Court Invalidates Patent Protection Order on Eliquis® – The Path to Generic Apixaban Opens

The Eliquis® ruling marks an important test case in the way Israel balances protection of the interests of the local generic industry and the broader public against the international interests of the pharmaceutical industry. Beyond the specific outcome of the case, the judgment sends a clear signal to stakeholders in the pharmaceutical sector as to how patent term extension mechanisms are likely to be interpreted in the future. For companies operating in the Israeli market, this is a decision that may affect launch timing, legal risk management, and preparedness for competition. Against this background, it is worth examining more closely the reasoning adopted by the Court and the practical implications arising from it.

Key Implications

• A blockbuster drug opens to generic competition. Eliquis, containing the active ingredient apixaban, is a widely prescribed anticoagulant used to prevent blood clots. It is among the highest-revenue pharmaceutical products globally. The Court’s ruling confirms that the Israeli patent extension order (Patent No. 160693) has expired, determining that the path had been cleared for generic manufacturers to produce and market generic apixaban in Israel.
• Retroactive revocation abroad triggers expiry in Israel. BMS argued that because the UK reference patent was revoked retroactively (“ab initio”) – as though it had never been granted – the revocation should not trigger the expiry of the Israeli extension order. This is because, as the argument goes, if the UK reference patent, or its SPC (Supplementary Protection Certificate), had not been issued in the first place, this would not have prevented a PTE from being granted in Israel. The Court rejected this argument, holding that the statute draws no distinction between retroactive and prospective revocations: any form of cancellation, revocation, or deletion of a reference patent extension in a recognized country causes the Israeli extension to expire.
• Strict statutory interpretation governs patent extensions. Following the Supreme Court’s landmark ruling in the Boehringer case, the Court reaffirmed that Israel’s patent extension regime must be interpreted strictly, adhering closely to the statutory text, even where the outcome in a particular case may appear harsh to the patent holder. The Court emphasized that the legislative scheme reflects a carefully negotiated compromise among the interests of the originator pharmaceutical industry and those of the generic industry and the Israeli public, and that this balance must not be disturbed through expansive judicial interpretation.
• Market alignment is the driving policy rationale. The Court endorsed the respondents’ position that the purpose of Section 64J(3) of the Patents Act is to ensure that Israeli patients (and the Israeli generic industry) are not denied access to generics already available to consumers in recognized reference countries. When a reference country opens its market – whether through prospective expiry or retroactive revocation – Israel’s market should open as well.

What This Means for You

For generic manufacturers: This ruling presents a clear opportunity. It confirms that any revocation of a reference patent extension abroad – including retroactive revocations resulting from validity challenges – will open the Israeli market to generics and permit the manufacture of generics in Israel. Companies should actively monitor patent revocation proceedings in recognized countries (the United States, Italy, the United Kingdom, Germany, Spain, and France) and prepare launch strategies accordingly.

For originator companies: The ruling narrows the scope for defending Israeli patent extensions following adverse outcomes abroad. Originator companies should be aware that a successful challenge to a reference patent in any single recognized country where a marketing authorization has been granted may result in the immediate loss of patent extension protection in Israel – even if extensions remain in force in all other reference jurisdictions.

For companies considering the Israeli market: Israel’s patent extension regime is closely tied to outcomes in reference countries. Foreign pharmaceutical companies – whether originators or generics – should understand that the Israeli framework does not operate independently; it mirrors and responds to developments in the United States and the five recognized European countries. This decision reaffirms that the system is designed to ensure that Israel does not provide broader patent protection than that available in leading international markets.

Tal Band, Ran Vogel and Yair Ziv represented Teva Pharmaceutical Industries Ltd. and the Manufacturers Association of Israel in these proceedings.