Patents

Novartis: Acting for Novartis AG and Novartis Pharmaceuticals Australia Pty Ltd in proceedings to enforce patents and prevent the entry of generic competition for its blockbuster heart failure/hypertension drug Entresto (sacubitril/valsartan). In June 2023, Novartis commenced proceedings against generic competitor, Pharmacor, which had threatened to launch a generic fingolimod product on 1 August 2023. In July 2023, Novartis successfully obtained a preliminary injunction restraining Pharmacor's launch. A trial took place in April/May 2024 and a judgment at first instance in November 2024. The primary judge found for Novartis on the alleged lack of inventive step, but found for Pharmacor on the claim construction and related PTE/infringement issues. An appeal has been brought, and the proceedings are ongoing, with a hearing before the Full Court of the Federal Court which took place in March 2025. We continue to act for Novartis entities in connection with enforcing patents to protect various other drugs in Novartis' Australian pharmaceutical product portfolio.

Royalty Pharma Collection Trust: Engaged by US counsel, Goodwin Proctor, for RPCT to give expert evidence in US arbitration proceedings on aspects of Australian patents and competition law central to a major ongoing contractual dispute between RPCT and Gilead Sciences, Inc. This matter is significant, as multi-jurisdictional patent portfolio licence agreements are becoming increasingly common, especially in the pharmaceutical and information technology industries. The monetary value of such agreements is often substantial, and the possibility of post-expiry royalty fees raises important questions about the interface between modern competition/anti-trust law and patents law, with different approaches taken in different jurisdictions globally.

Sandoz: Representing Sandoz Pty Ltd and Sandoz International GmbH in the long-running Lundbeck escitalopram (Lexapro) patent infringement litigation. This is a claim originally for around $150 million made by Lundbeck against Sandoz for alleged infringement of a patent covering the depression treatment Lexapro. This is one of the largest patent damages claims in recent times. The case concerns patent term extensions for pharmaceutical patents, contractual interpretation of patent licences, untested provisions of the Patents Act, and the methods of assessing damages in complex counterfactual scenarios. Following many years of litigation, the parties reached a confidential settlement in February 2025. We have also successfully acted for Sandoz in defending proceedings brought by Biogen in relation to its blockbuster multiple sclerosis drug, Tecfidera (dimethyl fumarate). Biogen sought access to confidential information about Sandoz's generic dimethyl fumarate products, and threatened to commence infringement proceedings, but the matter resolved following Sandoz's successful outcome on preliminary discovery.

Eli Lilly & Company: Acting for Eli Lilly in connection with patent infringement and revocation proceedings for its gemcitabine hydrochloride molecule which forms the basis of its successful anti-cancer treatment branded as GEMZAR. Various generic pharmaceutical companies were looking to introduce competing products which Eli Lilly asserted contravened its exclusive patent rights. These cases dealt directly with the complex interplay of patent rights, Therapeutic Goods Administration (TGA) product registration and Pharmaceutical Benefits Scheme (PBS) listing procedures.

Northern Territory Government v Collins: Successfully defended the Northern Territory Government in one of the very few patent cases to reach our highest court, the High Court of Australia. The case concerned the production of essential oils from trees removed from Crown land pursuant to statutory licences. This matter is significant not only because patent disputes of this type are rarely argued at all, let alone considered by the High Court of Australia, but also because it involves issues of the potential liability of parties for others' patent infringements. The litigation will have a significant impact on the way governments manage their profitable bio-prospecting regimes (the search for chemical compounds from biological resources, which are often used to create pharmaceutical and agrochemical products).

Amgen Inc: Representing Amgen in defending patent revocation proceedings brought by Hospira in the Federal Court of Australia. The patent in question relates to a protein called pegfilgrastim (Neulasta) used to assist in the treatment of neutropenic cancer patients. Related proceedings were prosecuted in the UK. The matter deals with the validity of a biotechnology patent, the extension of its term and the regulation of biosimilars. There have been few biotechnology patent disputes in Australia and this matter could give rise to one of first Federal Court judgments in the area. Our involvement demonstrates our breadth of expertise in advising the life sciences industry in matters dealing with complex scientific and intellectual property issues.

Major global pharmaceutical company: Advised our client on the appropriate patents to be referenced under the new Pharmaceutical Benefits Scheme Reforms. This matter was significant because the new reforms mandate price reductions for certain major pharmaceutical products by reference to remaining patent life. There was disagreement as to which patents should be referenced and our team managed to convince the Government that it had chosen the incorrect patent. It also generated substantial benefits in excess of US $200 million to our client over ten years.

Genetic modification: Acting in pioneering patent litigation in the Federal Court relating to patents for the genetic modification of cotton and corn plants. This matter was part of worldwide litigation involving the same suite of patents.

Medical device company: Advised a medical device company on certain issues arising as a result of litigation concerning patents for its dialysis machines.

Equine worming: Acting in Federal Court proceedings appealing a decision of the Patents Office concerning an equine worming preparation.

Osteoporosis and bone disorders: Advised a large US pharmaceutical company regarding pharmaceutical patents directed to treatments for osteoporosis and bone disorders.

Ophthalmic technology: Representing an Australian company with respect to cutting-edge patented ophthalmic technology.

Mechanical patent matters: Advised on a number of mechanical patent matters concerning machinery and components in relation to air conditioning systems and ducting for power stations.

Pre-paid call access information technology system: Acting in a patent infringement action brought in the Federal Court of Australia for infringement of an Innovation Patent directed to a real time pre-paid call access information technology system.

Mineral processing equipment: Advised on patent and copyright infringement issues concerning mineral processing equipment.