The end of an era for DNA patenting, says report

Feb 07, 2007

Human DNA patents are unlikely to be the barrier to medical and scientific innovation that they were first feared to be, according to new findings published this week.

In fact in recent years new guidelines at patent offices, legal developments, commercial sentiment and the growing volume of genetic information in the public domain have together raised the bar on patentability of genes and other genetic material.

In particular, rigorous examination and prohibitive costs are discouraging speculative patent applications in Europe.

The findings are the result of 18 months of research funded by the European Community and carried out by Dr Michael M Hopkins, Dr Surya Mahdi, Mr Pari Patel and Professor Sandy M Thomas at SPRU - Science and Technology Policy Research, at the University of Sussex, UK.

The race to patent human DNA began in the 1980s, when scientists in industry and academia started unraveling the human genetic code, culminating in the publication of a full draft of the human genome in 2001. As the human genome project published its results, so biotech businesses, pharmaceutical companies, and universities rushed to file patent applications to protect their stake in a fast-developing field. This stoked fears that DNA sequences important for research into the causes of disease such as cancer or diabetes would no longer be available for study, or that resulting drugs and diagnostics might only be available at excessive prices.

The authors identified 15,600 cases of inventions where patents had been filed claiming human DNA sequences (tiny strands of genetic material) at the world's leading Patent Offices in the USA, Europe and Japan.

They then interviewed patent holders - including some of the world's leading pharmaceutical companies - to find out what they intended to do with their patents. Their findings include:

-- To date, just one third of these inventions have actually been granted patents by one of the three patent offices studied - others were refused, have still to be processed or have been withdrawn by the applicant because the invention was considered to be no longer technically or commercially viable.

-- The US patent office has granted far more of these patents, which has led to concerns in the USA about access to research and diagnostics, particularly for some cancers. By contrast the patent offices in Japan and Europe have only granted between 3% and 5% of patent applications. Furthermore researchers in Europe benefit from laws which allow the use of this knowledge for non commercial research without patent infringement.

-- Patent examiners are more stringent, particularly in Europe and Japan, in rejecting applications that aren't supported by sufficient biological evidence.

-- Commercial interest in DNA patent applications remains, but increasingly the DNA is just a part of a more complex invention. Overall, such filings are likely to be made in much lower numbers than seen in the past.

Professor Thomas says: "A combination of policy change and developments in the commercial and scientific environment means that obtaining patents on DNA sequences has become generally more difficult and in some cases less commercially attractive. We believe these changes are in the interests of academic and commercial researchers, as well as patients."

Dr Hopkins says: "Patents are still necessary, however, as medical research is expensive and society needs to reward and encourage ingenuity. Developing a drug, for example, costs several hundred million dollars. Patent offices have focused increasingly on giving due rewards while rejecting overly broad or frivolous applications."

Citation: DNA Patenting: The end of an era? Debates on patenting DNA must evolve to reflect the global decline in filings and the regional disparities in patenting activity, by Michael M Hopkins, Surya Mahdi, Pari Patel and Sandy M Thomas. Published in: Nature Biotechnology, Vol 25, No 2, Feb 2007.

Source: University of Sussex

Explore further: Laser therapy on the repair of a large-gap transected sciatic nerve in a reinforced nerve conduit

add to favorites email to friend print save as pdf

Related Stories

Social Security spent $300M on 'IT boondoggle'

6 hours ago

(AP)—Six years ago the Social Security Administration embarked on an aggressive plan to replace outdated computer systems overwhelmed by a growing flood of disability claims.

Cheaper wireless plans cut into AT&T 2Q profit

6 hours ago

(AP)—AT&T posted lower net income for the latest quarter due to cheaper cellphone plans it introduced as a response to aggressive pricing from smaller competitor T-Mobile US.

Awarded a Pell Grant? Better double-check

6 hours ago

(AP)—Potentially tens of thousands of students awarded a Pell Grant or other need-based federal aid for the coming school year could find it taken away because of a mistake in filling out the form.

Recommended for you

Antioxidant biomaterial promotes healing

41 minutes ago

When a foreign material like a medical device or surgical implant is put inside the human body, the body always responds. According to Northwestern University's Guillermo Ameer, most of the time, that response can be negative ...

Immune response may cause harm in brain injuries, disorders

2 hours ago

Could the body's own immune system play a role in memory impairment and cognitive dysfunction associated with conditions like chronic epilepsy, Alzheimer's dementia and concussions? Cleveland Clinic researchers believe so, ...

One route to malaria drug resistance found

6 hours ago

Researchers have uncovered a way the malaria parasite becomes resistant to an investigational drug. The discovery, at Washington University School of Medicine in St. Louis, also is relevant for other infectious ...

Protein therapy successful in treating injured lung cells

6 hours ago

Cardiovascular researchers at The Ohio State University Wexner Medical Center have successfully used a protein known as MG53 to treat acute and chronic lung cell injury. Additionally, application of this protein proved to ...

User comments : 0