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The scope and reach of biological patents vary among jurisdictions, [1] and may include biological technology and products, genetically modified organisms and genetic material. The applicability of patents to substances and processes wholly or partially natural in origin is a subject of debate.
As with all utility patents in the United States, a biological patent provides the patent holder with the right to exclude others from making, using, selling, or importing the claimed invention or discovery in biology for a limited period of time - for patents filed after 1998, 20 years from the filing date.
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: . The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2).
Blood and blood products activities are managed through the Office of Blood Research and Review (OBRR) [2] Human cells, tissues, and cellular and tissue-based products (HCT/Ps), except vascularized organs for transplantation and the associated blood vessels. Vaccines for use in humans. Diagnostic and therapeutic allergenic extracts.
Licensed production is the production under license of technology developed elsewhere. [1] The licensee provides the licensor of a specific product with legal production rights, technical information, process technology, and any other proprietary components that cannot be sourced by the licensor.
Although that company did not commercialize the product themselves, instead, it licensed the production method to Eli Lilly and Company. 1978 also saw the first application for a patent on a gene, the gene which produces human growth hormone, by the University of California, thus introducing the legal principle that genes could be patented.
Some regulatory agencies use the terms biological medicinal products or therapeutic biological product to refer specifically to engineered macromolecular products like protein- and nucleic acid-based drugs, distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source.
2 December – The world's first regulatory approval for a cultivated meat product is awarded by the Government of Singapore. The chicken meat was grown in a bioreactor in a fluid of amino acids, sugar, and salt. [97] The chicken nuggets food products are ~70% lab-grown meat, while the remainder is made from mung bean proteins and other ...