When a new compound is discovered, years, sometimes even decades, may pass before it reaches the market as an approved therapy. Yet it would be a serious mistake to postpone patent protection until development of the compound is complete. Because patent rights are based on the date of filing, waiting too long risks losing exclusivity before the product is even commercialized.
To address this, pharmaceutical and biotech companies typically build patent protection in stages, filing a series of patent applications over time. These related applications form what is known as a patent family: a collection of patents that together protect different aspects of the same core invention throughout its development lifecycle.
In this article, we will dive into the different patent applications that form part of the lifecycle management of a life sciences company’s patent portfolio.
Composition of Matter
The first application filed is usually the “composition of matter” patent, which covers the compound itself and, if known at the time, initial therapeutic uses in broad terms. This patent is the foundation of the family and often the most valuable and most broad, as it defines ownership of the active molecule.
As research advances and more is learned about the compound’s properties and mechanisms of action, additional patents follow to cover new insights and developments.
Medical Use
The next major milestone is often a “medical use” patent, filed once preclinical or early clinical data identify specific therapeutic indications. These applications are filed once preclinical or early clinical data support specific therapeutic indications, defining the diseases or conditions in which the compound demonstrates efficacy.
Medical use claims are a distinctive feature of life sciences patents and vary across jurisdictions. For a deeper discussion of their structure and strategic importance, see our related article “Patent Applications in the Life Sciences”.
Formulation
As clinical development progresses, companies often file for a “formulation” patent. Clinical studies reveal how the compound behaves in patients, enabling optimization of key features such as salt forms, dosage levels, or delivery methods. These refinements, for example, developing a sustained-release tablet or an injectable formulation, can each form the basis for new patent protection.
Sometimes, formulation patents will contain additional medical use claims, covering specific dosage regimens or treatment protocols demonstrated to be effective in trials.
Purification
In parallel, a “purification” patent may be filed for to protect new or improved purification or manufacturing processes developed during scale-up of the production of the compound. These are particularly significant for biologic drugs, such as antibodies, where purification steps are critical to ensuring product consistency, potency, and safety.
Such process-oriented patents can provide valuable layers of protection, even after the compound’s composition itself is already known.
Further Patent Applications
As development continues, new opportunities for patent protection often emerge. Clinical data may reveal, for instance, that a compound is especially effective in a subset of patients, such as those with a specific genetic mutation or biomarker profile. This insight can support additional medical use claims, adding another layer of protection to the patent family.
Even after market approval, innovation often continues around the same compound. Follow-on patents may cover:
- New therapeutic indications,
- Combination therapies, or
- Optimized formulations and delivery systems.
Each of these filings helps to extend market exclusivity of the product and strengthen the company’s overall IP position.
Conclusion
Given the long development timelines typical in the life sciences, a single patent is rarely sufficient to protect an innovation. Instead, successful products are typically surrounded by a portfolio of interrelated patents, the patent family, that together form a robust and long-lasting shield around the core innovation.
Building such a portfolio requires foresight and specialized expertise. Enlisting the help of a patent attorney at an early stage is not simply an administrative step, it is a strategic investment.
A skilled life sciences patent attorney can identify what aspects of your research are truly patentable, ensure that sufficient experimental data is generated and disclosed, and help define the initial scope of protection in a way that allows for future expansion of the patent portfolio.
Early collaboration also prevents common pitfalls, such as premature publication or incomplete disclosure, which can jeopardize later filings. Over time, this proactive approach leads to a cohesive patent family and a strong IP position that investors and potential partners recognize and value.
Ultimately, patenting in the life sciences is not a one-time legal action but a continuous process that evolves with scientific and clinical development. Success lies in integrating IP strategy into the research and development cycle itself. This requires planning each new patent application not as an isolated document, but as a deliberate step in building the long-term value and defensibility of your company’s innovation.
At IFORI, we work closely with our clients to develop patent strategies that align with their scientific goals and business ambitions.
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