Date: 19981126
Docket: T-1628-98
Between :
PHARMASCIENCE INC.
Applicant
- and -
THE COMMISSIONER OF PATENTS
Respondent
- and -
G.D. SEARLE & CO.
Respondent
REASONS FOR ORDER
PINARD, J. :
[1] This is an application for judicial review pursuant to section 18.1 of the Federal Court Act, R.S.C. 1985, c. F-7, of two decisions made by the Commissioner of Patents.
[2] The Patent Co-operation Treaty ("PCT") establishes a system that allows a patent applicant to seek patent protection in 95 states around the world through the filing of a single International Patent Application. Canada became a party to the PCT on October 2, 1989 and the PCT came into force on January 2, 1990. The Patent Co-operation Treaty Regulations ("PCT Regulations") were registered on September 21, 1989 and came into force on January 2, 1990 when the PCT itself came into force. The PCT does not allow for the granting of patents but is simply an international patent-filing mechanism. The granting of the patent itself is done at the national level and a patent must be obtained in each state in which patent protection is sought. This process of obtaining a patent in a particular state is referred to as the national phase.
[3] International Patent Application Number PCT/US91/02980 was filed by the respondent G.D. Searle & Co. ("Searle") on May 1, 1991 for a "Pharmaceutical Composition". The priority date was May 3, 1990, based on U.S. application No. 518,353 (now abandoned). The deadline for national entry expired on November 3, 1992, 30 months from the priority date of May 3, 1990. Application Number PCT/US91/02980 became Canadian Patent Application 2,082,944 when, on November 13, 1992, Searle requested late entry into the national phase. Searle then filed an affidavit of its counsel, Dr. James R. Keneford, which was based upon a letter written by a legal assistant at Searle to Dr. Keneford. In his affidavit Dr. Keneford states:
| . . . the missed date of November 3, 1992 for entry into the national phase had arisen through a managerial and clerical error in the records and reminder system maintained by our client. |
[4] The late entry allowance was granted on December 15, 1992. A second decision, allowing Searle"s voluntary amendment to its patent, was granted on December 16, 1997. The Patent Application was allowed on September 2, 1998.
[5] The applicant Pharmascience Inc. ("Pharmascience") states that on June 10, 1997, it began developing formulations for its new product, Diclofenac and Misoprostol. Pharmascience alleges that the new product will be a generic equivalent to Searle's product Arthrotec, a drug used in the treatment of rheumatoid arthritis and osteoarthritis. After developing formulations for this product, Pharmascience says that it retained Canadian patent agents to conduct a patent search to see if there were any other patents of which it should be aware and that subsequently it was advised of Canadian Patent Application No. 2,082,944 filed by Searle. Over the period of June 1997 to July 1998, while testing and developing formulations, Pharmascience alleges that it monitored Searle's patent application. In July 1998, Pharmascience states that it was advised that an internal allowance had been granted on July 15, 1998 for Searle's patent application. Contending that one of its final test formulations is similar to the description found in the Searle"s patent application and that it expects to be sued for patent infringement, Pharmascience brought this application for judicial review.
[6] The application for judicial review relates to two decisions made by the Commissioner of Patents:
| (1) the decision to reinstate the application submitted by Searle; and |
| (2) the decision to allow Searle to amend its application. |
[7] As indicated above, the first decision was made on December 15, 1992, and the second decision, on December 16, 1997.
[8] Pharmascience bases its application on the following:
| a) The PCT Application was filed May 1, 1991, having a U.S. priority date of May 3, 1990. According to the PCT Treaty, Chapter II, the period for entry into the national phase expired on November 3, 1992. Searle did not file an application in Canada on or before November 3, 1992. |
| b) According to Rule 15(3) of the PCT Regulations1, Searle was obliged to show by way of affidavit evidence that the failure to apply to enter the Canadian national phase was not reasonably avoidable. The affidavit filed did not indicate that this was the case; rather, it showed that the failure to apply was reasonably avoidable. |
| c) Furthermore, there was no direct evidence as to the cause for failing to enter the national phase. There was no direct evidence that the failure to enter the national phase could not have been reasonably avoided. The evidence presented in the affidavit filed with the Patent Office was not based on the affiant"s belief in the information that was provided to him. There was insufficient evidence on which the Commissioner of Patents could have concluded that the failure to file an application was not reasonably avoidable. |
| d) The initial application filed was limited to compositions comprising a core consisting of nonsteroidal anti-inflammatory drugs (NSAIDs) selected from diclofenac and piroxicam. The application as recently amended broadens the description of the invention and includes claims to pharmaceutical compositions that comprise a core of a "therapeutically effective amount of non-steroidal anti-inflammatory agent" without limiting the type of agent. |
| e) According to section 38.2 of the Patent Act2, addition of new matter after the application has been filed is not permitted. |
| f) According to section 28.1 of the Patent Act, an applicant may request priority in respect of an application on the basis of a previously filed application where the previously filed application discloses the subject-matter defined by the claims. By broadening the scope of the invention and the claims, the application on which priority is claimed does not disclose the subject matter of the invention. Accordingly, the applicant is not entitled to claim priority. |
| g) Pharmascience is directly affected by the granting of the Patent Application as it intends to enter the marketplace with a product that may fall within the claims of the Patent Application. |
[9] Upon hearing counsel for the parties and upon reviewing the evidence, I am of the opinion that the application for judicial review ought to be dismissed on the following grounds:
| (1) the entirety of the delay in bringing this application for judicial review has not been satisfactorily explained (see Grewal v. Canada, [1985] 2 F.C. 263 at 277 (C.A.) and Beilin v. M.E.I. (1994), 88 F.T.R. 132 at 134). Subsection 18.1(2) of the Federal Court Act sets a thirty-day time limit within which a judicial review application must be commenced. More specifically, the provision requires that the application be made within 30 days of the date the impugned decision was first communicated by the federal board, commissioner or tribunal. The patent application system is a matter of public record. Thus, the patent application file for the application made by Searle was available for public review. By its own admission, Pharmascience acknowledges that it became aware of that application in June 1997, at which time the December 1992 reinstatement decision was documented in the public record. The December 1997 voluntary amendment decision was subsequently documented on the public record. Still, Pharmascience chose to wait until August 1998, over a year later, to bring its application for judicial review and that, simply because it did not believe that the examiner was going to grant the patent application. |
| (2) Pharmascience lacks standing. Subsection 18.1(1) of the Federal Court Act limits judicial review to "anyone directly affected by the matter in respect of which relief is sought". In my view, the only person "directly affected" by decisions taken during the prosecution of a patent application before the Canadian Patent Office is, generally, the patent "applicant" as defined in section 2 of the Patent Act. In my opinion, like in Re Canadian Telecommunications Union and Canadian Brotherhood of Transport & General Workers et al. (1981), 126 D.L.R. (3d) 228, Pharmascience is only affected indirectly by the decisions which merely create a situation which may, eventually, affect Pharmascience. Indeed, there is not enough evidence on the record to show that Pharmascience is directly affected by the decision of the Commissioner of Patents. For example, Pharmascience is still in the human pilot trial phase. On cross-examination, David Goodman, Vice President of Business Development for Pharmascience, noted that the results of the second pilot trial were "encouraging" but that the formulation will need "slight modification". Therefore, at present, Pharmascience does not market any product that will infringe the claims of the patent application, nor is there sufficient evidence to show that it will do so in the near future. |
| Pharmascience's alternative argument that it can be recognized as having public interest standing must also be set aside. In my view, Pharmascience has more of a private interest standing as it wants to produce a generic drug similar to Searle's. It does not allege violation of a statute, such as misleading marketing which would affect the public, as was the case in Hoechst Canada Inc. v. Genpharm Inc. (1991), 35 C.P.R. (3d) 280, where the public interest was misleading or false marketing of a product. Also, in that case, the plaintiff alleged public interest on the basis of the Trade-marks Act, which is an exercise of statutory authority. I find the respondents' argument persuasive that the impugned decisions of the Commissioner of Patents are discretionary decisions, and not an exercise of legislative authority. |
| (3) In any event, I do not find that judicial review is the appropriate remedy in the case at bar by reason of the existence of other avenues open to Pharmascience, namely section 10 of the Patent Rules, SOR/96-423, and subsection 60(1) of the Patent Act, which read: |
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| Rule 10 of the Patent Rules allows someone to file a protest against the grant of a patent, on the basis that the patent application contravened subsection 38.2(1) of the Patent Act in that the application included the addition of new subject matter or that an amendment went beyond what could reasonably be inferred to have been included in the original application. In my opinion, Rule 10 provides an adequate alternative remedy that should have been exhausted by Pharmascience before seeking judicial review, at least with respect to the voluntary amendment decision. As for subsection 60(1) of the Patent Act, I am of the view that the provision allows a third party, after the grant of a patent, to challenge the entitlement of any subject matter to a claim to priority by way of proceedings for invalidity (see, for example, Richter Gedeon Vegyészeti Gyar RT v. Merck & Co. (1996), 68 C.P.R. (3d) 8). As noted by Searle, judicial review could become an effective tool to delay the grant of a patent while the third party's application for regulatory approval is processed and granted. In Novapharm Ltd. v. Aktiebolaget Astra (1996), 68 C.P.R. (3d) 117 at 122, this Court held that discretion to entertain judicial review will be refused where the tribunal proceeds by stages in reaching a conclusion on the ultimate matter and judicial review of each and every preliminary or interlocutory decision could bring proceedings to a halt. |
[10] Any of the above reasons being sufficient to allow the matter to be disposed of without the necessity of dealing with the merits of the impugned decisions, the application for judicial review is therefore dismissed, with costs.
JUDGE
OTTAWA, ONTARIO
November 26, 1998
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