Patents on Genes

In mid-2000, patents on genes became popular, as the human genome was almost completely mapped. Therefore, several private and public businesses have filed patents on genes and their sequences. Currently, approximately 3,000 to 5,000 patents on human genes have been granted in the U.S. There is significant public debate regarding gene patenting, as the idea that genes can be owned is unethical to a lot of people.

Advantages of Gene Patenting

• Gene patenting gives businesses time to look at the genes without worrying about competition. Therefore, such businesses need not worry that other companies will compete to make the same discovery.

• Without having to worry about competition, smaller businesses don’t have to worry about competing with larger companies that have greater financial resources and a more well-known reputation.

• Gene patenting promotes research, development, and enhancement in the private industry.

• Such patenting also encourages innovation by giving companies a right to patent gene sequences.

• Allows for investing in genes and gene sequences. Both businesses and individuals can invest in a patented gene.

• Investing in gene patents also provides financial support for developing new genes or gene sequences. It can take hundreds of millions of dollars to introduce a new drug to the market. Most companies rely on investors to assist in the financing of new products.

Gene Patent Controversies

There are several ethical and legal concerns over gene patenting; these disputes deal specifically with therapeutic proteins, genetic diagnostic testing, and gene research.

• Therapeutic proteins. Inventions that enable the production of a protein to treat a disease. Examples include:

• Insulin

• Tissue plasminogen activator for stroke, growth hormones for small children, and a drug to assist with anemia.

• Diagnostic genetic tests. Genetic mutations can create an increased risk of cancer and other diseases. These patents are held on the genes, the mutation of such genes, and the testing that is developed to screen for the mutations.

There is strong concern that monopolies on the genetic tests increase pricing and reduce any incentive to correct or modify the flaws in the design of the mutations.

One of the biggest controversies in this area is the patenting of BRCA1 and BCA 2, which are genes that affect the risk of cancer. Mutations of these two types account for approximately 5-10% of breast cancer cases, as well as other types of cancer, including ovarian cancer.

Myriad Genetics Controversy

Regarding this type of mutation, a company by the name of Myriad Genetics secured such patents. In 2001, the company sent letters to laboratories worldwide indicating that the testing for such mutations had to be done in Myriad’s laboratories that the company licensed. In response, several people and businesses, including doctors, researchers, and even local governments were angered by the request. Specifically, the health ministry of Ontario, Canada refused to honor those terms. In Europe, the patents secured by Myriad were challenged, which resulted in a much more narrow scope of the BRCA1 patent.

Additional scrutiny has been placed against Myriad, as other BRCA patents were awarded to other businesses, one being the Cancer Research Campaign, a charity located in the UK, which specifically indicated that the BRCA2 gene can be accessed and used regardless of the patent’s existence.

One of the biggest fears of patenting genes is that it could prevent scientific progress. Creating genes is important for scientific research, but restricting the use of certain patented genes only hinders what type of research can be done.

However, research companies have not been sued for simply researching and studying patented genes. The reason for this is two-fold. First, patent holders can actually benefit from others researching the patented gene, so that the patent holder can learn how it really works. Second, the patent holder would have extreme difficulty in proving damages in an infringement suit. With that being said, there have been instances in which laboratories have been supplied with a ‘cease and desist’ indicating that they must stop research of the patented gene unless it obtains a license from the patent holder.

Patented genes also hinder research, as scientists might want to avoid even conducting research on patented genes due to the lengthy and expensive negotiations that must take place with multiple patent holders. This not only hinders research, but it prevents the enhancement of genes, and reduces innovation by creating what is called an ‘anticommons’ effect.

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