Single application to extend patent protection of medicinal and plant protection products for five years EU certificate to ensure protection across EU patent system and cut red tape and costs related to independent national certificates MEPs want clear, more transparent and time-efficient procedures on applications, appeals, oppositions and remedies administered by EUIPO   MEPs adopt their first reading position about EU supplementary certificates enabling longer protection of patented medicinal and plant protection products.   Innovative medicines and pesticides should enjoy 5-year longer EU-wide patent protection on top of 20-year protection of patent to compensate for lengthy testing requirements before these products are placed on the EU market. Unitary supplementary protection certificates aim to cover costs invested into research of innovative substances at the EU level.   Single procedure   The unitary character of certificate should ensure that EU patent holders do not have to apply for extended protection in each member states separately, but can save costs and time by applying for an EU certificate at the European Union Intellectual Property Office (EUIPO) and it would be applicable equally in all countries that have joint the EU patent system. Combined application would allow them to ensure protection of their patents at the national level in those EU countries, which have not joined the EU patent system. MEPs want the centralised application to be examined by one EUIPO member and two examiners from national patent offices with sufficient expertise and experience, who would be able to grant the certificate or refuse the application.   Easier procedure for plant protection products   Plant protection products can only be placed on the EU market with valid marketing authorisation and these are provided nationally at different times. MEPs thus want manufacturers of innovative plant protection products to be able to apply for EU certificate as soon as a marketing authorisation was granted in at least one EU country, which is part of the common patent system. MEPs also suggest the possibility of centralised authorisation procedure for plant protection products. They want the Commission to assess after five years whether such a procedure under the European Food Safety Authority would not be necessary and appropriate.   Electronic process for medicinal products   Manufacturers of innovative medicinal products already enjoy centralised procedure for obtaining marketing authorisations. It will therefore become basis for application for unitary protection certificate. MEPs want the manufacturers to be transparent in the process about public financial support received for development of their patented products. Given the importance of innovative medicines and vaccines in crises in particular, MEPs foresee the need for expedited examinations of medicinal products in some situations which should last four instead of the usual six months.MEPs also want certificate application and related exchanges on appeal to be electronic while the format of submissions should be provided by EUIPO.   Quote   Following the plenary vote, rapporteur Tiemo Wölken (S&D, DE) said: "The new rules will benefit Europeans Industry by reducing the cost and burden of obtaining or maintaining a supplementary protection certificate. Furthermore, thanks to the unitary nature we will remove the fragmentation that currently exists between Member States when it comes to the implementation of the regulatory framework and hence granting an SPC, providing predictability for both the innovative and generic industry."   Next steps   MEPs approved their position on unitary supplementary protection certificate for plant protection products with 516 votes in favour, 26 against and 74 abstentions and on supplementary protection certificate for plant protection products with 523 votes in favour, 26 against and 69 abstentions. European parliament position on unitary supplementary protection certificate for medicinal products was approved with 518 votes in favour, 29 against and 70 abstentions and on supplementary protection certificate for medicinal products with 526 votes in favour, 23 against and 70 abstentions.   Parliament is now ready to start talks with EU countries on the final shape of the legislation. The file will be followed up by the new Parliament after the European elections on 6-9 June.   Background   These proposals on revision, modernisation and introduction of a system for unitary supplementary protection certificates complement the unitary patent system, which is a major step towards the completion of the single market for patents. They were announced as part of the ‘EU patent package’ in 2023, which also includes a new initiative on compulsory licensing and legislation on standard-essential patents. From Agropages，https://news.agropages.com/News/NewsDetail---49378.htm

The Federal Government of Nigeria has approved the commercial release of transgenic insect-resistant and drought-tolerant maize varieties, known as TELA maize.   The approval was granted by the National Committee on Naming, Registration and Release of Crop Varieties, Livestock Breeds/Fisheries (NCNRRCVLF), headed by Prof Olusoji Olufajo at its 33rd meeting at the National Centre for Genetic Resources and Biotechnology (NACGRAB), Ibadan on January 11, 2024.   The four varieties approved by the NVRC are SAMMAZ 72T, SAMMAZ 73T, SAMMAZ 74T, and SAMMAZ 75T.   The new maize varieties are drought tolerant and are resistant to stem-borer and fall armyworms, resulting in a yield advantage of up to 10 tons per hectare under good agronomic practices. The national average for similar hybrids is six tons per hectare.   ‘Very proud of our scientists’   Stem borers reduce maize production in several countries in Africa. At the same time, fall armyworms can destroy up to 20 million metric tons of maize in Africa each year, enough to feed 100 million people.   The release and registration of the four varieties followed environmental release approval in October 2021, granted by the National Biosafety Management Agency (NBMA).   Development of the improved varieties was led by the Institute for Agricultural Research (IAR) Samaru, Ahmadu Bello University Zaria, through the TELA Maize Public-Private Partnership coordinated by AATF. The TELA Maize Project is being implemented in Ethiopia, Kenya, Mozambique, Nigeria, and South Africa.   Prof Ado Yusuf, Executive Director of IAR, expressed satisfaction with releasing the four new maize varieties, saying, ″IAR is very proud of our scientists who are addressing the maize productivity challenges in the country and beyond. These varieties have undergone thorough research and developed using biotechnology tools over several years of continuous testing and revalidation.″   Dr Canisius Kanangire, AATF’s Executive Director, said: ″The release of TELA Maize in Nigeria will contribute to food and nutrition security in line with the Federal Government’s Agricultural Transformation agenda. AATF reaffirms unwavering commitment to addressing challenges farmers face across the continent.″   Reduce the use of pesticides   Professor Garba Sharubutu, the Executive Secretary of the Agricultural Research Council of Nigeria (ARCN), said the approval of the TELA Maize variety in Nigeria is a critical milestone that confirms the potential of biotechnology in ensuring food and nutrition security and improved livelihood of farming households in Africa.   Prof Mustapha Abdullahi, Director-General of the National Biotechnology Development Agency (NABDA), celebrated the release, saying that, with the advent of TELA Maize, farmers will reduce the use of pesticides on maize to the bare minimum, which is beneficial to humans, livestock, and the environment.   Dr Sylvester Oikeh, the TELA Maize Project Manager, celebrated Nigeria’s decision by calling other African countries to act for farmers. ″I am encouraged by this decision by the Federal Government of Nigeria that reflects their commitment to the needs of farmers. I congratulate the scientists for their hard work and dedication that has seen the product getting closer to farmers. I look forward to other countries making similar decisions for the farmers’ good,″ Dr Oikeh said.   The other partners in the TELA Maize project are national agricultural research institutes in Kenya, Mozambique, Ethiopia, and South Africa; the International Maize and Wheat Improvement Center (CIMMYT) and Bayer, with funding from Bill and Melinda Gates Foundation and United States Agency for International Development (USAID).   From Agropages, https://news.agropages.com/News/NewsDetail---48855.htm

The Brazilian National Health Surveillance Agency (Anvisa) has opened a period for public comments on the pesticide Isopyrazam.    This fungicide is the active ingredient in various Syngenta products worldwide, including Rikali and Reflect. The outcome of this public consultation may determine the future of the product registration process in Brazil.   Isopyrazam belongs to the group of SDHIs (succinate dehydrogenase inhibitors), which targets complex II (or succinate dehydrogenase) in the mitochondrial respiratory chain, disrupting the flow of electrons and thus altering cellular respiration. SDHI group fungicides function by blocking a crucial step in fungal respiration provided by succinate dehydrogenase (SDH).   FRENCH ALERT   A team of French researchers argues that SDHI family fungicides are toxic not only to fungi but also to earthworms, bees, and human cells. Pierre Rustin, a researcher at Inserm (National Institute of Health and Medical Research) led the team, which also published a study in the scientific journal Plos One. In the research, they highlight the toxicity of eight SDHI family fungicides (Flutolanil, Fluopyram, Boscalid, Fluxapyroxad, Penflufen, Penthiopyrad, Isopyrazam, and Bixafen).   Those interested in supporting or contesting the market entry of the product can access the suggested draft and the form for consideration through the Anvisa website: http://antigo.anvisa.gov.br/consultas-publicas#/   From Agropages, https://news.agropages.com/News/NewsDetail---48588.htm

The agrochemical market in Nicaragua experienced significant and steady growth until 2018 and 2019, according to market intelligence agency AgbioInvestor. Currently, one of the major issues affecting the country is social and political instability, with tax rises leading to 30% inflation in the price of agrochemicals. As a result of this tax policy, there was a significant reduction in the importation of agrochemicals in 2019.     According to AgbioInvestor, the basic manufacturing and formulation of active ingredients is limited in Nicaragua. ″However, there are many importers and distributors. Initially, local formulation focused on biological products and insecticides, predominantly pyrethroids and organophosphates. More recently, the formulation of herbicides and fungicides has increased,″ analysts said.     The most important local distribution companies include Abrasa, AgriCentre, Agroinsumos del Tropica, Agrovvet Nicarao, Agro Alfa, Ramac, Cisa Agro, Servicio Agrícola Gurdián, Insecticidas San Cristóbal, Bellrod, BioQuim, Cindeco, DuWest, Foragro, Formunica, HanseAndina, Leiman Invest and Profiysa.     Major multinational companies in the country include Bayer, BASF, FMC, Syngenta, Helm and Jebagro. Agrochemical companies in Nicaragua are represented by the Nicaraguan Association of Formulators and Distributors of Agrochemicals (ANIFODA). The market is led by products imported from China, Guatemala, the USA and Costa Rica. However, products from Guatemala and Costa Rica often use active ingredients purchased from China or India, formulated and re-exported from these countries.   Nicaragua Outlook   Agriculture continues to be a fundamental part of Nicaragua's economy, employing 30.6% of the national workforce and representing 15.8% of GDP. "The use of agrochemicals per hectare is high compared to other developing markets, although similar to other Latin American countries, such as Bolivia, Guatemala and Ecuador," said the AgbioInvestor agency. However, Nicaragua has a limited capacity for agrochemical formulation, and intellectual property legislation is overseen by the Registro de la Propiedad Intelectual (RPI).   "Patents and trademarks are granted based on first registration, and patents have a term of 20 years. Trademarks are registered for ten years but can be indefinitely renewed. Illicit trade and copied products have been a longstanding issue in Nicaragua. The country is a member of the World Intellectual Property Organization," analysts stated.   From Agropages, https://news.agropages.com/News/NewsDetail---48452.htm

Rovensa Group, a global leader of agricultural inputs for sustainable agriculture, announces the acquisition of Agro-K, a leading family-owned biostimulants developer in the United States. Agro-K will be integrated over time into Rovensa Next, the business unit dedicated to biosolutions for agriculture.   Established in 1976 in Minneapolis, Agro-K has been at the forefront of sustainable agriculture through science-based development of an extensive portfolio of biostimulants and specialty nutrition products. The acquisition solidifies Rovensa Next's foothold in the United States, a key strategic growth market, and it brings a high-quality portfolio of complementary solutions and a technical sales team fully dedicated to biostimulation. As the largest biosolutions market globally and the fastest growing biostimulants region, the US plays a crucial role in Rovensa Next's ambitious expansion strategy.    Javier Calleja, Rovensa´s CEO, stated: ″We are extremely pleased to welcome Agro-K into Rovensa. This acquisition is an important strategic step towards achieving our ambition of becoming the leading biosolutions player in the United States, marketing a full spectrum of solutions nationwide. Both businesses are highly complementary and share a common go-to-market approach, the vision of an increasingly sustainable agriculture and the concern for people and society at large, which will contribute towards a swift integration and a successful joint value creation journey.″   Chapman Mayo, Agro-K’s President, added: ″We are very excited about the possibilities that an integration with Rovensa brings to the US marketplace. We strongly believe that the new products, technologies, R&D capabilities, and the global expertise that Rovensa brings will allow Agro-K to better service its customer base and ensure that Agro-K consolidates its position in the biosolutions arena″.    Rovensa was advised by Current Capital Partners, Honigman LLP, Uria Menendez, PwC, Context Network, Bracewell LLP and ERM. Agro-K was advised by B&A Corporate Advisors and Stinson LLP.   The financial terms of the transaction are not disclosed.   About Rovensa   Rovensa, a global leader in solutions for a sustainable agriculture, is dedicated to developing, manufacturing, and distributing a broad range of innovative products that empower farmers to cultivate safe, healthy and nutritious food for all.   Dedicated to making a positive impact, our 3,000+ employees work daily towards Rovensa's mission to feed the planet. Supporting farmers in 90 countries with over 45 global R&D centers and laboratories, we champion agricultural innovation to preserve and enhance soil, environmental and human health. Rovensa's products support the agricultural transition toward higher quality, resource-efficient food production.   With the integration of Agro-K, Rovensa’s revenues exceed 800 million euros.   About Agro-K    Founded in 1976, Agro-K has been a pioneer in the scientific development of biostimulants and specialty nutritional products for many important horticultural and field crops. Agro-K products evolve from a comprehensive understanding of plant physiology, nutrient demands, soil science and soil microbiology, all focused towards maximizing plant health and crop quality while minimizing grower inputs and environmental impacts. Its track record of helping growers improve crop quality and yield via nutrient use efficiency, long before the industry recognized its importance, together with the dedication and commitment of its employees, have enabled Agro-K to thrive and advance sustainable agriculture practices in the United States.   From Agropages, https://news.agropages.com/News/NewsDetail---48504.htm

Days ahead of a critical Supreme Court (SC) hearing, the Central government has prohibited the use of four insecticides from the initial list of 27. This list includes the controversial monocrotophos but with riders.   Regarding monocrotophos, activists and observers have highlighted that the recent directive provides a one-year transitional period for farmers to adopt alternatives. The order also states that the "sale, distribution or use of Monocrotophos 36 per cent SL shall be allowed only for clearance of existing stock till its expiry period."    The Pesticide Action Network (PAN) flagged concerns over the ambiguity of this phrasing. They fear that this might be exploited to amass stocks during this one-year window, allowing the prolonged use of Monocrotophos until these stocks are exhausted. PAN stressed the necessity of a distinct directive that prohibits the manufacture of all Monocrotophos formulations.   Along with monocrotophos, the three insecticides banned are Dicofol, Dinocap and Methomyl by the government through a Gazette Notification dated 29 th September, 2023, but published on 6 th October, 2023.   However, the mention of carbofuran, one of the original 27 prohibited pesticides, in the recent notice has perplexed activists. A statement from PAN clarified, "All other formulations of Carbofuran, except Carbofuran 3 per cent Encapsulated granule (CG) with specified crop labels, should be discontinued." This implies that the Carbofuran three per cent Encapsulated granule (CG) remains unbanned. Significantly, this Carbofuran 3 per cent CG formulation is the only one registered in India.     PAN India has urged the Central Insecticides Board and Registration Committee (CIBRC) to provide clarity on this matter.   Focusing on monocrotophos, PAN noted its association with multiple pesticide poisoning incidents in India, most notoriously the Yavatmal pesticide poisoning event in 2017.    The Maharashtra Association of Pesticide Poisoned Persons (MAPPP) has been persistently advocating for a ban on this and other harmful pesticides linked to fatalities and injuries among farmers and agricultural workers. In fact, the Maharashtra government has written a letter to the Union Government of India to ban this and four other pesticides.   The crux of this matter traces back to a May 2020 government order which banned 27 hazardous pesticides deemed a threat to public health and safety. These pesticides, part of the contentious 66 under scrutiny for toxicity over several years, encompassed 12 insecticides, eight fungicides, and seven herbicides, totalling nearly 130 formulations.   Reportedly, the government allowed the industry a period to voice their objections. Subsequently, at the behest of major industry players, a committee was instituted under the leadership of TP Rajendran, ex-assistant director general of the Indian Council of Agriculture Research (ICAR). The panel reportedly suggested retaining the prohibition on just three of the 27 pesticides, advocating for the release of the others.   However, certain activists petitioning the Supreme Court argued that the constitution and existence of such a committee remain unverified in the public domain, while others insist on its establishment and the availability of its report.   Following this, the government revisited the original ban in February 2023, maintaining the restriction on only three pesticides. Civil society groups approached the SC questioning the revised order.    From Agropages: https://news.agropages.com/News/NewsDetail---47961.htm

The U.S. Environmental Protection Agency (EPA) is proposing to register pesticide products containing the new active ingredient ledprona for three years, a timeframe that is consistent with EPA’s approach to other novel pesticide products.   Ledprona is a new type of pesticide that relies on a natural mechanism--called RNA interference (RNAi)--used by plants and insects to protect against disease. The proposed new biopesticide involves a sprayable double-stranded ribonucleic acid (dsRNA) product that targets the Colorado potato beetle (CPB), a major pest of potato crops grown in the United States, including in the potato-growing states of Colorado, Idaho, Maine, Michigan, Minnesota, North Dakota, Oregon, Washington, and Wisconsin. The CPB feeds heavily on potato plant foliage. If left uncontrolled, CPB will eat and destroy the leaves of the plant. If this occurs around the time of flowering, the plant may not produce potatoes. The CPB is also known to develop resistance to insecticides rapidly. This sprayable dsRNA product kills the pest by ″silencing″ the CPB gene needed to produce the PSMB5 protein, whose role is essential to keeping the CPB alive, without resulting in a genetically modified organism. If approved by EPA, this RNAi-based pesticide would be the first sprayable dsRNA pesticide in the world allowed to be used commercially and sprayed on plants.   EPA supports advancements in novel pesticide technology, which can offer alternatives to chemical-based pesticides that may pose higher potential risks or have reduced effectiveness because of resistance issues. Registered and recommended conventional active ingredients for foliar use against immature and adult CPB currently include the neonicotinoids (e.g., thiamethoxam), the spinosyns, abamectin, novaluron (an insect growth regulator), the diamides (e.g., cyantraniliprole), and some pre-mixes of these (e.g., abamectin and cyantraniliprole).   Consistent with its obligation to ensure that the product does not pose unreasonable adverse effects on the environment, including that residues of that product are safe for consumption, EPA has conducted a robust evaluation of this novel biotechnology product. EPA’s assessment also includes an Endangered Species Act (ESA) evaluation. In considering the risk for this technology, EPA has also been engaged with international partners and experts in the field via its leadership of the Organisation for Economic Co-operation and Development (OECD) Working Party on Pesticides Ad Hoc Expert Group on RNAi-based Pesticides.   In May 2023, EPA approved an experimental use permit (EUP) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for testing in 10 states (Idaho, Maine, Michigan, Minnesota, New York, North Dakota, Oregon, Virginia, Wisconsin, Washington). The EUP required the permittee to immediately notify EPA of any findings from the experimental uses that have a bearing on safety. No such findings have been reported to EPA thus far. Data generated from the EUP testing on product efficacy and application methods may be used in a future application for this product to amend its directions for use.   In addition to the proposal to limit the duration of this registration to three years in order to receive and assess any data from the EUP testing, EPA is proposing to require the same personal protective equipment as required under the EUP, including long-sleeved shirt, long pants, socks, shoes, protective eyewear, and a particulate filtering respirator.   To read more about the proposed registration of ledprona and to comment, see docket EPA-HQ-OPP-2021-0271 at https://www.regulations.gov/docket/EPA-HQ-OPP-2021-0271. The public comment period will be open for 15 days, closing on Friday, October 13th, 2023.

By DON JENKINS Capital Press A pesticide maker and farm groups have asked the 8th U.S. Circuit Court of Appeals to make the Environmental Protection Agency wait to see whether its ban on chlorpyrifos holds up before canceling products containing the chemical. EPA appears poised to cancel labels for three chlorpyrifos products registered for use on food crops by Gharda Chemicals International, even though the circuit court has yet to rule on the ban’s legality. If the EPA cancels the labels and the court later overturns the ban, reregistering products will cost more than $1 million and take three years, hurting Gharda and farmers, according to Gharda and the producer groups. The EPA has yet to respond to the motion, but has previously rejected requests to wait for a court ruling. The EPA late last month indicated it wanted to revoke Gharda’s labels soon, arguing canceling the labels was the next local step to enacting a ban. Chlorpyrifos has been widely employed in food and non-food uses since 1965. Anti-pesticide groups petitioned the EPA in 2007 to prohibit chlorpyrifos, alleging that even small amounts of residue on food damaged the brains of infants and unborn children. The Biden EPA, under pressure from an impatient 9th U.S. Circuit Court of Appeals on the West Coast, finally banned chlorpyrifos under the Federal Food, Drug and Cosmetic Act in 2022. Gharda, the American Farm Bureau, National Association of Wheat Growers and 17 other farm groups sued in the Midwest’s 8th Circuit Court to overturn the ban. The court heard oral arguments last December, but has yet to rule. Commercial farmers have been barred from applying chlorpyrifos for two growing seasons. Farm groups maintain that chlorpyrifos is still an important pesticide to confront a wide spectrum of pests. Gharda and producer groups are seeking to reinstate the EPA’s finding during the Trump administration that chlorpyrifos could be used safely on 11 crops in select geographic regions. The crops included apples in Washington, sugar beets in Idaho and strawberries in Oregon. Gharda invested in manufacturing chlorpyrifos as other companies voluntarily withdrew chlorpyrifos products. Gharda has stockpiles in India ready for U.S. distribution and a ban would be catastrophic to the company, according to a court declaration by Gharda President Ram Seethapathi.   From Agropages: https://news.agropages.com/News/NewsDetail---47759.htm