Intellectual Property Rights and Pharmaceuticals Flashcards
What is Intellectual Property (IP)?
Legal protection over creations of the mind, encouraging innovation and allowing ownership like physical property.
List different types of IP relevant to pharma.
Designs, Copyright, Database Rights, Trademarks, Know-how, Patents, Data Exclusivities.
What is a patent?
A legal right to exclude others from using an invention for 20 years, requiring public disclosure.
What are the 4 main patentability criteria?
- Novelty,
- Inventive Step,
- Industrial Applicability,
- Not Excluded (e.g., natural discoveries, medical treatments).
Why are pharma patents controversial?
Drugs are expensive during the patent term, causing access issues, but are seen as essential to innovation.
What are the CTD modules used in drug approval?
Module 1: Admin,
Modules 2–5: Overview, Quality, Non-clinical, Clinical; used in NDA and ANDA filings.
Why is IP crucial for pharmaceutical development?
Protects investment, enables commercialisation, bridges academic-industry ‘Valley of Death’.
Contrast academic and industry attitudes to IP.
Academia values publication, industry prioritises confidentiality and IP as core asset.
What did the Myriad and Brüstle cases determine?
Myriad: Natural genes not patentable in US; Brüstle: hESCs not patentable in EU if embryos destroyed.
Why is a granted patent not always commercially viable?
Real-world practicality and market need still determine success; example: centrifugal childbirth device.
What is the PCT and what does it enable?
Patent Cooperation Treaty; allows unified international patent filing with later national prosecution.
Summarise a typical pharma patent timeline.
Filing (t=0), Publication (18 months), Grant & MA (7–12 years), Term: 20 years + 5 years SPC possible.
What is a Supplementary Protection Certificate (SPC)?
Extends patent up to 5 years due to regulatory delay; applies only to first MA.
List types of patents filed in pharmaceuticals.
Molecules, Processes, Formulations, New Uses, Devices, Diagnostics.
What are other forms of exclusivity beyond patents?
Data Exclusivity (10 years), Orphan Drug (10 years), Pediatric Extension (6 months), Market Exclusivity.
What is the pharma IP approach in developing countries?
Often no patent filed; voluntary licenses issued; issues lie in access, not IP.
Summarise the key role of IP in pharma.
IP is critical to innovation, investment, commercial success, and health tech transfer.
