Drug Patents and Generic Medications

Patents protect drug manufacturers and their investments in new drugs by giving the drug company the exclusive right to sell the drug while the patent is in effect. Such investment costs include research, development and marketing costs. When a patent on a brand-name medication expires, manufacturers of generic drugs can submit an abbreviated new drug application (ANDA) to the Food and Drug Administration (FDA) to sell a generic version of the brand-name drug.

A generic drug is basically the same as (or bioequivalent to) the brand-name drug in dosage, safety, strength, quality, performance characteristics, administration and intended use. Generic drugs are usually less expensive then their brand-name counterparts because generic drug makers do not have the same research and development costs. In addition, once generic drugs are approved, there is greater competition, which keeps prices down. There are some situations, however, when there will not be a large market for a generic version of a drug. For example, manufacturers may be able to develop new medications that are more effective or have fewer side effects by the time their drugs' patents expire. In these cases, if people taking the old drug switch to the newer medication, the expiration of the old drug's patent will not lead to as much generic competition since there is a new, improved medication on the market.

Patents for drugs and medications are considered utility patents. The term for a utility patent (for patent applications pending and patents in effect as of June 8, 1995) is the longer of 17 years from the date the patent is issued or 20 years from the filing date.

Determining when a patent expires may not be as clear cut as figuring out when 20 years from the filing date is. Some medications may have different patent numbers — and thus different patent expiration dates — because they have more than one patent number because of different treatments for which they are used. In addition, it is possible for manufacturers to extend a patent term for a patent that claims a human drug product, a method of using a human drug product or a method of manufacturing a human drug product that has been subject to a regulatory review period before commercial marketing or use. Under the Drug Price Competition & Patent Term Restoration Act of 1984 ("Patent Term Act"), the term of a patent can be extended for an additional term equal to the period of pre-marketing administrative review, but not exceeding five years.

The Patent Term Act provides that a patentee may claim an extension if the regulatory review extends beyond the patent's issuance and delays the patentee from benefiting from the patent by selling the drug. Under 35 U.S.C. §156(a), a patent will be extended if the following requirements are met:

• The patent term has not expired prior to the application for the extension
• The patent term was never extended
• The owner of record or its agent submits the application for extension in compliance with the statute
• The patented product was subject to a regulatory review before its commercial marketing or use
• The permission for the commercial marketing or use of the product after the regulatory review period is the first permitted commercial marketing or use of a product manufactured under the process claimed in the patent

Because of the FDA's approval process, it is possible that by the time a drug is approved and authorized for sale in the marketplace, the patent's term may be nearing its expiration date. The Patent Term Act basically allowed generic drug manufacturers greater access to the prescription drug market while allowing the brand-name manufacturers to restore the patent lives of drugs that were lost during the FDA's approval process.

Learn More: Reasons to Contact an Intellectual Property Attorney

To read and print out a copy of the checklist, please follow the link below.

Reasons to Contact an Intellectual Property Attorney

You can download a free copy of Adobe Acrobat Reader here.

Copyright © 2008 FindLaw, a Thomson Reuters business

DISCLAIMER: This site and any information contained herein are intended for informational purposes only and should not be construed as legal advice. Seek competent counsel for advice on any legal matter.

View Previous Months' Selections