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Drug: Complera® tenofovir disoproxil fumarate,
emtricitabine and rilpivirine
The Federal Court dismissed a judicial review of a decision of
the Minister of Health refusing to list a patent on the Patent
Register. The drug at issue was a combination product containing
three medicinal ingredients. The patent was refused for listing as
the Minister decided it did not contain a claim for the medicinal
ingredients, as it referred to the class of non-nucleoside reverse
transcriptase inhibitors rather than specifically referring to the
medicinal ingredient rilpivirine.
After construing the claims, the Court held that rilpivirine is
not expressly referenced in any of the claims and can only be
included by deductive reasoning since it falls within a named
class. The Court held that on a plain reading of the Patented
Medicines (Notice of Compliance) Regulations, all of the
ingredients in the NDS must be found in the formulation in the
claim.
If not, the product specificity requirement is not met. Thus,
the Court held the Minister correctly concluded that the patent was
not eligible for listing on the Patent Register.
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