Allens Biotech News is a fortnightly news service to keep you on top of developments in this fast-moving industry.
- Therapeutic Goods Amendment Act 2007: re-evaluation of 'registered' or 'listed' devices
- Company News
- BioTip: Drafting a patent specification - issues to bear in mind
- Events
Therapeutic Goods Amendment Act 2007: re-evaluation of 'registered' or 'listed' devices
In brief: Lawyer Rachel Darvey reports on the recent introduction of the Therapeutic Goods Amendment Act 2007 and how it impacts on the transition period for medical devices.
Background
In October 2002, the Federal Government introduced changes to the Therapeutic Goods Act 1989 (the TGA Act) that required manufacturers and sponsors of certain medical devices currently marketed in Australia, and either 'registered' or 'listed' in the Australian Register of Therapeutic Goods (ARTG), to have such registered or listed goods re-evaluated by the Therapeutic Goods Administration (the TGA) and re-entered in the ARTG as an 'included' medical device by the cut-off date of 4 October 2007. The rationale for introducing these changes was to improve, on a uniform basis, the quality, safety and efficacy of the therapeutic goods supplied in or exported from Australia.
For those medical devices required to be re-evaluated, any failure by an affected manufacturer or sponsor to lodge an effective application for inclusion in the ARTG or to apply for a TGA Conformity Assessment certificate during the five-year transition period (ie by the 4 October 2007 cut-off date) would have resulted in their previous registration or listing being deemed to be cancelled on 4 October 2007. This would mean that the affected device would no longer be able to be supplied commercially in Australia beyond that date.
The amendments
The Therapeutic Goods Amendment Act 2007 (the Amendment Act), which came into force on 3 October 2007, has amended section 9B(2) of the TGA Act. This section expressly dealt with the transitional time frame for the cancellation of registered and listed medical devices in the ARTG, so that now any therapeutic device that is the subject of an effective application, for either:
- entry in the ARTG as an 'included' medical device; or
- an application for a TGA Conformity Assessment certificate,
can continue to be legally supplied after the 4 October 2007 cut -off date while the TGA processes the application, provided that an effective application was submitted before this time. For an application to be 'effective', it must have been made in the approved form, along with payment of the prescribed application fee and including information that is not false or misleading.
Prior to the introduction of the Amendment Act, it was necessary for the TGA to have completed its processing of the application and evaluation of any supporting documentation by 4 October 2007.
With the introduction of the Amendment Act, sponsors, manufacturers and their customers can continue to rely on existing contractual obligations while the TGA processes the backlog of applications. Cancellation of registrations and listings under the old regulatory framework will now be deemed to occur 30 days after the application has been 'finally determined' by the TGA.
Commercial considerations going forward
Following the 4 October 2007 cut-off date, in order to demonstrate compliance, sponsors and manufacturers of affected products that were required to transition under the new regulatory framework may provide their customers with the following:
- documents showing that an effective application was lodged with the TGA prior to 4 October 2007; or
- documents showing the inclusion of the product as an 'included' device on the ARTG.
Where an application for inclusion in the ARTG has not been successful, customers will need to consider alternative devices going forward and amend their existing contractual relationships accordingly.
Company news
In brief: Regular news from the biotech industry.
- Alchemia establishes Scientific Advisory Board
- AstraZeneca's stomach acid drug patent upheld in Europe
- GlaxoSmithKline announce new CEO
- GSK seeks WHO pre-qualification for Cervarix
- GSK and Synta enter US$1 billion deal for melanoma drug
- Pfizer launches bio-innovation centre
- Peptech and AVEO enter Superhumanisation partnership
- Wyeth announces new CEO
Alchemia establishes Scientific Advisory Board
4 October – Australian biotech Alchemia has announced the establishment of a Scientific Advisory Board (SAB), comprising several international experts with significant research and commercialisation experience to guide the development of Alchemia's patented VASTTM small molecule drug discovery platform. The platform is currently being applied to the discovery of drugs targeting G-protein coupled receptors (GPCRs). The SAB will be chaired by Dr Tracie Ramsdale, one of Alchemia's founders and former CEO. Dr Ramsdale said 'the expertise and backgrounds of the respected individuals comprising the Alchemia SAB are perfectly suited to understand the risk-reward nature of various GPCR drug markets and maximize the value of Alchemia's revolutionary drug discovery technology'. The SAB includes internationally renowned experts in the fields of GPCR pharmacology, toxicology, drug design and development, medicinal chemistry and molecular diversity. Alchemia will target indications that are associated with significant disability or death (ie diseases for which there is a significant unmet medical need).
[Source: Company announcement]
AstraZeneca's stomach acid drug patent upheld in Europe
9 October – The European Patent Office (EPO) Opposition Division has ruled that AstraZeneca's European process patent for the stomach acid drug Nexium is valid in amended form, despite an opposition by the German generic manufacturer Ratiopharm. The patent for Nexium covers a process for the manufacture of esomeprazole and its salts. The EPO's decision means that this patent in its amended form still covers the manufacturing process for Nexium and is to expire in 2015. Worldwide Nexium sales reached US$5.2 billion in 2006, with Europe accounting for US$1.2 billion.
[Source: Company announcement]
GlaxoSmithKline announce new CEO
8 October – GlaxoSmithKline (GSK) has announced the appointment of Andrew Witty as Chief Executive Officer Designate to succeed Dr Jean-Pierre Garnier upon his retirement as CEO at the end of May 2008. Mr Witty is currently President of Pharmaceuticals Europe for GSK. GSK Chairman Sir Christopher Gen said: 'Andrew's appointment follows a rigorous selection process by the Board of Directors. The fact that we have been able to select a successor to JP from three strong internal candidates is a testament to the quality of management at GSK. The Board is confident that Andrew will build on JP's considerable achievements which have positioned GSK as a leader of the pharmaceutical industry.'
[Source: Company announcement]
GSK seeks WHO pre-qualification for Cervarix
4 October – GSK has submitted a file on its cervical cancer vaccine Cervarix to the World Health Organization for pre-qualification, following the granting of a marketing authorisation approval by regulatory authorities in Europe. The pre-qualification mechanism is designed to speed the delivery of new vaccines to developing countries once the vaccines have received approval from a recognised national regulatory authority. Pre-qualification functions as a public health endorsement of a vaccine's efficacy, safety and quality, and confirms the manufacturer's ability to fulfil large-scale United Nations tenders. Products with prequalification status may be used by UN agencies, as well as mass vaccination programs across the developing world.
[Source: Company announcement]
GSK and Synta enter US$1 billion deal for melanoma drug
10 October – GSK and Synta Pharmaceuticals have announced a collaboration agreement for the joint development and commercialisation of STA-4783, a small-molecule oxidative stress inducer for the treatment of metastatic melanoma. Under the terms of the agreement, Synta will receive an upfront cash payment of US$80 million. Synta will also be eligible to receive potential milestone payments of up to US$135 million for events leading to approval of STA-4783 in metastatic melanoma, further development and regulatory milestone payments of up to US$450 million across various indications, and up to US$300 million in potential commercial milestone payments. The companies will share responsibility for development and commercialisation of STA-4783 in the US, and GSK will have exclusive responsibility for development and commercialisation of STA-4783 outside the US. The agreement is subject to antitrust clearance by the US Government.
[Source: Company announcement]
Pfizer launches bio-innovation centre
4 October – Pfizer has launched an independent,
stand-alone bio-therapeutics and bio-innovation centre in the US state of
California, under the direction of scientist and entrepreneur Dr Corey Goodman.
Dr Goodman will lead a centre that uses advanced applications of cell biology
and cutting-edge technologies focusing on discovering new medicines, as well as
securing new technologies and research tools that can be used across all of
Pfizer's therapeutic areas. Dr. Goodman said the Centre will, on one hand, be
independent and able to pursue its own research interests, while on the other
hand be able to leverage all of the vast strengths of Pfizer Global Research and
Development.
Pfizer has also appointed a new
global Research and Development President, promoting Vice President Dr Martin Mackay to
the role.
[Source: Company announcement]
Peptech and AVEO enter Superhumanisation partnership
2 October – Australian bio-pharmaceutical company Peptech and US company AVEO Pharmaceuticals have announced a non-exclusive research and commercialisation agreement in which AVEO will access Peptech's Superhumanisation technology. Under the terms of the agreement, AVEO will provide Peptech an upfront payment for access to Peptech's intellectual property surrounding the Superhumanisation methodology. AVEO will utilise the technology in-house and will be responsible for future clinical development and commercialisation of any products made using the technology. Peptech will receive annual license fees and payments upon the successful achievement of clinical milestones, as well as royalties on sales of any products resulting from the collaboration. The Superhumanisation technology modifies antibodies generated in animals so that they retain their essential therapeutic properties, but appear 'human-like' and will, therefore, not be rejected by the immune system of patients receiving them.
[Source: Company announcement]
Wyeth announces new CEO
27 September – Pharmaceutical company Wyeth has elected Bernard Poussot to the position of President and Chief Executive Officer. Mr Poussot began his career at Wyeth in 1986 and has held the position of President, Chief Operating Officer and Vice Chairman since January 2007. Mr Poussot replaces Robert Essner as CEO, who will continue as Chairman of the Board of Directors during the transition period.
[Source: Company announcement]
BioTip : Drafting a patent specification - issues to bear in mind
Drafting a patent specification to adequately protect an invention is an involved process requiring a patent attorney with experience in the relevant technology to understand the invention beyond its preferred embodiments. Also required is a consideration of the relevant prior art and sufficient written, diagrammatic and/or experimental material to support the breadth of the invention ultimately claimed. Time and money can be saved when as much as possible of this information is provided to your attorney at the time of giving instructions to draft a patent specification..
Events
Information on the latest conferences
See conferences in: | November
Pharma Partnering Event – One-to-One Licence
Meetings
Monday, 12 November – Tuesday, 13 November
Hilton Hotel,
Barcelona, Spain
http://www.pharmavenue.com/
NEW – Pacific Rim Summit on Industrial Biotechnology and
Bioenergy
Wednesday, 14 November - Friday, 16
November
Honolulu, Hawaii
http://www.bio.org/pacrim/
Asian Patent Attorneys Association (APPA) Annual Meeting
Saturday,
17 November – Tuesday, 20 November, 2007
Adelaide Convention Centre, South
Australia
As active members of APAA, we look forward to attending what promises to be a very enjoyable and rewarding conference and, of course, to meeting many of our clients and contacts there. If you are planning to attend this meeting, please do take the opportunity to come and visit us in our Sydney or Melbourne office while you are in Australia. Let us know by getting in touch with Dr Trevor Davies (contact details below).
NEW – Victorian Biotechnology Trade Mission
to England's North West region
Sunday, 18
November – Friday, 23 November
United Kingdom
http://www.ausbiotech.org/
For further information, please contact:
- Dr Trevor DaviesPartner, Allens Arthur Robinson Patent & Trade Marks Attorneys,
Sydney
Ph: +61 2 9230 4007
Trevor.Davies@aar.com.au
