Smart & Biggar uncovers and maximizes intellectual property and technology assets for our clients.
Today’s fast-paced innovation economy demands a higher level of expertise and attention to detail when it comes to IP strategy and protection. With over 125 lawyers, patent agents and trademark agents collaborating across five Canadian offices, Smart & Biggar is trusted by the world’s leading innovators to find value in their IP rights.
As market leaders in IP, Smart & Biggar’s team is on the pulse when it comes to the latest developments and the wider industry changes that impact our clients. To stay informed, visit smartbiggar.ca/insights, including access to our RxIP Update (smartbiggar.ca/insights/rx-ip-updates), a monthly digest of the latest decisions and law surrounding the life sciences and pharmaceutical industries.
On December 18, 2017, Health Canada published a Notice soliciting comments and recommendations from stakeholders regarding potential changes to its Guidance Document...
On December 18, 2017, Health Canada published a Notice soliciting comments and recommendations
from stakeholders regarding potential changes to its Guidance Document: Use of a Foreign-sourced
Reference Product as a Canadian Reference Product. The
Guidance, which took effect November 24, 2017 (previously reported), is directed to sponsors
of all Abbreviated New Drug Submissions or Abbreviated
Extraordinary Use New Drug Submissions that seek to obtain approval
based on a demonstration of pharmaceutical equivalence and
bioequivalence to a reference drug product marketed in a country
other than Canada (i.e., under the Canadian Reference Product
definition provided in paragraph (c) of section C.08.001.1 of the
Food and Drug Regulations). Stakeholder feedback, preferably in
electronic form, should be submitted to Health Canada by March 18,
2018.
The preceding is intended as a timely update on Canadian
intellectual property and technology law. The content is
informational only and does not constitute legal or professional
advice. To obtain such advice, please communicate with our offices
directly.
