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Court has broad discretion to order production of pharmaceutical samples – Rule 249

On February 19, 2013, the Federal Court of Appeal, in series of three decisions clarified that the Rule 249 provides the Court with  broad discretion to order the production of  drug samples in pharmaceutical patent litigation.  In the decision with the most substantive reasons, Apotex appealed an order of Justice Rennie who had dismissed appeals from three decisions of a Prothonotary permitting Eli Lilly to obtain samples of Apotex’s bulk raloxifene hydrochloride.  In the second matter Apotex has similarly sought to appeal an order requiring it to produce samples of escitalopram to Lundbeck. In the third matter, Apotex sought to appeal an Order requiring it to produce samples of bulk esomeprazole magnesium, blends, tablet cores and finished tablet to AstraZeneca.

Rule 249 of the Federal Court Rules provides:

249. (1) On motion, where the Court is satisfied that it is necessary or expedient for the purpose of obtaining information or evidence in full, the Court may order, in respect of any property that is the subject-matter of an action or as to which a question may arise therein, that

(a) a sample be taken of the property;

(b) an inspection be made of the property; or

(c) an experiment be tried on or with the property.

The Court concluded, consistent with various provincial Rules, that “necessary” in Rule 249 is understood to mean that there is a reasonable possibility that the proposed test will reveal something useful for the trier of fact. The Court rejected Apotex’s submission that the test under Rule 249 is more stringent, requiring that the proposed tests be the “only means” for the other party to establish their case and used only in exceptional cases as a “last resort”.

The Court held that since the test for Rule 249 is clear it would be unwise for the Court to provide a more detailed and strict guidelines in respect of its application. In pharmaceutical patent cases Rule 249 may serve to supplement otherwise insufficient disclosure available. In such cases, expediency may be a major factor in the Court exercising its discretion:

[15] Usually, the information that is available through discovery (for example, a full and detailed description of the property or machinery or photographs thereof) is sufficient to satisfy all the interests at play. However, in complex pharmaceutical patent cases like the present ones, the usual mechanisms of discovery may well not suffice and parties will often have to rely on Rule 249. Of course, orders will still only issue upon the Federal Court being satisfied that the requirements of Rule 249 have been met.

[16] In such cases, “expediency” may well be a major factor for the Court in exercising its  discretion (Richter Gedeon Vegyészeti Gyar RT v. Apotex Inc., Order of Lutfy, A.C.J. dated 4  December 2000, Docket T-2520-93; Richter Gedeon Vegyészeti Gyar RT v. Apotex Inc., 2002 FCT  1284, affirmed 2003 FCA 221; Glaxo Group Ltd. v. Novopharm Ltd, 87 A.C.W.S. (3d) 356, [1999]  F.C.J. no. 381 (QL) (F.C.T.D.))

A copy of the raloxifene Reason for Judgment (2013 FC 45) may be found here.

A copy of the escitalopram Reason for Judgment (2013 FC 46) may be found here.

A copy of the esomeprazole Reason for Judgment  (2013 FCA 47) may be found here.