Author Archive for: ‘sugroom’
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.
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’.
Just over 3 months after the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 was introduced into Parliament, and 2 weeks after it was passed unamended, the Governor General has given her Royal Assent to the Bill. The Amendment took effect on 28 May.
Further to our earlier post in relation to the introduction of the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011, the Bill has been passed unamended.
Further to our earlier post in relation to the Federal Court’s decision to revoke a patent claiming “substantially pure” fexofenadine, a compound which was disclosed in prior Australian and US patents, Justice Jessup’s decision provides useful clarification in relation to the test for novelty.
Earlier today, Justice Jessup of the Federal Court handed down judgment in AMRI v Alphapharm upholding Alphapharm’s challenge to AMRI’s patent which claimed substantially pure fexofenadine, a drug used to treat allergic reactions, on the ground that it lacked novelty, and for having been granted on the basis of a material false representation to the Patent Office. Mallesons acted for Alphapharm.
ACIP recommends amending the statutory test for patentability to match that which has been developed by the courts
The Australian Council of Intellectual Property (ACIP) has completed its review of the appropriateness and adequacy of the test of “manner of manufacture” as a threshold requirement for patentability. Submissions were sought in 2008, public forums were conducted in 2009, and a Report was provided to the Minister in December 2010. Yesterday, a report was released recommending a statutory test that is consistent with the test which is currently applied by the Courts.
Federal Court upholds TGA decision to refuse access to documents relating to applications to list generics on the ARTG
In December last year, Justice Emmett of the Federal Court handed down an important decision for originator pharmaceutical companies who seek access to documents evidencing applications to list generic versions of their products on the Australian Register of Therapeutic Goods (ARTG), and generic companies who assume such applications are kept confidential.
The TGA plans to implement a daily alert system to show new registrations on the ARTG. The move is the result of complaints made to the TGA by Medicines Australia in relation to originators not receiving notice when generic versions of their pharmaceutical products become registered.
The TGA has said that the system will be up and running within the next 2 months and is intended to list all registrations achieved.