Date: 19990319
Docket: T-431-94
BETWEEN:
GLAXO GROUP LIMITED and
GLAXO WELLCOME INC.
Plaintiffs
- and -
NOVOPHARM LIMITED
Defendant
REASONS FOR ORDER
EVANS J.:
[1] Glaxo has instituted proceedings alleging that Novopharm is infringing its patent in ranitidine hydrochloride in crystalline form, known as form 2. Novopharm's defence includes an allegation that the patent is invalid because form 2 is not a "new substance" for the purpose of subsection 39(2) of the Patent Act, and is obvious once form 1 has been discovered.
[2] In this motion, Novopharm seeks an order that Glaxo provide samples of ranitidine hydrochloride raw materials produced by Glaxo in the years 1977-1980. This period runs from the time that Glaxo started its experiments until the date when it claimed the discovery of form 2.
[3] Glaxo opposes the motion for the production of samples on the ground that the samples are not "necessary or expedient" within the meaning of Rule 249 of the Federal Court Rules, 1998 SOR/98-106 for enabling Novopharm to obtain "information or evidence in full" of any fact relevant to the defences that it has raised in the pleadings.
[4] On the evidence before me I am satisfied that Novopharm is entitled to an order requiring Glaxo to produce samples of the materials for experiments or batches from the years in question. An analysis of the samples will provide evidence of whether particular properties of form 2 are attributable to impurities or are inherent in form 1, and will be relevant to the defences of obviousness and "no new substance" raised by Novopharm. Moreover, unless Novopharm can conduct its own analysis, it will be dependent on the results reported by Glaxo.
[5] More difficult, however, is the amount of the materials to which Novopharm should be entitled. It is clear from the case law that inspection of property, including the production of samples, is exceptional and any order made should not unduly intrude on the rights of the party against whom the order is sought. In this case, Glaxo is concerned that Novopharm should not be entitled to a size of sample from a particular batch that would leave Glaxo with an insufficient amount to enable it to protect its own interests in this litigation and in any potential litigation in which it may be involved with respect to form 2, particularly since the batches in question are by now quite old.
[6] On the basis of the expert evidence submitted by the parties, I have concluded that Novopharm normally requires a minimum of 230 mg. of the material sought to conduct infra-red and x-ray analyses, using the methodologies currently employed and adopting a procedure that is most economical of the material.
[7] It seems to me that the size of sample to which Novopharm is entitled should not exceed more than one third of that particular batch in the possession of Glaxo, and that where the amount is less than 200 milligrams, Novopharm should be entitled to none of it.
[8] In view of the fact that neither party can claim a total victory in this motion, costs of the motion are in the cause.
"John M. Evans"
J.F.C.C.
TORONTO, ONTARIO
March 19, 1999
FEDERAL COURT OF CANADA
Names of Counsel and Solicitors of Record
COURT NO: T-431-94
| STYLE OF CAUSE: GLAXO GROUP LIMITED and |
GLAXO WELLCOME INC.
- and -
NOVOPHARM LIMITED
DATE OF HEARING: MONDAY, MARCH 15, 1999 and
FRIDAY, MARCH 19, 1999
PLACE OF HEARING: TORONTO, ONTARIO
REASONS FOR ORDER: EVANS J.
DATED: FRIDAY, MARCH 19, 1999
APPEARANCES: Mr. Peter R. Wilcox
For the Plaintiffs
Ms. Carol Hitchman
For the Defendant
SOLICITORS OF RECORD: Smart & Biggar
Barristers & Solicitors
| Box 111 |
| 1500-438 University Ave. |
Toronto, Ontario
| M5G 2R8 |
For the Plaintiffs
Hitchman & Sprigings
Barristers & Solicitors 2340-120 Adelaide St. W.
Toronto, Ontario
M5H 1T1
For the Defendant
FEDERAL COURT OF CANADA
Date: 19990319
Docket: T-431-94
Between:
GLAXO GROUP LIMITED and
GLAXO WELLCOME INC.
Plaintiffs
-and-
NOVOPHARM LIMITED
Defendant
REASONS FOR ORDER