Nicholas is a leading patent, intellectual property and life sciences regulatory lawyer and litigator. He is dual-qualified (Australia and the United States) and offers a level of experience unique to the Australian market, with over 25 years’ experience advising and acting for many of the world's leading life sciences and technology companies in Australia and the United States with respect to their patent, intellectual property and regulatory issues and disputes.
Nicholas heads DLA Piper's Life Sciences practice in both Australia and the Asia-Pacific, leads DLA Piper's Life Sciences Intellectual Property and Regulatory practices in Australia, and is a leading member of DLA Piper’s HealthTech practice.
Nicholas advises clients with respect to all aspects of patent law, particularly in relation to patent issues and disputes in the life sciences and technology sectors, as well as copyright and trade mark law, particularly as they relate to the internet and high technology.
Nicholas has been involved in a number of Australia's and the United States' most significant patent cases and has established a reputation acting as a member of global teams representing clients in complex, multi-jurisdictional matters. He has advised and acted for many of the world's leading life sciences companies in Hatch-Waxman patent disputes in the United States and in the Australian component of equivalent complex patent litigation. He has acted for clients in patent disputes before trial courts, intermediate appeal courts (the United States Court of Appeals for the Federal Circuit and the Full Court of the Federal Court of Australia) and final appeal courts (the Supreme Court of the United States and the High Court of Australia) in both jurisdictions.
Nicholas also advises life sciences companies on a broad range of regulatory issues including registration of pharmaceuticals and medical devices and technologies, promotion of products, pricing, compliance with industry codes, and clinical trials.
Nicholas is also a technophile and he has used his knowledge and understanding of technology to help numerous clients resolve multi-million dollar technology related legal disputes.
Patents - Life Sciences
- Advising numerous global life sciences companies on the ability for AI to be identified as an inventor under Australian law.
- Advised and acted for Wyeth in one of the largest and most complex life sciences patent litigations ever in Australia, involving three separate proceedings against eight separate parties (including the Commonwealth of Australia) in respect of their claims on undertakings as to damages ordered in return for interlocutory injunctions preventing the launch of generic extended release venlafaxine products. These three cases, which involved a six week trial, were the first cases in Australia to address claims on undertakings as to damages in pharmaceutical patent litigation by generic pharmaceutical companies, their suppliers and the Commonwealth of Australia.
- Advising and acting for Pfizer in Australia’s first biologic / biosimilar patent dispute, as well as several other patent disputes, involving six adverse parties, relating to Pfizer’s patents covering the process for producing etanercept, the active ingredient in Pfizer's blockbuster biological medicine Enbrel®. We have already achieved success in this ongoing matter before Australia’s highest court.
- Advising and acting for Israeli innovator pharmaceutical company, Neurim Pharmaceuticals 1991 (Ltd), in patent amendment, infringement and revocation proceedings against two generic pharmaceutical companies in relation to Neurim’s patent covering Neurim’s prolonged release melatonin medication for the treatment of primary insomnia characterised by non-restorative sleep. This ongoing case has already established new law in several areas, including in relation to patent amendment. We worked as part of a global team, managing and coordinating strategy across numerous jurisdictions.
- Advising and acting for Pfizer and Pharmacia in patent infringement and revocation proceedings in relation to Pharmacia’s patent covering the parecoxib reconstitutable powder injectable formulation for Pfizer's Dynastat® pain medicine.
- Advised and acted for Warner-Lambert in patent infringement and revocation proceedings in relation to Warner-Lambert’s patents relating to pregabalin, the active ingredient in the blockbuster pain medicine Lyrica®.
- Advised and acted for Pfizer in patent infringement and revocation proceedings with respect to Pfizer’s patents relating to sildenafil, the active ingredient in its blockbuster erectile dysfunction medication Viagra®.
- Advised and acted for an American global pharmaceutical company in relation to patent issues relating to a number of the company's products. This included acting for the company in multiple proceedings in Australia, and co-ordinating proceedings in other Asia-Pacific jurisdictions, as part of a global team involved in multi-jurisdictional patent infringement and revocation proceedings with respect to a family of patents relating to the company's successful anti-cancer treatment product. In the main Australian proceedings, the company successfully resisted a challenge to the patent term extension of one of the patents-in-suit, successfully amended the claims of that patent in the course of litigation and successfully obtained an interlocutory (preliminary) injunction enjoining the marketing of two generic competitors' products. The proceedings established an important set of guiding principles in Australia for determining when an interlocutory injunction will be granted in pharmaceutical patent infringement cases.
- Advising and acting for Neurim in the Australian Patent Office in patent opposition proceedings relating to Neurim’s application for a patent for a novel prolonged release mini-tablet melatonin formulation.
- Advising and acting for many of the world's top multinational innovator pharmaceutical companies on patent issues and disputes relating to a wide variety of their products including anti-cancer medications, proton pump inhibitors, selective serotonin reuptake inhibitors, calcium channel blockers, selective 5-HT3 receptor antagonists, JAK inhibitors, statins, pain medications, atypical antipsychotics, antihistamines, arthritis medications, anti-fungal medications, smoking cessation medications, vaccines, antibiotics, and insulin.
- Acted for many of the world's top multinational innovator pharmaceutical companies in patent disputes against almost 40 generic pharmaceutical companies, including almost every generic pharmaceutical company in Australia.
- Advising and acting for many of the world’s top multinational innovator pharmaceutical companies on patent - including patent term extension, patent portfolio management and patent litigation - and non-patent (including data exclusivity) strategies to maximise the commercial life of their product portfolio.
- Advised the world leader in implantable hearing solutions on a number of patent issues regarding a family of electrical and mechanical engineering patents in the field of hearing aids and hearing implants.
- Advised and negotiated on behalf of a leading biotechnology company in relation to the licensing of a family of RNAi patents.
- Advised and acted for a leading biotechnology company in a Federal Court appeal of a patent office opposition regarding a patent for the perfusion culturing of cells.
- Acted for one of the world's premier veterinary pharmaceutical companies in an appeal from the decision of the Australian Patent Office relating to a patent directed to an equine anthelmintic formulation.
Patents - Technology
- Acted for eight of the world's leading manufacturers of bar code scanning technology and one of the world's leading manufacturers of computer vision technology in a patent infringement action brought by a US inventor in relation to a family of patents directed to bar code scanning and machine vision technology. The case, which was appealed to the United States Supreme Court, established an important new defence to patent infringement.
- Advised several leading telecommunication companies on a number of patent issues relating to a variety of telecommunication technologies.
- Acted in patent infringement proceedings of an innovation patent directed to a real time pre-paid call access system.
Copyright / Technology
- Acted in one of Australia’s largest copyright and software licensing disputes, involving one of Australia’s largest computer networks and spanning several decades of computer and network technology.
Regulatory - Life Sciences
- Advising numerous life sciences companies on a broad range of regulatory issues including registration of pharmaceuticals and medical devices and technologies, promotion of products, compliance with industry codes, and clinical trials.
- Advising numerous global life sciences companies on various issues relating to telehealth.
- Acting for a global life sciences company to defeat a claim that it had breached the governing industry code.
- Advising numerous life sciences companies on, and undertaking the due diligence with respect to, the life sciences regulatory and intellectual property aspects of their corporate transactions to acquire pharmaceutical companies, medical technology companies, digital therapeutic companies, and telehealth companies, in support of DLA Piper's Corporate team.
- Advising numerous life sciences companies on the life sciences specific aspects of their real estate transactions, such as the issues that arise if the facility has been used to manufacture particular therapeutic goods, in support of DLA Piper's Real Estate team.
Transactions – Life Sciences
- Bachelor of Commerce, University of New South Wales, 1991
- Bachelor of Laws, University of New South Wales, 1991
- Master of Laws (Hons), Columbia University, New York, 1995
- Nicholas leads the Asia Pacific life sciences team, which is currently ranked in Chambers as Band 2
- Chambers (Global) Intellectual Property – Foreign Expertise in USA
- IP Stars, “Notable Practitioner”
- IAM Patent 1000, “Silver for Litigation”
- Client feedback on Nicholas includes:
- "One of the very best practitioners in the country, polished courtroom performer…Tyacke has practised extensively in the [US] as well as Australia. [He] is especially accomplished in life sciences matters." IAM Patent 1000
- "He is really our best lawyer. He is a quick forward thinker. He takes zero time to respond. He is very exact and trustworthy. He looks at things in a holistic way." Chambers IP & Life Sciences
- "Tyacke has strong strategic vision and amazing attention to detail and an unshakeable commitment to achieving the best possible outcome for his clients." The Legal 500, Australia
- "He has remarkable skill and expertise and is particularly good with US clients as he has experience in USA IP litigation and understands well the issues which may be important for a US client in Australia. He is particularly responsive to the client's needs and there has not been a question after years of being with him that he has not responded to thoughtfully and right away." Chambers IP & Life Sciences
- "Hotshot litigator…Tyacke…is a prime pick for pharmaceutical multinationals seeking someone to run the distance in cross-border clashes" IAM Patent 1000
- "He's got a very good understanding of the science, and he's very good at working with offshore clients. He seems to be an indefatigable worker – he's available nearly the whole time and is working in each of the time zones needed in order to liaise and speak to the lawyers working in different jurisdictions. He's very good at running a number of balls at the same time." Chambers IP & Life Sciences
- "He is very analytical and dedicated…[H]e is…very responsive...I think he is first class. He is so creative and always sees the footfalls before you enter – he is proactive." Chambers IP & Life Sciences
- "Nick is a very good patent lawyer and he has a good grasp of the legal side of that area of the law, but he also gets very much into the technical side, more so than lawyers often do here in Australia…He throws himself 110% into a matter. He's great to work with." Chambers IP & Life Sciences
Nicholas has written extensively about patent, intellectual property and life sciences issues. He is a regular contributor to Thomson Reuters Practical Law Life Sciences Australian chapters and a regular contributor to Cortex (the DLA Piper life sciences blog).
Memberships And Affiliations
- Copyright Society of Australia
- Computer Law Association Inc
- International Trade Mark Association
- Intellectual Property Society of Australia and New Zealand
- American Intellectual Property Law Association
My latest insights
Australian Court determines that an Artificial Intelligence system can be an inventor for...
4 August 2021 .8 minute read