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 virtually every area of life sciences law. Arnold & Porter offers renowned regulatory, white-collar defence, product liability and commercial litigation, antitrust, IP and transactional capabilities to clients who include a wide variety of pharmaceuticals, biotech, medical device and diag- nostic companies and trade associations, as well as
non-profits and universities. The firm has nearly 200 attorneys who provide integrated counselling to life sciences companies and represent 80% of the top 50 leading life sciences companies (in addition to repre- senting numerous emerging companies). The lawyers at Arnold & Porter help clients navigate their day-to- day legal problems as well as their most complex and high-stakes matters. 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.
Authors
Daniel Kracov is a partner at Arnold & Porter, where he chairs 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 expertise in biomedical public policy matters, including Congressional investigations and advising on FDA-related legislation.
Alice Ho is a senior associate at Arnold & Porter, where her practice focuses on a range of IP legal issues, including patent prosecution, litigation and transactions as well as IP portfolio counselling in life sciences
(among other areas). Alice has prosecuted and analysed patents involving a range of technologies, including medical devices, antibodies, pharmaceuticals, and medical diagnostics. She also supports litigation efforts in interferences, inter partes reviews, and other post-grant proceedings before the US Patent and Trademark Office’s Patent Trial and Appeal Board and the federal district courts. Alice’s further experience includes negotiating licence and collaboration agreements, preparing non-infringement and invalidity opinions, and performing freedom-to-operate and due diligence analyses.
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-Waxman issues, and patent procurement in the
biotechnology, business methods, chemical, clothing, computer media, consumer products, pharmaceuticals, and medical device areas. David’s
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