Archives for: ‘Health & pharmaceuticals’

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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The future is now: Gene therapy lands in the United States

The United States Food and Drug Authority (FDA) has just given the green light to America’s first ever gene therapy treatment. It’s called Kymriah and it’s a genetically-modified autologous T-cell immunotherapy (CAR-T cell therapy).  For the layman: individually customised, cancer-killing white blood cells. This is why it’s a big deal, and what the future could hold for us here in …

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Drugs in the fast lane: provisional drug registration and other proposed changes to the Therapeutic Goods Act

Following the Australian Government’s Response to the Review of Medicines and Medical Devices Regulation in 2016, the government recently released exposure drafts for a set of significant reforms to the Therapeutic Goods Act 1989 (Cth). The proposed changes include modifications to the regulation of complementary medicines, and a new class of “provisionally registered goods”.  This new class provides an opportunity …

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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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Productivity Commission’s final report pulls no punches on patents

Yesterday the Productivity Commission published its final report on Australia’s IP system. Our high level summary of the Commission’s recommendations across all aspects of the IP system can be found here. The Commission sees the patent system as tipped in favour of patent owners and its recommendations are designed to restore balance. This post provides an outline of the key …

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Counter-productive? Australia’s Productivity Commission releases Final Report into Australia’s Intellectual Property Arrangements

Yesterday, Australia’s Productivity Commission released their Final Report into Australia’s Intellectual Property Arrangements. This report was sent to Government on 23 September 2016. The Government is carrying out additional public consultation in relation to the recommendations made in the Final Report, which differ in key respects from some of the Commission’s draft recommendations. You can make a submission here – …

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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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Productivity Commission recommends extensive changes to Australian IP – including fair use, circumventing geoblocks, abolishing business method and software patents and more!

Today, the Productivity Commission has released its draft report into Australia’s intellectual property arrangements. IP Whiteboard readers may recall that last year, the Federal Government asked the Productivity Commission to undertake a comprehensive review of Australia’s intellectual property system (see our previous post here). At 600 pages, the draft report is certainly comprehensive! We have published an alert summarising the …

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