Ms Tierney GB Deluzio

Tierney GB Deluzio

Updates

Healthcare & Life Sciences

Health Canada requests feedback on company names added to Generic Submissions Under Review List
Canada | 20 February 2019

Health Canada recently requested feedback on the possible impact on and use to stakeholders if the Generic Submissions Under Review List is updated to include sponsor names (ie, the company that filed the generic submission). Sponsors are included in the Submissions Under Review List for new drug submissions (which includes biosimilars) accepted into review on or after 1 October 2018.

Apotex not permitted to plead promise-based invalidity grounds in Section 8 lansoprazole action
Canada | 21 November 2018

The Ontario Superior Court of Justice recently dismissed Apotex's motion to plead promise-based invalidity grounds in a Section 8 lansoprazole action. The motion had arisen in the context of a Section 8 action in which Apotex claimed damages for delay in the issuance of its notice of compliance for its generic lansoprazole product (Takeda's Prevacid) due to prohibition applications commenced by Abbott and Takeda.

Prohibition denied for Ranbaxy's bupropion extended-release tablets
Canada | 14 November 2018

The Federal Court recently dismissed Valeant's application under the Patented Medicines (Notice of Compliance) Regulations regarding Ranbaxy's bupropion extended-release tablets. The court found that the amount of permeation enhancer in the Ranbaxy formulation was outside the scope of the range claimed. As such, Ranbaxy's allegation of non-infringement was found to be justified.

Intellectual Property

Apotex not permitted to plead promise-based invalidity grounds in Section 8 lansoprazole action
Canada | 19 November 2018

The Ontario Superior Court of Justice recently dismissed Apotex's motion to plead promise-based invalidity grounds in a Section 8 lansoprazole action. Apotex claimed damages for delay in the issuance of its notice of compliance for its generic lansoprazole product due to prohibition applications commenced by Abbott and Takeda. Abbott and Takeda had pleaded patent infringement as a defence and brought a counterclaim for patent infringement. Apotex in turn challenged the validity of Takeda's patents.

Prohibition denied for Ranbaxy's bupropion extended-release tablets
Canada | 12 November 2018

The Federal Court recently dismissed Valeant's application under the Patented Medicines (Notice of Compliance) Regulations regarding Ranbaxy's bupropion extended-release tablets. The court found that the amount of permeation enhancer in the Ranbaxy formulation was outside the scope of the range claimed. As such, Ranbaxy's allegation of non-infringement was found to be justified.