Pharmaceutical Term Extension with Conflicting Approval Dates

The PTE is not automatic, and the deadline is not the patent expiry date. The application must be filed within the period prescribed by the Israeli PTE provisions, measured from the first marketing approval that qualifies.

• If the EU approval of 15 September 2025 is the first qualifying approval, 90 days later is 14 December 2025. A filing on 1 March 2026 is late.
• If Israeli law measures from the Israeli approval of 20 January 2026, 90 days later is 20 April 2026. The filing is timely.
• The Swiss approval of 10 August 2025 is potentially decisive. If Switzerland is a recognized jurisdiction for this purpose and that approval is the first qualifying approval, then neither the EU nor the Israeli date is the correct trigger, and the application misidentifies the first approval.

The attorney must therefore obtain the approval certificates, confirm which jurisdictions qualify, and check the exact statutory trigger. The patentee should not assume that the Israeli approval controls merely because Israel is the granting state. If the deadline has passed, the applicant must consider whether any correction, restoration or re-filing route exists; usually there is no easy cure.

They raise two separate issues.

First approval. If the Israeli regime uses the first approval in a recognized country, the Swiss approval of 10 August 2025 precedes the EU approval. The application relying on the EU approval would then be based on the wrong date and could be rejected or invalidated. If the regime uses the first Israeli approval, the Swiss approval is irrelevant. The attorney must verify the statutory wording and the list of recognized jurisdictions. The generic company will argue the first point; the patentee should prepare evidence either that Switzerland is not qualifying or that the Israeli approval is the statutory trigger.

Product coverage. A PTE extends protection for the approved product, not for every compound in the patent. If claim 1 covers compound A and its salts, the approved product may be the free base or a specific salt. The attorney must compare the marketing authorization's active ingredient with the claim. If the approved product is a salt within the claim, coverage is likely. If it is a different salt or formulation not covered, the extension may be refused or limited. The fact that the patent covers an unapproved salt does not automatically defeat the extension, but it may limit the scope.

The generic's argument is strongest on the first-approval point, not on the mere existence of salt claims.

The patentee should act on three fronts:

1. Deadline and trigger. File a corrected or supplemental submission identifying the proper first approval, with certificates and a legal explanation. If the filing is late, explore whether the Registrar has power to excuse or correct; do not assume a grace period. Document the date of the Israeli approval and the date the patentee first knew of the foreign approval.
2. Product scope. Align the PTE request with the approved product. Submit the marketing authorization, the active ingredient specification and a claim chart showing that the approved product falls within a claim. If the approved product is a specific salt, consider limiting the request to that salt rather than claiming the whole genus.
3. Challenge preparation. The generic may attack the extension before the Registrar or in court. Prepare evidence on the first approval, the qualifying jurisdiction and the product coverage. Consider whether the patent's remaining term and the extension cap affect the commercial value. If the extension is vulnerable, consider a settlement or a launch-date strategy.

The patentee should not ignore the Swiss approval. A candid analysis is better than filing a broad request that collapses on the first-approval issue.