2011 FC 626, (May 27, 2011)

This is an appeal of an Order whereby Madam Prothonotary Tabib allowed Lilly to amend its Statement of Claim after the Statement of Defence had been served but prior to examinations for discovery.  Lilly had originally alleged infringement of its '881 Patent which covered a process known as the SN2 reaction.  Hospira countered by alleging that it used a process known as a SN1 reaction.  The proposed amendment included a claim that the '881 SN2 process was the only cost-effective commercial process, and added an infringement allegation for an additional patent which covered the SN1 process.

Lilly's proposed amendment followed the production of documents related to Hospira's supplier's manufacturing process.  Lilly had sought and obtained a further and better affidavit of documents, including (1) the open part of Hospira's Drug Master File; and (2) the relevant and unredacted parts of its ANDS filed with the Minister of Health which led to its obtaining the NOC; and (3) the master production batch records which would disclose the exact nature of the reaction Hospira's supplier (Hansen) used.  Lilly had also issued a subpoena in the U.S. for the deposition of the vice-president of supplier's North American sales and regulatory agent.

Hospira had argued before the Prothonotary that it was abusive for Lilly to have obtained the process documents it did based on an affirmation that the SN2 reaction was commercially viable and then to use these details to assert infringement of another patent. The Prothonotary did not agree.

Reviewing the Prothonotary's decision de novo, the Federal Court upheld the order allowing the amendments.  There was no withdrawal of an admission, it was early on in the case (there had not yet been oral discovery) and the new cause of action was not a radical departure because the issue of the process used in the imported product, be it the SN1 or SN2 reaction, was always on the table.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2011/2011fc626/2011fc626.html