Details for Patent: 8,618,135

Which drugs does patent 8,618,135 protect, and when does it expire?

Patent 8,618,135 protects JUXTAPID and is included in one NDA.

This patent has twenty-seven patent family members in eighteen countries.

Summary for Patent: 8,618,135

Title:	Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Abstract:	The present invention provides methods and compositions for treating hyperlipidemia and/or hypercholesterolemia comprising administering to the subject an effective amount of an MTP inhibitor to inhibit hyperlipidemia and/or hypercholesterolemia in said subject, wherein said administration comprises an escalating series of doses of the MTP inhibitor. In some embodiments the method comprises administering at least three step-wise, increasing dosages of the MTP inhibitor to the subject. In some embodiments, the method further comprises the administration of one or more other lipid modifying compounds.
Inventor(s):	Rader; Daniel J. (Philadelphia, PA)
Assignee:	The Trustees of the University of Pennsylvania (Philadelphia, PA)
Application Number:	13/046,118
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,618,135
Patent Claim Types: see list of patent claims	Use; Delivery;

United States Patent 8,618,135: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,618,135, assigned to Novelion Therapeutics Inc., is a significant patent in the pharmaceutical sector, particularly for the treatment of rare diseases. This patent pertains to the dosage regimen of lomitapide, a drug used to treat homozygous familial hypercholesterolemia (HoFH), a rare genetic disorder.

Background on Lomitapide

Lomitapide is a microsomal triglyceride transfer protein (MTP) inhibitor that reduces the production of very-low-density lipoprotein (VLDL) and thereby lowers cholesterol levels. The drug is crucial for patients with HoFH who do not respond adequately to other treatments.

Patent Overview

Patent Number and Title

• Patent Number: 8,618,135
• Title: Methods of treating hypercholesterolemia

Assignee

• Novelion Therapeutics Inc.

Issue Date

• March 25, 2014

Claims and Scope

The patent 8,618,135 includes several claims that define the scope of the invention. Here are some key aspects:

Independent Claims

• The patent includes claims related to methods of treating hypercholesterolemia, specifically through the administration of lomitapide in a step-wise titration regimen. This regimen is designed to manage the side effects of the drug while maintaining its efficacy[2].

Dependent Claims

• Dependent claims further specify the dosage amounts, administration schedules, and patient populations. These claims provide detailed guidance on how to implement the step-wise titration regimen effectively[2].

Patent Landscape

Exclusivity Period

• The patent provides exclusivity for the dosage regimen of lomitapide until March 2025. This period is critical for Novelion Therapeutics to maintain market exclusivity and protect its intellectual property[2].

Related Patents

• The patent is part of a broader intellectual property portfolio for lomitapide, which includes other patents such as U.S. 7,932,268. These patents collectively extend the exclusivity period for the drug and its dosage regimen until August 2027[2].

Inter Partes Review (IPR)

The patent 8,618,135 has undergone an Inter Partes Review (IPR) by the U.S. Patent Trial and Appeal Board (PTAB). This review was initiated by challenges to the patent's validity, but the PTAB ultimately affirmed the patentability of all claims, supporting Novelion Therapeutics' argument that the step-wise titration of lomitapide was not obvious[2].

Industry Impact

Market Protection

• The affirmation of this patent by the PTAB ensures that Novelion Therapeutics maintains a strong intellectual property position in the market, protecting its investment in the development of lomitapide and its dosage regimen[2].

Competitive Advantage

• This patent provides a competitive advantage by preventing other companies from using the same dosage regimen, thereby safeguarding Novelion Therapeutics' market share for the treatment of HoFH[2].

Technological and Medical Significance

Treatment of Rare Diseases

• The patent highlights the importance of innovative treatments for rare diseases. Lomitapide and its specific dosage regimen offer a critical therapeutic option for patients with HoFH, a condition that is difficult to manage with conventional treatments[2].

Pharmaceutical Innovation

• The development and patenting of such specific dosage regimens encourage pharmaceutical innovation, as companies are incentivized to invest in research and development knowing that their intellectual property will be protected[1].

Global Patent Trends

International Patent Classification

• Patents like 8,618,135 are classified under specific technological fields, such as those defined by the World Intellectual Property Organization (WIPO). This classification helps in analyzing global trends in patenting, particularly in the pharmaceutical sector[1].

Global Dossier

• Tools like the Global Dossier facilitate the management of related patent applications across different jurisdictions, ensuring that intellectual property rights are consistently protected worldwide[4].

Search and Analysis Tools

USPTO Resources

• The U.S. Patent and Trademark Office (USPTO) provides various resources, such as the Patent Public Search tool and the Patent Examination Data System (PEDS), which can be used to search and analyze patents like 8,618,135[4].

Patent Claims Research Dataset

• The USPTO's Patent Claims Research Dataset offers detailed information on claims from U.S. patents, which can be used to analyze the scope and claims of patents like 8,618,135[3].

Conclusion

United States Patent 8,618,135 is a pivotal patent in the pharmaceutical industry, particularly for the treatment of rare diseases like HoFH. The patent's claims and scope define a specific dosage regimen for lomitapide, which has been upheld by the PTAB. This patent exemplifies the importance of intellectual property protection in driving innovation and ensuring market exclusivity.

Key Takeaways

• Patent Protection: The patent provides exclusivity for the dosage regimen of lomitapide until March 2025.
• IPR Affirmation: The PTAB affirmed the patentability of all claims, supporting Novelion Therapeutics' intellectual property position.
• Market Impact: The patent protects Novelion Therapeutics' market share and encourages pharmaceutical innovation.
• Global Trends: The patent is part of broader global trends in pharmaceutical patenting, classified under specific technological fields.
• Search and Analysis: Various USPTO resources are available for searching and analyzing patents like 8,618,135.

FAQs

What is the primary focus of United States Patent 8,618,135?

The primary focus of this patent is the dosage regimen of lomitapide for treating hypercholesterolemia, specifically homozygous familial hypercholesterolemia (HoFH).

Who is the assignee of this patent?

The assignee of this patent is Novelion Therapeutics Inc.

What is the exclusivity period for this patent?

The patent provides exclusivity until March 2025.

What was the outcome of the Inter Partes Review (IPR) for this patent?

The PTAB affirmed the patentability of all claims, supporting Novelion Therapeutics' argument that the step-wise titration of lomitapide was not obvious.

How does this patent impact the pharmaceutical industry?

This patent protects Novelion Therapeutics' market share and encourages pharmaceutical innovation by safeguarding the company's investment in the development of lomitapide and its dosage regimen.

Cited Sources:

1. National Science Foundation. Invention: U.S. and Comparative Global Trends. January 15, 2020.
2. GlobeNewswire. U.S. Patent Trial and Appeal Board Affirms Lomitapide Patents with Favorable IPR Decisions. March 7, 2017.
3. United States Patent and Trademark Office. Patent Claims Research Dataset. August 28, 2017.
4. United States Patent and Trademark Office. Search for patents - USPTO. October 18, 2018.

Drugs Protected by US Patent 8,618,135

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-001	Dec 21, 2012		RX	Yes	No	8,618,135					A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012		RX	Yes	No	8,618,135					A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012		RX	Yes	No	8,618,135					A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES

International Family Members for US Patent 8,618,135

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1725234		CA 2014 00002	Denmark
European Patent Office	1725234		C300634	Netherlands
European Patent Office	1725234		PA2014001	Lithuania