How Long Do Medical Patents Last: Everything You Need to Know
How long do medical patents last does not have a set-in-stone timeframe. Generally, a company owns a medical patent for a set period, which is estimated at about 20 years, which includes applicable extensions3 min read
How Long Do Medical Patents Last?
How long do medical patents last does not have a set-in-stone timeframe. Generally, a company owns a medical patent for a set period, which is estimated at about 20 years, which includes applicable extensions. A variety of extensions can affect the length of the patent.
Pros for Getting or Extending a Medical Patent
To balance out the loss of years a company may lose while waiting for a drug to be developed, tested, or certified, the Hatch-Waxman Act was implemented in 1984. The act allows for a company to receive an extension to help defray the loss of time. Extensions can be granted for no more than five years.
A pediatric exclusivity extension is available on medical patents when children are involved in the testing of the drug. In this case, an extension of six months is allowed but for no more than two times when it involves the same drug.
Another extension option approved by the FDA is known as the "three-year new use" rule. The rule applies if the original drug has been effective in producing another remedy other than what the original patent is for.
Companies developing drugs to battle a rare disease may apply for a 7-year extension. These are granted in an effort to encourage pharmaceutical companies to research, test, develop and make available treatments for these types of diseases.
Pharmaceutical companies can apply for new patents when the original drug is reformulated. This can be as simple as changing the way the drug is taken such as changing the dosage from taking a pill once a day instead of three times a day. The new patent allows the company to continue to manufacture its original drug almost indefinitely by reformulating aspects of the drug.
If the company develops a new way to administer the drug such as changing from pill form to a nasal spray, this may lead to an extension of the patent.
Along with a medical patent, a company may also have market exclusivity. This means the company has the right to exclusively market the drug to offset competition by companies manufacturing generic drugs. Depending on the type of drug determines the market exclusivity period.
Cons for Expired Medical Patents
When the timeframe for a medical patent expires, the drug is eligible to be manufactured by other companies as a generic drug. Because there is no longer a monopoly for manufacturing the drug by the originating pharmaceutical company, the new companies can manufacture and sell the drug at a lower price.
The original pharmaceutical company has the option to re-work/enhance the original drug and apply for a new medical patent. Because other companies have begun manufacturing a generic version of the original, the originating company will most likely be competing with its new drug against its former brand that is now available in a generic form.
A pharmaceutical company that develops generic drugs may apply for a patent for a drug being manufactured by the original company. When this happens, it can become a legal issue for the original company, the generic company, and the FDA. The outcome could result in a 30-month extension being granted to the original company. These are referred to as 30-Month Stays of FDA Approval.
Deadlines for Medical Patents
There are several reasons why the timeline for a medical patent may vary from its standard 20-year timeframe.
- Pharmaceutical companies that are in the process of developing a drug and applying for approval from the Federal Drug Administration may have the drug in a holding pattern for years. Since the start of the 20-year timeframe begins with the day the patent is approved. What this means to the medical market is once it's available, the patent lifespan may be significantly less than 20 years depending on how long the pharmaceutical company had the drug on hold.
- It has been considered to change the start of the patent to 15 years from the date the FDA approves the drug. In this way, patent life is not being used while the drug is either still in development or waiting for approval.
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