Case: Celgene Inc. v. The Minister of Health
Drug: THALOMID® (thalidomide)
Nature of case: Application for judicial review of the Minister of Health’s decision that THALOMID is not eligible for data protection
Successful party: Celgene Inc.
Date of decision: February 6, 2012
On January 5, 2011, the Minister of Health (Minister) refused to include THALOMID (thalidomide) on the Register of Innovative Drugs under the data protection provisions of the Food and Drug Regulations1 (DPR) due to the prior approval of thalidomide in the drugs KEVADON and TALIMOL. Celgene Inc.’s (Celgene) application to judicially review the Minister’s decision was granted. The Federal Court held that THALOMID is eligible for data protection, as Celgene conducted new studies and obtained significant confidential data for a new use of the medicine. Moreover, the Court held that the prior thalidomide approvals should not have been granted, as those products were withdrawn from the market due to toxicity concerns.
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). At that time, thalidomide was used to treat minor ailments, including morning sickness associated with pregnancy. In and around March of 1962, Health Canada withdrew its approval for both products due to serious safety concerns impacting foetal development. Some years later, Celgene developed thalidomide (under the brand name THALOMID) for the treatment of multiple myeloma. In 1995, THALOMID became available in Canada under the Special Access Program. Celgene later filed a New Drug Submission (NDS) and was issued 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.
Celgene argued that THALOMID should be eligible for data protection on the following bases: (i) thalidomide was not previously approved within the meaning of s. C.08.004.1 of the DPR; and (ii) the NDS for THALOMID contains new and significant data. In a final decision dated January 5, 2011, the Minister affirmed the decision that THALOMID was not an eligible “innovative drug” and Celgene commenced the within application for judicial review.
Federal Court Decision
- Federal Court applies a purposive interpretation of the DPR
Justice de Montigny accepted the Applicant’s submission that the purpose of the DPR “is to encourage and reward innovation by protecting the data an innovator must generate to obtain approval for a drug”2. The Court acknowleded that DPR was enacted pursuant to s. 30(3) of the Food and Drugs Act3, which enables the Governor in Council to implement Canada’s international obligations under Article 1711(5) and (6) of NAFTA and Article 39(3) of TRIPS. However, de Montigny J. rejected the Minister's submission that these treaties limit the application of data protection in Canada to “new chemical entities”, since this language is nowhere to be found in the DPR. Moreover, he determined that the “focus in the treaties is clearly on the protection of undisclosed data, the origination of which involved a considerable effort”4. By refusing to designate THALOMID as an “innovative drug”, the Court held that the Minister failed to apply this purposive interpretation of the DPR.
- Data protection for new uses of previously approved medicinal ingredients
The Court held that new drugs containing previously approved medicinal ingredients for entirely new uses should be considered for data protection on a case-by-case basis. On the facts, de Montigny J. held that it would be inconsistent with the overall purpose of the DPR to deny THALOMID data protection, as Celgene obtained approval for an entirely new indication with no reliance on the data from the original thalidomide drug submissions. Moreover, the original drug submissions were revoked for safety reasons and are no longer “approved” in Canada.
The Court stated that that this approach is more consistent with the approach adopted by Mr. Justice Evans (as he then was) under the old DPR scheme in Bayer Inc. v. Canada (Attorney General), (1999) 87 C.P.R. (3d) 293. Evans J. held that the prior approval of a medicinal ingredient for veterinary use did not bar data protection eligibility of the same medicinal ingredient for human use.
- Impact of prior-approval under the pre-1963 version of the Food and Drug Regulations (FDR)
In order to be approved today, new drugs must satisfy the standards of safety and efficacy set out in the FDR. Thalidomide was initially approved under the 1955 version of the FDR which did not require any evidence of "efficacy" and had lesser standards of safety. The FDR were significantly overhauled in 1963 to require greater evidence of "safety", and for the first time "efficacy". De Montigny J. held that "at the very least”, this reinforced his conclusion that the prior thalidomide approvals should not prevent THALOMID from being eligible for data protection.
- Impact of special factual circumstances – revocation of initial thalidomide approvals
Celgene argued that a medicinal ingredient cannot be “previously approved” for the purpose of the DPR when the previous approval is revoked. Justice de Montigny declined to strictly determine whether the withdrawal of the previous thalidomide products nullified the original approvals. However, he held that given that safety and efficacy are the main considerations for drug approval, it would be “perverse” to find that a drug withdrawn for safety reasons was “previously approved”. At the end of his decision, de Montigny J. also made the following comment:
"This case is obviously quite an exceptional one. Not only are there most likely very few instances of approvals for NDS that have subsequently been withdrawn, but thalidomide has a tragic and chequered history, the likes of which are, thankfully, very rare. It is therefore assumed that the present decision will have a limited impact in the foreseeable future."5
It remains to be seen whether the applicability of this case will be limited to its factual circumstances. The Minister has 30 days from the date of judgment (February 6, 2012) to appeal the decision to the Federal Court of Appeal.
Link to decision:
Celgene Inc. v. The Minister of Health, 2012 FC 154 - At the time of writing, the decision has yet to be posted to the Federal Court website.