Last updated: February 19, 2026
What is the core innovation protected by NO20061471?
Norwegian patent NO20061471, filed by Genentech, Inc. on July 27, 2006, protects a method for treating and preventing inflammatory conditions. The invention centers on the use of a specific antibody, identified as an anti-VEGF antibody, for inhibiting or neutralizing vascular endothelial growth factor (VEGF). This inhibition is crucial for managing diseases characterized by aberrant or excessive VEGF activity, leading to inflammatory responses. The patent claims define the antibody itself, its use in specific therapeutic contexts, and pharmaceutical compositions containing the antibody.
What are the key claims within NO20061471?
NO20061471 has several independent and dependent claims that collectively define the scope of protection. The primary claims focus on:
- Claim 1 (Independent): A method for treating or preventing an inflammatory condition in a subject. This method involves administering a therapeutically effective amount of an anti-VEGF antibody. The claim specifies that this antibody is a recombinant humanized monoclonal antibody. It further details that the antibody is characterized by having a particular amino acid sequence in its heavy chain variable region (VH) and light chain variable region (VL), which are precisely defined by their respective amino acid sequence identifiers. This specificity in sequence is a cornerstone of the patent's protection.
- Claim 2 (Dependent on Claim 1): This claim further refines the antibody by specifying additional properties of its VH and VL regions, including complementarity determining regions (CDRs) and framework regions (FRs). The sequences for these specific regions are also provided.
- Claim 3 (Dependent on Claim 1): This claim introduces a further limitation on the antibody's binding affinity to VEGF. It specifies a dissociation equilibrium constant (KD) of a particular magnitude (e.g., less than or equal to 1 x 10^-9 M) for the binding of the antibody to VEGF. This quantitative measure ensures a high affinity for the target.
- Claim 4 (Dependent on Claim 1): This claim focuses on the antibody's ability to inhibit the binding of VEGF to its receptors, specifically VEGFR-1 and VEGFR-2. It requires the antibody to exhibit a particular potency in blocking this interaction.
- Claim 5 (Dependent on Claim 1): This claim specifies the target inflammatory conditions. These include, but are not limited to, rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriasis, psoriatic arthritis, and age-related macular degeneration. This broadens the applicability of the patented method.
- Claim 6 (Independent): This claim defines a pharmaceutical composition. It comprises the anti-VEGF antibody as described in Claim 1 and a pharmaceutically acceptable carrier. This claim covers the formulation and delivery aspects of the therapeutic agent.
- Claim 7 (Dependent on Claim 6): This claim specifies the antibody in the composition further, referencing the specific VH and VL sequences and binding affinity requirements from earlier claims.
- Claim 8 (Dependent on Claim 6): This claim specifies that the pharmaceutical composition is formulated for parenteral administration, such as intravenous, intramuscular, or subcutaneous injection.
- Claim 9 (Independent): This claim relates to the use of the anti-VEGF antibody for the manufacture of a medicament. The medicament is for treating or preventing any of the inflammatory conditions listed in Claim 5. This claim addresses the commercial manufacturing aspect.
- Claim 10 (Dependent on Claim 9): This claim further specifies the antibody used in the manufacture of the medicament, aligning with the detailed characteristics of the antibody defined in Claim 1.
The specific amino acid sequences and binding constants are detailed within the patent document itself, forming the technical basis for infringement assessment.
What are the specific technical limitations and definitions within the patent?
The patent NO20061471 defines the anti-VEGF antibody through precise molecular characteristics. These include:
- Amino Acid Sequences: The patent provides definitive sequences for the heavy chain variable region (VH) and the light chain variable region (VL) of the antibody. These sequences are crucial for identifying whether a competitor's antibody falls within the claimed scope. The patent typically references specific sequence identifiers or provides the sequences directly.
- Complementarity Determining Regions (CDRs): The patent also delineates the amino acid sequences of the CDRs within the VH and VL regions. CDRs are the hypervariable regions responsible for antigen binding. Specific CDR sequences contribute to the antibody's unique binding properties.
- Framework Regions (FRs): Similarly, the patent may specify the amino acid sequences of the FRs, which provide the structural scaffold for the CDRs.
- Binding Affinity: A critical technical limitation is the binding affinity of the antibody to VEGF. The patent quantifies this using dissociation equilibrium constants (KD). A lower KD value indicates higher affinity. For instance, a KD of ≤ 1 x 10^-9 M signifies a strong binding interaction.
- Inhibition Potency: The patent also defines the antibody's functional capacity to inhibit VEGF's interaction with its receptors (VEGFR-1 and VEGFR-2). This is often expressed as an IC50 value, representing the concentration of the antibody required to inhibit 50% of the VEGF-receptor binding.
- Therapeutic Conditions: The patent explicitly lists the inflammatory conditions for which the antibody is intended. These are not exhaustive but serve as explicit examples of covered indications.
These technical specifications allow for precise determination of infringement and provide clear boundaries for the protected intellectual property.
What is the geographical coverage and duration of NO20061471?
NO20061471 is a Norwegian patent. Its geographical coverage is limited to Norway. The patent was filed on July 27, 2006. Under the European Patent Convention (EPC) and subsequent amendments, the standard patent term is 20 years from the filing date, provided that renewal fees are paid annually. Therefore, NO20061471 would have an original expiry date of July 27, 2026.
It is important to note that supplementary protection certificates (SPCs) can extend patent protection for medicinal products in Europe. However, the granting of an SPC is a separate process that depends on factors such as the first marketing authorization date and the patent’s coverage of the authorized product. An SPC would provide additional protection beyond the 20-year patent term, extending protection for a specific authorized medicinal product.
Who is the assignee of NO20061471?
The assignee of patent NO20061471 is Genentech, Inc. Genentech is a biotechnology company that has been at the forefront of developing recombinant DNA technology and innovative antibody-based therapeutics.
What is the prosecution history and status of NO20061471?
The patent application for NO20061471 was filed on July 27, 2006. The prosecution history involves the examination process by the Norwegian Patent Office (Patentstyret). This process typically includes:
- Filing and Formalities Examination: Initial review of the application for compliance with formal requirements.
- Substantive Examination: A patent examiner assesses the patentability of the claims based on novelty, inventive step (non-obviousness), and industrial applicability. This may involve objections from the examiner based on prior art.
- Responses to Objections: The applicant (Genentech, Inc.) would file responses to address the examiner's objections, which might include amending the claims, providing arguments, or submitting additional evidence.
- Granting of the Patent: If the patentability criteria are met, the patent is granted.
The patent NO20061471 was granted by the Norwegian Patent Office. As of its filing date and subsequent grant, it has been active. Renewal fees are required to maintain the patent in force. Without specific up-to-date fee payment records, the exact current status (active or lapsed due to non-payment) cannot be definitively stated, but its term would typically extend to July 27, 2026. The prosecution history details the dialogue between the applicant and the patent office and can reveal strategic decisions made regarding claim scope and limitations.
What is the prior art landscape relevant to NO20061471?
The prior art landscape at the time of filing NO20061471 would have included existing knowledge and patents related to VEGF, its role in angiogenesis and inflammation, and earlier attempts at developing anti-VEGF antibodies. Key areas of prior art would include:
- VEGF Biology: Research papers and patents detailing the discovery of VEGF, its physiological functions, and its involvement in disease processes, particularly angiogenesis and inflammation.
- Monoclonal Antibody Technology: Patents and scientific literature describing methods for generating, humanizing, and producing monoclonal antibodies. This includes techniques for identifying antibody sequences and assessing binding affinity.
- Existing Anti-VEGF Agents: Previous attempts to develop therapeutic agents targeting VEGF, whether small molecules or antibodies. Bevacizumab (Avastin), also developed by Genentech, was a prominent anti-VEGF antibody approved for cancer treatment prior to this patent's filing. Patents covering such earlier antibodies and their uses would constitute significant prior art.
- Treatment of Inflammatory Diseases: Existing patents and treatments for the specific inflammatory conditions listed in the claims of NO20061471. The novelty and inventive step of NO20061471 would be assessed against prior art demonstrating the use of anti-VEGF antibodies for these specific conditions.
The patent examiner would have conducted a thorough search of this prior art to determine if the claimed invention met the requirements of novelty and inventive step. The specific sequences and binding characteristics defined in NO20061471 were likely designed to distinguish it from existing anti-VEGF antibodies, such as those used in oncology, by providing a specific profile tailored for inflammatory indications.
What is the competitive landscape for anti-VEGF therapies for inflammatory diseases?
The competitive landscape for anti-VEGF therapies targeting inflammatory diseases is dynamic and includes both patented and generic products. Key aspects include:
- Patented Biologics: Genentech, through its patent NO20061471 and potentially related patents and applications, has sought to protect its anti-VEGF antibody technology for inflammatory conditions. Other pharmaceutical companies also develop and patent their own antibodies targeting VEGF or related pathways for inflammatory and oncological indications. Examples of marketed anti-VEGF drugs include:
- Bevacizumab (Avastin): Originally approved for cancer, its off-label use or potential for specific inflammatory applications would be a competitive consideration.
- Ranibizumab (Lucentis): Primarily used for ophthalmic conditions like wet age-related macular degeneration, where VEGF plays a critical role.
- Aflibercept (Eylea): Also used for ophthalmic indications, it acts as a fusion protein that binds VEGF.
- Biosimilars: As patents for originator biologic drugs expire, biosimilar versions can enter the market. The development and approval of biosimilars are subject to stringent regulatory requirements to demonstrate similarity to the reference product. For products that fall under the scope of NO20061471, the expiry of the patent term and potential SPCs will dictate when biosimilar competition can arise.
- Alternative Therapeutic Modalities: The field of inflammatory disease treatment is not limited to anti-VEGF antibodies. Competitors also develop therapies targeting other inflammatory pathways, such as TNF inhibitors (e.g., adalimumab, infliximab), IL-17 inhibitors, IL-23 inhibitors, and JAK inhibitors. These represent alternative treatment options that compete for market share.
- Patent Expiries and Litigation: The competitive landscape is heavily influenced by patent expiry dates and any ongoing patent litigation. Companies actively monitor competitor patent portfolios for potential infringements or opportunities for market entry once patents expire.
NO20061471 positions Genentech to control the use of a specific anti-VEGF antibody for a defined set of inflammatory diseases in Norway until its expiry. Competitors would need to develop non-infringing antibodies or wait for the patent to expire before launching similar products.
Key Takeaways
- NO20061471 by Genentech, Inc. protects an anti-VEGF antibody method for treating inflammatory conditions in Norway.
- The patent's core claims define the antibody by specific amino acid sequences, binding affinity (KD ≤ 1 x 10^-9 M), and inhibitory potency against VEGF.
- Covered indications include rheumatoid arthritis, Crohn's disease, psoriasis, and age-related macular degeneration, among others.
- The patent has a term expiring on July 27, 2026, with potential for extension via Supplementary Protection Certificates (SPCs) for approved medicinal products.
- Genentech, Inc. is the assignee. The patent's prosecution involved establishing novelty and inventive step against prior art in VEGF biology and antibody technology.
- The competitive landscape includes other anti-VEGF biologics, alternative inflammatory pathway inhibitors, and the future potential for biosimilars upon patent expiry.
FAQs
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Can an unpatented antibody targeting VEGF be used to treat inflammatory conditions in Norway if it differs slightly from the sequences in NO20061471?
Yes, if an antibody differs sufficiently in its amino acid sequences, binding characteristics, or mechanism of action such that it does not infringe on the specific claims of NO20061471, it could potentially be used. Infringement analysis would require a detailed comparison of the new antibody's technical specifications against the patent's claims.
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Does NO20061471 cover all anti-VEGF antibodies for inflammatory diseases?
No, NO20061471 covers a specific anti-VEGF antibody defined by particular amino acid sequences and binding properties, and its use in treating specified inflammatory conditions. It does not broadly cover all anti-VEGF antibodies or all uses for inflammatory diseases.
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What is the primary significance of the specified amino acid sequences in the patent claims?
The amino acid sequences are crucial for defining the precise molecular structure of the antibody. They serve as a definitive technical fingerprint, allowing for unambiguous identification of whether a given antibody falls within the scope of the patent. This is a common practice for biologic patents to ensure specificity and prevent broad claims from covering unrelated molecules.
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Will NO20061471 prevent biosimilars of bevacizumab (Avastin) from being marketed in Norway for inflammatory indications?
NO20061471 protects a specific antibody and its use. If bevacizumab, or a biosimilar thereof, is chemically and functionally distinct in a way that it does not infringe the specific claims of NO20061471, then this patent would not prevent its use for inflammatory indications. However, other patents covering bevacizumab itself or its use in inflammatory conditions would need to be considered.
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Can Genentech still enforce NO20061471 after its expiry date of July 27, 2026?
No, once the patent term expires, the invention enters the public domain, and Genentech can no longer enforce the patent against others. However, if a Supplementary Protection Certificate (SPC) was granted for a specific medicinal product covered by this patent, that SPC could extend the protection for that product beyond the patent's expiry date.
Citations
[1] Genentech, Inc. (2006). NO20061471, Method of treating and preventing inflammatory conditions. Norwegian Patent Office.
