Allens

Experience

Pharmaceuticals and biotechnology

M&A and merger control

Healthscope Limited
Acted for one of Australia's leading private healthcare operators, on its sale of its Australian pathology operations to Crescent Capital Partners for $105 million.

CSL
Advised on its US$3.1 billion proposed acquisition of Talecris Biotherapeutics, including the related A$1.75 billion institutional placement.

EBOS Group
Advised on its A$886 million acquisition of Symbion Health Limited, a leading Australian marketer, wholesaler and distributor of healthcare, medical and pharmaceutical products from The Zuellig Group.

Gambro AB
Advising on the Australian and New Zealand competition regulatory aspects of its acquisition by Baxter International, including negotiation of a complex undertaking.

Johnson & Johnson
Advised on the Australian aspects of the proposed sale of global trauma business (DePuy Orthopaedics) to Biomet. The global transaction was a follow-on from Johnson & Johnson's US $19.7 billion merger of Synthes with Johnson & Johnson's DePuy orthopaedics franchise.

Merck
Advised on its US$41 billion merger with Schering-Plough, including integration and transactions related to the merger.

Pfizer
Acted as Australian counsel on its US$68 billion acquisition of Wyeth, including the successful divestments of the Fort Dodge companion animal vaccines business to Boehringer Ingelheim and the Fort Dodge Australia livestock business to Virbac, and on the sale of its Australian consumer healthcare business to Johnson & Johnson.

Commercialisation

AstraZeneca
Negotiated and drafted licence, commercialisation and supply agreements for a market ready product in oncology pain relief for which Australia is being used as a test market.

Biota Holdings
Advised on licensing and collaboration arrangements, program acquisitions, funding agreements, research grants and recent NASDAQ listing.

Patent disputes

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co
Acting in patent infringement and revocation proceedings against two generic companies relating to the drug Abilify.

Les Laboratoires Servier
Acting in patent infringement and revocation proceedings in relation to gliclazide and perindopril containing drugs. We also advised Servier on its Australian patent portfolio and have successfully defended Servier in a number of patent oppositions.

Mundipharma
Successfully defended a challenge to the patent term extension for oxycontin, which kept generic competitors out of the market until the expiration of the full five year extended period.

Pfizer
Acting in patent infringement and revocation proceedings in relation to the drug pregabalin, marketed by Pfizer under the trade name Lyrica. We also advise Pfizer on patent filings in Australia.

Competition

Abbott Laboratories
Advised on Australian competition law issues regarding its global acquisition of Guidant Vascular's vascular business.

Medicines Australia
Advised on the authorisation of successive editions of the Medicines Australia Code of Conduct.

Pfizer
Acting in proceedings commenced by the ACCC for alleged misuse of market power and exclusive dealing in relation to the supply of atorvastatin to pharmacies.

Sanofi
Obtained ACCC clearance for the restructure of the Sanofi/BMS cardiovascular joint venture and acquisition of AVAPRO and ISCOVER brands.

Compliance and regulatory

Our regulatory expertise in pharmaceuticals and healthcare comes from having worked with a range of global pharmaceutical companies on significant commercial and regulatory matters. Our experience includes advising on:

  • The evidence required and prospects of success in challenging decisions regarding the registration of products.
  • Advertising and associated labelling, marketing and competitor complaints under the Therapeutic Goods Advertising Code, the Australian Self Medication Industry Code of Practice and the Medicines Australia Code of Conduct and in advertising and marketing issues before the Federal Court.
  • Pre- and post-acquisition reviews of marketing authorisations/drug approvals, labelling and promotional compliance and development of strategies to resolve non-compliance.
  • Challenges to Therapeutic Goods Act decisions regarding drug and labelling approval, decisions of relevant industry self-regulatory committees regarding promotional activities and decisions of other regulatory bodies, including appeals to the Administrative Appeals Tribunal and Federal Court.
  • Challenging decisions made in relation to marketing authorisation and reimbursement, including decisions of the Pharmaceutical Benefits Advisory Committee (PBAC).
  • Adverse event reporting, mandatory product liability reporting and the overlap between therapeutic goods and general product liability regulatory schemes.
  • Advising on newspaper, radio and television advertisements and marketing material to ensure compliance.
  • The scheduling of drugs and poisons and the implications for manufacture, storage, possession, transport and logistics of such products, including the overlap of Federal and State laws.
  • the overlap of the regulation of health care professionals and the regulation of drugs and poisons and the implications for possession, prescription and dispensing of drugs.

Healthcare Services

Healthe Care
Advised Archer Capital on its A$240 million acquisition of Australian private hospital business Healthe Care from a CHAMP Ventures consortium and on subsequent acquisition and disposal of various private hospitals and acquisition of Brisbane Waters Private Hospital from Healthscope Limited.

Healthscope
Advised on its bid for Symbion Health, as well as a number of capital raisings, on its acquisition of The Gribbles Group, Nova Health Limited and Quest Laboratories in Singapore and on its sale of various pathology centres in Australia.

Plenary Health Consortium
Advised the consortium on its bid to finance, design, construct and maintain the new main hospital building and community health facilities at the Royal North Shore Hospital.

Queensland Health
Advised on the drafting, review, and negotiation of a number of technology outsourcing agreements.

Ramsay Health Care (financiers)
Advised a syndicate of banks, led by ANZ, NAB and Westpac, on the refinancing of global private hospital group Ramsay Health Care Limited.

SA Health Partnership (financiers)
Advised the financiers of the preferred consortium to build and operate the New Royal Adelaide Hospital.

St John of God Health Care
Advised the preferred respondent to deliver a 370-bed integrated public/private hospital in Western Australia, including the outsourcing of core services to the private sector.

Medical devices

We have extensive experience in the area of medical devices, having assisted numerous medical device suppliers, including ABB Asea Brown Boveri, Abbott Medical Optics, Australian Medical Technology, Convatec Australia, EBOS Group, Healthscope, Johnson & Johnson Medical, Medela AG, Primary Healthcare, Sonic Healthcare and Varian Medical Systems.

Our experience includes:

  • Assisting with complaints made under the relevant codes of conduct applicable to the therapeutic goods sector.
  • Advising in relation to registration and listing of goods and devices under the Therapeutic Goods Act 1989 (Cth).
  • Challenging decisions made in relation to marketing authorisation and reimbursement, including decisions of the Medical Services Advisory Committee (MSAC).
  • Advising in relation to the regulatory aspects associated with marketing and patient support programs for therapeutic goods, including compliance with industry codes and ethical obligations.
  • Advising in relation to product recall under both the Therapeutic Goods Act 1989 (Cth) and ACCC requirements and assisting with minimising product liability risk.
  • Providing strategic advice about distribution and pricing of therapeutic goods covering aspects of ongoing PBS Reform, the Community Pharmacy Agreements and the codes of conduct issued by Medical Technology Association of Australia (MTAA), IVD Australia, Medicines Australia and similar codes applicable to OTC and complementary medicines.

We have also advised on acquisitions and divestments involving medical devices businesses. Our experience includes:

AstraZeneca
Advised on Australian aspects of its sale of the global Astra Tech AB dental implants and medical devices business to DENTSPLY International.

Gambro
Acting on the ACCC’s clearance of its acquisition by Baxter, including negotiation of a complex undertaking.

Johnson & Johnson
Acting on its acquisition of Synthes, a significant issue in the clearance of which was an analysis of the procurement practices of the public and private hospital sectors and the role of the Prostheses List in assessing competition.