Our International Experience

Decades of Experience:

• Initiating and successfully closing complex international technology transactions involving entities in the US, China, Japan, Korea, Singapore, Hong Kong, Canada, Mexico, Brazil, and throughout Europe.
• Obtaining granted international patents with respect to artificial intelligence (AI), biotechnology, chemistry, diagnostic, medical device, pharmaceutical, SaMD, and convergence technologies.
• Drafting and negotiating international IP license agreements involving combinations of startup companies, public and private universities, private research institutes, hospital systems, physician groups, and individual entrepreneurs.
• Conducting due diligence in transactions involving public and private financing, venture capital, mergers and acquisitions, licensing deals, angel investments, and seed investments involving IP, FDA regulatory, and other tangible and intangible assets.
• Protecting multiple paths to market involving regulated and unregulated strategies including Direct-to-Consumer (DTC), Over-the-Counter (OTC), Third-Party Administrator (TPA), and other business strategies.
• Extending patent term through implementation of pharmaceutical lifecycle management, Patent Term Extension (PTE), and European Supplementary Protection Certificate (SPC) strategies for both innovators and follow-on manufacturers.

• "Patent Mining" through interaction with R&D personnel, clinical trial managers, chemistry, manufacturing & controls (CMC), Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), and other technicians and scientists.
• Obtaining regulatory approvals and clearances for medical devices, in vitro diagnostics, and drugs throughout the world.
• Ensuring regulatory compliance in highly regulated markets for software -- especially artificial intelligence-implemented innovations -- worldwide.
• Drafting legal opinions related to intellectual property infringement, validity, and patentability.
• Supporting pre-litigation and IP litigation in US federal courts including providing written testimony as expert witnesses in pharmaceutical, biotechnology, and software matters.
• Responding to government investigations including Office of Inspector General (OIG), Health & Human Services (HHS), Food & Drug Administration (FDA), Securities & Exchange Commission (SEC), and Department of Justice (DOJ) investigations.
• Assisting with obtaining grant funding including SBIR, STTR, NIH, DOD, DOE, NSF, associated Technical and Business Assistance (TABA), and private grant funding.
• Advising on Patent Trial and Appeal Board (PTAB) patent appeals, inter partes review (IPR), ex parte review, Post-Grant Review (PGR), and covered business method review (CBM).