Date: 19980724
Docket: T-421-97
BETWEEN:
FAULDING (CANADA) INC.
Plaintiff
- and -
PHARMACIA S.P.A.
Defendant
REASONS FOR ORDER
REED, J.:
[1] This is a motion to strike a Counterclaim, which was added to the Statement of Defence on July 13, 1998.
[2] I note firstly that the Statement of Defence should not have been so amended to add thereto a Counterclaim without leave of the Court. Pleadings were closed on August 25, 1997, and discovery of the plaintiff took place on February 24, 1998. While the plaintiff amended two paragraphs of its Statement of Claim on June 22, 1998, this was in response to the defendant's successful attack on those paragraphs (by motion to strike) and was limited to the plaintiff's pleadings relating to anticipation. The defendant's right to amend its Statement of Defence in response thereto did not encompass the right to add a whole new cause of action to the proceedings.
[3] The plaintiff's action is for impeachment of Canadian Letter patent 1,291,037 ("the 3037 patent"). The action was commenced on March 12, 1997. The patent relates to a chemical solution used in the treatment of cancer. The patent covers solutions of anthracycline glycosides as a class and a process for making such solutions; doxorubicin hydrochloride is included therein.
[4] In 1990, the plaintiff filed a New Drug Submission ("NDS") with the Minister of Health and Welfare ("Minister"), seeking regulatory approval to market the drug doxorubicin hydrochloride in two dosage forms, a freeze direct powder and a dissolved solution. Following the enactment of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, a Notice of Compliance ("NOC") for the drug could not be issued by the Minister as long as the plaintiff uses the defendant's product as a comparison for its NDS and no allegation of non-infringement of the patent is filed. The powder dosage form has been the subject of other proceedings and is not relevant for present purposes.
[5] Information filed with the Minister as part of an NDS is confidential and not a matter of public record. An NOC not yet having been issued by the Minister, the plaintiff's product is not on the market. Thus information about the composition and formulation of the plaintiff's product is not publicly available. In the course of the examination for discovery of the plaintiff, the defendant sought to obtain information about the formulation and composition of the plaintiff's product. Madame Justice McGillis issued an order on June 30, 1998, confirming the plaintiff's position that such information was not relevant to the patent impeachment action.
[6] As noted above, on July 13, 1998, the Counterclaim was added to the Statement of Defence. It alleges that the plaintiff product has infringed and will infringe the 3037 patent. The Counterclaim after describing the patent claims asserts:
| 36. In the alternative to the assertions made in paragraphs 3 and 9 herein [that the plaintiff has insufficient interest to entitle it to bring an impeachment action], if the Plaintiff, Defendant by Counterclaim, is currently seeking regulatory approval to market a pharmaceutical preparation which is a ready-to-use injectable solution of doxorubicin hydrochloride then the Plaintiff, Defendant by Counterclaim, has and will infringe the 3037 patent, and in particular claims 1-6, 12-17, 23-25, 30, 31, 36, 39-43, 48, 51-55, 60-65, 69-74, 78-83, and 88-93. |
| 37. Since the issuance of the 3037 patent on October 22, 1991, the Plaintiff, Defendant by Counterclaim, has made or had made for it either in Canada or abroad, imported or had imported for it into Canada and used in Canada, a ready-to-use, injectable solution containing doxorubicin hydrochloride ("Plaintiff's Solution"). |
| 38. The Plaintiff's Solution was made by processes referred to in paragraphs 34 and 35 herein, and has the characteristics referred to in paragraphs 32 and 33 herein (Plaintiff's Infringing Solution"). |
| 39. The Plaintiff, Defendant by Counterclaim, also threatens to make or have made for it either in Canada or abroad, import or have imported for it into Canada, use in Canada, offer for sale and sell in Canada, Plaintiff's Infringing Solution. |
| 40. The Plaintiff, Defendant by Counterclaim, also threatens to commence sale of Plaintiff's Infringing Solution for consumption in Canada in the near future. |
| 41. The Plaintiff, Defendant by Counterclaim, intends to offer for sale and sell in Canada Plaintiff's Infringing Solution at least until the expiry of the 3037 patent. |
| 42. The aforesaid activities of the Plaintiff, Defendant by Counterclaim, have been without the licence or consent of the Defendant, Plaintiff by Counterclaim. |
| 43. By reason of the aforesaid activities, the Plaintiff, Defendant by Counterclaim, has and will infringe at least claims 1-6, 12-17, 23-25, 30, 31, 36, 39-43, 48, 51-55, 60-65, 69-74, 78-83 and 88-93. |
| 44. By reason of the aforesaid activities of the Plaintiff, Defendant by Counterclaim, the Defendant, Plaintiff by Counterclaim, has suffered damage and the Plaintiff, Defendant by Counterclaim has made a profit, and the Defendant, Plaintiff by Counterclaim is likely to continue to suffer damage and the Plaintiff, Defendant by Counterclaim, will continue to make profits unless the Plaintiff, Defendant by Counterclaim is restrained by this Honourable Court. |
[7] It is clear that this pleading must be struck for reasons in addition to the fact that leave to add it to the Statement of Defence was not sought and obtained from the Court. There are insufficient material facts pleaded to support the pleading. Paragraphs 32 and 33 of the Counterclaim recite a multiplicity of variable elements which are alleged to comprise the invention of the 3037 patent. The defendant can not identify the precise combination of elements which it alleges have been taken by the plaintiff. A prerequisite to a proper plea of patent infringement is a precise identification of the specific elements of the invention that are alleged to have been taken. See: Chart Industries Ltd. v. Hein-Werner of Canada Ltd. (1988), 21 F.T.R. 266; Gaf Corp. v. Hanimex (Canada) Ltd. (1972), 4 C.P.R. 110. The defendant cannot comply with this requirement because it does not know the formulation or composition of the plaintiff's product. Moreover the defendants are in effect attempting to circumvent the order of Madame Justice McGillis denying them discovery in relation thereto.
[8] Additionally, the Counterclaim is based on speculation and it is premature. It alleges that the plaintiff "will infringe" the 3037 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; Merck & Co. Inc. v. Apotex Inc. (1997), 74 C.P.R. (3d) 202. Similarly, pleas founded on the "intention" of a party to do certain acts are improper and will be struck: Amsted Industries Inc. et al. v. Wire Rope Industries Ltd. (1988), 23 C.P.R. (3d) 541; 32 C.P.R. (3d) 334.
[9] Also relevant is the fact that subsection 55.2(1) of the Patent Act, in force as of March 12, 1993, provides:
| 55.2(1) It is not an infringement of a patent for any person to make, construct, use or sell the patented invention solely for uses reasonably related to the development and submission of information required under any law of Canada, a province or a country other than Canada that regulates the manufacture, construction, use or sale of any product. |
[10] And lastly, the adding of a counterclaim at this stage of the proceedings would likely delay the trial of the impeachment action. This litigation is characterized by complex issues relating to the alleged invalidity of the defendant's patent and has reached a reasonably advanced stage. Introduction of a completely new cause of action at this point would delay the early trial of this matter. If the impeachment action is not successful, and if the plaintiff subsequently obtains an NOC and then begins to market a product which the defendant regards as an infringement of its patent, an infringement action will undoubtedly be brought. At that point the relevant factual information will be available to the defendant. There are simply insufficient facts alleged at this time to underpin a claim for infringement.
[11] Accordingly, for the reasons given, the plaintiff's motion will be granted.
Judge
OTTAWA, ONTARIO
July 24, 1998