FDA approval for a new drug is a rigorous process, with many new drugs not making the cut. Only fifty-nine novel drugs received FDA approval[1] in 2018, for example, which was a ten year high.

Though the number of new drugs receiving FDA approval is relatively small, many drugs that are already FDA-approved receive expanded FDA approval each year. Expanded approval may include use of already FDA-approved drugs for new therapies and for new patient populations, such as children, for example.

Depending on how long the drug has been used, there may be substantial historical data which can be used to provide guidance in developing protocols for the expanded therapy or population of the already FDA-approved drug. As an example, Lithium (first approved in 1980) obtained expanded approval from the FDA last year for use in treating several new adult illnesses,[1] likely taking advantage of over twenty years’ worth of historical data and reports to guide the development of these new therapies.

Given the advantages of historical data for substantial savings in research, expansion of FDA approval can be an attractive option for companies once initial FDA approval has been received.

So what does this all mean from an IP perspective? Can you receive any patent protection for new use of your known drug? What is the best strategy to protect the expanded approval of the drug?

As discussed in Patent Docs’ “Patenting Repurposed Drugs”  by John E. Conour, new uses for a known drug can be patent-eligible if the use is novel and non-obvious. Thus, so long as the manner in which the drug is being used is new, the main remaining concern is providing sufficient evidence to support that the new use for the known drug is not obvious. To establish that the new use of the drug is non-obvious, detailed discussion as to the specific unexpected benefits achieved via the new use of the drug may be particularly helpful. Furthermore, if available, trial data showing unexpected advantages can be another powerful tool to support non-obviousness of a new use for a known drug.

From an overall patent portfolio standpoint, coordinating patent coverage of the new drug itself with patent coverage on various uses for the new drug may be a wise strategy to protect a drug from initial FDA approval and through expanded approval.

At least one way to coordinate patent coverage over the initial approval of the drug and into subsequent expansion approvals is to file an initial patent application for the new drug with disclosure directed towards the new drug composition and any contemplated therapies for which the new drug may be used. Then, although the initial patent application may only include claims directed towards a composition of the new drug for example, child patent applications directed towards the various therapies may be filed at a later time.

Via the above approach to coordinating patent coverage, patent protection may be more easily catered to the new drug as the new drug progresses through various FDA approval stages. Moreover, coverage may be provided with as early of filing dates as possible, to help protect the new drug against potential competitors as FDA approval is expanded for the new drug.

Clearly, even though there are not many new drugs approved each year by the FDA, patent portfolio maintenance can be a key strategy for protection of downstream expanded FDA approvals.

[1] “Novel Drug Approvals for 2018.” U.S. Food & Drug Administration, FDA, 15 Jan. 2019, www.fda.gov/drugs/developmentapprovalprocess/druginnovation/ucm592464.htm.