USA Law and Practice Contributed by: Daniel Kracov, David Marsh and Alice Ho, Arnold & Porter
Arnold & Porter is a 1,000-lawyer firm with a global reach and extensive experience in vir- tually every area of life sciences law. Arnold & Porter offers renowned regulatory, white-collar defence, product liability and commercial litiga- tion, antitrust, IP and transactional capabilities to clients who include a wide variety of pharma- ceuticals, biotech, medical device and diagnos- tic companies and trade associations, as well as
non-profits and universities. The firm has nearly 200 attorneys who provide integrated counsel- ling to life sciences companies and represent 80% of the top 50 leading life sciences com- panies (in addition to representing numerous emerging companies). The lawyers at Arnold & Porter help clients navigate their day-to-day le- gal problems as well as their most complex and high-stakes matters.
Authors
Daniel Kracov is a partner at Arnold & Porter, where he chairs
David Marsh is a partner at Arnold & Porter, where he focuses extensively on IP counselling, patent prosecution, interferences, inter partes and ex parte matters, Hatch-
the life sciences industry practice. Daniel’s practice focuses on assisting biotech, medical device, diagnostics and pharmaceuticals companies – including global manufacturers, trade associations and emerging companies – in negotiating challenges relating to the development, approval and marketing of US Food and Drug Administration (FDA)-regulated products. In addition to day-to-day counselling on regulatory strategies and concerns, he regularly handles product- and compliance- related government and internal investigations, the development of global corporate compliance programmes, and due diligence in financings and M&A. Daniel has widely recognised experience in biomedical public policy matters, including Congressional investigations and advising on FDA-related legislation.
Waxman issues, and patent procurement in the biotechnology, business methods, chemical, clothing, computer media, consumer products, pharmaceuticals, and medical device areas. David’s experience includes lead counsel for numerous post-allowance proceedings at the US Patent and Trademark Office, appeal counsel at the US Patent and Trademark Office’s Patent Trial and Appeal Board, and lead co-ordinating counsel for multiple European opposition proceedings and other worldwide dispute resolution proceedings – as well as worldwide patent prosecution, non- infringement and invalidity analysis, and multiple due diligences.
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