Author Archive for: ‘sugroom’

IPO 2018: Insights from the USPTO, EPO and the bench (when digital natives meet digital immigrants)

The Intellectual Property Owners Association’s 46th Annual Meeting took place in Chicago on 23-25 September 2018.  Suzy Madar from the Sydney IP team reports on the conference highlights.

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United States FDA gets serious about biosimilars

The most significant advances in medical treatments are being made with biological products.  As biological medicines are significantly more expensive than traditional small molecule drugs, upward pressure is being placed on health spending. For example, in the United States, biological medicines accounted for 40% of all prescription drugs spending and 70% of the increase in healthcare spending in the five …

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Fast drugs, new drugs: new opportunities in the healthcare industry in Australia and China

Chinese and Australian businesses looking for overseas opportunities to expand in the healthcare industry should be aware of important regulatory changes that are taking place in both China and Australia. The healthcare industry in both Australia and China is undergoing significant growth that has been accompanied by rapid regulatory change. Both countries have invested significantly in the industry which increasingly …

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Second throw of the dice unsuccessful: Full Federal Court confirms Hepatitis C drug patent is invalid

The recent decision of the Full Court in Idenix Pharmaceuticals v Gilead Sciences [2017] FCAFC 196 illustrates the power of the grounds of lack of utility and lack of sufficiency under section 40 of the Patents Act when challenging the validity of a patent. The decision concerned lack of utility and lack of sufficiency as those grounds existed prior to the introduction …

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Biosimilars: balancing access to affordable medicines with safety

Biological medicines (biologics) are agents derived from a biological source.  As a consequence, they are complex and there is a high degree of variability between molecules of the same active substance.  Biosimilars are medicines that are closely related, pharmaceutically and therapeutically, to their reference biologic.  However, biosimilars are not identical to, and cannot be characterised as bioequivalent to, the reference …

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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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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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Australia signs Free Trade Agreement with China – important implications for IP owners and healthcare providers

After years of negotiation and months of drafting, Australia signed the Free Trade Agreement between the Government of Australia and the Government of the People’s Republic of China (ChAFTA). The Agreement addresses a number of important IP related issues and also sets out bilateral obligations to promote trade and investment in healthcare. Intellectual Property Chapter 11 of the ChAFTA aims …

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Blindsided on prior use

A recent decision of the Full Court of the Federal Court reaffirms that not every prior use of an invention will be novelty defeating (see Damorgold Pty Ltd v JAI Products Pty Ltd [2015] FCAFC 31). Damorgold’s patent related to a spring assisted mechanism for controlling blinds. JAI briefly marketed (but did not sell) a RolaShades product in Australia which possessed …

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