Faulding Canada Inc. v. Pharmacia S.p.A.
T-421-97
McGillis J.
30/6/98
8 pp.
In 1990, plaintiff filed New Drug Submission (NDS), seeking regulatory approval to market drug doxorubicin hydrochloride-Plaintiff required to take position in relation to two patents owned by defendant-In respect of one of these, patent 1,291,037 (_037), plaintiff seeking, in present action, impeachment of defendant's patent on basis not invention, and, in any event, invention not novel-Plaintiff further alleged patent invalid for insufficiency of specification, insufficiency of disclosure or lack of utility-During course of examination for discovery, defendant sought information and documents from plaintiff's confidential NDS in respect of its proposed product (pertaining to formulation, method of manufacture, finished product specifications, toxicity, stability and comparative efficacy)-Also sought production of plaintiff's sales projections for and information related to development of its proposed product, as well as product stability data-Plaintiff refused to answer all questions concerning those subjects-Appeal from Giles A.S.P.'s order requiring plaintiff to respond to those questions on examination for discovery-Issue whether Giles A.S.P. clearly wrong in so ordering-Appeal allowed-With respect to obviousness, contents of NDS not relevant in assessing obviousness as evidence therein postdated date of invention-Information in NDS irrelevant with respect to issue of insufficiency of disclosure on basis _037 patent issued and became public in October 1991, more than one year after filing of NDS-Plaintiff therefore could not have been able to rely on any directions in _037 patent in developing and formulating its proposed product-As general principle, question of insufficiency of disclosure must be determined in context of patent in issue, and not with reference to any other documents or information-Foreign patent similar to _037 patent cannot be used to assist in interpretation or construction of '037 patent-In any event, no evidence in record to establish that foreign patent identical to _037 patent-With respect to issue of utility, in applying appropriate test for utility, any toxicity or side effects caused by plaintiff's product irrelevant in assessing validity of defendant's patent-Chronology and development of plaintiff's proposed product, plaintiff's development work not relevant in determining whether defendant complied with duty of disclosure-Sufficient objective facts available to permit parties to argue at trial question of standing-Contents of NDS irrelevant in determining whether plaintiff interested person for purposes of bringing patent impeachment action-Given material date for assessment of prior art in determining validity of defendant's patent 1985 or 1986, requested information from NDS, prepared in 1990, not relevant on stability issue for purposes of action-Finally, Giles A.S.P. erred in ordering production of plaintiff's projected sales figures for proposed product as irrelevant in assessing commercial success of defendant's invention.