Expiring GMO Patents Raise Regulatory Issues; Private Sector Takes MeasuresPublished on 5 February 2013 @ 11:37 am
By Catherine Saez, Intellectual Property Watch
A number of patents on genetically modified organisms (GMOs) in agriculture will expire in the coming years and this could be a problem for the biotechnology industry in terms of regulatory authorisations. A private sector initiative has recently been launched to address the issue.
In the United States, the Biotechnology Industry Organization (BIO), along with the American Seed Trade Association (ASTA), started an initiative in 2010 to “address the opportunity and the challenges associated with patent expiration.” They jointly developed a framework, called “the Accord,” which is “a private-sector driven mechanism that provides for the transition of regulatory and stewardship responsibilities for biotechnology events, after patent expiration,” according to the Accord website.
The website states: “The first genetically engineered row crop was commercialized in 1996.” It further says that “currently, nearly ninety-percent of cotton, corn and soybean acreage in the United States is planted with seed varieties containing biotechnology events [traits].”
“Grain from these crops is traded globally, accounting for over $40 billion annually, making the United States the largest producer and exporter of crops and grain derived from biotechnology globally,” the site says.
The first of the commercial biotechnology traits are going off patent in 2015, and the Accord seeks to find a solution to the maintenance of global regulatory authorisations for those traits.
It includes two agreements: the Generic Event Marketability and Access Agreement (GEEMA), open for signature on 31 October 2012, and the Data Use and Compensation Agreement (DUCA), which is expected to be open for signature in 2013. According to the website, the GEEMA has five signatories: BASF Plant Science, Bayer CropScience, Dow AgroSciences, Dupont Pioneer, and Monsanto.
After patents expire, they fall into the public domain and can be used widely. Under the GEEMA, according to Matthew O’Mara, director of international affairs, food and agriculture at BIO, holders of the proprietary regulatory property (PRP, companies that have developed proprietary regulatory information supporting authorisations for biotechnology traits), have three options.
These options are: they can maintain the authorisation independently and therefore at no cost to the generic producer (a seed company that accesses the generic event to incorporate into its seed products); they can attempt, via negotiations, to share these costs and responsibilities; or they can choose to discontinue regulatory responsibilities, starting a seven-year clock, he told Intellectual Property Watch.
Under this scenario the originator steps away, and if no other signatory steps forward to negotiate for access to the PRP, then all signatories that are using the generic event free of cost must discontinue use, O’Mara said.
The GEEMA does not, however, address variety patents, O’Mara said, but focusses on single biological trait patents. The scope of GEEMA is limited to the US patents, he said, and thus only applies to US cultivation and “ensuring regulatory authorisations are maintained and obtained in export markets.”
“It is possible that the GEEMA could be a model for industry in other countries, but we intended to enable industry in other countries to determine the best path forward in their respective country,” he said.
Both the GEEMA and the DUCA agreements are voluntary, but according to the Accord’s website, “they are binding contracts among signatories.” The agreements “promote continued innovation in the seed industry, preserve strong protection for intellectual property rights and potentially provide for new business opportunities,” it says.
EU Commission: Rights and Obligations Independent of IPRs
According to Frédéric Vincent, spokesperson for health and consumer policy at the European Commission, under the EU legislation, “GMOs may be placed on the EU market, either to be used as food or feed or to be cultivated, only if they are authorised for that specific use.” The risk assessment is usually performed by the European Food Safety Authority and member states, he told Intellectual Property Watch.
“Decisions of authorisation of GMOs impose rights and obligations on the authorisation holder and on the users of the GMO,” he said, adding that these rights and obligations apply independently of the intellectual property rights on the genetic traits that could be held by the authorisation holder, which is usually an individual company.
“When the company loses its patents on the GMO, other seed companies can start selling seeds,” which means that the authorisation holder may experience difficulties in ensuring that its obligations are fulfilled, he said.
“Even if there is in principle no link between the GMO legislation and intellectual property rights, it is important that the decision of authorisation provides the conditions to allow the authorisation holder to fulfil its obligations,” according to Vincent.
On the specific question of environment monitoring, Vincent said the European Commission “is currently reflecting on how to adapt the obligations imposed respectively on the users and on the authorisation holder in order to ensure that the latter is able to fulfil its monitoring obligations imposed on him/her by the decision of authorisation with the same level of performance after the intellectual property rights have expired.”
Catherine Saez may be reached at email@example.com.