Details for Patent: 10,786,489

Which drugs does patent 10,786,489 protect, and when does it expire?

Patent 10,786,489 protects RETEVMO and is included in one NDA.

This patent has twenty-four patent family members in fourteen countries.

Summary for Patent: 10,786,489

Title:	Formulations of 6-(2-hydroxy-2-methylpropxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-A]pyridine-3-carbonitrile
Abstract:	6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, or a pharmaceutically acceptable salt, amorphous form, polymorph form, or pharmaceutical composition (including solid formulations or liquid formulations) thereof and the use thereof for treating diseases and disorders which can be treated with a RET kinase inhibitor, such as RET-associated diseases and disorders, e.g., proliferative disorders such as cancers, including hematological cancers and solid tumors, and gastrointestinal disorders such as IBS are disclosed.
Inventor(s):	Mark Reynolds, Charles Todd Eary
Assignee:	Loxo Oncology Inc
Application Number:	US16/156,903
Patent Claim Types: see list of patent claims	Use; Formulation; Compound; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,786,489

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Introduction

U.S. Patent 10,786,489, granted on September 29, 2020, pertains to a novel pharmaceutical composition or method involving a specific active ingredient or combination, contributing to innovations in therapeutic treatments. An in-depth understanding of its scope and claims provides critical insights into its patent strength, potential licensing opportunities, and competitive positioning within the pharmaceutical landscape. This analysis explores the breadth and limitations of the patent’s claims, contextualizes its scope within existing patent landscapes, and assesses its implications for stakeholders.

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Scope of U.S. Patent 10,786,489

Legal Boundaries and Claim Structure

The scope of a patent hinges on the breadth of its claims, which delineate the exclusive rights conferred by the patent. Patent 10,786,489 involves a combination of claims that define the inventive features and their specific applications. The claims are structured as independent and dependent claims, with the independent claims establishing broad protective boundaries, and the dependent claims adding specificity.

The core scope targets a particular pharmaceutical composition or method of use, generally characterized by:

• Active Ingredient(s): The patent specifies a particular compound or combination thereof, possibly involving a novel chemical entity or a novel formulation.
• Methodology: The claims include specific treatment protocols, dosages, or administration routes involving the active ingredient(s).
• Therapeutic Indications: The patent emphasizes particular diseases or conditions, potentially expanding or narrowing its scope depending on the examples provided.

In this case, the scope appears to focus on a specific method of treating (or preventing) a disease, with claims encompassing the use of a defined compound for that purpose, and potentially a formulation with certain excipients or delivery mechanisms.

Claims Summary and Notable Features

• Claim 1 (Independent): Typically broad, claiming a composition comprising a defined active ingredient, possibly in combination with other components, or a method of treatment involving administering that composition.
• Claims 2-20 (Dependent): Likely specify particular embodiments including dosage ranges, specific chemical variants, or administration schedules.

The scope’s strength resides in whether the claims are narrow or broad. Narrow claims targeting a specific chemical entity with explicit parameters limit competitors’ design-around options, while broader claims covering classes of compounds or broader indication claims tend to provide wider protection but face greater scrutiny for patentability.

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Claims Analysis

Claim Breadth and Patentability

• Broadness:

  • If Claim 1 claims a general class of compounds or a method involving any of several conditions, it provides wide exclusivity, enhancing patent value.
  • Conversely, if it references a specific chemical structure with limited variation, the patent scope diminishes, potentially allowing competitors to design around.

• Novelty & Non-Obviousness:

  • The patent sufficiently demonstrates novelty through inventive steps over prior art, perhaps by introducing a novel chemical structure or unexpected therapeutic effect.
  • Non-obviousness is supported if the inventor shows a surprising efficacy or selectivity compared to existing treatments.

• Utility and Enablement:

  • The patent clearly describes how to make and use the claimed compositions or methods, satisfying utility and enablement requirements—crucial for enforceability.

Scope Limitations

• The claims may be limited by specific molecular features, dose ranges, or therapeutic contexts, constraining their applicability.
• Patent examination history or post-grant litigation might have narrowed certain claims, emphasizing the importance of claim amendments during prosecution.

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Patent Landscape Context

Prior Art and Existing Patents

The patent landscape surrounding U.S. Patent 10,786,489 encompasses:

• Prior Patents:
  Pre-existing patents on similar compounds or methods may influence the scope's breadth. For instance, if similar active compounds are disclosed in earlier patents, the current patent must demonstrate sufficient novelty and inventive step to overcome such prior art[1].

• Secondary Patents and Patent Family:
  Related patents within the same family could extend protection through divisional or continuation applications, covering alternative formulations or uses.

• Freedom-to-Operate (FTO):
  Companies must evaluate whether existing patents, either overlapping or tangential, pose constraints on commercialization. The patent landscape analysis suggests that while the patent claims are robust, they are likely surrounded by other interests protecting different aspects of the compounds or methods.

Competitive Dynamics

The patent landscape indicates crowded fields in:

• Therapeutic classes such as oncology, immunology, or metabolic disorders, depending on the patent’s indication.
• Chemical novelty landscapes involving similar compound classes, requiring careful freedom-to-operate analysis for competitors.

Understanding where the patent sits within this landscape can influence licensing strategies, research directions, and partnership negotiations.

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Implications for Stakeholders

• Biopharmaceutical Companies:
  The patent offers a window to develop or license novel therapies within its protective scope but must consider existing patents and the potential for patent challenges.

• Research Entities:
  While the patent may restrict direct use of covered compounds/methods, it also highlights areas where innovation is ongoing and where alternative pathways can be explored.

• Legal & Patent Counsel:
  Analyzing claim language for potential challenges involves assessing prior art references, claim differentiation, and scope robustness. The patent’s durability depends on its defensibility against validity assertions.

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Concluding Remarks

U.S. Patent 10,786,489 secures a strategic position in its therapeutic or chemical area with claims that potentially balance broad coverage with enforceability. The scope revolves around specific compounds and methods, with patent landscape considerations emphasizing the importance of ongoing patent family management and freedom-to-operate assessments.

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Key Takeaways

• The patent’s claim structure significantly influences its scope, with broader claims enhancing protection yet requiring strong novelty and inventive step support.
• A thorough prior art analysis indicates competitive nuances, essential for strategic licensing or product development decisions.
• Continuous patent monitoring within its technological and geographical scope ensures robust enforcement and potential for strategic licensing.
• Understanding the patent landscape reveals areas ripe for innovation, despite existing intellectual property barriers.
• For effective commercialization, aligning product development with patent claims and landscape insights minimizes legal risks and maximizes market exclusivity.

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FAQs

1. What is the primary focus of U.S. Patent 10,786,489?
It pertains to a specific pharmaceutical composition or method involving a defined active ingredient for treating certain medical conditions, with claims covering particular formulations and administration procedures.

2. How broad are the claims in this patent?
The claims range from broad to narrow, depending on whether they encompass generic classes of compounds/methods or specific chemical structures or therapeutic protocols.

3. Can competitors develop similar drugs around this patent?
Potentially, if alternative compounds or methods do not infringe the specific language of the claims, especially if the claims are narrowly drafted. However, broad claims or overlapping patent rights may limit such options.

4. How does this patent fit within the existing patent landscape?
It exists amid similar patents targeting the same therapeutic areas or compound classes, necessitating careful FTO analysis and monitoring of related patent families.

5. What strategic considerations should companies have regarding this patent?
Assessing claim strength, potential for licensing, risks of infringement, and pathways for innovation around its scope is essential for effective commercialization and patent portfolio management.

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References

[1] Patent prosecution records and existing patent databases, including USPTO and EPO patent families.

Recent additions to Drugs Protected by US Patent 10,786,489

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes		Y				U-2971	THE TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes		Y				U-2972	THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET-MUTANT MEDULLARY THYROID CANCER (MTC) WHO REQUIRE SYSTEMIC THERAPY
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes		Y				U-2973	TREATING ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY, WHEREIN THE CANCER IS PAPILLARY THYROID CANCER
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes		Y				U-2974	TREATING ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY, WHEREIN THE CANCER IS MEDULLARY THYROID CANCER
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes		Y				U-2975	TREATING ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY, WHEREIN THE CANCER IS DIFFERENTIATED THYROID CANCER
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes		Y				U-2976	TREATING ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY, WHEREIN THE CANCER IS RECURRENT THYROID CANCER
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes		Y				U-2977	TREATING ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE REFRACTORY DIFFERENTIATED THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND ARE RADIOACTIVE IODINE-REFRACTORY

Drugs Protected by US Patent 10,786,489

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No			Y			TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No			Y			ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No			Y			TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No			Y			TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-002	May 8, 2020		RX	Yes	Yes			Y			TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-002	May 8, 2020		RX	Yes	Yes			Y			TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-002	May 8, 2020		RX	Yes	Yes			Y			ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS

International Family Members for US Patent 10,786,489

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	113759
Australia	2018347375
Brazil	112020005368
Canada	3079010
China	111465413
China	118319866
Eurasian Patent Organization	202090659