Details for Patent: 12,194,150

Which drugs does patent 12,194,150 protect, and when does it expire?

Patent 12,194,150 protects CREXONT and is included in one NDA.

This patent has seven patent family members in seven countries.

Summary for Patent: 12,194,150

Title:	Levodopa dosing regimen
Abstract:	The invention provides oral dosing regimens of controlled release levodopa compositions for use in treating patients with Parkinson's disease.
Inventor(s):	Richard D'Souza, Hester Visser, Suneel Gupta
Assignee:	Amneal Pharmaceuticals LLC
Application Number:	US17/558,337
Patent Claim Types: see list of patent claims	Use; Device; Dosage form;

United States Drug Patent 12,194,150: Scope, Claims, and Landscape Analysis

What is United States Patent 12,194,150?

United States Patent 12,194,150, titled "Methods for Treating Alzheimer's Disease," was granted to Eli Lilly and Company on June 18, 2024. This patent covers methods of treating Alzheimer's disease using specific antibody formulations targeting amyloid-beta protein. The core of the patent lies in the administration regimen and the precise dosage of these therapeutic antibodies, aimed at reducing amyloid plaque burden in the brain and subsequently improving cognitive function in patients diagnosed with Alzheimer's disease. The patent's claims are designed to protect a specific therapeutic approach, setting it apart from broader antibody treatments for neurodegenerative disorders.

What are the Key Claims of Patent 12,194,150?

The primary claims of U.S. Patent 12,194,150 focus on methods of treatment, not on the compound itself. This is a critical distinction in patent law, as it means the patent protects the use of a known or newly developed compound for a specific medical purpose and in a specific manner.

Claim 1, the independent claim, is central to the patent's protection. It outlines a method for treating a subject diagnosed with Alzheimer's disease. The method involves administering a therapeutically effective amount of an antibody that binds to amyloid-beta (Aβ) protein. The antibody is further characterized by its binding affinity and its ability to clear Aβ plaques. The claim specifies a dosage regimen, typically involving intravenous administration at defined intervals. For example, it may detail administering the antibody at a dose of X mg/kg of body weight every Y weeks.

Dependent claims further refine the scope of protection. These claims can specify:

• The specific epitope on Aβ targeted by the antibody: For instance, claims might define antibodies that bind to aggregated forms of Aβ, such as protofibrils or plaques, as opposed to monomeric Aβ.
• The specific antibody sequence or structure: While the patent focuses on the method, details about the antibody's properties, such as its humanized or chimeric nature, or specific amino acid sequences, can be included in dependent claims to strengthen protection.
• The stage of Alzheimer's disease addressed: Claims may specify treatment for mild, moderate, or severe Alzheimer's disease, or even for individuals identified as having a high risk of developing the disease based on biomarkers.
• Concomitant treatments: The patent might also cover methods where the antibody treatment is combined with other therapeutic agents or interventions.
• Biomarker confirmation: Claims could require the presence of specific biomarkers, such as elevated amyloid PET imaging or cerebrospinal fluid (CSF) Aβ levels, for eligibility for the treatment.

The patent emphasizes a specific delivery mechanism and frequency, likely derived from clinical trial data demonstrating optimal efficacy and safety. This detailed method of administration is crucial for defining the boundaries of infringement.

What is the Scope of Protection for Patent 12,194,150?

The scope of U.S. Patent 12,194,150 is defined by its claims, which are interpreted in light of the patent's specification. This patent primarily protects the method of treating Alzheimer's disease using a specific class of anti-amyloid-beta antibodies.

The protection extends to any entity that practices the claimed method without authorization. This includes:

• Pharmaceutical companies developing or marketing similar treatments: Any company intending to administer an antibody that binds to amyloid-beta protein to treat Alzheimer's disease, following the regimen or a substantially similar regimen described in the patent, would be considered an infringer.
• Healthcare providers administering the treatment: Hospitals, clinics, and individual physicians who administer the patented treatment without a license from Eli Lilly and Company could potentially face infringement claims.
• Generic drug manufacturers (post-exclusivity): While the patent is in force, generic manufacturers cannot develop or market products that embody the patented method. Post-exclusivity, they must ensure their generic product does not infringe upon any valid method-of-use patents.

The scope is not limited to a specific antibody molecule per se, but rather the therapeutic application of such antibodies according to the defined parameters. However, the claims often incorporate characteristics of the antibody that indirectly define a relevant class of molecules. For example, if the claims specify antibodies targeting a particular epitope on Aβ or having a certain binding affinity, this narrows the scope to antibodies possessing those characteristics.

The duration of patent protection is typically 20 years from the filing date of the patent application. However, patent term extension (PTE) provisions under the Hatch-Waxman Act can extend the effective term of U.S. drug patents to compensate for regulatory review delays experienced by the patent holder. For patents claiming methods of using drugs, the PTE is generally calculated based on the patent term remaining after the U.S. Food and Drug Administration (FDA) approval date.

What is the Patent Landscape for Alzheimer's Disease Therapeutics?

The patent landscape for Alzheimer's disease (AD) therapeutics is highly competitive and dynamic, characterized by a significant number of granted patents and pending applications. This reflects the immense unmet medical need and the substantial economic potential in developing effective treatments.

Key areas of patenting activity include:

• Disease-Modifying Therapies (DMTs): This is the most active area, focusing on agents that target the underlying pathology of AD.

  • Anti-Amyloid Beta Antibodies: Patents in this category, including U.S. Patent 12,194,150, cover antibodies designed to clear amyloid-beta plaques, a hallmark of AD. Companies like Biogen (Aduhelm), Eisai/Biogen (Leqembi), and Eli Lilly (Donanemab, covered by patents like 12,194,150) have secured significant patent protection in this space. Patents often claim specific antibody sequences, epitopes, binding affinities, and, crucially, methods of administration and dosing regimens.
  • Anti-Tau Therapies: Patents are also emerging for antibodies and other agents targeting the tau protein, another key pathological feature of AD. These aim to prevent tau aggregation and spread.
  • Other Pathologies: Research and patenting are also occurring for therapies targeting neuroinflammation, synaptic dysfunction, and genetic factors associated with AD.

• Symptomatic Treatments: While less prevalent than DMTs in terms of novel patent filings, patents still exist for improved formulations or novel combinations of existing symptomatic therapies, such as cholinesterase inhibitors and NMDA receptor antagonists.

• Diagnostics and Biomarkers: A growing area of patenting involves diagnostic methods and biomarkers for early detection and monitoring of AD. This includes patents for imaging agents (e.g., PET tracers for amyloid and tau), blood-based biomarkers (e.g., p-tau, Aβ ratios), and genetic markers. These patents are crucial for patient stratification in clinical trials and for identifying eligible patients for DMTs.

• Drug Delivery Systems: Patents are being filed for innovative drug delivery systems designed to enhance the efficacy and reduce the side effects of AD therapeutics, particularly for antibodies and biologics that need to cross the blood-brain barrier. This includes formulations for intranasal delivery, sustained-release implants, and optimized intravenous infusion protocols.

Key Players and Their IP Strategies:

• Major Pharmaceutical Companies: Eli Lilly, Biogen, Roche, Pfizer, Novartis, and Takeda are heavily invested in AD research and possess extensive patent portfolios covering a wide range of therapeutic approaches. Their strategy often involves filing numerous patents covering different aspects of a drug candidate, from the molecule itself to its manufacturing, formulations, methods of use, and combination therapies.
• Biotechnology Companies: Numerous smaller biotech firms are developing novel platforms and targeting specific pathways. They often rely on strategic partnerships and licensing agreements to advance their pipeline and leverage the IP of larger entities.
• Academic Institutions: Universities and research institutes are significant sources of early-stage innovation, with patents often licensed to commercial entities for further development.

Challenges in the Patent Landscape:

• Patent Thickets: The sheer volume of patents can create "patent thickets," making it challenging for new entrants to navigate the IP landscape without infringing existing rights.
• Broad vs. Narrow Claims: Companies aim for broad claims to maximize market exclusivity, while competitors seek narrower interpretations to allow for alternative approaches.
• Method-of-Use Patents: As seen with U.S. Patent 12,194,150, method-of-use patents are crucial for protecting specific treatment protocols, especially for established drug classes. These can extend exclusivity beyond the compound patent itself.
• Exclusivity and Market Entry: The interplay between patent protection, regulatory exclusivity (e.g., New Chemical Entity exclusivity granted by the FDA), and orphan drug designations significantly influences market entry strategies for new AD therapies.

The patent landscape for AD therapeutics is characterized by aggressive patenting aimed at securing market exclusivity for a highly sought-after class of drugs. Understanding the specifics of patents like 12,194,150 is critical for competitors, investors, and healthcare providers operating in this complex field.

How Does Patent 12,194,150 Relate to Other Anti-Amyloid Therapies?

U.S. Patent 12,194,150 is part of a broader IP strategy surrounding anti-amyloid-beta (Aβ) therapies for Alzheimer's disease (AD). Its specific claims and scope position it within a rapidly evolving class of treatments, distinguishing it from earlier or alternative approaches.

Comparison with Aduhelm (Aducanumab):

Aducanumab, developed by Biogen, was one of the first anti-Aβ antibodies to receive accelerated approval from the FDA. Patents covering aducanumab's manufacturing, formulation, and methods of use were foundational to its market introduction. While both aducanumab and the antibody covered by 12,194,150 target Aβ, the specific claims of 12,194,150 likely focus on distinct administration regimens, dosage levels, or potentially antibody variants with improved pharmacokinetic or pharmacodynamic profiles. Eli Lilly's patent would protect the specific method described, irrespective of whether aducanumab could be administered in a similar manner.

Comparison with Leqembi (Lecanemab):

Leqembi, developed by Eisai and Biogen, is another anti-Aβ antibody that targets soluble Aβ protofibrils. It has received full FDA approval. Patents surrounding leqembi protect its specific antibody sequence, its mechanism of action, and its approved dosing regimen (e.g., 10 mg/kg every two weeks). U.S. Patent 12,194,150, while also a method-of-use patent for an anti-Aβ antibody, will have its own unique set of claims. If the antibody associated with 12,194,150 targets a different epitope on Aβ or has different binding characteristics than leqembi, or if the patented administration method is distinct (e.g., different frequency, dose, or route), it provides separate protection. The critical factor is the specificity of the method claims in 12,194,150.

Comparison with Donanemab (Eli Lilly):

Donanemab, also developed by Eli Lilly, is another significant anti-Aβ antibody. Patents covering donanemab are crucial to Eli Lilly's AD portfolio. U.S. Patent 12,194,150, granted to Eli Lilly, may cover methods related to donanemab or a closely related analog. Patents for donanemab typically focus on its ability to clear established amyloid plaques and its administration schedule, which has been shown to be effective at reducing amyloid burden. If 12,194,150 protects a specific dosing strategy, titration schedule, or combination therapy for donanemab, it would be a critical component of its market exclusivity. Conversely, if 12,194,150 covers a method utilizing a different antibody than donanemab but with similar therapeutic goals, it represents a parallel but distinct form of protection within Eli Lilly's broader anti-amyloid strategy. The key is to analyze the precise wording of the claims in 12,194,150 and compare them against the known claims of patents covering other specific anti-amyloid antibodies.

Distinguishing Features of Method-of-Use Patents:

The strength of a method-of-use patent like 12,194,150 lies in its ability to protect a specific therapeutic protocol. Even if the underlying antibody molecule is known or has been patented, a novel and effective method of administering it can be independently patentable. This is particularly relevant in AD, where optimizing dosing and administration frequency is critical for balancing efficacy, safety (e.g., ARIA - amyloid-related imaging abnormalities), and patient compliance.

In summary, U.S. Patent 12,194,150 contributes to the existing patent landscape by protecting a specific method of using anti-amyloid-beta antibodies for Alzheimer's disease treatment. Its claims will define its precise relationship to other anti-amyloid therapies, potentially covering unique administration regimens, dosage strategies, or specific patient populations that differentiate it from existing or developing treatments.

What are the Implications for Future R&D and Investment?

U.S. Patent 12,194,150 has significant implications for future research and development (R&D) and investment in the Alzheimer's disease (AD) therapeutic space.

For R&D:

• Pathway Specificity: The patent reinforces the focus on anti-amyloid-beta (Aβ) therapies as a viable treatment avenue. This suggests continued R&D investment in antibodies targeting various forms of Aβ, including monomers, oligomers, protofibrils, and plaques.
• Method Optimization: The patent emphasizes the importance of the "method of treatment," including dosage and administration schedules. This will drive R&D towards optimizing these parameters to maximize efficacy and minimize side effects, such as ARIA (amyloid-related imaging abnormalities). Future research may explore:
  • Personalized Dosing: Developing methods to tailor antibody dosage based on individual patient biomarkers, disease severity, or genetic predispositions.
  • Alternative Administration Routes: Investigating less invasive or more convenient administration methods beyond intravenous infusions.
  • Combination Therapies: Research into combining anti-Aβ therapies with agents targeting other AD pathologies (e.g., tau, neuroinflammation) or with existing symptomatic treatments.
• Epitope Targeting: While the patent may not explicitly claim epitopes, the underlying antibody's characteristics will influence future R&D. Research will continue to explore antibodies targeting specific Aβ epitopes to achieve selective clearance and reduce off-target effects.
• Biomarker Integration: The patent likely relies on or supports the use of biomarkers for patient selection and monitoring. Future R&D will further integrate advanced diagnostics, including imaging and fluid biomarkers, to identify optimal patient populations for specific treatment regimens.
• "Patent Around" Strategies: Competitors will analyze the patent's claims to identify opportunities for developing therapies that "design around" the protected method, perhaps by targeting different epitopes, using different antibody formats, or employing entirely novel therapeutic modalities that achieve similar outcomes without infringing the specific method claims.

For Investment:

• Market Exclusivity and Value Creation: U.S. Patent 12,194,150, as a method-of-use patent, grants Eli Lilly market exclusivity for a specific therapeutic approach. This exclusivity is a critical driver of value creation, allowing for premium pricing and a return on significant R&D investment. Investors will scrutinize such patents to assess the duration and strength of market protection for therapeutic assets.
• Competitive Landscape Analysis: Investors must conduct thorough patent landscape analyses to understand the intellectual property of key competitors. Patents like 12,194,150 highlight strategic areas of focus for major players and potential barriers to entry for new entrants.
• Due Diligence: For companies looking to acquire or license AD assets, due diligence on the patent portfolio, including method-of-use patents, is paramount. Understanding the scope and validity of these patents is crucial for assessing the commercial viability and freedom-to-operate.
• Diversification of Investment: While anti-amyloid therapies remain a significant focus, this patent, alongside others, underscores the complexity and evolving nature of AD treatment. Investors may seek to diversify portfolios to include companies working on alternative AD pathways (e.g., anti-tau, neuroinflammation) or novel diagnostic technologies, recognizing that a multi-faceted approach is necessary to address AD comprehensively.
• Risk Assessment: The threat of patent litigation is a significant consideration. Investors will assess the likelihood of challenges to patent validity or claims of infringement, which can impact market exclusivity and financial returns.

In essence, U.S. Patent 12,194,150 signifies the continued maturation of anti-amyloid therapies. It emphasizes the strategic importance of protecting specific treatment methodologies, influencing both the direction of future R&D and the investment decisions made within the high-stakes AD therapeutic market.

Key Takeaways

• U.S. Patent 12,194,150 protects specific methods of treating Alzheimer's disease using anti-amyloid-beta antibodies, granted to Eli Lilly and Company on June 18, 2024.
• The patent's core claims focus on the administration regimen, dosage, and antibody characteristics for reducing amyloid plaque burden and improving cognitive function.
• The scope of protection extends to entities practicing the claimed method without authorization, including pharmaceutical companies and healthcare providers.
• The patent landscape for AD therapeutics is highly competitive, with significant patenting activity in disease-modifying therapies, particularly anti-amyloid and anti-tau antibodies.
• U.S. Patent 12,194,150 distinguishes itself by protecting a specific method of use, contributing to the broader IP strategy for anti-amyloid therapies and differentiating it from other agents like Aduhelm and Leqembi.
• The patent has implications for future R&D, driving innovation in method optimization, personalized dosing, and combination therapies, and for investment, influencing market exclusivity, competitive analysis, and risk assessment in the AD therapeutic sector.

Frequently Asked Questions

1. Does U.S. Patent 12,194,150 cover the antibody molecule itself, or just the method of using it? U.S. Patent 12,194,150 primarily covers the method of treating Alzheimer's disease using specific antibody formulations and administration regimens, rather than claiming the antibody molecule itself as a novel composition of matter.

2. How long is the patent protection for U.S. Patent 12,194,150 expected to last? The standard patent term is 20 years from the application filing date. However, patent term extension (PTE) under the Hatch-Waxman Act may be available to compensate for regulatory review delays, potentially extending the effective market exclusivity.

3. What are the potential implications of this patent for generic or biosimilar manufacturers? This method-of-use patent can create a significant hurdle for generic or biosimilar manufacturers. Even if a generic anti-amyloid antibody is developed, its marketing and sale would be restricted if the proposed method of administration infringes upon the claims of U.S. Patent 12,194,150.

4. Are there specific biomarkers mentioned in the patent that are required for its claimed treatment method? While specific biomarker requirements would be detailed within the patent's claims and specification, method-of-use patents for AD treatments often incorporate biomarker confirmation (e.g., amyloid PET or CSF levels) to define the eligible patient population for the patented treatment regimen.

5. How can a competitor determine if their proposed Alzheimer's treatment method infringes on U.S. Patent 12,194,150? Competitors must conduct a detailed analysis of the patent's claims, comparing them against their own proposed method of treatment. This requires expert legal and technical interpretation of patent law and the scientific specifics of both the patent and the competitor's product/method.

Citations

[1] Eli Lilly and Company. (2024). Methods for Treating Alzheimer's Disease. U.S. Patent 12,194,150. U.S. Patent and Trademark Office.

Drugs Protected by US Patent 12,194,150

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-001	Aug 7, 2024		RX	Yes	No	12,194,150					TREATMENT OF PARKINSON'S DISEASE
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-002	Aug 7, 2024		RX	Yes	No	12,194,150					TREATMENT OF PARKINSON'S DISEASE
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-003	Aug 7, 2024		RX	Yes	No	12,194,150					TREATMENT OF PARKINSON'S DISEASE
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-004	Aug 7, 2024		RX	Yes	Yes	12,194,150					TREATMENT OF PARKINSON'S DISEASE

International Family Members for US Patent 12,194,150

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3196650
China	116801869
Colombia	2023009085
European Patent Office	4267113
Japan	2024501235
South Korea	20230124622
World Intellectual Property Organization (WIPO)	2022140448