Summary

36798

Sandoz Canada Inc., et al. v. Attorney General of Canada, et al.

(Federal) (Civil) (By Leave)

(Sealing order)

Keywords

None.

Summary

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(SEALING ORDER)

Intellectual property – Constitutional law – Patents – Medicines – Generic pharmaceutical companies permitted to sell innovator’s patented medicines – Patented Medicines Prices Review Board investigating pricing of certain medicines sold – Whether federal price regulation of generic drugs exceeds federal jurisdiction and encroaches upon provincial jurisdiction over property and civil rights – Whether appropriate standard of review requires clarification – Whether generic companies can be “patentees” within meaning of s. 79(1) of the Patent Act, R.S.C. 1990, c. P.4 – Whether approach endorsed by Federal Court of Appeal will have negative economic, administrative and human consequences

Sandoz Canada Inc. and Ratiopharm Inc. are both engaged in the business of selling medicines in Canada. Ratiopharm sold an anti-asthmatic medicine, the generic equivalent of the brand name Ventolin HFA manufactured and sold in Canada by GlaxoSmithKline (“GSK”). GSK sold ratio HFA to Ratiopharm in final packaged form in a series of supply and licensing agreements. Ratiopharm was granted an exclusive licence to set the price and sell ratio HFA in Canada without a right to sub-licence. Ownership in the patent and intellectual property rights remained with GSK. Ratiopharm entered into similar arrangements with respect to brand name version of other medicines with other patent-holder companies. In each case, Ratiopharm did not obtain any patent rights but held its own Notice of Compliance from Health Canada on consent from the owner of the patent.

Sandoz is a wholly owned subsidiary of Novartis Canada Inc., which is a wholly owned subsidiary of Novartis Pharma AG which is a wholly owned subsidiary of Novartis AG. The patent owners sold their brand name version of the medicines in question but allowed Sandoz to enter the market and sell its generic version after other generics had entered the market and consented to Sandoz referring to their medicines in obtaining the required Notices of Compliance. There was no express licencing agreement linking Sandoz with the owners of the patents.

The staff of the Patented Medicines Prices Review Board (“PMPRB”) initiated proceedings against ratiopharm and Sandoz for allegedly having sold their products in Canada for excessive prices, contrary to ss. 83 and 85 of the Patent Act. Pursuant to ss. 80, 81 and 88 of the Act, Board staff sought orders requiring Ratiopharm and Sandoz to provide the Board with certain sales and pricing information.

Lower Court Rulings

May 27, 2014
Federal Court

T-1252-11, T-1058-11, T-1616-12, 2014 FC 501, T-1825-11, 2014 FC 502
Sandoz’s application for judicial review allowed. Matter referred back to Board with direction that Sandoz not a patentee. Ratiopharm’s application for judicial review allowed. Matter referred back to Board with direction that Ratiopharm not a patentee. Ratiopharm’s application for judicial review allowed. Matter referred back to Board with direction that Ratiopharm not a patentee.
November 6, 2015
Federal Court of Appeal

2015 FCA 249, A-303-14, A-302-14
Respondent’s appeal allowed; Sandoz and Ratiopharm considered patentees and subject to Board’s jurisdiction.