Patent Term Extension Considerations for BioPharma Patents

On December 13, 2023, Directors John Covert and Gaby Longsworth, Ph.D. presented the webinar “Patent Term Extension Considerations for BioPharma Patents.” It is important that life sciences companies and patent practitioners understand the intricacies of patent term extension (PTE) procedures and strategy, and how an extended patent relates to overall exclusivity. PTE aims to restore up to five (5) years of the patent term that was effectively “lost” while the patent holder is awaiting regulatory approval of the product. An application for PTE is filed with the USPTO and determination whether or not PTE should be granted is made by the USPTO in consultation with the Food and Drug Administration (FDA).

Our webinar covered the interplay between PTE, Patent Term Adjustment (PTA), and obviousness-type double patenting (ODP) as well as strategies for choosing a patent to extend; managing multiple PTE requests; the pitfalls of interim extensions; and the provisions and responsibilities of the USPTO and FDA. The program concluded with an interactive Q&A session.

Some common questions from our Q&A included:

Q: If an active ingredient does not have approval before the patent expires, is it eligible for PTE?

A: Yes, it may be eligible for interim patent term extension depending upon where in the approval process the application for approval is.

Q: Generally, what are some of the PTE terms outside of the U.S.—are they also five years or do they vary?

A: Each jurisdiction is different and the best practice is to contact an associate in the jurisdiction of interest. We are aware of PTE provisions in Japan, South Korea, Taiwan, and Israel. Europe also has Supplemental Protection Certificates that work quite differently than PTE in the United States.

Q: What is the active ingredient of an antibody-drug conjugate?  The drug, the antibody, or the conjugate?

A: The active ingredient is likely the antibody-drug conjugate, but if both the antibody and the drug were never approved before, it is theoretically possible that each one could be considered the active ingredient. The facts are critical here.

Note: CLE is not available for On Demand viewing.