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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
Herbicides covered are aminocyclopyrachlor, aminopyralid,
bicyclopyrone, florpyrauxifen-benzyl, halauxifen-methyl,
indaziflam, methiozolin, pyrasulfotole, pyroxasulfone, pyroxsulam,
saflufenacil, and thiencarbazone-methyl.
Insecticides covered are afidopyropen, chlorantraniliprole,
cyantraniliprole, cyflumetofen, flupyradifurone, pyrifluquinazon,
spinetoram, and sulfoxaflor.
Nematicides
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
