A recent decision of the Australian Federal Court in Spirit Pharmaceuticals v Mundipharma proceedings was whether a patent claiming a controlled release formulation of a known drug is validly entitled to a patent term extension.
This decision is one of a series of recent decisions addressing whether a patent claiming a new formulation of a known drug is eligible for a patent term extension.
Extension of term of standard patents relating to pharmaceutical substances
Under the Australian Patents Act 1990 certain pharmaceutical patents can be granted a patent term extension if specific criteria are met. In this case, the criterion under consideration was whether or not the claims defined “one or more pharmaceutical substances per se”
Spirit Pharmaceuticals contended the patent term extension as they believe that the patent does not disclose a pharmaceutical substance per se.
A pharmaceutical substance is defined in the act as a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves:
The Court’s conclusion as to the meaning of the term “pharmaceutical substance per se”
The court considered that the use of the expression of “pharmaceutical substance” in the Act when read with its definition meant a substance, including a mixture, that involves a chemical interaction with a human physiological system to achieve the “therapeutic use”.
The court considered how the controlled release formulation OxyContin worked when the formulation is taken orally and ingested. In particular, the Court considered that there are at least two chemical interactions in the human physiological system for the OxyContin formulation to have the therapeutic use.
The court decided that the patent term extension was valid.
This decision highlights that patents claiming new formulations of known drugs can be eligible for a patent term extension in certain circumstances.
However, it appears from the decision that a merely formulating a known drug in a new way would not be enough.
This decision has now been appealed to the Full Court of the Federal Court.
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