Drug delivery sits at the intersection of science, business, and patient care. A well-designed patent strategy protects innovation, differentiates products, and extends the commercial life of therapies.
At PPG, we help our clients navigate the drug delivery patent process by crafting strategies that not only protect new dosage forms and delivery systems but also provide the flexibility to succeed as their science and business needs evolve.
Why Drug Delivery Matters
Drug delivery is never just a ‘delivery’ mechanism. It often determines the true value of a therapy, both medically and commercially. Improvements in how medicines are administered can:
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Increase safety and effectiveness
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Reduce unwanted side effects
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Encourage patient compliance
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Improve therapeutic effectiveness and treatment longevity in veterinary care
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Extend the commercial life of established drugs
From inhalable epinephrine that avoids the needle-stick of a self-injected device, to once-monthly injections that replace daily pills, to long-acting formulations for livestock, innovations in drug delivery connect laboratory discoveries to real-world outcomes.
Our Approach to Drug Delivery Patent Strategy
Protecting Early-Stage Ideas
Much of our work begins with universities, tech transfer offices, and early-stage companies. At that point, data is often limited. We help broaden protection from the first set of results into claims that anticipate future dosage forms, release profiles, and administration routes. This approach ensures early work is protected while allowing for pivoting as research progresses.
Controlled Release and Advanced Profiles
We advise clients on matters involving a wide range of delivery profiles, including:
- Immediate, sustained, delayed, and pulsatile release systems
- Single-dose regimens designed to release in stages over time
- Multi-ingredient formulations combined into one pill, patch, or injection
- Targeted delivery systems using nano- or micro-scale carriers
These strategies improve convenience and compliance, as well as create real opportunities to extend product lifecycles and maintain market value.
Due Diligence and Freedom to Operate
Protecting an invention is only half the equation. We also conduct thorough due diligence to help clients navigate the competitive drug delivery landscape by:
- Identifying potential infringement risks
- Flagging licensing needs early
- Avoiding crowded patent areas that could block commercialization
This combined focus on protection and risk management helps clear the path from concept to approval.
Human and Veterinary Applications
Our practice spans both human and animal health.
- In human health, we focus on innovations that improve compliance, safety, and access, whether through more convenient dosage forms or advanced delivery profiles.
- In veterinary health, we’ve helped clients working to improve the well-being of household pets, as well as large-scale farm livestock care, where delivery systems can provide long-acting protection in a single administration, reducing costs, simplifying recordkeeping, and improving outcomes.
Patent Term Adjustment, Patent Term Extension, and FDA Timing
Pharmaceutical patents face unique timing pressures. A standard term runs 20 years from the earliest non-provisional filing, but navigating both the patent office and the FDA can consume a large part of that timeframe.
- Patent Term Adjustment (PTA) adds time back when the U.S. Patent and Trademark Office causes delays.
- Patent Term Extension (PTE) adds up to five years for patents covering drugs that undergo lengthy FDA review.
Together, these tools can make a meaningful difference in how long a patent delivers value. We work with clients to structure filings and claims, and to align them with regulatory milestones, to ensure they maximize every available extension.