Life sciences and export control

Before filing a patent application abroad, an applicant for a life science patent should first obtain a foreign filing licence from the US Patent and Trademark Office (USPTO). However, a full release of the life science technology in the patent application may also be subject to the Export Administration Regulations and the Deemed Export Rule. Among US export control regulations, the Export Administration Regulations control dual-use and commercial items, while the International Traffic in Arms Regulations control items designed for military use, including lists of technology and technical data that are controlled and cannot be exported without a licence. Life science research does not generally rise to the military level controlled under the International Traffic in Arms Regulations, so the most relevant export control regulations are the the Export Administration Regulations. If the technology relates to an item that is listed in the Export Administration Regulations by an export control classification number, an export licence is required in addition to the foreign filing license issued by the USPTO.  

In the field of life sciences, export control applies to biological agents and genetic elements, such as:

• human and animal pathogens;
• genetic elements for controlled agents and toxins;
• nucleic acid sequences associated with the pathogenicity of controlled microorganisms;
• viruses;
• vaccines; and
• medical toxins.

In addition, controlled life sciences materials and technologies are also subject to the Deemed Export Rule.   

'Deemed export' refers to disclosures and releases of controlled technology or information of the patentable invention to a foreign person who is located inside the United States and has access to the patentable invention. In this situation, the government considers or 'deems' the controlled technology or information to be exported to the foreign person's home country – that is, when the controlled items are shared with a foreigner, regardless of where the foreigner is located, the government deems this to be as if the information is sent to the foreigner's home country. The government assumes that the foreign person will share the information with other non-US persons in violation of the export control regulation. The rule is if an export licence is required to export the technology or information to a foreign country, an export licence is also required to release the technology or information to a national of that country – even when he or she is in the United States.

Certain categories of life science technology are excluded from export controls under the Export Administration Regulations, especially technology that arises during or results from fundamental research. Many patent applications are generated from university-based fundamental research. 'Fundamental Research' is defined in the Export Administration Regulations as:

"basic and applied research in science and engineering, where the resulting information is ordinarily published and shared broadly within the scientific community. Such research can be distinguished from proprietary research and from industrial development, design, production, and product utilization, the results of which ordinarily are restricted for proprietary reasons or specific national security reasons."

If the life science technology satisfies the requirement of fundamental research under the Export Administration Regulations, the technology is not controlled under US export control rules.

Therefore, to ensure compliance with US export laws, a well-developed export control compliance programme with screening procedures for a full understanding of US regulatory obligations should be in place for companies and universities performing life science research. When export control is required for certain life science technology and information in patent applications, export licence requirements should be considered and appropriate action should be taken to avoid unintentional export violations of the export control regulations.