A patent is a property right granted by the U.S. Patent and Trademark Office (USPTO). In the U.S., a patent typically lasts 20 years from the date of filing. Where the exclusivity is a “period of transition” granted by the FDA upon approval of a drug. During this time, the FDA is prohibited from approving a competing generic version. It varies depending on the type of drug:
- Orphan Drug (ODE): 7 years (for rare diseases).
- New Chemical Entity (NCE): 5 years.
- Generating Antibiotic Incentives Now (GAIN): 5 years added to certain exclusivities.
- New Clinical Investigation: 3 years.
- Pediatric Exclusivity (PED): Adds 6 months to existing patents/exclusivity.
- Generic First-to-File: 180 days (6 months) of exclusivity for the first generic company that successfully challenges a patent.
In USA, the patent system for pharmaceuticals governed by USPTO and market exclusivity governed by FDA:
- Governed by: USPTO (patent); FDA (exclusivity).
- Duration: 20 years from filing (patent); 180 days to 7 years (exclusivity)
- Patent Term Extension: Maximum 5 years.
- Total Post-Approval Cap: 14 years.
- Add on exclusivities: 6 months for conducting pediatric studies requested by agency and 5 years for Generating Antibiotic Incentives Now (GAIN) exclusivity.
Most of the generic projects (small molecule) will fall under Section 505 of the Federal Food, Drug, and Cosmetic Act.
- NDA 505(b)(1) – Full New Drug Application: Used for a New Chemical Entity (NCE)
- NDA 505(b)(2) – Hybrid / Incremental Innovation: This is a highly strategic pathway for repurposed drugs or new dosage forms (e.g., switching an IR tablet to an ER version).
- ANDA 505(j) – Abbreviated New Drug Application: The standard Generic pathway.
- BLA (Biologics License Application): The “Full NDA” equivalent for biologics.
- 351(k) – Biosimilar Application: The “ANDA” equivalent for biologics. It requires proving the product is “highly similar” to the reference biologic with no clinically meaningful differences.
A strategic approach to US pharmaceutical patent filing involves much more than simply protecting a new chemical entity. It requires building a layered portfolio of protections that leverages regulatory pathways like the Hatch-Waxman Act to maximize market exclusivity.
- A robust pharmaceutical IP strategy involves a primary patent covering the core invention, shielded by a layer of secondary patents that protect the commercial product and block competitive entry.
- The primary patent covering the New Chemical Entity (NCE) or New Biological Entity (NBE) is a key asset for an investor. The goal is to obtain broad ‘composition of matter’ claims that cover the active ingredient itself, including its salts, esters, and polymorphs. It provides the strongest form of protection and is the most difficult for generic competitors to design around.
- Secondary patents are filed later in the development cycle and are crucial for extending market exclusivity well beyond the expiration of the primary patent. Key secondary protections include: Polymorph Patents, Formulation Patents, Process Patents, Method in Use Patents etc.
- File a provisional patent application as soon as the invention is sufficiently described. This secures an early filing date and provides a 12-month window to refine the invention before filing a non-provisional application.
- Compensates for delays caused by the USPTO or FDA through PTA or PTE.
- Defense against generics through a strategic timing issue arises when they file a Paragraph IV certification (claiming a patent is invalid) and ensure 30-months stay.
Note: Delaying a patent application can allow a competitor to secure rights to a similar invention. The best practice is to file a provisional patent application as soon as the invention is sufficiently described. This secures an early filing date and provides a 12-month window to refine the invention before filing a non-provisional application.
Generic drug manufacturers must understand the patent and exclusivity for getting the market opportunity for generic drugs, especially ‘first-to-file’ mechanism to secure 180-day exclusivity. For a detailed explanation of patent exclusivity rules for generic drug entry in US market, we offer a high value course from Pharma Lesson Masterclass → Patents & Exclusivities: The Blueprint for US Market Entry.
