AstraZeneca Canada Inc (AstraZeneca) has initiated an action against Apotex in the Superior Court of Justice for Ontario alleging infringement of AstraZeneca's copyright in product monographs for LOSEC tablets (omeprazole magnesium) and LOSEC capsules (omeprazole). AstraZeneca is seeking, among other things, interim and interlocutory injunctions restraining Apotex from infringing AstraZeneca's copyright. As an alternative relief, AstraZeneca is seeking partial summary judgment.
The action, if it proceeds to a determination of the merits, will be (to our knowledge) the first in Canada by a pharmaceutical manufacturer asserting copyright infringement of a product monograph. In Canada, a pharmaceutical manufacturer must file a New Drug Submission with Health Canada, which includes a product monograph. The product monograph is a summary, among other things, of information about the use, conditions of use and safety of the drug.
Apotex has applied for, but has not yet received, government approval to market generic versions of omeprazole magnesium tablets and omeprazole capsules. In connection with other litigation, Apotex placed its proposed product monographs in the public record. AstraZeneca alleges that Apotex' product monographs are substantial reproductions of AstraZeneca's product monographs.
In response to the action, Apotex has initiated proceedings in the Federal Court for expungement of copyright registrations obtained by AstraZeneca for the product monographs.
The ultimate disposition of AstraZeneca's claim for copyright infringement could have significant implications for generic drug approval since generic manufacturers do not independently develop product monographs, relying instead on the innovator's monograph. Generic manufacturers argue that the contents of the product monograph are mandated by the Minister of Health and as a result, either no copyright subsists in the product monograph, or the copyright is owned by the Minister.
We will report on further developments in this area in future issues of Rx IP Update.