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
The Commonwealth Government and NSW Government will both be offering financial support to NSW businesses impacted by the recent COVID-19 restrictions and stay-at-home orders. We have tabled the key components of the 2021 COVID-19 package in this article.
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.
Is your company new to the United States or still discovering its economic opportunities? Our Doing Business in the United States Guidebook covers many relevant issues, from forming corporations and limited liability companies, to intellectual property protection, to real estate development.
We welcome your email, but please understand that if you are not already a client of K&L Gates LLP, we cannot represent you until we confirm that doing so would not create a conflict of interest and is otherwise consistent with the policies of our firm. Accordingly, please do not include any confidential information until we verify that the firm is in a position to represent you and our engagement is confirmed in a letter. Prior to that time, there is no assurance that information you send us will be maintained as confidential. Thank you for your consideration.
