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Allens Biotech News is a fortnightly news service to keep you on top of developments in this fast-moving industry.


Feature article: Privacy Commissioner's biometrics recommendations in response to ALRC privacy review

In brief: Partner Peter Jones and Law Graduate Valeska Bloch provide an outline of the Privacy Commissioner's recent recommendations on biometrics in response to the Australian Law Reform Commission Review of Privacy.


Introduction

The development of new biometric technologies, the increasing frequency of identity fraud and discussions about a national identity card have emphasised the need to rethink our approach to privacy, which was developed almost 30 years ago.1

A review of Australia's privacy law is being conducted by the Australian Law Reform Commission (the ALRC). The Office of the Privacy Commissioner has recently responded to the 142 questions posed by the ALRC in Issues Paper 31 by putting forward a submission (the submission) for the ALRC's consideration. 

The submission emphasises the need for national consistency in privacy legislation, arguing that this would reduce compliance difficulties and help individuals to understand and exercise their privacy rights. It also recommends further research into the development of a tort of privacy. However, one of the newer areas raised in the submission is biometrics. A central theme of the submission is the need for strict privacy protections for biometric information, having regard to its sensitivity and the increasing ease with which it can be obtained. 

The Privacy Act 1988 (Cth) regulates the collection, handling and disclosure of individuals' personal information by government agencies, all large private sector organisations, health service providers and some small businesses. 

Why are biometrics a privacy concern

'Biometric technology records unique physical human traits for the purposes of later recognition, identification or authentication of an individual.'2 When the current privacy principles were developed, biometric technology was largely limited to ink fingerprints. Today, however, biometric technology has greatly enhanced capabilities, including voice, iris and facial recognition and DNA identification. Furthermore, other new technologies have facilitated the ease with which personal information can be disseminated, stored and accessed. 

The submission identifies the following risks with the use of biometric identifiers:

  • the enhanced capacity for data linking and function creep associated with the use of unique identifiers ('function creep' is what occurs when a procedure designed for a specific purpose ends up serving another purpose);
  • the difficulty of re-securing biometric information once its security has been breached (eg it is possible to issue a customer with a replacement credit card if security has been breached, however it is not possible to do the same for a biometric indicator);
  • the capacity for covert collection and monitoring of biometrics (eg facial recognition technology may be utilised without the subject's knowledge);
  • revealing more information than is necessary for a transaction (eg iris recognition and retinal scans may also reveal health information, which is recognised as being more sensitive); and
  • the commonly presumed accuracy of biometric technologies, particularly where individuals are incorrectly identified

Recommendations relating to biometrics

As a result of these risks, the submission makes the following recommendations: 

  • biometric information should be included within the definition of 'sensitive information' under section 6 of the Privacy Act. The submission notes that care would be required to ensure that a distinction is drawn between 'raw' biometric information (such as a photograph of someone) and information that is collected expressly in the form of biometric data for the purpose of generating a digital representation that would identify an individual;3
  • all organisations, including small businesses, that handle biometric information should be covered by the Privacy Act, to limit how they handle that information in a manner similar to the treatment of health information; and
  • the definition of 'identifier' should be clarified to include 'a number, symbol or other particular' assigned to an individual to uniquely identify the individual for the purposes of the organisation's operations. Currently, 'identifier' is defined in the Privacy Act to include:

    a number assigned by an organisation to an individual to identify uniquely the individual for the purposes of the organisation's operations. However, an individual's name or ABN [...] is not an identifier.4

Conclusions

The extension of the Privacy Act to specifically protect biometric information is a logical follow-up to the 2006 reforms regarding the inclusion of genetic information and recognises the potential for abuse of biometric identifiers. The higher standard of protection afforded to sensitive information is to be welcomed for biometric information, but cannot be accorded to biometric information without legislative amendment.

Footnotes
  1. Australian Government Officer of the Privacy Commissioner, Submission to the Australian Law Reform Commission's Review of Privacy – Issues Paper 31, February 2007, p6.
  2. Submission to the Australian Law Reform Commission's Review of Privacy – Issues Paper 31, p422.
  3. Submission to the Australian Law Reform Commission's Review of Privacy – Issues Paper 31, p424.
  4. Privacy Act 1988 (Cth), NPP 7.3, Schedule 3.

Company news

In brief: Regular news from the biotech industry.


Acrux US licensee VIVUS sub-licenses EvaMist rights to KV Pharmaceutical

2 April – Australian biotech company Acrux reported that its US licensee VIVUS has executed an agreement to sub-license its rights and assets related to Acrux's Estradiol MDTS® (EvaMist™ in the US) to KV Pharmaceutical Company. EvaMist is a small hand held spray designed to deliver a preset dose of estradiol via the skin. KV Pharmaceutical will be responsible for the manufacturing, selling, marketing and regulatory requirements once the product is approved by the FDA. Under the agreement VIVUS is eligible to receive an upfront payment of US$10 million and an additional US$140 million upon the approval of the New Drug Application for EvaMist. Acrux Chairman Ross Dobinson commented 'With the transaction valued at more than US$150 million, this is strong independent validation of the value of our spray technology, applied to one product in a single market'. Acrux's rights under its license to VIVUS will remain unchanged by this transaction.

[Source: Company announcement]

Dendreon prostate cancer drug Provenge positively reviewed by FDA Advisory Committee

29 March – The FDA Office of Cellular Tissue and Gene Therapies Advisory Committee recommended to the FDA that there is substantial evidence of efficacy and safety of Provenge (sipuleucel-T) for the treatment of patients with asymptomatic, metastatic, androgen-independent prostate cancer. If approved for marketing, Provenge would become the first active cellular immunotherapy and the first biologic approved to treat prostate cancer. A decision on Provenge is anticipated by May 15, 2007.

[Source: Company announcement]

Merck & Co type 2 diabetes drug Janumet approved by FDA

2 April – Merck announced that the FDA has approved Janumet™, its oral medicine combining sitagliptin phosphate and metformin, for the treatment of type 2 diabetes. The FDA approved Janumet, as an adjunct to diet and exercise, to improve glucose control in adult patients with type 2 diabetes who are not adequately controlled on metformin or sitagliptin alone, or in patients already being treated with the combination of sitagliptin and metformin.

[Source: Company announcement]

Mesoblast apply to FDA to begin a revolutionary trial of stem cell therapy in heart attack patients

2 April – Melbourne biotech company Mesoblast Ltd announced that its US sister company Angioblast Systems have filed an Investigational New Drug submission to the FDA to commence a phase II clinical trial of its allogeneic adult stem cells in patients with heart attacks. Both companies are now at advanced stages of clinical development and commercialisation of the patented technology, which is a high margin adult stem cell product obtained from a single donor that can be used in up to thousands of unrelated, or allogeneic, recipients at the time and place of need. The trial design will enable evaluation of the safety and effectiveness of the stem cells in patients suffering acute heart attack. Stem cells will be received by catheter injection after an initial angioplasty procedure to open the blocked artery. In preclinical trials supporting the submission, implantation of the stem cells resulted in significant improvement of heart function and reduction in congestive heart failure. Filing of the submission was reached more than three months ahead of the company's original schedule. 

[Source: Company announcement]

pSivida signs Collaborative Research and Licensing Agreement with Pfizer

4 April – ASX, Nasdaq and Frankfurt Stock Exchange -listed West Australian bio-nanotech company pSivida Ltd announced it has signed an exclusive collaborative research and license agreement with Pfizer for pSivida's controlled drug delivery technologies. This includes the Medidur™ technology in ophthalmic applications. Medidur™ is a tiny, injectable device designed for the sustained release of drugs with potential for the treatment of Diabetic Macular Edema, a leading cause of blindness. PSivida will receive up to AU$191 million in development and sales -related milestones under the terms of the agreement. The two companies will work together on a joint research program aimed at developing ophthalmic products using pSivida's technology. Pfizer who will fund the cost of the joint research program, will have an exclusive license to market all products developed as part of this research collaboration in ophthalmic applications and will pay pSivida a royalty on net sales of those products. Pfizer may terminate the agreement on 60 days notice without cause. Pfizer has also agreed to invest AU$12.2 million in pSivida shares and common equity. 

[Source: Company announcement]

Purdue Pharma L.P. announces agreement to end OxyContin® patent lawsuit with IMPAX laboratories

2 April – Purdue Pharma L.P and IMPAX Laboratories have agreed to end their lawsuit concerning certain Purdue Pharma patents on OxyContin® tablets. Under the settlement agreement, IMPAX acknowledges that Purdue Pharma's patents are valid, enforceable and infringed by IMPAX's extended release oxycodone products and Purdue agrees it will not pursue damages against IMPAX for past infringement. Purdue will also grant a license to permit IMPAX (through its marketing partner, DAVA pharmaceuticals) to keep its products on the market until June 14 2007, with limited rights to resume distribution. The parties will be submitting the agreement to federal US antitrust authorities for review.

[Source: Company announcement]

Roche acquires BioVeris to expand immunochemistry business

4 April – Roche and BioVeris announced that they have signed a definitive merger agreement under which Roche will acquire 100 per cent of BioVeris for USD $21.5 per share in cash, a total of approximately US$600 million. This acquisition will expand Roche Diagnostics' immunochemistry business (driven by its Elecsys product line) from the human diagnostics field into new market segments such as life science research, life science development, patient self-testing, veterinary testing, drug discovery, drug development and clinical trials. Through this acquisition Roche will own the complete patent estate of the electrochemiluminescence technology deployed in the Elecsys product line. The boards of directors of BioVeris and Roche have each unanimously approved the terms of the merger agreement, and the board of directors of BioVeris has recommended that its shareholders approve the transaction. Samuel J. Wohlstadter, Chairman and Chief Executive Officer of BioVeris, has entered into a voting agreement with Roche pursuant to which he has agreed to vote all of his shares, representing approximately 20 per cent of the shares of BioVeris entitled to vote, in favour of the transaction. It is expected that the transaction will be closed during the third quarter of 2007.

[Source: Company announcement]

Roche acquires gene sequencer 454 Life Sciences

29 March – Roche and CuraGen announced that they have signed a definitive agreement under which Roche will acquire 454 Life Sciences, a majority owned subsidiary of CuraGen active in high-throughput DNA sequencing. Roche will pay 454 Life Sciences' shareholders US$140 million in cash. In addition 454 Life Sciences' shareholders may receive up to US$14.9 million in cash from the holders of currently outstanding stock options and warrants. Roche Diagnostics is the exclusive worldwide distributor of the Genome Sequencer systems based on 454 Life Sciences' fast 454 sequencing technology. The acquisition will give Roche Diagnostics access to 454's future generation of sequencing products and the use of 454 sequencing for in-vitro diagnostic applications. Roche plans to maintain the 454 Life Sciences facility in Connecticut as a fully integrated part of the Roche Diagnostics organization. 

[Source: Company announcement]

Stem Cell Sciences closes share offer early

3 April – Global biotech company Stem Cell Sciences (SCS), established in Melbourne in 1994 and due to list on the ASX shortly, has closed its share offer early following strong demand from investors. SCS provides products in the stem cell research and drug discovery markets. SCS has raised AU$12 million through the issue of 11.2 million Chess Depository Interests at AU$1.07. SCS is expected to list on the ASX on 12 April with a post -listing market capitalisation of AU$49.6 million based on SCS' closing price in the UK on April 2. SCS' shares will continue to be traded on the Alternative Investment Market of the London Stock Exchange.

BioTip: Provisional patent applications

Those inexperienced in strategic patent protection often remark: 'it's only a provisional patent application' when referring to their first filing to protect an invention. Such consideration underestimates the importance, and misconstrues the significance, of a provisional patent application (Provisional). The filing of a Provisional sets a priority date for subject-matter ultimately claimed in a later filed national patent application claiming priority from that Provisional (Later Application). Any subject-matter claimed in a Later Application for which there was insufficient supporting disclosure in the Provisional may not be entitled to the benefit of the priority date of the Provisional. Loss of priority may result in loss of patent rights. Thus, failure to take great care in the preparation and filing of a Provisional may jeopardise potential future patent rights and be extremely costly in the long run.

Events

Information on the latest conferences

See conferences in: April | May

April

Life Science Alliances World 2007
Monday 16 April – Wednesday 18 April
Victoria Park Plaza, London, UK
http://www.terrapinn.com/2007/alliance/

NEW – RNAi World Conference
Tuesday 24 April – Wednesday 25 April
Hilton Philadelphia, City Avenue, Philadelphia, USA

NEW – Bio Business Forum – The role of the Chairman in High Growth Biotech and Medical Device Companies
Thursday 26 April
Australian Technology Park Conference Centre, Eveleigh, NSW
http://www.ausbiotech.org/events/states.asp?state=Other

May

BIO 2007
Sunday, 6 May – 9 Wednesday, May
Boston Convention & Exhibition Centre, Boston, MA, USA

For further information, please contact:

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