When developing a new drug or biologic, companies often focus on regulatory milestones like Investigational New Drug (IND) submission and Biologics License Application (BLA) approval. Just as important, however, is the intellectual property (IP) strategy that protects the product throughout the long development process.

Two key tools can extend patent life:

• Patent Term Adjustment (PTA, 35 U.S.C. §154): Extra patent time awarded when the Patent Office delays examination beyond statutory deadlines (reduced by applicant delays). PTA only accrues during USPTO prosecution and does not apply to the time period spent in the PCT international stage.

• Patent Term Extension (PTE, 35 U.S.C. §156): Extra time added after a patent’s expiration date to compensate for delay due to regulatory review of a particular product. PTE can be up to five years, but post-FDA-approval patent life (original term + PTE) cannot exceed fourteen years. Importantly, PTE applies to only one patent per approved product and the extension only applies to the approved products (not the full scope of the patent claims).

The Strategic Question

To maximize value, patent strategy must be aligned with the regulatory timeline. Timing is everything:

• Filing a fast-track application (e.g., Track 1) can be used to obtain a granted patent early, such as before FDA approval, and in some cases before FDA review begins. This strategy can be used to maximize PTE because only regulatory delay after patent issuance counts toward PTE.

• Filing a standard U.S. utility application or a U.S. national phase application may take longer to grant but can accumulate PTA due to docket backlogs in the USPTO. This allows applicants to take advantage of inherent delays in prosecution, potentially pushing out the expiration date for the granted U.S. patent when expedited issuance is not a high priority.

• These strategies rarely align perfectly—an application that gains PTA may issue relatively late in the FDA approval process, reducing the total amount of available PTE.

Why Some Companies Do Both

For high-value assets, a dual-track strategy may be utilized:

• Track 1 application to secure an issued patent by the IND acceptance date and maximize possible PTE.

• Early national stage entry of a corresponding PCT application without expediting prosecution under Track 1 or another USPTO program to allow PTA to accrue, thereby creating a later-expiring patent within the family.

This hedges risk and provides flexibility. The downsides include cost and the potential for double patenting rejections when two patents cover similar subject matter. In practice, these risks can often be managed with careful claim strategy to avoid the need to file a terminal disclaimer.

Additional Considerations

• 14-Year Cap: Even if five years of PTE is available, the effective term post-FDA approval cannot exceed 14 years. For long development timelines, this cap often limits the real value of PTE.

• One Patent Rule: Because only one patent per approved product can receive PTE, patent owners must select the patent that best extends exclusivity. This is usually the patent with the longest-lasting coverage at the time of approval.

• Stacking PTA and PTE: In many cases, it is difficult to gain both forms of extension on the same application. PTA benefits accrue only if examination is delayed, while PTE requires issuance before regulatory review starts. Thus, a portfolio approach is essential.

Key Takeaway

Patent strategy for drug and biologic assets is a portfolio management exercise, not a single-patent decision. Securing a patent before FDA review begins maximizes PTE potential, while balancing examination speed may preserve PTA on companion filings. The right choice—or combination—depends on development goals, timelines, and tolerance for parallel filings.

With careful planning, companies can extend exclusivity beyond the standard 20-year term, protecting their investment and strengthening their market position.