Overview of Key Findings
Israel drug patent IL292492 represents a critical component of the country’s pharmaceutical intellectual property ecosystem, reflecting global trends in secondary patenting strategies and localized regulatory practices. This analysis integrates legal frameworks, claim structures, and competitive dynamics to elucidate the patent’s scope and commercial implications.
Legal and Regulatory Framework Governing IL292492
Statutory Foundations Under Israeli Patent Law
Israel’s Patents Law 5727-1967 establishes the groundwork for patent eligibility, emphasizing novelty, inventive step, and industrial applicability[17][20]. For IL292492 to be valid, it must satisfy Section 4 (novelty) and Section 5 (non-obviousness), with the Israel Patent Office (ILPTO) conducting rigorous examinations[19]. The patent’s claims must also avoid exclusions under Section 7, which prohibits methods of medical treatment[18].
Modified Examination and Foreign Parallels
IL292492 likely underwent a modified examination under Section 17(c), allowing the ILPTO to leverage prior examinations from jurisdictions like the U.S. or Europe[18]. This expedites approval but requires claims to align precisely with foreign counterparts, limiting deviations in scope[18]. For example, if IL292492 claims a drug formulation, its specifications must mirror the reference patent’s claims to avoid rejections[18].
Structural and Functional Analysis of Patent Claims
Claim Categories and Scope
While the exact claims of IL292492 are undisclosed, analogous patents (e.g., EP3808369A1) suggest common strategies:
- Composition Claims: Covering active ingredients, formulations, or dosage forms (e.g., IL-22 dimers with Fc domains)[1].
- Method-of-Use Claims: Targeting specific therapeutic indications, such as treating metabolic disorders or inflammatory diseases[1][4].
- Process Claims: Detailing synthesis or manufacturing techniques for improved stability[1][6].
Post-approval patents, which constitute 72% of blockbuster drug filings, often emphasize peripheral aspects like formulations or delivery devices[4]. If IL292492 follows this pattern, its claims may extend exclusivity beyond the primary compound patent by protecting incremental innovations[10].
Enablement and Validity Risks
Under Israeli law, claims must satisfy enablement requirements, meaning the specification must enable a skilled artisan to practice the invention without undue experimentation[16]. Overly broad claims risk invalidation if the disclosure lacks sufficient detail—a common challenge for secondary patents[16]. For instance, a claim covering "any formulation of X with enhanced bioavailability" without specific excipients or methods could be deemed invalid[16].
Patent Landscape and Competitive Dynamics
Market Exclusivity and Thicket Strategies
IL292492 likely contributes to a patent thicket, a common tactic to delay generics. Blockbuster drugs average 37 pre-approval and 99 post-approval patents, with biologics like Humira accumulating 247 patents to extend protection[4][10]. If IL292492 is part of a thicket, it may overlap with:
- Primary Patents: Covering the active ingredient (e.g., sodium phenylbutyrate in IL296490)[7].
- Secondary Patents: Targeting formulations, dosing regimens, or combination therapies[4][10].
Competitor Activity and Freedom-to-Operate
Competitors must navigate IL292492’s claims to launch biosimilars or generics. Tools like the FDA’s Orange Book and Israel’s Drug Registry provide visibility into listed patents, but ambiguities in claim language (e.g., "configured to") create litigation risks[2][13]. For example, a claim stating "a controller configured to administer X dosage" could be interpreted broadly unless constrained by prior art[13].
Strategic Implications and Recommendations
For Innovator Companies
- Layered Patenting: File secondary patents early in the drug lifecycle to build defensive thickets[6][10].
- Global Alignment: Ensure claim consistency across jurisdictions to streamline modified examinations in Israel and abroad[18].
- Disclosure Specificity: Avoid enablement challenges by detailing experimental data for all claimed embodiments[16].
For Generic/Biosimilar Developers
- Prior Art Mining: Use databases like PATENTSCOPE® to identify weak claims for invalidation[5][9].
- Paragraph IV Challenges: Contest patents listed in Israel’s Drug Registry if claims lack novelty or are overly broad[2][8].
Conclusion
Israel drug patent IL292492 exemplifies the intersection of global IP strategies and local regulatory rigor. Its scope, likely encompassing formulation or method-of-use claims, underscores the pharmaceutical industry’s reliance on secondary patents to prolong exclusivity. However, evolving judicial scrutiny of patent quality—both in Israel and globally—poses risks for overly speculative claims. Stakeholders must balance aggressive IP strategies with robust technical disclosures to navigate this complex landscape.
"The sheer breadth of post-approval patents signals strategic behavior to delay competition rather than protect innovation."
— Kesselheim et al., JAMA Internal Medicine [4]
Key Takeaways
- IL292492’s validity hinges on enablement and alignment with prior foreign examinations.
- Secondary patents dominate Israel’s pharmaceutical landscape, necessitating rigorous freedom-to-operate analyses.
- Regulatory reforms targeting "patent thickets" may curtail long-term exclusivity strategies.
Frequently Asked Questions
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What is modified examination in Israel?
A process allowing the ILPTO to rely on foreign patent grants, expediting approval if claims align[18].
-
How do secondary patents extend drug exclusivity?
By protecting formulations, dosages, or methods beyond the primary compound patent[4][10].
-
What risks do overly broad claims pose?
Invalidation due to insufficient enablement or obviousness[16][19].
-
How can generics challenge IL292492?
Through prior art submissions or Paragraph IV-like litigation[2][8].
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What trends shape Israel’s patent landscape?
AI-driven innovations, sustainability focus, and alignment with global examination practices[19].
References
- https://patents.google.com/patent/EP3808369A1/it
- https://www.gov.il/en/service/israeli-drug-index
- https://www.ip-israel.com/en/patents
- https://www.medpagetoday.com/publichealthpolicy/healthpolicy/110102
- https://www.uspto.gov/patents/search
- https://www.evalueserve.com/blog/mapping-the-patent-landscape-process-for-product-and-business-managers/
- https://www.drugpatentwatch.com/p/international/index.php?query=IL296490
- https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity
- https://www.knowmade.com/patent-analytics-services/patent-report/semiconductor-patent-landscape/power-electronics-devices-patent-landscape/power-gan-patent-landscape/
- https://www.theregreview.org/2023/10/16/dolbow-how-patents-contribute-to-high-drug-prices/
- https://www.drugpatentwatch.com/p/international/index.php?query=IL249669
- https://pubchem.ncbi.nlm.nih.gov/patent/US-8758779-B2
- https://www.trademarkcopyrightpatentlaw.com/post/the-scope-of-configured-to-in-patent-claims
- https://ipwatchdog.com/2014/07/12/understanding-patent-claims/id=50349/
- https://en.wikipedia.org/wiki/Patent_claim
- http://blueironip.com/ufaqs/what-does-enablement-commensurate-in-scope-with-the-claims-mean-in-patent-law/
- https://iclg.com/practice-areas/patents-laws-and-regulations/israel
- https://jmbdavis.com/knowledgebase/modified-examination-for-israel-patent-applications/
- https://www.luzzatto.co.il/en/intellectual-property-landscape-in-israel-2023-unveiling-developments-and-challenges/
- https://wipolex-res.wipo.int/edocs/lexdocs/laws/en/il/il001en.pdf
Last updated: 2025-04-23
