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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
Further to our legal update in March, the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 has been passed by both Houses of Parliament, and has received royal assent
Proposed amendments to the Copyright Act could have the effect of preventing pharmaceutical companies from commencing legal proceedings for copyright infringement of their TGA approved pharmaceutical Product Information documents
