Practical Strategic Reasons For Manufacturers Licensing A Medical Patent
May 18, 2026
Phase IV: It’s Not Over ‘Till It’s Over
May 25, 2026
Medical Patents Broker Inc.
By Kenneth Pearce, President
Biologics really are big. Compared to pharmaceuticals—the so-called "small molecules" that can have quite large chemical structures—Biologics are gigantic. They are defined by WHO Biomolecular International Units (IU), a system of measurement that has outgrown traditional IUPAC chemical designations. Biochemistry includes organic chemistry and much more; it is the science of life itself.
The Discernible Discovery (Years 1–4)
Scientists generally spend years in the lab identifying the right protein or cell line. While AI can assist in reducing this timeline, this remains a new science and, even when combined with new AI, it still requires human wisdom to advance. Data without direction does not advance the biologic to the patient.
The Clinical Gauntlet (Years 5–9)
The risk of a project running "dead in the water" is at its greatest during the gauntlet.
- Phase I & II: Small groups of patients test for safety and dosage.
- Phase III: Thousands of patients are tested to prove the biologic is safe, effective, and a potential improvement over currently available treatments. If the gauntlet surrenders to the human evidence, it is possible to complete Phase III in four years. However, don't put such a narrow window in the business plan for shareholders.
Regulatory Drive: In Neutral While the Engine Races (10–12 Months)
If the data and evidence submitted to the FDA is flawless, the Biologics License Application (BLA) review begins. In fulfilling its Congressional mandate, the FDA reviews the new biologic, the process of making it, and the exact conditions of manufacture. The failure to wear required protective equipment for just a few minutes in a lab can be enough to require a new study. If someone is tempted to “fudge,” it may work temporarily, but when the truth becomes public, product recalls and lawsuits will quickly quash any earlier profits.
The Final Hurdle: Reimbursement
Even after the FDA says "Yes," the patient still waits. Now comes the battle with insurance companies and the Centers for Medicare & Medicaid Services (CMS) for coverage. Biologic treatments can sometimes cost $100,000 to $500,000 per year. Without CMS coverage, only extremely wealthy patients could afford treatment.
The President’s Viewpoint
From the first scribble in a lab notebook to the first infusion in a clinic, the average timeline for a biologic to reach the patient is about 12 to 15 years. We, the People, make it difficult for something new to make it to market. This is to protect us from ourselves. "Too speedy" usually includes safety issues, and "too slowly" increases costs and heartbreak for the patient. The real cost of delay is that many patients who could have been helped have died in waiting.
If it were not for the medical patent, there would be very few new treatments for any patient. The patent is the only thing that justifies the 15-year gauntlet. Now that’s the really big picture – the sacrifices of helping humankind.
