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Results: 1-6 of 6

Apotex appeal fails: no implied license over Sanofi's copyright in leflunomide product information

  • Davies Collison Cave
  • -
  • Australia
  • -
  • August 27 2012

The Full Court of the Federal Court of Australia has recently confirmed that Apotex did not have an implied licence to copy the Product Information (PI) for trade rival Sanofi's anti-arthritis drug, Arava (active ingredient leflunomide) for the purposes of obtaining TGA approval of Apotex's generic leflunomide products

Pharmaceuticals - copyright in PIs and indirect patent infringement

  • King & Wood Mallesons
  • -
  • Australia
  • -
  • August 4 2011

In the recent decision in Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3), Justice Jagot of the Federal Court found liability for indirect patent infringement in the context of supply of a pharmaceutical product

Federal court rules on copyright in pharmaceutical product information documents

  • Clayton Utz
  • -
  • Australia
  • -
  • August 2 2011

In the recent case between Sanofi-Aventis Australia Pty Ltd and Apotex Pty Ltd 2011 FCA 846, the Federal Court of Australia addressed for the first time the issues of copyright subsistence and infringement in relation to product information documents (PI) for pharmaceutical products

Exemption of product information from copyright infringement

  • Piper Alderman
  • -
  • Australia
  • -
  • June 7 2011

The Therapeutic Goods Legislation Amendment (Copyright) Act 2011 received Royal Assent on 27 May 2011 and commenced operation on 28 May 2011

Copyright law amendments shut down litigation options for proprietary drug owners

  • Watermark Patent & Trade Marks Attorneys
  • -
  • Australia
  • -
  • June 1 2011

Following approval of the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 by the Senate, Australian consumers and health professionals will have more ready access to generic drugs, but proprietary drug companies will have fewer options in the twilight years of patent protection for shutting down access to Australian markets by generic medicines

Federal Court raises barriers for claiming copyright in works created by multiple authors

  • Herbert Smith Freehills LLP
  • -
  • Australia
  • -
  • July 14 2010

In the Federal Court decision in Primary Health Care Limited v Commissioner of Taxation 2010 FCA 419, the failure to provide evidence to identify each author of the patient records from a number of medical centres ultimately led to the rejection of a claim that copyright subsisted in those patient records

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