Is a prodrug patentable?

For example, prodrugs and especially metabolites thereof can be viewed as anticipated inventions although they may not have been previously disclosed in the parent claim. At the same time, prodrugs can be viewed as a separate subject matter eligible for a new patent.

Can a drug have multiple patents?

In fact, most small-molecule drugs are protected by multiple patents. The average was nearly 3.5 patents per drug in 2005, with over five patents per drug for the best-selling pharmaceuticals; these numbers have increased over time.

Can you patent a combination of drugs?

According to critics, combination drug patents have granted drug makers unearned and extended protection over existing drugs or biological products. But, quite simply, when properly issued by the USPTO under existing patentability standards, these are new patents for new products or processes.

Does experimental use patent infringement?

The law exempts certain experimental activities during research and development that would normally be considered patent infringement.

Can a metabolite be patented?

The chemical structure of pharmacologically active metabolites differs from the compounds originally administered. Theoretically, it is patentable if a metabolite is novel, non-obvious, and possess sufficient utility.

What is a formulation patent?

As the name implies, a formulation patent is a patent that seeks to cover the pharmaceutical formulation of an active pharmaceutical ingredient, i.e., the unique combination of the active pharmaceutical ingredient with excipients that make up the dosage form that is administered to the patient.

What does multi patented mean?

Double patenting is the granting of two patents for a single invention, to the same proprietor and in the same country or countries. According to the European Patent Office, it is an accepted principle in most patent systems that two patents cannot be granted to the same applicant for one invention.

How long does a patent on a drug last?

20 years
Patent terms are set by statute. Currently, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States.

What is an exception to patent infringement?

Anyone who uses a patented invention without authorization is liable for patent infringement under patent statute 35 U.S.C. § 271(a). There is a longstanding common-law exception to this provision. The experimental use exception allows for de minimis use of a patented invention when the purpose is experimental.

How long can drug companies hold a patent?

Drug Patents and the U.S. Food and Drug Administration Although patents are good for 20 years after the invention of the drug, it can take up to eight years for a pharmaceutical company to do enough testing for approval from the U.S. Food and Drug Administration (FDA) and investors.

What is a double patent?

What does it mean if a drug is off patent?

The shift from proprietary product (in-patent), practically produced and marketed exclusively by the innovator pharmaceutical company, to equivalent drug (off-patent), potentially produced by an unlimited number of companies, has indeed changed the structure of the reference pharmaceutical market [3].