Lee Miles, Senior Associate and Andrew Gregory, Senior Associate at FB Rice, continue the FB Rice series into patents. In Part 2, they explore Australia’s Patent Term Extension, its application to pharmaceutical substances and recombinant DNA technology. Follow their series here.
Australia is at the forefront in many fields of life sciences research. To protect the commercial aspects of such research, institutions rely upon the global patent system. For most jurisdictions a standard patent term is 20 years. However, given the highly regulated nature of human pharmaceuticals, the effective patent term may be somewhat shortened.
Like a number of other patent regimes, Australia’s patent system provides for the possibility of an extension of term for pharmaceutical and biotechnology patents relating to pharmaceutical substances. These patent term extension (PTE) provisions are available in Australia to extend eligible pharmaceutical and biotech patents for up to five years.
Whilst PTE in Australia is relatively generous, the eligibility requirements are strict:
- goods containing, or consisting of, a pharmaceutical substance for which PTE is sought must be included on the Australian Register of Therapeutic Goods (ARTG);
- at least 5 years must have elapsed between the patent filing date and the date of first regulatory approval of the pharmaceutical goods;
- the patent claims must include within their scope:
- a pharmaceutical substance per se; or
- a pharmaceutical substance when produced by a process involving recombinant DNA (rDNA) technology; and
- the pharmaceutical substance, or its production by rDNA technology, must in substance be disclosed in the patent.
Failure to satisfy all of these criteria will result in rejection.
Unlike some jurisdictions, the Australian PTE provisions are limited to pharmaceutical substances. The Act defines a pharmaceutical substance as a therapeutic substance (or mixture), which involves either:
- a chemical or physico-chemical interaction with a human physiological system; or
- action on an infectious agent, toxin or other poison, in a human body.
Substances used solely for in vitro diagnosis or testing are excluded.
With the exception of claims defining methods of producing a pharmaceutical substance involving rDNA technology, claims directed to methods, processes and uses, are ineligible for PTE in Australia. This has been confirmed by a recent decision, which clarified that Swiss-style use claims are directed to the manufacture of a pharmaceutical product and not the pharmaceutical product per se.
The Australian Patent Office (APO) has also clarified that for claims defining a pharmaceutical substance in combination with other integers (e.g. a controlled-release dosage form or transdermal drug delivery patch) there must be a sufficient level of interaction or integration between the pharmaceutical substance and the other integers relevant to the therapeutic effect for PTE eligibility.
Recombinant DNA technology
Claims defining methods of producing pharmaceutical substances involving rDNA technology may be the subject of PTE. Examples include patents relating to the production of vaccine antigens or antibody-drug conjugates by recombinant means. Two APO decisions provide guidance, namely that:
- the claim on which PTE is based needn’t be limited to the product which is produced by the rDNA technology;
- a product-by-process claim is not required; and
- whilst rDNA technology must be involved, the specific rDNA process needn’t be novel and inventive.
Timing is everything
An application for PTE must be filed during the term of the patent and within six months of the latter of the date the patent was granted, or the date of first inclusion in the ARTG of goods that contain, or consist of, any pharmaceutical substance eligible for PTE.
Goods “containing” a pharmaceutical substance is interpreted broadly. It is therefore not necessary for the pharmaceutical substance to be expressly recorded as an active ingredient on the goods, e.g. a racemic mixture registered with the ARTG could constitute the first inclusion of a single enantiomer. Consequently, as long as the pharmaceutical substance per se is proven to be present in some form, even as an impurity, the relevant criterion for inclusion on the ARTG should be met.
‘First inclusion in the ARTG’ means the first time any good containing the pharmaceutical substance is included in the ARTG, including pre-TGA marketing approval. This is regardless of ownership of the registered pharmaceutical. Accordingly, where a patent includes claims encompassing multiple pharmaceutical substances, the first substance registered on the ARTG will be used to determine both the eligibility and length for a PTE. Patentees and patent applicants should therefore be careful to consider all approved pharmaceutical substances covered by their claims, and not just those pharmaceutical substances they are seeking to commercialise. Failure to do so can be potentially fatal to a PTE request.
Notwithstanding the strict criteria around timing, where the deadline for filing a request for PTE is missed due to an error or omission, Australia’s generous extension of time provisions may be relied upon to file a late request for PTE.
The maximum term extension is five years calculated as the amount of time which has elapsed between the filing date of the patent and the date of first Australian regulatory approval for the pharmaceutical good upon which the PTE is based, less five years.
Patentee rights during PTE
Although PTE extends to the patent as a whole, exploitation of any form of the invention that is not a pharmaceutical substance or is in non-therapeutic applications, will not constitute infringement of the patent during the extended term.
Since the standard 20 year patent term isn’t always enough, Australia’s PTE provisions provide a valuable means of extending the period of exclusivity for manufacture and sale of a patented drug. To maximise the chances of obtaining a PTE, applicants should:
- Ensure that their patent describes and claims a pharmaceutical substance per se, or one produced by rDNA technology, which is potentially relevant to a commercial product.
- Avoid claim language which restricts the scope of a compound/composition claim to specific applications.
- Carefully monitor the date of grant and first regulatory approval to ensure that an application for PTE is filed within the requisite six month window.
- Consider filing one or more divisional applications where a patent application covers more than one pharmaceutical substance; separation of the respective pharmaceutical substances will enable the patentee to maximise the term of PTE for each of the substances.
 Part 3, Patents Act 1990 (Cth).
 Subsection 70(3)(a), Patents Act 1990 (Cth).
 Subsection 70(3)(b), Patents Act 1990 (Cth).
 Subsection 70(2), Patents Act 1990 (Cth).
 Subsection 70(2), Patents Act 1990 (Cth).
 Schedule 1, Patents Act 1990 (Cth).
 Commissioner of Patents v AbbVie Biotechnology Ltd  FCAFC 129 at .
 Merck & Co., Inc v Arrow Pharmaceuticals Ltd  FCA 1344
 Aspen Pharma Pty Ltd and Ors v Commissioner of Patents and H Lundbeck (Joined Party)  AATA 851 (confirmed on appeal in Alphapharm Pty Ltd v H Lundbeck A/S  HCA 42), and followed by the tribunal in Merck Sharp and Dohme Corp and Commissioner of Patents  AATA 71 at )
 Merck & Co., Inc v Arrow Pharmaceuticals Ltd  FCA 1344 at .
 Subsection 70(3)(a), Patents Act 1990 (Cth).
G.D. Searle LLC  APO 31; Pfizer Corp v Commissioner of Patents (No 2)  FCA 1176; Ono Pharmaceutical Co., Ltd. et al  APO 43
Section 223, Patents Act 1990 (Cth).
 H Lundbeck A/S v Alphapharm Pty Ltd  FCAFC 70.
Lee Miles is a senior associate in FB Rice’s Sydney biotechnology team. He provides a range of intellectual property services to clients, with experience in IP strategy and counselling, preparing and prosecuting patent applications and coordinating prosecution of global patent portfolios. With a broad background in biological sciences, Lee has experience in a range of technology areas including genetics and genomics, gene silencing, gene editing, cloning and expression, antibodies and immunology, gene therapy, diagnostics and vaccine development. His varied technical experience means that he is well positioned to assist clients in a range of sectors within the life sciences space. Connect with Lee via email or LinkedIn
Andrew Gregory is a senior associate in FB Rice’s Sydney chemistry team. His intellectual property work spans prosecution, coordinating patent portfolios, oppositions, searching and freedom-to-operate opinions, drafting, and strategic advisory services. Andrew provides advice to both domestic and international clients, utilising Australian and New Zealand practice to help with the commercialisation of his clients’ products. His client base covers universities to global companies in a range of technological areas including: pharmaceuticals, polymers, veterinary sciences, green technology, inorganic materials and nanotechnology. Connect with Andrew via email or LinkedIn