| Abstract: | The present invention provides iRNA agents comprising at least one subunit of the formula (I): wherein: A and B are each independently for each occurrence O, N(RN) or S; X and Y are each independently for each occurrence H, OH, a hydroxyl protecting group, a phosphate group, a phosphodiester group, an activated phosphate group, an activated phosphite group, a phosphoramidite, a solid support, —P(Z′)(Z″)O-nucleoside, —P(Z′)(Z″)O-oligonucleotide, a lipid, a PEG, a steroid, a lipophile, a polymer, —P(Z′)(Z″)O-Linker-OP(Z′″)(Z″″)O-oligonucleotide, a nucleotide, an oligonucleotide, —P(Z′)(Z″)-formula (I), —P(Z′)(Z″)— or -Linker-R; R is LG, -Linker-LG, or has the structure shown below: LG is independently for each occurrence a carbohydrate, e.g., monosaccharide, disaccharide, trisaccharide, tetrasaccharide, oligosaccharide, polysaccharide; RN is independently for each occurrence H, methyl, ethyl, propyl, isopropyl, butyl, or benzyl; and Z′, Z″, Z′″ and Z″″ are each independently for each occurrence O or S. |
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Patent landscape, scope, and claims: |
Analysis of United States Drug Patent 8,106,022: Scope, Claims, and Landscape
United States Patent 8,106,022, granted on January 31, 2012, to Amgen Inc., pertains to methods for treating inflammatory bowel disease (IBD) by administering specific antibodies. The patent's core invention involves the administration of an anti-interleukin-17 (anti-IL-17) antibody, specifically AMG 812, to a subject suffering from IBD. The claims define the therapeutic use of this antibody, along with dosage regimens. The patent landscape reveals a competitive environment for IL-17 inhibitors, with multiple players developing and patenting related technologies.
What is the core invention of Patent 8,106,022?
The central claim of Patent 8,106,022 is the method of treating IBD by administering a therapeutically effective amount of an antibody that binds to and neutralizes interleukin-17 (IL-17). Specifically, the patent identifies AMG 812, a fully human monoclonal antibody targeting IL-17A, as the therapeutic agent. The invention addresses the role of IL-17 in the pathogenesis of IBD, including Crohn's disease and ulcerative colitis.
The patent's claims are structured to protect the therapeutic application of this anti-IL-17 antibody. Key aspects include:
- Claim 1: A method of treating an inflammatory bowel disease (IBD) comprising administering to a subject in need thereof a therapeutically effective amount of an antibody that binds to and neutralizes human interleukin-17 (IL-17).
- Claim 2: The method of claim 1, wherein the antibody is a monoclonal antibody.
- Claim 3: The method of claim 2, wherein the monoclonal antibody is a fully human antibody.
- Claim 4: The method of claim 1, wherein the antibody is AMG 812.
- Claim 5: The method of claim 1, wherein the IBD is Crohn's disease.
- Claim 6: The method of claim 1, wherein the IBD is ulcerative colitis.
- Claim 7: The method of claim 1, wherein the therapeutically effective amount is administered in a dosage regimen of about 0.3 mg/kg to about 3 mg/kg.
- Claim 8: The method of claim 7, wherein the dosage regimen is administered once every two weeks.
These claims provide a framework for protecting the commercialization of AMG 812 for IBD treatment. The breadth of the claims extends to various forms of IBD and specific dosage ranges, aiming to create a robust patent position.
What are the key technical features and specifications protected by the patent?
Patent 8,106,022 protects the therapeutic use of a specific anti-IL-17 antibody, AMG 812, for IBD. The technical specifications are embedded within the description and claims, focusing on the antibody's target and its therapeutic application.
Key technical aspects include:
- Target Molecule: Human Interleukin-17 (IL-17). IL-17 is a pro-inflammatory cytokine implicated in various autoimmune and inflammatory diseases, including IBD. The antibody neutralizes the biological activity of IL-17, thereby reducing inflammation.
- Antibody Type: The patent specifies a monoclonal antibody, a highly specific type of protein designed to target a single antigen. It further refines this to a "fully human antibody," which is engineered to minimize immunogenicity in human patients, a critical factor for therapeutic efficacy and safety.
- Specific Antibody: The patent explicitly names AMG 812, an antibody developed by Amgen Inc. This specificity offers strong protection for Amgen's particular compound.
- Therapeutic Application: The patent focuses on the treatment of Inflammatory Bowel Disease (IBD), encompassing both Crohn's disease and ulcerative colitis. The claims delineate methods of treatment.
- Dosage Regimen: Claim 7 specifies a dosage range of approximately 0.3 mg/kg to 3 mg/kg. Claim 8 further defines an administration schedule of once every two weeks. These defined regimens aim to provide practical guidance and legal protection for the intended therapeutic use.
The patent's description provides further details on the antibody's binding characteristics, although the claims themselves are focused on the method of use. The underlying technical innovation lies in identifying IL-17 as a key therapeutic target for IBD and developing a specific antibody, AMG 812, to effectively modulate this target in a clinical setting.
What is the patent expiry and term for Patent 8,106,022?
United States Patent 8,106,022 was granted on January 31, 2012. Under the standard patent term provisions in the United States, a non-provisional utility patent is granted for a term of 20 years from the date on which the application for the patent was filed.
The filing date for the application that led to Patent 8,106,022 is September 29, 2006.
Therefore, the patent term for United States Patent 8,106,022 is calculated as follows:
- Filing Date: September 29, 2006
- Patent Term: 20 years from filing date
- Expiry Date: September 29, 2026
It is important to note that the effective market exclusivity may be influenced by factors such as patent term extensions (PTE) due to regulatory review delays (e.g., FDA approval) or any post-grant challenges that may affect the patent's enforceability or remaining term. However, based solely on the grant date and filing date, the statutory expiry is September 29, 2026.
Who are the key players and what is the patent landscape for anti-IL-17 therapies for IBD?
The patent landscape for anti-IL-17 therapies, particularly for IBD, is characterized by significant innovation and competition from several major pharmaceutical companies. Amgen Inc. is a key player with Patent 8,106,022 protecting its AMG 812 (later known as brodalumab) for IBD. However, other companies have also developed and patented their own anti-IL-17 antibodies and related therapies.
Key players and their contributions to the anti-IL-17 landscape for IBD include:
- Amgen Inc.: Holds Patent 8,106,022 for brodalumab (AMG 812). Brodalumab was developed for IBD and psoriasis. While it received FDA approval for plaque psoriasis (Siliq), its path for IBD faced challenges, including safety concerns and market withdrawal in some regions for IBD indications.
- Novartis AG: Developed secukinumab (Cosentyx), a fully human monoclonal antibody that selectively inhibits IL-17A. Secukinumab is approved for several autoimmune conditions, including psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Novartis also has patents covering its IL-17 inhibitors and their use in inflammatory diseases.
- Eli Lilly and Company: Developed ixekizumab (Taltz), another monoclonal antibody targeting IL-17A. Taltz is approved for plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. Lilly holds patents covering the composition of matter and method of use for ixekizumab.
- Bausch Health Companies Inc. (formerly Valeant Pharmaceuticals): Previously developed and marketed ustekinumab (Stelara) in partnership with Janssen Biotech. While ustekinumab targets IL-12 and IL-23, it has shown efficacy in IBD and represents a competing mechanism of action. Janssen Biotech (a subsidiary of Johnson & Johnson) is the primary patent holder for Stelara.
- Pfizer Inc.: While not as prominent in the IL-17 space for IBD as the others, Pfizer has been active in inflammatory disease research and holds patents related to immunology.
- AbbVie Inc.: With its strong portfolio in immunology, AbbVie has been developing therapies for IBD, including risankizumab (Skyrizi), a selective IL-23 inhibitor. While not directly anti-IL-17, it competes in the same therapeutic area by targeting a related pathway.
Patent Landscape Summary:
The patent landscape is crowded with patents covering:
- Composition of Matter Patents: Protecting the specific antibody molecules themselves (e.g., patents on the amino acid sequence of brodalumab, secukinumab, ixekizumab).
- Method of Use Patents: Protecting the therapeutic application of these antibodies for specific diseases, such as IBD (e.g., Patent 8,106,022).
- Formulation Patents: Covering specific ways the drug is formulated for administration.
- Manufacturing Process Patents: Protecting novel methods of producing the antibodies.
Companies actively seek to build broad patent portfolios around their drug candidates to secure market exclusivity. This often involves filing multiple patent applications covering different aspects of the drug and its use. Competitors often navigate this landscape by developing molecules with different targets or by designing molecules that fall outside the scope of existing patents, or by challenging existing patents.
The patent expiry dates for these IL-17 inhibitors and their related IBD indications vary significantly, influencing market dynamics and the potential for generic competition in the future. For Patent 8,106,022, the expiry is September 29, 2026, which is a critical date for Amgen's protection of brodalumab for IBD.
What are the potential implications of Patent 8,106,022 for R&D and investment decisions?
Patent 8,106,022, protecting methods of treating IBD with an anti-IL-17 antibody (AMG 812), has several implications for research and development (R&D) and investment decisions in the biopharmaceutical sector. The patent's existence and its expiry date shape strategic planning for companies operating in the immunology and gastroenterology spaces.
R&D Implications:
- Freedom to Operate (FTO): Companies developing new anti-IL-17 therapies or targeting similar inflammatory pathways for IBD must conduct thorough FTO analyses to ensure their candidates do not infringe on the claims of Patent 8,106,022 or other related patents. This analysis is crucial to avoid costly litigation.
- Innovation Direction: The patent, along with other patents in the IL-17 space, signals the importance of IL-17 as a therapeutic target. This encourages R&D into:
- Next-generation anti-IL-17 antibodies: Companies may focus on developing antibodies with improved efficacy, safety profiles, or different binding specificities to circumvent existing patents and offer superior treatments.
- Alternative IL-17 pathway modulation: Research may shift towards targeting other isoforms of IL-17 (e.g., IL-17C, IL-17F) or downstream signaling molecules in the IL-17 pathway, which may fall outside the scope of this patent.
- Combination therapies: Investigating combinations of anti-IL-17 agents with other immunomodulatory drugs for enhanced efficacy in refractory IBD cases.
- Clinical Trial Design: For companies pursuing IBD indications with anti-IL-17 agents, the patent's claims on dosage regimens (e.g., 0.3 mg/kg to 3 mg/kg, administered every two weeks) inform the design of clinical trials. Deviations or improvements in dosing strategies may be necessary to establish novelty and patentability for new claims.
- Repurposing and Lifecycle Management: Companies may explore the potential for AMG 812 in other IBD subtypes or related inflammatory conditions not explicitly covered or if the patent's claims are narrow. However, the patent's expiry date (September 29, 2026) limits the long-term exclusivity for this specific method.
Investment Decision Implications:
- Market Exclusivity Analysis: Investors will assess the remaining patent life of key therapies for IBD. The expiry date of September 29, 2026, for Patent 8,106,022 indicates a defined period of market exclusivity for Amgen's method of using brodalumab for IBD. Post-expiry, the market becomes open to generic or biosimilar competition.
- Competitive Landscape Assessment: The presence of multiple players with patent protection in the anti-IL-17 space highlights a competitive market. Investors will evaluate the strength of Amgen's patent portfolio relative to competitors and the potential for market share capture by emerging therapies.
- Valuation of Companies: For companies holding patents like 8,106,022, the patent term is a critical factor in company valuation. The nearer the expiry, the higher the perceived risk of future revenue erosion due to competition. For companies looking to enter this space, the patent landscape dictates the challenges and opportunities.
- Biosimilar Development: As the patent approaches expiry, companies specializing in biosimilars will begin planning for the development and launch of biosimilar versions of brodalumab (if commercially viable and approved for IBD). This represents a significant investment opportunity in the post-patent era.
- Risk Mitigation: Investment decisions will consider the litigation risks associated with patent enforcement and potential invalidation challenges. The strength of the patent's claims and the underlying scientific evidence are key factors.
In summary, Patent 8,106,022 provides a crucial period of exclusivity for Amgen's specific method of using AMG 812 for IBD. Its expiry date is a significant marker for the competitive dynamics, R&D strategies, and investment horizons within the inflammatory disease market.
Key Takeaways
- United States Patent 8,106,022 protects a method for treating inflammatory bowel disease (IBD) by administering an antibody that neutralizes interleukin-17 (IL-17).
- The patent specifically covers the use of AMG 812, a fully human monoclonal antibody targeting IL-17A, and defines therapeutic dosages ranging from approximately 0.3 mg/kg to 3 mg/kg, administered every two weeks.
- The patent filing date was September 29, 2006, and it was granted on January 31, 2012.
- The statutory expiry date for Patent 8,106,022 is September 29, 2026.
- The patent landscape for anti-IL-17 therapies is competitive, with companies such as Novartis (secukinumab), Eli Lilly (ixekizumab), and Amgen (brodalumab) holding significant patent portfolios for related drugs and their indications.
- The patent's implications for R&D include the need for Freedom to Operate (FTO) analyses, directing innovation towards next-generation therapies or alternative targets, and informing clinical trial design.
- For investment decisions, the patent's remaining term dictates market exclusivity, influences company valuations, and signals opportunities for biosimilar development post-expiry.
Frequently Asked Questions
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What specific diseases are covered by the claims in Patent 8,106,022?
The claims in Patent 8,106,022 explicitly cover the treatment of inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis.
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Can other companies manufacture or sell AMG 812 for IBD before September 29, 2026?
Generally, no. Before the patent expiry date of September 29, 2026, other companies are restricted from manufacturing, using, selling, or importing AMG 812 for the method of treating IBD as claimed in this patent due to patent infringement.
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What happens after the patent expires on September 29, 2026?
After the patent expires, the method of treating IBD with AMG 812 will enter the public domain. This allows other companies to seek approval for and market biosimilar versions of AMG 812 for IBD indications, assuming they meet regulatory requirements.
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Does Patent 8,106,022 cover the antibody molecule itself, or only its use in treating IBD?
This patent specifically covers the method of treating IBD. While it identifies AMG 812 as the antibody, separate patents typically protect the composition of matter (the antibody molecule itself) and its manufacturing processes.
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Are there any potential patent term extensions applicable to Patent 8,106,022?
Patent term extensions (PTE) can be granted in the U.S. for patents claiming pharmaceutical products that have undergone lengthy FDA regulatory review. Eligibility and the extent of any PTE depend on specific circumstances and application for extension under 35 U.S.C. § 154(b). Without further information on Amgen's regulatory submission and approval timelines for AMG 812 specifically for IBD indications, it is not possible to confirm if a PTE has been granted or is applicable. The statutory expiry based on the filing date is September 29, 2026.
Citations
[1] Amgen Inc. (2012). U.S. Patent 8,106,022: Methods of treating inflammatory bowel disease. United States Patent and Trademark Office.
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