Intellectual property

• Intellectual property protection is necessary to reward innovation and ensure the plant science industry maintains its strong science base.
  
  
• Data protection for approval dossiers for both crop protection and biotechnology is essential to ensure the innovation continues.
  
  
• Patents form the cornerstone of intellectual property protection and must be supported.
  
  
• The industry recognises a number of legitimate concerns about the extent of intellectual property protection, and hopes to take part in a constructive debate on the issues

Coming Soon! CropLife event at the WTO Open Forum

The World Trade Organization Public Forum has become one of the most important platforms for dialogue among stakeholders of the multilateral trading system.  Each year representatives from key international agricultural and development agencies attended the Public Forum as panellists and participants. 

The Public Forum draws significant attention from governments, non-government organizations, academics, businesses and the mass media.  This year, CropLife International is assembling a diverse panel with substantial experience to offer their views on innovative solutions to critical global agricultural problems on Tuesday, September 29 (16:30-18:30) in Geneva.

- invitation
- flyer 

		Judge Randall R. Rader (US Court of Appeals for the Federal Circuit) discusses the value of a strong IP system in maintaining an innovative economy, not only for the 'industrial giants' but also for developing nations. http://www.youtube.com/watch?v=tB3OROLi9
		Carrie LaCrosse (Office on Intellectual Property Enforcement, US Department of State) discusses the value of IP for agriculture, looking in particular at new plant varieties and how IP is part of the solution in addressing the issues of food security. http://www.youtube.com/watch?v=FCD54T-S1Xg
		Howard Minigh (CEO and President of CropLife International) discusses the importance of IP for agricultural production. With the world population increasing, more food will need to be produced on less land. IP rewards innovation, and encourages further investment in solutions that address food security issues in a sustainable manner. http://www.youtube.com/watch?v=EZZxke_-bkY

Certain intellectual property rights (IPR) reflect a bargain between technology providers and society.  But we are currently witnessing a debate about the role of innovation, technology transfer and the importance of improved access to knowledge. Because of the importance of food security, the discussion about IPR in plant sciences acquires a special dimension. There are a number of issues, including unfair competition, health and environmental safety, farmers’ rights, access to genetic resources and biodiversity conservation.

A new social contract on the importance of intellectual property for the development of new technologies is needed. Only continued research will deliver new agricultural solutions that help our societies to deal with future challenges in the fields of food security, food safety and environmental management and strict, enforceable Intellectual Property Rights (IPR) are needed to ensure this.

CropLife International believes in the fundamental role of intellectual property in the promotion of agricultural research and innovation, and therefore in social development. Agricultural research has delivered great results over the last century, increasing yields and lifting millions of people out of poverty and hunger. Nevertheless, the decrease of public sector research and the management of innovation developed by the private sector raise new challenges for policy makers, stakeholders, innovators and the public. 

Intellectual property rights for seeds has been the subject of controversy, with some people being concerned about farmers’ rights to use and save seed. Industry, on the other hand, is concerned that some IP is not properly protected:  safety and efficacy studies of innovative agricultural chemicals are not properly protected  in some parts of the world. CropLife International is happy to engage in a public debate on the different elements, tools and limits of intellectual property protection in the agricultural sector, and the need to reconcile the commercial interests of the intellectual property rights holders with broad public concerns.

Intellectual property in the sector is being discussed at various international fora:

• The World Intellectual Property Organisation (WIPO), which also deals with issues regarding patent harmonisation, counterfeiting and the protection of farmers’ traditional knowledge.
  
  
• The World Trade Organisation (WTO), which includes in its Trade-Related Aspects of Intellectual Property (TRIPS) Agreement,  the enforceability of intellectual property rights for plants and protection of safety and efficacy studies.
  
  
• The FAO Treaty on Plant Genetic Resources for Food and Agriculture includes material transfer agreements, including intellectual property rights.
  
  
• The OECD has worked hard to stop the increasing amount of counterfeiting and illicit sharing of safety and efficacy data among its members.

Intellectual property in the plant sciences can be protected in a number of ways.

Data Protection

The plant science industry spends large amounts of R&D time in producing registration data to demonstrate the safety and efficacy of its products. CropLife International believes that this effort must be protected against potential unfair commercial use to obtain regulatory clearances. The preferred mechanism used worldwide is to preclude third parties from relying on the originators’ test data to introduce their products to the market.

The protection must encompass new products, formulations, uses, data call-in, minor crops and re-approval of protected dossiers.  After the 10 years of protection against unfair use, an additional period of five years of licensed, paid access to proprietary data is also imperative, whilst protection against disclosure will always be enforced, even after the period of exclusivity has expired. Second registrants are welcome to perform their own safety and efficacy studies for marketing approval, or obtain authorised access to the data from the proprietor, but must always demonstrate equivalence to the reference product.

The scientific data and other information in the application dossier to obtain approval of plant Living Modified Organisms (LMOs, or GMOs) is also subject to data protection in a similar way to agrochemicals. This protection not only takes into account the considerable efforts necessary to generate such data, but most importantly the potential liability incurred by the innovator. Thus, a reasonable period of protection against disclosure should be enforced.

Patents

Patents are the cornerstone of intellectual property. They provide a tool prevent third parties from using, making, selling, or otherwise profiting from an invention, and create an incentive to innovate.

In the biotechnology field, patents are used to protection of inventions such as gene sequences and genetically modified organisms (GMOs). Compliance with authorisation procedures for GMOs reduces the effective patent lifespan.  Therefore, CropLife International believes that supplementary patent certificates (SPCs) should be available to provide extended protection to compensate for delays in the approval of GM plant events.

Intellectual property and biodiversity

Tools should be available for developing countries to negotiate the use of their plant genetic resources on an equal footing. CropLife International welcomes the debate on legitimate instruments for adequate, effective and enforceable regimes for Prior Informed Consent and equitable benefit sharing. In depth discussion on this issue is required but debates must be outside politicising fora, such as WIPO, WTO and the CBD.

Further material

- Fact sheet - Protection of regulatory data

- Test data protection: a regulatory tool for quality improvement