Year Ahead: Biotech And Patentability Under Debate In The US, EU

Biotechnology lies at the intersection of a wide spectrum of fields, such as agriculture, health and environment. Because biotechnology relates to life sciences, it is often the subject of ethical, sometimes intense political debates between stakeholders, in particular involving intellectual property rights. In 2010, as the first signs of global economic recovery are emerging, the debates are expected to increase.

Some court rulings will be taken in 2010 in the European Union and the United States, with possible impact on legislation. Meanwhile, the biotechnology industry says the innovation process is becoming more costly and complex, and the financial crisis took a toll by shrinking investment.

In Europe, attention is on a case involving patents on plant breeding methods. And some dissension seems to be arising between breeders’ associations over an exemption from patents for breeders to develop new plant varieties.

The Enlarged Board of Appeal of the European Patent Office (EPO) will proceed with consideration of the so-called “broccoli” case involving a “patent referring to methods containing plant breeding steps, but also steps of a technical nature,” Siobhán Yeats, director, biotechnology patent applications at the EPO, told Intellectual Property Watch. The decision is being closely watched by activists as it “will redefine the impact of patents on food sovereignty,” Francois Meienberg from the Berne Declaration told Intellectual Property Watch. The public oral proceedings in the broccoli case will be held on 20-21 July in Munich. The patentee, opponents and the president of the EPO will be heard by the Enlarged Board of Appeal, and the decision will be pronounced “in due course,” according to the EPO.

The “no patents on seeds” coalition, composed of the Berne Declaration, Swissaid, Misereor, No Patents on Life, Greenpeace and the Development Fund (Norway), claims the board of appeal decision will have consequences for the patentability of non-genetically modified plants or animals in Europe, and that this decision will be binding for all pending patent applications. They are calling for a change in patent legislation so that patents on conventional plants and animals are eliminated (IPW, Biodiversity/Genetic Resources/Biotech, 21 October 2009).

“Plants are affirmed as patentable in the European Directive 98/44/EC on biotech patenting, provided the technical teaching of the invention concerned is not confined to a single plant variety,’ Yeats said. “What is important when considering a patent application claiming a ‘non-GMO’ plant is whether the invention is based on a novel and inventive technical teaching that is generally applicable,” she said.

The so-called European biotech directive on the legal protection of biotechnological inventions is undergoing discussion in “many different fora,” said Yeats. One of them has been brought up by Plantum, a Dutch breeders association, which issued a position paper [pdf] in May 2009 on the relationship between patent and plant breeders’ rights. The group proposed that “biological material protected by patent rights should be freely available for the development of new varieties, that the use and exploitation of those new varieties is free, in line with the breeders’ exemption of the UPOV Convention.” The International Union for the Protection of New Varieties of Plants (UPOV) Convention aims to protect new varieties of plants by an intellectual property right. Patent rights should not hinder this process, the paper said.

Plantum called for the breeders’ exemption to be incorporated into the biotech directive after which national patent laws and the European Patent Convention would need to be amended likewise. In the current directive, there is no specific provision on scientific research or on the crossing and selection with the patent holder’s variety, which leaves room for interpretation at the national level, they said. In Europe, according to Plantum, the right to be allowed to develop new varieties has been explicitly included in patent laws in France and Germany.

In the Netherlands, the ministries of agriculture and economic affairs “are currently investigating whether there is any need for amending the Dutch patent legislation or to propose an amendment of the biotech directive,” said a Plantum official. Recommendations to the Parliament should be done in the coming months, she said.

In a slight departure from Plantum’s position, Brussels-based international breeders’ group CropLife considers patents fundamental to stimulate research and development in traits and new genes, Denise Dewar, executive director of plant biotechnology at Croplife, told Intellectual Property Watch. Without patent rights, there would not have been such a yield increase per hectare in the last 50 years, Dewar said.

Germplasm need to be protected, she added, as patents do allow access to research and development, but there has to be a licence. Discussions are ongoing with other breeders associations, she said.

Meanwhile, the International Seed Federation (ISF), takes the view that “protection by patent of a biotechnological invention should not be exhausted when that biotechnological invention, inserted in a plant variety, is used by others,” Marcel Bruins, secretary general of ISF, told Intellectual Property Watch. Nevertheless, he said, ISF would allow breeding with a variety containing the patented trait of technology (PTT), but in case the new developed variety is an “essentially derived variety” or if it is inside the scope of the patent’s claims, consent must be obtained from the owner of the initial variety or of the patent,” he said.

ISF considers the most appropriate protection for biotechnological inventions to be through patents, Bruins said. However, “further clarification is needed as regards the use of transgenic varieties containing patented elements and protected by breeders’ right for further breeding,” he said, adding that “ISF is strongly attached to the breeders’ exception provided for in the UPOV Convention and is concerned that the extension of the protection of a gene sequence to the relevant plant variety itself could extinguish this exception.”

The ISF annual congress will take place in Calgary, Canada from 31 May to 2 June. A conference on “adventitious presence and low level presence” will follow the congress on 3 June. Adventitious presence refers to the “incidental, small amounts of biotech material with the necessary regulatory approval in a conventional commercial product” such as seed, feed or food. The term is used “in the context of labelling when the inadvertent presence exceeds a set threshold,” Bruins said. Low level presence refers to “incidental, small amount of biotech material, approved in at least one country but not in the country of import, in a commercial product,” he said.

Another ongoing debate on the protection of patents in biotechnology is around the case involving Argentinean soymeal. Monsanto, which has patents on Roundup Ready soybeans in Europe but not in Argentina, tried to have its patent rights enforced on Argentinean exports of processed soymeal to Europe. The case has been brought to the European Court of Justice.

The conclusion of the case is expected on 9 March, according to the European Court of Justice.

A conference on Agricultural Biotechnologies in Developing Countries will take place in Guadalajara, Mexico on 1-4 March. The conference organised by the UN Food and Agriculture Organization (FAO), is cosponsored by the International Fund for Agricultural Development (IFAD). The Consultative Group on International Agricultural Research (CGIAR), the Global Forum on Agricultural Research (GFAR), the International Centre for Generic Engineering and Biotechnology (ICGEB) and the World Bank are major partners in the conference. The event is looking at an alternative approach to “business-as-usual” to address the growing food insecurity in developing countries, according to the FAO.

UN Special Rapporteur to the Right to Food Olivier De Schutter warned in his last report to the UN General Assembly in New York in July that the commercial seed system might be jeopardising the farmer seed system. By providing inputs that are protected by IP rights to developing countries farmers, it creates a system in which they are dependent on the acquisition of seeds, De Schutter said.

On 5 March, De Schutter will make a presentation to the Human Rights Council in Geneva to give the main findings and recommendations of his report on the role of agribusiness and the right to food. The report aims to identify the contribution of the private sector to food security, according to the rapporteur’s website.

US: Decision on Gene Patenting in 2010, Reform Pending

Uncertainty about reform of the healthcare system in the US has created doubts on how the debate will wind up and has led to investor reluctance to invest in biotechnology, said Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO). Well-established companies with products on the market were not too affected by the crisis, but small and medium-sized companies took a blow, he said.

In 2010, the biotech industry will be working on getting the US Congress to resolve its patent reform legislation, and on advancing legislation on what are they?, known as biosimilars, and tax credit legislation in the framework of the healthcare debate, Greenwood said.

This year, negotiations should start on the pharmaceutical drug user fee act: Every five years the Food and Drug Administration and the drug industry negotiate an agreement as to the size of the fees that will be paid to the FDA with application for drug approval. The next act should be approved in 2012 so negotiations are starting now. “We negotiate with the FDA, we ask them to agree to certain reforms to make the process more transparent, more user-friendly, to expedite the approval of our products, and in exchange we agree to support a legislative statutory increase of the size of the FDA fees,” Greenwood said.

Separately, the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) presented the final report of their study to the full committee on 5 February in Washington, DC, according to James Evans, chairman of the task force on gene patenting for SACGHS and a professor of genetics and medicine at the University of North Carolina.

The study focuses on the effects of patents and licensing practices on patient access to genetic tests. SACGHS advises the US Health and Human Services (HHS) secretary on human health and the potential impact of the development and use of genetic technologies.

The draft report issued in October gave a set of recommendations such as the exemption from patent infringement liability “for those who use patent-protected genes in the pursuit of research.” The draft report brought many comments from the biotechnology industry, which remains attached to the importance of patents in innovation (IPW, Biodiversity/Genetic Resources/Biotech, 29 October 2009).

On the eve of the final report’s approval by the SACGHS Committee on 5 February, BIO issued a letter asking Health and Human Services Secretary Kathleen Sebelius to disregard the recommendations of the report, as the biotech industry finds those recommendations, if implemented, “would do more harm to patients than good, by impairing the research, development and commercialisation of the medicines and diagnostic tests of tomorrow.”

Considerable controversy will remain in 2010 about “the subject of human gene patenting and licensing,” Evans said, adding “I hope that our efforts will add some data, logic and light to the ongoing discussions among parties who have very different agendas.”

Meanwhile, a lawsuit brought against a US biotech company Myriad and the US Patent and Trademark Office (USPTO) by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) should be decided in February. The lawsuit was filed against the patenting of two human genes associated with breast and ovarian cancer.

While the ACLU considers patents as a barrier to innovation and patient access to gene testing, the biotech industry asserted patents are essential to innovation (IPW, IP Burble, 3 November 2009), (IPW, Biodiversity/Genetic Resources/Biotech, 2 September 2009).

Greenwood argued that a court ruling in favour of the ACLU would negatively impact the biotechnology industry and the hopes held by “millions of patients.” The enterprise of biotechnology drug discovery and development is very costly and risky, he said, and relies upon the expectations of investors that the billions of dollars that need to be invested every year in this industry will get a good return. If companies are not able to secure IP rights from the ability to isolate the genetic causes of diseases and to use the genetic sequence that they discover, then “investors will not find those companies attractive.” The ability of other companies to piggyback on their work and “dilute” the value of IP “would undo the whole business model for genetic medicine,” he said.

Hans Sauer, associate general counsel for intellectual property at BIO, said the lawsuit was overly broad and strikes at all patent owners in biotechnology, possibly leading to unintended consequences. BIO filed an amicus brief [pdf] in support of Myriad, which is not a BIO member, said Sauer. “It is too early to say if that [a decision in favour of ACLU] would send a blow to the whole biotech industry but it has a very broad reach which triggers a response” from many sides, he said.

During a 21 January broadcast of the radio programme, Chris Hansen, ACLU senior national staff counsel, downplayed the industry worries about patients, saying that new drugs would still be patented and new therapeutic techniques too. However, what nature has created cannot be patented, he added.

If the ruling goes the ACLU way, it will lead to a vast increase in genetic research and the number of new test and new drugs as more scientists will have access to genes, Hansen said.