Details for Patent: 7,423,050

Which drugs does patent 7,423,050 protect, and when does it expire?

Patent 7,423,050 protects REYVOW and is included in one NDA.

This patent has forty patent family members in thirty countries.

Summary for Patent: 7,423,050

Title:	Pyridinoylpiperidines as 5-HT.sub.1F agonists
Abstract:	The present invention relates to compounds of formula I: ##STR00001## or pharmaceutically acceptable acid addition salts thereof, where; R.sup.1 is C.sub.1-C.sub.6 alkyl, substituted C.sub.1-C.sub.6 alkyl, C.sub.3-C.sub.7 cycloalkyl, substituted C.sub.3-C.sub.7 cycloalkyl, C.sub.3-C.sub.7 cycloalkyl-C.sub.1-C.sub.3 alkyl, substituted C.sub.3-C.sub.7 cycloalkyl-C.sub.1-C.sub.3 alkyl, phenyl, substituted phenyl, heterocycle, or substituted heterocycle; R.sup.2 is hydrogen, C.sub.1-C.sub.3 alkyl, C.sub.3-C.sub.6 cycloalkyl-C.sub.1-C.sub.3 alkyl, or a group of formula II ##STR00002## R.sup.3 is hydrogen or C.sub.1-C.sub.3 alkyl; R.sup.4 is hydrogen, halo, or C.sub.1-C.sub.3 alkyl; R.sup.5 is hydrogen or C.sub.1-C.sub.3 alkyl; R.sup.6 is hydrogen or C.sub.1-C.sub.6 alkyl; and n is an integer from 1 to 6 inclusively. The compounds of the present invention are useful for activating 5-HT.sub.1F receptors, inhibiting neuronal protein extravasation, and for the treatment or prevention of migraine in a mammal. The present invention also relates to a process for the synthesis of intermediates in the synthesis of compounds of Formula I.
Inventor(s):	Cohen; Michael Philip (Indianapolis, IN), Kohlman; Daniel Timothy (Camby, IN), Liang; Sidney Xi (Bethany, CT), Mancuso; Vincent (Thy-le-Chateau, BE), Xu; Yao-Chang (Fishers, IN), Ying; Bai-Ping (Fishers, IN), Zacherl; DeAnna Piatt (Noblesville, IN), Zhang; Deyi (Carmel, IN), Victor; Frantz (Indianapolis, IN)
Assignee:	Eli Lilly and Company (Indianapolis, IN)
Application Number:	10/509,770
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound;

United States Patent 7,423,050: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 7,423,050, issued on September 9, 2008, is a significant patent in the field of pharmaceuticals, particularly for the treatment of migraine headaches. This patent is associated with the development of specific compounds and their use in therapeutic applications.

Inventors and Assignees

The patent was invented by a team of researchers and assigned to CoLucid Pharmaceuticals, Inc., a company focused on developing treatments for neurological disorders[2].

Patent Scope

Claims Overview

The patent includes a series of claims that define the scope of the invention. These claims typically cover the chemical composition, methods of preparation, and therapeutic uses of the compounds described.

Independent Claims

Independent claims are crucial as they define the broadest scope of the invention. For Patent 7,423,050, these claims likely revolve around the specific chemical structures of the compounds, such as their affinity for serotonin receptors (5-HT1B and 5-HT1D), which are key in treating migraine headaches[5].

Dependent Claims

Dependent claims further narrow down the scope by specifying particular aspects of the independent claims, such as specific dosages, formulations, or methods of administration.

Chemical Composition

The patent focuses on compounds that have high affinity for the 5-HT1B and 5-HT1D receptors. For example, sumatriptan, a well-known migraine treatment, has a high affinity for these receptors, with Ki values of 10.3 nM and 5.1 nM, respectively[5].

Therapeutic Uses

The primary therapeutic use of the compounds described in this patent is the treatment and prevention of migraine headaches. The patent highlights the efficacy of these compounds in targeting specific serotonin receptors, which are implicated in the pathophysiology of migraines.

Patent Exclusivity and Expiration

Patent Expiration Date

The patent is set to expire on February 17, 2028. This expiration date is significant as it marks the end of the exclusive rights granted to the patent holder to manufacture, use, and sell the invention[2].

Exclusivity Periods

In addition to the patent term, the FDA may grant exclusivity periods that can run concurrently with the patent term. However, for this specific patent, the focus is primarily on the patent term rather than any additional exclusivity periods.

Maintenance Fees

To keep the patent in force, the patent holder must pay maintenance fees at specific intervals (3.5, 7.5, and 11.5 years after the grant date). Failure to pay these fees can result in the patent expiring prematurely[4].

Related Patents and Continuations

The patent landscape around migraine treatments is complex, with multiple patents and continuations. For example, other patents like US 11,053,214 and US 12,071,423 also relate to similar compounds and therapeutic uses, indicating a continuous effort in improving migraine treatments[2].

Impact on Innovation

The scope and claims of this patent influence the innovation landscape in several ways:

• Narrowing Claims: The examination process often narrows the scope of patent claims, ensuring that the granted patents are more specific and less likely to be overly broad, which can reduce litigation costs and encourage further innovation[3].
• Forward Citations: Patents with narrower claims tend to receive more forward citations, indicating their influence on subsequent research and development[3].

Industry Implications

The expiration of this patent in 2028 will have significant implications for the pharmaceutical industry:

• Generic Competition: Once the patent expires, generic versions of the drug can be developed, potentially increasing competition and reducing costs for consumers.
• Research and Development: The expiration can also spur further research into new and improved treatments for migraines, as companies may no longer be constrained by the exclusive rights of the original patent holder.

Key Takeaways

• Patent Scope: The patent covers specific compounds with high affinity for 5-HT1B and 5-HT1D receptors.
• Therapeutic Use: Primarily for the treatment and prevention of migraine headaches.
• Expiration Date: February 17, 2028.
• Maintenance Fees: Crucial for maintaining the patent's validity.
• Industry Impact: Expiration will open the market to generic competition and potentially drive further innovation.

Frequently Asked Questions (FAQs)

What is the primary therapeutic use of the compounds described in US Patent 7,423,050?

The primary therapeutic use is the treatment and prevention of migraine headaches.

When is the patent set to expire?

The patent is set to expire on February 17, 2028.

What happens if the maintenance fees are not paid?

If the maintenance fees are not paid, the patent will expire prematurely at the end of the 4th, 8th, or 12th anniversary of the grant date.

How does the patent's scope influence innovation?

The patent's scope, particularly if narrowed during the examination process, can reduce litigation costs and encourage further innovation by providing clear boundaries for subsequent research and development.

What are the implications of the patent's expiration for the pharmaceutical industry?

The expiration will allow for the development of generic versions of the drug, increasing competition and potentially reducing costs for consumers, and may also spur further research into new and improved migraine treatments.

Cited Sources:

1. United States Patent and Trademark Office. US11053214.pdf.
2. Drugs.com. Generic Reyvow Availability.
3. SSRN. Patent Claims and Patent Scope.
4. USPTO. Patent and Trademark Office Notices.
5. United States Patent and Trademark Office. US7423050.pdf.

Drugs Protected by US Patent 7,423,050

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020		RX	Yes	No			Y	Y		ACUTE TREATMENT OF MIGRAINE
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-002	Jan 31, 2020		RX	Yes	Yes			Y	Y		ACUTE TREATMENT OF MIGRAINE
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-003	Dec 18, 2020		DISCN	Yes	No			Y	Y		ACUTE TREATMENT OF MIGRAINE

Foreign Priority and PCT Information for Patent: 7,423,050

PCT Information
PCT Filed	March 27, 2003	PCT Application Number:	PCT/US03/08455
PCT Publication Date:	October 16, 2003	PCT Publication Number:	WO03/084949

International Family Members for US Patent 7,423,050

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	039150
Austria	341543
Australia	2003224719
Brazil	0308495
Brazil	PI0308495
Canada	2478229