13.3 Intellectual property rights and patenting in biotechnology
3 min read•august 7, 2024
Intellectual property rights are crucial in biotechnology, protecting inventions and innovations. , , , and 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 and . Recent legal decisions have changed the landscape of gene patenting, while 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
- refers to all publicly available knowledge before the filing date of a patent application
- Includes published scientific papers, public presentations, and existing patents
- 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
- 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
- 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 (2013)
- Court ruled that naturally occurring DNA sequences are not patentable, but synthetically created DNA () may be patentable
- Has implications for diagnostic testing and research using patented genes ( and 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)
Key Terms to Review (15)
Association for Molecular Pathology v. Myriad Genetics: Association for Molecular Pathology v. Myriad Genetics is a landmark Supreme Court case that addressed the legality of patenting human genes. The decision focused on whether isolated DNA, particularly in relation to BRCA1 and BRCA2 genes associated with breast cancer, could be patented. This case highlighted the balance between intellectual property rights and access to genetic testing, sparking discussions on the implications of gene patenting in biotechnology.
BRCA1: BRCA1 is a gene located on chromosome 17 that produces a protein responsible for repairing damaged DNA. It plays a critical role in maintaining genomic stability and has been closely linked to hereditary breast and ovarian cancer when mutated. Its connection to cancer risk has also influenced intellectual property rights and patenting in biotechnology, particularly in genetic testing and therapies.
BRCA2: BRCA2 is a gene that provides instructions for making a protein involved in the repair of DNA breaks. Mutations in this gene are linked to an increased risk of breast, ovarian, and other cancers. In the context of biotechnology, BRCA2 raises important issues regarding intellectual property rights and patenting, as the ownership and commercialization of genetic information become crucial for research and medical advancements.
CDNA: cDNA, or complementary DNA, is a form of DNA synthesized from a messenger RNA (mRNA) template through a process called reverse transcription. This allows researchers to create a DNA copy of mRNA, enabling them to study gene expression and produce recombinant proteins. cDNA is crucial for various molecular biology techniques, making it integral in research and application areas such as gene cloning and diagnostics.
Copyrights: Copyrights are legal protections granted to the creators of original works, giving them exclusive rights to use, reproduce, and distribute their creations. This protection encourages innovation and creativity by ensuring that authors and artists can benefit from their work without fear of unauthorized use. In the context of biotechnology, copyrights are crucial as they apply to a wide range of intellectual property, including research publications, databases, and software related to biotechnological innovations.
Gene patenting: Gene patenting is the practice of obtaining legal rights to specific sequences of DNA, allowing patent holders exclusive rights to utilize, sell, or license these genetic materials. This process connects innovation in biotechnology with intellectual property laws, where unique discoveries can be protected to encourage research and development. However, it raises ethical questions about ownership of genetic information and access to medical advancements.
Licensing: Licensing is a legal agreement that allows one party to use, produce, or sell another party's intellectual property under specified conditions. This process plays a crucial role in biotechnology, as it enables companies and researchers to share innovations while protecting the original creator's rights. Licensing arrangements can lead to collaborations that promote research and development, especially in the competitive and fast-paced field of biotechnology.
Non-obviousness: Non-obviousness is a legal standard used in patent law to determine whether an invention is eligible for patent protection. An invention is considered non-obvious if it is not evident to a person having ordinary skill in the relevant field at the time of the invention. This standard ensures that only inventions that represent a significant advance over existing knowledge can receive patent rights, promoting innovation while preventing the monopolization of basic ideas.
Novelty: In the context of biotechnology, novelty refers to the uniqueness or originality of an invention or discovery that sets it apart from existing knowledge or products. It is a critical factor in determining whether an invention is eligible for patent protection, as patent laws require that an invention be novel to prevent others from claiming ownership over previously known concepts.
Patents: Patents are exclusive rights granted by a government to an inventor or assignee for a limited period, typically 20 years, allowing them to exclude others from making, using, selling, or distributing the patented invention without permission. This system encourages innovation by providing inventors with a temporary monopoly on their creations, thereby incentivizing investment in research and development. In biotechnology, patents play a critical role in protecting inventions related to new drugs, genetic engineering techniques, and biotechnological processes.
Prior Art: Prior art refers to any evidence that your invention or idea is already known before the filing of a patent application. This can include previous patents, published articles, products already on the market, or any public disclosures that showcase the existence of similar ideas. Understanding prior art is essential in evaluating the novelty and non-obviousness required for obtaining a patent.
Technology transfer: Technology transfer is the process of sharing or disseminating technology, knowledge, and expertise from one organization or entity to another. This can occur between different sectors, such as universities, research institutions, and private companies, and plays a crucial role in advancing innovation and commercialization in various fields, particularly in biotechnology. By facilitating the movement of scientific discoveries into practical applications, technology transfer helps bridge the gap between research and real-world implementation.
Trade Secrets: Trade secrets are a type of intellectual property that encompasses confidential business information providing a competitive edge. This can include formulas, practices, processes, designs, instruments, or patterns that are not generally known or readily accessible to others. Protection of trade secrets relies on their secrecy and the efforts made by the owner to maintain it, distinguishing them from patents and copyrights, which require formal registration.
Trademarks: Trademarks are distinctive signs or symbols used by businesses to identify and distinguish their products or services from those of others. They play a crucial role in protecting the brand identity and reputation of a company, as they ensure that consumers can easily recognize and associate a specific product with its source. In the context of biotechnology, trademarks help safeguard the intellectual property rights associated with innovative products, including pharmaceuticals and biotechnological advancements.
Utility: Utility refers to the practical value or usefulness of a product, invention, or process, particularly in terms of its ability to fulfill a specific function or meet a particular need. In the realm of intellectual property rights and patenting, utility is a critical criterion that determines whether an invention is patentable, as it must demonstrate that it provides some benefit or serves a purpose that is recognized as beneficial to society or a specific sector.