In a recent decision – Celgene Inc. v. Canada (Minister of Health) – the Federal Court of Canada declared that a drug containing a previously approved medicinal ingredient is nevertheless subject to data protection.
To attract data protection, a drug must be an innovative drug under the data protection regulations. A key aspect of the definition of "innovative drug" is that the medicinal ingredient in the drug must not have been "previously approved" by the Minister of Health. This was the issue decided in Celgene.
Data protection effectively provides a drug manufacturer with eight years of market exclusivity for a drug product, regardless of whether Canadian patents exist for the product. If a drug product attracts data protection, a generic manufacturer cannot rely on the innovative manufacturer’s data and cannot obtain a notice of compliance (NOC) for a generic version of the drug until eight years after the issuance of the innovator’s NOC. Thus, data protection is an important tool to protect innovation by providing innovative manufacturers with a specified period of market exclusivity.
The drug in question – Thalomid – contains the active ingredient thalidomide. Thalidomide was first approved in Canada in 1960 for, among other indications, the treatment of morning sickness in pregnant women. In 1962, the federal government ordered thalidomide to be removed from the market for safety reasons.
Celgene eventually became interested in the use of thalidomide for the treatment of cancer and a condition associated with leprosy. The company conducted clinical trials to prove the safety and efficacy of Thalomid for those uses. Celgene filed a new drug submission, including 180 volumes of data, seeking approval for thalidomide capsules for use in the treatment of multiple myeloma. The Minister of Health granted a NOC for Thalomid in August 2010.
At the same time, the Minister advised Celgene that Thalomid was not eligible for data protection because thalidomide had been previously approved. Celgene disagreed with the Minister’s conclusion and ultimately commenced an application for judicial review of the Minister’s refusal to provide data protection to Thalomid.
The Federal Court Decision
On the application for judicial review, the Federal Court of Canada agreed with Celgene that Thalomid should be granted data protection.
The judge referred to the fact that Canada’s data protection regulations (DPR) were enacted to implement Canada’s treaty obligations under the North American Free Trade Agreement (NAFTA) and the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS). The judge noted that the interpretation of the implementing legislation, in this case the DPR, must be made with reference to those international treaties.
The Court found that both NAFTA and TRIPS "seek to provide protection to innovators in respect of 'undisclosed tests or other data' that they must provide to government entities to obtain approval for their new drugs." Both agreements also "provide a scheme for protecting against the unfair commercial use of undisclosed data, the origination of which involved considerable effort." The Court therefore considered it important that Celgene was required to and did submit a considerable volume of information in order to obtain its NOC.
The Court explicitly rejected the Minister’s contention that NAFTA and TRIPS were restricted to "genuinely new and innovative medicinal ingredients" and not new uses of ingredients that had been previously approved for a different use.
The purpose of the DPR, said the Court, is to encourage and reward innovation by protecting the data that an innovator must develop to obtain approval for a drug. The Court stated that "it would simply be inconsistent with these treaties to refuse data protection when a chemical entity is put to an entirely new use, on the basis of extensive and genuinely new data ensuring its effectiveness and safety." It went on to state that "new uses of previously approved ingredients must be considered on a case-by-case basis to determine how innovative they are and whether the data supporting them was gathered at considerable cost which is not otherwise publicly available in that assembled form."
The Court also concluded that when the approval of a drug is withdrawn for safety reasons, the drug cannot be considered to have been "previously approved."
In summary, the Court found that
- the prior approval of thalidomide was short-lived and should never have been given;
- the use of thalidomide was effectively banned until Celgene filed its submission for Thalomid; and
- approval for Thalomid was granted on the basis of completely new studies and data.
These findings – re-enforced by the fact that the current drug approval process requires significantly more data than was required when thalidomide was first approved – resulted in the conclusion that the prior approvals for thalidomide should not stand in the way of data protection for Thalomid. And the drug was therefore found to be an "innovative drug" entitled to data protection.
The Court concluded by noting that the Thalomid case is "quite an exceptional one" and stated that it is "assumed that the present decision will have a limited impact in the foreseeable future." The accuracy of this assumption will be tested as innovative companies review their new drug submissions for potentially similar cases.
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