Canada: Order Of Prohibition Issues – No Promise To Treatment In Humans Or Reduced Side Effects Was Found (Intellectual Property Weekly Abstracts Bulletin (Week Of April 28, 2014)

Patent Cases

Order of Prohibition Issues – No Promise to Treatment in Humans or Reduced Side Effects was Found

Pfizer Canada Inc. v. Apotex Inc., 2014 FC 314

Drug: celecoxib

Pfizer's Canadian Patent No. 2,177,576 for Celebrex® has withstood Apotex's allegations and was found to be valid; therefore the Minister is prohibited from issuing a NOC to Apotex. Apotex had alleged that the inventors lacked demonstrated utility or a sound prediction of utility at the time of filing, and that the patent was not properly disclosed. Celebrex® is used for treating inflammation and associated pain.

The same '576 patent had been considered twice previously, once where the patent was construed to claim both the anti-inflammatory properties and lesser side effects, and once where there was no promise of reduced side effects.

The Court noted that the patent refers to the treatment of a "subject", not humans. The patent described testing in rats, and thus demonstrated its utility in rats. Since that was all that was promised, that was all that needed to be delivered. Following the recent jurisprudence from the Court of Appeal, the judge found that this means there was no clear promise that Celebrex® would be useful in treating inflammation in humans.

A similar decision was made in regard to whether the patent promised reduced side effects. Although the Court noted that the patent specification referred to side effects, a statement of mere advantage, or a target, without more, is not a promise.

Lastly, the patent was not found to be insufficient. The Court held that the true invention was a class of compounds. The claims narrowed down from a genus of compounds to three individually claimed compounds, and the Court found that all three compounds had demonstrated utility. Although claim 4 was the lead compound at the time, there was no obligation for the patentee to disclose that hope, as the best mode requirement applies to machines. Also, the Court said that a person of skill in the art would find it surprising if all the compounds made it to market, as commercial viability depends on a number of factors which would be developed later in the process.

Apotex has appealed the decision (A-194-14).

Supreme Court Denies Apotex Leave to Appeal; Prohibition Order Stands

Apotex Inc. v. Eli Lilly Canada Inc., et al., leave to appeal to SCC refused, 35714 (April 24, 2014)

Drug: olanzapine

The Supreme Court of Canada (SCC) denied Apotex leave to Appeal the decision of the Federal Court of Appeal (FCA) in a s. 8 case (decision here, summary here). Apotex had brought a motion requesting the Court to set aside a prohibition order. Apotex was unsuccessful in its NOC proceeding. However, the patent was held invalid in an action (FCA decision here). The FCA upheld the Motion's Judge's decision refusing to set aside the prohibition order. The FCA held that it was bound by its own decisions and that if Apotex wanted to argue that those previous decisions were bad law, it should seek leave to appeal to the SCC. The SCC then denied that leave.

Trade-Marks Cases

Default Judgment Awarded in respect of Infringement of Registered Trade-mark

Teavana Corporation v. Teayama Inc., 2014 FC 372

The Plaintiff commenced an action for trade-mark infringement, passing off and depreciation of goodwill. The Plaintiff owns one registered trade-mark, TEAVANA, in relation to particular services, and has two pending trade-mark registrations. The Defendant failed to respond to the Statement of Claim, and the Plaintiff brought this ex parte motion for default judgment.

The Court considered sections 19 and 20 of the Trade-marks Act and whether the evidence demonstrated that the Defendant's trade-mark/trade-name TEAYAMA is confusing with the Plaintiff's trade-mark TEAVANA. After considering each of the factors under section 6 of the Trade-marks Act, the Court concluded that the Defendant infringed the trade-mark TEAVANA. The Court also found that the Defendant contravened section 7(b) of the Trade-marks Act. However, the Court found that there was insufficient evidence to make a finding of passing off pursuant to section 7(c), depreciation of goodwill pursuant to section 22 or with respect to the use of the pending trade-marks.

The Plaintiff claimed $25,000 in damages but the Court awarded $10,000, holding that the Plaintiff could not properly address damages because of the failure of the Defendant to appear in the proceeding but an amount for compensatory damages can be fixed by the Court in the absence of proof of the amount of damages.

Copyright Cases

Court Assesses Statutory Damages for Breach of Copyright in Language Proficiency Tests

Attorney General of Canada v. Rundle, 2014 ONSC 2136

This was an uncontested assessment of damages for breach of copyright. The Plaintiff obtained summary judgment (decision here) and the Court directed that the Plaintiff's damages be determined at trial.

The Defendant in this case provided language training services to federal public service employees. It was determined at the summary judgment hearing that the Defendant ignored Crown copyright and assisted students by improperly providing access to confidential and test-specific training. The Public Service Commission (the "PSC") incurred significant costs when it was required to design and implement replacement testing when it became apparent that the integrity of six different tests had been compromised. The Plaintiff argued that it was entitled to damages from breach of copyright, breach of confidence and punitive damages, but requested only statutory damages for breach of copyright and punitive damages. The Plaintiff sought the maximum in statutory damages ($20,000) for each of the six tests that were compromised and replaced, as well as punitive damages of $15,000.

The Court held that, generally, while punitive damages are available in addition to an award of statutory damages, such an award was not appropriate here. On the specific facts of this case, including the important role of deterrence as a factor in assessing damages in copyright cases, the Court held that statutory damages were sufficient without awarding an additional amount for punitive damages. After considering the relevant factors, the Court awarded damages of $7,500 for each of the breaches of copyright in four tests and $15,000 for each of the two replacement tests. The Court found that a higher award for the two replacement tests was justified because the tests were implemented after the PSC initially ascertained that the copyright and confidentiality of certain tests had been compromised, and because the Defendant continued her infringing activity after the replacement tests were put in use.

Therefore, the Court awarded statutory damages totalling $60,000 and costs to the Plaintiff on a partial indemnity basis.

Other Industry News

The PMPRB has published a new analytical report: Utilization of Prescription Opioids in Canada's Public Drug Plans, 2006/07 to 2012/13.

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