The end of an era for DNA patenting, says report

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patents by one of the three patent offices studied - others were refused, have still to be processed or have been withdrawn by the applicant because the invention was considered to be no longer technically or commercially viable.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

Related stories:

New class of drug offers hope to treatment-resistant AIDS patients
For the estimated millions of AIDS patients worldwide who are resistant or are developing resistance to currently available medicines, a discovery by a University of Georgia researcher may offer a new treatment option by targeting a previously elusive enzyme in the complex retrovirus responsible for the devastating disease.
'Failed' experiment yields a biocontrol agent that doesn't trigger antibiotic resistance
A failed experiment turned out to be anything but for bacteriologist Marcin Filutowicz. As he was puzzling out why what should have been a routine procedure wouldn't work, he made a discovery that led to the creation of a new biological tool for destroying bacterial pathogens - one that doesn't appear to trigger antibiotic resistance.
Scientists closer to new cancer detection method
University of Florida researchers say they are a step closer to a technique to easily detect a wide variety of cancers before symptoms become apparent. The findings, currently online in the Proceedings of the National Academy of Sciences, involve introducing molecularly engineered strands of DNA into cell cultures and observing whether they unleash a fluorescent burst after they adhere to cancer proteins.
Nanogen Issued Patent for Method of Monitoring PCR Using Fluorescent Energy Transfer
Nanogen, Inc., developer of advanced diagnostic products, announced today it was issued Patent No. 6,911,310, "Hybridization of polynucleotides conjugated with chromophores and fluorophores to generate donor-to-donor energy transfer system" by the U.S. Patent and Trademark Office. The '310 patent relates to a method of monitoring polymerase chain reaction (PCR) amplification of nucleic acid (DNA or RNA) using fluorescent resonant energy transfer (FRET), which is an essential part of molecular diagnostics. Marking the 131st patent to issue to Nanogen, it is closely related to the patents previously issued that describe nanofabrication and self-assembly of photonic molecular structures.
Oil Worth Its Weight in Gold in Directed Nanomachining
The world of nano-machines has moved a step closer to reality, thanks to researchers who have found a way to sculpt material at the nanoscale in a predictable, controllable and inexpensive manner by using a conducting liquid medium.
Nanogen Issued Patent for Electronic Microarray With Memory
Nanogen, Inc., developer of advanced diagnostic products, announced today that it was issued U.S. Patent No. 6,867,048, "Multiplexed Active Biologic Array" by the U.S. Patent and Trademark Office. The '048 patent relates to a method of addressing one or more electrodes (or "test sites") across multiple rows and columns of a microarray. The patent also covers a method for storing the value of the voltage associated with each electrode in a local memory. This "smart chip" technology is a key feature of Nanogen's NanoChip 400 electronic microarray, the company's second generation multi-purpose system for developing and performing molecular diagnostic tests.
Nanogen Issued Patent for Ligation-Based Strand Displacement Amplification Technologies for DNA Analysis
Nanogen, Inc., developer of advanced diagnostic products, announced today that it was issued U.S. Patent No. 6,864,071, "Multiplex amplification and separation of nucleic acid sequences using ligation-dependent strand displacement amplification and bioelectronic chip technology," by the U.S. Patent and Trademark Office. The '071 patent relates to amplifying and analyzing multiple samples of nucleic acid using ligation-based strand displacement amplification (SDA) technologies. The intellectual property pertains to research Nanogen conducted in collaboration with Becton Dickinson and increases Nanogen's portfolio of technologies for multiplex amplification on a chip.
Fujitsu Microelectronics, Taiwan's Nanya settle patent disputes
Fujitsu Microelectronics Ltd. of Japan and Nanya Technology Corp. of Taiwan said Tuesday have agreed to settle their patent disputes.

News discussion:

Medicine & Health news