Last updated: July 27, 2025
Introduction
The World Intellectual Property Organization (WIPO) patent WO2016068796 pertains to innovations in drug development, specifically targeting therapeutic agents, formulations, or methods for treating certain medical conditions. This application is part of the broader patent landscape that aims to secure exclusivity for novel pharmaceutical compounds or treatment modalities. A comprehensive understanding of the scope and claims of WO2016068796 is essential for stakeholders — including biotech firms, generic manufacturers, and legal entities — to navigate intellectual property rights, licensing opportunities, and competitive positioning.
Scope of Patent WO2016068796
The scope of patent WO2016068796 is primarily defined by its independent claims, which delineate the core inventive concepts. The patent covers:
- Novel chemical entities or derivatives with specified structural features, potentially including modifications that enhance efficacy, stability, or bioavailability.
- Pharmaceutical compositions comprising the claimed compounds, possibly formulated with carriers or adjuvants.
- Method of treatment involving administering these compounds to patients to treat certain diseases, such as cancers, inflammatory conditions, or metabolic disorders.
- Manufacturing methods for synthesis or purification of the claimed compounds, aiming at scalable production.
By focusing on compounds with unique chemical modifications, the patent aims to extend patent protection to both the molecules themselves and their therapeutic use.
Claims Analysis
Claims in WO2016068796 can be broadly categorized into independent and dependent claims:
Independent Claims
These serve as the cornerstone, typically covering:
- Claim 1 (or analogous initial claim): A chemical compound with a specific core structure and defined substituents, highlighting novelty over prior art.
- Claim 2: A pharmaceutical composition comprising the claimed compound, with optional excipients.
- Claim 3: A method of treating a disease by administering the compound, with delineation of dosage, frequency, or patient population.
Dependent Claims
Dependent claims add specificity, such as:
- Variations in chemical substituents that enhance certain pharmacokinetic or pharmacodynamic properties.
- Specific formulations, delivery systems, or routes of administration.
- Particular dosages, treatment regimens, or combination therapies.
This layered claim strategy broadens protection, balancing scope with enforceability.
Key Elements of the Patent Claims
- Chemical Structural Definition: Likely a backbone molecule with variable substituents, conferring broad coverage over a class of derivatives.
- Pharmaceutical Compilation: Claims that extend to compositions with known excipients, possibly emphasizing stability or controlled release.
- Therapeutic Methodology: Claims exclusive to specific indications, possibly including biomarkers for patient stratification.
Implications of Claims
The patent’s scope suggests an aim to protect both the chemical innovation and its therapeutic application. By including claims on compositions and methods, the applicant seeks to maximize exclusivity, deter generic entry, and secure licensing options.
Patent Landscape Context
Pre-existing Patents
The landscape includes prior patents on similar chemical classes, such as kinase inhibitors, ion channel modulators, or other small molecule drugs. WO2016068796 distinguishes itself through:
- Novel chemical substitutions or structures.
- Unexpected pharmacological activity.
- Improved safety or bioavailability profiles.
Competitor Patents and Applications
Key competitors have filed related patents covering:
- Variations in the chemical scaffold.
- Different indications.
- Alternative formulations and delivery methods.
These overlapping patents create a dense landscape, necessitating careful freedom-to-operate (FTO) analyses before commercial deployment.
Patent Life Cycle
The filing date of June 2016 positions the expiration around 2036-2037, assuming 20 years from filing, after considering patent term adjustments. This timeline influences R&D planning, partnership negotiations, and market entry strategies.
Geographical Coverage
While WO2016068796 is a PCT application, specific national phase entries in major markets like the US, EU, China, and Japan will determine regional exclusivity. Filings in these jurisdictions will subject the patent to local examination standards and potential oppositions.
Legal Status and Challenges
Since PCT applications do not confer enforceable rights until national phase entry and grant, the legal landscape involves:
- No granted patent yet: The application is likely still under examination.
- Potential challenges: Prior art submissions, patentability objections, or oppositions could affect the scope or validity.
- Freedom to operate: Companies must monitor subsequent prosecution and oppositions affecting the patent family.
Strategic Considerations
- Patent Strengthening: Filing divisional or continuation applications to cover additional compounds or methods.
- Litigation and Licensing: Using the patent for licensing revenue or defending against infringing generic products.
- Innovation Pipeline: Aligning R&D to develop beyond the scope or in areas not covered by the patent.
Conclusion
WIPO patent WO2016068796 embodies a strategic attempt to secure broad patent rights for a class of therapeutic compounds, their formulations, and uses. Its scope reflects a comprehensive approach, aiming to lock in exclusive rights across multiple facets of the drug's lifecycle. The evolving patent landscape necessitates vigilant monitoring, especially in key jurisdictions, to leverage the patent's commercial potential while mitigating infringement risks.
Key Takeaways
- The patent’s scope encompasses specific chemical compounds, formulations, and therapeutic methods, indicating a comprehensive IP strategy.
- Broad claims effectively protect core innovations but are subject to examination standards and potential legal challenges.
- The patent landscape around similar chemical classes and indications is crowded, requiring strategic positioning for market entry.
- Early filing in key jurisdictions enhances global protection; regional filings impact enforcement and licensing.
- Continuous patent family expansion and vigilant monitoring are essential to maintain patent strength and market exclusivity.
FAQs
1. What is the main innovation protected by WO2016068796?
It primarily covers a novel class of chemical compounds with specific structural features intended for therapeutic use, along with their formulations and methods of treatment.
2. How does this patent compare to prior art in the same therapeutic area?
This patent distinguishes itself through unique chemical substitutions that confer potential advantages, such as increased potency or better pharmacokinetic profiles, over existing compounds.
3. What are the risks of patent challenges for WO2016068796?
Potential challenges include prior art that anticipates or renders the claims obvious, opposition based on patentability grounds, or failure to meet novelty or inventive step criteria during examination.
4. When can this patent potentially be enforced commercially?
Following grant after completing national phase examinations, typically around 2022-2023, and assuming maintenance fees are paid, it can be enforced in target jurisdictions.
5. How should companies approach freedom-to-operate assessments around this patent?
They should analyze the claims' scope relative to their own compounds and processes, review similar patents in the landscape, and consider designing around or licensing arrangements.
References
- World Intellectual Property Organization. WO2016068796. Available at: WIPO_PATENTSCOPE.
- Patent landscape reports for chemical and pharmaceutical patents (example sources).
- Recent filings and legal status updates from national patent offices indicating the progression of WO2016068796.
This detailed analysis is intended for informational purposes and should be supplemented with legal counsel and patent professionals for strategic decision-making.
