Date: 19980630 Docket: T-421-97
BETWEEN:
FAULDING CANADA INC.
Plaintiff
- and -
PHARMACIA S.p.A.
Defendant
REASONS FOR ORDER
MCGILLIS, J.
INTRODUCTION
[1] The plaintiff has appealed from an Order of Giles A.S.P., dated June 19, 1998, requiring it to respond to certain questions on examination for discovery. Giles A.S.P. gave no reasons in support of his Order.
FACTS
[2] In 1990, the plaintiff filed a New Drug Submission with the Minister of National Health and Welfare ("Minister"), seeking regulatory approval to market the drug doxorubicin hydrochloride in two dosage forms, namely a freeze dried powder and a dissolved solution. Following the enactment of the Patented Medicines (Notice of Compliance) Regulations,
Page: 2 SOR/93-133 ("Regulations"), the plaintiff was required to take a position in relation to two patents owned by the defendant, one of which was Canadian Patent No. 1,291,037 ("'037"). The plaintiff did not make an allegation of non-infringement in relation to patent '037. In judicial review proceedings instituted under the Regulations, the defendant unsuccessfully sought an order prohibiting the Minister from issuing a Notice of Compliance until the expiry of both patents. In 1995, the plaintiff received a Notice of Compliance for its powder product. To date, its application for a notice of compliance in relation to its proposed solution product remains outstanding.
[3] In 1997, the plaintiff commenced the present action seeking the impeachment of the '037 patent. In its Statement of Claim, the plaintiff has alleged that the subject matter of the '037 patent was not an invention and, in any event, that the invention was not novel. It further alleged that the patent was invalid for insufficiency of specification, insufficiency of disclosure or lack of utility on a number of grounds. The defendant has denied all allegations of invalidity, and has also pleaded that the plaintiff has no standing to bring the action.
[4] The defendant examined the plaintiff for discovery on February 24, 1998. During the course of the examination, the defendant sought information and documents from the plaintiff's confidential New Drug Submission in respect of its proposed solution product. In particular, the defendant requested information and documents pertaining to the formulation, method of manufacture, finished product specifications, toxicity, stability and comparative efficacy of the plaintiff's proposed solution product. The defendant also sought production of
Page: 3 the plaintiff's sales projections for and information related to the development of its proposed solution product, as well as product stability data. The plaintiff refused to answer all questions concerning those subjects.
ISSUE
[5] The question to be determined on this appeal is whether Giles A.S.P. was clearly wrong in ordering the plaintiff to answer the questions in issue.
ANALYSIS
i) obviousness
[6] Counsel for the plaintiff submitted that the information in the New Drug Submission concerning the proposed solution product is irrelevant to the issues of patent invalidity in the action on the basis that it was not asserted as prior art against the '037 patent. Furthermore, with respect to the question of obviousness, which must be determined as of the date of invention, she noted that the '037 patent has two components, namely a principal disclosure and a supplementary disclosure, with respective priority dates of August 2, 1985 and December 5, 1986. Since the New Drug Submission was not filed until September 28, 1990, she submitted that the evidence contained in that document could not be relevant with respect to obviousness on the basis that it postdated the date of invention. I agree with that submission. The contents of the New Drug Submission are therefore not relevant in assessing obviousness.
Page: 4
ii) insufficiency of disclosure
[7] Counsel for the plaintiff further submitted that the information in the New Drug Submission is irrelevant to the patent invalidity issue of insufficiency of disclosure on the basis that the '037 patent was issued and became public on October 22, 1991, more than one year after the filing of the New Drug Submission. As such, the plaintiff would not have been able to rely on any directions in the '037 patent in developing and formulating its proposed solution product. In support of her position, she relied on Allied Signal Inc. v. DuPont Canada Inc. (1995), 61 C.P.R. (3d) 417 (F.C.A.), in which the Federal Court of Appeal held that the date of the issuance of the patent was the material date for determining whether a patent was invalid for insufficiency of disclosure.
[8] In response to that position, counsel for the defendant noted that the '037 patent was a hybrid claim, containing a principal and a supplementary disclosure. In 1986 or 1987, a foreign patent, which contained the same information as at least part of the '037 patent, issued and was made publicly available prior to the filing of the New Drug Submission. As a result, he submitted that the plaintiff had access to the information which was ultimately contained in the '037 patent prior to preparing its New Drug Submission. He therefore submitted that the contents of the New Drug Submission were relevant in assessing the patent invalidity issue of insufficiency of disclosure.
[9] I cannot accept the submissions of counsel for the defendant. As a general principle, the question of insufficiency of disclosure must be determined in the context of the patent in
Page: 5 issue, and not with reference to any other documents or information. [See Beecham Canada Ltd. et al. v. Proctor & Gamble Co. (1982), 61 C.P.R. (2d) 1 (F.C.A.); Hi-Qual Manufacturing Ltd. et al. v. Rea's Welding & Steel Supplies Ltd. (1994), 55 C.P.R. (3d) 224 (F.C.T.D.)]. The question of insufficiency of disclosure must therefore be addressed in relation to the date of issuance of the '037 patent, and not a patent in a foreign jurisdiction. In other words, the foreign patent cannot be used to assist in the interpretation or construction of the '037 patent. In any event, I note that there is no evidence in the record to establish that the foreign patent is identical to the '037 patent. I have therefore concluded that the contents of the New Drug Submission, which the defendant alleges may be based on directions in the foreign patent, are not relevant in assessing the question of the insufficiency of disclosure in the '037 patent.
iii) utility
[10] With respect to the patent invalidity issue of utility, counsel for the plaintiff noted that
the test for determining the utility of an invention was outlined by Simpson J. in Visx Inc. v.
Nidek Co. Ltd. et al. (1995), 68 C.P.R. (3d) 272; affirmed 72 C.P.R. (3d) 19 (F.C.A.), in the
following terms, at page 275:
The true test of utility of an invention is whether it will, when put into practice by a competent person, do what it assumes to do, and be practical and useful at the time when the patent was granted for the purposes indicated by the patentee.
[111 Counsel for the plaintiff therefore submitted that, in applying the appropriate test for
utility, any toxicity or side effects caused by the plaintiff's product are irrelevant in assessing
Page: 6 the validity of the defendant's patent. I agree with that submission. In my opinion, utility
must be assessed in relation to the actual invention described in the patent, and not any other product. Alternatively, the contents of the New Drug Submission are not relevant in assessing the issue of utility on the basis that the directions in the '037 patent, which became public in October 1991, were not available to the plaintiff at the time of the preparation of the New Drug Submission in 1990. Furthermore, for the reasons indicated earlier, the directions in the foreign patent cannot be used in construing the '037 patent.
iv) development of plaintiffs product
[12] With respect to the questions concerning the chronology and development of the plaintiff's proposal solution product, counsel for the plaintiff submitted that the plaintiff's development work is not relevant in determining whether the defendant has complied with its duty of disclosure. I agree with that submission.
v) standing
[13] Counsel for the plaintiff also submitted that Giles A.S.P. erred in permitting the defendant to ask questions concerning the substantive content of the New Drug Submission in order to gather information relevant to the plaintiff's standing to bring the action. The plaintiff alleges, among other things, that it has standing to bring the patent impeachment action on the basis that the '037 patent prevents it from obtaining a Notice of Compliance for its solution product. In my opinion, there are sufficient objective facts available in order to permit the parties to argue at trial the question of standing. Furthermore, I am satisfied that
Page: 7 the contents of the New Drug Submission are irrelevant in determining whether the plaintiff is an interested person for the purposes of bringing its patent impeachment action.
tability
.v
[14] The laiiltiffjhas pleaded facts concerning the stability of reconstituted doxorubicin as
the relevant prior art. Counsel for the plaintif submitted, however, that w
comprising part o any evidence in th it could not have fo regards, counsel for the applied for a Notice of Co
New Drug Submission relating to stability is not relevant on the basis that ed part of the prior art at the material date in 1985 or 1986. In that laintiff noted that the plaintiff was incorporated in 1988, and only liance in 1990.
[15] Although counsel for the defendant addressed the stability issue, he did not respond directly to the submissions made by counsel for the plaintiff. Rather, he submitted that stability related to the question of utility, and that any information in the New Drug Submission relating to stability is relevant.
[16] Given that the material date for the assessment of the prior art in determining the validity of the defendant's patent is 1985 or 1986, I agree with counsel for the plaintiff that the requested information from the New Drug Submission, which was prepared in 1990, is not relevant on the stability issue for the purposes of the action.
Page: 8
vii) commercial success
[17] Finally, counsel for the plaintiff submitted that Giles A.S.P. erred in ordering the production of the plaintiffs projected sales figures for its proposed solution product. I agree. In my opinion, the speculative future sales of the plaintiff's proposed solution product are irrelevant in assessing the commercial success of the defendant's invention.
DECISION
[18] For these reasons, I have concluded that Giles A.S.P. was clearly wrong in ordering the plaintiff to answer all of the questions in issue. The appeal is allowed with costs. The plaintiff is also awarded its costs from the motion before Giles A.S.P.
OTTAWA
MCGILLIS
Judge
June 30, 1998
FEDERAL COURT OF CANADA TRIAL DIVISION
NAMES OF SOLICITORS AND SOLICITORS ON THE RECORD
COURT FILE NO.: T-421-97
STYLE OF CAUSE: FAULDING CANADA INC. v. PHARMACIA S.p.A.
PLACE OF HEARING: OTTAWA, ONTARIO
DATE OF HEARING: JUNE 25, 1998
REASONS FOR ORDER OF MADAME JUSTICE McGILLIS
DATED: JUNE 30, 1998
APPEARANCES
SUSAN BEAUBIEN REPRESENTING THE PLAINTIFF
GUNARS GAIKIS REPRESENTING THE DEFENDANT and
SHONAGH McVEAN
SOLICITORS OF RECORD:
SHAPIRO COHEN FOR THE PLAINTIFF OTTAWA, ONTARIO
SMART & BIGGAR FOR THE DEFENDANT TORONTO, ONTARIO