Opposition to Amendments to a Patent Specification in Israel: Grounds, Deadlines and Procedure

An amendment to a patent claim may appear to be a minor technical change, yet it can materially affect the scope of patent protection and the position of a competitor preparing to introduce a product into the Israeli market. Once a patent application has been accepted, and particularly after a patent has been granted, Israeli law does not permit the applicant or patent owner to rewrite the claims freely. Amendments must serve specific statutory purposes, comply with substantive restrictions and remain open to opposition by third parties.

Opposition to an amendment of a patent specification concerns whether the proposed amendment is permissible. It differs from opposition to the grant of a patent in Israel, which primarily addresses whether the invention qualifies for patent protection, and from cancellation proceedings against a granted patent. The distinction determines the available grounds, applicable deadlines and evidence required.

For foreign patent attorneys and international companies, particular attention should be paid to the procedural stage of the Israeli application or patent. A request to amend claims during examination is subject to rules different from those governing an amendment after acceptance, and a further procedure applies where a patent opposition is already pending.

What Amendments Are Permitted After Acceptance of a Patent Application?

Sections 22 and 23 of the Israeli Patents Law, 5727-1967, regulate amendments before a patent application is accepted, including the potential effect of a substantive amendment on the application’s filing date. A different regime applies once the application has been accepted.

Section 29 applies the statutory provisions governing amendments to granted patents to an applicant whose application has been accepted, as though the applicant were the patent holder. Regulation 101 of the Patents Regulations applies the amendment procedure during the period between acceptance and grant.

Under Section 65, a patent holder may seek to amend the specification for one of three purposes: clarifying the specification, correcting a mistake or restricting the patent claims. Section 66 imposes two cumulative substantive restrictions. The amendment must neither broaden the scope of the claims nor introduce subject matter that was not substantially disclosed in the specification from the outset.

If the Registrar is satisfied that the relevant conditions have been met, permission to amend is granted and the decision is published online. Section 67 permits any person to oppose that permission.

The distinction between pre-acceptance and post-acceptance amendments is fundamental. During examination, the scope of the proposed protection remains under consideration. Following acceptance, third parties may rely on the published claims in planning their commercial activities. The flexibility available before acceptance should therefore not be assumed to remain available afterwards. The different rules applicable during examination are discussed in Patent Application Amendments in Israel: Substantive Changes Before Acceptance.

Statutory Grounds for Opposing an Amendment Under Section 68

Section 68 sets out two grounds for opposition: there is a reason why the Registrar was entitled to refuse permission to amend, or the amendment does not achieve the purpose for which it was requested.

An opponent may contend that the proposed change does not clarify an existing ambiguity, correct a mistake or restrict the claims, or that it impermissibly broadens the scope of protection or adds technical subject matter not substantially disclosed in the original specification.

Consider a patent claiming a mechanism with an arm, a hinge and a particular locking arrangement. The patent owner proposes to change the definition of the locking arrangement so that the claim covers additional types of locks not covered by the earlier wording. If a competing product that did not previously fall within the claim would fall within the amended claim, the change may amount to an impermissible broadening of protection. Conversely, adding a limitation clearly disclosed in the original description and drawings may constitute a permissible restriction.

The test is not the number of words added or deleted. The legal and technical effect of the amendment must be assessed.

Chapter 12.6 of Yonatan Drori’s Patent Law (2023, Hebrew) discusses the two-stage analysis: first, whether the amendment pursues one of the purposes permitted by Section 65; second, whether it complies with Section 66. The cases discussed there, including proceedings involving Teva, Unipharm, Iscar and Sanofi, demonstrate that amendments characterized as “clarifications” or “restrictions” must still be examined for their substantive effect. Drafting a new claim as dependent on an existing claim does not, by itself, make the addition permissible.

What Is the Deadline for Opposition to a Patent Specification Amendment?

Section 67 prescribes a three-month period from publication of the Registrar’s permission to amend. The relevant official publication must therefore be identified, and its date recorded.

The opposition period does not automatically begin when the patent owner submits the amendment request or when a competitor becomes aware informally that an amendment is contemplated.

Under Regulation 98, opposition is filed with the Israeli Registrar of Patents by written notice specifying the grounds and accompanied by the prescribed fee. Regulation 99 applies the procedural rules governing patent grant oppositions, with the necessary modifications. The initial notice of opposition must be distinguished from the subsequent pleadings and evidence submitted in accordance with the applicable procedure.

Where an amendment is requested while an opposition to the grant of the patent is already pending, Regulation 102 establishes a special procedure for the existing opponent. The ordinary three-month publication period should not be applied without determining whether this special regime governs the particular circumstances.

Amendments During a Pending Opposition to the Grant of a Patent

Regulation 102(a) addresses service of the amendment request on a party opposing the grant of a patent. Under Regulation 102(c), that opponent may object to the proposed amendment within two months after receiving a copy of the amendment request, or by the deadline for submitting evidence under Regulation 60 if the opponent has not yet submitted that evidence, whichever is later.

The objection must be accompanied by the opponent’s statement of case and evidence relating to the proposed amendment.

This procedure differs from an opposition brought by a member of the public within three months of publication of permission to amend under Section 67. When an existing patent opposition is pending, counsel must examine both the procedural status of that opposition and the dates of service and evidence submission applicable to the particular opponent.

Regulation 102 also governs the relationship between the amendment request and the underlying opposition. Regulation 102(d) addresses the suspension of the main opposition pending completion of the amendment procedure, while Regulation 102(e) generally provides for the coordinated consideration of the relevant oppositions in appropriate circumstances. The remaining provisions of Regulation 102 and their exceptions must also be considered.

For foreign counsel coordinating an Israeli opposition, the practical issue is identifying the version of the claims that will ultimately be considered. Technical evidence prepared against superseded claims may no longer address the patent applicant’s operative case.

How Can an Opponent Establish That an Amendment Is Impermissible?

The central evidence is often found in the patent documents themselves: the claims before and after the proposed amendment, the specification, drawings, marked-up amendments and the prosecution correspondence.

An opponent alleging broadening should identify the products, processes or technical embodiments covered by the amended claims but not by the original claims. An opponent alleging added subject matter should identify the technical feature that could not substantially be derived from the original disclosure.

Under Regulation 95, an amendment request must be accompanied by the prescribed fee, an explanation of the amendment’s purpose and reasons demonstrating compliance with Sections 65 and 66. Regulations 97 and 100 address, among other matters, the presentation of the amended text and completion of the amendment process.

The initial publication of permission to amend does not necessarily mean that the amendment procedure has been completed. Under Section 71, once the amendment has been recorded, the amended specification is treated as though it had been accepted in that form from the outset. The potential effect on commercial situations that arose before the amendment must therefore be considered carefully.

Technical expert evidence may be necessary where the dispute concerns the meaning of a claim term or support in the original description and drawings. An expert should explain the technical difference and its consequences, rather than merely assert that the amendment “adds matter”.

An opposition to an amendment should not be treated as an automatic substitute for a challenge based on lack of novelty or inventive step, which addresses the validity of the underlying patent.

Claim Amendments in the Teva–Astellas and Genentech Proceedings

In proceedings involving Teva and Astellas, an application to amend the specification was considered during an opposition to the grant of a patent. The decision examined the distinction between permissible restriction or clarification and the introduction of claims that failed to satisfy the statutory requirements. It also addressed how the amendment affected the continuation of the opposition.

In Celltrion and Perrigo v. Genentech, the proposed amendment of a granted patent arose during cancellation proceedings and included the addition of new claims. The opposition to the introduction of those claims was upheld.

The Genentech matter illustrates why a patent holder cannot rely solely on an assertion that the proposed new claim is no broader than an existing claim. The amendment must also serve one of the purposes identified in Section 65 and satisfy the limitations imposed by Section 66. The decision is discussed in Amending a Patent Specification and Claims to a Registered Patent.

Amendment During Patent Infringement or Cancellation Proceedings

Where proceedings concerning patent infringement or cancellation are pending before a court, Section 70 of the Patents Law and Regulation 95(c) restrict the Registrar’s consideration of a new amendment application. The Registrar may not consider an application filed at that stage without the court’s permission.

Where court proceedings begin after the amendment application has been filed with the Registrar, the Registrar may continue considering the application unless the court orders otherwise.

Regulation 108 establishes a corresponding arrangement for amendments during patent cancellation proceedings before the Registrar, applying Regulation 102 with the necessary modifications.

The legal questions should be kept separate: an opposition to an amendment challenges a proposed change to the specification, while a cancellation proceeding challenges the patent’s entitlement to remain in force. These may be related proceedings, but their grounds and consequences are not identical.

Appealing a Registrar’s Decision on a Patent Amendment

A decision concerning an amendment request is not necessarily a final decision carrying an immediate appeal as of right.

In proceedings involving Tnuva and Strauss, arising during an opposition to the grant of a patent, the Israeli Supreme Court held that a decision on an amendment request that did not conclude the underlying opposition was an interlocutory decision. Challenging that decision at the intermediate stage required leave to appeal. In appropriate circumstances, the decision could also be challenged in an appeal from the final determination.

The appropriate appellate procedure therefore depends on the classification of the decision, the status of the principal proceedings and the applicable time limits.

Assessing Whether to File an Opposition in Israel

Before commencing opposition proceedings, the proposed specification should be compared carefully against the prior version. The analysis should identify every material change to the claims, the purpose asserted for the amendment, the support in the original description and drawings, and whether the change broadens the scope of protection.

The potential commercial consequences for a competitor may also be relevant when deciding whether to oppose, but the legal ground must remain tied to the statutory limitations on amendments. The filing deadline must be determined by reference to the actual procedural route, particularly where an opposition to the grant of the patent is already pending.

Opposition to the amendment of a patent specification forms part of Patent Litigation in Israel, but requires a focused examination of the proposed changes rather than a generalized challenge to the patent. The principal provisions are Sections 29 and 65–71 of the Israeli Patents Law, 5727-1967, and Regulations 95–102 and 108 of the Patents Regulations.

Further analysis appears in Yonatan Drori, Patent Law (Hebrew, 2023), Chapter 12, particularly Sections 12.6–12.9.

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