Pharmaceutical patents protect various aspects of drug development, primarily categorized into product (active ingredients), process (manufacturing methods), formulation (dosage/delivery), and method-of-use (new applications) patents. These, along with polymorph, combination, and product-by-process patents, form "patent walls" to extend market exclusivity.
Key Types of Pharmaceutical Patents
- Product Patents: Protect the active pharmaceutical ingredient (API) or chemical molecule itself, offering the strongest protection.
- Process/Manufacturing Patents: Protect the specific methods used to create the API or the final drug.
- Formulation/Composition Patents: Cover the specific mixture, dosage form (e.g., tablet, syrup), or inactive ingredients.
- Method-of-Use Patents: Protect new therapeutic uses for previously known drugs.
- Product-by-Process Patents: Define a product based on how it is manufactured.
- Polymorph Patents: Protect different crystalline structures of an existing drug compound.
- Combination Patents: Cover mixtures of two or more active ingredients.
- Markush Claims: Broad claims covering a range of related chemical compounds.
- Design Patents: Protect the unique, ornamental design of packaging or delivery devices like inhalers.
Other Forms of Exclusivity
- New Chemical Entity (NCE) Exclusivity: FDA provides 5 years of market protection for new active ingredients.
- Orphan Drug Exclusivity: 7 years for drugs treating rare diseases.
- Pediatric Exclusivity: A 6-month extension granted for conducting pediatric studies.
Common Patenting Strategies
Pharmaceutical companies often use "evergreening" tactics, filing multiple patents for a single drug—such as for new formulations or dosages—to extend protection beyond the initial 20-year term of the main product patent.
Pharmaceutical companies often use "evergreening" tactics, filing multiple patents for a single drug—such as for new formulations or dosages—to extend protection beyond the initial 20-year term of the main product patent.
