2. SETUP Inhouse capabilities for IP/Patenting/Trademarks/ etc
3. Trainings for IP & R&D Teams for seamless- Innovative R&D Culture with upcoming enriching products portfolio for development
4. R&D laboratory setup as per customized need and capabilities
5. Technology Support for APIs, Chemistry, Agrochemicals, Intermediates, Key starting Materials, Specialty Chemicals, Pharma Products, Polymers and its Chemistry etc.
● We help in R&D work ideation, Invention and merits identification, Invention Crafting
● Invention Data Generation and Compiling
● Patent Drafting (Claims and Patent Specification
● Online or Offline Patent Submissions (IN/US/Global)
● Patent Prosecution for issuance(Global-IN/US/EP etc)
● Third Party Observations, Pregnant and Post grant Opposition Drafting and filing
● Drafting Patent Examination Report Response and online submission within stipulated time
● APIs , Agrochemicals and Formulations related regulated dossier queries evaluating and drafting response for IN/US/EU/CN/ Global
6. Customs Consignment’s Scientific Queries for APIs, Intermediates etc – Response Drafting and Declarations preparing
7. Online US Patent Filing
8. Patent Specifications Preparing according to Statutory requirements of US, EU, VE, CN and other countries
9. DSIR Approval for Small and Large R&Ds
10. Services related to Equipments Calibrations and Certifications (NABL Accredited)
11. ISO and other documents and system based support including Certification
What we do….
1. Pharma Chemistry, Agrochemicals, Intermediates, Key strating Materials, Speciality Chemicals, Polymers and its Chemistry, Additives, Performance Enhancers, Fire Retardants, Antiodiants, UV Stabilizers etc..related1. A R&D work ideation
2. Invention and merits identification, Invention Crafting
3. Invention Data Generation and Compiling
4. Patent Drafting (Claims and Patent Specification
5. Online or Offline Patent Submissions (IN/US/Global)
6. Patent Prosecution for issuance(Global-IN/US/EP etc)
7. Third Party Observations, Pregnant and Post grant Opposition Drafting and filing
8. Drafting Patent Exasmination Report Response and online submission within stipulated time
9. APIs , Agrochemicals and Formulations related regulated dossier queries evaluating and drafting response for IN/US/EU/CN/ Global
What we do….
1. Customs Consignment’s Scientific Queries for APIs, Intermediates etc – Response Drafting and Declarations preparing2. Online US Patent Filing
3. Patent Specifications Preparing according to Statutory requirements of US, EU, VE, CN and other countries
4. SETUP Inhouse capabilities for IP/Patenting/Trademarks/ etc
5. Trainings for IP & R&D Teams for seamless- Innovative R&D Cculture with upcoming enriching products porfolio for development
6. R&D laboratory setup as per customized need and capabilities
7. DSIR Approval for Small and Large R&Ds
8. Services related to Equipments Calibrations and Certifications (NABL Accredited)
9. ISO and other documents and system based support including Certification
APIs & Formulation
APIs (GENERICS)
● IP Landscape (DLR- IP)● Development timelines (BD/MKT/MGT Plan)
● Process development- based on IP Landscape
● Scheme- review & finalization –IP GCl-1
● Sourcing RMs/KSMs
● Feasibility & Optimization
● Lab Validation - IP GCl-2
● Tech. Transfer to GMP Site
● Plant Validation (Trial+3 Plant Validations)-IP GCl-3
● Stability Data (Zone I/II/III/IVa/IVb)
● DMF submission-RA Team- IP GCl-4
● API sale- Domestic/Captive/Export
FORMULATIONs (GENERICs)
● IP Formulations Landscape (DLR- IP)● Development timelines (BD/MKT/MGT Plan)
● Markets- Clarity
● Dosage Forms/RLD Availability
● Strategy- based on DLR-IP (PII/PIII/PIV/505(b)2]
● Product development- based on IP Landscape
● Proposed Compositions review & finalization–IP GCl-1
● Sourcing RMs/Excipients
● Feasibility & Optimization
● FR&D Lab Validation - IP GCl-2
● Scale up at GMP Site
● Exhibit Batches (Trial/3 EB) IP GCl-3
● Stability Data (Zone I/II/III/IVa/IVb)
● BE study (If required)- Results- Dossier Compilation)
● Dossier Submission- RA (ANDA/MA etc)
Other Important work!
➢ KSMs Vendor approval (Regulated MKT-Important)➢ R&D –DQA activities? (PDR? Data Integrity while Data generation)
➢ Stability system/ Protocols etc (ICH- Zones)
➢ DSTR/DPTR?
➢ Impurities Synthesis- Inhouse-sourcing delays/Plan? Expensive?
➢ Polymorphism/Solid state- Characterizations
➢ Patentable inventions- drafting/ filing?
➢ DMF compilation
ORGANIZATION STRUCTURE/ALIGNMENT TOWARDS STRATEGY
➢ Team Work-Plan- Learning?➢ Integrated Efforts
➢ SPOC
➢ Project Drivers
Role of IP in Pharmaceuticals Development
During -● Developing Non-infringing process/compositions- Assessment
● Developing New/Novel processes/compositions- Assessment
● Developing new APIs POLYMORPHS/SALTS-Assessment
● Developing new APIs POLYMORPHS/SALTS-Assessment
● RISK AND GO ASSESSMENT ON PATENT PROTECTION
Some points –Useful to know
➢ IP is a currency for today’s economy.➢ There are 3 I’s of IP- Invest- Innovate- Industrial Use. An additional I came as Incentivize the innovation or invention drive.
➢ India files about 45000 patent/year and is 7th highest in the world after US/CN/KR/JP/JP/EPO/Germany
➢ Patents are unquestionably an incentive for invention , Investment and Innovation
➢ Section 3(d) of Indian Patent Act- Highest standard of patentability.
➢ Indian courts have started giving PIs (Permanent Injunctions) in IP cases e.g Merck- Sitagliptin (Januva) against Teva/Glenmark etc.; Novartis -Vildagliptin (Galvis) for Ranbaxy injunction-2014