Sepracor v. Pharmascience; appeal of an interlocutory motion to strike a notice of appearance; June 27, 2008; desloratadine;

The Court of Appeal overturned the motions judge's decision striking the notice of appearance. The Court of Appeal held that a respondent who does not oppose an application is entitled to file a notice of appearance in a modified form to reflect their interest in the proceedings. In this case, the respondent patentee will thus be "fully able to represent its interest as befits someone who is intended to be bound by the result".

The Court of Appeal saw that there is little advantage to a person who has the rights and status of a party being required to seek the limited discretionary status of an intervener. Furthermore, the respondent patentee did not need to be added as an applicant. Any procedural fairness and orderliness issues could be dealt with by way of case management as they arise.

The full text of the decision can be found at:

http://decisions.fca-caf.gc.ca/en/2008/2008fca230/2008fca230.html

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Laboratoires Servier v. Apotex; merits of infringement proceeding; July 2, 2008; perindopril

The trial judge found the patent to be valid and infringed. The Court also dismissed the Competition Act counterclaim.

The Court found that Apotex directly infringed the patent. However, there was no inducement of infringement as the evidence indicated that title does not pass until the product is delivered in the destination country. The Court also found that the non-ADIR foreign plaintiffs did not have standing to bring a claim as the evidence did not show that they were licensed.

Apotex argued that the patent was invalid due to obviousness, utility, sound prediction, inventorship and missed conflict. On each of these issues, the Court found the patent to be valid.

Furthermore, Apotex alleged a conspiracy pursuant to the Competition Act. This alleged conspiracy stemmed from a settlement that arose from a conflict proceeding. The settlement happened prior to the grant of the patents. Thus, the Court found that there was no market power and no impairment of competition at that point. Furthermore, the rules and practices of the Federal Court allow for the settling of actions. Thus, the Court dismissed Apotex' claim under the Competition Act. The Court further found that Apotex was beyond the two-year limitation period in the Competition Act and thus was statute barred from bringing the claim.

The Court also granted the plaintiffs the ability to elect an accounting of profits instead of damages if they so choose. However, the Court declined to order compound interest. The Court and parties agreed it would be premature to make a determination regarding punitive or exemplary damages prior to the reference on damages.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2008/2008fc825/2008fc825.html  

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Nu-Pharm v. Canada (Minister of Health); appeal of summary judgment motion; July 3, 2008; enalapril

The Court of Appeal upheld a summary judgment decision dismissing Nu-Pharm's action on the basis that there was no genuine issue for trial.

In 1997, Nu-Pharm filed an ANDS comparing its drug NU-ENALAPRIL to APO-ENALAPRIL. The Federal Court granted a judicial review and allowed Health Canada to review Nu-Pharm's ANDS. When Nu-Pharm received its Notice of Compliance (NOC), Merck applied for an order quashing the NOC. This was granted in 1999 and upheld by the Court of Appeal. After the decision of the Court of Appeal, the Minister of Health wrote to the Provincial Drug Benefit Managers and advised that Nu-Pharm's NOC was no longer valid and NU-ENALAPRIL products could no longer be sold as it was contrary to the Food and Drug Regulations.

Nu-Pharm commenced a judicial review of this decision. Nu-Pharm also filed a Statement of Claim seeking damages from the Ministry of Health. Nu-Pharm then discontinued the judicial review and maintained only the damages action.

The Court found that the success of Nu-Pharm's action in damages is entirely dependent upon Nu-Pharm showing the unlawful character of the decision of the Ministry. If Nu-Pharm wishes to challenge that decision, it must do so by judicial review. It cannot by-pass the requirements of the Federal Court Act. The within action was found to be collateral attack or an indirect challenge to the decision.

The full text of the decision can be found at:

http://decisions.fca-caf.gc.ca/en/2008/2008fca227/2008fca227.html  

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Eli Lilly v. Novopharm; appeal of scheduling order; July 16, 2008; olanzapine

In the Scheduling Order, the case management Prothonotary reversed the order of evidence with respect to invalidity. The Court also set a schedule for evidence. Novopharm appealed and the Court dismissed the appeal.

The Court held that scheduling matters are discretionary in nature and a Prothonotary's decision should be left undisturbed unless the questions are vital to the final issue of the case.

The Court held that reversing the order of evidence is explicitly contemplated by the Practice Direction of the Court. Thus, the Prothonotary had the jurisdiction to do so. Accordingly, there was no error of law and there was nothing clearly wrong in the exercise of the Prothonotary's discretion.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2008/2008fc875/2008fc875.html  

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Novopharm v. "Company X"; interlocutory motion to issue a Confidential Statement of Claim; July 4, 2008

The Court dismissed Novopharm's motion to maintain the Statement of Claim as confidential in the proceeding.

Initially, the Court refused to clear the court room as it is only in the rarest of circumstances where in camera hearings should be permitted.

Novopharm argued that it wished to protect its commercial interest in the development of its "X" product as the confidentiality of its business strategy is important and it would suffer prejudice if this is disclosed. Competitors could learn of the name of the defendant and the details of the patent and "catch up" with Novopharm to enter the market at the same time, causing Novopharm to lose generic exclusivity. It also tried to argue that it should be granted this exclusivity because it is proceeding by way of impeachment action instead of by way of proceeding under the PM(NOC) Regulations, thus it is seeking judicial economy.

The Court held that without having the benefit of the input of the defendant or the Minister of Health or the Attorney General or other potentially interested parties, the Court should be leery of granting a Confidentiality Order. Confidentiality Orders in both PM(NOC) proceedings and patent actions generally protect documents dealing with trade-secrets, drug formulations and the like. It is naïve to believe that the public has any interest in this information. However, in this case, the applicant is seeking to protect information that the public does have an interest in knowing: the parties that appear before the Court and the issues of the proceeding, including the name of the drug. Thus, the motion must be dismissed.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2008/2008fc840/2008fc840.html  

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Bayer Inc. v. The Minister of Health et al., judicial review of listing decision, July 10, 2008,

The Court upheld decisions of the Minister of Health to not list a patent in respect of submissions for two drugs on the basis that the patent claims were not claims to the dosage form nor did the SNDS represent a change in dosage form. The claims at issue related to a transdermal drug delivery device comprising, a carrier (patch), including a drug, a dessicant and a package containing the carrier and dessicant. The Court found that the invention was the product packaging that enhances the stability and performance of the drug, but that the claim was not in the Court's view a dosage form or novel delivery system in the sense intended by the PM(NOC) Regulations.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2008/2008fc857/2008fc857.html