Overview of Israel's Patent System
Israel is renowned for its innovative and technologically advanced environment, particularly in the fields of biotechnology and pharmaceuticals. The Israel Patent Office (ILPO) is the central authority responsible for granting and managing patent rights in the country. Here are the key insights into patentability, enforceability, and the scope of claims for biopharmaceutical patents in Israel.
Patentable Subject Matter
Under Section 2 of the Israel Patents Law, an invention is considered patentable if it is new, useful, has industrial application, and involves an inventive step. This applies to both products and processes in any field of technology[1][2].
Biotechnological Compositions of Matter
Biopharmaceutical inventions that are patentable include isolated polynucleotides of known function, constructs containing these sequences, vectors, host cells comprising these vectors or constructs, and the polypeptides encoded by isolated polynucleotide sequences. However, animals or plants per se, except for microorganisms not derived from nature, are excluded from patentability[1].
Exclusions from Patentability
Certain types of subject matter are excluded from patentability under Section 7 of the Israel Patents Law. These include:
- Methods of therapeutic treatment on the human body.
- New varieties of plants or animals, except for microbiological organisms not derived from nature[1][2].
Exceptions and Alternatives
While methods of therapeutic treatment are excluded, products or compositions used for the treatment of the human body can be patented. Purpose-limited product or composition claims, formerly known as Swiss-type claims, are recognized and provide protection for primary, secondary, and subsequent medical indications of an active ingredient[2].
Patent Term and Extensions
Patent protection in Israel is granted for a term of 20 years from the filing date. Additionally, patent term extensions can be granted to compensate for delays in market approvals. These extensions are based on the extension periods granted in reference countries such as the USA, UK, France, Germany, Spain, and Italy[2].
Marketing Exclusivity
Pharmaceuticals containing a new chemical entity may be granted a marketing exclusivity period of up to 6.5 years from the first registration in a recognized country (e.g., US, EU)[2].
Pre-Grant Opposition
The ILPO allows pre-grant opposition to patent applications within a non-extendable period of 3 months. This procedure can last for 2 to 3 years or longer and provides an avenue for generic manufacturers to oppose patents[2].
Examination and Prior Art
The ILPO relies on the examination results of parallel applications in leading jurisdictions such as Europe and the US. Applicants must submit their applications in Israel within 12 months of the previous application to claim priority. The ILPO conducts an independent prior art search and examines applications on various grounds, including unity of invention and sufficient support for the claimed invention[2].
Patent Prosecution Highway (PPH)
Israel participates in the Patent Prosecution Highway (PPH) program with the European Patent Office (EPO) and other offices. This program allows for accelerated examination of patent applications based on the work done by the participating offices, enabling faster and more efficient patent granting processes[4].
Scope of Claims
The scope of claims for biopharmaceutical patents in Israel must adhere to specific criteria:
- Claims must be new and involve an inventive step.
- Claims related to biologic drugs must meet the criteria set by the Patents Registrar, including being reviewed as a new active substance, having structural differences from previously listed proteins, and these differences impacting the activity or pharmacokinetic profile[3].
Claim Correspondence in PPH
Under the PPH program, claims in the Israeli application must sufficiently correspond to the patentable/allowable claims in the Office of Earlier Examination (OEE). This means the claims must be of the same or similar scope, or narrower in scope, with any additional features supported in the specification[4].
Enforceability of Patents
Patent litigation in Israel often revolves around the proper scope of regulatory approvals and the criteria for patent term extensions. The Patents Registrar and the courts ensure that patents are enforced in a manner that respects both the rights of the patent holder and the public interest[3].
Litigation and Opposition
Patent litigation can involve complex issues such as the first regulatory approval principle and the structural differences between biologic drugs. Pre-grant opposition and post-grant litigation procedures are available to challenge the validity of patents, ensuring that only deserving inventions are protected[2][3].
Role of the Israel Patent Office
The ILPO is housed under the Ministry of Justice and is responsible for providing legal protection for industrial intellectual property through the registration of patents, designs, trademarks, and appellations of origin. The office employs over 100 patent examiners organized into specialized teams based on distinct technologies, including biotechnology and pharmaceuticals[5].
Guidance and Resources
The ILPO provides information and guidance to the public on its functions and responsibilities. The office's website offers detailed procedures, work instructions, and submission guidelines for various types of intellectual property applications[5].
Key Takeaways
- Patentable Subject Matter: Biopharmaceutical inventions must be new, useful, have industrial application, and involve an inventive step.
- Exclusions: Methods of therapeutic treatment and new plant or animal varieties (except microorganisms) are excluded.
- Patent Term and Extensions: 20-year term with possible extensions for delayed market approvals.
- Pre-Grant Opposition: Available within 3 months, providing a mechanism for generic manufacturers to challenge patents.
- Examination and Prior Art: ILPO relies on international examination results and conducts independent prior art searches.
- Scope of Claims: Claims must meet specific criteria, including novelty and inventive step, and correspond to patentable claims in PPH programs.
- Enforceability: Patents are enforced through litigation and opposition procedures, ensuring respect for both patent holders' rights and public interest.
FAQs
What is the term of patent protection in Israel?
Patent protection in Israel is granted for a term of 20 years from the filing date, with possible extensions to compensate for delays in market approvals[2].
Can methods of therapeutic treatment be patented in Israel?
No, methods of therapeutic treatment on the human body are excluded from patentability. However, products or compositions used for treatment can be patented[1][2].
How does the Patent Prosecution Highway (PPH) program benefit applicants in Israel?
The PPH program allows for accelerated examination of patent applications based on the work done by participating offices, enabling faster and more efficient patent granting processes[4].
What types of biotechnological compositions are patentable in Israel?
Isolated polynucleotides, constructs, vectors, host cells, and the polypeptides encoded by isolated polynucleotide sequences are patentable[1].
Can generic manufacturers oppose patent applications in Israel?
Yes, generic manufacturers can oppose patent applications through the pre-grant opposition procedure within a non-extendable period of 3 months[2].
Cited Sources
- Patentable Subject Matter for Biotech & Pharma in Israel - KM Miller IP
- Israel's less stringent IP laws help create conducive business environment - PharmaBiz
- Israel: Patent Litigation – Country Comparative Guides - Legal 500
- Patent Prosecution Highway programme between the European Patent Office and the Israel Patent Office - EPO
- Patent Office - IPAA
