13.3 Intellectual property rights and patenting in biotechnology

Intellectual property rights are crucial in biotechnology, protecting inventions and innovations. Patents, copyrights, trademarks, and trade secrets offer different forms of protection, each with unique requirements and durations. Understanding these rights is essential for researchers and companies in the biotech industry.

Biotechnology-specific IP issues include gene patenting and technology transfer. Recent legal decisions have changed the landscape of gene patenting, while licensing and tech transfer play key roles in moving research from labs to market. These aspects highlight the complex interplay between science, law, and commerce in biotech.

Intellectual Property Types

Patents, Copyrights, and Trademarks

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• Patents provide exclusive rights to an invention for a limited period of time, typically 20 years from the filing date
• Copyrights protect original works of authorship, such as literary, musical, and artistic works, for the life of the author plus 70 years
• Trademarks protect words, phrases, symbols, or designs that identify and distinguish the source of goods or services (Nike swoosh, Apple logo)

Trade Secrets

• Trade secrets are confidential business information that provides a competitive advantage
• Can include formulas, patterns, compilations, programs, devices, methods, techniques, or processes (Coca-Cola formula, Google's search algorithm)
• Protected as long as the information remains secret and reasonable measures are taken to maintain secrecy
• No formal registration process required unlike patents, copyrights, and trademarks

Patent Requirements

Prior Art and Novelty

• Prior art refers to all publicly available knowledge before the filing date of a patent application
• Includes published scientific papers, public presentations, and existing patents
• Novelty requires the invention to be new and not previously disclosed in the prior art
• If an invention has been described in a printed publication, used publicly, or sold before the filing date, it is not considered novel

Non-Obviousness and Utility

• Non-obviousness means the invention must not be obvious to a person with ordinary skill in the relevant field
• Combines prior art references to determine if the invention would have been obvious
• Utility requires the invention to have a specific, substantial, and credible use
• Must be useful and provide a tangible benefit (new drug compound, improved manufacturing process)

Biotechnology Specific IP

Gene Patenting

• Patenting of isolated and purified genes was allowed in the US until the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics (2013)
• Court ruled that naturally occurring DNA sequences are not patentable, but synthetically created DNA (cDNA) may be patentable
• Has implications for diagnostic testing and research using patented genes (BRCA1 and BRCA2 for breast cancer risk)

Licensing and Technology Transfer

• Licensing allows others to use patented inventions in exchange for royalties or other compensation
• Exclusive licenses grant rights to a single licensee, while non-exclusive licenses can be granted to multiple parties
• Technology transfer is the process of transferring scientific findings from research institutions to the commercial sector for development
• Often involves licensing of intellectual property to startup companies or established firms (university-developed drug candidates licensed to pharmaceutical companies)