Mr Kevin Siu

Kevin Siu

Updates

Healthcare & Life Sciences

No Section 8 liability for valid and infringed patent in Nexium proceeding
Canada | 18 April 2018

If a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) Regulations against a generic entrant, but subsequently prevails in an infringement action regarding the same patent, can it be liable for Section 8 damages under the regulations? According to a recent Federal Court decision, the answer appears to be no.

Appeal of summary dismissal under PMNOC Regulations: dismissal order stayed
Canada | 28 February 2018

The Federal Court recently dismissed a Patented Medicines (Notice of Compliance) Regulations application concerning Apotex's generic aripiprazole product on a summary basis under Section 6(5)(b) of the regulations. An appeal was subsequently filed. On December 15 2017 the Federal Court of Appeal granted a motion by the appellants to stay the dismissal order until the appeal could be heard. The appeal was recently allowed on the parties' consent.

Federal Court grants summary dismissal motion under PMNOC Regulations
Canada | 14 February 2018

The Federal Court recently issued its judgment in Bristol-Myers Squibb v Apotex Inc, in which it granted Apotex's motion under Section 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations. As a result, the court granted an order dismissing the underlying application in respect of Apotex's proposed generic aripiprazole product.

Government issues statement of intended actions to implement CETA
Canada | 15 November 2017

Global Affairs Canada recently published its statement of intended actions regarding the implementation of the Canada-EU Comprehensive Economic and Trade Agreement, which has been provisionally applied since September 21 2017. The document summarises the Canadian government's position on its obligations and how it intends to implement the treaty. A number of the document's chapters are relevant to the pharmaceutical industry.

Life sciences update
Canada | 13 September 2017

Recent life sciences developments include the release of the Patented Medicine Prices Review Board's July 2017 newsletter, the issuance of a Common Drug Review Update by the Canadian Agency for Drugs and Technologies in Health and the release of the Therapeutic Products Directorate Statistical Report 2016/2017 by Health Canada.

Gilead prevails in SOVALDI appeal
Canada | 06 September 2017

The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead's SOVALDI (sofosbuvir). In the trial decision, the court had declared Idenix's patent invalid on the basis of insufficiency of disclosure and inutility, while upholding the validity of Gilead's patent. While the case did not raise new issues of law, some points arose which may have broader applicability to future cases.

Ontario Superior Court dismisses summary judgment motion in Lansoprazole Section 8 claim
Canada | 10 May 2017

A recent Ontario Superior Court of Justice decision is significant to patentees and innovative drug companies facing a claim brought under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. First, the decision illustrates the importance of motions for summary judgment and the associated risk of dispositive findings. Second, it adds to the growing jurisprudence on the relationship between Health Canada's regulatory approval process and Section 8 of the regulations.

Federal Court denies prohibition of generic combination tablet
Canada | 30 November 2016

The Federal Court recently dismissed Gilead's prohibition application against Apotex for its tenofovir disoproxil fumarate (TDF) and emtricitabine fixed-dose combination tablet. Gilead sought to prohibit the issuance of a notice of compliance until the expiry of Patent 2,512,475, which claims a formulation comprising TDF and emtricitabine. However, the court found that Apotex's allegations of invalidity were justified on the basis of anticipation and obviousness.

Federal Court prohibits issuance of notice of compliance to Teva for atazanavir sulfate
Canada | 07 September 2016

The Federal Court recently issued an order under the Patented Medicines (Notice of Compliance) Regulations prohibiting the minister of health from issuing a notice of compliance to Teva for atazanavir sulfate (Bristol-Myers Squibb's (BMS) Reyataz) until expiry of Novartis AG's Patent 2,250,840. The court dismissed the prohibition application relating to BMS's Patent 2,317,736.

Federal Court grants Janssen nearly C$20 million against Teva for patent infringement
Canada | 24 August 2016

The Federal Court recently issued its judgment on the quantification of damages arising from infringement of Daiichi Sankyo's Patent 1,304,080 for levofloxacin. In the earlier liability phase of the action, Teva (then Novopharm) was held liable for damages for patent infringement. The court awarded a total of C$18,841,219 in damages and pre-judgment interest to the two plaintiffs.

Intellectual Property

No Section 8 liability for valid and infringed patent in Nexium proceeding
Canada | 23 April 2018

If a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) Regulations against a generic entrant, but subsequently prevails in an infringement action regarding the same patent, can it be liable for Section 8 damages under the regulations? According to a recent Federal Court decision, the answer appears to be no.

Court declares that administrative errors during application cannot void issued patent
Canada | 27 November 2017

The Federal Court of Appeal recently ruled that Pfizer's failure to pay the correct issue fee did not render its patent void. In the context of a Section 8 case, Apotex had brought a partial summary judgment motion to have Pfizer's patent declared void for failure to comply with the Patent Act. The court cited the general principle that "pre-patent issuance defects in the administrative process for applying for a patent cannot be relied upon by an alleged infringer to render a patent void".

A new frontier for global IP litigation
Canada | 25 September 2017

A series of recent cases, from big trials to precedent-setting appeals before the Supreme Court, have garnered international attention from IP owners. With these decisions, changes in law and improved court procedures for assisting litigants in getting to trial and obtaining interlocutory remedies more efficiently, Canada is proving to be an attractive jurisdiction for the protection and enforcement of IP rights.

Gilead prevails in SOVALDI appeal
Canada | 11 September 2017

The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead's SOVALDI (sofosbuvir). In the trial decision, the court had declared Idenix's patent invalid on the basis of insufficiency of disclosure and inutility, while upholding the validity of Gilead's patent. While the case did not raise new issues of law, some points arose which may have broader applicability to future cases.

Ontario Superior Court dismisses summary judgment motion in Lansoprazole Section 8 claim
Canada | 15 May 2017

A recent Ontario Superior Court of Justice decision is significant to patentees and innovative drug companies facing a claim brought under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. First, the decision illustrates the importance of motions for summary judgment and the associated risk of dispositive findings. Second, it adds to the growing jurisprudence on the relationship between Health Canada's regulatory approval process and Section 8 of the regulations.

Federal Court prohibits issuance of notice of compliance to Teva for atazanavir sulfate
Canada | 05 September 2016

The Federal Court recently issued an order under the Patented Medicines (Notice of Compliance) Regulations prohibiting the minister of health from issuing a notice of compliance to Teva for atazanavir sulfate (Bristol-Myers Squibb's (BMS) Reyataz) until expiry of Novartis AG's Patent 2,250,840. The court dismissed the prohibition application relating to BMS's Patent 2,317,736.

Federal Court grants Janssen nearly C$20 million against Teva for patent infringement
Canada | 22 August 2016

The Federal Court recently issued its judgment on the quantification of damages arising from infringement of Daiichi Sankyo's Patent 1,304,080 for levofloxacin. In the earlier liability phase of the action, Teva (then Novopharm) was held liable for damages for patent infringement. The court awarded a total of C$18,841,219 in damages and pre-judgment interest to the two plaintiffs.

Canadian Federal Court of Appeal clarifies test for double patenting
Canada | 30 May 2016

The Canadian Federal Court of Appeal has issued its decision in Mylan Pharmaceuticals ULC v Eli Lilly Canada Inc, a case relating to tadalafil (Eli Lilly's Cialis). The court dismissed the appeal and upheld the Federal Court's order of prohibition regarding Canadian Patent 2,226,784. The court also remarked on the use of prior art and on the distinction between prior art and common general knowledge.