CasePfizer Canada Inc. v The Minister of Health and Teva Canada Limited

Drug: AROMASIN® (exemestane)  

Nature of caseMinister’s discretion under the Patented Medicines (Notice of Compliance) Regulations

Successful partyPfizer Canada Inc.  

Date of decisionDecember 19, 2014

CaseActelion Pharmaceuticals Canada Inc. v The Minister of Health and Pharmascience Inc., Mylan Pharmaceuticals ULC, Cobalt Pharmaceuticals Company and Sandoz Canada Inc.  

Drug: TRACLEER® (bosentan)  

Nature of case: Minister’s discretion under the Patented Medicines (Notice of Compliance) Regulations

Successful partyActelion Pharmaceuticals Canada Inc.

Date of decision: December 19, 2014

Summary

The Federal Court released two decisions on December 19, 2014 granting the innovators’ applications to set aside the Minister’s decision to issue NOCs to second persons based on administrative drug submissions without complying with the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”). The three generic drug submissions at issue each cross-referenced the submission of another generic company that had previously complied with the requirements under the PM(NOC) Regulations. The Minister had not required these three companies to comply with the PM(NOC) Regulations.

Background

Pfizer Canada Inc. (“Pfizer”) brought an application for judicial review against the Minister of Health (“Minister”) to set aside the Notice of Compliance (“NOC”) issued to Teva Canada Limited (“Teva”) for its product, Teva-Exemestane, on the basis that Teva should have been required to serve a Notice of Allegation (“NOA”) in respect of the listed patents on the Patent Register. Similarly, Actelion Pharmaceuticals Canada Inc. (“Actelion”) brought an application for judicial review seeking a declaration that the Minister did not have the authority to issue NOCs to Cobalt Pharmaceuticals Company (“Cobalt”) and Sandoz Canada Inc. (“Sandoz”) for their bosentan drug product and to set aside the respective NOCs.

Pfizer v Teva  

In May 2012, Generic Medical Partners Inc. (“GMP”) filed an abbreviated new drug submission (“ANDS”) to market Med-Exemestane, a generic version of Pfizer’s AROMASIN breast cancer drug. Pursuant to subsection 5(1) of the PM(NOC) Regulations, GMP served Pfizer with a NOA for the patent associated with AROMASIN. Pfizer chose not to commence prohibition proceedings under the PM(NOC) Regulations. Teva filed an “administrative” drug submission for Teva-exemestane given that it had a licensing agreement with GMP, where it cross-referenced GMP’s ANDS to seek marketing approval. Under such submissions, a generic company need not file any data; its submission is identical in all respects to the cross-referenced submission with the exception of the product and/or manufacturer name.

GMP and Teva were issued NOCs for their respective exemestane products on October 1, 2013. Teva was issued a NOC without addressing Pfizer’s patents listed on the Patent Register. This was in accordance with the Minister’s revised Guidance Document entitled, “Patented Medicines (Notice of Compliance) Regulations (revised 2012)”, that such cross-referenced submissions need not address any patents on the Patent Register when the submission to which they are cross-referencing had complied with the requirement to address such patents.

Actelion v Cobalt and Sandoz et al.  

Generic manufacturers Mylan Pharmaceuticals ULC (“Mylan”) and Pharmascience Inc. (“Pharmascience”) were both issued NOCs for their respective bosentan products in May 2012 after serving NOAs to Actelion and complying with subsection 5(1) of the PM(NOC) Regulations.

Subsequently, Cobalt and Sandoz each reached a licensing agreement with Pharmascience to market their respective bosentan products and filed administrative drug submissions cross-referencing Pharmascience’s submission. The Minister issued NOCs to Cobalt and Sandoz on June 4, 2012 based on the Minister’s interpretation of the PM(NOC) Regulations set out under the revised Guidance Document.

Issue

The main issue in both applications is whether the Minister was permitted to issue NOCs to Teva, Cobalt and Sandoz without requiring them to address relevant patents on the Patent Register.

Cross-referenced administrative drug submissions trigger the PM(NOC) Regulations  

The Court considered whether the Minister correctly interpreted subsections 5 and 7 of the PM(NOC) Regulations.

The Minister argued that its decision to issue the NOCs was consistent with its revised Guidance Document on the PM(NOC) Regulations. The revised Guidance Document provides that filing an administrative drug submission for a change in manufacturer’s name and/or product name, including where a manufacturer is licensed to sell an identical drug in Canada by way of a cross-referenced drug submission to the licensor’s drug submission, does not re-trigger section 5 of the PM(NOC) Regulations.1 The Court rejected the Minister’s argument and held that the revised Guidance Document contravenes the PM(NOC) Regulations.  

The Minister also argued that the type of administrative submission like those submitted by the generic companies in these cases is not a “submission for a NOC” as set out under subsection 5(1) the PM(NOC) Regulations for a number of reasons, including the fact that the companies did not make use of the early working exception. The Court did not accept the Minister’s submission and held that taking advantage of the early working exception is irrelevant to the object of subsection 5(1). The purpose of the PM(NOC) Regulations is to balance the rights of innovators, generic manufacturers and the public, “and it is consistent with that balancing exercise and the structure of the Regulations that a company that wishes to enter the market with a generic version of a drug listed on the Patent List be required to address the relevant patents.”2

Upon a comprehensive review of the jurisprudence, the Court held that the legislative text of section 7 of the PM(NOC) Regulations prevents the Minister from issuing an NOC until the listed criteria are met. Further, the PM(NOC) Regulations do not afford the Minister with discretion or deference in issuing an NOC, unlike the broader authority granted to the Minister under the Food and Drugs Act.

The Court in the Teva case concluded: “[i]t is clear that Teva sought an NOC to market a drug in Canada based on the direct comparison of its product to AROMASIN on an indirect comparison of its drug to AROMASIN by piggy-backing on GMP’s comparison. Such comparisons engage subsection 5(1) of the PMNOC Regulations under a purposive interpretation of the requirements of the Regulation because the Regulations strike the required balance between competing interests by requiring generic companies who make such comparison to address the patents on the Patent Register.”3

The Court held that the decisions of the Minister to issue the NOCs were made in contravention of section 7 of the PM(NOC) Regulations and as such, the decisions of the Minister to grant the NOCs to the generic companies were set aside.

Teva has filed an appeal of the decision of Justice Gleason in respect of its exemestane product.

Link to decisions:

Pfizer Canada Inc. v. The Minister of Health and Teva Canada Limited, 2014 FC 1243

Actelion Pharmaceuticals Canada Inc. v. The Minister of Health and Pharmascience Inc., Mylan Pharmaceuticals ULC, Cobalt Pharmaceuticals Company and Sandoz Canada Inc.,2014 FC 1249