Intellectual Property

Patent Rights vs. Patients' Rights

New ideas and creations are protected under intellectual property law. When a person or company invents something, they can apply for a patent. A patent is a set of exclusive rights granted by the government to an inventor for a limited time, in exchange for financial rights.

The field of intellectual property law can sometimes be vague. A controversy perplexing courts, inventors, researchers and citizens is whether human genes fall can be patented.

The Case

Myriad Genetics is a biopharmaceutical company specializing in drug development and genetic testing for cancer. They've obtained a patent on several genes causing breast and ovarian cancer. People with this gene are more likely to get breast cancer and screening could save their lives. Doctors can run these tests to see if you carry this and other forms of this gene, potentially saving your life.

The American Civil Liberties Union (ACLU), the Public Patent Foundation and several patients and medical organizations challenged these patents. They argued that genes are a natural occurrence, like blood or air. Further, they reasoned these patents limit research and innovation.

Myriad and the Research Foundation at the University of Utah defend their patents. They claimed their research and work isolating this sequence of DNA from the rest of the genes in the human body is enough to qualify for patent protection. They argued that if living organisms can be patented, so can genes.

A federal judge decided these patents involved a law of nature and thus shouldn't have been granted. Therefore, these patents have been invalidated causing quite a stir in the legal and medical fields.

Impact of this Decision

This case has a broad impact on many industries. An estimated 20 percent of human genes have already been patented by multibillion-dollar companies. This decision impacts these companies' profits and the future of medicine and research.

Reasons for and against Granting Such Patents

Patent rights exist to protect inventors, giving them an incentive to create new discoveries. After spending time and resources to develop something new, these creators need to know their invention is protected from people who might copy them.

Also, investors are more likely to fund research projects knowing they'll ultimately get a return on their investment. However, patents can also have a negative impact. Rather than encourage innovation, patents can act as a barrier.

Prior to this decision, only Myriad was able to offer such tests to screen for these genes, charging over $3,000 for such tests. There was no competition because Myriad has sued companies developing similar tests based on this gene. Not only has this prevented the development of new tests but it's become an obstacle for patients who want second opinions or can't afford the Myriad screening.

As a result, the company has received negative criticism, especially about moral issues. Critics point out how broad these patents extend, covering many gene sequences. They explain that if such patents are valid and enforced, they can apply to just about every single gene, and every person, in the world.

To make matters worse, these patents have created a barrier to innovation. Many doctors and research labs are prevented from performing, developing or improving such screening tests because of these patents. This raises moral concerns about patent law getting in the way of patients' rights to healthcare.

The Future

Myriad will likely appeal this decision. Meanwhile, other companies can now explore their own forms of genetic testing based on these genes. However, we must also recognize that the loss of these patent protections will have a negative impact.

Incentives for genetic research are likely to be reduced and companies will have a difficult time getting funding for new projects. This will likely limit new discoveries and affect healthcare as well.

Questions for Your Attorney

  • Is there anything that can't be patented?
  • Can I copyright or trademark my own genes?
  • Would insurance cover procedures available from Myriad or will I have to pay for them out of pocket?
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