Biological deposits under the Budapest Treaty
In order to obtain patent protection in Australia, an invention must be novel, involve an inventive step and have industrial applicability. There is also a disclosure and enablement requirement...
In order to obtain patent protection in Australia, an invention must be novel, involve an inventive step and have...
Read More
Pfizer suffers setback in ENBREL battle
Pfizer suffered a setback last week in its Australian battle to protect ENBREL (etanercept), when its preliminary discovery application against Sandoz was dismissed by Justice Burley in the Federal...
Pfizer suffered a setback last week in its Australian battle to protect ENBREL (etanercept), when its preliminary discovery application...
Read More
Australian Patent Office considers the plausibility of Swiss-style claims
Gliknik, Inc. v CSL Behring Lengnau AG  APO 46 (“Gliknik”) concerned a patent application for engineered proteins intended for use as replacements for intravenous immunoglobulin.  The application included claims...
Gliknik, Inc. v CSL Behring Lengnau AG  APO 46 (“Gliknik”) concerned a patent application for engineered proteins intended for...
Read More
Pharmaceutical patent term extensions: broader is not always better
Ono Pharmaceutical Co., Ltd. et al  APO 43 (16 September 2020) Background Australia’s Patents Act provides a patent term extension (PTE) to account for the delays that can occur when obtaining...
Ono Pharmaceutical Co., Ltd. et al  APO 43 (16 September 2020) Background Australia’s Patents Act provides a patent term extension (PTE)...
Read More
How to use post-filing experimental data to help establish sufficiency and support
The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 was introduced in Australia with the intention of aligning Australia’s written description requirements with those in the UK and Europe. Under...
The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 was introduced in Australia with the intention of aligning Australia’s written...
Read More
Patenting proteins: an Australian perspective
Biological molecules, including polypeptides and, in some cases, nucleic acids, can be patented under Australian law.  The level of disclosure that is required to support and enable a claim...
Biological molecules, including polypeptides and, in some cases, nucleic acids, can be patented under Australian law.  The level of...
Read More
Switching from Biologic to Biosimilar: Australia’s Unique Approach
Switching patients from an originator biologic (the reference product) to a biosimilar version has been a topic of keen interest in recent years, both in Australia and globally, as...
Switching patients from an originator biologic (the reference product) to a biosimilar version has been a topic of keen...
Read More
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...
In Part 1 of this series (available here), we examined the impact of the proposal by Australia’s Therapeutic Goods Administration (TGA) to...
Read More