Debunking the Myth: Your Genes are Patented

 

MYTH: YOUR GENES ARE PATENTED.

FACTS:  IT IS NOT POSSIBLE TO PATENT YOUR GENES

The term “gene patent” is a misnomer, because genes as they exist in the body cannot be patented. Because a naturally-occurring gene – even a newly-discovered one – cannot be patented, patents don’t provide ownership rights over our genes, and nobody can infringe a patent by having a certain gene, or by passing it on to their children.

If genes aren’t patentable, what is?

Natural genes are not eligible for patenting, but artificial preparations of DNA molecules are, because they have new qualities that distinguish them from natural genes. Like other chemicals that are derived from nature (such as antibiotics or natural dyes), preparations of DNA molecules are patentable because they have been transformed through human intervention into something that is so different from the natural state as to qualify as new, useful, and man-made. This transformation begins with the purification and isolation of the natural DNA. But isolating and purifying is not enough. The resulting DNA preparation must have new qualities, advantages, and technical applications that allow it to be used in important new ways that are not possible with the natural gene, making it different not just in degree, but in kind. For these reasons, every nation in the developed world recognizes the patentability of such inventions.

How is a patented DNA preparation different from a natural gene?

Patented DNA preparations contain isolated DNA molecules that are stripped of everything that is necessary for the normal operation of a gene in its natural state. Such purified DNA molecules also are often reconfigured in ways that eliminate large parts of the genetic sequence of the natural gene, giving rise to DNA molecules that do not exist in nature. Such DNA molecules can be used in ways that are simply not possible with the natural gene – for example, to conduct gene transfer experiments, to make DNA vaccines, or to produce therapeutic proteins in large scale cell culture.

What else is required to make a DNA molecule patentable?

It is impermissible to patent a DNA molecule, even if isolated and purified, unless the scientist establishes the detailed biological function of the gene from which it was derived and identifies a credible, specific and substantial utility for it. Identifying a gene’s biological role and establishing a credible, specific and substantial use for the claimed DNA molecule are often harder than identifying the new gene itself, and certainly meets the standard thresholds for inventiveness. Furthermore, in every case, the inventor has to satisfy the “novelty” and “unobviousness” requirements under which the claimed DNA must be new and distinct from all preexisting scientific knowledge. Finally, the patent application must contain a detailed scientific disclosure that enables other scientists to replicate the invention.

Overall, identifying, deriving, characterizing and describing a DNA sequence in this way requires the same level of human ingenuity as synthesizing a new chemical, composing a new metal alloy, or other human creations that are commonly deemed patentable.

This post was authored by Hans Sauer, Ph.D., J.D. Deputy General Counsel for Intellectual Property at BIO and Adjunct Professor of Law, Georgetown Law.

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IP Position Critical to Biotech Investment

A great article from Genetic Engineering and Biotechnology News written by Lisa Haile reviewing the Myriad case and its implications for future medical advances.

Interesting Quotes:

“While it is unfortunate, I have seen quite a few technologies over the years that would be of potential great benefit to patients, but the intellectual property was simply not there to support protecting the product from fast followers in the market place,” explains Robert More, a general partner at Frazier Healthcare Ventures.

“Unfortunately, because of the enormous sums of money required to discover, develop, test, and approve anything in the healthcare sector, quite aside from the time it takes, IP is critical.” More further states that since “patents have definitive lifetimes, 20 years or less of exclusivity, and then an infinite time in the public domain, I think that is a small price for us to pay for innovation.”

“When evaluating opportunities to determine whether we will come in and underwrite the deal, we look at the IP position as one of the key questions,” explains Robert Dentice, head of life sciences investment banking at Cantor Fitzgerald. “We know that if the IP position is not strong, it is unlikely that we will pursue the opportunity further, knowing that the IP strategy and position will be one of the top three questions that the investors will ask about.”

Takeaways: The Case for Gene Patents

 Gene patents are the foundation of the biotech industry and precluding them would halt forward progress.

The patent system promotes innovation and stimulates investment in R&D.

If there were no exclusive rights in the final product, there would be little incentive to invest time and money into developing it.

Without the incentives offered by the issuance of patents, the industry and, ultimately, patients would suffer. 

BIO Press Release: BIO and AUTM file Amicus Brief in Myriad Case

The Biotechnology Industry Organization (BIO) filed an amicus brief in the U.S. Court of Appeals for the Federal Circuit on Friday, October 29^th, in an appeal of a lawsuit brought by the American Civil Liberties Union on behalf of a number of plaintiffs against Myriad Genetics, the U.S. Patent and Trademark Office, and others.

The brief, filed jointly with the Association of University Technology Managers (AUTM), supports the patentability of isolated DNA molecules, noting that invalidating the patentability of these molecules would discourage future biotechnological innovation.  DNA-based patents are a critical tool that help enable the fundamental research and development of new biotech products, therapies and technologies to fight deadly diseases, expand agricultural production, clean the environment, and reduce our dependence on foreign sources of oil. 

Isolating a DNA molecule, in addition to creating a new chemical molecule that does not exist in nature, imparts new utilities and functions that are not available from native DNA.  The utility of isolated DNA molecules derives from their chemical structure, which is developed by human ingenuity using complex scientific expertise and equipment. As a result, isolated DNA molecules are patentable subject matter based on decades of U.S. case law.

 “Unless reversed, the district court’s ruling will seriously harm the U.S. biotechnology industry, which consists largely of small firms that are engaged in foundational research and dependent on private investment to fund their work,” stated BIO President & CEO Jim Greenwood.  “Patent protection is critical for the ability of biotechnology firms to secure the private investment necessary for the research and development of innovative diagnostic, therapeutic, environmental and agricultural products. This innovation will lead to domestic job creation and help sustain our country’s global competitiveness.”

 If the Court of Appeals affirms the district court’s categorical rejection of the patentability of isolated DNA molecules, it would cast a cloud of uncertainty over thousands of similar patents and compromise the ability of biotechnology firms to pursue groundbreaking discoveries in human healthcare, renewable energy, and sustainable agriculture. 

 “Patentability of isolated DNA molecules is critical to the translation of university research discoveries for the public good. Without this, many promising discoveries would not make their way from the university research lab and into the hands of companies for development of products which improve the public health,” stated AUTM President Ashley J. Stevens.

“From the mass production of life-saving medicines by cell cultures to the screening of our blood supply for life-threatening viruses, patented DNA molecules have been put to countless uses that have benefited society,” concluded BIO President and CEO Jim Greenwood. 

The joint BIO-AUTM amicus brief is available at http://bio.org/ip/amicus/BIO_AUTM_Amicus_Brief_AMP_v_USPTO_2010-1406_FedCir.pdf.  Additional background materials are available at http://bio.org/ip/genepat