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Apotex receives divided success on its motion to amend on the eve of trial

With only a few days remaining before trial, Apotex brought a motion to amend its Further Amended Statement of Defence to include references to the parent application (the 574 Application) related to a divisional patent (the 851 Patent) originally pleaded in support of its Gillette Defence. In pleading its Gillette Defence, Apotex relied on the 851 Patent “published on April 29, 2004 and issued on April 30, 2013.”

Apotex proposed two amendments:

  1. Clarifying that the publication date of the 851 Patent mentioned in its pleading, “April 29, 2004”, referred to publication of the 574 Application; and
  2. Pleading that the allegations regarding its Gillette Defence apply, with necessary modifications, to the 574 Application.

Under Rule 75 of the Federal Courts Rules, the Court may, at any time, allow a party to amend a document on such terms as will protect the rights of the parties. The general rule is that an amendment should be allowed at any stage of the proceeding for the purpose of determining the real issues if it would serve the interests of justice. If, as a threshold proposition, it is established that the proposed amendment has a reasonable prospect of success, the Court will go on to consider factors relevant to the interests of justice, including:

  • The timeliness of the motion to amend;
  • The extent to which the amendments would delay the expeditious trial of the matter;
  • The extent to which a position taken originally by one party has led another party to follow a course of action in the litigation which it would be difficult or impossible to alter; and
  • Whether the amendments will facilitate the Court’s consideration of the true substance of the dispute on its merits.

Justice Furlanetto allowed Apotex’s first proposed amendment, noting that the reference to the 574 Application being published on April 29, 2004 is “a clarification of the facts that cannot be disputed – i.e., as the parent application, the 574 Application was the document actually published on April 29, 2004.” There was no prejudice to Takeda because the amendment clarified a relationship already reflected on the face of and within the patent documents.

Justice Furlanetto disallowed Apotex’s second proposed amendment for want of material facts to support the allegation. In support of its Gillette Defence, Apotex originally alleged that “the pharmaceutical compositions used in the Apotex Product are consistent with the teachings of the 851 Patent and are encompassed within the scope of at least claims 1 to 3, 7 and 8 of the 851 Patent.” Apotex’s second proposed amendment did not specify which portions of the 574 Application were asserted to cover the preparation of the Apotex Product.

Though Apotex had provided some notice of what portions of the 574 Application it considered relevant by way of evidence, there were outstanding issues for trial relating to that evidence, including:

  • Which party had the onus to lead evidence on the Gillette Defence; and
  • Takeda’s objection to Apotex’s Gillette Defence evidence as being improper case splitting.  

These outstanding issues for trial grounded Takeda’s prejudice argument.

Justice Furlanetto allowed only the first proposed amendment to the extent that it clarified the pleaded publication date referred to the publication of the 574 Application.

A copy of the decision is available here.