IP SPOTLIGHT 20 APRIL 2020

Patentees of pharmaceutical substances are frequently unable to exploit their inventions until receiving regulatory approval for their products, often many years after the commencement of the patent term. Recent decisions from IP Australia and the Australian Federal Court indicate that the Australian patent term extension system is quite favourable to patentees at the moment. Multiple patents can be extended based on the registration of a single pharmaceutical product. So, how can this system enhance the term and value of your Australian patent rights?

WHAT FACTORS MUST BE SAT I SF I ED TO OBTA I N A PTE? The following factors must be satisfied in order to obtain a PTE:

The term of a standard patent in Australia is 20 years 2 . However, provisions in the Patents Act 1990 ( Cth ) ( the Act ) provide for the term of certain patents relating to pharmaceutical substances to be extended by up to five years. Patentees of pharmaceutical substances are frequently unable to exploit their inventions until receiving regulatory approval for their products, often many years after the commencement of the patent term. Accordingly, the effective term during which the patentee is able to enjoy their monopoly may be much shorter than the full 20 year term. The rationale for patent term extensions ( PTEs ) is to partially compensate such patentees. Recent decisions from IP Australia and the Australian Federal Court indicate that the PTE system in Australia is quite favourable to patentees at the moment compared with other jurisdictions. Multiple patents can be extended based on the registration of a single pharmaceutical product. Further, the PTE system is not limited to novel active agents, and while methods of treatment and processes are not eligible for PTE, patents which cover salt forms of the active, formulations and even novel patches, dosage forms, nanoparticulates and sustained release compositions can be extended provided they meet the criteria of the Act.

– – at least one pharmaceutical substance per se, or a

pharmaceutical substances produced by a process that involves the use of recombinant DNA technology ( PSPS ), must in substance be disclosed in the specification and fall within the scope of the claims; 3 – – goods containing or consisting of the substance must be included in the Australian Register of Therapeutic Goods ( ARTG ) 4 ; – – the first regulatory approval for that pharmaceutical substance must have occurred more than 5 years after the date of the patent 5 ; and – – the application must be made within 6 months of either the date the patent was granted or the date of the first inclusion in the ARTG of goods that contain or consist of any of the PSPS, whichever is later. 6 Only one PTE can be granted per patent, 7 but multiple patents can be extended based on a single registration on the ARTG.

PHARMACEUTICAL PATENT TERM EXTENSIONS IN AUSTRALIA

2 Section 67 Patents Act 1990 (Cth). 3 Section 70(2) Patents Act 1990 (Cth). 4 Section 70(3) Patents Act 1990 (Cth). 5 Section 70(3) Patents Act 1990 (Cth). 6 Section 71(2) Patents Act 1990 (Cth). 7 Section 70(4) Patents Act 1990 (Cth).

8 | wrays.com.au

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