Closely monitoring the patent expirations of well-known branded drugs, such as Abilify for schizophrenia and Abaraxane for cancer treatment, is essential. This practice of monitoring patents can give generic drug makers a significant competitive edge, ultimately granting them an advantage in the generic drug market.
As top blockbuster drugs approach patent expiration, strategic ANDA filings are critical to secure early mover advantage. Download the Pharsight Digester report now for a deep dive into the patent strategies of the top 5 blockbuster drugs nearing expiration.
In this study, we analyzed how industry leaders can effectively harness the power of patent monitoring to plan their generic drug launches into 2024.
The strategic approach to monitor a branded patent
The appropriate strategy here involves understanding the vulnerability of a branded drug and challenging the validity of a granted patent.
This approach is crucial for the leaders in the generic pharmaceutical industry, as it imparts valuable insights into the status of patent protection for branded drugs.
Through proactive monitoring, they can anticipate patent expirations and address potential legal challenges, thereby enabling strategic preparation for their product launch in the generic drug market.
Understanding the vulnerability of a branded drug
Abandoned Patents
When a branded drug’s patent is abandoned, it signifies that the patent holder has relinquished protection for that specific patent.
For example, Ocaliva, a famous prescription medicine for primary biliary cholangitis (PBC), was recently marked as “abandoned” due to non-response to an office action.
This development serves as a clear indicator that the branded drug’s level of protection has diminished. Consequently, this could be an opportunity to initiate strategic preparations for the launch of a generic alternative.
Patent term extension
A patent extension can delay the branded drug’s patent expiration, leading pharmaceutical leaders to make crucial adjustments to their launch strategies. This is important as it extends the branded drug’s market exclusivity, potentially limiting generic manufacturers.
Therefore, to secure success in generic drug launches, leaders should consider –
Reevaluating Timelines: Leaders should consider revising their launch timelines according to the extended exclusivity of the branded drug. This might delay the generic drug launch to align with the revised patent expiration.
Strategic Adaptation: A strategic shift may be necessary to effectively navigate the extended exclusivity period. This could include targeting alternative markets or therapeutic indications, conducting additional research and development, or exploring collaboration opportunities.
Legal Considerations: Legal experts should be consulted to confirm that any modifications made comply with intellectual property laws and regulations. This may involve investigating potential legal issues associated with patent extensions if necessary.
Market Analysis: Leaders should consider conducting a comprehensive market analysis to understand the potential impact of the extended exclusivity period on the generic drug market and consumer demand.
Divisional Application
Filing a divisional application signifies submitting a new application built upon a previously filed one. It indicates the patent holder’s proactive intent to expand their coverage. This valuable insight can enable adjustments in product launch timelines or patent challenge strategies.
Considering the Ocaliva drug we mentioned earlier, where some patents have important events labeled as “Abandoned,” the next step is to check for any divisional filings within these patents.
However, reviewing many patents becomes tedious and increases the chance of manual errors. Elixir, however, allows you to automate this process.
Elixir closely monitors any Divisional applications filed within the drug patents. If such applications are identified, they will automatically be added to your tracking portfolio. This efficient procedure ensures swift responsiveness to new applications and facilitates careful monitoring.
Sign up today to check out this feature on Elixir.
Challenging the validity of a granted patent
Here are a few events associated with post-grant proceedings that serve as legal mechanisms to contest the legitimacy of a granted patent.
Incomplete Inter Partes Reexam Request
This indicates that the reexamination request submitted by a third party to question the validity of a granted patent is incomplete and requires additional details to be processed.
The third party here could be any entity or individual not part of the original patent application process but is interested in challenging the patent’s validity.
As a result, this situation allows leaders in the generic industry to challenge the patent’s validity.
Examiner Affirmed and Patent Board Decision
These outcomes are linked to a request for patent reexamination. In these instances, the Patent Trial and Appeal Board (PTAB) assesses the patent’s validity, either confirming or challenging the initial determination.
Such developments hold significant weight for leaders in the generic drug industry as these decisions reveal the strength or weakness of a patent, guiding strategies of generic drug companies for developing their drug versions.
Notice of Allowance
Once this happens, the patent is officially granted. To minimize risks, generic companies can either prepare to challenge the patent through third-party oppositions or adjust their products.
Managing all these events and more becomes a daunting task. Elixir makes it easier by sending early notifications to you, streamlining your planning processes.
Elixir offers an all-in-one platform designed to keep you well informed about the status of patent protection for branded drugs. Our patent monitoring solution is a powerful tool for the companies leading the generic drug market.
Integrating automated patent insights into your generic drug launch strategies allows you to capitalize on opportunities and proactively handle risks.
Try Elixir’s effective drug patent monitoring!
Conclusion
Failure to monitor patent statuses can result in missed opportunities on generic drug launches and setbacks, which could give competitors an early advantage in the generic drug market.
Additionally, it could result in unintentional infringements, leading to legal disputes and significant financial burdens.
Therefore, monitoring patent events is not just an effective but an essential strategy you must adopt to remain competitive in the market.
Authored By: Smiksha Sood, Product Development Team
Edited By: Ridhima Mahajan, Marketing
