Details for Patent: 8,071,643

Which drugs does patent 8,071,643 protect, and when does it expire?

Patent 8,071,643 protects XENLETA and is included in two NDAs.

This patent has forty-three patent family members in thirty-one countries.

Summary for Patent: 8,071,643

Title:	Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Abstract:	A pleuromutilin derivative compound of general formula (I) ##STR00001##
Inventor(s):	Mang; Rosemarie (Vienna, AT), Heilmayer; Werner (Zillingtal, AT), Badegruber; Rudolf (Vienna, AT), Strickmann; Dirk B. (Vienna, AT), Novak; Rodger (Vienna, AT), Ferencic; Mathias (Vienna, AT), Bulusu; Atchyuta Rama Chandra Murty (Perchtoldsdorf, AT)
Assignee:	Nabriva Therapeutics AG (Vienna, AT)
Application Number:	12/531,839
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,071,643
Patent Claim Types: see list of patent claims	Composition; Compound;

United States Patent 8,071,643: A Detailed Analysis of Scope and Claims

Introduction to Patent 8,071,643

Patent Overview

United States Patent 8,071,643 is a significant patent in the pharmaceutical industry, specifically related to the treatment of diseases mediated by microbes. This patent was granted on December 13, 2011, and is owned by Celgene Corporation[4].

Scope of the Patent

Background and Context

The patent claims cover pleuromutilin derivatives, which are compounds used for pharmaceutical treatment. These derivatives have shown potential in treating various microbial infections. The patent's scope includes the use of these compounds alone or in combination with other medications to combat microbial diseases[4].

Claims and Their Significance

Claims Analysis

The patent contains several claims that outline the specific pleuromutilin derivatives and their applications. Key claims include:

• Claim 1: A compound of the invention, which is a pleuromutilin derivative, useful for treating diseases mediated by microbes[4].
• Claim 2: A pharmaceutical composition comprising a compound of the invention and a suitable carrier[4].
• Claim 3: A method for treating a disease mediated by microbes using a compound of the invention[4].

These claims highlight the innovative aspect of the patent by specifying the exact compounds and their therapeutic applications.

Patent Landscape

Patent Landscape and Related Patents

To understand the patent landscape, it is essential to examine related patents and their interactions. Here are some key points:

• Related Patents: Other patents in the same family or related to pleuromutilin derivatives include US8071643B2 (the subject patent) and US12/531,839 (a continuation application)[4].
• Continuation Applications: The availability of continuation applications allows inventors to protect multiple aspects of an invention without overburdening the Patent and Trademark Office (PTO). This is particularly important in the pharmaceutical space where inventions often have multiple applications[1].
• Patent Term Extension: The patent term extension (PTE) rules have been refined over time to ensure that patent terms are guaranteed even in the face of administrative or regulatory delays. However, the current patent regime no longer has the loophole that the Non-Double Patenting Doctrine (NSDP) was developed to address[1].

Impact on Innovation and Industry

Impact on Innovation and Industry

The grant of Patent 8,071,643 has significant implications for innovation in the pharmaceutical industry:

• Innovation Incentives: The patent's scope and claims provide strong incentives for innovation by protecting the intellectual property rights of inventors. This encourages further research and development in the field of microbial treatments[3].
• Market Dominance: The exclusive rights granted by this patent can lead to market dominance for Celgene Corporation, allowing them to control the market for pleuromutilin derivatives and related treatments[3].

Regulatory Environment

Regulatory Environment and FDA Approval

The regulatory environment plays a crucial role in the approval and commercialization of pharmaceuticals:

• FDA Approval: The FDA has approved XENLETA tablets (lefamulin), which is a human drug product related to the pleuromutilin derivatives covered by this patent. This approval indicates that the regulatory framework supports the development and marketing of such treatments[2].
• Regulatory Compliance: Compliance with FDA regulations is essential for ensuring the safety and efficacy of pharmaceutical products. This compliance process involves rigorous testing and approval procedures that must be met before a drug can be marketed[2].

Conclusion

Conclusion

In conclusion, United States Patent 8,071,643 is a critical patent in the pharmaceutical industry, covering pleuromutilin derivatives for treating microbial diseases. The scope and claims of this patent highlight its significance in protecting intellectual property rights and encouraging innovation. The patent landscape, including related patents and continuation applications, underscores the importance of patent law in supporting technological advancements. Regulatory compliance and FDA approval processes further ensure that such treatments meet stringent safety and efficacy standards.

Key Takeaways

1. Patent Scope: The patent covers pleuromutilin derivatives useful for treating diseases mediated by microbes.
2. Claims Analysis: Specific claims outline the compounds, pharmaceutical compositions, and methods for treatment.
3. Patent Landscape: Related patents and continuation applications are crucial for understanding the patent's impact.
4. Innovation Incentives: The patent provides strong incentives for innovation in the pharmaceutical industry.
5. Market Dominance: Exclusive rights granted by this patent can lead to market dominance for Celgene Corporation.

FAQs

1. What does the patent cover?

   • The patent covers pleuromutilin derivatives for treating diseases mediated by microbes.

2. What are the key claims of the patent?

   • Key claims include a compound of the invention, a pharmaceutical composition, and a method for treating microbial diseases.

3. How does the patent landscape impact innovation?

   • The patent landscape, including related patents and continuation applications, encourages innovation by protecting intellectual property rights.

4. What is the significance of FDA approval for XENLETA tablets?

   • FDA approval indicates that the regulatory framework supports the development and marketing of pleuromutilin derivatives, ensuring safety and efficacy.

5. How does regulatory compliance affect pharmaceutical development?

   • Regulatory compliance involves rigorous testing and approval procedures that must be met before a drug can be marketed, ensuring safety and efficacy standards are met.

---

Cited Information:

1. [1] Supreme Court of the United States. (2024). In the Supreme Court of the United States. Retrieved from https://www.supremecourt.gov/DocketPDF/23/23-1231/315439/20240621114354424_Cellect%20Amicus%20Brief%20-%20FINAL.pdf
2. [2] FDA. (2021). XENLETA Tablets New Drug Application 211672. Retrieved from https://www.regulations.gov/document/FDA-2020-E-1843-0006
3. [3] Hoover Institution. (2016). Patent Claims and Patent Scope. Retrieved from https://www.hoover.org/sites/default/files/ip2-wp16001-paper.pdf
4. [4] Google Patents. (2011). US8071643B2 - Pleuromutilin derivatives for the treatment of diseases mediated by microbes. Retrieved from https://patents.google.com/patent/US8071643B2/en

Drugs Protected by US Patent 8,071,643

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Nabriva	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673-001	Aug 19, 2019		RX	Yes	Yes	8,071,643		Y	Y
Nabriva	XENLETA	lefamulin acetate	TABLET;ORAL	211672-001	Aug 19, 2019		RX	Yes	Yes	8,071,643		Y	Y

Foreign Priority and PCT Information for Patent: 8,071,643

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	07450053	Mar 20, 2007

PCT Information
PCT Filed	March 19, 2008	PCT Application Number:	PCT/AT2008/000097
PCT Publication Date:	September 25, 2008	PCT Publication Number:	WO2008/113089

International Family Members for US Patent 8,071,643

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2137143		CA 2020 00046	Denmark
European Patent Office	2137143		PA2020531	Lithuania
European Patent Office	2137143		LUC00178	Luxembourg
European Patent Office	2137143		CR 2020 00046	Denmark