Details for Patent: 11,260,053

Which drugs does patent 11,260,053 protect, and when does it expire?

Patent 11,260,053 protects LIVMARLI and is included in one NDA.

This patent has six patent family members in three countries.

Summary for Patent: 11,260,053

Title:	Bile acid recycling inhibitors and satiogens for treatment of diabetes, obesity, and inflammatory gastrointestinal conditions
Abstract:	Provided herein are methods of utilizing bile acid transport inhibitors and/or enteroendocrine peptide enhancing agents for the treatment of obesity, diabetes, and inflammatory gastrointestinal conditions.
Inventor(s):	Gedulin; Bronislava (Del Mar, CA), Young; Andrew A. (Chapel Hill, NC), Greene; Howard E. (Frankfort, MI)
Assignee:	SATIOGEN PHARMACEUTICALS, INC. (San Diego, CA)
Application Number:	16/276,540
Patent Claim Types: see list of patent claims	Use; Formulation; Delivery;

Understanding the Scope and Claims of United States Patent 11,260,053

Introduction

United States Patent 11,260,053, assigned to Mirum Pharmaceuticals, is a significant patent in the pharmaceutical industry, particularly in the treatment of rare diseases. This patent is part of a broader intellectual property strategy that protects innovative treatments and methods. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape it operates within.

Patent Overview

Patent Number and Title

• The patent in question is US 11,260,053 B2, titled "Method of Treatment: Dosing" and related to the use of specific compounds for therapeutic purposes.

Assignee

• The patent is assigned to Mirum Pharmaceuticals, a company focused on developing treatments for rare diseases such as Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC)[1].

Scope of the Patent

Therapeutic Area

• The patent pertains to the treatment of rare liver diseases, specifically focusing on the use of maralixibat (marketed as LIVMARLI) and other related compounds. These compounds are bile acid transport inhibitors designed to treat conditions like ALGS and PFIC[1].

Claims

• The patent claims cover specific methods of treatment involving the dosing of these bile acid transport inhibitors. These claims are detailed and include:
  • The administration regimen of the drug.
  • The dosage forms and strengths.
  • The patient populations for which the treatment is indicated.
  • Any specific monitoring or adjustment criteria for the treatment[1].

Claim Structure and Breadth

Genus Claims vs. Species Claims

• The patent claims may include both genus claims and species claims. Genus claims are broader and cover a class of items, while species claims are narrower and specific. In the pharmaceutical industry, genus claims are critical but must comply with the enablement and written description requirements of 35 U.S.C. § 112(a)[3].

Enablement and Written Description

• For a patent claim to be valid, it must meet the enablement and written description requirements. This means the specification must describe the invention in "such full, clear, concise, and exact terms as to enable any person skilled in the art" to make and use the invention. The Federal Circuit has been stringent on genus claims, requiring "full scope" enablement, which can be challenging in pharmaceutical and biotechnology inventions[3].

Patent Landscape

Competitive Environment

• The patent landscape in the pharmaceutical industry is highly competitive, with numerous companies vying for market share. Patents like US 11,260,053 are crucial for protecting innovative treatments and preventing competitors from designing around the claims. The breadth and specificity of the claims determine the level of protection and the ability to enforce the patent against infringers[3].

Regulatory Environment

• Patents in this sector must navigate complex regulatory requirements. The approval process involves clinical trials, regulatory submissions, and compliance with laws and regulations. The patent's validity and enforceability can be affected by regulatory outcomes and the availability of generic or biosimilar alternatives[1].

Intellectual Property Protection

Patent Term and Exclusivity

• The patent provides exclusivity for the treatment methods described, protecting Mirum Pharmaceuticals' investment in research and development. The patent term, typically 20 years from the filing date, ensures that the company can recoup its investment and generate revenue before generic competition enters the market[1].

Orphan Designation

• The patent may also benefit from orphan drug designation, which provides additional exclusivity and incentives for developing treatments for rare diseases. This designation can extend the market exclusivity period and offer other benefits such as tax credits and reduced regulatory fees[1].

Impact on Innovation

Encouraging Innovation

• Patents like US 11,260,053 encourage innovation by providing a financial incentive for companies to invest in research and development. The protection afforded by the patent allows companies to recoup their investments and continue to innovate in the field of rare disease treatments[3].

Challenges in Patenting

• However, the current jurisprudence on patent claims, particularly genus claims, poses challenges for innovators. The stringent requirements for enablement and written description can make it difficult to obtain broad patent protection, which is essential for pharmaceutical and biotechnology inventions[3].

Case Law and Jurisprudence

Federal Circuit Rulings

• The Federal Circuit's rulings on patent claims, such as those related to enablement and written description, significantly impact the scope and validity of patents like US 11,260,053. Cases like Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. have set precedents that affect how patent claims are drafted and enforced[3].

In re Maatita

• The In re Maatita decision highlights the importance of clear and definite claims. The case emphasizes that patent claims must inform those skilled in the art about the scope of the invention with reasonable certainty, which is crucial for maintaining the validity of patents in the pharmaceutical sector[5].

Conclusion

The scope and claims of United States Patent 11,260,053 are critical components of Mirum Pharmaceuticals' intellectual property strategy. Understanding the breadth and specificity of these claims, as well as the regulatory and competitive environment, is essential for navigating the complex landscape of pharmaceutical patents.

Key Takeaways

• Patent Scope: The patent covers specific methods of treatment using bile acid transport inhibitors for rare liver diseases.
• Claim Structure: The claims must balance breadth and specificity to comply with enablement and written description requirements.
• Competitive Environment: The patent landscape is highly competitive, and broad claims are necessary to prevent design-around strategies.
• Regulatory Environment: Regulatory approvals and compliance are crucial for the patent's validity and enforceability.
• Intellectual Property Protection: The patent provides exclusivity and incentives for innovation in rare disease treatments.

FAQs

Q1: What is the main focus of United States Patent 11,260,053?

• The main focus is on the treatment of rare liver diseases using bile acid transport inhibitors.

Q2: Who is the assignee of the patent?

• The patent is assigned to Mirum Pharmaceuticals.

Q3: What are the key challenges in drafting patent claims for pharmaceutical inventions?

• The key challenges include meeting the enablement and written description requirements, particularly for genus claims.

Q4: How does the Federal Circuit's jurisprudence impact pharmaceutical patents?

• The Federal Circuit's rulings on enablement and written description requirements significantly affect the scope and validity of pharmaceutical patents.

Q5: What additional protections might the patent benefit from?

• The patent might benefit from orphan drug designation, which provides additional exclusivity and incentives.

Sources

1. Mirum Pharmaceuticals: Transforming Lives in Rare Disease - Mirum Pharmaceuticals Corporate Presentation.
2. Patent Claims Research Dataset - USPTO.
3. Eviscerating Patent Scope - DigitalCommons@NYLS.
4. Bile acid recycling inhibitors and satiogens for treatment of diabetes, obesity, and inflammatory gastrointestinal conditions - Google Patents.
5. In re Maatita - Court of Appeals for the Federal Circuit.

Drugs Protected by US Patent 11,260,053

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)

International Family Members for US Patent 11,260,053

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2575821
European Patent Office	2995317
European Patent Office	3593802
European Patent Office	4137137