|Therapeutic product per se||Compound for specified therapeutic purpose||Method of medical treatment|
|Papua New Guinea||Yes||Yes||No|
29 November, 2016
A comparative study of strategies for patenting human therapeutics in the Asia Pacific Region: Part 2 – Wider Asia PacificA comparative study of strategies for patenting human therapeutics in the Asia Pacific Region: Part 2 – Wider Asia Pacific
[caption id="attachment_1699" align="alignright" width="150"] By Dr Tim Fitzgerald.[/caption] In our previous article we provided a detailed overview of Australian practice with regard to patenting of inventions related to therapeutic treatment of humans. As noted in that article, the claiming strategies used for therapeutic inventions vary considerably among jurisdictions. As such, to complement our discussion of practice in Australia, here we summarise the approach to therapeutic patenting in selected jurisdictions in the Asia-Pacific Region. [caption id="attachment_319" align="alignright" width="150"] For more information about intellectual property protection contact Dr Mark Egerton[/caption] Notably, while directly claiming a method of medical treatment (e.g. a method of surgery or of administering a drug treatment regime) is permissible in Australia, in many other jurisdictions in the Asia-Pacific, such ‘method of medical treatment’ claims are excluded by statute or precedent. Nevertheless, where a therapeutic product is itself new, protection is generally available as for any other new product, regardless of the permissibility of claiming methods of medical treatment in a particular jurisdiction. Often, however, the contribution of an invention directed to therapeutic treatment is use-related. This is particularly the case for drug compounds, for which a first or further therapeutic use may be determined long after the compound itself is discovered. In jurisdictions in the Asia-Pacific where method of medical treatment claims are precluded, it may still be possible to obtain protection for such inventions if another mechanism for claiming a new use of a known product is available. As described in our previous article, European ‘for use’ claims, and ‘Swiss-type’ claims are suitable for this purpose, where permissible. In Table 1, for jurisdictions in the Asia-Pacific region, a summary is presented of the allowability of claims providing protection for: (i) new therapeutic products per se; (ii) known compounds for new therapeutic uses; and (iii) methods of medical treatment. We then provide comments on notable issues in a subset of these jurisdictions. Table 1. Summary of allowable therapeutic claiming strategies in the Asia-Pacific region.
Patent law in Australia and New Zealand has historically shared substantial similarities, with the approach in both jurisdictions drawing influence from the United Kingdom. With the respective changes of the ‘Raising the Bar’ Act in Australia, and the introduction of Patents Act 2013 in New Zealand, the law has been brought into even closer alignment.
Nevertheless, with particular regard to therapeutic claiming, the approach in New Zealand still features substantial differences as compared to that of Australia. Most notably, methods of medical treatment are expressly prohibited in New Zealand by Section 16 of the Patents Act 2013, which has provided a legislative exclusion to support previous practice, based on the precedent of Pfizer Inc v The Commissioner of Patents. Neither are claims in the format ‘product X when used to treat condition Y’, which, as discussed in our previous article, are considered de facto method of medical treatment claims in Australia, allowable in New Zealand.
However, Swiss-type claims are considered permissible in New Zealand, as per the New Zealand High Court decision in Pharmaceutical Management Agency Ltd v Commissioner of Patents & Ors (‘Pharmac’). In Pharmac, the High Court confirmed that the correct approach in regard to the construction of Swiss-type claims is to acknowledge that “novelty and inventiveness resides in the newly discovered purpose for which the medicament is to be used”, in accordance with practice established in Europe.
Although not a PCT contracting state, Bangladesh provides substantive examination of patent applications, and allows for enforcement of patent rights in court. Notably however, neither method of medical treatment nor use-limited therapeutic claims are allowable in Bangladesh. As such, it is not possible to obtain protection for a new therapeutic use of a known medicament in Bangladesh.
Despite historic concerns regarding the protection available for intellectual property, a high and rising number of patent filings and lawsuits demonstrate that China is increasingly affording robust patent protection. Furthermore, with its vast and increasingly wealthy population, China represents a market with huge potential, including for therapeutics.
In regard to therapeutic claiming, methods of medical treatment cannot be claimed in China, however Swiss-type claims are permissible. It is also notable that methods of diagnosis of diseases can also be claimed in a similar fashion, e.g. “Use of product X in the preparation of a kit for diagnosing diseases”.
Similar to China, patenting activity in India has increased substantially in the last decade. Nevertheless, there are substantial challenges associated with gaining patent protection for therapeutics in this jurisdiction. Relevantly, both methods of medical treatment and claims to a new use of a known product are impermissible in India.
Notably, in May 2016, the Indian government released a document regarding IP policy, entitled ‘National Intellectual Property Rights Policy’. However, it has been commented by some that this policy statement provides little of substance to encourage changes in the Indian approach to IP protection, including patenting of therapeutics.
With a population of over 250 million, Indonesia is the fourth most populous country in the world, behind only China, India, and the United States. This represents a vast market for therapeutics, which is likely to increase in coming years with predicted economic growth and improvement in standards of human development. Although Indonesia is a party to the PCT and The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Indonesia’s patent system is currently in a state of development, with limited capacity for local examination. As such, patents are generally granted based upon evidence of grant in a foreign jurisdiction, which can be provided with an application in Indonesia. Notably however, Indonesian patent applications must be filed in the official language (Bahasa Indonesia).
Importantly, there have been recent amendments to patent law in Indonesia that significantly affect patent protection available for therapeutics. Specifically, as of 28 August 2016, use-limited therapeutic product claims are considered impermissible in Indonesia. Given that methods of medical treatment are also excluded in Indonesia, the effect of this change is that it is no longer possible to obtain protection for a new therapeutic use of a known product in this jurisdiction.
In Singapore, methods of medical treatment are excluded from patentability, but Swiss-type claims are permissible. It is noteworthy that all patent prosecution and litigation is performed in English in Singapore. Additionally, the Singapore patent system is considered to provide robust protection for IP rights. For example, in the World Economic Forum’s Global Competitiveness Report for 2015 to 2016, Singapore ranked 3rd worldwide for intellectual property protection.
Similar to Singapore, Taiwan is considered to provide for a high standard of patent protection in global terms. Notably however, Taiwan is not a PCT contracting state. Furthermore, all patent prosecution and litigation in Taiwan is conducted in Mandarin. In specific regard to therapeutic claiming, methods of medical treatment are excluded in Taiwan, however use-limited product claims are permissible.
It will be evident from the above that the approach to claiming inventions relating to therapeutic treatment of humans varies substantially throughout the Asia-Pacific. The allowability of methods of medical treatment in Australia is unusual in the region. However, while methods of medical treatment are generally excluded in other Asia-Pacific jurisdictions, most allow for use-limited claims to therapeutic compounds, providing for protection of a new therapeutic use of a known substance. In a small number of countries such as Bangladesh, India, and Indonesia, the impermissibility both method of medical treatment and use-limited compound claims provides significant limitations in regard to protection available for known therapeutics.
On a related issue, it is noteworthy that there is generally little guidance with respect to the permissibility of use-limited claims to therapeutic products other than drugs (e.g. medical devices) in jurisdictions in the Asia-Region region. Relevantly, in Europe, protection for new uses is restricted to instances wherein the new use is of a ‘substance’ or ‘composition’. In practice this appears to preclude use-limited claiming of medical devices in most circumstances. As noted in our previous article, in Australia any product (regardless of whether the product is for therapeutic use) can be claimed in both ‘for use’ and ‘when used for’ format, with such claims given an interpretation that is specific to this jurisdiction. However it is not entirely clear in Australia and in other Asia-Pacific regions whether use-limited claim formats adopted specifically for protection of new therapeutic uses (e.g. Swiss-type claims) can be validly used to confer use limitation to products other than substances or compositions.
Notwithstanding this issue, although the specific approach to claiming inventions in the field of therapeutic treatment of humans varies within the Asia-Pacific, there is substantial scope to protect such inventions in most jurisdictions in this region. However, it will be apparent that it is of considerable importance to be aware of specific practice in a given jurisdiction when seeking protection. Preparing claims guided by a clear understanding of local practice will help to provide optimal protection for therapeutic inventions in a given Asia-Pacific jurisdiction. Such protection can be of great value, particularly given the predicted continuing strong economic growth in the region.
For more information about IP protection for new therapeutics contact us on +61 (0)7 3011 2200 or firstname.lastname@example.org. You can also follow all of our IP updates at www.linkedin.com/company/fisher-adams-kelly.
 Fisher Adams Kelly Callinans. Fitzgerald et al. (2016). Therapeutic Patenting in Australia.
 Notably, product claims will generally provide protection for any manufacture, sale, or use of the product, regardless of whether the use is therapeutic in nature.
 Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth).
  NZLR 362.
 Nor are claims in similar format, including “Treatment of condition Y with product X”; “Use of product X to treat condition Y”; and “Use of product X as a pharmaceutical”, considered allowable.
  2 NZLR 529.
 See, for Example, Spicy IP. Shamnad Basheer (6 June 2016). India’s New IP Policy: A “Bare” Act? <http://spicyip.com/2016/06/indias-new-ip-policy-a-bare-act.html>.
 Under Article 54 of the European Patent Convention.
 See e.g. Meyer et al. (2016) Patentability of Known Medical Devices with a New Medical Use – Case Law of the European Patent Office. GRUR International, 2, 109-113.