Drug Patents International

Take 200g of fresh snow crab shells, that is, leftovers produced by fresh snow crabs just after aquatic processing in the previous process. After crushing, add 1000g of citric acid solution with a concentration of 5% by mass, soak for 15 hours, filter with gauze, and use tap water or The crab shell is washed with pure water to obtain a decalcified crab shell. The washing residue and the filtrate are combined to obtain a mixture. The mixture is filtered through a plate and frame, and the filter residue is dried to obtain calcium citrate. Add 1000g of 5% citric acid solution and repeat the above steps once to obtain decalcified crab shells; add 1000g of water to the decalcified crab shells, add 2g of flavor enzymes, keep them at 49°C for 3 hours, inactivate the enzymes, filter, and obtain The filtrate is concentrated and spray-dried to obtain crab protein powder. The obtained crab shells are added to 400 g of 10% citric acid solution, soaked for 6 hours, filtered with gauze, and the resulting filter residue is washed and dried to obtain chitin. The obtained filtrate is recovered for subsequent processing. For use, add 55% KOH solution (containing 0.1% potassium acetate) to the obtained chitin, where the mass percentage of chitin and KOH solution is 1:5, at 90°C, keep for 6 hours, filter after cooling, wash, and recover the filtrate and The washing liquid is used again after subsequent treatment. The washed filter residue is irradiated with ultraviolet rays for 12 hours, and 24.2 g of chitosan is obtained after drying.

Every difficulty is an opportunity

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Friday 6 September 2019

EP Patent Validation Service

Traditional route

The conventional route for EP patent validation is for the client to instruct their EP attorneys to execute the validation. The EP attorneys would then instruct a validations provider (like us) or perform the validations themselves using attorney partners in each country who they use based on a reciprocity model, which is usually not cost or quality selective. The EP attorneys would add significant fees for each country.

About our EP Patent Validation service : Why you should go with us.

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Validation is a significant part of the cost of a European Patent lifecycle, especially if many countries are required. Filing tens of thousands of validations per year, and translating millions of words into every language, means that ours buying power is enormous. We provide user-friendly and extremely efficient processes to our agents and suppliers which further reduce their costs, and all of this means we are able to pass on these savings to our customers.

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Director at De Science Infoware Pvt Ltd

linkedin.com/in/sandeep-mishra-35b215b

scienceinfoware@gmail.com

///////////Sandeep Mishra, Director, e Science Infoware, ep, patent

Thursday 4 July 2019

New patent, Opicapone, WO 2019123066, Unichem

WO-2019123066

https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2019123066&tab=PCTDESCRIPTION

Process for the preparation of opicapone and its intermediates, useful for treating parkinson's disease. Bial-Portela has developed and launched opicapone, for treating Parkinson's disease.

Opicapone is a selective and reversible catechol-O-methyltransferase (COMT) inhibitor, use as adjunctive therapy for parkinson’s disease. Opicapone was approved by European Medicine Agency (EMA) on June 24, 2016 and it is developed and marketed as ONGENTYS® by Bial-Portela in Europe. Opicapone is chemically described as 2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-l,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-l-oxide and depicted below as compound of formula (I).

Opicapone and a process for preparation of it is disclosed in US 8,168,793. The process disclosescondensation of 3, 4-dibenzyloxy-5-nitrobenzoic acid with (Z)-2, 5-dichloro-N'-hydroxy-4, 6-dimethylnicotinimidamide in presence of N, N’-Carbonyl diimidazole in N, N’-dimethylformamide. The crude condensation intermediate was subjected to tetrabutylammonium fluoride (TBAF) mediated cyclization in tetrahydrofuran to give l,2,4-oxadiazole derivative, purifying it by precipitating in 1:1 mixture of dichloromethane: diethyl ether and recrystallized it in isopropyl alcohol. Oxidation of l,2,4-oxadiazole compound is carried out using 10 fold excess of urea hydrogen peroxide complex and trifluoroacetic anhydride in dichloromethane and was purified by column chromatography. Obtained N-oxide compound was converted into opicaponecompound of formula (I) by deprotection O-benzoyl groups by exposure it to boron tribromide (BBr3) in dichloromethane at -78°C to room temperature. Final product was purified in mixture of toluene and ethanol. Above synthetic stepsare outline in scheme 1.

c eme

This process has several drawbacks like cyclization reaction involve use of TBAF and THF. Use of expensive TBAF, leads to high cost in the production and therefore uneconomical for industrial production, whereas use of THF during this reaction has limitation due to peroxide contents. . Similarly diethyl ether is a potential fire hazard and can form peroxides rapidly and thus should be avoided in commercial scale production. Above cyclization is also carried out in presence of DMF and CDI at l20°C.

Similar approach was reported in W02008094053 which describes preparation of opicapone by one pot cyclization of 3,4-dibenzyloxy-5-nitrobenzoic acid with (Z)-2,5-dichloro-N'-hydroxy-4,6-dimethylnicotinimidamide using N,N'-Carbonyl diimidazole in N,N'-dimethylformamide followed by heating the reaction mixture at l35°C for 5 hours to obtain l,2,4-oxadiazole derivative. This oxadiazole derivative was purified by recrystallization from isopropyl alcohol. Further oxidation using urea hydrogen peroxide complex followed by o-debenzylation using boron tribromide (BBr3) was achieved to obtain Opicapone.

This process also suffers from drawback like use of elevated temperature (l35°C) and use of expensive BBr3.

US 9,126,988 also disclose process for the preparation of opicapone, whichinvolves several chemical steps: 1) nitrating vanillic acid in presence of nitric acid in acetic acidfollowed by recrystallization with acetic acid to get nitro compound with yield 40-46%; 2)which converted into acid chloride compoundby treating it with thionyl chloride in presence of catalytic amount of N, N-dimethylformamide in dichloromethane or l,4-dioxane; 3) condensing acid chloride compound with (Z)-2, 5-dichloro-N'-hydroxy-4, 6-dimethylnicotinimidamide in presence of excess amount of pyridine in N,N-dimethyl acetamide/ tetrahydrofuran/ dichloromethane or l,4-dioxane at 5-10 °C and then heating the reaction mixture at H0-l l5°C for 5-6 hours to get 1,2,4-oxadiazole compound; 4) which was oxidized using urea hydrogen peroxide complex and trifluoroacetic anhydride in dichloromethane to get N-oxide product which was purified by repeated recrystallization (2 or more times) using mixture of formic acid and toluene to get pure product with 59% yield; 5) O-methyl group was deprotected using aluminium chloride and pyridine in N-Methyl pyrrolidone at 60 C to obtain opicapone. After completion of reaction, the crude product was isolated by quenching the reaction mixture in mixture cone. HC1: water followed by filtration, washing with water: isopropyl alcohol and recrystallization from ethanol. Final purification was done in mixture of formic acid and isopropyl alcohol. Above synthetic steps are outline in scheme 2.

Scheme 2

As described above, cited literature processes suffers from some drawbacks like elevated reaction temperature and longer duration, use of excess amount of pyridine for cyclization reaction which is difficult to handle on large scale preparation. Another drawback of reported procedure is unsafe workup procedures for isolation of N-oxide as residual peroxides were not quenched by any peroxide quenching reagent. Also repeated crystallizations (more than two) are required for purification of N-oxide derivative to remove unreacted starting material which is tedious and time consuming process. Also for its purification mixture of solvent i.e. formic acid and toluene are used which hamper its recovery and is not cost effective process.

US 9,126,988 also disclosed process for the preparation of 2,5-dichloro-N'-hydroxy-4,6-dimethylnicotinimidamide compound of formula (IV), in which 2,5-dichloro-4,6-dimethylnicotinonitrile compound of formula (VIII) was reacted with hydroxyl amine solution in the presence of catalytic amount of 1,10-phenanthroline in methanokwater at 70-80°C for 6 hrs. After completion reaction mixture was cooled, filtered and dried to get 2,5-dichloro-N'-hydroxy-4,6-dimethylnicotinimidamide of formula (IV) (88%).

Bioorganic & Medicinal Chemistry 13 (2005) 5740-5749, Karl Bailey et.al. disclosed process for preparation of 3,4-dimethoxy-5-nitro benzoic acid compound of formula (Ilia). In which a solution of Cr03, concentrated H2S04 and water was added to solution of 3,4-dimethoxy-5-nitro benzaldehyde in acetone and water. The obtained solution was stirred for 24 hrs and then isopropanol was added to eliminate any unreacted Cr(VI) species to obtained crude green sludge, which was extracted into ethyl acetate and washed with 1M HC1 to remove remaining Cr(III) species. Obtained product is then recrystallized from water and ethanol to yield 69 % of 3,4-dimethoxy-5-nitro benzoic acid compound of formula (Ilia).

US 5,358, 948 also disclosed process for preparation of 3,4-dimethoxy-5-nitro benzoic acid compound of formula (Ilia). In which a solution of potassium permanganate was added to a solution of 3,4-dimethoxy-5-nitro benzaldehyde in acetone. The mixture was then stirred at 20°C for 18 hrs togives 3,4-dimethoxy-5-nitro benzoic acid compound of formula (Ilia) with 72% yield.

Disadvantage of the above cited literature (Karl Bailey et.al and US’ 948) processes are harsh, acidic condition and involve expensive reagents. The process is both uneconomical and time consuming, (18-24 hrs) hence not suitable for commercial production.

Oxidation of aldehydes to the corresponding carboxylic acids, on the other hand, are commonly carried out using KMn04 in acidic or basic media, or K2Cr207 in acidic medium or chromic acid. These heavy metal-based reagents are hazardous and the protocols produce metal wastes that require special handling owing to their toxicities.

It is therefore, desirable to provide efficient, robust, alternative simple process, cost effective process which is used on a large scale and allows product to be easily workup, purified and isolate without the disadvantages mentioned above.

Example 1: Preparation of 3, 4-dimethoxy-5-nitro benzoic acid (Ilia).

To a cooled solution of 3,4-dimethoxy-5-nitro benzaldehyde (lOOg, 0.474 mole) in DMF (500 ml) was added Oxone (294.1 g, 0.478 mole) lot wise at 5-10 °C. Reaction mixture was stirred for 30 minutes at same temperature, allowed to warm to room temperature and stirred for 2-3 hours. After completion, the reaction mixture was diluted with 1500 ml of water and filtered. The solid was washed with water until all peroxides removed and drying at 50°C under vacuum afforded 3,4-dimethoxy-5-nitro benzoic acid of formula (Ilia) (l02g, 95%).

Example 2: Preparation of 2 ,5-dichloro-N' {[(3,4-dimethoxy-5-nitrophenyl) carbonyl]oxy}-4, 6-dimethylpyridine-3-carboximidamide (Va)

To a solution of 3,4-dimethoxy-5-nitro benzoic acid of formula (Ilia) (5 g, 0.022 mole)in 60 ml of acetonitrile was added N,N'-Carbonyldiimidazole (4.28g, 0.026 mole) in portions and the reaction mixture was stirred at room temperature for 1.5 hours. Then was added 2,5-dichloro-N'-hydroxy-4,6-dimethylnicotinimidamide of formula (IV) (5.4g, 0.023 mole) and stirring was continued for 3 hours. After completion, the reaction mixture was diluted with 240 ml of water and 300 ml of dichloromethane. Organic layer was separated and washed with water (200 ml x 3), concentrated under reduced pressure to obtain 2,5-dichloro-N'{ [(3,4-dimethoxy-5-nitrophenyl)carbonyl]oxy}-4,6-dimethylpyridine-3-carboximidamide of formula (Va) (8.67g, 88.9%).

Example 3: Preparation of 2, 5-dichloro-3-[5-(3, 4-dimethoxy-5-nitrophenyl)-l,2,4-oxadiazol-3-yl]-4,6-dimethylpyridine (Via)

To a solution of 2,5-dichloro-N'{ [(3,4-dimethoxy-5-nitrophenyl)carbonyl]oxy}- 4,6-dimethylpyridine-3-carboximidamide of formula (Va) (0.5g, 0.0011 mole)in 10 ml of dichloromethane was added isopropyl alcohol (1 ml) followed by KOH (0.075g, 0.001 lmole) dissolved in 0.1 ml of water. After stirring for 1 hour at room temperature the reaction mixture was diluted with 30 ml of dichloromethane and washed with water (lOml x 2). The reaction mixture was concentrated under reduced pressure to obtain 2,5-dichloro-3-[5-(3,4-dimethoxy-5-nitrophenyl)-l,2,4-oxadiazol-3-yl]-4,6-dimethylpyridine of formula (Via) (0.4 g, 83%).

Example 4: Preparation of 2,5-dichloro-3-[5-(3,4-dimethoxy-5-nitrophenyl)-l,2,4-oxadiazol-3-yl]-4,6-dimethylpyridine (Via) (One pot cyclization procedure)

To a stirred solution of 3,4-dimethoxy-5-nitro benzoic acid formula (Ilia) (lOOg, 0.44 mol)in 1000 ml of dichloromethane was added N,N'-Carbonyldiimidazole (86g, 0.53 mole) in portions and the reaction mixture was stirred at room temperature for 1.5 hours. Then was added 2,5-dichloro-N'-hydroxy-4,6-dimethylnicotinimidamide of formula (IV) (l08g, 0.46 mole) and stirring was continued for 3 hours. Isopropyl alcohol (200 ml) and KOH (30g, 0.53 mole) dissolved in 30 ml of water was then added to the reaction mixture. After stirring for 1 hour at room temperature the organic layer was washed with water (1000 ml x 2). Solvent was distilled out at atmospheric pressure, added 1000 ml of isopropyl alcohol and suspension was stirred at 55-60°C for 2 hours. The reaction mixture was allowed to cool to room temperature, stirred for 2 hours and filtered. The solid was washed with isopropyl alcohol (100 ml x 2) and dried at 50-60°C under vacuum to obtain 2,5-dichloro-3-[5-(3,4-dimethoxy-5-nitrophenyl)-l,2,4-oxadiazol-3-yl]-4,6-dimethylpyridine of formula (Via) (l60g, 85%).

Example 5: Preparation of 2,5-dichloro-3-[5-(3,4-dimethoxy-5-nitrophenyl)-l,2,4-oxadiazol-3-yl]-4,6-dimethylpyridine (Via) (cyclization procedure using thionyl chloride)

To a stirred solution of 3,4-dimethoxy-5-nitro benzoic acid of formula (Ilia) (lOOg, 0.44 mol) in 500 ml of dichloromethane was added 0.4 ml of N,N-dimethyl formamide followed bythionyl chloride (82g, 0.69 mole) drop wise at room temperature and the reaction mixture was heated at 40°C for 4 hours. After completion, dichloromethane and excess of thionyl chloride was distilled out under reduced pressure at 40°C. The obtained residue was dissolved in 500 ml of dichloromethane and was added to pre-cooled mixture of 2,5-dichloro-N'-hydroxy-4,6-dimethylnicotinimidamide of formula (IV) (l03g, 0.44 mole) and triethyl amine (73 ml, 0.53 mole) in 500 ml of dichloromethane at 5°C. After addition, the reaction mixture was allowed to warm to 25-30°C and stirred for 2 hours. Then was added isopropyl alcohol (200 ml) followed by KOH (62g, 1.1 mole) dissolved in 62 ml of water and stirring was continued for 2 hours at room temperature. The reaction mixture was washed with 1000 ml of water, 1N aqueous HC1 solution (500ml x 2) followed by 500 ml of 5% aqueous sodium bicarbonate solution. Solvent was distilled out at atmospheric pressure at 40°C. To the residue was added 1200 ml of methanol and the suspension was stirred at 55-60°C for 2 hours. The reaction mixture was allowed to cool to room temperature, maintained for 2 hours and filtered. The solid product was washed with methanol (100 ml x 2) and dried at 50°C under vacuum to obtain 2,5-dichloro-3-[5-(3,4-dimethoxy-5-nitrophenyl)- 1, 2, 4-oxadiazol-3-yl]-4, 6-dimethyl pyridine of formula (Via) (l65g, 88%).

Example 6: Preparation of 2,5-dichloro-3-[5-(3,4-dimethoxy-5-nitrophenyl)-l,2,4-oxadiazol-3-yl]-4,6-dimethylpyridine-l-oxide (Vila)

To a cooled solution of 2,5-dichloro-3-[5-(3,4-dimethoxy-5-nitrophenyl)-l,2,4-oxadiazol-3-yl]-4,6-dimethylpyridine of formula (Via) (25g, 0.0588 mole) in 300 ml of dichloromethane was added urea hydrogen peroxide complex (l8.26g, 0.194 mole) in portions followed by trifluoroacetic anhydride (37g, 0.176 mole) maintaining temperature below l0°C. After stirring at 5-l0°C for 1 hour, the reaction mixture was allowed to warm to room temperature and stirred for 5 hours. The reaction mixture was washed with water (300 ml x 2), 300ml of 5% aqueous sodium sulphite solution to quench residual peroxides and finally with 300 ml of water. Dichloromethane layer was distilled out at atmospheric pressure. The obtained solid was suspended in 250 ml of ethyl acetate and 12.5 ml of cone. HC1 was added at room temperature. The resulting suspension was then stirred at 65-70°C for 1 hour and allowed to cool to room temperature. After stirring for 2 hours, the reaction mixture was filtered, solid was washed with ethyl acetate (50 ml x 2) followed by water (50 x 3) and dried at 50°C under vacuum to obtain (5-(3,4-bis(methoxy)-5-nitrophenyl)-l,2,4-oxadiazol-3-yl)-2,5-dichloro-4,6-dimethylpyridine 1 -oxide of formula (Vila) (18g, 69%).

Example 7: Preparation of 5-[3-(2,5-Dichloro-4,6-dimethyl-l-oxido-3-pyridinyl)-l,2,4-oxadiazol-5-yl]-3-nitro-l,2-benzenediol (Opicapone, I)

To a cooled solution of 2,5-dichloro-3-[5-(3,4-dimethoxy-5-nitrophenyl)-l,2,4-oxadiazol-3-yl]-4,6-dimethylpyridine-l-oxide of formula (Vila) (25g, 0.056 mole) in 200 ml of N,N-Dimethylformamide was added AlCl3 (l l.34g, 0.085 mol) at 5-l0°C in portions. The reaction mixture was then heated at 85 °C for 6 hours. After completion, the reaction mixture was cooled to room temperature and poured onto cold mixture of cone. HC1 (200 ml) and water (400 ml). The reaction mixture was filtered, solid washed with water (100 ml X 3) followed by methanol (50 ml x2) and dried at 50°C under vacuum to obtain 5-[3-(2,5-Dichloro-4, 6-dimethyl- l-oxido-3-pyridinyl)- 1,2, 4-oxadiazol-5-yl]-3-nitro- 1,2-benzenediol of formula (I) (22 g, 94%).

Example 8: Preparation of 2, 5-dichloro-N'-hydroxy-4, 6-dimethyl nicotinimidamide of formula (IV)

To a suspension of 2,5-dichloro-4,6-dimethylnicotinonitrile of formula (VIII) (lOOg, 0.497 mole) in l,4-dioxane (400 ml) and water (900 ml) was added 50% aqueous solution of hydroxyl amine (l30g) and N-methyl morpholine (50.2g, 0.497) at room temperature. The reaction mixture was then stirred at 70-80°C for 10 hours. After completion, water (1100 ml) was added to the reaction mixture at 70-80°C and allowed to cool to room temperature. After stirring for 2 hours the reaction mixture was filtered, solid was washed with water (200ml x 3) and dried at 50°C under vacuum to obtain 2,5-dichloro-N'-hydroxy-4,6-dimethylnicotinimidamide of formula (IV) (68 g, 58%).

Example 9:Preparation of 2,5-dichloro-N'-hydroxy-4, 6-dimethylnicotinimidamide of formula (IV)

To a suspension of 2,5-dichloro-4,6-dimethylnicotinonitrile of formula (VIII) (lOOg, 0.497 mole) in methanol (600 ml) and water (800 ml) was added 50% aqueous solution of hydroxyl amine (l30g) and 2-methylpyrazine (7.02g, 0.0746) at room temperature. The reaction mixture was then stirred at 70-80°C for 6-8 hours. After completion, water (800 ml) was added to the reaction mixture at 70-80°C and allowed to cool to room temperature. After stirring for 2 hours the reaction mixture was filtered, solid was washed with water (200ml x 3) and dried at 50°C under vacuum to obtain 2,5-dichloro-N'-hydroxy-4,6-dimethylnicotinimidamide of formula (IV) (82 g, 70%).

Example 10: Preparation of 2,5-dichloro-N'-hydroxy-4,6-dimethylnicotinimidamide of formula (IV)

To a solution of hydroxylamine hydrochloride (86.4g, 1.243 mole) in 400 ml of water was added LiOH.H20 (52.7g, 1.25 mole) at room temperature and heated at 50°C for 30 minutes. To the reaction mixture was added 300 ml of methanol, 2-methylpyrazine (3.5 lg, 0.037 mole) and 2,5-dichloro-4,6-dimethylnicotinonitrile of formula (VIII) (50g, 0.248 mole) at 50°C. The reaction mixture was then stirred at 70-80°C for 6 hours. After completion, water (500 ml) was added to the reaction mixture at 70-80°C and allowed to cool to room temperature. After stirring for 2 hours the reaction mixture was filtered, solid was washed with water (lOOml x 3) and dried at 50°C under vacuum to obtain 2,5-dichloro-N'-hydroxy-4,6-dimethylnicotinimidamide of formula (IV) (37.6 g, 64%).

Example 11: Purification of 5-[3-(2,5-Dichloro-4,6-dimethyl-l-oxido-3-pyridinyl)-l,2,4-oxadiazol-5-yl]-3-nitro-l,2-benzenediol (Opicapone, I)

The crude 5-[3-(2,5-Dichloro-4, 6-dimethyl- l-oxido-3-pyridinyl)- 1,2, 4-oxadiazol-5-yl]-3-nitro-l,2-benzenediol of formula (I)(25.0g) was suspended in 250 ml of N,N-dimethylformamide and reaction mixture was heated at 60-65°C to obtain clear solution. Then was added 500 ml of methanol and reaction mixture was cooled to room temperature. After stirring for 2-3 hours, the reaction mixture was filtered, solid was washed with methanol and dried at 50°C under vacuum to obtain 5-[3-(2, 5-Dichloro-4, 6-dimethyl- l-oxido-3-pyridinyl)- 1,2, 4-oxadiazol-5-yl]-3-nitro-l,2-benzenediol of formula (I) (22.0 g, 88%).

/////////////New patent, Opicapone, WO 2019123066, Unichem, WO2019123066

Wednesday 15 May 2019

GUEST POST, POOJA KUMAR, CURRENT SCENARIO OF PATENTS IN INDIA

CURRENT SCENARIO OF PATENTS IN INDIA

By Ms. Pooja Kumar

(Registered Patent agent/Director of Innove Intellects)

Email id: pooja@innoveintellects.com

Patent is a monopoly, exclusive rights given to an individual or a company or an organization to make, sell, use and import an invention for a limited period of years. In India patents are granted to inventions that meets three important criteria namely novelty, inventive step and industrial applications. Patents can be given to either product or process. The product can be a device or apparatus or any formulations.

Over the years in India, people are getting serious about the protection of intangible property. And this can be observed by the below mentioned graph:

The WTO is the governing body at the international level, which covers Trade Related Aspects
of Intellectual Property Rights (TRIPs) and several allied agreements. The World Intellectual
Property Organization (WIPO) is another international organization that helps and ensures the
rights of creators and owners of Intellectual Property are protected worldwide and that inventors
thus, recognized and rewarded for their ingenuity.
PATENTS IN THE INDIAN SCENARIO:

The laws pertaining to Patent in India is governed by the Patents Act, 1970 which has been
amended twice by The Patents (Amendment) Act, 1999 and The Patents (Amendment) Act,
2002.
Now-a-days, India has become one of the top patent filers in the world. This graph shows the
efforts of our government and the people who take the initiative to aware people about
Intellectual Property rights (IPR). Indian government has started various startup schemes which
led to the 12-fold increase in the establishment of startups in last year. India, which has 1.6
million active trademarks, registered a total of 339,692 new one last year, 287,139 from domestic
and 52,553 of foreigners, according to the WIPO. Also, government has been provided different
facilities such as early publication, expedited examination, online filing procedures, online
hearings, etc to make the procedure of getting patent easier. Recently, Indian Oil Corporation
emerges as the one of the top patent filing organization in India.
Patent applications are divided into one or more types by the patent office, and as per Indian
Patent Office, a patent applicant can type multiple kinds of patent applications. The documentary
requirements and other formalities for each patent application type are different, and hence it is
crucial to identify the exact type of patent application before initiating the patent filing process.
While filing for a patent, few things are to be considered. The first is which type of application
you are filling. In patents, there are five types of patent applications:
(a) Ordinary Application is the application which is made at the Patent Office for grant of
patent and does not contain any priory claims of application made in any convention country or
countries.
(b) Convention Application is a subsequent application made under Section 135 of the Patent
Act, 1970, claiming the priority date on the application which was filed earlier, where applicant
has already filed an application for grant of patent in a convention country or countries.
(c) PCT Application stands for Patent Cooperation Treaty. The Patent Cooperation Treaty
(PCT) is an international patent law treaty, concluded in 1970. It provides a unified procedure for
filing patent applications to protect inventions in each of its contracting states/countries. The
applicant gets 30-31 months’ time to enter into these countries for getting protection on its
invention, wherein such an application is called PCT National Phase Application. In addition,
patent applicants can file a PCT International Application, either with the Indian Patent Office as
Receiving Office, or directly with International Bureau (IB) of the World Intellectual Property
Organization (WIPO).
(d) Divisional Application is filed under two circumstances:
When the applicant believes that his/her application contains more than one invention and the
other inventions can be differentiated from the original application and filed as a separate
application.

When the controller of patent is of the opinion that the application contains of claims for more
than one invention.

STEPS INVOLVED PATENT FILING TO GRANT:
1. The Filing of an application for grant of a patent accompanied by either a provisional
specification or a complete specification.
2. In case provisional specification accompanies the original application, then filing of the
complete specification within 12 months from the date of filing of the provisional
specification.
3. After the expiry of 18 months time the patents get published on Indian patent office journal.
4. Filing of examination request can be made on form 18 within 48 months from the date of
filing.
5. The patent office send FER response to the applicant and the said response should filed
within 6month of time period.
6. Pre grant opposition can be applied by any interested person after publication and before
grant of patent.
7. Finally Grant and sealing of the patent.
8. Renewal or Maintenance fees paid by the applicant after the grant of patent

BENEFITS OF PATENTS FOR STARTUPS
Patents have become the yardstick for growth for the startup industry. Disruptive start-ups are
currently challenging the incumbent industries with their patented ideas. Having a patent in their
name helps the startups to get noticed in the industry and also helps in securing funding from
potential investors. In 2015, the Government of India announced its flagship initiative of
“Startup India” and offered various incentives for businesses that drives entrepreneurship and
innovation. The key takeaway points from the initiative are as follows:
 Simplifying the startup process with Single Window Clearance through a mobile app
 Fund of funds with a total corpus Rs 10,000 crore (Covered for four years)
 Compliance based Self-certification
 Start-up India hub – A single point of communication for the entire Startup ecosystem
 Patent protection – Fast track mechanisms for start-ups patent applications
 Exception from Capital Gain Tax and tax on earnings for three years)

 Exemption from tax for incubators investing above Fair Market Value
 Faster Exits (90-day exit window)
 New initiatives for IPR rights protection
 Encourage entrepreneurship through Credit Guarantee Fund (Rs 500 crore per year)
 Promoting entrepreneurship through Atal Innovation Mission
 Innovation-centred initiatives for students – Five lakh schools to target ten lakh children
for innovation program.
 Establishing 35 new incubators in institutions
The Patents Act, 1970 has also made special provisions for startups and small entities via the
amendment done in 2016. Rule 24C allows for expedited examination of patent applications, if
the applicant is a small entity or a startup. For a company to be recognized as a startup, it must
satisfy the following criteria:
 The company is enrolled as a Private Limited company
 Its age should not be more than five years
 Its turnover has not exceeded INR 25 crore in any financial year
 It is working towards innovation, development, and commercialization of new product or
services driven by technology
 It has not been formed by reconstruction of an existing business already in operation or as
a subsidiary.

PATENTS AND PHARMACEUTICALS
Since India became a TRIPS member in 1995, the Government of India had to amend the India
Patent Act, 1970. Prior to 2005, product patents were not allowed, only patents to novel
processes were granted and that too for a period of only 14 years. This all changed after 2005,
when the new act allowed the product patents especially of pharmaceutical products and the term
of patent was extended up to 20 years.
A pharmaceutical patent claim may cover any one of the following:
 Active ingredient (API) independently
 API along with formulations, isomers, salts, prodrugs etc
 A manufacturing process
 A manufacturing process and a product
Since the amendment of 2005, it has been difficult for foreign pharmaceutical companies to get
their drugs patented in India, since the majority of the inventions have been slight alterations of
the already existing drugs. Section 3(d) of the Indian Patents Act, 1970 forbids against such
“evergreening” of drugs as is evident from the Novartis case. In 2013, after decades long battle,

the Supreme Court promptly upheld the decision of the lower court and the patent office by
saying that the invention was a slight modification of the known drug (disclosed in 1993) and
that the company did not provide enough evidence to distinguish it from the prior art. This
stringent patent laws have allowed the development of generic drugs, which the people from
even the lower socio-economic groups can afford.
About the author:
POOJA KUMAR
She is the founder and director of Innove Intellects and is also a registered patent agent and start-
up facilitator with the Government of India and having more than 12+ years of experience in
searching, drafting, and filing patent application for diverse companies, organizations and
universities. Pooja has worked with Sanshadow Consultants as a Patent Consultant and also with
Amity University in IPR cell. She has also been involved in conducting training and awareness
programs related to Intellectual Property Rights in over 20+ universities. She has also been
awarded for women entrepreneur in 2018 by GECL foundation. She had also helped university
in developing IPR Policy and IPR cell. Till now she had filed more than 200 application in India
She had opened IPR Cell facility in Swami Vivekanad University Meerut in May 2018. Many of
applications from different IPR category like copyright design and trademark has been granted
from the patent offices. Patent status is still pending with the Indian patent office.
Disclaimer
Actual resolution of legal issues depends upon many factors, including variations of fact
and laws of the land. Though the author has taken utmost care in the preparation of this
article, the information contained herein is not intended to constitute any legal advice and
the firm cannot accept any responsibility towards those who rely solely on the contents of
this article without taking further specialist advice. The reader should always consult with
legal counsel before taking action on matters covered by this article.
Reference:
1)India is granting patents like never before by Ananya Bhattacharya
2) https://drugpatentsint.blogspot.com/search/label/INDIA
3)https://www.spiegel.de/international/world/india-disregards-evergreening-drug-patents-to-
help-companies-and-poor-a-869601.html
4) https://www.dr-hempel-network.com/digital-health-startups/start-up-india/
5) http://www.mondaq.com/india/x/27903/Patent/Patents+The+Present+Indian+Scenario

Pooja Kumar

Founder & Director

Innove Intellects

Mobile: +91-9910627125

Email: Info@innoveintellects.com, pooja@innoveintellects.com

Web: www.innoveintellects.com

pooja@innoveintellects.com

/////////GUEST POST, POOJA KUMAR, CURRENT SCENARIO, PATENTS, INDIA

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