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
On 10 May 2022, the European Commission (the Commission) finally published the official final version of the European Vertical Block Exemption Regulation (VBER) and guidelines (Vertical Guidelines).
The Victorian Government's proposed Occupational Health and Safety Amendment (Psychological Health) Regulations (Vic) (the Proposed Regulations) are expected to commence on 1 July 2022.
The rise of cryptocurrencies and digital assets (together, crypto) in the financial markets, including the investment management industry, has given rise to a crucial question: which federal regulator - the Securities and Exchange Commission (SEC) or the Commodities and Futures Trading Commission (CFTC) will be primarily responsible to regulate the use of crypto and crypto-related activities?
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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