Agrochemicals and

patents

DR. ASHWINI SANDU

Discussion on :

• GENERAL OVERVIEW OF PATENT SITUATION

IN INDIA

• AGROCHEMICAL INDUSTRY

• Importance of patent regime

• Do’s and Don’t

• Competitive Intelligence

• Product Patents Expiry and

challenges

• Question Answer Session

GENERIC PROMISE – PATENT EXPIRY

• Agrochemical firms spot a 'generic' promise in patent

expiry in their sector

• Indian agrochemical companies are looking to replicate

the success that the country's generic drug makers

have had with medicines going off patent. They want to

exploit the opportunity opening up with the patent

expiry of several significant agrochemicals in the North

and Latin American markets, India and ROW.

PRODUCT PATENT

• Most important sought information in the entire

patent scenario is the expiry of product patent.

• Everything in a generic company starts based on

this date.

• Product launches.

• Challenges - process patents, crystal, polymorph,

method of use, formulation patent, combination

patent

• Tug of war continues……

Product patent - Challenges

• Highly technical

• Searching the right product patent

• Granted copy

• Family equivalents

• Expiry date calculation and patent term

extensions

• Other patents – polymorphs, crystal,

formulation, combination patents, method of use

patents

Clomazone - FMC

• Product patent FMC Corp

• Expired in 2000

• GB patent expired in 2000. SPC in DE, DK, GB expired

in 2006

• Around 1996, FMC developed low volatility

microencapsulated formulation under the trade name

Command 3ME. Formulation patent of low volatility

formulation expired around 2014-2015

trifloxystrobin

• CAS: 141517-21-7

• Product Patent US 6407100

• US Patent Expiry 18 June 2019

• EP0460575 Expired in 2011

• Some EP countries had SPC of 2 years. All

expired now.

• No Indian Equivalent

• Jurisdiction and expiry

Boscalid - basf

Product Patent expired in 2012

Crystal Patents (IP exist) expiry around 2022 and 2024

Anhydrate of Boscalid is referred as Modification I

Monoclinic anhydrate of Boscalid-Modification II

• Anhydrate of Modification II does not form crystals during crop treatment.

Spirotetramat - bayer

• Product patent : IN233121

• Expired July 2017

• Cis- Isomer Patent

• Intermediate n-1

• Divisional Patent Intermediate n-2

• Expiry 2023

Fipronil- Bayer basf

• The product patent for the fipronil chemical expired in August 2010.

• However, BASF, had another set of patents related to the manufacturing process that would prevent a rival from marketing any generic versions.

• US Patent 6414010 and 6825743

• BASF sued Israel-based Makhteshim Agan and Cheminova for patent infringement based on the process patents.

Section 3 (d) of the

Patents Act, 1970

• In order to prevent ‘evergreening’ (extension of the life of a patent over products that are about to expire on account of minor and incremental improvements in the invention) of patents, section 3 (d) of the Act provides that:

• A mere discovery of a new form/ use/ property/ process etc. of a known substance which does not result in enhanced efficacy is not patentable.

• Salts, esters, ethers, polymorphs, etc. of known substance are to be considered to be the same substance until these differ significantly in properties with regard to efficacy.

• Mere use of a known process, machine or apparatus is not patentable unless such known process results in a new product or employs at least one new reactant.

Off patent Actives

Acibenzolar-S-methyl (Syngenta)Amicarbazone (Bayer CropSciene sold rights to Arysta LifeScience)Azoxystrobin (Syngenta)Carfentrazone-ethyl (FMC Corp.)Clothianidin (Sumitomo Chemical Takeda Agro Co. jointly developed with Bayer)Cyazofamid (ISK Biosciences)Cyclosulfamuron (originally invented by Cyanamid (now BASF)Cyprodinil (Syngenta)Famoxadone (DuPont Crop Protection)Fenamidone (Bayer CropScience)Florasulam (Dow AgroSciences LLC)Flufenacet (Bayer CropScience)Flupyrsulfuron-methyl-sodium (DuPont Crop Protection)Indoxacarb (DuPont Crop Protection)Iprovalicarb (Bayer CropScience)Isoxaflutole (Bayer CropScience)

Off patent Actives

Mefenpyr-diethyl (Hoechst (now Bayer CropScience))Mesotrione (Syngenta)Picolinafen (BASF Corp.)Picoxystrobin (Syngenta)Propoxycarbazone (Bayer CropScience)Pyraflufen-ethyl (Nihon Nohyaku Co.)Quinoxyfen (Dow AgroSciences)Silthiofam (Monsanto)Spinosad (Dow AgroSciences)Spiroxamine (Bayer CropScience)Sulfentrazone (FMC Corp.)Thiacloprid (Bayer CropScience)Trifloxystrobin (was Syngenta but had to sell rights to Bayer)Triticonazole (Rhone-Poulenc (now Bayer) but sold to BASF)Tritosulfuron BASF Corp.Zoxamide (Rohm & Haas (now Dow AgroSciencs) rights acquired by Gowan Co.

Identifying the next

generation off-patent actives

• The Marketing Environment

• Intellectual Property Rights

• Chemistry/Technology of Manufacture

• Registration Issues

• Develop new opportunities in the buoyant and expanding off-patent/generic agrochemical sector.

• Understand the issues of developing new off-patent/generic agrochemicals.

• Analyze strategies for post-patent expiry market defense strategies.

• Monitor competitor intelligence.

Future Off-patent actives

• There are 26 agrochemical AIs losing their patent protection between 2017 and 2022, including 13 herbicides,4 insecticides, 8 fungicides and a safener. Some well known products, like Rynaxypyr (Chlorantraniliprole) are in the list as well as some niche products such as the eco-friendly fungicide Isotianil used on rice.

• Bayer holds the most 7 products with patents expiring in the coming 5 years, the same numbers as from Japanese companies.

• Amisulbrom from Nissan Chemical Industries,

• Pyrimsulfan from Ihara Chemical Industry,

• Pyroxasulfone from Kumiai Chemical Industry,

• Flubendiamide and Pyrifluquinazon from Nihon Nohyaku,

• Fenpyrazamine and Metofluthrin from Sumitomo Chemical will all lose their patents protection in the period.

Some challenges

• Getting the correct information out of the patent

document

• Filed patent

• Published patent

• Examination reports

• Amended claims

• Final granted patent

• Prosecution history

• Legal status of patent

• Patent Family

Key Agrochemical

Players in India

COMPETITIVE INTELLIGENCE

• What are the patents filed by the key players?

• What are the patents granted to them?

• What is it that is not allowed to be practiced?

• Is there a way to circumvent the patent?

• Can the patent be challenged?

• Is there a prior art which teaches similar

invention?

Patent searches

• Do you perform patent searches when you

initiate a project?

• Is landscape of prior art studied before initiating

formulation development for an active?

• Are you aware of the problems and challenges

faced by the active?

• Are you reinventing the wheel?

Patent filing

• Has your R and D hit upon a block buster idea?

• Is it patentable?

• Have you done a proper prior art search?

• Is the invention new, non-obvious and useful?

• Have you done enough experimentation?

• Are you ready to file a patent?

Indian patent journal

• Are you aware every Friday Indian Patent Office publishes a

journal which gives all the patents filed by Indian Companies?

• Are you watching patents filed by your competitors?

• Are you aware what blocking technology patents are filed in

India?

• Are you aware patents can be opposed successfully?

WAY AHEAD : SUCCESS MANTRA

• PRODUCT INNOVATION

• VALUE CREATION

• Looking ahead, formulation technology and the

intellectual property surrounding it will continue

to be the focus of fierce competition.

• Formulation Innovation is, and will remain to be,

the competitive battle ground in agriculture.

Any questions???

• Feel free to pen your queries to

ashwinisandu@gmail.com

• You can reach me on 9930408348 also