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Intellectual Property
Australian patent term extension in favour of patentees
Australian patent term extension in favour of patentees - Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643 Summary: · Ono Pharmaceutical Co, Ltd’s (Ono) Australian patent No. 2011203119 concerns two cancer drugs: third party’s KEYTRUDA and the patentee’s own OPDIVO. · Both KEYTRUDA and OPDIVO received regulatory approval in Australia, but the third party’s KEYTRUDA was approved earlier than the patentee’s own OPDIVO. · To cover all its bases, Ono applied for a patent term extension (PTE) based on the two products, but its preferred option was to acquire the PTE based on OPDIVO’s approval to obtain the maximum term of the PTE. · However, the Commissioner of Patents granted the PTE based on KEYTRUDA because KEYTRUDA was approved first and therefore should form the basis of the request. · Ono challenged the decision in the Federal Court of Australia, which overturned the Commissioner’s decision, finding that a PTE must be granted based on the regulatory approval date of a patentee's own pharmaceutical product. The regulatory examination of a new pharmaceutical product is the apex for research, development and commercialisation within the pharmaceutical industry. For this reason, developing and receiving regulatory approval for pharmaceutical products takes a lengthy time. Recognising the time required between when a patent is filed and when regulatory approval is acquired, the Australian Patents Act 1990 (Act) allows applicants to apply for a patent term extension up to five years in addition to the statutory term of twenty years. For a patent to be eligible for a term extension, the following criteria must be satisfied: · a pharmaceutical substance must be disclosed in the patent and must fall within the scope of a claim; · products containing or consisting of that pharmaceutical substance must be included in the Australian Register of Therapeutic Goods (ARTG); and · there must be at least five years between the date of the patent and the date of the first regulatory approval for the substance. Background Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643 concerned Ono’s Australian patent No. 2011203119 on monoclonal antibodies that bind to PD-1. The substance of those antibodies were disclosed in its competitor’s product, namely KEYTRUDA, and Ono’s own product, OPDIVO. Both KEYTRUDA and OPDIVO were approved by ARTG, but on different dates (KEYTRUDA first and 9 months later OPDIVO). Ono simultaneously filed two PTE requests: one based on KEYTRUDA, which received ARTG approval on 16 April 2015 and another based on OPDIVO, which received approval on 11 January 2016. The PTE request based on KEYTRUDA was accompanied by a request for an extension of time. Although the patentee filed two requests, its preferred option was to acquire the PTE on OPDIVO’s regulatory approval date, as it would have resulted in a longer extended term for them (almost 9 months). Thus, the question at issue was which regulatory approval date was relevant for deciding the patentee’s PTE request. The Australian Patent Office found that because KEYTRUDA was the first pharmaceutical product to fall within the scope of the claims, the PTE should be granted on the date of KEYTRUDA’s approval even though it was produced by a third party. Federal Court of Australia’s decision Ono disagreed and appealed the Commissioner’s decision in the Federal Court of Australia. The appeal was heard by Justice Beach, who overturned the Deputy’s Commissioner’s decision on 11 June 2021. His Honour reached this conclusion by analysing s 70, 71, and s 77 of the Act, claiming that the Commissioner’s interpretation of the Act was ‘dictated by strict textualism.’ Justice Beach queried, ‘The extension of term regime is beneficial and remedial. It is designed to compensate a patentee of a pharmaceutical substance for the loss in time before exploiting its invention. It is designed to remedy the mischief of a shortened period for an effective monopoly that has been caused by delays in obtaining a regulatory approval. Accordingly, a liberal rather than a literal construction is to be preferred.’ [135]. For this reason, Justice Beach agreed with Ono that interpreting the Act in such a way that approval of a PTE application being based on a product held by an unrelated third party rather than a product developed by the patentee is ‘manifestly absurd and/or unreasonable’ because a patentee would be denied compensation for the time lost in securing marketing approval for its product, which will be contrary to the legislative intention. His Honour added that it was not open to the Commissioner to calculate the term of the extension solely based on products sponsored by the patentee. Instead, that the patentee’s interpretation of the statutory language should be consistent with the legislative objective. Accordingly, the Court found that Ono’s patent should be extended on the basis of the date of the regulatory approval of its own product. Implications The fundamental implication is that the six-month timeframe for filing a PTE application begins when the patentee’s own products are first included on the ARTG, not when they are first included on the ARTG of a third party. Consequently, this decision will now be the blueprint that sets out that patentees will no longer be burdened with the task of monitoring product listings on the ARTG to avoid situations in which their PTE request is forced to be based on a third-party product. Ultimately, this approach simplifies the extension regime and enables patentees to maximise their term extension. This adaptation is much more workable, bringing Australia into conformity with other key markets like the USA. In contrast, explicit discussions such as licensee or sponsors of the patentee have not been discussed. It appears that the PTE rules are meant to capture such ‘friendly’ arrangements in which the patentee has a commercial interest in the product listed on the ARTG by its commercial partners, as Justice Beach’s reasoning implies. Further, in circumstances where a patent covers more than one approved pharmaceutical substance, the decision implies that a PTE request does not have to be based on the substance that was approved earliest if the earliest product was produced by a third party. Noting that the Federal Court’s approach is contrary to longstanding practice of the Commissioner, the Patents Office has appealed the decision so there will be more news to come. Disclaimer: The contents of this publication are general in nature and do not constitute legal advice. The information may have been obtained from external sources and we do not guarantee the accuracy or currency of the information at the date of publication or in the future. Please obtain legal advice specific to your circumstances before taking any action on matters discussed in this publication.
Intellectual Property
Introduction of New Australian Domain Name
The auDA (.au Domain Administration Ltd) manages and oversees the development and administration of Australian domains such as .com.au, .net.au, and .org.au. Australian domain names must meet the auDA’s minimum registration criteria, and only an Australian company, a foreign company registered in Australia, or an applicant or a registrant of the Australian trade mark are eligible for registration. The domain name should also be in the applicant’s legal name, business name, Australian trade name, or brand name closely associated with its trading name. In April 2021, auDA implemented more rigorous qualifying conditions for domain names and proscribed its proprietors from licensing, renting, or leasing a domain name to third parties. Previously, all an entity had to do was show that its trade mark and its chosen domain name had a similar or close affiliation. That, however, is no longer the case. Now, the domain name must contain the same word as the trade mark. For instance, if ‘Beauty & the Beast Salon' is a registered trade mark, then an available domain name would be 'beautybeastsalon.com.au', whereas abbreviated forms such as bbsalon.com.au and other mix and match words such as beautybestsalon.com.au may violate the rules. In the case of the .org.au domain, religious organisations, sports clubs, charitable organisations, and other unincorporated associations that are not registered with ACNC (Australian Charities and Not for Profit Commission) are no longer eligible to have that domain. Under the amended rules, .au domain owners are no longer permitted to rent, lease, or sub-license their domain names. Since auDA aims to improve consumer website management and transparency by ensuring that the registration of a domain name is the website’s operator, any sub-domains derived from a company’s primary domain are also subject to this limitation. auDA also introduced new complaint-handling procedures which allow an entity to request that a domain name be revoked through a systematic process if the registrant does not fulfil the eligibility pre-requisite. This is a significant change from the past when domain name complaints or disputes had to be resolved through court proceedings or auDRP (.au Domain Dispute Procedure) mediation. Thereby, the complaints handling process is projected to be more efficient and cost-effective because of this adjustment. The above-changed rules were already in effect from 12 April 2021 and apply to all registrations, renewals, licencing, renting, and leasing to third parties from this date. It is crucial to verify that your current domain names comply with the new rules, so you do not inadvertently lose your domain names. In addition to the tightened domain rules, a new Australian .au domain will be introduced. It is anticipated that overseas-based companies with corporations or branches in Australia will commonly employ this strategy to show their affiliation to Australia, for instance maintaining the new .au domain name toyota.au in addition to toyota.com.au. To register for the new .au domain under this new scheme, you must be (i) an Australian citizen or permanent resident, (ii) an enterprise registered under the Australian Corporations Act (The Corporations Act 2001 (Cth)), (iii) a foreign company with an ARBN under the Australian Corporations Act, or (iv) an individual or business with an ABN under the Australian Corporate Law. In addition, if you hold an Australian trade mark and the applicable domain name that explicitly matches the trade name, you may meet qualifying criteria. Applications for the new domain is now open from 24 March 2022, and registrants of the existing .com.au domain will be able to register the new .au domain with the same name as the current domain name through the ‘Priority Status’ application for six months until 24 September 2022. Domains that were not registered during the six months will be available for public registration on a first-come, first-served basis. If multiple people apply for priority registration under the same domain name and there is no agreement between the parties, auDA will intervene and decide who owns the domain. We urge those who own or manage a website in Australia to be familiar with the new Aussie domain and the rule changes, and to seek advice from intellectual property law professionals if you encounter any domain-related issues. written on 25 Nov 2021 Disclaimer: The contents of this publication are general in nature and do not constitute legal advice. The information may have been obtained from external sources and we do not guarantee the accuracy or currency of the information at the date of publication or in the future. Please obtain legal advice specific to your circumstances before taking any action on matters discussed in this publication.
Intellectual Property
Is it possible for an AI (Artificial Intelligence) to be an inventor?
Is it possible for an AI (Artificial Intelligence) to be an inventor? - Thaler v Commissioner of Patents [2021] FCA 879 Summary: ● Dr Stephen Thaler (Thaler) filed an Australian patent application for an invention that was created autonomously by an AI system called ‘DABUS’. ● IP Australia rejected the patent application, determining that only a human can be named as an inventor for an Australian patent. ● Thaler successfully appealed to the Federal Court, which ruled that an AI could be appointed as an inventor for the purpose of the Patents Act 1990 (Cth) (Act). In recent years, the topic of whether AI can be an inventor has been at the forefront of patent laws in numerous countries. Defining the term ‘AI-generated invention’ has triggered a heated discussion over the future of patent law and policy. While it is widely agreed that such discoveries contradict the concept of human inventorship, it is unclear to what extent topics regarding ‘non-human’ creativity are justified. This raises the question of how AI may autonomously create innovations and how AI-generated ideas differ from AI-assisted ideas. The Australian Federal Court recently handed down the world’s first judgment in Thaler v Commissioner of Patents [2021] FCA 879, acknowledging AI as an inventor under Australian patent law with the broad interpretation of s15(1) of the Act. This advances our understanding of who can be the owner of the ‘solutions’ made accessible by these new technologies and how to utilise artificial intelligence to promote economic wellbeing through technological innovation. Background Thaler filed Australian Patent Application No. 2019363177 for ‘Food Container and Devices and Methods for Attracting Enhanced Attention’ on 17 September 2019 by the national entry of the corresponding PCT application. Thaler created The Device for Autonomous Bootstrapping of Unified Sentience (DABUS) to devise, on its own accord, novel ideas such as enhanced storage beverage containers and ‘neural flame’ for search-and-rescue operations. Equivalent patent applications have also been filed in 16 countries including Canada, China, Germany, India, Israel, South Africa, the UK, South Korea and the US. However, the European Patent Office refused to examine Thaler’s patent application on 21 December 2019, citing a failure to comply with their requirement that “an inventor designated in the application must be a human being, not a machine.” Based on the ideology that only natural individuals can be inventors, most countries, including the US, the UK and South Korea, have rejected Thaler’s patent application. So far, the South African Patents Office has only accepted the application but bear in mind that there was no substantive examination prior to this grant in South Africa, Australia is the first jurisdiction to permit a patent invented by a robot creator. IP Australia’s decision The Deputy Commissioner of Patents determined that Thaler’s application did not satisfy the requirements under s15 of the Act since the ordinary meaning of the word “inventor,” as defined by numerous dictionaries, is essentially human (natural or legal). The Deputy Commissioner asserted that the Patent Regulations 1991 (Cth) (Regulations) imply that the term ‘inventor’ refers to a person and that s15(1) of the Act, which specifies who is eligible for a patent, also stipulates that the inventor must be a human. Further, an AI system cannot have a beneficial interest or title in the property, so an AI’s invention cannot be assigned. Consequently, the Deputy Commissioner rejected Thaler’s patent application since it failed to designate a human inventor. Thaler applied for a judicial review to the Federal Court of Australia. Federal Court of Australia’s decision The appeal was heard by Justice Beach, who overturned the Deputy Commissioner’s decisions on 30 July 2021. Justice Beach noted that neither the Act nor the Regulations explicitly define the term ‘inventor’. The term ‘inventor’ is a noun that acts as an ‘agent,’ which can be a person or a thing. Therefore, claiming that a non-human/non-person cannot be an inventor is a fallacy. Henceforth, DABUS can be referred to as an ‘inventor’ as it satisfies the agent noun component. Justice Beach queried, ‘If the output of an artificial intelligence system is said to be the invention, who is the inventor? And if a human is required, who? The programmer? The owner? The operator? The trainer? The person who provided input data? All of the above? None of the above?’ In this regard, the Court acknowledged that Thaler owned DABUS’ source code (as the copyright owner of the source code) and the computer on which it was administered. Based on the concept of ‘deriving a title’ extending to assignments and title transfers, Thaler was found to have absolute ownership and control of the computer on which the program runs (i.e. DABUS). His Honour reached his conclusion based on a combination of legislative interpretation and policy considerations. Justice Beach believes that the term ‘inventor’ should not be interpreted narrowly since doing so would hinder innovation not just in the field of computer science but in all other scientific areas that may benefit from the output of an artificial intelligence’s system. Similarly, His Honour emphasised the fundamental significance of giving effect to the Act’s objective unless its terms or context requires the statutory definition. Justice Beach added that computer inventorship facilitates and incentivises computer scientists to develop novel inventions, resulting in new scientific advantages. So unlike the copyright law which mandates a human author, the Act does not exclude non-human inventors. Implications Justice Beach posited in this case that “We are both created and create. Why cannot our own creations also create?” This significant judgment implies that applications claiming AI as their inventor will no longer be denied on the grounds of failing to name a human inventor. Subsequently, some critics have voiced concerns that granting patent protection to AI-generated inventions may increase the threshold of originality of ‘person skilled in the art,’ making it more challenging for human inventors to obtain patent rights. Furthermore, allowing AI to be an inventor may encourage humans to create AI systems that undertake innovative activities on behalf of humans. It is worth considering whether this serves the Act’s objective of ‘providing a patent system in Australia that promotes economic wellbeing through technological innovation and the transfer and dissemination of technology’ (s2A of the Act). On the other hand, those who favour patent rights for AI-generated ideas believe that the decision will encourage more creation and publication of AI-based breakthroughs. Especially because many pharmaceutical and computer science enterprises and other scientific areas may greatly benefit from an AI system’s output. IP Australia announced on 30 August 2021 that the Commissioner of Patents has decided to appeal the Federal Court’s decision. So stay tuned for more exciting news. Written by Noel Kim (Partner) & Lisa Kwak (Paralegal) Written on 10/09/2021 Disclaimer: The contents of this publication are general in nature and do not constitute legal advice. The information may have been obtained from external sources and we do not guarantee the accuracy or currency of the information at the date of publication or in the future. Please obtain legal advice specific to your circumstances before taking any action on matters discussed in this publication.