Introduction
A patent for an invention is issued by the government to the inventor, granting the inventor the right to prevent others from creating, using, or selling the invention without their permission for a specified time. When a patent is issued, the innovation becomes the inventor's property, and it can be purchased, sold, rented, or hired, just like any other type of property or commercial asset. A patent is normally granted for a duration of 20 years from the date of submission of a patent application.
Gene patenting is the process of securing a license to use gene sequences and gene-related chemical compounds that are not found in nature in their complete form. Once a gene patent is issued, the patent holder determines how the gene can be used in both commercial contexts, such as clinical genetic testing, and noncommercial situations, such as research.
What Is Gene Patenting?
A gene patent is a patent issued to a unique isolated gene sequence, a natural series that has been altered, the procedures and methods for obtaining or exploiting it, or any combination of these. Gene patents in the United States have only been issued to gene sequences with established functions. Patents on human genes are the consequence of the cloning and description of a gene's sequence, whose function or role has been somewhat explored. In the 1980s, as cloning and sequencing technologies advanced quickly, an increasing number of patents on human genes were submitted. Gene patents encompass three different categories of invention. They are diagnostics, material formulations, and practical applications.
What Are the Different Types of Gene Patents?
Gene patents are classified into four types: diagnostics, functional uses, processes, and substance compositions. These patents may cover a single gene but are more likely to cover a process utilizing genetic material or a small strand of linked genes. They often cover the sections of genes involved in protein creation.
Diagnostic Patents - This includes patent procedures for detecting genetic anomalies or variances. These patents are occasionally called disease gene patents, as they are frequently linked to identifying genetic markers involved in illnesses, including cancer, Alzheimer's disease, and cystic fibrosis. One gene may have numerous different mutations, or one test may evaluate additional genes for the same ailment, complicating this area of gene patents. All possible combinations of created mutations and tests may also be patented. These patents often include every known testing technique, including DNA chips, Southern analysis, PCR (polymerase chain reaction), and hybridization. The following are examples of diagnostic gene patents.
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BRACA 1 AND BRACA 2 (breast and ovarian cancer).
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CFTR (cystic fibrosis).
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SMN1 (spinal muscular atrophy).
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HFE (hemochromatosis).
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Apo-E (Alzheimer's disease).
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CMT-1A, CMT-X (Charcot-Marie-Tooth disease).
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SCA1-12 (spinocerebellar ataxia).
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HNPCC, FAP (colon cancers).
Functional Patents - The functional usage of a gene is claimed in these patents. Patents for functional uses result from research that identifies the functions of particular genes in triggering disease or controlling physiological processes. These patents are often given out for medicines that interfere with how genes work. These patents are based on discovering the genes' role in disease or other biological and cellular activities or pathways. They claim methods and compositions of matter (known as "small molecule" medications) that are utilized to up or downregulate the gene.
Process Patents - These patents are employed to safeguard a technique for extracting or manipulating genes and are largely self-explanatory. These patents protect a method rather than actual human genetic material. It commonly includes patents for isolated and purified genes and derivative products like recombinant proteins, viral vectors, or recombinant drugs.
Composition of Matter Patents - Composition of matter patents are filed to cover "inventions" that mainly result from combining diverse genetic material and are typically filed for vaccines and drugs. A wide range of substances and methods are covered under patents on human genetic compositions of matter. Human growth hormone, human insulin, and proteins isolated from human urine or blood can be patented. This patent is central to much of the legal debate surrounding genetic patents.
What Are the Challenges of Gene Patenting?
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Legal Challenges - The legal argument over gene patenting is a disagreement between "natural products" and "matter compositions." Proponents of gene patents argue that if a gene is removed from the body and changed in any way, it becomes a "composition of matter" that can be legally patented. Opponents of gene patenting believe that genes are nature's fundamental creations and therefore are not patentable and should not be allowed.
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Social, Ethical, and Economic Challenges - Opponents of gene patenting argue that the genetic material inside the human body belongs to humanity, not a laboratory and that the law forbidding the patenting of "natural products" clearly applies in this scenario. They also claim that once one laboratory obtains a patent on a certain gene or sequence of genes, research in other labs will be restricted due to costs paid to the patent holder to use their work in similar research areas. Proponents of gene patents claim that this system encourages research by allowing scientists to keep the rights and credit for their work. They claim that keeping the rights gives research companies a financial benefit to examine genetic materials because they have the assurance of a profit for at least 20 years.
What Are the Pros and Cons of Gene Patenting?
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Pros - Gene patenting encourages private sector research and development by granting firms rights to gene sequences and promoting innovation and creativity. A patentable gene can be purchased by both individuals and companies. This gives financial assistance for the creation of useful ideas. The prospect of obtaining a patent motivates and encourages researchers to think more imaginatively and work more to secure a patent for their work.
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Cons - Gene patenting may cause gene monopolization. Companies with gene patents have exclusive rights to certain genes and may refuse to allow other companies to look at them. This could result in a monopoly and encourage a secretive culture among research firms. If a corporation owns a gene patent, they have exclusive rights to research and test that gene. If a patient is tested for that gene, the samples must be delivered to the firm that owns the gene patent to be tested. This could lead to delays in receiving test results.
Conclusion
Patents on human genes are the consequence of the cloning and description of a gene's sequence, whose function or role has been somewhat defined. A government authority usually grants a gene patent to a particular isolated gene sequence, a naturally occurring sequence that has been modified, the procedures and techniques for getting it or using it, or any combination of these. However, human gene patents raise several issues. One of the main issues is that they will make research more challenging, slowing down or preventing the development of newer diagnostics and treatment methods.
