Canada: Pharma In Brief - Canada: Federal Court Of Appeal Reverses Lower Court Decision And Holds That THALOMID® Is Not An "Innovative Drug"

Case: The Minister of Health v. Celgene Inc.

Drug: THALOMID® (thalidomide)

Nature of case: Appeal from a decision of the Federal Court that had allowed Celgene's application for judicial review of the Minister of Health's decision finding that THALOMID was not eligible for data protection

Successful party: Minister of Health

Date of decision: February 15, 2013

Summary

This was an appeal from a decision of the Federal Court granting Celgene Inc.'s ("Celgene") application for judicial review and quashing a decision of the Minister of Health (the "Minister") refusing to list THALOMID (thalidomide) on the Register of Innovative Drugs.1 The Federal Court of Appeal ("FCA") granted the Minister's appeal (per Gauthier JA; Sharlow JA concurring) with Nadon J.A. writing a dissenting opinion.

The main issue on appeal was whether THALOMID contains a "medicinal ingredient not previously approved in a drug by the Minister", thereby falling within the definition of an "innovative drug" in subsection C.08.004.1(1) of the Food and Drug Regulations, C.R.C. c.870 (the "Regulations"). The FCA construed the phrase "previously approved" and held that once a medicinal ingredient has received regulatory approval, it is "previously approved" for the purposes of the Regulations, even if the drug is subsequently removed from the market.

Background

The medicinal ingredient thalidomide was first approved for sale in Canada on November 22, 1960 (under the brand name KEVADON) and again on October 11, 1961 (under the brand name TALIMOL). In 1962, Health Canada withdrew its approval for both products due to serious safety concerns impacting foetal development. Celgene later developed thalidomide (to be marketed under the brand name THALOMID) for the treatment of multiple myeloma. This product became available in Canada under the Special Access Programme ("SAP"). Celgene received a Notice of Compliance ("NOC") for THALOMID on August 4, 2010. The Minister, however, refused to include THALOMID on the Register of Innovative Drugs due to the prior approval of thalidomide (i.e., the same medicinal ingredient) in KEVADON and TALIMOL.

Summary of Decisions Below

Celgene applied to list THALOMID on the Register of Innovative Drugs. The Minister denied this request, as the medicinal ingredient contained in THALOMID had been "previously approved" by the Minister in two other drugs (viz. KEVADON and TALIMOL). Celgene sought judicial review of the Minister's decision and argued that the Minister had misinterpreted the Regulations. The Federal Court agreed with Celgene and held that THALOMID is eligible for data protection, as Celgene conducted new studies and generated significant confidential data for a new use of the medicine. Moreover, the Federal Court held that the prior thalidomide approvals should not have been granted, as those products were withdrawn from the market due to toxicity concerns.

The Minister appealed the decision of the Federal Court.

THALOMID is not an "innovative drug"

Interpretation of the Phrase "previously approved" in the Definition of an "innovative drug"

The main issue in the FCA was whether THALOMID contains a medicinal ingredient "not previously approved in a drug by the Minister".

Celgene argued that the word "approved" ought to be based on the current status of the medicinal ingredient, as this interpretation is consistent with the purpose, objective and scheme of the data protection provisions in the Regulations as well as Canada's Trade Related Aspects of Intellectual Property Rights Agreement ("TRIPS") and North American Free Trade Agreement Implementation Act ("NAFTA") obligations. The FCA rejected Celgene's interpretation. The Court held that TRIPS and NAFTA limit the application of data protection in Canada to "new chemical entities". A medicinal ingredient that once received regulatory approval is "previously approved" for the purposes of the Regulations.

The Effect of a Withdrawn NOC

The FCA disagreed with Celgene's argument to construe "previously" as meaning "currently", or to read in the words "and currently" before the word "approved" in the definition of an "innovative drug". While the FCA considered thalidomide's unique history, the Court was concerned that unintended consequences could arise if medicinal ingredients have have been withdrawn from the market are deemed to not have been "previously approved" and are eligible for data protection. Accordingly, the appeal was allowed and the judgment of the Federal Court was set aside.

Dissenting Opinion

Nadon J.A. held that taking into account the previous approvals of thalidomide would disregard the purpose and intent of the Regulations. As such, he would have dismissed the appeal and affirmed the decision of the Court below.

Nadon J.A. disagreed with the majority's interpretation of the phrase "previously approved". He held that if a drug is considered to be "previously approved" after its sale is prohibited in Canada, this would lead to incoherent results. In coming to his conclusion, Justice Nadon's primary consideration was whether the revocation of thalidomide's ministerial approval amounted to a nullification of these previous approval(s).

In Nadon J.A.'s view, there was sufficient evidence, including the legislative history resulting from the removal of thalidomide from the Canadian market and the requirement for Celgene to submit an NDS for THALOMID, that the withdrawal of thalidomide from the Canadian market had nullified Health Canada's prior approvals. As such, data protection should be provided to THALOMID as the "previously approved" condition in the definition of an "innovative drug" had not been met. In response to the Minister's concerns, Nadon J.A. stated that the scope of any precedent set by providing THALOMID data protection is likely to be narrow and should not create a "slippery slope".

Link to decision:

The Minister of Health v. Celgene Inc. and Canadian Generic Pharmaceutical Association, 2013 FCA 43.

Footnotes

1 The Federal Court's decision ( 2012 FC 154) was previously summarized in a Pharma in Brief and can be found here.

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