The debate over seed patenting and intellectual property protection continues to grow as countries around the globe debate the rights of technology providers versus society. In the past year, many countries have taken strides towards trying to determine these rights but discussions remain ongoing. Intellectual property rights are falling under debate concerning the role of innovation and technology transfer among companies and countries. The issues surrounding IPR include: competition concerns, safety aspects, farmers rights’ and access to genetic resources to name a few.
Besides various countries discussing IPR, various organizations
are also stepping up to the plate and not only are they addressing
IPR but they are also dealing with issues such as counterfeiting,
patent harmonization and protection of safety and efficacy
studies. Organizations addressing the issue include:
• World Intellectual Property Organization
• World Trade Organization
• United Nations Food and Agricultural Organization
• International Union for the Protection of New Varieties of
Plants
• Organization for Economic Co-Operation and Development
IPR remains controversial regarding seeds as many in the
industry are concerned about farmers’ rights to use and save
seed, while others do not believe current intellectual property is
properly protected. CropLife International believes intellectual
property in plant sciences can be protected in a number of
ways. The first way is through data protection. The plant science
industry spends large amounts of research and development
time in producing registration data to demonstrate the safety
and efficacy of its products. CropLife believes this effort must
be protected against potential unfair commercial use to obtain
regulatory clearances. The second way to protect IP are patents.
They provide a tool to prevent third parties from using, making,
selling, or otherwise profiting from an invention, and create
an incentive to innovate. Thirdly, CropLife believes that tools
should be available for developing countries to negotiate the
use of their plant genetic resources on an equal footing.
U.S. IPR Perspective A U.S. health department advisory group this fall produced a new draft report on gene patenting and licensing with recommendations suggesting that excessive patenting can limit access to gene testing and might not foster genetic research. The draft report provided by the U.S. Health and Human Resources Secretary’s Advisory Committee on Genetics, Health and Society gave a set of recommendations including the exemption from patent infringement liability “for those who use patent-protected genes in the pursuit of research.” It also called “for anyone making, using, ordering, offering for sale or selling a test developed under the patent for patient care purposes.” Biotechnology representatives, meanwhile, vehemently reasserted the indispensable role of patents in innovation. The process leading to the report started in March 2004 when SACGHS identified gene patents and licensing as a priority issue. In December 2008, an approved public consultation draft report was ready for release. The committee will reconvene, early in the new year, to review the revised draft report.
The committee sought to “evaluate whether patents induce innovation in the genetics area.” According to the latest draft report, case studies show that “although patents offer an incentive to companies to conduct research and develop genetic diagnostics, exclusive rights are not needed to advance the development of most genetic tests.” If patents do not appear to raise the price of genetic tests, evidence in some cases shows that patents and licensing practices “have limited laboratories’ ability to perform testing,” it said. Also, quality issues can arise when there is only a single provider of genetic tests. “Patent claims on isolated genes and association patent claims…have the potential to create a thicket of intellectual property rights that can prevent innovators from creating these multiplex tests or reporting the full extent of results,” said the draft report.
Some recommendations asked for federal efforts to promote broad licensing and patent access and enhanced transparency in patents and licensing. They also asked that the health secretary use “her powers to discourage the seeking, the granting, and the invoking of simple association patent claims”. Related research entities should also benefit from this exemption, the draft report recommendations said.
The European Union achieved a political breakthrough on an enhanced patent system in November 2009. The Council unanimously adopted conclusions on an enhanced patent system in Europe. The package covers major elements to bring about a single EU patent and establish a new patent court in the EU. Both together will make it less costly for businesses
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