and
Beverley Moore
NOC PROCEEDINGS
Production of Product and Manufacturing Information Denied
Bristol-Myers Squibb Canada Co. et al v. Mylan Pharmaceuticals ULC et al.
Drug: efavirenz
This is an appeal of a decision of a Prothonotary, refusing to order Mylan to produce requested information about its manufacturing process and the crystal structure of efavirenz in its product. On appeal, the Applicants alleged that the Prothonotary imposed an unduly high and improper burden to justify production; that the Prothonotary erred in failing to follow a previous decision; and that the Prothonotary erred in considering the amount of documentary production already undertaken by Mylan. The Court dismissed the appeal.
The Court determined that that the standard of review was whether the Order was based upon a wrong principle or a misapprehension of the facts, given that the questions raised in the motion are not vital to the final issues. The Court found that the Prothonotary correctly identified the burden of proof as being on a balance of probabilities that the information requested was important, required and relevant. The Court further found that the Prothonotary did not misapprehend the expert evidence and that the Prothonotary properly distinguished the within case from that of the previous decision relied upon by the Applicants. Finally, the Court held that the reference by the Prothonotary to the amount of documentary production by Mylan was an observation made by the Prothonotary and not the basis for the decision.
OTHER CASES OF INTEREST
Motion to Convert Application to Action Denied
BBM Canada v. Research In Motion Limited
BBM brought an application for infringement, damages for infringement, depreciation of goodwill and passing off, punitive damages, injunctive relief and delivery up. Research in Motion (RIM) initially brought a motion to strike the application on the basis that there was no jurisdiction in the Federal Court to determine these issues by way of application. The Court held that the matters should not proceed by way of application and ordered the matter to proceed by way of action, but this decision was overruled by the Court of Appeal. Consequently, RIM brought the within motion to convert the application to an action.
The Court first considered whether it was possible to bring a motion to convert an application to an action. It concluded that it is possible, jurisdiction being found either in the Court's inherent jurisdiction to control its own process, or in Rule 3 which states that "these Rules shall be interpreted and applied so as to ensure the just, most expeditious and least expensive determination of every proceeding on its merits". The Court then outlined factors to consider when determining whether such a conversion is appropriate and concluded based on a review of the facts of the within case that the conversion was not appropriate. The Court dismissed RIM's motion.
Commissioner of Patents Allows Claims to Skin Equivalents
The Commissioner of Patents issued a decision allowing claims to aged skin equivalents; specifically an epidermis equivalent and an aged dermis equivalent. The Commissioner held that the components are made in vitro, and that everything claimed is the result of in vitro manipulations in a laboratory, performed by scientists or technicians. Furthermore, all the components of the claimed products are themselves patentable per se, and have been combined by a person. Thus, they do not equate to organs or tissues as described by the Harvard Mouse case or CIPO's 2006 Practice Notice.
The Commissioner also held that the artificial skin is "equivalent" to natural skin only insofar as it meets the Applicant's limited requirements. It is not structurally or functionally equivalent and does not approach the complexity of natural skin. Furthermore, it is anatomically and functionally different than true tissues or organs. Thus the patent was to proceed to allowance.
OTHER INDUSTRY NEWS
Health Canada published a revised Draft Guidance Document Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format.
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