TGA transparency reforms (part 2): Early publication of major innovator prescription medicine applications

In Part 1 of this series (available here), we examined the impact of the proposal by Australia’s Therapeutic Goods Administration (TGA) to provide early confidential notification to innovators of applications under evaluation for generic and biosimilar product registration. In this Part 2, we focus on the TGA’s other proposed reform, the earlier publication of applications

Federal Court dismisses first Commonwealth damages claim against an unsuccessful pharmaceutical patentee

In an unprecedented decision, the Federal Court of Australia has considered and dismissed a claim by the Commonwealth Government for compensation from sponsors of innovator pharmaceutical products, pursuant to undertakings as to damages given in exchange for an interlocutory (preliminary) injunction restraining the launch of the first generic product: Commonwealth of Australia v Sanofi (No

TGA transparency reforms (part 1): Notification of generic and biosimilar medicines to impact pharmaceutical patent disputes in Australia

Regulatory changes recently approved by the Australian Government are likely to impact the way in which pharmaceutical patent litigation is conducted in Australia. The Therapeutic Goods Administration (TGA) is currently seeking feedback on options for implementing the proposed Prescription Medicines Transparency Measures by 9 June 2020. The reforms are directed at:   1. Early publication

Heading off generic market entry which does not patent infringe

A preliminary discovery application brought in the Federal Court of Australia by GlaxoSmithKline Australia Pty Ltd (GSK) shortly before Christmas has sparked interest in the potential for patentees to prevent non-patent infringing generic pharmaceutical products entering the Australian market. Background facts The paracetamol market in Australia saw significant legal attention in the last months of

Injunction appeal success leaves generics companies in a world of pain

Warner-Lambert and the Pfizer group successfully appealed to the Full Federal Court to broaden the scope of an interlocutory injunction restraining the supply of Apotex’s pregabalin products (Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCAFC 59). This decision suggests that efforts made by generics companies to restrict the registration of a bioequivalent pharmaceutical product

Patent Office decision highlights identification of applications eligible for a pharmaceutical patent term extension

The term of an Australian pharmaceutical patent may be extended if a product covered by the claims receives regulatory approval in Australia. An extension of the term of a patent can be worth literally hundreds of millions of dollars to the patentee. Consequently, this is an area of Australian patent law that is of significant