Federal Court Holds AstraZeneca’s LOSEC Formulation Patent Valid and Infringed By Apotex

On March 16, 2015, Barnes J of the Federal Court issued his decision finding certain claims of AstraZeneca’s Canadian Patent No. 1,292,693 (693 Patent) valid and infringed by Apotex’s manufacture, promotion and sale of APO-OMEPRAZOLE® capsules in Canada and elsewhere (AstraZeneca Canada Inc v Apotex Inc, 2015 FC 322). The 693 Patent relates to a new omeprazole preparation comprising “an inert subcoating” “disposed on” an alkaline core and an outer enteric coating.

Apotex did not separately apply a subcoating to its omeprazole core; however a subcoating was formed in situ from a reaction of components in the enteric coating and core. The 693 Patent also did not disclose a process for making an in situ subcoating. Therefore, a key construction issue was whether Apotex’s capsules contained the claimed “inert subcoating”. Apotex argued that on a purposive construction, the “inert subcoating” covered only a subcoating that was physically applied to the core but not a reaction product between the enteric coating and the core. Barnes J rejected this argument, cautioning against “the danger of relying too heavily on the disclosure as an interpretive guide to claim language”. Noting that the claims were not limited to any particular manufacturing process, Barnes J found that the patentee was “entitled to protect the product regardless of the means of its creation.”

Regarding validity, Barnes J rejected Apotex’s arguments on the grounds of anticipation, obviousness, overbreadth, inutility and ambiguity. Barnes J also found that Apotex’s capsules infringed the asserted claims and that there was induced infringement.

Barnes J however declined to apply the doctrine of foreign issue estoppel to rely on the US Court’s finding that AstraZeneca’s US Patent was valid and infringed by Apotex.

For commentary, see: http://tinyurl.com/oc6tll5