Do the requirements for an extension of term for pharmaceutical patents make sense and are they applied correctly? This post will take a closer look at the requirement for the patent to disclose a ‘pharmaceutical substance per se’ that is included on the Australian Register of Therapeutic Goods (ARTG).
According to the Patents Act 1990, the patent must disclose either a pharmaceutical substance per se or a pharmaceutical substance when produced by recombinant DNA technology. So while patents that claim a process for producing a pharmaceutical wouldn’t usually be eligible for an extension, in the case of biologics it may be the best or only way to precisely describe the substance. The explanatory memorandum of the bill introducing the extension of term provisions says that “claims to pharmaceutical substances per se would usually be restricted to new and inventive substances.” It clarifies this by saying that extensions would not be available for claims to new processes of making, or new uses for, known pharmaceutical substances.
A consequence of these exclusions is that where a known substance is found to be useful in treating a different condition, it is unlikely to be eligible for an extension of term.
Key decisions on the meaning of “pharmaceutical substance per se” in cases include:
- that a container, or device directed to a method of treatment, is not a pharmaceutical substance per se (Boehringer [2001] FCA 647);
- that a claim to a method of use is not a claim to a pharmaceutical substance per se (Prejay [2003] FCAFC 77);
- that a claim that “includes features specifying the spatial configuration of the entities in the substance [in this case a transdermal patch],… is not a claim to a pharmaceutical substance per se” (LTS Lohmann [2002] APO 12);
- that a claim to a thermoplastic material for the slow release of a pharmaceutical substance it contains, is a claim to a new method of delivery of known active ingredients and not to a pharmaceutical substance per se (LTS Lohmann [2010] AATA 809 in disagreeing [at 36] with the decision in N V Organon [2009] APO 8).
It has previously been argued that the definition remains unclear. However, it appears that the Administrative Appeals Tribunal in LTS Lohmann [2010] has provided clarity where earlier decisions in cases may have seemed contradictory. Is the applied definition of pharmaceutical substance per se consistent with the intention of the parliament, or has it been broadened? Do inconsistencies remain from case decisions on the definition of a pharmaceutical patent per se?
For an extension to be granted, the Patents Act also requires that goods containing, or consisting of, the substance be included in the ARTG.
Key decisions on the meaning of ‘included in the ARTG’ and ‘first regulatory approval date’ include:
- that it is enough for a substance to be contained in a good listed on the ARTG, even where that substance is only listed as an impurity (Merck [2003] FCA 1344);
- that where a pharmaceutical substance consists of or contains a substance which has already obtained ARTG approval, then the ARTG listing date for the earlier pharmaceutical substance will be the date of first regulatory approval (Lundbeck [2009] FCAFC 70).
The extension of term provisions are intended to provide recognition of the market time lost in gaining regulatory approval. Therefore it could be argued that where a patent is granted for a new therapeutic product, and that product requires a separate approval process, an extension of term based on the timing of that approval process should be available. The Prejay and Lundbeck cases already mentioned above are examples of where this was not the case:
- In Prejay Holdings Ltd v Commissioner of Patents [2003] FCAFC 77, the patent claimed a method of administering progestogen and estrogen for treating menopausal and post-menopausal disorders. The relevant substance, Premia 2.5 Continuous, was registered on the ARTG. The extension of term was refused on the grounds that a patent claim that includes a substance mentioned only in the context of claiming a method or process is not a claim for a pharmaceutical substance per se.
- In H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, Lundbeck had previously been granted a patent for citalopram which was later registered on the ARTG. Citalopram is a mixture of two mirror image forms of a molecule. Following the successful separation of these mirror image forms, Lundbeck was granted a patent for one of the forms, escitalopram. Escitalopram was then registered on the ARTG and it is the patent on escitalopram that Lundbeck sought an extension of term for. The court found that citalopram could be said to consist of or contain escitalopram and therefore the ‘first regulatory approval date’ should be the date of inclusion of citalopram on the ARTG, and not escitalopram.
These are important differences between Australian law and the law of other jurisdictions. In the US and Japan, extensions of term are available for patents claiming pharmaceutical methods. In the US, Japan and Europe, the relevant approval date is for the product falling within the claims of the patent.
Therefore, Australia offers extensions of term for a narrower class of pharmaceutical innovations than many other countries that offer extensions. In some cases Australia may also provide shorter extensions of term than other countries. On the other hand, many other countries like Canada, New Zealand and India offer no extensions at all.
What are the practical implications of differences in Australia’s extension of term provisions compared with other countries? Is there any evidence of the effects of these differences on investment, availability and/or the price of medicines?
Paul Stockwell
Pharmaceutical Patents Review Secretariat
Unfortunately a number of patent term extension (PTE) decisions are based on an incorrect understanding of what the expression “mixture or compound of substances”, as it appears in the definition of “pharmaceutical substance” means. The first decision to go off the rails was the LTS Lohmann 2002 decision where the ...
... Delegate (a physicist) went to great lengths to rule out a PTE for a transdermal patch. The term “pharmaceutical substance” is defined in the Patents Act 1990 as including a “mixture or compound of substances”. The Delegate tried to justify why a transdermal patch could not be a mixture or compound of substances by applying restrictive definitions of the terms “mixture” and “compound”. His definition of “compound” was most controversial because he applied the definition of a “chemical” compound, which requires “chemical” bonds between the component atoms, rather than the definition of a “pharmaceutical” compound, which is a product prepared by combining an active pharmaceutical agent with other components so that it can be administered to a subject. While the active pharmaceutical agent is itself a “chemical compound” it is the agent presented in a form suitable for administration, in combination with other components, which is a “pharmaceutical compound” of the type contemplated by the definition of pharmaceutical substance.
Pharmaceutical or medicinal compounds are devised by formulation scientists. They can also be prepared at a “Compounding Pharmacy”, where they make up “compounds” on the spot for administration. Tablets, capsules, supensions, suppositories, inhalable powders etc are all examples of pharmaceutical “compounds”. It is also possible that a transdermal patch could be characterised as a “pharmaceutical compound”. Such “compounds” are applied to the largest organ of the body, the skin. Why should “compounds” which are applied to this organ be treated differently to “compounds” ingested orally?
The LTS Lohmann 2002 decision was applied by the Delegate (another physicist) in the Euro-Celtic 2007 case. We then had a remarkably sensible decision in Sanofi-Aventis 2007 where the Delegate (this time a pharmaceutical expert) applied the correct definition of a pharmaceutical “compound”, making reference to the famous “medicinal compound” invented by Lydia Pinkham, which is the subject of the 1968 hit song, “Lily the Pink”. The Sanofi decision was the applied in the NV Organon 2009 decision to again arrive at a sensible result. Unfortunately the LTS Lohmann 2010 decision of the AAT makes no reference to the Sanofi-Aventis 2007 decision and characterised the NV Organon decision as an “inconsistent with judicial reasoning”. Rather than clarifying the meaning of “pharmaceutical substance per se” the AAT decision clouds the meaning. See http://www.davies.com.au/pub/detail/360/extending-the-patent-term-for-drug-delivery-systems-muddying-the-waters-of-the-meaning-of-pharmaceutical-substance for a discussion of this decision. Accordingly I disagree strongly with the statement appearing above that LTS Lohmann 2010 decision has “provided clarity where earlier decisions in cases may have seemed contradictory”. It has done the opposite!