Year Ahead: Biotech, IP Promise to Create Controversy From Farms To Big Pharma In 2014

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The intersection of biotechnology and intellectual property continues to be a hot policy topic across the globe. From the patenting of certain plant varieties to human genes, to biodiversity and food security, to genetic resources, countries from developing to developed are attempting to navigate often blurred lines in terms of what can and cannot be patented, what should – and shouldn’t – be patented, and protecting innovators from farmers to plant breeders to drug manufacturers.

Patents & Conventional Plants

Little green plants continue to raise a ruckus.

There is continued opposition against a European Patent Office (EPO) patent granted to Syngenta for an insect resistant pepper plant copied from a wild pepper. On 3 February, a coalition consisting of 34 NGOs, farmers and breeders’ organisations from 27 European countries filed an opposition to the patent.

“Never before have so many organisations from all over Europe been part of a formal opposition,” Francois Meienberg, campaign director at the Berne Declaration – a Swiss NGO opposed to patents on life forms – told Intellectual Property Watch.

The opposition argues that Syngenta merely crossed commercial pepper plants with a wild pepper plant from Jamaica that was already very much pest-resistant; therefore, Syngenta should not be able to patent the insect-resistance plants, their seeds, and/or their fruits.

Since October 2013, the EPO has stayed the registration of conventionally grown plants and animals as “intellectual property.” This move comes amidst the uproar over the Syngenta patent and the pending decisions over patents in what are known as the “broccoli” and “tomato” cases.

The EPO’s highest judiciary, the Enlarged Board of Appeal (EBoA), previously decided that a process for the production of plants cannot be patented, even if it contains an additional step of a technical nature, such as the use of molecular genetic markers. The EBoA has been asked to clarify whether the products of such non-patentable processes (i.e., plants or fruits) are also excluded from patentability. There is no indication yet as to any progress or decision being made in the case.

“In view of the importance these two proceedings before the EBoA, the EPO announced to stay all decisions on conventional plant cases pending in examination and opposition respectively” until the EBoA hands down its ruling, explained Rainer Osterwalder, EPO director of media relations. “This means that at present we do not decide on further grants until the product questions has been clarified.”

Groups such as Brussels-based industry association CropLife International argue that strong and predictable IP protection is needed, since biotechnology innovation of plants can take years – even decades – and millions of dollars to. Dominic Muyldermans, senior legal consultant, IGO affairs, to CropLife, stressed that patents that facilitate research and breeding are also risky investments, and investors need to be confident, else research and commercialisation will stall. Patents provide a different balance of access and protection than what is provided by the plant variety protections (PVP) outlined in the UPOV system, he added.

And while many traits such as pest-, disease- or drought-resistance are present as native traits, only a minority are in the pool of widely used varieties being bred under the PVP system. “It is therefore important not to exclude these inventions from the protection of the patent system,” Muyldermans said.

“Any refusal to allow a patent or attempts to reduce the scope of these patent rights reduce the effectiveness of the patent system, which will have a detrimental effect on the incentive for R&D activities and consequence innovations related to native traits.”

Meienberg said this EBoA outcome “will be crucial regarding the patentability of conventional plants.”

“But we hope that … there will also be a political decision on this question by the administrative council later,” perhaps in 2015, he added.

Meanwhile, protest are also ongoing in countries such as Thailand, Canada and Ghana against their governments signing on to the 1991 International Convention for the Protection of New Varieties of Plants (UPOV convention).

The Africa Regional Intellectual Property Organisation (ARIPO), for example, drafted a law last year – the Draft Regional Policy and Legal Framework for Plant Variety Protection, based on UPOV 1991 – to help protect breeders’ rights. A source told Intellectual Property Watch that ARIPO is expected to hold a diplomatic conference sometime this year to adopt the draft text as a protocol to be ratified by member states.

“ARIPO could have a very positive effect on the availability of new plant varieties, which could substantially improving the livelihood of African farmers and food security for the region,” Muyldermans of CropLife said.

But groups such as the Alliance for Food Sovereignty, which includes networks and farmers’ organisations working in Africa, oppose it, arguing that the proposal will damage their ability to exist in those countries and that the draft law will criminalise farmers’ rights and undermine seed systems in Africa. Other civil society groups have questioned the legitimacy of the ARIPO process (IPW, Biodiversity, Genetic Resources, Biotech, 30 October 2013). The source told Intellectual Property Watch that none of the civil society concerns, nor those of the farmers, have been taken into account thus far.

The Quaker UN Office in Geneva in January announced two new briefing papers on intellectual property, agriculture, food and biological diversity. These papers look at alternatives in India and Thailand to PVP systems styled after UPOV.

Biodiversity/Food Security/Agriculture

Expiring GMO patents are raising regulatory issues, since a number of patents on genetically modified organisms will expire in coming years.

In the US, the Biotechnology Industry Organization (BIO), along with the American Seed Trade Association (ASTA), have opened the Data Use and Compensation Agreement (DUCA) for signatures after the two groups completed the AgAccord, a voluntary private sector mechanism to support a transition of global regulatory responsibilities and authorisations for patented traits after the patents expire. BIO says that although the number of events coming off-patent in the next few years likely will be small, it is expected to increase significantly after 2020.

“These agreements are designed to provide confidence to the agriculture biotechnology value chain that off-patent events will be available to interested signatories and that U.S. exports will not be disrupted due to patent expiry,” Cathleen Enright, BIO executive vice president for food and agriculture, said in a statement.

The AgAccord consists of two initiatives: The Generic Event Marketability and Access Agreement (GEEMA) – which became fully operational in 2012 – and the DUCA. The DUCA will become operational once six parties sign – three that hold proprietary regulatory property or have petitioned the US Department of Agriculture to deregulate an event, and three parties that do not hold such property – such as a seed company or national farm group.

A number of new GMOs are likely to be released in developing countries in the next few years, but are already meeting protest in a number of countries.

In Ghana, for example, the Coalition for Farmers Rights and Advocacy Against GMOs (COFAM) – a group of farmers, labour unions, religious, political and civil society organisations – argue that the Genetically Modified Foods and Breeders Bill gives away Ghanaians’ agricultural heritage and their agriculture future to western multinational corporations (Monsanto, for one) with little in return, and will force farmers to buy new seeds every year, along with toxic chemicals required for use with those corporate seeds.

The fact that the Plant Breeders’ Bill has gone through two readings in Ghana’s Parliament “without expunging the obnoxious clauses from it speaks volumes of the vulnerability of our branches of government to undue external influences inimical to Ghana,” the group argued. “The Bill is being rushed to comply with the [World Trade Organisation Agreement Trade and Related Intellectual Property Rights (TRIPS)] rules without proper scrutiny.”

Meanwhile, a case pending in Australia is viewed as a landmark case for whether a neighbour growing genetically modified crops – in this case, with seeds from Monsanto – has an obligation to not contaminate organic crops of a neighbour. Whereas the US, Japan and European Union allow trace amounts of GMO in organic foods due to possibilities of contamination by wind or pollen transfer, Australia has a zero tolerance policy.

In the US, the Organic Seed Growers and Trade Association on 31 January issued new guidelines in a book, Protecting Organic Seed Integrity, distributed for free to organic growers to help them avoid genetically engineered contamination in response to the rising cases of GMO contamination.

The book comes on the heels of the US Supreme Court decision, OSGATA et al v. Monsanto. The court refused to hear an appeal by OSGATA and a number of American and Canadian farmers to require Monsanto to issue a blanket vow to never sue farmers if their fields had plants containing the company’s patented genetically modified traits as a result of cross-contamination from neighbours. Monsanto has said that as a practice, it won’t sue such farmers, but it routinely sues farmers who it says intentionally plants its genetically engineered (GE) seeds without paying for the technology.

Gene Patenting

Europe already has seen some legal decisions handed down in 2014 that could help chart its course in the area of gene patenting.

On 4 February, one of the EPO Technical Boards published a decision “confirms the approach taken by the EPO’s patent examiners regarding the patentability in human embryonic stem cells (hESCs),” Osterwalder explained.

The board dismissed an appeal by Technion Research and Development in Israel, saying: “Inventions which make use of publicly available human embryonic stem cell lines which were initially derived by a process resulting in the destruction of the human embryos are excluded from the patentability” under the European Patent Convention (EPC).

There is one other ongoing examination relating to hESCs in which a decision may be expected soon. The California-based Geron Corporation applied to patent islet cells from human embryonic stem cells. The EPO refused to grant the patent, and Geron appealed the decision in March 2013. Oral proceedings in this appeal are scheduled for 3 April.

In the US, many are watching the US Patent and Trademark Office (USPTO) to see what guidance it will issue to implement the Myriad gene patent decision. In June 2013, the US Supreme Court determined that isolated, naturally-occurring genes are not patent eligible when it struck down patent claims of Myriad Genetics to genomic DNA in the BRCA1 and BRCA2 genes. The decision could have far-reaching implications for the biotech industry, and also leaves questions over how Myriad can be applied to other areas of biotech – such as proteins and antibodies – or new chemicals isolated from natural sources.

Meanwhile, a new genomic editing system has the potential to usher in a new era of genetic medicine, and could unleash a flood of patent activity.

One of the goals of personalised medicine and genetic therapies has been to edit the human genome. If a disease – Alzheimer’s, for example – is associated with a particular genetic mutation, the idea was to create therapies to correct that mutation. Genomic editing technologies were created to design proteins to hone in on a particular target gene to do just that.

The new CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) genomic editing system utilises guide RNA – instead of complex proteins – as a gene-homing mechanism and a Cas-9 nuclease to cut targeted DNA to make a mutation that can be studied. This technology has been called by The Independent newspaper as a “jaw-dropping breakthrough” in the fight against hereditary diseases.

“One of the hopes is that we can use this guide RNA and this protein to identify and target a mutation – a mutated gene – and basically replace it with the correct gene. That’s the potentially revolutionary therapeutic power of this technology,” explained Chelsea Loughran, an associate in the litigation group of Boston-based law firm Wolf Greenfield.

In early February, news broke that scientists in China created twin monkeys with customised gene mutations using CRISPR; it was reportedly the first time the technology has been used successfully in primates. Earlier test subjects of genome manipulation included rats, zebra fish and mice.

Research groups out of Harvard, MIT (Massachusetts Institute of Technology) and the University of California, Berkeley, are working on CRISPR. The technology and the IP it could help create is so new, Loughran explained, that few patent applications have been published yet. But what could be patented are methods of treating a particular disease using CRISPR, or specific sequences of programmable RNA guide molecules used to correct DNA mutations that could be used to create new gene changes.

“We’re watching this landscape develop in real-time, which is the cool thing about this new technology and IP,” Loughran said. And while what develops in the next year or so could impact technology officers’ ability to licence technology involving CRISPR/Cas9, Loughran noted that many of the groups doing much of the legwork are universities and like-minded entities when it comes to ownership of IP.

”We don’t know yet who is going to get the first patent claim to CRISPR” or genomic editing, she said. “The hope is that it will be accessible.”

The European Commission last year set up an expert group to examine the implications of patent law in the field of biotechnology and genetic engineering; members were announced in December 2013, and the first meeting took place that month in Brussels. Two more meetings are expected to be organised in 2014. More information on forthcoming meetings can be found here.

Genetic Resources, Traditional Knowledge & Geographical Indications

During the 26th session of WIPO’s Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) on 3-7 February, many discussions centred around protecting genetic resources from biopiracy. Members continued work on a draft text of what could become an international instrument of protection of genetic resources (IPW, WIPO, 6 February 2014).

The results of a forthcoming study by the Third World Network will shed light on 187 international patent applications relating to claims on genetic resources. Delegates were also urged to draft an international instrument compliant with the internationally recognised rights of Indigenous People and Local Communities in IGC negotiations (IPW, WIPO, 6 February 2014).

At a side event hosted by QUNO, WIPO negotiators were urged to find more ways to support small farmers’ innovation, since those farmers play a vital role in international food security and biological diversity (IPW, Biodiversity/Genetic Resources/Biotech, 7 February 2014).

And a new website of the UN Convention on Biological Diversity – the Access and Benefit Sharing Clearing-House (ABS-CH) – will allow tracking of the use of genetic resources in order to ensure access and benefit-sharing of those resources (IPW, United Nations, 7 February 2014). Under the Nagoya Protocol, countries will have an obligation to provide permits when granting access to genetic resources. These permits will be communicated to the ABS-CH and an international certificate of compliance will be issued. The pilot phase will be launched after this month.

More meetings of the IGC will be held this year, with the next scheduled for 24 March – 4 April, and a stock-taking in July, before the September annual WIPO General Assembly.

Meanwhile, at the annual Global Congress on IP, Innovation and the Public Interest held in Cape Town, South Africa, in December, participants highlighted a draft “TK Documentation Toolkit” developed at WIPO aimed at giving countries a way to impede further loss of TK, supporting benefit-sharing, and protecting TK and TCEs from unwanted uses. It also offers guidance on how to address critical IP-related issues. The draft toolkit is currently being field-tested.

And on geographical indications, WIPO members party to a special agreement on the protection of appellations of origin agreed to recommend to convene a diplomatic conference in 2015 to adopt a revision of the 1958 Lisbon Agreement that would extend to all geographical indications the protection already granted to appellations of origin (IPW, WIPO, 10 January 2014).

 

Liza Porteus Viana may be reached at lizapviana@gmail.com.

Attribution-Noncommercial-No Derivative Works 3.0 Unported

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