Detection methods

Principles for the Transfer and Use of Intellectual Property

CLI member companies provide proprietary intellectual property, which includes reference materials and PCR methodology, to some regulatory authorities as requirement for regulatory approval for biotech traits. There are some basic principles of intellectual property rights that must apply to these materials:

  • Non-commercial use: The regulatory authority’s use of a registrant’s proprietary intellectual property is solely for the purpose of fulfilling its regulatory obligations pursuant to the applicable laws and regulations. No commercial uses are authorized.
  • Commercial use: Certain uses of a registrant’s proprietary intellectual property (including detection methods) may constitute an unauthorized commercial use and may require an agreement with the registrant. Examples might include the distribution of materials to labs conducting fee-for-service activities or for the purpose of developing or selling kits.
  • Method and material validation: A registrant should be involved in the generation and review of the data from validation of detection methods.
  • Analysis and derivation: A regulatory authority should not analyze, characterize, or develop derivative analytical protocols from the materials and protocols provided.
  • Publication: A registrant should review and/or approve the draft of any manuscript resulting from the regulatory authority’s use of a registrant’s materials and protocols
  • Duration of Supply: Conditions of maintenance and use should anticipate that the registered trait and products may be discontinued at a future time.

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