As researchers explore and exploit even the smallest particles of life – our genetic code – legal and ethical issues need to be dealt with. As the pharmaceutical industry seeks to learn more about the impact of our DNA and profit from it with the help of patent protection, as technology evolves, the ethical and legal issues evolve with it.

For many years there was a debate about patent protection for human genes. Those for it claimed it was needed to drive investment to find medical treatments and cures. Those opposed feared it would hinder medical research and result in corporate control of a basic building block of life.

Patent appeal success went to which side of the debate over patenting human DNA?

The U. S. Supreme Court in Association of Molecular Pathology v. Myriad Genetics ruled last year that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it was isolated from the rest of human DNA.  Patent law offers protection to a “new and useful…composition of matter” but not to naturally occurring phenomena like DNA. Prior to this decision, the U.S. Patent and Trademark Office had awarded human gene patents for nearly thirty years.

The court ruled complementary DNA (or cDNA) is patent eligible because it is not naturally occurring. Synthetically created cDNA is an artificially edited version of DNA.

What are the ethical issues concerning the patent prosecution of cDNA for the pharmaceutical industry?

The Myriad decision has put to an end the debate over ethical issues involving the patenting of DNA, since it can no longer be patented. Though cDNA can be patented, there are ethical issues with allowing that to happen, according to an article in Scientific American, because:

  • Animal models of diseases are essential for researching new treatments and cures, and that research could be restricted if cDNA used in research are patented.
  • cDNA is critical for developing new diagnostic tests for genetic disorders. It may be possible to develop new genetic tests without access to patented cDNA, but it makes the process much more difficult.
  • Given research labs’ dependence on cDNA, the labs may file patents to head off opportunistic companies that might try to privatize invaluable research tools, but that might also limit research by others.

Although the Myriad decision closed the door on naturally occurring human DNA patents, the door is open for patent protection for synthetic DNA. The pharmaceutical industry, and the law firms that help it, can make the most of those opportunities with the help of the search capacities of LexisNexis® TotalPatent® and the online tools provided by Patent Advisor℠ that allow for more efficient patent prosecution.

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