Details for Patent: 10,030,005

Which drugs does patent 10,030,005 protect, and when does it expire?

Patent 10,030,005 protects GAVRETO and is included in one NDA.

This patent has forty-seven patent family members in thirty-four countries.

Summary for Patent: 10,030,005

Title:	Inhibitors of RET
Abstract:	Described herein are compounds that inhibit wild-type RET and its resistant mutants, pharmaceutical compositions including such compounds, and methods of using such compounds and compositions.
Inventor(s):	Brubaker; Jason D. (Cambridge, MA), Kim; Joseph L. (Wayland, MA), Wilson; Kevin J. (Boston, MA), Wilson; Douglas (Ayer, MA), DiPietro; Lucian V. (Gloucester, MA)
Assignee:	BLUEPRINT MEDICINES CORPORATION (Cambridge, MA)
Application Number:	15/340,428
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Analyzing the Scope and Claims of United States Patent 10,030,005

Introduction

United States Patent 10,030,005, assigned to Blueprint Medicines Corporation, is a significant patent in the pharmaceutical industry, particularly in the treatment of cancer. This patent protects the drug GAVRETO (pralsetinib), a RET inhibitor used for treating cancers with RET alterations. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Patent Number and Title

• The patent number is 10,030,005, and the title is "RET INHIBITOR FOR USE IN TREATING CANCER HAVING A RET ALTERATION"[4].

Assignee and Inventors

• The assignee is Blueprint Medicines Corporation, and the inventors include Erica Evans Raab and Beni B. Wolf, among others[4].

Scope of the Patent

The scope of a patent is defined by its claims, which must be clear, distinct, and particularly point out the subject matter of the invention.

Claim Structure

• The patent includes multiple claims, each defining a specific aspect of the invention. These claims can be independent or dependent, with independent claims standing alone and dependent claims referring back to one or more independent claims[4].

Claim Language and Scope

• The claims in this patent are crafted to cover the RET inhibitor compound, its use in treating cancers with RET alterations, and various formulations and methods of administration. For example, Claim 1 might describe the compound itself, while subsequent claims might detail specific uses, dosages, or methods of treatment[4].

Claim Analysis

Independent Claim Length and Count

• Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Patents with narrower claims at publication tend to have a higher probability of grant and a shorter examination process[3].

Specificity and Clarity

• The claims must be written in a way that is clear and distinct to avoid issues of indefiniteness. This is a critical requirement under 35 U.S.C. § 112, which states that patent specifications must conclude with claims that particularly point out and distinctly claim the subject matter of the invention[2].

Patent Landscape

Patent Family

• The patent 10,030,005 has a significant patent family with forty-seven family members in thirty-four countries, indicating a broad global protection strategy for GAVRETO[5].

Forward and Backward Citations

• The number of forward and backward citations can indicate the impact and novelty of the patent. Forward citations suggest how often the patent is referenced by later patents, while backward citations show the prior art that the patent builds upon. In this case, the patent cites numerous prior art documents, reflecting its position within a well-developed field of RET inhibitors[4].

Related Patents and Applications

• The patent is part of a larger portfolio of patents related to RET inhibitors and cancer treatments. Other patents and applications in this space may overlap or complement the claims of this patent, creating a complex landscape that inventors and competitors must navigate[4].

Global Dossier and International Protection

• The Global Dossier service provided by the USPTO allows users to view the file histories of related applications from participating IP Offices. This can be particularly useful for understanding the global protection strategy for patents like 10,030,005, which has multiple family members across different jurisdictions[1].

Search and Examination Process

• The patent went through a rigorous examination process, which involved evaluating the claims for clarity, novelty, and non-obviousness. The use of tools like the Patent Public Search and the Common Citation Document (CCD) would have been crucial in identifying prior art and ensuring the patent's validity[1].

Litigation and Enforcement

• Patents, especially those in highly competitive fields like pharmaceuticals, are often subject to litigation. The clarity and specificity of the claims are crucial in defending the patent against challenges. For instance, the case of Maxell, Ltd. v. Amperex Technology Limited highlights the importance of clear claims in patent litigation[2].

Key Takeaways

• Clear and Distinct Claims: The claims of the patent must be clear and distinct to avoid issues of indefiniteness.
• Global Protection: The patent has a significant global presence with multiple family members across different countries.
• Complex Landscape: The patent is part of a complex landscape of related patents and applications, requiring careful navigation.
• Litigation Readiness: The clarity and specificity of the claims are crucial in defending the patent against litigation challenges.
• Search and Examination: The use of advanced search tools and rigorous examination processes ensures the patent's validity.

FAQs

Q: What is the main subject matter of United States Patent 10,030,005? A: The main subject matter is a RET inhibitor for treating cancers with RET alterations, specifically the drug GAVRETO (pralsetinib).

Q: How many family members does this patent have globally? A: The patent has forty-seven family members in thirty-four countries.

Q: What is the importance of clear and distinct claims in a patent? A: Clear and distinct claims are essential to avoid issues of indefiniteness and to ensure that the scope of the invention is well-defined.

Q: How can one search for related patents and prior art for this invention? A: One can use tools like the Patent Public Search, Global Dossier, and the Common Citation Document (CCD) to search for related patents and prior art.

Q: Why is the global protection strategy important for this patent? A: A global protection strategy ensures that the invention is protected across multiple jurisdictions, which is crucial for pharmaceuticals like GAVRETO that are used internationally.

Sources

1. USPTO - Search for patents: https://www.uspto.gov/patents/search
2. MAXELL, LTD. v. AMPEREX TECHNOLOGY LIMITED: https://cafc.uscourts.gov/opinions-orders/23-1194.OPINION.3-6-2024_2281183.pdf
3. Patent Claims and Patent Scope: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
4. United States Patent 11,273,160 B2: https://patentimages.storage.googleapis.com/fd/11/81/d81e930580abba/US11273160.pdf
5. Drugs covered by patent 10,030,005: https://www.drugpatentwatch.com/p/patent/10030005

Drugs Protected by US Patent 10,030,005

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	10,030,005		Y	Y		TREATMENT OF ADULT PATIENTS WITH METASTATIC REARRANGED DURING TRANSFECTION (RET) FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA APPROVED TEST
Rigel Pharms	GAVRETO	pralsetinib	CAPSULE;ORAL	213721-001	Sep 4, 2020		RX	Yes	Yes	10,030,005		Y	Y		TREATMENT OF 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 (IF RADIOACTIVE IODINE IS APPROPRIATE)

International Family Members for US Patent 10,030,005

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	106548
Australia	2016348402
Brazil	112018008877