20

Post-Patent ANALYSIS 18

16

Chart 1: Number

The Next Generation

14
of AIs Losing Basic
12
Patent Protection

Patent Expirations
by Year and 10

of Number of New
AIs with Data
8

Protection Expiring 4
By Dr. Nigel Uttley are introduced into the market each year. As a result, only about by Year in the EU.
Contributing Writer 25% of the total market is accounted for by proprietary patented 2 2024
2022 2023
AIs. The generic sector (where no IPR exists) accounts for 25% 2020 2021

W
0 2018 2019
ith the world population soon to top 7 billion, we have to 30% of the total market, leaving 45% to 50% that is defined as = Year = EU 2014 2015
2016 2017
Source: Enigma Marketing Research report:
more than 1 billion people who have very little food the proprietary off-patent sector. 2012
2013 “New off-patent/generic agrochemicals – post 2015”
security and do not know where their next meal will This sector can be further defined by products that:
come from – that’s more than the population of North America
• Include a primary AI that is off-patent
and Europe combined. Global food supply and global peace are EU SPC -
• Have some proprietary technology (such as a new delivery
interlinked. Agrochemicals play a small part in the PATENT MAXIMUM
cost of food production and other factors such as food ACTIVE EXPIRY EXPIRY
wastage. Other inputs such as fertilizers and machin-
Table 1: AIs Losing Patent Protection 2014-2020 SUBSTANCE COMPANY YEAR YEAR
ery and delivery infrastructure are all contributors. ACTIVE INGREDIENT ACTIVITY INVENTOR COMPANY Foramsulfuron Bayer 2015 2016 • Foramsulfuron is a foliar, post-emergence, sulfonylurea herbicide
Nevertheless, during the last 60 years agrochemicals Amisulbrom Fungicide Nissan Chemical Industry Crop- discovered and developed by AgrEvo (now Bayer CropScience)
have made significant contributions to improving Science • EP and US patents to the basic AI expire 2015 and 2016 respectively
Benthiavalicarb Fungicide Kumiai Chemical Industry
yields and will continue to underpin food security • Main markets: Extensive geographical spread
Cyflufenamid Fungicide Nippon Soda • Main crops: corn/maize and turf
and contribute to global peace.
There will inevitably be greater use of agrochemi- Cyprosulfamide Safener Bayer CropScience • Main mixture products: isoxadifen-ethyl + iodosulfuron-methyl-
cals and greater need to deliver safe, innovative prod- Fenpyrazamine Fungicide Sumitomo Chemical Co. sodium and thiencarbazone + cyprosulfamide
ucts to increase yields and counter resistance problems Fentrazamide Herbicide Bayer CropScience Pyraclostrobin BASF 2015 2016 • P yraclostrobin is a broad-spectrum, strobilurin fungicide discov-
in a cost-effective way. This will be more important Flubendiamide Insecticide Nihon Nohyaku ered and developed by BASF
than ever. There must be a balance between the in- Flucetosulfuron Herbicide LG Life Sciences • EP and US patents to the basic AI expire 2015
novator companies reaping the rewards for providing • Main markets: Extensive geographical spread
Fluopicolide Fungicide Bayer CropScience
new products and a healthy, generic sector that con- • Main crops: barley, cereals, citrus, corn/maize, cotton, grapes,
tributes to driving the cost of pesticides down. Fluoxastrobin Fungicide Bayer CropScience nuts, oats, peanuts, soybeans, sunflower, vegetables and wheat
In 2013, the agrochemical crop protection industry Foramsulfuron Herbicide Bayer CropScience • Many mixture products
was worth more than $50 billion at the distributor Metalaxyl-M Fungicide Syngenta Pyridalyl Sumitomo 2015 2020 • P yridalyl is an insecticide discovered and developed by
level, and it is forecast to continue to grow at 6% to Metamifop Herbicide Dongbu Hannong Chemical Chemical Sumitomo Chemicals
8% per year over the next three to five years. There Metofluthrin Insecticide Sumitomo Chemical Co. • EP and US patents to the basic AI expire 2015
are approximately 500 active ingredients (AIs) manu- • Main markets: China, India, Japan, Netherlands, South Africa,
Metrafenone Fungicide BASF
factured from organic synthesis that account for more South Korea and United States
than 90% of the total market. As a result of mixture Orthosulfamuron Herbicide ISAGRO
• Main crops: cotton, ornamentals and vegetables
products containing more than one AI and different Penoxsulam Herbicide Dow AgroSciences • No mixture products
types of formulations containing a variety of formu- Penthiopyrad Fungicide Mitsui Chemical Agro Inc. Prothiocon- Bayer 2015 2019 • Prothioconazole is a triazolinthione fungicide discovered and
lation additives – for example adjuvants and surfac- Pinoxaden Herbicide Syngenta azole Crop- developed by Bayer CropScience
tants – there are many thousands of products avail- Prothioconazole Fungicide Bayer CropScience Science • EP and US patents to the basic AI expire 2015
able to the farmer. Intellectual Property Rights (IPR) • Main markets: Extensive geographical spread
Pyraclostrobin Fungicide BASF
in the form of patents and data protection for registra- • Main crops: barley, canola, cereals, corn/maize, peanuts, rice,
tions are fundamentally important to the dynamics Pyridalyl Insecticide Sumitomo Chemical Co.
rye, soybeans, sugar beet and wheat
of the agrochemical industry and dictate the balance Pyrifluquinazon Insecticide Nihon Nohyaku • Many mixture products
between the R&D sector (innovator companies) and Spirotetramat Insecticide Bayer CropScience
Cyflufenamid Nippon 2015 2020 • C yflufenamid is an amidoxine fungicide discovered and
the generic sector. These mixture products and new Tembotrione Herbicide Bayer CropScience Soda developed by Nippon Soda
formulations can also be granted patent protection Thiencarbazone Herbicide Bayer CropScience • EP and US patents to the basic AI expire 2015
and have resulted in significant segmentation of the • Main markets: EU, also Australia, Morocco, South Korea and US
Topramezone Herbicide BASF
market and protection from generic competition. • Main crops: cereals, fruit, vegetables, grapevines, turf and ornamentals
During the last 15 years agrochemical innovation Valifenalate Fungicide ISAGRO
• Mixture products with triflumizole, difenoconazole and hexaconazole
has declined, and now only four to eight new AIs Source: Enigma Marketing Research report: “New off-patent/generic agrochemicals – post 2015”

8 FARM CHEMICALS INTERNATIONAL September 2014 September 2014 FARMCHEMICALSINTERNATIONAL.com 9

 Post-Patent
system, surfactant or safener, or is linked to GMO crops)
• A re mixtures containing at least one patented AI
• Have data protection issues restricting generic competition
Table 1 (p. 8) lists the 28 AIs slated to lose patent protection from
2014 through 2020, and Chart 1 (p. 9) illustrates the number of AIs
that will lose patent protection in a given calendar year.
Basic Protection and SPCs
In 2015, seven of the profiled AIs lose basic patent protection,
but will generic companies be successful in entering the market?
Or, as we have emphasized in previous articles, will secondary
patents, patent term extensions and data protection restrict the
generic sector or indeed eliminate it from the market for a number
of years still to come? Five of these AIs are marketed in Europe,
and as such, they have had patent terms extended as a result of
Supplementary Protection Certificates (SPC) being granted (see
Table 2). (See “How to Bridge the Knowledge Gap” for a more
in-depth explanation on SPCs as well as Uttley’s other articles
on data protection, how to analyze market demand and more at
www.farmchemicalsinternational.com).
In addition to the AI patent, other patents such as process and
mixture patents may exist. Prothioconazole and its mixture products
were discussed in the March FCI article, which concluded that over
80% of the EU market for prothioconazole is for mixture products,
and thus, generic entrants will find it very difficult to take significant
market share for a number of years still to come.
Pyraclostrobin is a broad-spectrum, strobilurin fungicide dis-
covered and developed by BASF. It is active against a broad range
of pathogens on cereals, peanuts, grapevines, vegetables, bananas,
citrus, soybeans, cotton, sugar beet, sunflowers and turfgrass.
It is mixed with many other active ingredients including:

Table 2: Patent Extensions Provided by SPCs • epoxiconazole • fenpropimorph

• boscalid • triticonazole + metalaxyl
EU SPC - • metiram • kresoxim-methyl
PATENT MAXIMUM • tebuconazole • metconazole
ACTIVE EXPIRY EXPIRY • thiophante-methyl • fluxapyroxad
SUBSTANCE COMPANY YEAR YEAR
• fipronil • mancozeb
Foramsulfuron Bayer CropScience 2015 2016 • folpet • thiophanate-methyl
Pyraclostrobin BASF 2015 2016 • triticonazole • dithianon
Pyridalyl Sumitomo Chemical 2015 2020 • dimethomorph
Prothioconazole Bayer CropScience 2015 2019 SPCs exist for a number of these mixtures, extending
Cyflufenamid Nippon Soda 2015 2020 patent protection well beyond 2015, including:
Source: Enigma Marketing Research report: “New off-patent/generic agrochemicals – post 2015” • boscalid + • fenpropimorph
epoxiconazole • folpet
• dimethomorph • metiram
Table 3: Number of Years • epoxiconazole
of Data Protection Extended Beyond Data protection can be as significant as patent protection in
Basic Patent Expiry restricting generic competition. Chart 1 (p. 9) shows the number of
Additional number of new AIs with data protection expiring by year in the EU.
years of data protection All the AIs profiled in our latest report are classed as new AIs
Active Ingredient after basic patent expiry under Directive 91/414 and, as such, received a 10-year data-
Amisulbrom 6 protection period. For many of these, the data-protection period
Benthiavalicarb 3 extends well beyond patent expiry.
Table 3 shows the number of additional years data protection
Cyflufenamid 5
extends for some AIs whose basic patents expire in the next six years.
Fenpyrazamine 3 As the examples of prothioconazole and pyraclostrobin demonstrate,
Flubendiamide 5 it is not sufficient just to determine when the patent for the AI expires,
Fluopicolide 1 it is essential that would-be generic suppliers assess any extended IPR
for mixture products, process patents, data protection and many other
Fluoxastrobin 1
aspects before attempting to enter the market. •
Penoxsulam 3
Penthiopyrad 8 Dr. Nigel Uttley is founder and CEO of Enigma Marketing
Prothioconazole 3 Research. His AgriBase database and Reports help analyze
Pyridalyl 9 new market opportunities for post-patent companies.
EMR has just published the eighth report, “New off-patent/
Spirotetramat 7
generic agrochemicals – post 2015”, which profiles 28 AIs
Tembotrione 5 that will lose patent protection between now and 2020. Uttley
Thiencarbazone 4 can be reached at nigel.uttley@enigmamarketingresearch.
Valifenalate 5 com and a sample AgriBase can be demonstrated at www.
enigmamarketingresearch.com
Source: Enigma Marketing Research report:
“New off-patent/generic agrochemicals – post 2015”

10 FARM CHEMICALS INTERNATIONAL September 2014