On February 23, 2022, the Federal Court issued its public
reasons for judgment in a patent infringement action pursuant to
subsection 6(1) of the Patented Medicines (Notice of
Compliance) Regulations relating
to risedronate sodium
(Allergan's ACTONEL
DR): Allergan Inc v Apotex Inc, 2022 FC 260. Justice Kane found Canadian
Patent No. 2,602,188 (the 188 patent) valid but not
infringed.
The 188 patent relates to a dosage form of a bisphosphonate,
specifically, risedronate, that displays pharmaceutically effective
absorption when taken with or without food. At the time of the
priority filing date of the 188 patent, oral bisphosphonates used
to treat osteoporosis, including risedronate, were known to be
poorly absorbed, especially when taken with food. As a result,
these drugs were required to be taken on an empty stomach. The
inventors of the 188 patent had sought to overcome this issue,
termed the food effect.
