Legal Definitions - biological material

In the context of patent law, biological material refers to living organisms, typically microorganisms, that possess the inherent ability to reproduce or replicate themselves. These materials can be eligible for patent protection if they meet specific legal criteria, such as being novel (new), non-obvious (not an obvious modification of something already known), and having a useful application. A crucial requirement for patenting such material in the U.S. is that the applicant must deposit a sample of the specific biological material in a recognized public repository. This ensures that the invention is fully disclosed and can be independently verified and reproduced by others, fulfilling a key legal principle of patent law.

• Example 1: A Genetically Engineered Bacterium for Drug Production

  A biotechnology company develops a unique strain of bacteria that has been genetically modified to efficiently produce a new type of therapeutic protein. This engineered bacterium is a living organism capable of self-replication, making it a form of biological material. To obtain a patent for this invention, the company would need to deposit a sample of this specific bacterial strain in an approved facility, allowing other scientists to access and study it once the patent is granted.

• Example 2: A Novel Fungal Strain for Bioremediation

  Researchers discover and isolate a previously unknown strain of fungus from a remote forest that exhibits an extraordinary ability to break down certain industrial pollutants at an accelerated rate. This unique fungal strain, which can reproduce itself, qualifies as biological material. If the researchers seek a patent for its use in environmental cleanup, they would be required to deposit a sample of this specific fungus to demonstrate its existence and allow for its future study and verification.

• Example 3: A Modified Viral Vector for Gene Therapy

  A pharmaceutical firm engineers a specific virus to act as a "vector" that can safely deliver corrective genes into human cells to treat a particular genetic disease. This modified virus is designed to replicate within the target cells to ensure the therapeutic genes are widely distributed. As a self-replicating entity, this engineered virus is considered biological material. To secure a patent for this gene therapy delivery system, the firm would need to deposit a sample of this precise viral vector in a designated repository.