Patent Expiration in different countries:
- The duration of pharmaceutical patents varies across countries based on national patent laws and international agreements like the TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights) under the World Trade Organization (WTO). Below is a general overview of patent expiration rules in key pharmaceutical markets:
1. Standard Patent Term
Most countries grant a 20-year patent term from the date of filing. This applies to both active pharmaceutical ingredients (APIs) and formulations. However, effective market exclusivity can differ due to factors like patent term extensions and regulatory approval delays.
| Country/Region | Standard Patent Term | Patent Term Extensions (PTE) / Regulatory Exclusivity |
| United States | 20 years from filing date | Up to 5-year extension under Hatch-Waxman Act |
| European Union | 20 years from filing date | Supplementary Protection Certificate (SPC) extends up to 5 years |
| Japan | 20 years from filing date | Up to 5-year extension for regulatory delays |
| India | 20 years from filing date | No patent term extension |
| China | 20 years from filing date | Up to 5-year extension for new drugs |
| Canada | 20 years from filing date | Certificate of Supplementary Protection (CSP) extends up to 2 years |
| Australia | 20 years from filing date | Up to 5-year extension |
| Brazil | 20 years from filing date | Extensions granted only for delays in approval |
| Russia | 20 years from filing date | No standard extension, but can apply for supplementary protection |
2. Factors That Affect Patent Expiration
- (a) Patent Term Extensions (PTE) / Supplementary Protection
- Some countries extend patent life to compensate for regulatory delays in drug approvals.
- The U.S. Hatch-Waxman Act and the EU’s Supplementary Protection Certificate (SPC) system grant up to 5 extra years for approved drugs.
(b) Data and Market Exclusivity:
Even after a patent expires, regulatory exclusivities can delay generic or biosimilar competition:
- U.S.: New chemical entities (NCEs) get 5 years of data exclusivity; biologics get 12 years.
- EU: Data exclusivity lasts 8 years, with an extra 2 years of market exclusivity.
- India & China: Limited data exclusivity rules; patent expiration usually allows generic entry.
(c) Evergreening Strategies
- Brand companies often file secondary patents (e.g., on formulations, delivery systems) to extend monopoly beyond the original 20-year term.
- These secondary patents can delay generic competition unless successfully challenged.
3. When Do Generics Enter the Market?
- Small-molecule generics typically enter immediately after patent expiration, especially in markets with strong Bolar exemptions (e.g., U.S., EU, India).
- Biosimilars (generic versions of biologics) face longer regulatory approval times, even after patent expiry, due to clinical trial requirements.
Why Patent Expiry Matters
Understanding global patent expiration is crucial for pharmaceutical companies to:
- 1. Plan generic and biosimilar launches strategically.
- 2. Optimize R&D investments by analyzing upcoming patent cliffs.
- 3. Monitor evergreening tactics that may impact exclusivity timelines.
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