FCA Interprets “Innovative Drug” Purposively, and Arguably Broadly

Published June 4th, 2012

Teva Canada Ltd. v Sanofi-Aventis Canada Inc. 2012 FCA 106 (Blais, Noël, Stratas)

Summary – The Federal Court of Appeal (“FCA”) has agreed with Health Canada that due to its prior preliminary Special Access Program (“SAP”) approval, oxaliplatin (ELOXATIN™ – a cancer drug) does not qualify as a “previously approved” drug under the Food and Drug Regulations (the “Regulations”).  A drug is only “previously approved” if it already has a Notice of Compliance (“NOC”) and a Drug Identification Number (“DIN”).  The result is that Sanofi can continue to list its oxaliplatin product on the register of “Innovative Drugs” and enjoy an 8 year period of market exclusivity without generic competition.

Analysis – Between the years 1999-2007, oxaliplatin had been “widely available” in Canada as a cancer drug, under the SAP.  Generic versions of the drug were also available [para. 13].  The SAP is for “emergency treatment” of life-threatening conditions and involves a physician making a specific request for the drug, explaining why other drugs are ineffective, and providing data on the use, safety and efficacy of the drug (presumably from the brand manufacturer).  Central to the FCA’s decision was that an NOC does not issue with an SAP drug.  “Typically, medicines authorized under the SAP are treatments of last resort and are not subject to the same level of scrutiny for safety and efficacy as medicines for which an NOC has been issued.  Nonetheless, Health Canada reviews the SAP request and any other available data on the new medicine in order to “manage the risk” of its use” [para. 27, citing from an earlier FCA decision].

Subsection C.08.004.1(1) of the Regulations, CRC c 870 defines an “innovative drug” as containing a medicine “not previously approved”. 

Teva argued unsuccessfully that the drug was “previously approved” because it had been previously “widely available” in Canada under the SAP and that granting Sanofi data exclusivity as an innovative drug was “an inordinate and unjustifiable monopoly” and inconsistent with Canada’s NAFTA and TRIPS treaty obligations.

The FCA rejected all of Teva’s arguments for three reasons:

1)    The innovative drug definition is not a brand/generic compromise.  The correct “prism” to interpret “previously approved” is drug safety and efficacy.  There is no safety and efficacy review until a drug receives an NOC [paras. 17, 28].

2)    Teva’s approach creates unnecessary uncertainty.  “Clarity and certainty” are required to determine if a drug is previously approved.  “For this reason, the Regulations have been carefully drafted to create clarity and certainty as to when a drug is approved.  Under the Regulations, the magic moment of approval is signalled by the issuance of a notice of compliance and a drug identification number.” [para. 31]  It is arguable of course that the Regulations were not crafted very clearly – the impugned section would have been clearer had it said that an innovative drug means a drug that was not previously granted an NOC.

3)    The Minister’s interpretation of “previously approved” as meaning previously granted an NOC, is consistent with, and implements Canada’s treaty obligations.  “Broadly speaking, these treaty provisions aim to protect an innovator who submits undisclosed data in support of an … approval to market a … new chemical entity.  The treaty provisions accomplish this by preventing others from using the innovator’s data in support of their own applications for drug approval.  This encourages the development of new drugs” [para. 35].  If mere first time SAP authorization “stripped” innovative drug status, “the treaty protections would be undercut almost immediately”.

Practice Point – The FCA’s approach should arguably minimize future litigation involving the definition of a “previously approved” drug.  It is a very clear event when a drug receives an NOC– a certification is issued by the Minister.  It is interesting to see the FCA’s overt denial that the Data Protection Regulations (unlike the NOC Regulations) involve a considered balance between the brand and generic regimes.  Arguably, this decision may further “encourage” the use of the SAP – and this may have been an underlying theme in the FCA’s reasoning.  To find that the SAP qualified as “previously approved” may have resulted in brands avoiding the SAP at all costs (given this is admittedly a restricted marketing phase where full advantage of the innovative drug does not occur).  The FCA currently has another “innovative drug definition” case before it dealing with the old and previously discontinued drug thalidomide (A-75-12).  The Federal Court found that, because Celgene had discovered a new cancer use for a drug that had been previously removed from the Canadian market for decades because of serious safety issues, the drug qualified as an “innovative drug” (Celgene Inc. v Minister of Health 2012 FC 154).  The Canadian Generic Association has intervened in the appeal.  A hearing is expected in the next year.  It will be interesting to see whether the FCA again interprets the definition of “innovative drug” benevolently, and perhaps blurs the lines between an innovative and a patented drug.  Given the clear pro-brand “prism” the FCA used with oxaliplatin, it is expected a similar “prism” will be used with thalidomide.

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