[2017] 3 F.C.R. D-8
Patents
Infringement
Applicants seeking order prohibiting Minister of Health from issuing, pursuant to Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 notice of compliance to respondent Mylan Pharmaceuticals ULC (respondent) respecting generic naproxen-esomeprazole magnesium tablet product until expiry of Canadian Patent No. 2449098 (‘098 Patent) — Nonsteroidal anti-inflammatory drugs (NSAIDs) commonly used to treat pain, fever, inflammation through analgesic, anti-inflammatory properties — NSAIDs amongst world’s most widely used medications, capable of causing gastrointestinal (GI) injuries — Approaches to mitigating side effects including taking co-therapy drugs such as misoprostol, proton pump inhibitors (PPIs) with NSAIDs — Present application relating to formulation of immediate-release prophylactic medication to address deleterious effects of NSAIDs, namely VIMOVO, marketed by applicant AstraZeneca Canada Inc. — VIMOVO brand name of AstraZeneca’s patented naproxen-esomeprazole magnesium tablet pairing naproxen (NSAID) with esomeprazole magnesium — ꞌ098 patent owned by applicant Pozen Inc., listed on Health Canada Patent Register against AstraZeneca’s VIMOVO drug — ꞌ098 patent stating new method of reducing GI risks ensuing from single unit dosage form providing coordinated, sequential release of acid inhibitor first, NSAID second — Respondent filing abbreviated new drug submission with Minister of Health for issuance of notice of compliance (NOC) respecting generic naproxen-esomeprazole magnesium tablet product; serving notice of allegation (NOA) on AstraZeneca wherein claiming non-infringement of certain claims of 098 Patent, invalidity on several grounds, in particular obviousness — Applicants thereafter initiating present proceeding under Regulations, s. 6(1), asserting specific claims — Whether asserted claims of ꞌ098 patent invalid — In analysing obviousness, analysis turning on which experts providing most compelling evaluations of common general knowledge held by POSITA (person of ordinary skill in the art), state of art, other factors — Common general knowledge at relevant time including several approaches to formulating acid-sensitive compounds such as PPIs; that alternatives to enteric coating PPI existing — As to inventive concept, nothing novel or inventive about combining NSAID, PPI nor specific type of each used in asserted claims — Therefore, inventive concept tablet formulated for immediate release of portion or all of PPI — Application of sequential release profile in NSAID-PPI co-formulation novel — Thus, difference between state of art, inventive concept lying in sequential release profile achieved by decision not to fully enteric coat PPI — “Obvious to try” test warranted herein — Inventive concept in present case obvious to try because: (i) limited number of predictable solutions in managing GI injury existing that would have been more or less self-evident to work; (ii) invention not involving undue amount of effort to achieve; (iii) strong motive existing to combine NSAID with PPI in single dosage combination with sequential release profile — Would have been self-evident to POSITA that ARTHROTEC-type of architecture could be successfully applied to NSAID-PPI formulation — Therefore, would have been more or less self-evident to POSITA that sequential release profile in asserted claims, achieved in part by decision not to fully enteric coat PPI, would work — Only limited amount of effort required to achieve inventive concept — Even if prior art would have alerted skilled person that something might be “worth trying”, remaining insufficient to make it obvious to try unless invention more or less self-evident — Asserted claims obvious to try — Would have been more or less self-evident to POSITA to try to obtain sequential release formulation addressed in asserted claims, that such formulation would work — Also would have been self-evident to POSITA to combine ample common general knowledge known at relevant time with limited amount of prior art to arrive at inventive concept, expecting it to work — Therefore, respondent’s allegations that obvious to try to obtain sequential release of NSAID-PPI formulation in single oral dosage combination having air of reality — AstraZeneca failing to establish that respondent’s allegations of invalidity on basis of obviousness unjustified — Application dismissed.
AstraZeneca Canada Inc. v. Mylan Pharmaceuticals ULC (T-336-15, 2017 FC 142, Diner J., judgment dated February 7, 2017, 57 pp.)