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New Generics update 2022: Agribusiness report on active ingredients coming off patent up to 2027
The newly-released Agribusiness report, New Generics in Crop Protection 2022 details important herbicide, fungicide, insecticide and nematicide active ingredients coming off patent over the period from 2020 to 2027. Active ingredients included are registered either in the European Union or in the United States, or both.
The report comprises profiles covering 12 herbicides, 17 fungicides, 8 insecticides and 2 nematicides. A brief background to patents and data protection is also given, and all the active ingredients described are profiled.
Herbicides covered are aminocyclopyrachlor, aminopyralid, bicyclopyrone, florpyrauxifen-benzyl, halauxifen-methyl, indaziflam, methiozolin, pyrasulfotole, pyroxasulfone, pyroxsulam, saflufenacil, and thiencarbazone-methyl.
Fungicides covered are ametroctadin, amisulbrom, benzovindiflupyr, bixafen, fluopicolide, fluopyram, flutianil, fluxapyroxad, isofetamid, isopyrazam, mandestrobin, mandipropamid, oxathiapiprolin, penflufen, picarbutrazox, pyriofenone, and sedaxane.
Insecticides covered are afidopyropen, chlorantraniliprole, cyantraniliprole, cyflumetofen, flupyradifurone, pyrifluquinazon, spinetoram, and sulfoxaflor.
Nematicides covered are fluensulfone and tioxazafen. They are registered in the EU, the US or both. Fluopyram, profiled as a fungicide, is also marketed as a nematicide.
Patent duration and data protection
The filing dates of the identified patents are noted in the active ingredient profiles and in the summary tables at the beginning of the chapters covering herbicides, fungicides, insecticides and nematicides. Patents expire 20 years after the filing dates of the relevant same or related patents, but some protection may remain in force.
In recent years, intellectual property offices have recognised that agrochemical ("plant protection products") and pharmaceutical active ingredient inventions cannot be exploited commercially until regulatory approval has been obtained and that this can be a lengthy process.
As a result, in compensation, special forms of intellectual property have been developed to extend the protection of a patented active ingredient after the expiry of the patent. In the UK this is by way of a Supplementary Protection Certificate (SPC). This is explained in more detail on the website of the UK's Intellectual Property Office.
Normally an SPC will confer a further 5 years of protection for a patented active ingredient. This protection only pertains to uses that have been authorised by regulatory authorities before the expiry of the patent.
Similar arrangements are available in other European Union Members States. Regulation (EC) No 1610/96 of the European Parliament and Council created a Supplementary Protection Certificate for plant protection products. This was published in the Official Journal of the European Communities on 8 August 1996 and entered into force on 8 February 1997. The United States Patent and Trademark Office may also amend the term of a patent for various reasons.
An analysis of SPCs in the EU published in Agrow Crop Protection News (15 February 2019), pointed out that for a generic company aspiring to enter the EU market, not only must the position on composition of matter, mixtures and manufacturing be understood, but also that concerning SPCs in individual countries. Analysis of SPCs is useful competitor intelligence, because it can show where efforts are being made to protect portfolios and where there may be gaps in IPR.
The patent information given in this report is for initial guidance only and a thorough investigation of the intellectual property rights relevant to and currently prevailing upon any active ingredient must be made before embarking on any course of action.
The status of US patents can be checked via the Patent Information Retrieval System (PAIR). The European Patent Office provides comprehensive online search tools for researching intellectual property worldwide.
Intellectual property extends beyond patents. In the particular case of crop protection products, safety and efficacy data required for regulatory approval are protected from unauthorised commercial use.
However, the ownership rights of such data are limited by law. Most countries provide 10 years of protection after approval. During that time protected data must not be used or cited by secondary registrants without the express permission of the data owner.
For further details, please contact the Crop Science special reports publisher Dr Alan Bullion atalan.bullion@s&pglobal.com
Go here to download free sample report data and request more information on the full report.
This article was published by S&P Global Commodity Insights and not by S&P Global Ratings, which is a separately managed division of S&P Global.
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