Training Material



Pharmaceutical Industry – Innovators & Generics

  • Innovators among pharma industries, their history, their business strategies, their financial figures etc.

  • Classification of Drugs

  • Difference between bio-similar and generics

  • Critical evaluation of Bolar exemption in Indian patent law

  • Categories for drugs patented after 1 January 1995 [new chemical entities(NCEs) or new biological entities (NBEs)

  • various factors which drive business of pharma

  • Article41 & Article 51 (Suspension of Release by customs authorities) of the trIPS Agreement


Legal and regulatory perspective

  • Various regulatory approvals (Indian as well as global) required by Pharma companies such as DRA, FDA etc.

  • System of Patent linkage in India, US and Patent linkage in other countries.

  • Generate solutions to global challenges (vaccines, drugs etc.)

  • NBA approval issues

  • Bio piracy (Convention on Biological Diversity (CBD))

  • The Rio Earth Summit (1992), Nagoya Protocol on biodiversity, negotiated in Japan (2010)

  • TKDL (traditional Knowledge Digital library)


Intellectual Property Laws


  • IP laws, their existence, threshold, applicability, importance etc. & Post trips IP environment

  • Basics of patents, patent searches, patent drafting, patent filing strategies (India as well as global), patent oppositions, patent infringement, patent commercialization, enforcement.

  • Patent Ever-Greening Strategies (Drug price competition and Patent term restoration act)

  • Exclusive Marketing Rights & Data Exclusivity

  • New CRI guidelines on Patents (section 3(d) and section 3(k))

  • Competition Law and Indian Patent Act for Pharmaceuticals

  • Patentability criteria under Indian Patent Law

  • US and EU Patent Law Basics including America Invents Act (AIA)


  • Advantages of trademarks for pharmaceutical products and goals for trademark development

  • Territorial rights and Nationality issues

  • Madrid

  • Central Drugs Standard Control Organization (Resources for unregistered names)

Designs –

Basics of designs, filing & registration processes, valuation, international design protection strategies, enforcement.

Copyrights –

  • Basics of copyrights, filing & registration processes

  • Intellectual Property Protection for Computer software patent or copyright

  • Package Inserts / Information Leaflet for copyright in pharmaceuticals

  • New amendments under CRI

  • Statutory Exception, Copyright infringement, licensing

  • Copyright & its Principles- Indian and International Scenario

  • Copyright in Pharmaceutical and life Sciences Industry (licensing agreements with the Copyright Clearance Center and journal subscriptions, Content sharing habits and challenges, Displaying information for educational purposes and Copyright compliance easy)

  • Case Law


Pharmaceuticals and Intellectual Property (IP) Laws

Biopharmaceutical Intellectual Property Rights

  • Biopharmaceutical Intellectual Property Rights, their impact on R&D and related challenges.

  • Pharma industry with reference to competition Law as well as IP law

  • Current scenario and future challenges in Pharma segment

  • Patent non-infringement

  • Freedom to Operate analysis and Opinions

  • Pre-grant Opposition and Post-grant Oppositions

  • IPAB & S. 64 Revocations in IPAB High Court



  • Specification and Claim Drafting exercises

  • Applications of Prior Art Search with examples & live case studies

  • Claim chart drafting

  • Workshop on Filing and searching of Patents

  • Tools of Patent searching and analytics

  • Patent mapping.

  • Analyzing last 3 to 4 past Examination Papers of Patent Agent Exam conducted by the Indian Patent Office