Archives for: ‘Kim O’Connell’

Tribunal grants stay of decision to cancel ARTG registrations for prescription pain killers

The Administrative Appeals Tribunal (“the Tribunal”) has granted Aspen Pharmacare Australia Pty Limited (“Aspen”) a stay of a decision of the Thereapeutic Goods Administration (subsequently affirmed by the Minister for Health and Ageing) to cancel from the Australian Register of Therapeutic Goods two prescription pain killers – Di-Gesic and Doloxene.  Aspen was required to move swiftly in seeking the interim relief from the Tribunal as the Minister’s decision (made on 23 January 2012) proposed to cancel the products as at 1 March 2012.  Aspen applied for a st

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Justice Jagot rejects ‘manifestly absurd and unreasonable’ construction of new copyright exemption for PI documents

When Justice Jagot handed down her judgment in Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3) in August this year (read our Alert here, her Honour found that Apotex’s proposed supply of a generic leflunomide product would infringe Sanofi’s patent.  Her Honour also found that Apotex had infringed the copyright in Sanofi’s leflunomide product information (“PI”).  Un

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Breaking news – Generics knock out anti-depressant patent

The Full Court of the Federal Court of Australia on Friday upheld a claim by Alphapharm (together with Sigma and Generic Health) that claims 1 to 17 and 27 of Wyeth’s patent relating to venlafaxine, an anti-depressant used in the treatment of depression, are invalid.

Mallesons acted for Alphapharm in the proceeding.

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Agreement over pain killer a tender issue in Europe

A 2009 inquiry into the European pharmaceutical sector identified competition between ‘originator’ and ‘generic’ companies as an area where pharmaceutical markets “are not working as well as they should”.  The inquiry was particularly concerned about originator pharmaceutical companies launching pre-emptive litigation against potential generic competitors, and subsequent settlement agreements in which would-be generic competitors would be paid to delay entry to the market. 

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European Court of Justice says no to patents requiring the destruction of a human embryo – an Australian perspective

Article 6(2)(c) of the European Biotech Directive excludes inventions which use human embryos for industrial or commercial purposes from patentability.  Interpreting this exclusion, the European Court of Justice decided yesterday that an invention is not patentable if the claimed process requires the destruction of a ‘human embryo’. 

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Natco pushes ahead with bid to compulsorily licence anti-cancer drug from Bayer

Natco Pharma, an Indian generic pharmaceutical company, has lodged an application with the Indian Patent Office requesting the grant of a compulsory licence to produce a generic version of Bayer’s anti-cancer drug Nexavar.  If granted, this would be the first-ever compulsory licence issued by the Indian Patent Office and would set the bar for future applicants.

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Senate Committee throws its support behind opponents of the Gene Patents Bill

 

 

 

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US Senate passes patent reform measures

The New York Times reported last week that the US Senate has passed a bill to bring about a suite of changes to the American patent system.  Known as the America Invents Act, the bill was passed by the Senate 89 votes to 9 without any furtehr amendments by the Senate.  President Obama is scheduled to sign this bill into law on Friday, US time.

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TGA gets tough on sponsors who fail to comply with advertising rules

Sponsors beware!  The TGA may now publicise a failure to comply with advertising rules for therapeutic goods.

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