For Israeli Companies Entering the U.S.
For many Israeli device companies, the United States is the first major commercial market and the place where acquirers and investors judge the portfolio. The U.S. patent position deserves the same rigor as the FDA plan.
Israel's medical device sector is heavily venture-backed and startup-driven, supported by the Israel Innovation Authority and the Israel Advanced Technology Industries association (IATI), which together publish an annual life sciences industry report. U.S. strategic acquirers have long been active: Medtronic completed its acquisition of Israel-based Mazor Robotics, a developer of robotic-assisted spine surgery systems, in December 2018. For companies on that path, the U.S. patent portfolio is frequently the asset that diligence examines most closely.
Patents in Israel are handled by the Israel Patent Office (ILPO). Israel is a member of the Patent Cooperation Treaty, and since 1 June 2012 the ILPO has served as an International Searching and Preliminary Examining Authority, available to Israeli and U.S. applicants. Israel is not a contracting state of the European Patent Convention, so European protection is pursued through the EPO as a separate step. Two home-country rules affect the U.S. filing sequence. First, the Israeli Patents Law restricts foreign filing by Israeli nationals and residents for inventions in weaponry or of military value unless the Minister of Defense permits it, or the application is first filed in Israel and six months pass without a secrecy order. Second, Israel's grace period is limited to specific situations such as unauthorized disclosure and recognized exhibitions; proposals for a broader 12-month grace period modeled on U.S. law have been discussed but not enacted. U.S. law generally disregards an inventor's own disclosure made within one year of filing, yet an early disclosure can still be fatal elsewhere.
At home, device registration with AMAR, the Medical Devices Division of the Ministry of Health, generally relies on prior approval in a recognized reference market such as the United States or the EU. For many Israeli companies, the FDA submission is therefore the pivotal regulatory event. A foreign establishment whose devices are imported into the United States must register with FDA and designate a U.S. agent.
U.S. rights are territorial and must be secured directly: a U.S. application within the 12-month Paris Convention priority year, or U.S. national stage entry from a PCT application by 30 months from the priority date. Before launch, a U.S. freedom-to-operate review is prudent, because importing an infringing device can support federal court litigation or a Section 337 investigation at the U.S. International Trade Commission, where exclusion orders can bar products at the border.
Home-country organizations active in this sector include Israel Advanced Technology Industries (IATI), Israel Innovation Authority. Knechtel Law Group is not affiliated with them.
Patent Strategy Considerations
Diligence teams look for U.S. claims that read on the commercial product, a clean chain of title, and a credible freedom-to-operate position. Where development was supported by Israel Innovation Authority funding, transfers or licenses of funded know-how outside Israel can require IIA approval; Israeli counsel should confirm those obligations so the U.S. strategy fits within them.
For inventions that may fall within Israel's defense-related filing restriction, waiting six months after an Israeli filing uses half of the Paris priority year. Deciding early, with Israeli counsel, whether the restriction applies lets U.S. and PCT filings proceed on a planned schedule rather than under deadline pressure.
Investor meetings, clinical publications and hospital pilots often come early in an Israeli company's life. Because Israel and Europe forgive far less pre-filing disclosure than the United States, a filing strategy that precedes those disclosures protects options in every market, not only the U.S.
How Engagements Work
Knechtel Law Group is based in Carefree, Arizona, and advises on U.S. patent strategy. Questions of Israeli or European law are for your home-country counsel; the work here is coordinated with them so priority claims, filings and deadlines line up. Consultations are scheduled across time zones.
Request a Confidential ConsultationCommon Questions
Yes. Israeli counsel continues to handle Israeli filings and home-country requirements, including any defense-related filing questions, while we handle U.S. strategy, prosecution and freedom-to-operate work. We do not advise on Israeli law.
Yes. The ILPO serves as a PCT International Searching Authority for Israeli applicants, and a PCT application can enter the U.S. national stage by 30 months from the priority date. The search results can inform U.S. claim strategy before that deadline.
No. FDA clearance or approval concerns market authorization, not exclusivity against competitors. Patent protection in the United States comes only from U.S. patents.
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