Mallesons Stephen Jaques
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Life sciences

Representative matters

Commercial legal advice:

Primary Health Limited and Symbion Health Limited
We acted for Primary Health Limited (Primary) on its recent takeover of Symbion Health Limited (Symbion) which succeeded after a lengthy and hard-fought tussle between competing bidders Primary and Healthscope Limited (Healthscope). Primary first used a 20% stake in Symbion to block Healthscope's takeover bid for Symbion in September 2007. It then launched its $2.1 billion cash takeover bid ($4.10 for each Symbion share it did not already hold) in November 2007.

Strides Arcolabs and Genepharm Ltd
We acted for Strides Arcolabs (a major Indian generic drug manufacture and distributor), in its acquisition of a majority shareholding in Australian drug distributor public company Genepharm Ltd. As part of the deal, Genepharm acquired the Asian operations of Strides. A preferred supply agreement was also negotiated to give Genepharm access to Strides drug pipeline and local distribution arrangements with third parties.

Columna Pty Ltd Consulting Agreement
Columna Pty Ltd is an Australian company specialising in emerging technologies for spinal surgery, including minimally invasive techniques for spinal fusion procedures. We acted for Columna Pty Ltd in connection with the negotiation and documenting of a consulting agreement with an industry expert responsible for expanding Columna’s research and development, clinical trial and commercial activities into the United States.

BEELINE Technologies Commercial Agreements
BEELINE Technologies is a Queensland-based company and a pioneer of hands-free autosteer technology which has resulted in significant efficiency gains and reduced environmental impact in the agriculture industry. We acted for BEELINE in a number of teaming agreements and other early stage agreements with third party OEM partners on the development and commercialisation of new vehicle products that deliver automation and navigations solutions -- with benefits in efficiency and to the environment -- to the agricultural, mining, materials handling and other industries.

Regulatory and administrative law:

Alphapharm Pty Ltd v H Lundbeck A/S & Lundbeck Australia Pty Ltd
We acted for Alphapharm Pty Ltd in Federal Court of Australia pharmaceutical patent revocation and infringement proceedings. The patent purports to cover the anti-depressant medicine escitalopram (Lexapro) and is owned by a Dutch company, H Lundbeck A/S, and licensed to its Australian subsidiary, Lundbeck Australia Pty Ltd. In these proceedings, and in separate proceedings involving the Commissioner of Patents, Alphapharm sought amendment of the Patents Register to remove a five year extension of the term of the patent.

Medical device recall
We acted for a US corporation in relation to a medical device in Australia. It was found that the medical device did not have the necessary regulatory registration (as it was thought unnecessary) and malfunctioning issues began to emerge.

Biota
Biota is an Australian company which pioneered flu treatments. It was the first biotech Australian company to have a product Relenza brought to market (by GSK).

Biota has since been developing a further flu treatment product which is about to enter into clinical trials. We were asked to assist in negotiations and documentation of (i) the supply of the virus (hazard materials issues), (ii) the clinical trial agreement, (iii) regulatory issues concerning patient enrolment liabilities, and (iv) ownership of IP.

Patent and trade mark registration:

Patents
We have a significant prosecution and portfolio management practice and provide strategic advice to some of the largest and most dynamic technology life sciences companies and institutes. These include Respironics, Shire, Medrad, Mayne Pharma, Monash University, Calgon Corporation, BioMerieux, Monogen, Wisconsin University, Jefferson Davis University.

Trade marks
We provide strategic advice to the owners of some of the most valuable Australian and international life science brands, including Cadbury Schweppes, Campbell Soup Company, Nestlé and Wyeth.

As well as a significant prosecution and portfolio management practice, we have a strong advisory focus on “whole of product” and “whole of brand” strategies, with advice covering the legal aspects of brand management and commercial work, including licensing and portfolio structuring.

Patent litigation:

Alphapharm Pty Ltd v H Lundbeck A/S & Lundbeck Australia Pty Ltd
We acted for Alphapharm Pty Ltd in Federal Court of Australia pharmaceutical patent revocation and infringement proceedings. The patent purports to cover the anti-depressant medicine escitalopram (Lexapro) and is owned by a Dutch company, H Lundbeck A/S, and licensed to its Australian subsidiary, Lundbeck Australia Pty Ltd. In these proceedings, and in separate proceedings involving the Commissioner of Patents, Alphapharm sought amendment of the Patents Register to remove a five year extension of the term of the patent.

Alphapharm Pty Ltd v Merck & Co, Inc
We acted for Alphapharm in patent revocation proceedings against Merck & Co Inc in relation to Merck’s patent for alendronate.The revocation proceedings involved issues of obviousness, lack of sufficiency and inutility. Merck’s patent purports to cover not only an improved process for the production of alendronate, but also alendronate itself. This matter reached a successful commercial resolution in 2007.

Inamed Development Company v Morton Surgical Pty Limited
We acted for Inamed Development Company (now part of the Allergan Group) in Federal Court infringement and revocation proceedings concerning a patent for a gastric band device. The band is placed around the upper portion of the stomach in laparoscopic surgery. Morton Surgical is the Australian distributor of a band manufactured by a French company.

Conor Inc v Angiotech Pharmaceuticals Inc - patent litigation
We are acting for Boston Scientific Corporation who are the licensees of a suite of patents to a drug eluting stent which is in use as a coronary stent. Sales of these stent by our client represent billions of US dollars each year. Our client is in patent litigation with Conor in a number of countries. Conor has sought revocation of these patents which are owned by Angiotech.

Deltapine Australia Pty Ltd - Patent litigation relating to genetically modified cotton
We represented Deltapine Australia, the Australian subsidiary of a US company, in a patent infringement action concerning genetically modified cotton. The litigation involved highly technical material and specialised areas of law. These include patent law and the regulatory regimes governing genetically modified products (OGTR) and pesticides (APVMA). The case had multi-jurisdictional implications for the parties involved and international significance.

Novartis Vaccines and Diagnostics Inc. v SmithKline Beecham Biologicals SA - Federal Court
This was an appeal by SKB Inc from Novartis' successful opposition to SKB's patent application for a multivalent ('multishot') vaccine. SKB's patent application has been litigated in many jurisdictions by Novartis. Mallesons was retained by FB Rice (leading Australian life science patent attorneys) to act for Novartis and contest SKB's appeal to the Federal Court. The matter ran for 14 months and Mallesons worked very closely with FB Rice and Novartis's UK patent attorneys. The distinguishing feature of the dispute was a contested hearing on whether the appeal should consider the original or amended claims of the patent application.

AMR v Alphapharm
We act for Alphapharm in proceedings brought by AMR, the owner of a patent in relation to fexofenadine, which is used in the treatment of allergies. AMR alleges that Alphapharm infringes the patent through sales of its Xergic product. Alphapharm has cross claimed alleging that the patent is invalid on numerous grounds. The matter involves complex synthetic chemistry and pharmacology. The proceedings have recently been brought together with proceedings between AMR and Arrow (another generic pharmaceutical company) and related entities.

Product liability:

Claim for loss arising from defective prosthetic medical device
This claim involves a specific incidence of defect (following a previous product recall). However our client, an insurer, has a wide interest in ensuring similar defective products are not distributed for use elsewhere with consequent serious injury and damages claims.

Recall of a medical device
This was a voluntary recall by a leading US manufacture who discovered potential defects with its devices. We were able to negotiate a voluntary recall with the TGA and manage the regularly risk for this client to avoid imposition of penalties.

 

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