BP603TSemester 62 creditsTheory

Intellectual Property Rights

Complete unit-wise syllabus for BP603T as per the PCI B.Pharm NEP 2020 curriculum (Semester 6 — AI in Pharma + Analysis + Internship II).

URL:https://pharmacode.in/syllabus/semester-6/bp603t-intellectual-property-rights/

Unit-wise Syllabus

5 Units

Types of Intellectual Property6 Hours

Patents: definition, types (utility, design, plant), criteria for patentability; patents in pharmaceutical industry
Trademarks, copyrights, geographical indications, trade secrets, plant variety protection — relevance in pharmacy and healthcare
Traditional knowledge and biodiversity: Convention on Biological Diversity (CBD); Nagoya Protocol; TKDL (Traditional Knowledge Digital Library) India

Patent Filing and Prosecution6 Hours

Patent filing in India: process at CGPDTM (Patent Office, India); types of applications (provisional, complete); fees, timelines
PCT (Patent Cooperation Treaty): national and international phases; receiving office, international searching authority; designated offices
Patent prosecution: examination, first examination report (FER), response, grant; post-grant opposition; revocation; maintenance fees

Pharmaceutical Patent Strategies6 Hours

Patent analysis tools: Espacenet, Google Patents, Derwent Innovation; freedom-to-operate (FTO) analysis; patent landscaping
Pharmaceutical patent strategies: compound patents, formulation patents, process patents, method-of-use patents; secondary patents and evergreening; Section 3(d) of Indian Patents Act
Compulsory licensing: TRIPS Article 31; Bayer vs. Natco case study; government use; parallel imports

Technology Transfer and Licensing6 Hours

Technology transfer: types (vertical, horizontal); know-how; technology transfer agreements; licensing (exclusive, non-exclusive, cross-licensing)
Royalties: calculation, milestone payments; confidentiality agreements (NDA/CDA); material transfer agreements (MTA)
Technology Transfer Offices (TTOs): role in academic-industry partnership; commercialisation of research; case studies from Indian pharma

IP Litigation and Case Studies6 Hours

IP litigation in pharma: patent infringement suits, patent invalidity; design and trademark infringement; regulatory data exclusivity (data protection)
Case studies: Novartis vs. Union of India (imatinib/Gleevec, Section 3d); Roche vs. Cipla (erlotinib/Tarceva); Bayer vs. Natco (sorafenib/Nexavar — compulsory licensing)
International treaties: TRIPS, WIPO, Paris Convention, Patent Cooperation Treaty; Doha Declaration on TRIPS and Public Health

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