Manufacturers in the pharmaceutical and biotechnology sector are driven to rapidly produce and introduce innovative drugs and therapies to the market. While the sector is fueled by scientific advances, it also faces a number of challenges, many of which have legal implications. Among them are product liability, regulation and compliance, and patent and other intellectual property issues.
We counsel clients with a global perspective supported by a deep understanding of the science (organic chemistry, molecular biology, biochemistry, and pharmacology) as well as the venues (U.S. district courts, Patent Trial and Appeal Board, Federal Court of Australia, and the Unified Patent Court).
We have extensive experience with pharmaceutical patent work and a successful track record of representing pharmaceutical companies in more than 40 Hatch-Waxman cases over the past decade, numerous inter partes review proceedings, hundreds of opinions, and thousands of patent applications.
Underpinning our work is a deep understanding of the pharmaceutical industry and technology from first-hand knowledge and experience:
Intellectual property lawyers with doctorates
Lawyers and agents with biotechnology-related degrees
Lawyers and agents with chemistry or chemical degrees
Environmental, social, and governance (ESG) and the sustainable economy are concepts that often overlap and frequently intertwine. Whether viewed separately or together, they have significantly changed global investing and business practices and will continue to evolve.
On Friday 1 October 2021, an announcement was made by the Premier of Victoria that all Authorised Workers will be required to receive a COVID-19 vaccine to continue working on-site. The Directions which give effect to this announcement were released late on Thursday 7 October 2021.
A first of its kind, The H2 Handbook provides a comprehensive summary of the regulatory, commercial, and policy issues that hydrogen may face on its path to becoming a global commodity and a significant part of the energy mix. The handbook covers hydrogen-related issues in a number of jurisdictions across the globe, including Australia, the European Union, France, Germany, Japan, Singapore, the United Kingdom, and the United States. Check back regularly as new region handbooks are published.
On 22 December 2020, the U.S. Securities and Exchange Commission (SEC) adopted amendments (the final rule) to Rule 206(4)-1 under the Investment Advisers Act of 1940 (the Advisers Act) to modernize the regulation of investment adviser advertising and solicitation practices.
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