There is something almost poetic about the way patents work. An inventor spends years; developing something the world has never seen before. The law rewards that effort with a patent: a twenty-year window during which the inventor alone has the right to make, use, sell, or license the invention.
Twenty years sounds generous. But here is the part that most people outside the patent world never quite appreciate: that twenty-year clock starts ticking from the very day the patent application is filed, not the day the patent is granted. And in a world where regulatory approvals, examination backlogs, and procedural delays routinely eat up years of that window, inventors often find themselves holding a patent with only a fraction of its commercial life left.
This is the problem that Patent Term Adjustment (PTA) and Patent Term Extension (PTE) were designed to solve. However, it depends enormously on which country you are standing in.
India’s Approach: A Significant Silence
The Patents Act, 1970, India’s principal patent legislation, as amended most significantly in 2005 to align with the TRIPS Agreement, grants a patent term of twenty years from the date of filing under Section 53. But when you look for provisions that compensate an inventor for delays caused by the Patent Office itself, or for the regulatory maze that pharmaceutical inventors must navigate before their drug reaches the market, you find a conspicuous gap. India does not have a formal PTA mechanism.
There is no statutory provision under which a patent applicant can seek additional patent life to compensate for delays caused by the Indian Patent Office during examination. Similarly, there is no PTE framework for pharmaceutical or agrochemical products that must undergo regulatory approval before commercialisation.
The Indian system operates on a straightforward, unadjusted twenty-year term, and that is the end of the matter: at least for now.
This is not to say that India is entirely insensitive to the problem. The Office of the Controller General of Patents, Designs and Trade Marks (CGPDTM) has, in recent years, undertaken significant efforts to reduce examination pendency.
The Patent (Amendment) Rules, 2024 introduced streamlined procedures, including revised timelines for examination and disposal of applications. But reducing future delays is not the same as compensating inventors for delays that have already occurred.
The United States: A Comprehensive Compensation Regime
If India represents one end of the spectrum, the United States sits firmly at the other. The US has developed arguably the most detailed and litigated patent term compensation regime in the world, built around two distinct mechanisms that serve different purposes. PTA in the US is governed by 35 U.S.C. § 154(b), introduced as part of the American Inventors Protection Act of 1999.
Congress recognised that the new filing-based calculation exposed inventors to a risk that the old system had insulated them from: delays caused by the USPTO’s own examination process would now eat directly into effective patent life. Section 154(b) addresses this by entitling applicants to a day-for-day extension of the patent term for three specific categories of USPTO delay; informally called A-delays, B-delays, and C-delays.
A-delays cover the USPTO’s failure to meet specific examination milestones: issuing a first office action within fourteen months of filing, responding to a reply within four months, and issuing a notice of allowance or final rejection within four months of the applicant’s response. B-delays kick in when the total prosecution period; from application to grant, exceeds three years. C-delays account for delays caused by interference proceedings, secrecy orders, and appellate review before the Patent Trial and Appeal Board or the federal courts.
The adjustment is calculated as the sum of these delays, minus any applicant-caused delays, and is added to the end of the twenty-year term. The USPTO calculates this automatically and prints the adjusted expiry date on the face of the patent. Separately, and serving an entirely different function, is PTE under 35 U.S.C. § 156.
This provision, introduced by the Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act; allows patent holders to extend the term of a patent covering a drug product, medical device, food additive, or colour additive to compensate for time lost to FDA regulatory review.
The extension can be up to five years, with the remaining patent term after extension not exceeding fourteen years from the date of FDA approval. This is not automatic; the patent owner must apply to the USPTO within sixty days of approval, and the FDA assists in calculating the regulatory review period.
Europe: Harmonisation Through Supplementary Protection Certificates
Europe takes a different approach. The European Patent Office (EPO), established under the European Patent Convention (EPC), grants patents that then become national rights in the designated contracting states. The EPC provides a twenty-year term from the date of filing under Article 63, and unlike in the US; the EPO does not have a general PTE mechanism for prosecution delays. If your EPO application sits in the examination queue for four years, that loss is yours to absorb.
What Europe does have and this is where it becomes genuinely sophisticated; is the Supplementary Protection Certificate, or SPC. Introduced at the EU level through Council Regulation (EEC) No 1768/92 for medicinal products and Regulation (EC) No 1610/96 for plant protection products (now consolidated and updated), the SPC is not technically an extension of the patent itself.
It is a separate intellectual property right that kicks in when the patent expires, providing up to five additional years of protection for a specific product that has received marketing authorisation in the EU. The effective maximum is five years of SPC protection, with the total protection period (patent plus SPC) capped at fifteen years from the date of the first EU marketing authorisation.
The SPC system has generated a remarkable body of jurisprudence from the Court of Justice of the European Union (CJEU). It is also worth noting that the SPC is a national right, granted by national patent offices in each EU member state. This means that an innovator seeking SPC protection across the EU must file separate applications in each relevant jurisdiction, with associated costs and the risk of divergent outcomes; a complexity that the proposed EU SPC Regulation is intended, at least in part, to address.
Placing India in Perspective: What the Gap Means in Practice
When you place these three systems side by side, the contrast is striking. The US offers both PTA (compensating for prosecution delays) and PTE (compensating for regulatory delays), creating a layered safety net for innovators. Europe, while it lacks a general PTA mechanism at the EPO level, provides the SPC system as a sophisticated regulatory-delay compensator. India, meanwhile, has neither. The twenty-year-from-filing term is the beginning and the end of the story.
This difference strongly affects pharmaceutical innovation, investment, and R&D incentives. At the same time, India’s approach benefits its powerful generic drug industry by enabling earlier market entry and improving access to affordable medicines, making any patent-term reform a delicate balance between innovation and public health.
Where Does India Go from Here?
India is not standing still. The National IPR Policy of 2016 explicitly acknowledged the need to modernise the patent system, and ongoing discussions around potential amendments to the Patents Act have included questions about examination delays and their impact on patent life.
There is growing academic and policy interest in whether a limited PTA mechanism, covering only egregious delays caused by the Patent Office, not regulatory delays could be introduced without significantly compromising access to medicines. Such a calibrated approach might address the most glaring inequity while preserving the policy balance that India has carefully constructed over decades.
References
- National IPR Policy, 2016, Department for Promotion of Industry and Internal Trade (DPIIT), Government of India.
- 35 U.S.C. § 154(b) — Patent Term Adjustment (United States).
- 35 U.S.C. § 156 — Patent Term Extension (United States).
- American Inventors Protection Act of 1999, Pub. L. No. 106-113, 113 Stat. 1501.
- Council Regulation (EEC) No 1768/92 of 18 June 1992 on the creation of a supplementary protection certificate for medicinal products.
- Regulation (EC) No 1610/96 of the European Parliament and of the Council on the creation of a supplementary protection certificate for plant protection products.
- Neurim Pharmaceuticals (1991) Ltd v. Comptroller-General of Patents, Case C-130/11, CJEU (2012).
- Teva UK Ltd and Others v. Gilead Sciences Inc., Case C-121/17, CJEU (2018).
- Royalty Pharma Collection Trust v. Deutsches Patent- und Markenamt, Case C-650/17, CJEU (2020).
- TRIPS Agreement (Agreement on Trade-Related Aspects of Intellectual Property Rights), Article 33, WTO, 1994.
- European Patent Office, Supplementary Protection Certificates — Guide for Applicants, EPO Publication, available at https://www.epo.org.