Preparing an Israeli patent application for a biotechnology or pharmaceutical invention requires more than translating claims granted by the USPTO or EPO. The Israel Patent Office applies Israeli patentability, disclosure and claim-drafting requirements, including specific examination instructions for antibodies, biological materials and pharmaceutical solid forms. Drori Stav IP advises biotechnology and pharmaceutical companies and foreign patent counsel on drafting and prosecution of such applications in Israel.
Patent drafting in biotechnology and pharmaceuticals involves distinctive challenges. Where an invention concerns an antibody, genetic sequence, protein, pharmaceutical compound or formulation, its activity cannot always be predicted from its structure alone. A small change in a biological sequence may affect protein activity, while a different crystalline form of a drug may change its stability or dissolution rate.
The central task is to draft claims that provide appropriately broad protection while ensuring that their scope is supported by the specification, working examples and experimental data.
Patentability and Disclosure Requirements for Biotechnology in Israel
Sections 3–5 of the Israeli Patents Law, 5727-1967, govern patentable inventions, novelty and inventive step. Section 12(a) requires disclosure sufficient to enable a person skilled in the art to perform the invention, while Section 13(a) requires that the claims reasonably arise from the description. Israeli examiners also apply the unity-of-invention requirement in Section 8 and the clarity rules under Regulation 20(a)(3) of the Patents Regulations.
The Israel Patent Office’s filing guidance calls for a description of the technical problem, relevant prior art, methods of performing the invention, and experimental examples and results where available. The Office’s examination instructions contain specialist annexes on antibody claims and the examination of polymorphs and salts. Those Israeli requirements, rather than foreign patent-office guidance, provide the framework for an Israeli application.
For foreign pharmaceutical and biotechnology companies, the practical consequence is that a broad PCT or foreign claim set may require a distinct Israeli analysis. The description, sequences, examples and experimental results must support the scope sought in Israel, including any functional antibody definitions or claims to a newly identified solid form.
Genetic Sequences and Proteins: From a Specific Sequence to a Family of Variants
In patent applications concerning DNA, RNA or proteins, it is important to distinguish a specific sequence identified by the inventor from a broader family of related sequences.
For example, a biotechnology company may identify a protein with improved enzymatic activity and seek protection for variants of that protein. If a claim covers every protein having at least 90% sequence identity to the disclosed sequence, the drafter must assess whether the specification supports the proposition that proteins throughout the claimed range can perform the relevant function.
Sequence identity does not, by itself, guarantee equivalent biological activity. Substituting an amino acid within an enzyme’s active site may affect its function differently from a substitution elsewhere in the protein.
Depending on the invention, the specification should describe the original sequence, tested variants, regions essential to activity and the relationship between sequence modifications and observed results.
Where a patent application requires a formal listing of nucleotide or amino acid sequences, compliance with WIPO Standard ST.26 is also necessary. The standard specifies an XML-based sequence listing format and replaced ST.25 for applications filed from 1 July 2022.
However, a formally compliant sequence listing is not a substitute for a specification explaining the sequences’ functions and supporting the scope of the claims. See WIPO’s guidance on ST.26.
Antibody Patent Claims: Can Every Antibody with the Same Function Be Protected?
Consider a biotechnology company that develops an antibody binding to a protein involved in an inflammatory process and inhibiting its activity. The company identifies the antibody’s amino acid sequence and demonstrates its biological effect experimentally.
Can the company claim every antibody that binds the same protein and inhibits it?
This is one of the more difficult questions in antibody patent drafting. A claim defined solely by antibody function may encompass an enormous number of antibodies with different sequences and structures. Successfully producing one antibody does not necessarily establish that the applicant has disclosed how to make and use the entire class covered by the functional definition.
Israel has specific examination guidance on this issue. Annex XX of the Israel Patent Office’s examination instructions addresses antibodies under Sections 4, 5, 12 and 13 of the Patents Law. For sufficiency under Section 12, it identifies possible enabling disclosures, including the antibody’s amino acid sequence, variable-region or CDR sequences, an appropriate biological deposit, or a specific or conventional method of production. Measured binding affinity or biological activity alone is not treated as a sufficient manufacturing disclosure for a particular antibody.
Under the same Israeli instructions, an antibody claim defined only by its antigen, epitope or measured functional characteristics is examined as a functional claim under Section 13(b). It is not automatically treated as covering every conceivable antibody with that function: the examination considers the structures disclosed and the antibodies that the described or conventional methods can reliably produce. This affects the decision whether to draft claims around CDRs, full antibody sequences, binding properties or combinations of those features.
A useful foreign comparison is the US Supreme Court’s 2023 decision in Amgen Inc. v. Sanofi. The claims concerned a broad class of antibodies that bind to PCSK9 and prevent its interaction with LDL receptors. Although sequences for 26 antibodies were described, the Court held that the full claimed scope was not enabled under US law.
The lesson is not that functional antibody claims must always be avoided. Rather, the extent to which the disclosure supports the proposed claim scope must be examined. Depending on the evidence, the drafting strategy may combine claims to particular antibody sequences or complementarity-determining regions (CDRs) with claims directed to biological activity or shared structural features.
European practice raises an additional question. A new antibody binding to a known antigen does not necessarily involve an inventive step. According to the 2026 EPO Guidelines relating to antibodies, unexpected advantages in therapeutic activity, stability or immunogenicity may be relevant to inventive step.
Foreign counsel should therefore assess the disclosure and claims separately under the applicable Israeli, US and European standards rather than assume that a functional claim acceptable in one jurisdiction will be treated identically in another.
Depositing Biological Material: When a Written Description Is Insufficient
Some biological materials cannot be described through a chemical formula or genetic sequence alone in a way that enables a person skilled in the art to reproduce the invention.
Suppose a company develops an engineered microbial strain for producing a commercially valuable protein. If the strain is not publicly available and cannot be reproduced adequately from the written description, depositing the biological material with a recognized depositary institution may need to be considered.
In Israel, Section 12(b) of the Patents Law expressly addresses inventions involving biological material. Where a qualifying material has been deposited with a recognized depositary institution, part of the disclosure or method of carrying out the invention may, subject to the prescribed conditions, be provided by reference to that deposit. The statutory definition concerns material that is not publicly available, cannot adequately be described to enable the invention, and is capable of replication or reproduction as specified by law.
A biological deposit is therefore not required for every Israeli biotechnology application. It becomes relevant where a written description alone cannot meet the disclosure requirement. Counsel should evaluate the need for a deposit before the relevant filing date, rather than assume that omitted technical information can always be introduced later.
Yonatan Drori, Patent Law (Hebrew, 2023), Section 3.2.5, discusses biological material deposits as part of the disclosure requirements. Related questions concerning examples, demonstrations and deposits are also examined in Chapter 5.
Internationally, the Budapest Treaty provides a system for recognizing deposits of microorganisms for patent procedure in contracting states, subject to the relevant legal requirements.
When preparing the application, counsel should consider the date of deposit, precise identification of the material and the depositary’s details. It should not be assumed that every omission in the original disclosure can be remedied after filing.
Drafting Pharmaceutical Patents: Active Ingredients, Formulations and Crystalline Forms
The inventive contribution in a pharmaceutical patent does not necessarily reside in a new active ingredient. It may concern a formulation that improves drug stability, a particular salt, a crystalline form or a manufacturing process yielding a product with improved properties.
Suppose a company discovers a new crystalline form of a known active ingredient. Experiments show that the form offers improved stability under specified storage conditions or a different dissolution profile.
The invention may need to be defined through measurable properties, such as an X-ray powder diffraction (XRPD) pattern, together with a description of the preparation process and relevant characteristics.
For an application examined in Israel, Annex XVIII of the Israel Patent Office’s examination instructions deals specifically with polymorphs and salts. The instructions emphasize careful scrutiny of the specification, examples and structural-characterization data. Methods such as XRPD, FTIR, FT-Raman and solid-state NMR can be relevant to identifying the claimed solid form. The instructions distinguish these from supplementary techniques such as DSC, TGA and melting-point measurement, which are not, on their own, considered sufficient to characterize a solid form diagnostically.
Israeli examination under Sections 4 and 5 must also establish novelty and inventive step. An additional foreign illustration is EPO Board of Appeal decision T 777/08, concerning a crystalline form of atorvastatin hydrate. The EPO considered the routine nature of polymorph screening and the need to identify an inventive contribution under European law. The decision may assist international comparison, but the application in Israel must be evaluated under the Israeli statute and Patent Office examination instructions.
This highlights the importance of explaining the actual technical contribution in the specification, rather than relying solely on the discovery of a substance in a different physical form.
Likewise, where the invention concerns a controlled-release formulation, the drafter should determine whether the novelty resides in the combination of ingredients, their quantitative ratios, the structure of the formulation or the release profile achieved by those features. The claims should reflect the identified contribution in a manner supported by the specification.
Drori, Patent Law, Section 3.2.3, discusses inventive step in pharmaceutical inventions and considerations specific to the examination of drug patents.
Experimental Evidence: What Must Be Established Before Filing?
Biotechnology and pharmaceutical development often continues long after the initial discovery. A company may identify a compound with therapeutic potential and wish to file a patent application before clinical trials begin.
There is no general rule requiring every proposed medicine to have undergone human clinical trials before a patent application can be filed. As discussed in Drori, Patent Law, Section 2.1.4.2, the Israeli Supreme Court’s decision in a Sanofi matter addressed the use of animal experiments, in appropriate circumstances, to support the utility of a medical invention, and distinguished patentability requirements from regulatory approval requirements.
Nevertheless, a general assertion that a substance might treat a disease will not necessarily provide adequate support for a broadly framed therapeutic claim.
For example, a laboratory experiment may show that an antibody inhibits a particular protein. If the application seeks protection for treating a broad range of diseases, the scientific relationship between the measured effect and the proposed therapeutic uses must be considered.
The timing of supporting evidence may also matter. In EPO Enlarged Board of Appeal decision G 2/21, it was held that evidence of a technical effect cannot be disregarded for inventive-step purposes solely because it was filed after the patent application. However, the claimed effect must be encompassed by the technical teaching of the application as filed, under the test established by the decision.
Later-filed evidence does not necessarily cure an insufficient disclosure at the filing date. The practical approach is to describe accurately what has been tested, which results have been demonstrated and which possibilities remain at the research stage.
New Medical Uses of Known Compounds: Differences Between Jurisdictions
Pharmaceutical patent drafting also raises the question whether an existing substance can be protected when a new therapeutic use has been discovered.
Under Article 54(5) of the European Patent Convention, further medical uses of known substances or compositions may be protected under specified conditions. This may be relevant to new therapeutic indications, particular patient populations or dosing regimens. See the EPO Guidelines on further medical uses.
Israeli law excludes a process for therapeutic treatment of the human body from patent protection under Section 7(1). However, the distinction between a therapeutic method and a product claim is important. The Israel Patent Office’s examination instructions, reflecting Registrar Circular 034/2017-Patents, expressly recognize claim formulations such as Product X for use as a medicament and Product X for use in the treatment of Y for a new use of a known product, subject to the remaining statutory requirements.
The same instructions do not accept a formulation such as Use of X in the manufacture or preparation of Y as a process claim where the manufacturing steps themselves lack novelty or inventive step and the alleged contribution lies only in a new use. Consequently, claim formats chosen for Israel should reflect the actual technical contribution and the Israeli examiner’s substantive treatment of product and process claims. The European framework for further medical uses can be informative, but it should not replace the relevant Israeli analysis.
Preparing a Patent Application That Reflects the Biological or Pharmaceutical Invention
Effective patent application drafting begins by identifying exactly what has been discovered. For antibodies, this involves the relationship between structure and function; for biological sequences, the extent to which variants are supported; and for pharmaceutical formulations, the features responsible for the claimed technical result.
Separate claims may be appropriate for an active ingredient, a pharmaceutical composition or a new manufacturing process. Each claim category must nevertheless be examined for novelty, inventive step and compliance with the disclosure requirements.
This process is part of a coordinated strategy for patent prosecution in Israel and abroad. In biotechnology and pharmaceuticals, particular importance attaches to aligning the available research, the filing date and the protection sought, so that the claims reflect the technological contribution without exceeding the supporting disclosure.
For a detailed legal discussion, see Drori, Patent Law (Hebrew, 2023), Sections 2.1.4.2, 3.2.3, 3.2.5 and 5.2.3, addressing utility of medical inventions, inventive step in drug patents, biological deposits and sufficiency of disclosure.
Related guidance: Chemical and Materials Patent Drafting, Provisional Patent Application Drafting and How to Draft an Independent Patent Claim.
