Archives for: ‘Kim O’Connell’

Off to a running start? Federal Court of Australia permits generic manufacturer to make PBS application before patent expiry

Can a manufacturer apply for Pharmaceutical Benefits Scheme (PBS) approval for a generic drug before the patent has expired? Justice Nicholas held in February in Apotex Pty Ltd v Warner-Lambert Company LLC (No 3) [2017] FCA 94 that the answer was “Yes”, and his Honour’s decision was recently affirmed by the Full Federal Court in Warner-Lambert Company LLC v Apotex …

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Don’t you wanna dance with me? US Supreme Court to hear Amgen v Sandoz biosimilars case

The US Supreme Court has granted petitions for certiorari in Amgen v. Sandoz confirming that the Court will examine the operation of the “patent dance” regime under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), as well as clarifying when notice of commercial marketing can be given. Biosimilar boffins and patent pedants will be (justifiably) excited. Who Dances …

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Full Court warns against dangerous affliction of parameteritis (and confirms invalidity of aripiprazole patent)

On Wednesday the Full Court of the Federal Court of Australia handed down a decision in which it upheld Justice Yates’ findings that Otsuka’s patent relating to aripiprazole, a drug used in the treatment of schizophrenia, is invalid for want of novelty and inventive step.  Otsuka had alleged that Generic Health’s aripiprazole products, which were registered for the treatment of schizophrenia, …

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Same same but different? Federal Court finds Reckitt Benckiser’s/Nurofen’s marketing of the ‘specific pain relief’ range constitutes misleading and deceptive conduct

Last week Justice Edelman delivered judgment in the Federal Court, finding that Reckitt Benckiser (Australia)’s packaging and website descriptions of the Nurofen ‘Specific Pain Range’ constituted misleading or deceptive conduct under section 18 of the Australian Consumer Law (‘ACL’). Reckitt Benckiser was found to have represented that the four products in the Nurofen Specific Pain Range were each specifically formulated …

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The Trans-Pacific Partnership’s IP provisions: Biologics and biosimilars, copyright and privacy

The Trans-Pacific Partnership (TPP) was concluded on 5 October 2015, after 8 years of negotiations. Its twelve signatories, who together account for 40% of world GDP, are Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, United States and Vietnam. The details of the agreement have yet to be released, but a number of drafts of the agreement …

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High Court States the Obvious: AstraZeneca AB v Apotex Pty Ltd Appeal Decided

by Kim O’Connell, Suzy Madar and James Ellsmore In a widely anticipated decision, the High Court has upheld a decision of the Full Federal Court that AstraZeneca’s patent relating to low dosages of rosuvastatin is invalid for want of inventive step. Rosuvastatin is used in the treatment of high cholesterol and is marketed by AstraZeneca as Crestor. The decision will …

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Hackers cause recall of 1.4 million cars

by Kim O’Connell, Amanda Engels and Olivia Goudal As foreshadowed in our post on cyber resilience, available here, data breaches and cybercrime are becoming increasing prevalent. These issues are well illustrated by the recent recall by Fiat Chrysler of 1.4 million cars in the United States. On Friday 24 July 2015, Fiat Chrysler issued the recall of 1.4 million vehicles …

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Consultation period commences for China’s new draft cybersecurity law

by Rui Wang (Beijing), Martyn Huckerby, Colin Bailey and Yijia Tu (Shanghai) and Kim O’Connell (Sydney) Foreign companies doing business with Chinese entities or on their own account in China should be aware of the changing landscape for digital information. A Consultation Draft of a New PRC Cyber Security Law was posted on the National People’s Congress website on 6 …

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Next steps after Australia China Free Trade Agreement – how to make the most of the opportunity

The China-Australia Free Trade Agreement represents significant opportunities for Australian health and aged care providers. However, it is important to move quickly and strategically to make the most of the opportunities. See our Business Spectator article here for what to do next.    

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