Drug Patent Information

Drug patents last 20 years in the United States.

The U.S. Constitution gives Congress the right “to promote the progress of s cience and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.” Congress has tasked the U.S. Patent and Trademark Office (USPTO) to oversee, administer and grant U.S. patents. The USPTO allows inventors and pharmaceutical companies to obtain drug patents provided they follow prescribed guidelines.

Types

The USPTO offers three distinct types of patents. Plant patents provide intellectual property protection for new varieties of asexually reproduced plants, design patents for new and original ornamental design for manufactured products and utility patents for new and useful processes, machines, manufactured products or compositions of matter. According to patent attorney Louis Venture Jr., the USPTO grants utility patents to new drugs and medicines.

Claims

Within a patent application, inventors and pharmaceutical companies must spell out their intellectual property claims. Inventors submit a utility patent process claim when attempting to patent the manufacturing process of a new drug. Inventors also use utility patent process claims to patent the usage of a drug for specific illnesses. Finally, utility patent composition of matter claims accompany drug patent applications seeking to patent the chemical composition of a new drug.

Process

To obtain a patent from the United States Patent and Trademark Office, inventors must submit a patent application and the appropriate fees to the USPTO. Utility patent application contain several sections: an application data sheet, a fee transmittal form, the drug specification (including the intellectual property claim), drawings and an executed declaration or oath. Once received, the USPTO reviews the patent application then grants a patent, denies the request or seeks additional information.

Time Frame

By congressional authority, the USPTO grants utility patents, including drug patents, in the United States for 20 years. The 20-year clock starts when the inventor submits the patent application to the USPTO. USPTO processing time and FDA drug approval time eat into the useful lifespan of a drug patent.

Extension

To combat complaints from pharmaceutical companies, Congress sought ways to increase the useful lifespan of drug patents. In 1984, Congress debated and passed the Drug Price Competition and Patent Term Restoration Act. This law extends the life of drug patents either 14 years or as long as the drug approval process, whichever is shorter.

References

• The National Archives: Transcript of the Constitution of the United States
• U.S. Patent and Trademark Office: Patents
• The Law Firm of Louis Venture Jr.: Patenting Drugs
• USPTO: Non-Provisional (Utility) Patent Application, A Guide to Filing
• U.S. Patent and Trademark Office: MPEP: 2701 Patent Term [R-2]-2700 Patent Terms and Extensions

Resources

• The Library of Congress: Drug Price Competition and Patent Term Restoration Act of 1984