This article is written by Ankur Saxena, pursuing a Certificate Course in Intellectual Property Law and Prosecution from LawSikho.
Table of Contents
Introduction
A patent is a techno-legal document that grants the inventor an exclusive right to produce, use or sell the invented product or process for a particular number of years, usually 20 years. There are certain ways by which we can extend this term. These ways include both constitutional and basic laws which are either suggested or explicitly give the extended term of the patent. It is found that since the day the patent application is filed, due to various reasons, the grant of a patent may be delayed due to the time taken to develop into a patent. To overcome this problem in the system or other words when there is some inadvertent delay due to the Patent and Trademark Office (PTO), the time that is wrongly received can be regained through the Patent Term Adjustment (PTA).
It must be noted that the delay due to the Patent and Trademark Office (PTO) within the initial examination of biotechnology and pharmaceutical patent applications is particularly severe. Once the delay in the patent grant is eliminated the commercial value of the patent can be achieved — for example, the cases under which the Food and Drug Administration (FDA) will approve the patented pharmaceutical product before it can be marketed. This type of delay can be compensated by a patent term extension (PTE). PTAs are relevant to all patents but are specifically related to biotechnology and pharmaceutical patents because of their time required in extended prosecution.
Therefore, in simple words, it can be said that Patent Term Adjustment (PTA) and Patent Term Extension (PTE) are two distinctive courses of action concerning the patent term of a particular patent. PTA is to restrain the loss of rights and term of patent life due to the prosecutorial delays made by the Patent Office beneath the doctrine of prosecution history laches for unreasonable and undue delay in prosecution, whereas PTE may result due to any number of reasons counting Regulatory Agencies’ endorsement and/or review processes, other than the prosecutorial delay.
Patent Term Adjustment: A Brief
Patent Term Adjustment is a law that suits for delays caused by the patent office (USPTO) amid the prosecution of a patent application in addition to the term of the patent. After the Uruguay Round Agreement Act (1994) and to realize patent harmonization, the term of the patent was adjusted from 17 years from the date of grant/issuance to 20 years from the date of filing of the national patent application, with effect from June 8th, 1995, subsequently including the prosecution time within the ambit of the patent term. This sets the onus on the PTO to conclude patent prosecution within 3 years from the filing date of application failing which would decrease the actual term expectancy of the patent, and exclusive monopoly worked out therewith. In this manner, PTA is a guaranteed tool to get a term extension of the patent for any category of patents when the delay happens from the patent office side in the countries where this provision is applicable.
The PTA provision is established in the United States and is well known in the public sector. Apart from the USA, some other countries have also amended their patent laws to include PTA provisions in their patent laws. Such countries are South Korea, Singapore, Colombia, Republic of El Salvador, Chile, Republic of Costa Rica, Guatemala, Chile, Honduras, and Nicaragua.
Determining when a patent is set for the patent term adjustment
The PTO process commences using a computer-produced calculation executed by the PTO based on the information entered into the automated Patent Application Information Retrieval (PAIR) database by the PTO. The PTA is calculated twice in this way for all patent applications: firstly when the PTO has notified the Notice of Allowance and later when the PTO matches the patent issuance notification. Thus, all acceptable patent applications are qualified for PTA. The outcome of the initial PTA calculation is reflected in the notice of allowance.
What is Patent Term Extension?
Patent Term Extension is only available for certain types of patents, such as pharmaceutical products and medical devices related patents. Patent holders of such patents usually benefit the most after a drug or device is commercially launched and is excluded from the competition. However, because drugs and devices must undergo a lengthy review process at the Federal Drug Administration (FDA) before commercial use or launch, related patents are filed long before FDA approval (typically beginning a 20-year clock). PTE is designed to restore some of the patent terms “lost” during the FDA review process.
The term can be extended for a maximum of 5 years, only if the extension will not cause a patent term to extend for more than 14 years which is a total remaining patent term. These 14 years are restrained by the date the pharmaceutical product receives regulatory approval for patent expiration (with a date extension). An extension of any term is only granted from the patent’s actual expiry date, including PTA. In the case where a fatal disclaimer is filed, the extension of term is measured from the expiry date to the date of the disclaimer, not from the date the patent expires in the absence of a terminal disclaimer. Accordingly, these two requirements to increase the term of a patent (PTA and PTE) are calculated individualistically and run separately rather than alongside.
A patent will only be qualified for an extension if it contains at least one claim covering an approved pharmaceutical product (or an approved method of its use or a method of making it) and pleases the following five conditions:
- The patent is still alive and not expired;
- The patent period has not extended previously;
- The patent Applicant or his agent submits a complete and timely application for extension;
- The product is subjected to a regulatory review period before its commercial marketing or use; and
- The authorization for commercial marketing or use is first permitted, except for patents claiming only the method of making a product.
Scenario of PTE and PTA in Indian Patent Office
Regulators approve by extending the patent term and delaying the investigation and prosecution of patent applications. Such delays are more significant in pharmaceutical invention cases, where the product is not marketed for many years for timely regulatory approval. The Government of India first mooted the suggestion for patent term extension in the context of the second committee appointed on the direction of the Hon’ble High Court of Delhi in the Nitto Denko case – the main purpose of considering PTE for the time being lost in processing the application. The committee concluded that the 20-year patent term that was originally provided for a 7-year or 14-year delay and nothing prevents the applicant/inventor from taking steps for regulatory approval and commercialization while the patent application is pending. India has not yet implemented such provisions.
These provisions have long been sought by the Big Pharma lobby of developed countries criticizing India’s ‘weak’ IP policies. Companies like Bayer, Novartis have tried to tie up with the legislature for this purpose. Several generic pharma companies and access-to-medicine activists such as Médecins Sans Frontières (Doctors without borders) have consistently warned India of the implications of such provisions, saying that India will no longer be the ‘Pharmacy of the world’.
Conclusion
The provision of Patent Term Extension (PTE) and Patent Term Adjustment (PTA) in countries where they are applicable is beneficial to patentees for an extended patent term, which increases monopoly and does not allow third-parties to access it. However, such an extension could avoid the entry of a generic player into these markets, which could be important for public health in biotechnology and pharmaceutical patents. Therefore, countries applying PTE and PTA provisions should be particularly cautious in biotechnology and pharmaceutical patents to avoid patent office delays that limit patent life spans to 20 years despite allowing and maintaining patent applications. Understandably, the United States, the Confederation of the European Union and Russia, and some other countries have the luxury of using the PTE and PTA provisions.
The only drawback is to follow all the procedures mentioned in the respective methods. But most Southeast-Asian countries lack such a provision. The future of patent term extension (PTE) in India still seems blurred as the syllabus of jurisprudence does not confirm this. Implementing these will only benefit innovator companies, and millions of people will be stripped of their right to live a healthy life. The Chinese are being banned for saying that these provisions will promote trade and innovation in India. On the other hand, if these provisions are not introduced, India will be under constant pressure to do so as soon as possible, but it will not kill anyone. Now it is up to the policymakers whom they are going to put first.
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