Divided FCA Denies Data Protection for THALOMID

Divided FCA Denies Data Protection for THALOMID

Canada (Health) v. Celgene Inc., 2013 FCA
43

This was an appeal from a Federal
Court decision granting Celgene’s application for judicial review and quashing
the decision of the Minister of Health to refuse to register Celgene’s drug
THALOMID on the Register of Innovative Drugs.

The main issue was whether THALOMID
contains a medicinal ingredient not previously approved, and as such falls
within the definition of an “Innovative Drug” under subsection C.08.004.1(1) of
the Food and Drug Regulations that can benefit from the data protection
provisions of the Regulations.

Per Gauthier J.A. (Sharlow J.A.
concurring):

The appeal is allowed.

The true question is whether under
the Regulations thalidomide is an “innovative drug”, i.e. a drug
that contains a “medicinal ingredient not previously approved in a drug by the
Minister.”

These words do not lend themselves
easily to the construction proposed by Celgene, which in fact would require the
Court to construe “previously” as meaning “currently” or to read in the words
“and currently” before the word “approved” in the definition. Reading the words
“and currently” into the data protection provisions could well open the door to
all kinds of unintended scenarios.

Thalidomide was approved for sale in
Canada in the 1960s in KEVADON and TALIMOL. Although that approval was later
revoked, thalidomide is a previously approved medicinal ingredient.

The fact that Celgene had to submit
a considerable amount of confidential data gathered at great cost does not, in
and of itself, justify stretching the language of the definition of “innovative
drug”.

 

Per Nadon J.A. (dissenting)

The appeal is dismissed.

This appeal is about whether
“previously approved” should encompass a medicinal ingredient that briefly
satisfied Canadian regulatory requirements before its approval was revoked.

Drugs are either innovative – drugs
containing medicinal ingredients or indications appearing in the Canadian
market for the first time, or generic – versions of innovative drugs made by
non-research based companies, which achieve approval through an abbreviated
compliance mechanism by demonstrating bioequivalence to the innovative drug.
Since thalidomide was not on the Canadian market prior to its reintroduction by
Celgene, and therefore not available to serve as a reference product for a
generic manufacturer, it follows that the more appropriate space for
thalidomide to occupy is that of an innovative drug.

The fact that thalidomide was
unavailable to serve as a reference product is important as Celgene did not
have any other manner of getting its drug approved in Canada. It had no
comparator to demonstrate bioequivalence with: it had to start from scratch and
create a data set to prove to the Minister that thalidomide was safe and
effective.

Because there was no available drug
to serve as a reference, Celgene had to submit an NDS to obtain approval for
thalidomide. Indeed, the Minister of Health specifically requested it and
Celgene undertook to produce 180 volumes of data in order to satisfy the
request. The absence of a reference product supports the view that there is no
prior approval, justifies the way in which Celgene proceeded in this case, and
bolsters the rationale for extending data protection.

In addition, the phrase “previously
approved” cannot be intended to mean that a medicinal ingredient remains
previously approved even after its sale was disallowed. After being removed
from the market by legislative decree in 1962, thalidomide was not “previously
approved” by either a common sense understanding of the term, or by the
definition offered in previous case law. The approval was revoked. For all
intents and purposes, the manner in which thalidomide has been treated has
amounted to a nullification of any previous approval. Accordingly, it should be
considered to meet the definition of an “innovative drug” and be entitled to
data protection.

The fact situation of thalidomide is
highly unusual and unlikely to reoccur. Any precedent set by this decision is
necessarily narrow in scope.

 

Commentary

Celgene raised the argument that the spirit of the data protection
provisions in NAFTA and TRIPS is to provide protection for data that is
gathered through considerable effort and to guard against its unfair commercial
use, and that the data set produced on thalidomide is captured by this purpose.

The argument is that the underlying purpose of the data protection provisions
is to incentivize pharmaceutical companies to investigate and demonstrate the
safety of medicinal ingredients that have not been shown to be safe.
Thalidomide was clearly understood to be unsafe and was banned in Canada for
many years. Celgene took the time and expense of demonstrating thalidomide’s
safety.

However, both the majority and the dissent opinions of the Court
deflected the argument and focussed instead on the meaning of “previously
approved”.

Had the Court instead undertaken a purposive approach to construing the Regulations
with due attention being paid to the intentions underlying the data protection
regime, it is possible that a different result might have been reached.