Health, Pharmaceuticals & Biotechnology

The pharmaceutical and biotechnology sector is one of the most dynamic and fastest growing in Australia today. From small start-ups to large multinationals, the industry includes a diverse range of organisations, from some of the largest companies in the world today, to those which are not much more than an idea. The sector also embraces government and research organisations.

High profile, high impact

Deacons is the professional services firm most recognised by the pharmaceutical industry in Australia. Our pharmaceutical and biotechnology group is an active participant in the industry with a client portfolio that includes many local and international companies. We have played a key role in driving many industry issues including campaigning for the industry in respect of new legislation.

A hallmark of the industry is its heavy regulation, and understanding those regulations end to end, and how the whole jigsaw fits together is one of our key strengths.

All bases covered

Deacons knows the pharmaceutical and biotechnology industries, the legal principles applicable and the practical issues and problems. We take a holistic view of these matters and understand the context in which they occur.

Our expert lawyers provide clients with advice on all aspects of the law as it applies to the pharmaceutical and biotechnology industries including regulatory requirements, intellectual property, technology transfer agreements, licensing, clinical trial agreements and trade practices. In addition, we advise in related areas such as venture capital.

We are heavily involved in new aspects such as those around stem cells, and make an active contribution to the many and various dialogues around ethical issues in this area.

Our services

Pharmaceutical and biotechnology

• legislation: advice on industry specific legislation, especially the National Health Act, Therapeutic Goods Act (and related regulations, codes, orders and instruments – see further below), Gene Technology Act, Trade Practices Act and the various State Pharmacy Acts
• agreements: licensing, materials transfer, joint venture, distribution, co-marketing, confidentiality, acquisitions/mergers, technology transfer, research & development, shareholder, subscription
• pharma regulatory: Therapeutic Goods Act, gene technology, categorisation of products, clinical trials and guidelines, code of conduct, labelling, pharmacy regulation, privacy, scheduling, CMIs and Pis conduct of clinical trials: investigator agreements, consents, insurance, ethical guidelines, genetic testing
• intellectual property: patents, trademarks, copyright, confidential information, know how, litigation, licensing and technology, use of internet product liability: risk assessment and minimisation strategic advice, product recall advice and strategy, crisis management
• review of decisions: AAT, ADJR, Freedom of Information marketing and promotion: industry codes

Other areas of innovation, such as nanotechnology, allow us to draw on our broader technology base, including extensive skills in the IT and biotechnology platform areas.

General

• financing including venture capital
• privatisation and corporatisation including joint ventures, partnering arrangements
• property: leasing, redevelopment, planning approval, building and construction issues, property management
• taxation:125% R&D, co-operative research centres, withholding tax, division 10B, international tax
• transfer pricing: audit defence, internal documentation, contemporaneous documentation
• agreements: service provision, outsourcing, acquisition, trust deeds, maintenance services
• tender requirements
• employment and related law

Please call us if you would like to know more about how we can help you.

• Legal update: Lundbeck v Alphapharm

  In a much anticipated decision the Full Federal Court has upheld the validity of Lundbeck’s escitalopram patent for its 20 year term but would not allow an extension of the term.

  29 Jun 09 Kerin Forstmanis , George Cameron and Emma Nelson

• Legal update: R & D changes in 2009 Budget

  Changes to the research and development tax incentive system will see small companies receive a tax refund of 45% of their R & D spending when they file their tax return.

  28 May 09 Bernard O'Shea, David Stavropoulos , Anna Wilson

• Legal update: Therapeutic Goods Act 1989 – First Civil Penalties Case

  In the recent case of Secretary, Department of Health & Aging v Pagasa Australia Pty Limited, the Federal Court has for the first time considered the approach which should be taken in determining the civil penalties to be imposed under the Therapeutic Goods Act 1989 (Cth). The civil penalty provision was introduced into the Act in 2006 and at present the maximum civil penalty for an individual is $550,000 and for a body corporate $5,500,000. Factors which the Court will take into account include a party’s co-operation once a contravention has been identified and the existence of an effective compliance program.

  16 Dec 08 Lindsay Houghton

• Newsletter: Competition and Consumer Law Update - October 2008

  Welcome to the October edition of the Competition & Consumer Law Update. In our October 2008 edition, we: Review the Government’s discussion paper on “creeping acquisitions”, released on 1 September 2008; Discuss proposals to provide the ACCC with significant new enforcement powers, which will allow it to issue ‘infringement notices’ without first obtaining an order from the Court as it is currently required to do; Summarise the outcomes of the ACCC’s successful appeal in the Baxter Healthcare case and the implications arising from that case of offering “bundled” tenders, particularly to government purchasing authorities; Review the key findings from the ACCC’s inquiry into the grocery sector; and provide a stock take on the use – or non-use as is the case – of the collective bargaining notification process that can be used by small businesses to obtain legal immunity from breaches of the Trade Practices Act, since the notification process was introduced in January 2007.

  1 Oct 08 Emma Parmenter , Andrew Bell and Claire Forster

• Legal update: Australian Emissions Trading Scheme becomes Carbon Pollution Reduction Scheme

  The Government’s eagerly awaited Green Paper on its climate change strategy was released yesterday. Following hot on the heels of Professor Garnaut’s draft report, the Green Paper finally provides some clarity on the Government’s approach to an Australian emissions trading scheme.

  17 Jul 08 Elisa de Wit

• Legal update: New .au Domain Name Transfer Policy from 1 June 2008

  In last month’s Legal Update on Upcoming Changes to .au Domain Name Transfer Policy we noted that the Australian domain name administrator (auDA) had approved an implementation plan for a new policy on the transfer on .au domain name licences. auDA has now confirmed that the new policy will take effect on 1 June 2008.

  18 Apr 08 Michael Park

• Legal update: New Guidance Note issued by the Takeovers Panel on equity derivatives

  On 11 April 2008, the Takeovers Panel (Panel) released Guidance Note 20 - Equity Derivatives (Guidance Note) outlining when, and in what circumstances, the use of equity derivatives may constitute unacceptable circumstances and require disclosure to the market.

  17 Apr 08 Shane Bilardi, Robert Sultan , Natalie Trezise

• Legal update: Upcoming changes to .au domain name transfer policy

  The Australian domain name administrator (auDA) recently announced that it has approved an implementation plan for a new policy on the transfer of .au domain names licences. (It is the exclusive licence to use the domain name that is transferred, rather than ownership of the domain name itself.) This announcement follows auDA’s earlier acceptance of the recommendation from the 2007 Names Policy Panel that the current policy be relaxed to allow a registrant to transfer its domain names for any reason.

  27 Mar 08 Michael Park , Ka-Chi Cheung

• Legal update: Market volatility - ASX and ASIC respond

  Sensing a growing controversy, the ASX and ASIC have issued a number of media releases in response to market concerns, reminding market participants of laws designed to protect the integrity of markets. This update discusses the ASX and ASIC statements in light of the current apparent market volatility.

  17 Mar 08 Tim Woodforde

• Legal update: ACCC releases new draft merger guidelines

  The ACCC recently published its 2008 Draft Merger Guidelines for consultation. These guidelines are intended to provide an explanation of the framework the ACCC will apply when considering whether a merger or a proposed merger could substantially lessen competition in a market. Guidelines such as these issued by the ACCC from time to time, provide a useful overview of polices and procedures applied by the ACCC when reviewing proposed mergers.

  4 Mar 08 Jyoti Singh and Chris Mitchell