In the last century, innovations in the life sciences have allowed for treatment and prevention of numerous diseases and disorders, enabling higher life expectancy and improved quality of life. It is well-recognised that development of new therapeutics requires an enormous investment of resources including time and money. For example, a study conducted in 2014 estimated that the average cost of bringing a new drug to market exceeded US$2.5 billion. The availability of a limited monopoly in the form of patent protection provides encouragement for commercial entities to expend these resources, and expose themselves to substantial risk, in order to attempt to develop new therapeutics.
Most jurisdictions offer some form of patent protection for human therapeutics. However, the specific manner in which an invention in this field of technology can be claimed in a patent varies considerably. In this respect, practice in Australia and other Asia-Pacific jurisdictions includes some distinctive features, which we discuss here. This article is a comparative piece, addressing patent protection for human therapeutics in a range of Asia-Pacific countries.
Depending on legal practice in a particular jurisdiction, various claiming strategies may be available to seek patent protection for inventions directed to therapeutic treatment of humans. The most direct approach to protecting a method of treatment is a claim to the method itself. Such ‘method of medical treatment’ claims may be patentable where (i) they relate to use of a new product (even where the method steps are conventional) and/or (ii) involve new method steps. Examples of the latter can include treatment of a new disease with a known drug, and methods directed to new treatment regimes, e.g. dosage amounts and/or timing. Notably, however, direct claiming of methods of medical treatment is precluded in many jurisdictions, either by legislation, or case law precedent.
Where a therapeutic product can be shown to be patentable itself, a claim to this product will generally be permissible, even if claims to treatment using the product are not permitted in a given jurisdiction. Thus, where a new drug or medical device is developed, protection of the therapeutic use thereof will normally be obtainable by way of product claims. Nevertheless, in many instances the contribution of an invention directed to therapeutic treatment may be use-related. This is particularly the case for therapeutically active compounds. For example, it may only be demonstrated that a known compound is therapeutically useful long after the discovery of the compound itself. Similarly, a compound that is known to be useful for treating certain conditions may later be demonstrated to be effective for treatment of other conditions. Under these circumstances, claims to the known product itself, i.e. regardless of use, will not be obtainable. However, even in jurisdictions where method of medical treatment claims are precluded, it may be possible to obtain protection if another mechanism for claiming a new use of a known product is available.
The Approach in Australia
Method of Medical Treatment Claims
As noted above, claims to methods of medical treatment are impermissible in many jurisdictions. However, it has been clearly established that such claims are allowable in Australia; in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd  HCA 50, a majority of the Australian High Court found that methods of medical treatment of the human body was patentable subject matter under Australian law.
Given the ability to claim methods of medical treatment in Australia, it is further notable that the Australian Patents Act features provisions regarding ‘infringement by supply’, in regard to use of a product for a particular claimed purpose. Specifically, Section 117 states that:
‘If the use of a product by a person would infringe a patent, the supply of that product by one person to another is an infringement of the patent by the supplier unless the supplier is the patentee or licensee of the patent.’
Importantly, these provisions can allow for a finding of infringement of a medical treatment claim against a manufacturer of a composition or medical device, despite the direct scope of the claim relating to steps generally performed by a physician or a patient. Notably however, making out infringement by supply can be relatively involved, as exemplified below with reference to the recent case of Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) (Otsuka).
Use-limited Product Claims
As alluded to above, in some jurisdictions, use-limited claiming of therapeutic products is possible, allowing for a position to be obtained in relation to a product, such as a drug, used for a specific purpose. Although claims for this purpose are allowable in Australia, Australian practice is somewhat unusual in this respect, for the following reasons.
Under Australian practice, claims in the form “product X for [or for use in] purpose Y” are allowable, and can be used to claim a therapeutic use. However, unlike in some other jurisdictions, notably Europe, therapeutic claims in such a format are considered limiting only to the extent that the product must be ‘suitable for’ the recited purpose. The effect of this is that if a product (e.g. a drug) is known, an Australian claim directed to the drug ‘for’ or ‘for use’ in a particular therapeutic purpose will be considered to lack novelty (as it will be considered that the known drug was inherently suitable for the recited purpose).
Australian law also allows for claiming in the unconventional form “product X when used for purpose Y”, with such claims given a construction that is particular to Australian practice. Specifically, as per the High Court decision in Wellcome Foundation Ltd v Commissioner of Patents such claims are considered ‘disguised process claims’, having essentially equivalent scope as a method claim directed to the recited use. As a result, claims in this form can confer novelty for a new use of a known product, including a therapeutic product, in Australia. However, as for a method of medical treatment claim, a therapeutic use claim in “when used for” format will only be directly infringed by use of the product in the claimed manner, i.e. the claim will not be considered directed to the product per se.
Yet another approach for claiming a particular use of a therapeutic product is available in Australia by the use of ‘Swiss-type’ claims. A Swiss-type claim is generally drafted in the form “Use of compound X in the manufacture of a formulation for the treatment of condition Y” (or similar). The scope of Swiss-type claims has been subject to limited assessment in Australia. However, these claims have been generally assumed to be directed to manufacture when there is an intention of use of the formulation for the recited purpose, in accordance with construction in other jurisdictions, and as such, Swiss-type claims are currently treated as use-limited in Australia. Notably however, in Otsuka (referred to above and discussed further below) a single judge of the Australia Federal Court has recently commented on interpretation and infringement of Swiss-type claims.
Another relevant aspect of Australian law in regard to use-limited claiming is the approach to allowability of ‘first medical use’ claims. Such claims, permissible in Europe, allow for all medical uses of a known compound to be claimed, upon first recognition that the compound has at least one medical use. Due to the particularities of Australian law in regard to sufficiency, first medical use claims were achievable for applications for which examination was requested prior to 15 April 2013. However, under the provisions of the ‘Raising the Bar’ Act of 2012, the current approach is that a use-limited product claim will only be considered supported by the disclosures of a patent specification if it could reasonably be expected that the product would be effective for the recited purpose. In practice, this precludes claiming all possible medical uses of a compound, as these claims will be objected to for lack of support. As such, first medical use claims in the form available in Europe are not likely to be obtainable in Australia.
Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4)
As referred to above, in Otsuka, a single judge (Justice Yates) of the Federal Court has recently commented on the interpretation of Swiss-type claims in Australia. An opinion on the comparative requirements for infringement of Swiss-type and method of medical treatment claims was also provided by his Honour, notwithstanding that the assessed claims were ultimately found invalid in this case. The decision in Otsuka focused on claims relating to aripiprazole (defined by a specific structural formula) for the treatment of schizophrenia under certain conditions.
In regard to the interpretation of Swiss-type claims, his Honour opined that, ‘an invention defined by a Swiss type claim is appropriately characterised as method or process’, rather than as a claim to the product itself. This generally accords with the interpretation of Swiss-type claims in other jurisdictions. It would also appear to clearly support the current approach to examination in Australia, wherein such claims are considered use-limited. This is because, where the claim is considered a method, the recited use is a step of that method that must be performed in order to be encompassed by the scope of the claim.
In regard to infringement, his Honour’s position was that the direct infringer of a Swiss-type claim was the manufacturer of the composition (which again accords with prior assumptions under Australian practice, and the approach in many other jurisdictions). His Honour went on to state that, had the claims been valid, to establish infringement the evidence must demonstrate that the alleged infringing medicament, was ‘effective in the treatment’ of the recited conditions as per the claim. In this regard, his Honour took into consideration that the alleged infringer (the Respondent, Generic Health) had sought marketing approval for use of its products containing the claimed compound for treatment of schizophrenia, and considered that this included all types of schizophrenia, including that recited in the claim. On this basis, it was opined that, had the claims been valid, Generic Health’s products would have infringed the claims.
Notably, to attempt to avoid possible infringement, Generic Health proffered an undertaking that it would not advertise or promote its products for the specific use recited in the Swiss-type claim being assessed. In response, his Honour stated that, in assessing infringement of Swiss-type claims, ‘[t]he question is whether, objectively ascertained, the medicament that results from the claimed method or process is one that has the therapeutic use defined in the claim’. His Honour went on to state that ‘[t]he question is not really about how the alleged infringer markets its product, although, plainly, its conduct in that regard may well assist in determining, objectively, whether the accused product has the claimed therapeutic use’.
It will be apparent from the above that there is no clear indication in Otsuka that his Honour considers a manufacturer’s intention regarding the use of a composition to be of central significance to infringement. Rather, his Honour could be interpreted as stating that a product will infringe a Swiss-type claim so long as it has therapeutic use that falls within the scope of the claims. However, if this was indeed the intention of his Honour, it would raise serious questions regarding the relative scope of novelty and infringement of Swiss-type claims under Australian law.
In this respect, as noted previously, current practice in Australia (as in other jurisdictions) is that Swiss-type claims will be considered novel if directed to a new therapeutic use of a known compound. This appears entirely consistent with his Honour’s characterisation of Swiss-type claims as method or process claims, as explained above. However, if his Honour was suggesting that it need only be demonstrated for infringement of a Swiss-style claim that a product be effective for the claimed use, rather than intended for that use, this would appear in direct conflict to the current approach to novelty. By way of elaboration, under these circumstances, a Swiss-type claim for a new use could be granted for a composition that was previously known, with the previously known composition then infringing the claim by virtue of being effective for the new use. It would appear very unlikely that his Honour was, in fact, advocating in Otsuka for such a situation to arise. Nevertheless, further clarification on this issue would be highly desirable.
It is noteworthy that the decision in Otsuka comes at a time when similar issues regarding Swiss-type claims are receiving attention in Europe and the UK. In this respect, in the UK, the Court of Appeal decision in Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others (Warner Lambert) has established that infringement of a Swiss-type claim by a manufacturer requires that the manufacturer knows (including constructive knowledge) or can reasonably foresee that the medicine would ultimately be used for the claimed method. It will be appreciated that such an approach reconciles issues in relation to novelty and infringement of use-limited Swiss type claims as described above, and is consistent with current examination practice in Australia.
Infringement of Method of Medical Treatment Claims
The decision in Otsuka also provides an exemplification of an assessment of infringement by supply with respect to a method of medical treatment claim under Australian law. Specifically, a method claim which recited corresponding features to the Swiss-type claim discussed above was also assessed by his Honour for infringement in this case.
In considering possible infringement of the method of medical treatment claim, his Honour first addressed the issue of whether aripiprazole compounds should be considered a ‘staple commercial product’. In this regard, if the compounds were not considered to be a staple commercial product, under Australian law, where it was demonstrated that Generic Health (as a supplier) had ‘reason to believe’ that their product might be used in an infringing manner, this would be sufficient to make out infringement by supply. In contrast, if it was held that aripiprazole was a staple commercial product, infringement by supply would only be found if either the product was only reasonably capable of the infringing use, or it could be demonstrated that Generic Health has supplied instructions or inducement to use the product in an infringing manner.
Despite submissions from Generic Health to the contrary, his Honour found that aripiprazole was not a staple commercial product. As such, the issue of potential infringement turned upon whether Generic Health had reason to believe that the product supplied would be put to the infringing use. In view of substantial evidence provided by both parties, his Honour ultimately concluded that a ‘not insignificant’ number of Australian clinicians would use Generic Health’s products for treatment in accordance with Otsuka’s method of medical treatment claim. It was therefore held that Generic Health did have reason to believe that this would occur, and that infringement by supply could apply in this case (had the claim been valid).
Although it was ultimately found that infringement could have applied in Otsuka, it will be apparent that his Honour’s decision relied upon a somewhat subjective characterisation that the product at issue was not a staple commercial product, and subsequent determination of whether it would reasonably be expected that the Respondent’s product would infringe, based on expert testimony from both sides. This serves to highlight the potential complexity of making out infringement by supply of a method of medical treatment claim in Australia.
Given the tremendous investment required for the development of new therapeutics, and the key role of patent protection in encouraging this investment, obtaining suitable patent protection for therapeutic inventions is of critical importance.
As discussed above, Australia offers a flexible approach to therapeutic claiming, with the ability to claim as (i) ‘product for purpose’ (limiting only to the extent that the product must be suitable for the purpose); (ii) ‘product when used for purpose’ (use-limited but construed essentially as a method claim); and (iii) in Swiss-type format. Notably however, given Yates J’s comments in Otsuka, clarification of the requirements for infringement of Swiss-type claims in Australia would be desirable. It is suggested that the approach to infringement established in the UK case of Warner Lambert (discussed above) is consistent with current practice and reconciles potential issues in relation to novelty and infringement of Swiss-type claims.
Notwithstanding this issue, in view of the idiosyncrasies in relation to therapeutic claiming described herein, preparing claims guided by a clear understanding of local practice is strongly beneficial for obtaining optimal protection for therapeutic inventions in Australia.
The approach in the wider Asia Pacific
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.
Please click here to view table.
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.