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DECEMBER 2007
 
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Welcome to the twentieth edition of Spruson & Ferguson's Biotech E-news – a bi-monthly breakdown of important IP issues in the Australian biotech industry including expert analysis and practical advice to advance your business.

It is our intention that this e-Newsletter will provide useful news and information for our clients and associates. Please feel free to send us your feedback, particularly suggestions for topics you would like to see addressed in future issues to BiotechEnews@sprusons.com.au

NEWS IN BRIEF
New model for researching HIV

Professor Sharon Lewin and her team, at the Alfred Hospital have recognized a very important limitation of a recently approved class of drugs for treating HIV, those being integrase inhibitors, which work by preventing integration of HIV DNA into the genome of immune cells (e.g. T cells).

They noticed upon early diagnosis (within the first week or two of infection) of HIV in patients that a pool of latently infected T cells (i.e. T cells with integrated HIV DNA) was present in the body and that the integrase inhibitors were ineffective in treating these cells.  Trying to identify drugs that would be effective in targeting these cells has been difficult due to a lack of an experimental model. Lewin’s team has changed that.

Based on observations that particular chemokines appear to be directing T cells that are circulating in the body to take up HIV DNA into their genomes, Lewin’s team was able to generate latently infected T cells in vitro by taking resting T cells from blood donors, incubating those T cells with specific chemokines, and then infecting these cells with HIV. Professor Lewin’s team will now apply this model in studies which are aimed at

  • discovering how the chemokines “change” the cell to allow integration of HIV DNA into the genome of T cells and
  • screening drug candidates to identify therapeutics that deter HIV infection by effectively targeting latently infected cells.

Sourced from official ABC News on-line sites (www.abc.net.au/news/stories) and (www.abc.net.au/rn/healthreport/stories)

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Sleep disorder drug offers hope for “ice” addicts

Modafinil is a known therapeutic for treating sleeping disorders such as narcolepsy and shift work sleep disorder. Scientists at the National Drug and Alcohol Research Centre (NDARC) have identified that it also helps "ice" addicts overcome their addiction.

It is thought that Modafinil is effective for treating sleep disorders and ameliorating the urge to take “ice” by restoring depleted neurotransmitters since both the disorders and the addiction have a similar and deleterious effect on various neurotransmitters in the brain.

James Shearer from the NDARC suggests that Modafinil would most likely be “a supportive drug for someone who's making an effort to quit". If Modafinil becomes available for this purpose to the general community, it could potentially be prescribed by doctors, rather than drug clinics on the premise that unlike methadone for example, which is currently used in "ice" addiction, Modafinil would not be classed as a drug of addiction.

Sourced from the University of New South Wales official website at www. ndarc.med.unsw.edu.au/ndarcweb.nsf/website/Research and from www.danaonline.org/.

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Drink your cordial! It’s good for you!

Don’t be surprised if you hear this being said by a mother who wants their child to eat and drink healthily.

Dr Jas Sing from the University of Sydney’s ANZAC Research Institute and Dr Qihan Dong from the Bosch Institute at the University of Sydney have discovered that an antioxidant drink called “Blueberry Punch” appears to be effective in the fight against prostate cancer. It was found that tumours in the prostates of rats were reduced by 25 per cent after they were fed “Blueberry Punch”, a cocktail of blueberries, tarragon, turmeric, raspberry, citrus peel, and olive leaf extract, over a 14 day period.

“Blueberry Punch” was developed by Greg Jardine, a biochemist from Dr Red Nutraceuticals. Nicola Fox, a dietician from that company suggests that the combination of ingredients works synergistically to effectively reduce the tumours in the rats. The ingredients in the punch were chosen on the basis that they all contain high levels of antioxidants which are known to assist in deterring cancer growth. Drs Sing and Dong will now trial the drink in humans.

Time will tell as to what effect the punch will have in fighting cancer in humans.

Sourced from the University of Sydney website (see www.usyd.edu.au/news/84.html?newsstoryid=2077) and http://au.news.yahoo.com/071208/21/157b7.

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GETTING TO KNOW

 

Professor Philip Hogg

Director of the UNSW Cancer Research Centre, Head of the CCIA Drug Discovery Program and NH&MRC Senior Principal Research Fellow

 

What is your particular area of expertise?

My team has described a novel way in which protein action is controlled. All life forms make proteins that contain strong links called disulphide bonds. We have shown that some disulphide bonds have evolved to control how proteins work by breaking or forming in a precise and dynamic way. We have called these bonds ‘allosteric disulphides’.

Application of my basic research has led to the development of a novel class of anti-cancer drugs and a novel cell death imaging agent which are both in clinical development.

The first anti-cancer drug inhibits tumour blood vessel formation and tumour growth. Clinical trials of the compound have begun in the UK. The drug technology has led to the formation of a new biotechnology company, Cystemix.

The imaging agent non-invasively detects dying and dead tumour cells. The agent would be used to assess whether chemotherapy or radiotherapy are working by measuring within a few hours the extent of tumour cell death triggered by the treatments. Should the results in animals translate to efficacy in humans the technology could markedly change how cancer patients are currently treated. The agent has been licensed to Covidien for clinical development.

What has been your career path to date?

I received my Ph.D. in biochemistry from the University of Queensland in 1987. After post-doctoral stints in the laboratories of Prof. Craig Jackson in the USA and Prof. Johan Stenflo in Sweden, where I worked on the protein chemistry of blood coagulation, I returned to Australia in 1991 and am now Director of the UNSW Cancer Research Centre.

What have you been working on in the last three months?

Apart from the usual aspects of running a lab, I have been finalizing the plans for the new Lowy Cancer Research Centre.

What do you find the most interesting aspect of your work?

The discovery aspect of research - the Eureka moments. I also enjoy the challenges of commercializing my research and the satisfaction that comes with getting a deal done.

What practical advice would you give to innovators?

The discovery is the easy part. Commercialising the discovery is the hard part. Get help from experienced technology transfer people and be prepared to invest your time and resources for a number of years.

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UNJUSTIFIED THREATS OF LEGAL PROCEEDINGS
 

A recent decision of the Federal Court of Australia provides a reminder of the need for caution in the manner of correspondence between a patentee and a party suspected of infringing the patentee's rights.

Section 128 of the Australian Patents Act (1990) provides that a person unjustifiably threatened with infringement proceedings may apply to a Court to restrain the making of those threats and to recover any damages sustained as a result of the threat.

In the case recently decided in the Federal Court , Occupational and Medical Innovations Limited (OMI), an Australian company and patentee of a patent directed to retractable syringes, alleged that Retractable Technologies Inc (RTI), an American company with Australian and US patents in the same field of technology, had made unjustified threats of patent infringement proceedings. In 2004 and 2006 OMI was the recipient of several letters written on behalf of RTI which stated, among other things, that RTI:

'is prepared to take any legal action necessary to protect its patented and unpatented technology, its products and its proprietary position with respect to [RTI's supplier] and any company with which [the supplier] or its affiliates may be dealing.'

Notably, the RTI letter did not explicitly assert infringing conduct in Australia nor did it explicitly refer to the commencement of infringement proceedings. Nevertheless, the reference in the RTI letter to "protecting patented technology" was interpreted by the Court to "suggest infringement proceedings or, perhaps, an application to revoke [OMI's] patent with the intention that infringement proceedings follow".

Accordingly, the Court was satisfied that "a recipient in the position of [OMI] would have understood the letter to threaten enforcement or similar proceedings in Australia, pursuant to an Australian patent held by RTI, in connection with the importation into, and/or other exploitation in, Australia of retractable needles manufactured in China." The Court therefore held the letter referred to above included unjustified threats.

Although in this case the Court exercised its discretion to not grant an injunction (as the Court formed the view that it was "unlikely there will be any further unjustifiable threats" by RTI), the case serves to remind that any approach by a patentee to an alleged infringer must be couched with caution.

Section 131 of the Patents Act makes it clear that the "mere notification" of the existence of a patent or patent application does not (by itself) constitute a threat of proceedings under s128 of the Act. Indeed, given that s123 of the Act provides the Court with a discretion not to award damages or make an order for an account of profits if an infringer can establish that, at the time of the infringement, it was unaware of the existence of a relevant patent and had no reason to believe one existed (so-called "innocent infringement"), notifying a suspected infringer of your patent may be a desirable course of action. However, as is made clear in this case, any words used beyond a mere notification may be interpreted by a Court as a threat of proceedings. Therefore it would be prudent to consult with a patent attorney or legal adviser before sending a letter of notification to anyone or before making any allegation of patent infringement.

1Occupational and Medical Innovations Limited (ACN 091 192 871) v Retractable Technologies Inc [2007] FCA 1364 (31 August 2007)

For more information please contact Dr Martin O'Brien at martin.obrien@sprusons.com.au

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RECENT ACTIVITIES
The 24th annual RNSH, UTS, USyd, Kolling Scientific Research Meeting
13-14 November 2007, Royal North Shore Hospital

Spruson & Ferguson was proud to be a sponsor of the joint scientific meeting between the Royal North Shore Hospital, University of Technology Sydney, the University of Sydney and the Kolling Institute of Medical Research which was held on the 13th and 14th of November 2007 on the Royal North Shore Hospital campus. Many researchers from these esteem institutions presented their exciting and latest work in their fields of expertise, such as neurobiology and cell signaling. We look forward to continuing our support of this meeting and other scientific meetings and conferences in the future.

Pictured from left to right: Dr Andrew Blattman, Rob Baxter, Sonia Saad and Professor Michael Field

 
FEEDBACK ASK US
We are interested in your feedback. Email biotechenews@sprusons.com.au to let us know if Biotech eNews is of interest or to give your suggestions for future issues. Please also let us know if you have a colleague who would like to be added to our circulation list.

We are here to be of service to you. If you have any questions about how to best protect your IP or if you wish to discuss the patentability of your ideas, we would be happy to arrange a meeting. Our principals and associates are also available to present seminars and information sessions to your staff. Please call Dr Martin O'Brien or Dr Andrew Blattman on (02) 9393 0100 or email martin.obrien@sprusons.com.au or andrew.blattman@sprusons.com.au

CONTACT US

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© Spruson&Ferguson 2007. This Newsletter is for the general information of our clients. Its contents are not a complete statement of the law on any subject. Professional advice should be sought before any course of action is pursued.

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