How to Patent a Drug

Patent a drug by filing a utility patent application with the USPTO.

Pharmaceutical companies spend billions of dollars developing several new drugs every year; patents allow these companies to protect the intellectual property rights associated with those drugs. Additionally, drug patents allow pharmaceutical companies to recover drug development costs, which, according to Matthew Herper of Forbes Magazine, may exceed $800 million. By granting exclusive intellectual property rights, patents protect a drug from generic competition during the life of the patent, ensuring all drug proceeds go to the company that developed the drug. Patenting a drug follows a similar process to patenting any other invention, though some nuances exist.

Things You'll Need

• Description of the drug manufacture process
• Detailed chemical composition of the drug

Instructions

1. Select which type of utility patent to pursue. Louis Venture Jr., a registered patent law attorney, states that pharmaceutical companies protect most new drug compounds with utility patents. If patenting the process of manufacture or the method of using a new drug, inventors file a utility patent claim for process. If patenting the chemical makeup of a drug, inventors file a utility patent claim for composition of matter.

2. Conduct a prior art search to show the drug's novelty. In 2005, the Federal Circuit Court of Appeals ruled that inventors should only consider a drug compound original if it does not fall under inherent anticipation. In other words, inventors cannot patent any drug where prior art discloses the process of making that drug--regardless if manufacture took place or not. If a currently patented drug creates a new drug compound during its manufacture or use, inventors may not patent that new drug.

3. Establish the drug's usefulness. According to the United States Patent and Trademark Office, only a new and useful process or composition of matter is patentable. As ruled by the Supreme Court in 1966, a new drug compound must show a specific benefit to receive patent protection.

4. Complete a patent application. After determining the type of patent to pursue as well as a drug's novelty and usefulness, write a utility patent application. The United States Patent and Trademark Office, or USPTO, provides information on utility patent application and completion. Provide a description of the drug manufacture process or the detailed chemical composition of the drug.

5. Submit the patent application to the United States Patent and Trademark Office. Send the patent application to the USPTO either online or through the mail with the appropriate fee. Once received, the USPTO examines the patent application and makes a determination to grant a patent, reject the application, or request more information.

Tips & Warnings

• Hire a patent law attorney to assist in completing a utility patent application--well written applications gain superior intellectual property protection.

• Submit a patent application early; USPTO review may take several years before granting a patent.

• Differentiate between patent protection, granted by the USPTO, and marketing exclusivity, granted by the Food and Drug Administration.

References

• Forbes: Drug Patent Peril
• The Law Firm of Louis Venture, Jr.: Patenting Drugs
• United States Court of Appeals for the Federal Circuit: Smithkline Beecham v. Apotex Corp.
• University of Connecticut Law School: Brenner v. Manson (1966)
• United States Patent and Trademark Office: Non-Provisional (Utility) Patent Application, A Guide to Filing

Resources

• United States Patent and Trademark Office: Process for Obtaining a Utility Patent
• Massachusetts Institute of Technology: Inventor's Handbook