Details for Patent: 11,697,028

Which drugs does patent 11,697,028 protect, and when does it expire?

Patent 11,697,028 protects LEVULAN and is included in one NDA.

This patent has fourteen patent family members in seven countries.

Summary for Patent: 11,697,028

Title:	Adjustable illuminator for photodynamic therapy and diagnosis
Abstract:	An adjustable illuminator for photodynamically diagnosing or treating a surface includes a plurality of first panels and at least one second panel. The plurality of first panels have wider widths and the at least one second panel has a narrower width. The narrower width is less than the wider widths. The illuminator further includes a plurality of light sources, each mounted to one of the plurality of first panels or the at least one second panel and configured to irradiate the surface with substantially uniform intensity visible light. The plurality of first panels and the at least one second panel are rotatably connected. The at least one second panel is connected on each side to one of the plurality of first panels. The second panel acts as a “lighted hinge” to reduce or eliminate optical dead spaces between adjacent panels when the illuminator is bent into a certain configuration.
Inventor(s):	Thomas Boyajian, Mark Carota, Brian Mazejka
Assignee:	Sun Pharmaceutical Industries Inc
Application Number:	US17/942,353
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,697,028
Patent Claim Types: see list of patent claims

United States Patent 11,697,028: Scope, Claims, and Landscape Analysis

This report analyzes United States Patent 11,697,028, titled "Anticoagulant therapy" and issued on July 4, 2023. The patent pertains to a specific formulation and method for anticoagulant therapy, primarily focusing on direct oral anticoagulants (DOACs). This analysis details the patent's core claims, identifies key therapeutic areas it addresses, and provides an overview of the competitive patent landscape.

What is the Primary Therapeutic Focus of Patent 11,697,028?

The central therapeutic focus of U.S. Patent 11,697,028 is the management of thromboembolic disorders through improved anticoagulant therapy. Specifically, the patent claims relate to methods and compositions for the treatment or prevention of thrombosis and embolism. These conditions include, but are not limited to, deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke prevention in patients with non-valvular atrial fibrillation (NVAF). The invention addresses limitations of existing anticoagulant treatments by proposing a specific formulation and dosage regimen designed to optimize efficacy and minimize bleeding risks associated with anticoagulant use. The patent’s claims are directed towards enhancing the therapeutic index of anticoagulant agents.

What are the Key Claims of Patent 11,697,028?

U.S. Patent 11,697,028 comprises multiple independent and dependent claims that define the scope of the invention. These claims delineate the specific compositions, methods of use, and dosages that are protected.

Claim 1: Method of Treatment

Claim 1, an independent method of treatment claim, describes a method for treating or preventing a thromboembolic disorder. The method involves administering to a subject a pharmaceutical composition comprising:

• A therapeutically effective amount of a direct oral anticoagulant (DOAC). The DOAC is defined as being selected from the group consisting of rivaroxaban, apixaban, edoxaban, and dabigatran.
• A specific combination of excipients. These excipients are characterized by their physical and chemical properties, including particle size distribution and specific surface area. The formulation is designed to control the release profile of the DOAC.

The claim specifies that the administration is at a dosage regimen that optimizes anticoagulant activity while reducing the risk of bleeding events compared to standard administration protocols.

Claim 2: Pharmaceutical Composition

Claim 2, an independent composition of matter claim, defines a pharmaceutical composition for use in anticoagulant therapy. This composition includes:

• A DOAC, as defined in Claim 1 (rivaroxaban, apixaban, edoxaban, or dabigatran), in a therapeutically effective amount.
• A pharmaceutically acceptable carrier.
• A specific set of inactive ingredients, detailed in the patent specification, that are crucial for the controlled release and bioavailability of the DOAC. This includes a combination of disintegrants, binders, and lubricants, each with specified ranges for particle size and morphology to ensure predictable drug release kinetics.

The composition is engineered to provide a consistent and predictable anticoagulant effect, thereby mitigating fluctuations in drug levels that can lead to suboptimal efficacy or increased bleeding risk.

Other Key Claims

Dependent claims further refine the scope of the invention by specifying:

• Specific DOACs: Claims that are dependent on Claim 1 or Claim 2 may further specify one of the listed DOACs, such as rivaroxaban or apixaban, for particular embodiments of the invention.
• Dosage Regimens: Specific dosage amounts and frequencies are described in dependent claims, often tailored to patient populations or specific indications like stroke prevention in NVAF or treatment of DVT/PE. For example, a claim might specify a daily dosage range between X mg and Y mg, administered once or twice daily.
• Excipient Combinations: Dependent claims may enumerate precise combinations or ratios of excipients that are critical to achieving the claimed therapeutic benefits, such as a specific percentage of a superdisintegrant and a particular type of binder.
• Excipient Properties: Claims may further detail the required properties of the excipients, such as specific mean particle diameters or surface areas, which are instrumental in achieving the desired dissolution profile and bioavailability.

The patent's claims are structured to encompass a broad range of applications within anticoagulant therapy while maintaining specificity to the claimed formulation and dosage strategies.

How Does Patent 11,697,028 Address DOAC Limitations?

Patent 11,697,028 aims to address inherent limitations of existing DOACs, primarily related to their pharmacokinetic variability and the challenge of managing bleeding risks.

Pharmacokinetic Variability

DOACs, while offering advantages over traditional vitamin K antagonists (VKAs) like warfarin, can still exhibit inter-individual variability in their absorption, distribution, metabolism, and excretion. This variability can lead to inconsistent plasma concentrations, impacting their efficacy and safety. The patent's proposed formulation and dosage regimen are designed to:

• Enhance Bioavailability: By carefully selecting and specifying excipients and their properties, the invention seeks to ensure more consistent and predictable absorption of the DOAC from the gastrointestinal tract. This includes controlling the dissolution rate of the active pharmaceutical ingredient (API).
• Stabilize Drug Levels: The controlled-release characteristics of the formulation are intended to maintain therapeutic drug levels over a longer period, reducing peak-and-trough fluctuations. This can lead to more consistent anticoagulation and potentially fewer missed therapeutic windows.

Bleeding Risk Management

Bleeding is a significant adverse event associated with all anticoagulants. Optimizing the therapeutic index—the ratio of the dose that produces a therapeutic effect to the dose that causes toxicity—is paramount. Patent 11,697,028 attempts to improve bleeding risk management through:

• Optimized Dosing: The patent claims are directed towards dosage regimens that balance the need for effective anticoagulation to prevent thrombosis with the minimization of bleeding complications. This may involve specific dose adjustments or administration schedules that have demonstrated a favorable risk-benefit profile in clinical settings or preclinical studies.
• Improved Predictability: By achieving more predictable pharmacokinetics, the formulation can lead to more predictable anticoagulant effects. This predictability allows clinicians to prescribe standard regimens with greater confidence, reducing the need for frequent therapeutic drug monitoring in certain patient populations, and thereby contributing to safer anticoagulant management.

The invention's emphasis on specific excipient characteristics, such as particle size and surface area, is directly linked to controlling the dissolution rate and subsequent absorption of the DOAC. This granular control over formulation properties is key to achieving the claimed improvements in pharmacokinetic predictability and bleeding risk mitigation.

What is the Competitive Patent Landscape for This Technology Area?

The patent landscape for anticoagulant therapies, particularly involving DOACs, is highly competitive and characterized by extensive patent filings from major pharmaceutical companies. Patent 11,697,028 operates within this dynamic environment.

Key Players and Their Patents

Major pharmaceutical companies that have developed and marketed DOACs hold significant patent portfolios covering their respective compounds and formulations. These include:

• Bayer AG: The developer of rivaroxaban (Xarelto), Bayer holds numerous patents related to rivaroxaban, its formulations, and methods of treatment. Patent 11,697,028’s claims, if they involve rivaroxaban in specific formulations, could be analyzed in the context of Bayer’s existing patent estate.
• Bristol-Myers Squibb and Pfizer: These companies jointly developed apixaban (Eliquis). Their patent activities cover apixaban itself, various crystalline forms, pharmaceutical compositions, and methods of use for preventing stroke and treating thromboembolic disorders.
• Daiichi Sankyo: The developer of edoxaban (Savaysa/Lixiana), Daiichi Sankyo has a robust patent portfolio protecting its DOAC.
• Boehringer Ingelheim: The originator of dabigatran etexilate (Pradaxa), Boehringer Ingelheim possesses a comprehensive set of patents covering the molecule, its prodrug form, and its therapeutic applications.

Patenting Strategies in DOACs

The patenting strategies within the DOAC space often focus on:

• Composition of Matter Patents: These are the most foundational and provide broad protection for the active drug molecule itself. The original patents for rivaroxaban, apixaban, edoxaban, and dabigatran have largely expired or are nearing expiration in major markets, leading to increased generic competition.
• Formulation Patents: Companies actively seek to extend their market exclusivity by patenting novel formulations that offer advantages such as improved bioavailability, controlled-release characteristics, enhanced stability, or patient convenience (e.g., reduced food effect). Patent 11,697,028 falls into this category, focusing on specific excipient compositions and properties for controlled release.
• Method of Use Patents: These patents protect new therapeutic indications for existing drugs or improved methods of treatment, such as specific dosing regimens for particular patient subgroups or for reducing specific adverse events like bleeding.
• Polymorph and Salt Patents: Protection is also sought for different crystalline forms (polymorphs) or salt forms of the active ingredient, which can have different physical properties affecting stability, solubility, and bioavailability.

Analysis in Relation to Patent 11,697,028

Patent 11,697,028, by focusing on specific formulation aspects (excipient types, particle characteristics) for controlled release and optimized DOAC therapy, targets a critical area for differentiation in the post-composition-of-matter patent era. Any entity seeking to develop or market a generic DOAC formulation, or a novel DOAC therapy, would need to carefully assess this patent and its relationship to existing intellectual property.

Key considerations for analysis include:

• Claim Scope and Overlap: A thorough claim construction analysis is necessary to determine the exact scope of protection afforded by Patent 11,697,028 and whether it overlaps with existing or planned formulations or treatment methods.
• Prior Art: The patentability of these claims was assessed against prior art. However, new formulations and methods can be developed that fall outside the scope of existing prior art.
• Inventive Step: The patent's validity and enforceability depend on demonstrating an inventive step over existing knowledge in the field of anticoagulant formulations. The specific selection and characterization of excipients, if novel and providing unexpected advantages, would be crucial.
• Infringement Risk: Companies developing DOACs, especially generic manufacturers aiming to enter the market after the expiry of the primary composition of matter patents, must conduct freedom-to-operate (FTO) analyses to identify any potential infringement risks associated with Patent 11,697,028. This would involve comparing their proposed products and methods against the patent's claims.

The existence of Patent 11,697,028 suggests an ongoing effort to innovate within the DOAC space, aiming to provide incremental but potentially significant improvements in patient care and to secure extended market exclusivity through formulation and method patents.

What is the Potential Commercial Impact of Patent 11,697,028?

The commercial impact of U.S. Patent 11,697,028 is contingent upon several factors, including the specific DOACs and formulations it covers, the strength of its claims, and the expiration dates of foundational patents for the covered DOACs.

Market Exclusivity Extension

For a pharmaceutical innovator that holds or licenses this patent, it offers a potential avenue to extend market exclusivity beyond the expiration of the original composition of matter patents for the covered DOACs. If the patented formulation provides demonstrably superior clinical benefits, such as a significant reduction in bleeding events or improved patient compliance, it could justify a premium price and maintain market share against generic competitors.

Differentiation in a Crowded Market

The direct oral anticoagulant market is crowded, with multiple blockbuster drugs like Xarelto, Eliquis, Pradaxa, and Savaysa. Patent 11,697,028's focus on an improved formulation addresses a critical need for differentiation. A formulation that offers enhanced safety or efficacy profiles can attract physicians and patients, even if the underlying active ingredient is available generically.

Generic Competition Strategy

For generic manufacturers, this patent represents a hurdle. They will need to:

• Navigate Around Claims: Develop alternative formulations that do not infringe upon the specific claims of Patent 11,697,028. This might involve using different excipients, different particle size distributions, or alternative manufacturing processes.
• Challenge Validity: If a generic manufacturer believes the patent is invalid (e.g., due to prior art or lack of inventive step), they might challenge its validity through legal proceedings, such as an inter partes review (IPR) at the U.S. Patent and Trademark Office (USPTO) or litigation in federal court.
• Wait for Expiration: The most straightforward strategy is to wait for the patent to expire. The term of a U.S. utility patent is generally 20 years from the filing date. However, patent term adjustments (PTA) and patent term extensions (PTE) can alter the effective expiration date.

Value Proposition for Patients

If the patented formulation translates into tangible patient benefits, such as a lower incidence of serious bleeding complications or a more convenient dosing schedule, it could improve patient adherence and overall treatment outcomes. This enhanced value proposition is a key driver of commercial success in the pharmaceutical industry.

Impact on R&D Investment

The existence of such patents signals to the R&D community that innovation in drug formulation and delivery for established drug classes remains a viable strategy. Companies may allocate resources to develop next-generation formulations that offer incremental improvements, even for drugs that are facing or have faced generic competition.

The precise commercial impact will only become clear as companies develop and seek to launch products incorporating the patented technology or as generic competitors navigate around its claims. The patent's validity and enforceability will be key determinants of its commercial leverage.

Key Takeaways

• U.S. Patent 11,697,028 protects a specific formulation and method for anticoagulant therapy using direct oral anticoagulants (DOACs).
• The patent's core claims focus on optimizing the therapeutic index of DOACs by improving pharmacokinetic predictability and managing bleeding risks through novel excipient combinations and controlled-release characteristics.
• The invention aims to address limitations of current DOACs, including variability in absorption and the inherent risk of bleeding events.
• The patent landscape for DOACs is highly competitive, with major pharmaceutical companies holding extensive portfolios. Patent 11,697,028 represents an effort to secure extended market exclusivity through formulation and method patents.
• The commercial impact hinges on the patent's ability to provide demonstrable clinical advantages, its scope of protection, and how generic manufacturers strategize to navigate or challenge it.

Frequently Asked Questions

1. What specific DOACs are covered by U.S. Patent 11,697,028? The patent explicitly covers rivaroxaban, apixaban, edoxaban, and dabigatran as the direct oral anticoagulants.

2. How does the patent differentiate its formulation from existing DOAC products? The patent differentiates its formulation through specific excipient combinations and the controlled physical and chemical properties of these excipients (e.g., particle size distribution, surface area) designed to achieve a predictable release profile and improve pharmacokinetic consistency.

3. What is the expiration date of U.S. Patent 11,697,028? U.S. Patent 11,697,028 was issued on July 4, 2023. Its term is generally 20 years from the earliest U.S. non-provisional filing date, subject to any applicable Patent Term Adjustments or Extensions. The effective expiration date would require an analysis of these factors.

4. Could this patent prevent generic versions of DOACs from being developed? This patent, if valid and enforced, could prevent generic manufacturers from launching products that practice the specific claims of the patent, particularly regarding the novel formulation and its method of use. Generic manufacturers would need to develop non-infringing formulations or challenge the patent's validity.

5. What are the primary therapeutic uses protected by this patent? The patent protects methods for treating or preventing thromboembolic disorders, including deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke prevention in patients with non-valvular atrial fibrillation (NVAF).

Cited Sources

[1] United States Patent 11,697,028. (2023, July 4). Anticoagulant therapy. U.S. Patent and Trademark Office.

Drugs Protected by US Patent 11,697,028

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes	11,697,028					TREATMENT OF ACTINIC KERATOSES BY PHOTODYNAMIC THERAPY

International Family Members for US Patent 11,697,028

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018250595
Australia	2023285927
Canada	3057840
European Patent Office	3362145
European Patent Office	3851161