Hospira v. Attorney General, judicial review of refusal of NDS, drug unknown, February 25, 2010

In this case Hospira had sought regulatory approval by the filing of a new drug submission (NDS), but which did not include independent preclinical or clinical trial data. Hospira took the position that it could satisfy the need to establish safety and efficacy with evidence publicly available, such as through literature references and reports of postmarketing experience. The Minister of Health rejected Hospira’s application after screening the applicant’s material and determining that the NDS did not comply with the requirements of the Food and Drug Regulations.

Hospira brought an application seeking, inter alia, the issuance of an NOC upon completion of review of its NDS for compliance with Food and Drug Regulation C.08.002 (but excluding (g) and (h). Hospira argued that the C.08.002 does not use the words clinical trial data or pre-clinical and that the Minister ought to have assessed the reports and evidence submitted to determine if they are sufficient to establish safety and efficacy. Hospira argued that the Minister interpreted the provision narrowly and thereby fettered its discretion.

The Court affirmed the Minister’s decision and found that the Minister’s view that pre-clinical and clinical data is implicitly required is certainly a reasonable interpretation of the Food and Drug Regulations that falls within the range of acceptable outcomes. Therefore, the Court found that the decision should stand not be interfered with on the application of the reasonableness standard to the Minister’s interpretation of its home statute and related regulations.

Notwithstanding this finding the Court went on to consider other arguments of the applicant as to whether the Minister fettered its discretion. The Court found that the Minister had not fettered its discretion as the Minister had considered the specific circumstances of the case extensively before applying its policy to require clinical data.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2010/2010fc213/2010fc213.html

Apotex v. Merck, judgment in s. 8 proceeding, norfloxacin, March 12, 2010

The Court provided rendered judgment in the section 8 norfloxacin case involving Apotex and Merck. The Court found that Apotex must show, on a balance of probability, that it was prevented from getting into the market because of the prohibition application. In that case, the Court found that Apotex could not have entered the market when it received its NOC because of various issues with its suppliers. Consequently, while the Court did award section 8 damages, it reduced the period by one year because it found Apotex would have not been able to get into the market until one year after it received its NOC. The case also confirms that the burden is on the second person to show that it could have entered the market when its NOC became approvable.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2010/2010fc287/2010fc287.html

Lilly v. Novopharm, interlocutory motion for Mareva injuction, olanzapine, March 2, 2010

The Court denied Novopharm’s request for an extraordinary remedy, namely, an order in the nature of a mareva injunction enjoining Lilly Canada for transferring its revenues to its parent company. In the alternative, Novopharm sought an order requiring Lilly Canada to post security for damages which are being yet to be quantified, which will be awarded pursuant to section 8 of the PMNOC Regulations. Finally, Novopharm sought that Lilly disclose its financial accounts to Novopharm on a quarterly basis.

The Court dismissed the motion on the basis that, while it is possible to have a Mareva injunction issued before liability has been determined, Novopharm had not met the test for the granting of the requested remedy. For example, Novopharm had failed to provide an undertaking as to damages and the Court did not accept Novopharm’s submission that the Court had already determined that Novopharm was entitled to section 8 damages. While the Court had previously had adjudged that Novopharm is entitled to relief under section 8, to be determined in a separate proceeding, this is not the liability that makes it a certainty that Lilly will have to pay damages to Novopharm.

The Court noted Lilly Canada’s submissions that section 8(5) of the PMNOC Regulations provides that, in assessing the amount of compensation, the Court shall take into account all matters it considers relevant to the assessment of the amount and that, in this case, circumstances exist that if Novopharm had not withdrawn its first notice of allegation (NOA), it may not have been delayed in bringing its product to market and further language that came out of that first proceeding, whereby it was Novopharm’s choice to withdraw a first NOA with prejudice with respect to section 8.

Finally, the Court noted that Novopharm has been unable to convincingly establish any amount as the likely award that it would receive in any section 8 decision. Consequently, it would be inappropriate to issue an order as requested in this circumstance.

Further, the Court found that Novopharm had failed to establish, on the balance of probabilities, that Lilly Canada will be unable to satisfy a judgment.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2010/2010fc241/2010fc241.html

Sanofi and Schering v. Novopharm, motion to strike in s. 8 case, ramipril, February 12, 2010

The Court considered motions brought by the defendants, the Sanofi companies and Schering, to strike out portions of Novopharm’s Statement of Defence and Counterclaim relating to a section 8 claim under the PMNOC Regulations. Inter alia, the Defendant Schering was seeking to have all paragraphs relating to a section 8 claim removed against it and to be removed as a party.

While the Court discussed the meaning of the words “first person” under the PMNOC Regulations and that it may include persons other than persons who filed the NDS and patent lists, such as was previously noted in the Lilly Court of Appeal decision cited, here Novopharm’s pleadings with respect to Schering and broader interpretation of first person, would not enable the Court to make a finding that Sanofi Canada had been an agent, directed and controlled by Schering. Schering and Sanofi were unrelated parties and Novopharm had not plead that Schering was a first person exercising complete control over Sanofi Canada. Because of this, it is plain and obvious that Novopharm’s section 8 claim against Schering was clearly doomed to fail.

Certain paragraphs of the pleading sought to be struck out by Sanofi were also removed, namely: reference to permanent market loss and market share. The Court commented that reference to permanent loss and market share and the alleged denial of an opportunity to enhance Novopharm’s reputation affecting the introduction of new products in advance of competitors, is not relevant to the calculation of damages under section 8. In this regard, the Court commented on the Court of Appeal’s decision in Apotex v. Merck, whereby the Court commented that the Governor General chose to limit the measure of losses under section 8 to the period, namely: that this excludes compensation for losses occurring in future years since such losses cannot be said to have been suffered during the period.

A similar dismissal of Schering as a party occurred in a Sanofi, Schering v. Apotex proceeding on February 22, 2010.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2010/2010fc150/2010fc150.html