2022 Year In Review: Life Sciences

• Jurisdiction: Canada
• Law Firm: Bereskin & Parr LLP
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law, Biotechnology & Nanotechnology
• Author: Luba Naiberger, Jessica Sudbury, Nyrie Israelian and Noel Courage
• Published date: 23 February 2023

The Canadian life sciences patent news was diverse and non-stop the past year. Here is our update on all that you need to know.

Patentable Subject Matter - Dosage Regimen Claims

The issue of what constitutes a patent-ineligible method of medical treatment in the dosing area remained a hot topic in 2022, and there was some good news for patent applicants. Progress was made in several Patent Appeal Board (PAB) and Federal Court cases. In general, medical use claims containing a dosage or dosing regimen are not patentable subject-matter if the exercise of professional skill and judgment of a medical professional is part of the claimed invention.

The PAB allowed medical use claims reciting a dosage range (for treating osteoporosis or stimulating bone growth)¹. The PAB held that there was nothing in the description that indicated that the claimed doses within the range would not all work for all subjects falling within the patient group. The dosage was also not selected based on any patient-specific features. This decision reinforces that a dosage range is patent eligible.

The Federal Court upheld as patentable the claims directed fixed dose amounts, fixed intervals and fixed injection sites with elements involving choices such as dosing windows and injection sites for the maintenance dose². Fixed dose amounts are typically patent-eligible. It is helpful for applicants that this court case addressed a claim with additional choices.

In another case, the PAB initially concluded that claims directed to treating a variety of conditions, containing a range of doses and time intervals were not patent-eligible subject matter³. The PAB held that the claims encompassed the exercise of skill and judgment of a medical professional. The only claims allowed by the PAB were claims directed to specific conditions with fixed dosage regimens and timing.

The PAB allowed medical use claims including a fixed dosage regimen and a treatment period of either "at least 6 months" or "at least 12 months"⁴. The PAB concluded that the decision by a physician to stop treatment would be outside the scope of the claims. It is helpful to applicants that dosage regimens involving a time limitation were confirmed to be patent-eligible.

Patent Validity

In a positive decision for patent owners,⁵ the FCA declared Canadian Patent Nos. 2,461,202 and 2,791,171 valid. Both patents are directed to Factor Xa inhibitors and apixaban compounds marketed as ELIQUIS. Pharmascience appealed on the basis that...