the basis of the challenged pleading and without evidence. The facts alleged in a statement of claim are to be taken as true for the purpose of a motion to strike: Hunt v. Carey Canada Inc. (1990), 74 D.L.R. (4th) 321 (S.C.C.). Further, the standard is whether it is "plain and obvious" that the pleading discloses no reasonable cause of action: Hunt v. Carey, supra. [20] In Connaught Laboratories Ltd. v. Smithkline Beecham Pharma Ltd. (1998), 86 C.P.R. (3d) 36 (F.C.T.D.), Justice Gibson described the elements necessary to bring a quia timet action and stated at paragraph 20: From the foregoing authorities, I derive the following criteria for allegations that must be evident on the face of a statement of claim initiating a quia timet proceedings alleging patent infringement: the statement of claim must allege a deliberate expressed intention to engage in activity the result of which would raise a strong possibility of infringement; the activity to be engaged in must be alleged to be imminent and the resulting damage to the plaintiff must be alleged to be very substantial if not irreparable; and, finally, the facts pleaded must be cogent, precise and material. It is not sufficient that they be indefinite or speak only of intention or amount to mere speculation. [21] Further, in Faulding (Canada) Inc. v. Pharmacia S.p.A. (1998), 82 C.P.R. (3d) 435 (F.C.T.D.), affirmed (1999), 3 C.P.R. (4th) 575 (F.C.A.), Justice Reed stated as follows at paragraph 8: Additionally, the Counterclaim is based on speculation and it is premature. It alleges that the plaintiff "will infringe" the '037 patent and makes allegations with respect to the plaintiff's future conduct. It alleges that the plaintiff "threatens" to make or have made, to import, or have imported a product that will infringe the patent. It alleges that the plaintiff "threatens" to commence the sale of an infringing product. Claims for infringement that are premised on indefinite acts in the future are in the realm of speculation. As such they are premature and should be struck out: Merck & Co. Inc. v. Apotex Inc. (1997), 72 C.P.R. (3d) 515 (F.C.T.D.); Merck & Co. Inc. v. Apotex Inc. (1997), 74 C.P.R. (3d) 202 (F.C.T.D.). Similarly, pleas founded on the "intention" of a party to do certain acts are improper and will be struck: Amsted Industries Inc. v. Wire Rope Industries Ltd. (1988), 23 C.P.R. (3d) 541 (F.C.T.D.); affirmed 32 C.P.R. (3d) 334 (F.C.A.). [22] In Faulding, supra, regulatory approval from the government, that is a Notice of Compliance from the Minister of Health, had not yet been issued to the Plaintiffs. This is analogous to the present case, where the regulatory approval necessary for the Defendants to do the things alleged in the Amended Statement of Claim has not occurred, and the Plaintiffs cannot say, without engaging in speculation, when, if at all, the government will approve the Defendant's product. [23] Finally, Justice Rothstein, as he then was, in Merck & Co., Inc. et al. v. Apotex Inc. (1997), 72 C.P.R. (3d) 515 (F.C.T.D.) held that a portion of a pleading that referred to a threat of infringement of a patent which was approximately one year in the future was premature and should be struck out. [24] In my opinion, the Plaintiffs have failed to plead sufficient facts in their Amended Statement of Claim to satisfy the necessary criteria for launching a quia timet action. The Defendants have brought an action relative to the validity of the Patent, court file number T-341-02. In that Statement of Claim, their intentions are expressly set out, as seeking regulatory approval for tadalafil in order to offer it for sale in Canada as an oral therapeutic agent for the treatment of male erectile dysfunction. However, the Plaintiffs have not satisfied me that action by the Defendants upon this deliberate, expressed intention is imminent. [25] I make no finding as to whether this deliberate, expressed intention of the Defendants raises a strong possibility of infringement. The Plaintiffs have not demonstrated the temporal aspect of the criteria for commencing a quia timet action. Neither party has control over when, or if, the government will issue regulatory approval for its product. In my opinion, the Plaintiffs have not pleaded facts to support its allegation that the Defendants' allegedly infringing activities are imminent. This motion for an order striking out the Amended Statement of Claim in its entirety is granted as the Plaintiffs have failed to properly plead a quia timet action; it is plain and obvious that the pleading discloses no reasonable cause of action. [26] In light of my findings above, it is not necessary to address the remaining arguments attacking the pleading, concerning the scope of the Plaintiffs' claim for relief and the request for particulars related to alleged "threats" as set out in paragraphs 13 and 15 of the Amended Statement of Claim. ORDER The motion to strike out the Amended Statement of Claim in its entirety is granted, with costs to the Defendants. "E. Heneghan" J.F.C.C. FEDERAL COURT OF CANADA TRIAL DIVISION NAMES OF COUNSEL AND SOLICITORS OF RECORD DOCKET: T-2082-02 STYLE OF CAUSE: PFIZER CANADA INC. ET AL. PLAINTIFFS - and - LILLY ICOS LLC ET AL. DEFENDANTS PLACE OF HEARING: TORONTO, ONTARIO DATE OF HEARING: MARCH 24, 2003 REASONS FOR ORDER AND ORDER HENEGHAN J. DATED: JUNE 17, 2003 APPEARANCES: Mr. Robert H.C. MacFarlane FOR THE PLAINTIFFS Mr. Donald E. Cameron FOR THE DEFENDANTS SOLICITORS OF RECORD: Mr. Robert MacFarlane BERESKIN & PARR Barristers & Solicitors 40th Floor, Scotia Plaza, 40 King Street West Toronto, Ontario M5H 3Y2 Telephone No.: 416-364-7311 Fax No.: 416-361-1398 FOR THE PLAINTIFFS Mr. Donald Cameron OGILVY RENAULT Barristers & Solicitors 200 King Street West, Suite 1100 Toronto ON M5H 3T4 Telephone No.: 416-340-6000 Fax No.: 416-977-5239 FOR THE DEFENDANTS