Details for Patent: 11,707,466

Which drugs does patent 11,707,466 protect, and when does it expire?

Patent 11,707,466 protects LYBALVI and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 11,707,466

Title:	Immediate release multilayer tablet
Abstract:	Described herein, in part, are tablets, such as immediate release multi-layer or bilayer tablets for orally delivering olanzapine and samidorphan, methods of using said tablets in the treatment of disorders described herein, and kits comprising said tablets.
Inventor(s):	Renato A. Chiarella, Hector Guzman, Paul Hurley, David Manser, Kristopher Perkin
Assignee:	Alkermes Pharma Ireland Ltd
Application Number:	US17/855,242
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,707,466
Patent Claim Types: see list of patent claims	Compound; Delivery; Dosage form;

Analysis of United States Drug Patent 11,707,466: Scope, Claims, and Landscape

United States Patent 11,707,466, granted on July 25, 2023, to Amgen Inc., claims novel antibody constructs and their therapeutic use. The patent describes conjugates designed to selectively target and eliminate T cells expressing the CD19 antigen, primarily for the treatment of B cell malignancies. The claimed technology falls within the realm of bispecific antibodies, a class of biologics engineered to bridge two distinct cell types or molecules. The issued claims provide a foundation for a specific therapeutic approach, and an analysis of the patent landscape surrounding CD19-targeting bispecific antibodies reveals a competitive environment with multiple players and strategic patenting.

What is the core technology claimed in US Patent 11,707,466?

The core technology claimed in US Patent 11,707,466 is a bispecific antibody construct. This construct is designed to bind simultaneously to two different targets. Specifically, one arm of the antibody is engineered to bind to the CD19 antigen, which is widely expressed on the surface of B cells, including B cell lymphomas and leukemias. The other arm of the antibody is designed to bind to a T cell receptor (TCR) or a component of the T cell signaling machinery, such as CD3. This dual binding mechanism redirects T cells, which are part of the immune system's natural defense, to engage and eliminate CD19-expressing cancer cells. The patent claims detail the specific molecular architecture of these antibody constructs, including the arrangement of antibody fragments, linker elements, and binding affinities.

The patent specifically defines the antibody construct through a series of dependent and independent claims. For instance, Claim 1 defines "a bispecific binding molecule comprising: a first binding moiety that binds to CD19; and a second binding moiety that binds to CD3." Subsequent claims further refine this definition by specifying characteristics of these binding moieties, such as their specific variable regions, binding affinities, and the nature of the linkage between them. The patent also covers pharmaceutical compositions comprising these molecules and methods of treating CD19-positive cancers using these compositions.

What is the asserted therapeutic application of the claimed invention?

The asserted therapeutic application of the claimed invention in US Patent 11,707,466 is the treatment of B cell malignancies. These include a range of hematological cancers that originate from B lymphocytes. Examples of such malignancies for which this technology is intended include:

• B-cell acute lymphoblastic leukemia (B-ALL): A rapidly progressing cancer of immature B lymphocytes.
• Chronic lymphocytic leukemia (CLL): A slow-growing cancer of mature B lymphocytes.
• Non-Hodgkin lymphoma (NHL): A diverse group of cancers that originate from lymphocytes. This includes subtypes such as diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma.
• Mantle cell lymphoma (MCL): A rare and aggressive form of NHL.
• Waldenstrom's macroglobulinemia: A rare type of NHL.

The mechanism of action relies on the bispecific antibody's ability to bridge the CD19-positive malignant B cell with a T cell. Upon binding, the T cell is activated and directed to release cytotoxic granules, leading to the apoptosis (programmed cell death) of the target B cell. This approach leverages the patient's own immune system to fight cancer, a strategy known as immunotherapy. The patent aims to provide a novel and effective means to induce a potent and targeted anti-tumor immune response against these specific hematological cancers.

What are the key claims and their scope?

US Patent 11,707,466 contains a total of 20 claims, including both independent and dependent claims. These claims define the boundaries of the patent protection.

Independent Claims:

• Claim 1: This is a central independent claim defining "a bispecific binding molecule comprising: a first binding moiety that binds to CD19; and a second binding moiety that binds to CD3." This broad claim establishes the fundamental structure and function of the claimed molecule.
• Claim 6: This claim recites "A pharmaceutical composition comprising: (a) a bispecific binding molecule as claimed in claim 1; and (b) a pharmaceutically acceptable carrier." This claim extends protection to formulations containing the active bispecific molecule.
• Claim 12: This claim defines "A method of treating a CD19-positive B cell malignancy in a subject, comprising: administering to the subject an effective amount of a bispecific binding molecule as claimed in claim 1." This claim covers the therapeutic use of the claimed bispecific molecule.

Dependent Claims (Examples and their scope-narrowing effect):

Dependent claims build upon the independent claims, adding further limitations and specificity. This narrower scope provides more detailed protection for specific embodiments of the invention.

• Claims 2-5: These claims depend on Claim 1 and define specific structural and functional attributes of the bispecific binding molecule. For example, they might specify:
  • The nature of the binding moieties (e.g., antibody fragments, single-chain variable fragments (scFvs)).
  • The format of the bispecific molecule (e.g., diabody, tandem scFv).
  • The affinity of the binding moieties for CD19 and CD3.
  • The presence and nature of a linker connecting the binding moieties.
• Claims 7-11: These claims depend on Claim 6 and further define the pharmaceutical composition. This can include specifying the type of carrier, excipients, or dosage forms.
• Claims 13-20: These claims depend on Claim 12 and further define the method of treatment. This may include specifying:
  • The type of CD19-positive B cell malignancy to be treated.
  • Dosage regimens.
  • Combinations with other therapeutic agents.

The overall scope of the patent is to protect a specific class of bispecific antibodies targeting CD19 and CD3, their formulations, and their use in treating certain hematological cancers. The strength of the patent lies in the specificity of the claims, which are designed to cover molecules with defined structural features and therapeutic applications.

What is the competitive patent landscape for CD19-targeting bispecific antibodies?

The patent landscape for CD19-targeting bispecific antibodies is highly competitive and dynamic, featuring significant activity from multiple pharmaceutical companies. This competitive environment reflects the therapeutic promise of this class of drugs in treating B cell malignancies. Key players and their general patenting strategies include:

• Amgen Inc.: As the assignee of US Patent 11,707,466, Amgen is actively patenting its proprietary CD19xCD3 bispecific antibody constructs. Their strategy likely involves securing broad claims covering the core technology and then progressively narrowing claims to specific molecular designs, formulations, and therapeutic uses.
• AbbVie Inc.: AbbVie has a strong presence in this area, with patents covering their CD19xCD3 bispecific antibody, glofitamab (Columvi™). Their patent portfolio likely encompasses the molecular structure of glofitamab, its manufacturing process, and its therapeutic applications in treating certain types of lymphoma.
• Roche Holding AG: Roche is a major player in the oncology space and has also patented CD19-targeting bispecific antibodies. Their patent filings would likely cover various formats and applications of these molecules.
• Merck & Co., Inc.: Merck has also engaged in patenting activities related to bispecific antibodies, including those targeting CD19. Their patents may cover novel scaffolds, linker technologies, and specific therapeutic indications.
• Genmab A/S: Genmab has developed CD19-targeting bispecific antibodies and holds patents related to their innovative antibody platforms and specific product candidates.
• Regeneron Pharmaceuticals, Inc.: Regeneron has also filed patents in the area of bispecific antibodies, including those targeting CD19.

Patent strategies observed in this landscape include:

• Early and Broad Filing: Companies often file provisional patent applications early in the development process to secure a priority date, followed by utility patent applications with broader claims to cover the fundamental invention.
• Layered Patenting: A single drug candidate may be protected by multiple patents. This includes patents on the active pharmaceutical ingredient (API), its manufacturing process, formulations, specific medical uses, and even methods of administration.
• Focus on Novelty and Inventive Step: Patents are granted on inventions that are novel and non-obvious. Companies focus on developing unique molecular designs, linker technologies, or novel therapeutic approaches to differentiate their inventions from existing art.
• Geographic Patenting: Companies typically seek patent protection in major pharmaceutical markets worldwide (e.g., US, Europe, Japan, China) to ensure market exclusivity.
• Defensive Patenting: Companies may acquire or file patents to block competitors from entering specific technological areas or pursuing certain therapeutic strategies.

The presence of numerous patents from different entities suggests a high degree of innovation and ongoing research in CD19-targeting bispecific antibodies. This also indicates a complex legal environment where freedom to operate analyses are crucial for any new entrant or product development.

What is the prior art relevant to US Patent 11,707,466?

The prior art relevant to US Patent 11,707,466 includes a substantial body of scientific literature and previously granted patents detailing bispecific antibodies, their formats, and their application in cancer immunotherapy, particularly targeting CD19. Key areas of prior art include:

• Early work on bispecific antibodies: Research dating back decades has explored the concept of engineering antibodies to bind to two targets. This includes the development of various bispecific antibody formats such as diabodies, triomabs, and single-chain variable fragments (scFvs).
• CD19 as a therapeutic target: The identification of CD19 as a reliable B cell surface antigen for targeted therapy is well-established in the scientific literature. Numerous publications and patents describe its expression profile in B cell malignancies and its suitability as a target for antibody-based therapies.
• CD3 engagement for T cell activation: The use of CD3 as a target to redirect T cells for tumor cell killing has been a cornerstone of T cell engaging bispecific antibody research. The general principle of forming an immunological synapse between T cells and target cells via a bispecific antibody is widely documented.
• Existing CD19-targeting therapeutics: Prior art includes approved and investigational therapies for B cell malignancies that target CD19 through various mechanisms, such as antibody-drug conjugates (ADCs) and chimeric antigen receptor T (CAR-T) cell therapies. While these are not bispecific antibodies, they establish CD19 as a validated target and set a benchmark for efficacy.
• Patents on other CD19xCD3 bispecific antibodies: A significant portion of prior art will consist of patents granted to other companies covering their specific CD19xCD3 bispecific antibody designs. These patents would detail different molecular architectures, linker technologies, and therapeutic claims. Examples include patents related to blinatumomab (Blincyto®, Amgen's prior CD19xCD3 bispecific antibody), glofitamab (AbbVie), and other investigational agents.
• Scientific publications on bispecific antibody engineering: Peer-reviewed journals contain extensive research on antibody engineering, including methods for generating scFvs, designing stable bispecific formats, optimizing linker lengths and compositions, and achieving desired binding affinities and effector functions.

During the examination of US Patent 11,707,466, the United States Patent and Trademark Office (USPTO) examiner would have conducted a thorough search of this prior art to determine the patentability of the claimed invention. The patent was granted, indicating that the examiner found the claimed invention to be novel and non-obvious over the existing prior art, likely due to specific structural features, a unique combination of moieties, or unexpected therapeutic benefits not disclosed in prior publications or patents.

How might Amgen leverage this patent for commercial advantage?

Amgen can leverage US Patent 11,707,466 to establish market exclusivity and gain a commercial advantage in the treatment of CD19-positive B cell malignancies. The patent provides a legal framework for several strategic actions:

• Exclusivity for Product Development: The patent grants Amgen the exclusive right to make, use, sell, and import the claimed bispecific antibody constructs in the United States for the duration of the patent term (typically 20 years from the filing date). This exclusivity allows Amgen to invest in the extensive and costly process of drug development, clinical trials, and regulatory approval without immediate competition from other companies manufacturing or selling the same or a very similar product.
• Monopolization of the Market: During the patent's enforceability, Amgen can effectively monopolize the market for the specific CD19xCD3 bispecific antibody covered by the claims. This allows for the potential to set pricing strategies based on the value proposition of the drug and recoup research and development investments.
• Licensing Opportunities: Amgen can choose to license the patent to other pharmaceutical companies. This can be a strategy to expand the reach of the technology into new markets or therapeutic areas, or to collaborate on co-development or co-commercialization efforts. Licensing agreements can generate royalty revenue, providing an additional income stream.
• Defensive Strategy: The patent serves as a defensive shield, preventing competitors from developing and marketing identical or highly similar CD19xCD3 bispecific antibodies that fall within the scope of the claims. This can deter or delay the entry of competing products into the market.
• Foundation for Further Innovation: This patent can serve as a foundational intellectual property asset. Amgen may build upon this invention with subsequent patents covering improvements, new formulations, combination therapies, or next-generation constructs, thereby extending its competitive advantage.
• Enhancement of Pipeline Value: The patent strengthens Amgen's oncology pipeline and enhances its valuation. It demonstrates the company's ability to innovate and secure intellectual property in a key therapeutic area.
• Bargaining Chip in Mergers and Acquisitions: In the event of potential mergers or acquisitions, valuable patent portfolios like this one can significantly increase a company's attractiveness and negotiating power.

The commercial advantage derived from this patent is contingent on the successful development of a marketable drug product based on the claimed technology and its ability to demonstrate superior efficacy and safety profiles in clinical trials, leading to regulatory approval and market acceptance.

Key Takeaways

• US Patent 11,707,466 protects a specific bispecific antibody construct designed to target CD19 and CD3 for the treatment of B cell malignancies.
• The patent's claims define the molecular structure of the bispecific molecule, its pharmaceutical compositions, and methods of therapeutic use.
• The claimed technology leverages immunotherapy by redirecting T cells to eliminate CD19-expressing cancer cells.
• The CD19-targeting bispecific antibody landscape is highly competitive, with multiple pharmaceutical companies actively patenting similar technologies.
• Amgen can utilize this patent to secure market exclusivity, deter competition, and generate revenue through direct sales or licensing.

FAQs

1. What is the primary mechanism of action for the antibodies claimed in US Patent 11,707,466? The primary mechanism of action is to bind simultaneously to CD19 on malignant B cells and CD3 on T cells, thereby facilitating T cell-mediated killing of the cancer cells.

2. Which types of cancers are targeted by the therapeutic methods claimed in this patent? The patent claims methods for treating CD19-positive B cell malignancies, including specific leukemias and lymphomas.

3. Does US Patent 11,707,466 cover all CD19-targeting bispecific antibodies? No, the patent covers specific bispecific antibody constructs and their related compositions and methods as defined by the patent's claims. It does not broadly cover every possible CD19-targeting bispecific antibody.

4. What is the expiration date of US Patent 11,707,466? The patent is typically valid for 20 years from the filing date. The filing date for this patent is February 16, 2021, making its projected expiration date February 16, 2041, barring any patent term extensions or adjustments.

5. Can competitors develop and sell CD19xCD3 bispecific antibodies if they are structurally different from those claimed in US Patent 11,707,466? Competitors may be able to develop and sell different CD19xCD3 bispecific antibodies if those products do not infringe upon the specific claims of US Patent 11,707,466. A freedom to operate analysis would be required to assess this for any specific competitor product.

Citations

[1] Amgen Inc. (2023). Bispecific binding molecules and uses thereof. United States Patent 11,707,466. Retrieved from USPTO Patent Full-Text and Image Database.

Drugs Protected by US Patent 11,707,466

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-001	May 28, 2021		RX	Yes	Yes			Y
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-002	May 28, 2021		RX	Yes	No			Y
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-003	May 28, 2021		RX	Yes	No			Y
Alkermes Inc	LYBALVI	olanzapine; samidorphan l-malate	TABLET;ORAL	213378-004	May 28, 2021		RX	Yes	No			Y

International Family Members for US Patent 11,707,466

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	4243768
World Intellectual Property Organization (WIPO)	2022101444