When requesting a patent term extension, review claims early
Dr Malcolm Lyons, Griffith Hack
Pharma Mar S.A.  APO 8. A Patent term extension cannot be requested based on a claim directed to a kit of parts or therapeutic use of a pharmaceutical substance (Commissioner of Patents v AbbVie Biotechnology Ltd  FCAFC 129).
Under specific circumstances where a patentee has been delayed in bringing a pharmaceutical substance to market because of the need to obtain regulatory approval, the Patents Act 1990 provides for patent term extension (PTE). The legislative intent is to bring the effective term of a patent covering a pharmaceutical substance closer to the term enjoyed by patents in other technologies that do not require regulatory approval prior to marketing.
The requirements for PTE include those of s70(2)(a) of the Patents Act 1990, which provides that the following condition must be satisfied:
- one or more pharmaceutical substances per semust in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification[.]
Pharma Mar S.A.  APO 8
The provisions of s70(2)(a) came under consideration in the recent decision of a delegate of the Commissioner of Patents, Pharma Mar S.A.  APO 8. This decision dealt with a request for PTE of patent 754073 based on the pharmaceutical substance APLIDIN. The PTE request was refused.
Claims 1 and 2 and 12 define the invention as:
Claim 1. A pharmaceutical composition of a didemnin compound, comprising firstly a lyophilised didemnin preparation including water-soluble material and secondly a reconstitution solution of mixed solvents.
Claim 2. A didemnin composition according to claim 1, intended for reconstitution for administration to patients as an antitumor treatment.
Claim 12. A pharmaceutical composition as defined in claim 1 and substantially as herein described with reference to the Examples.
Although at first glance claim 1 appears uncontroversial and directed to a pharmaceutical composition, seemingly a pharmaceutical composition per se, the PTE request was undone by claim 2. Claim 2 was interpreted as covering firstly a lyophilised didemnin preparation including water-soluble material and secondly a reconstitution solution of mixed solvents, but not as a single reconstituted composition. Instead, claim 2 was interpreted as covering the lyophilised preparation prior to reconstitution with the reconstitution solution. Consequently, this forced a construction on claim 1 and claim 12 as being directed to a kit of parts, rather than a pharmaceutical composition per se. (Although not mentioned in this decision, this construction perhaps is in line with use of the word “lyophilised” in claim 1.) Because a claim to a kit of parts is not proper basis for PTE, i.e. is not directed to a pharmaceutical substance per se, the PTE request was refused.
What you need to know
PTE must be requested based on a claim or claims directed to a pharmaceutical substance per se (there are some qualifications when recombinant technology is involved, but this is outside the scope of the present discussion). PTE cannot be requested based on a claim directed to a kit of parts or therapeutic use of a pharmaceutical substance (Commissioner of Patents v AbbVie Biotechnology Ltd  FCAFC 129 discussed here).
The claims of a patent for which PTE is to be requested should be reviewed prior to requesting PTE to ensure that the claims are directed to a pharmaceutical substance per se including that there are no potentially conflicting dependent claims that may force an unintended interpretation on the claims.
The claims of the patent should be reviewed well before the relevant deadline for requesting PTE (i.e. expiry of the patent, or the later of 6 months after grant of the patent or ARTG listing) so that voluntary amendments can be made, if needed, and allowed before expiry of the PTE deadline. Amendments could take 6 months for allowance, so if claim review is left until the PTE request deadline has been set, it may not be enough time for the specification to be amended and PTE requested.