On 18 March 2022, the Full Court of the Federal Court of Australia issued decisions relating to term extensions of patents covering pharmaceutical products: Commissioner of Patents v Ono Pharmaceutical Co. Ltd FCAFC 39 (‘Ono’); and Merck Sharp & Dohme Corp. v Sandoz Pty Ltd FCAFC 40 (‘MSD’). The two decisions have (at least) three things in common. First, both were decided unanimously by a panel comprising Chief Justice Alsop and Justices Yates and Burley. Second, both found against the patentee, with the court reversing the primary judge’s decision in Ono granting an extension of term, and confirming the primary judge’s decision in MSD nullifying a previously granted extension of term. And, third, both referred to the principle set out in the objects clause (section 2A) of the Patents Act 1990 that ‘the patent system balances over time the interests of producers, owners and users of technology and the public’ (emphasis added).
The scheme for extending the term of pharmaceutical patents inherently involves a balancing act. Its primary purpose is to ensure that patentees are not excessively disadvantaged by delays in securing regulatory approval to market patented products. For example, if a drug is not approved for use until 10 years or more after a patent application is filed, the patentee may have less than half of the standard 20 year patent term remaining to compensate for its investment in discovery and development before becoming exposed to generic competition. On the other hand, an extended period without competition necessarily exposes the wider public to higher costs of medical treatment. In an effort to balance these competing interests, the relatively complex provisions of the Patents Act aim to ensure that a ‘typical’ pharmaceutical patentee benefits from up to 15 years of exclusivity, by granting extensions of the patent term of up to five years, i.e. to a maximum of 25 years from filing. (A 2013 review of pharmaceuticals patents – which the government initially declined to release – found that 53% of such patents have an effective life of 15 years, while 89% have an effective life of over 10 years.)
The primary provisions of the Patents Act governing extensions of patent term are:
section 70, which sets out the conditions that must be satisfied before a patentee can apply for an extension of the term of its patent;
section 71, which sets time limits for filing of applications for extensions of term; and
section 77, which specifies how the duration of an extension of term is to be calculated.
In each of Ono and MSD, the patentee sought to obtain an advantage, or avoid disadvantage, by arguing for beneficial interpretations of the extension of term provisions. In each case they failed. And in both cases the Full Court upheld the principle that the purpose of the extension of term scheme is to balance the competing interests of the patentee of a pharmaceutical substance against the public interest in the unrestricted use of the pharmaceutical invention after expiry of the patent. In Ono, in particular, the Full Court rejected the proposition that sections 70, 71, and 77 should be construed to achieve a commercial outcome for the patentee. In MSD the Full Court again invoked the principle of ‘balance’ in declining to permit an extension of term based on a later Australian marketing approval, in circumstances where the patentee had already obtained the benefit of an ‘export only’ approval of a substance falling within its patent claims with an effective life of over 15 years.
The relevance of the Full Court’s focus on balancing of interests, and its references to the objects clause, could extend beyond these cases. The three judges here are all among the five who recently heard the appeal in the Thaler ‘AI inventor’ case, in which the competing interests of developers and owners of ‘invention machines’, and of the broader public (who might not see the same benefit in granting patent monopolies on automatically-generated inventions), are potentially at stake. It will be interesting to see whether they adopt a similar approach to weighing up the balance of interests in that case, also.
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ZURICH, SWITZERLAND, Mar 22, 2022 - (JCN Newswire) - Hitachi Energy, the global technology and market leader in power grids, announced today that it has won an order from Suzano, the world's leading eucalyptus pulp producer and one of Latin America's largest paper producers, to design and deliver a complete grid connection solution for the company's new pulp mill in Brazil.
Suzano's new factory will be the world's largest single-line eucalyptus pulp mill and Brazil's first pulp production facility to be fossil fuel free when completed in the second half of 2024. It will have an annual production capacity of 2.5 million tons and will increase Suzano's output by 20 percent. About half of the electricity generated will be transferred to the national power grid, enough to supply around 2.3 million people for one month.
The two companies have worked closely together on grid solutions for Suzano's fleet of mills over the past 20 years. In this spirit of collaboration and co-creation, Hitachi Energy has contributed its pioneering technologies and its unique system integration capabilities, engineering expertise and extensive experience of local grid code requirements. This enables Hitachi Energy to design and supply complete solutions with exceptional levels of reliability, that are fundamental for these types of application.
"We are honored and delighted to be working with Suzano again on this landmark project that sets a new benchmark in sustainable pulp production and shares its emission-free electricity with society at large," says Niklas Persson, Managing Director of Hitachi Energy's Grid Integration business. "This is another example of how our solutions are advancing the world's energy system to be more sustainable, flexible and secure."
"The construction of the new factory is the biggest investment in Suzano's history, so it is vital that the grid connection through which we generate additional revenue from our surplus energy operates at outstanding levels of reliability and availability," says Mauricio Miranda, Engineering Director at Suzano. "We chose Hitachi Energy as our technology partner based on more than 20 years of successful collaboration and consistent delivery of innovative, reliable solutions and exceptional project execution."
Hitachi Energy will supply a state-of-the-art grid connection solution to enable the surplus renewable power to be transferred reliably, safely and securely into the national power grid. The solution's compact footprint is based on advanced gas-insulated switchgear and offers excellent performance in terms of efficiency and availability, while minimizing the total lifecycle cost and CO2 footprint.
To secure reliability and availability, key elements of the grid connection, such as the transformers will be equipped with Hitachi Energy's digital monitoring systems to provide real- time data and performance insights and enable predictive maintenance. Hitachi Energy will provide a complete solution across the value chain, from system studies and grid code compliance to design and engineering, supply and installation and commissioning.
Hitachi Energy is the world's leading provider of grid connections and power quality solutions, with an installed base of more than 10,000 projects worldwide, over 800 of which connect renewable energy sources to the grid.
About Hitachi Energy Ltd.
Hitachi Energy is a global technology leader that is advancing a sustainable energy future for all. We serve customers in the utility, industry and infrastructure sectors with innovative solutions and services across the value chain. Together with customers and partners, we pioneer technologies and enable the digital transformation required to accelerate the energy transition towards a carbon-neutral future. We are advancing the world's energy system to become more sustainable, flexible and secure whilst balancing social, environmental and economic value. Hitachi Energy has a proven track record and unparalleled installed base in more than 140 countries. Headquartered in Switzerland, we employ around 38,000 people in 90 countries and generate business volumes of approximately $10 billion USD. https://www.hitachienergy.com https://www.linkedin.com/company/hitachienergy https://twitter.com/HitachiEnergy
About Hitachi, Ltd.
Hitachi, Ltd. (TSE: 6501), headquartered in Tokyo, Japan, contributes to a sustainable society with a higher quality of life by driving innovation through data and technology as the Social Innovation Business. Hitachi is focused on strengthening its contribution to the Environment, the Resilience of business and social infrastructure as well as comprehensive programs to enhance Security & Safety. Hitachi resolves the issues faced by customers and society across six domains: IT, Energy, Mobility, Industry, Smart Life and Automotive Systems through its proprietary Lumada solutions. The company's consolidated revenues for fiscal year 2020 (ended March 31, 2021) totaled 8,729.1 billion yen ($78.6 billion), with 871 consolidated subsidiaries and approximately 350,000 employees worldwide. For more information on Hitachi, please visit the company's website at https://www.hitachi.com.
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comHitachi Energy, the global technology and market leader in power grids, announced today that it has won an order from Suzano, the world's leading eucalyptus pulp producer and one of Latin America's largest paper producers, to design and deliver a complete grid connection solution for the company's new pulp mill in Brazil.
Over the last week, Chinese stocks have fallen dramatically. Of course, other markets have had substantial drops over-generalized risk-off moves around the war in Ukraine. The drama of the war has overshadowed a lot of financial markets. The situation in China could have been dismissed as another manifestation of the consequences of geopolitics. However, China […]