Table of Contents
Introduction
Patent oppositions are a crucial tool in the pharmaceutical industry, allowing civil society to challenge the validity of patents on medicines, diagnostics, vaccines, and other medical tools. This process can be complex and time-consuming, but it is essential for ensuring that patents are valid and do not hinder the development of generic versions of drugs. In this article, we will explore the steps involved in building an opposition, the requirements for a patent to be valid, and the different routes to oppose patents.
Understanding Patent Opposition
Patent oppositions are a mechanism that allows anyone to question the validity of a patent. This can be done at various stages of the patent application process, including before the patent is granted (pre-grant opposition) or after it has been granted (post-grant opposition). The goal of an opposition is to highlight information and evidence that shows the patent application does not meet the patentability standards of a country.
Requirements for a Patent to be Valid
For a patent to be valid, it must meet three main requirements: novelty, inventiveness, and industrial application. Novelty means that the product was not previously known by the public, inventiveness means that it is not simply an obvious solution that anyone could have thought of, and industrial application means that it can be demonstrably used in some kind of industry. If a patent does not meet these requirements, it can be revoked.
Routes to Oppose Patents
There are several routes to oppose patents, including administrative and judicial routes. Administrative oppositions are filed with the patent office, while judicial oppositions are filed in the courts. The procedure for challenging patents and applications may differ between countries, so it is essential to check the specific laws of the country in question.
Importance of Patent Oppositions
Patent oppositions are important for several reasons. Firstly, they help to ensure that patents are valid and do not hinder the development of generic versions of drugs. Secondly, they provide a mechanism for challenging the validity of patents that may have been granted in error. Finally, they help to promote innovation by encouraging the development of new and improved treatments.
Case Study: Tenofovir Disoproxil Fumarate (TDF)
One example of the success of patent oppositions is the case of Tenofovir disoproxil fumarate (TDF), an essential antiretroviral used in the treatment of HIV. In India, Gilead filed several patent applications for TDF, including applications covering the pro-drug, fumarate salt, intermediates, and fixed-dose combinations. These applications were successfully opposed by networks of people living with HIV/AIDS and civil society, resulting in the avoidance of a 28-year patent monopoly.
Recent Patent Oppositions in the Pharmaceutical Industry
The pharmaceutical industry has seen a significant number of patent oppositions in recent years. For example, Novartis’ patent EP2959894B1 and Biogen’s patent EP2653873B8, both focusing on multiple sclerosis treatment, have faced over 23 and 14 oppositions, respectively. Similarly, Novo Nordisk’s patent EP3448416A1 for Semaglutide, a treatment for type 2 diabetes, encountered substantial opposition but still managed to secure a notable position in the rankings.
Major Pharmaceutical Companies Filing Patent Oppositions
Several major pharmaceutical companies are actively involved in filing patent oppositions. Generics has filed the maximum number of oppositions, totaling 26, followed by Sandoz, Teva Pharmaceutical Industries, and Stada Arzneimittel.
Conclusion
“Patents are a social tool, so in many countries, anyone may question whether the claims of a patent are factually true, and whether the patent was granted in error. And it’s not a hopeless task: many groups and individuals have already been successful by following the steps described in this tutorial.” – Patent Opposition Database
Navigating patent oppositions in the pharmaceutical industry is a complex and often challenging process. However, it is essential for ensuring that patents are valid and do not hinder the development of generic versions of drugs. By understanding the requirements for a patent to be valid and the different routes to oppose patents, civil society can effectively challenge the validity of patents and promote innovation in the industry.
References
- Patent Opposition Database. (n.d.). How to Build an Opposition. Retrieved from https://www.patentoppositions.org/en/how_to_build_an_opposition/
- Patent Opposition Database. (n.d.). Things You Should Know. Retrieved from https://www.patentoppositions.org/en/how_to_build_an_opposition/things_you_should_know/
- PatentPC. (2023, November 13). How to Navigate Biopharmaceutical Patent Oppositions. Retrieved from https://patentpc.com/blog/how-to-navigate-biopharmaceutical-patent-oppositions/
- Finnegan. (2023, December 12). Navigating Your Life Sciences Opposition: Tips for Best Practice. Retrieved from https://www.finnegan.com/en/insights/events/navigating-your-life-sciences-opposition-tips-for-best-practice-when-you-are-opposing-or-opposed-12122023.html
- GreyB. (2024, March 6). Recent Patent Oppositions in the Pharmaceutical Industry. Retrieved from https://www.greyb.com/blog/oppositions-in-pharmaceutical-industry/
