Data exclusivity
Topic: International Trade Policy, WTO and Intellectual Property · NCERT: Beyond NCERT
Meaning
Data exclusivity is a period during which drug regulators cannot rely on the original company's clinical-trial data to approve cheaper generic versions. Generic makers would have to repeat costly trials or wait. This can delay generics even after the patent has expired. India rejects data exclusivity. TRIPS Art. 39.3 requires only protection against "unfair commercial use" of such data.
Example
Suppose a drug's patent ends. Under data exclusivity, an Indian generic maker still could not get approval by relying on the original company's trial results. Cheap generics would reach patients later. The US cites India's weak data protection when it places India on the Special 301 "Priority Watch List".
Don't confuse with
- Patent: a patent protects the invention for 20 years from filing. Data exclusivity protects the test data and can run separately from the patent.
Related concepts
- Intellectual property rights
- TRIPS
- Patent
- Evergreening of patents
- Pre-grant opposition
- Compulsory licensing
- Parallel import
- TRIPS-plus provisions
- Patent pool
- Patent thicket