The pharmaceutical industry is known for its complex regulatory environment and lengthy product development processes. One often overlooked aspect of this industry is the potential benefits of abandoned and expired patents. These patents can provide opportunities for companies to bring new products to market at a lower cost and with reduced development time. However, navigating the intricacies of abandoned and expired patents requires diligence and a thorough understanding of the patent system.
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Understanding Abandoned and Expired Patents
A patent confers exclusive rights to the patent holder for a defined period, typically 20 years. During this time, the patent holder has the right to prevent others from commercially making, selling, or distributing the patented invention without permission. Patents can be sold, licensed, assigned, transferred, or even mortgaged. If a patent owner fails to pay the required maintenance fees, the patent is considered abandoned. Similarly, when a patent reaches the end of its 20-year term, it expires.
Reviving an Abandoned Patent
If a patent owner revives an abandoned patent, they have 24 months to file for revival and pay the applicable fees. Even if the patent owner revives the patent, a company that has used the abandoned patent to create a new product may maintain their rights to sell the product as long as they went into production in good faith that the patent had become part of the public domain. However, it is crucial to ensure that the patent has indeed been abandoned before investing significant resources into product development.
Expired Patents: Diligence Is Required
Expired patents do not automatically grant freedom to use the invention. It is possible that the patent owner has filed a similar patent or applied for a continuation while letting the original patent expire. In such cases, the pharmaceutical company could still be liable for infringement. Therefore, a thorough patent search is essential to identify similar inventions and reduce the risk of infringement.
Establishing Freedom to Operate
Finding a patent file history on an expired or abandoned patent is only the first step in building a new product based on it. An additional search for new prior art informs the acquiring party about what was known about the pharmaceutical product in question before any original patent applications were filed. To bring a product to market based on an abandoned or expired patent, it is necessary to establish Freedom to Operate (FTO). An FTO investigation determines if there are patents or patent applications controlled by third parties that could block the commercialization of the pharmaceutical product.
Industry Insights
“Abandoned and expired patents can have outstanding potential for pharmaceutical manufacturing. Patents confer a set of exclusive rights for a defined time period. Outside that time period lie many opportunities.” – Industry Expert
“Before moving forward based on an expired or abandoned patent, due diligence is essential. It is possible the patent owner has filed a very similar patent or applied for a continuation while letting the original patent expire.” – Industry Expert
Conclusion
Abandoned and expired patents offer significant opportunities for pharmaceutical companies to bring new products to market at a lower cost and with reduced development time. However, navigating these patents requires diligence and a thorough understanding of the patent system. Companies must ensure that they have established Freedom to Operate and have conducted thorough patent searches to avoid potential infringement risks.
References
- DrugPatentWatch. (2017, October 24). Abandoned and Expired Patents in Pharma Manufacturing. Retrieved from https://www.drugpatentwatch.com/blog/abandoned-and-expired-patents-in-pharma-manufacturing/
- Miller-Hidic, D. (2024, May 22). Can You Claim an Abandoned or Expired Patent or Trademark? Retrieved from https://www.linkedin.com/pulse/can-you-claim-abandoned-expired-patent-trademark-devin-miller-hidic
- United States Patent and Trademark Office. (n.d.). 711-Abandonment of Patent Application. Retrieved from https://www.uspto.gov/web/offices/pac/mpep/s711.html
- Federal Register. (2017, June 29). Revival of Abandoned Applications, Reinstatement of Abandoned Reexamination Proceedings. Retrieved from https://unblock.federalregister.gov
- United States Patent and Trademark Office. (2014, December 10). Instructions for Responding to a Notice of Abandonment. Retrieved from https://www.uspto.gov/patents/maintain/keeping-your-patent-alive/instructions-responding-notice-abandonment
