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 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-carb- onitrile
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-car- bonitrile, 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):	Reynolds; Mark (Stamford, CT), Eary; Charles Todd (Longmont, CO)
Assignee:	Loxo Oncology Inc. (Stamford, CT)
Application Number:	16/156,903
Patent Claim Types: see list of patent claims	Use; Formulation; Compound; Dosage form;

Understanding the Scope and Claims of United States Patent 10,786,489

Introduction

Patent US10,786,489, titled "Formulations of 6-(2-hydroxy-2-methylpropxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3-pyridinyl)pyridin-2-yl)pyrimidine-2,4-diamine," is a patent that delves into specific chemical formulations. To analyze this patent, we need to break down its components, understand the claims, and place it within the broader patent landscape.

Patent Overview

Publication Number and Authority

The patent in question is US10,786,489B2, issued by the United States Patent and Trademark Office (USPTO)[4].

Prior Art and Background

The patent builds upon prior art related to chemical compounds, particularly those with applications in fields such as cancer treatment. The prior art keywords include "compound," "cancer," "formula," and "amino acid," indicating the patent's focus on pharmaceutical formulations[4].

Claims Analysis

Types of Claims

Patent claims are the heart of any patent, defining the scope of protection afforded by the patent. They can be independent or dependent, with independent claims standing alone and dependent claims referring back to an independent claim[2].

Claim Construction

The claims in US10,786,489B2 must be precise enough to afford clear notice of what is claimed, as mandated by the definiteness requirement under 35 U.S.C. § 112(b). This means the claims, viewed in light of the specification and prosecution history, must inform those skilled in the art about the scope of the invention with reasonable certainty[2].

Specific Claims

The patent includes multiple claims, each detailing a specific aspect of the formulation. For example:

• Claim 1 might describe the general formulation of the compound.
• Subsequent claims could detail specific variations, such as different concentrations or methods of preparation.

Each claim must be clear and distinct, avoiding ambiguity that could lead to disputes over the scope of the invention.

Specification and Drawings

Detailed Description

The specification of the patent provides a detailed description of the invention, including text, drawings, and flowcharts. This section explains how the formulation is made, its components, and any relevant processes or methods. For instance, the specification might describe the synthesis of the compound, its chemical structure, and any testing or validation procedures[2].

Illustrative Figures

Figures and drawings are crucial in patents, especially for complex chemical formulations. These visual aids help in understanding the molecular structure, synthesis pathways, and any other critical aspects of the invention. In the case of US10,786,489B2, figures might illustrate the chemical structure of the compound, its derivatives, or the process of its formulation[4].

Patent Scope and Landscape

Patent Scope Measurements

The scope of a patent is a critical aspect that determines its breadth and the extent of protection it offers. The USPTO's Patent Claims Research Dataset provides insights into patent scope measurements, including claim-level and document-level statistics. This dataset can help in understanding how the claims of US10,786,489B2 fit into the broader landscape of similar patents[3].

Related Patents and Prior Art

To fully understand the scope of US10,786,489B2, it is essential to review related patents and prior art. This involves searching through historical patents, such as those listed in the "Digest of Patents: 1790 to 1839" or more recent patents in the same field. This search helps in identifying what is novel about the current patent and how it distinguishes itself from existing knowledge[1].

Legal and Policy Considerations

Claim Indefiniteness

Claims must be definite to avoid legal challenges. The case of Nature Simulation Systems Inc. v. Autodesk, Inc. highlights the importance of claim construction and the definiteness requirement. The court emphasized that claims must provide clear notice of what is claimed, thereby informing the public of what is still open to them[2].

Small Claims Patent Court

The concept of a small claims patent court, as studied by the Administrative Conference of the United States (ACUS), could impact how patents like US10,786,489B2 are enforced and litigated. Such a court would aim to provide a more streamlined and cost-effective process for resolving patent disputes, which could be particularly beneficial for smaller entities[5].

Practical Implications

Enforcement and Litigation

Understanding the claims and scope of US10,786,489B2 is crucial for both the patent holder and potential infringers. Clear and definite claims help in enforcing the patent and defending against infringement claims. In litigation, the construction of these claims will be a key focus, as seen in cases like Nature Simulation Systems Inc. v. Autodesk, Inc.[2].

Licensing and Collaboration

The patent's scope also affects licensing and collaboration opportunities. Companies looking to license or collaborate on the development of the formulation need to understand the boundaries set by the patent claims to avoid infringement and ensure compliance.

Key Takeaways

• Clear Claims: The claims of US10,786,489B2 must be clear and definite to provide notice of the invention's scope.
• Specification and Drawings: The specification and drawings are essential for understanding the invention's details.
• Patent Scope: The patent's scope is critical in determining its protection and distinguishing it from prior art.
• Legal Considerations: The patent must comply with legal requirements such as definiteness to avoid challenges.
• Practical Implications: Understanding the patent's claims and scope is vital for enforcement, litigation, licensing, and collaboration.

FAQs

What is the main focus of US10,786,489B2?

The main focus of US10,786,489B2 is on specific chemical formulations, particularly those related to pharmaceutical applications.

How are patent claims constructed?

Patent claims are constructed to be clear and definite, providing notice of the invention's scope. They are viewed in the context of the specification and prosecution history[2].

Why is the definiteness requirement important?

The definiteness requirement is crucial because it ensures that the claims provide clear notice of what is claimed, thereby informing the public of what is still open to them[2].

How does the patent landscape impact US10,786,489B2?

The patent landscape, including related patents and prior art, helps in understanding what is novel about US10,786,489B2 and how it distinguishes itself from existing knowledge[1].

What is the potential impact of a small claims patent court on patents like US10,786,489B2?

A small claims patent court could provide a more streamlined and cost-effective process for resolving patent disputes, which could be particularly beneficial for smaller entities[5].

Sources

1. NYPL Libguides: How to Search for an Historical U.S. Patent.
2. United States Court of Appeals for the Federal Circuit: Nature Simulation Systems Inc. v. Autodesk, Inc.
3. USPTO: Patent Claims Research Dataset.
4. Google Patents: US10786489B2 - Formulations of 6-(2-hydroxy-2-methylpropxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3-pyridinyl)pyridin-2-yl)pyrimidine-2,4-diamine.
5. Administrative Conference of the United States: U.S. Patent Small Claims Court.

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
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes	10,786,489	Y				U-2971	THE TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes	10,786,489	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
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes	10,786,489	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
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes	10,786,489	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
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes	10,786,489	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

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
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No	10,786,489		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
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No	10,786,489		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
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No	10,786,489		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
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No	10,786,489		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
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-002	May 8, 2020		RX	Yes	Yes	10,786,489		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

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