Full Federal Court strikes down claims to salts of enantiomer - Plavix Patent invalid - 1 October 2009
The Full Federal Court has handed down its findings in Apotex Pty Ltd v Sanofi-Aventis [2009] FCAFC 134, an important decision in relation to the validity of patents claiming enantiomers of known racemic compounds, and their salts.
Speeding up procedure: IP Australia announces additional reforms - 19 June 2009
IP Australia has released three further consultation papers outlining proposed reforms to the IP Rights System in Australia. Any organisation which has an interest in the processes subject to review may make a written submission to IP Australia by 17 August 2009.
Full Court confirms enantiomers patentable for 20 yr term - 17 June 2009
The Full Federal Court recently handed down its decision in H. Lundbeck A/S and anor v Alphapharm Pty Ltd (and 2 other appeals).The appeals related to a patent for escitalopram, the S-enantiomer (in this case the (+)-enantiomer) of citalopram, a selective serotonin reuptake inhibitor used in the treatment of major depressive disorder.
Australia gets inventive major changes to Patents Act proposed - 3 April 2009
The Australian government is proposing significant changes to the patent system with an aim to harmonise Australia’s laws with its major trading partners. The changes include raising the threshold for inventive step and enacting an ‘experimental use’ defence to patent infringement. Other key changes to patentability criteria include full description, fair basing and priority claim requirements.
Australia’s National Innovation Report- Key Points for Corporate Counsel - 11 September 2008
On 9 September 2008, the Federal Government released a major report on Australia’s National Innovation System. The Report was prepared by a panel chaired by Dr Terry Cutler, which included respected economists and research industry experts. This Alert identifies the specific key recommendations and issues raised by the Report which would have a legal impact on major corporations.
Enantiomer claims fail; salt claims stand - 21 August 2008
In a recent decision by the Federal Court of Australia, Justice Gyles found that certain claims of Sanofi-Aventis’ (Sanofi) Australian Patent AU 597784 (AU 784) relating to the dextro-rotatory isomer of methyl alpha-5 (4,5,6,7 - tetrahydro (3,2-c) thioeno pyridyl) (2-chlorophenyl)-acetate (clopidogrel) were invalid for lack of novelty and lack of inventive step. Despite this finding however, claims relating to specific salts of the isomer were found to be novel and not obvious and consequently, were found valid.
ALRC recommends changes to regulation of health information - 12 August 2008
The Australian Law Reform Commission has recommended significant changes to the regulation of health information handling. If adopted, the recommendations would sweep away the current patchwork of overlapping and inconsistent State and Federal regulations and replace them with nationally consistent laws on health privacy.
Full Federal Court delivers judgment in Ranbaxy v Warner-Lambert - 30 May 2008
The Full Court of the Federal Court has dismissed an appeal in Ranbaxy v Warner-Lambert, revoking Warner-Lambert’s patent for an isolated enantiomer of the cholesterol-inhibiting drug atorvastatin calcium but found that Ranbaxy’s product would infringe Warner-Lambert’s earlier patent covering the racemic mixture of the drug.
How to speed up processing of your Australian or US patent application - 11 April 2008
On 14 April 2008, a 12 month Patent Prosecution Highway (PPH) pilot program commences at IP Australia and the USPTO. The PPH enables your patent application to be expedited and thus jump the queue to be considered by a patent examiner earlier than normal. It is equivalent to a request for accelerated examination in Australia or a Petition to Make Special in the USA.
Federal Court Upholds Xenical Advertising Ban – 3 September 2007
On Thursday the Federal Court upheld the decision of the National Drugs and Poisons Schedule Committee banning direct-to-consumer advertising of Xenical, Roche's obesity drug. The Court held that the nature of the advertising of Xenical and the intense criticism of the advertising run during the 2006 season of Australian Idol were properly considered by the Committee when deciding whether the drug may be advertised directly to consumers.
ANZTPA on the backburner - New Zealand says “No” - 17 July 2007
The New Zealand government announced that the joint regulatory scheme and establishment of ANZTPA has been postponed. The main issue of contention was the inclusion of complementary medicines in the scheme.
Medicines Australia Code of Conduct - New Reporting Requirements- 2 July 2007
The Australian Competition Tribunal imposed special conditions on its authorisation of the Medicines Australia Code of Conduct, to require public disclosure of hospitality given to healthcare professionals.
NZ moves closer to approving Trans Tasman Therapeutic Goods & Devices regulator - 14 June 2007
The plan to create a Trans Tasman regulator for therapeutic goods and medical devices (ANZTPA) may be inching towards implementation.
ANZTPA implementation - Australian Bill released - 4 April 2007
Last night an exposure draft of the first of the Australian Bills to implement the scheme for joint regulation of pharmaceuticals and medical devices in Australia and New Zealand (ANZTPA) was released. The draft Bill is open for public comment. The deadline for submissions to the Department of Health and Ageing in relation to the Bill is 4 May.
ANZTPA legislation: New Zealand Bill passes first reading in House of Representatives - 13 December 2006
The New Zealand Therapeutic Products and Medicines Bill narrowly passed its first reading in the New Zealand House of Representatives on 12 December 2006. The Bill aims to establish the trans-Tasman regulatory scheme for the Australia New Zealand Therapeutic Products Authority (ANZTPA).
ANZTPA second round consultation begins - 19 October 2006
The second round of consultation with stakeholders starts today about the proposed joint regulatory scheme for the Australia New Zealand Therapeutic Products Authority (ANZTPA). You have until 6 December 2006 to comment on the three draft documents which have been released.
Intellectual property update - Spring 2006
This update includes articles on Merck v Arrow Pharmaceuticals, the Trade Marks Amendment Bill 2006, geographic names as trade marks, the proposed Australian and New Zealand Therapeutic Products Authority, the Trade Marks Office ruling over the word "McBrat" and the first judgment on calculating damages for a moral rights infringement.
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