Pay-for-delay pharmaceutical agreements have attracted scrutiny from regulators in the US and EU and are at greater risk of Australian regulatory attention
Last year, Bayer was awarded more than $25 million (plus interest and indemnity costs) against Generic Health in the first Federal Court award of damages for pharmaceutical patent infringement.
Australia’s digital health sector received a major boost in April this year when the Federal Government announced a $55 million cash injection to launch the new Digital Health Cooperative Research Centre (CRC) and its programs which will bring together a consortium of more than 60 health, medical technology and pharmaceutical companies, universities and research institutes operating across the health, aged care and disability sectors.
Following the Australian Government’s Response to the Review of Medicines and Medical Devices Regulation in 2016, the government recently released exposure drafts for a set of significant reforms to the Therapeutic Goods Act 1989 (Cth).
Further to our post of 7 July 2015, the proceedings brought by Otsuka and Bristol Myers Squibb (the “exclusive licensee” of Otsuka’s patents for aripiprazole) against Generic Health have taken another turn.
A novel WIPO program brings IP owners and researchers together to facilitate scientific research into neglected diseases, with the aim of bringing royalty-free treatments to least developed countries.