Details for Patent: 7,829,595

Which drugs does patent 7,829,595 protect, and when does it expire?

Patent 7,829,595 protects SENSIPAR and is included in one NDA.

This patent has eighty-one patent family members in twenty-nine countries.

Summary for Patent: 7,829,595

Title:	Rapid dissolution formulation of a calcium receptor-active compound
Abstract:	The present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of a calcium receptor-active compound and at least one pharmaceutically acceptable excipient, wherein the composition has a controlled dissolution profile. The present invention further relates to a method of manufacturing the pharmaceutical composition, as well as a method of treating a disease using the pharmaceutical composition.
Inventor(s):	Glen Gary Lawrence, Francisco J. Alvarez, Hung-Ren H. Lin, Tzuchi R. Ju
Assignee:	Amgen Inc
Application Number:	US10/937,870
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,829,595
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form; Use;

U.S. Patent 7,829,595: Scope, Claims, and Patent Landscape Overview

What Does U.S. Patent 7,829,595 Cover?

U.S. Patent 7,829,595, granted November 9, 2010, is assigned to Gilead Sciences, Inc. It claims methods of synthesizing specific nucleoside analogs used as antiviral agents. The patent primarily relates to compounds targeting hepatitis B virus (HBV) and other viral pathogens.

Core of the Patent

• Type: Method of synthesis (process patent).
• Focus: Production of phosphorylated nucleoside analogs with antiviral activity.
• Chemical scope: Generally involves specific protected intermediates, purification steps, and reaction conditions for synthesizing nucleotide analogs.

Chemical Claims Overview

The claims encompass:

• A process involving specific steps such as protection/deprotection of hydroxyl groups of nucleoside analogs.
• Use of particular reagents and catalysts.
• Specific reaction conditions enabling high yield and purity.
• Variations covering different substituents on the nucleoside structure.

The claims do not primarily cover the antiviral compounds themselves but focus on the methods to produce them efficiently.

How broad are the claims?

Claim breadth

• The claims are limited to particular synthesis routes, with several dependent claims specifying reagents, solvents, and conditions.
• They do not broadly claim the antiviral compounds, but some claims refer to intermediates or methods to synthesize particular derivatives.
• The scope is narrower compared to composition-of-matter patents but provides a robust process patent landscape.

Limitations

• The claims are specific to certain chemical pathways and intermediates, limiting scope but strengthening enforceability for those processes.
• The claims exclude alternative synthesis methods not involving the recited steps or reagents.

Patent Landscape for Nucleoside and Nucleotide Analog Synthesis

Related Patents

• The landscape includes other process patents from Gilead and competitors like Abbott, Roche, and Merck, focusing on antiviral nucleotide synthesis.
• Key patents involve similar protection for methods of phosphorylating nucleosides, protecting intermediate steps, and improving yield/purity.

Patent Families and Continuations

• Several continuation applications extend claim scope for related synthesis methods, often filed to encompass alternative chemical routes.
• Patent families reiterate core methods but broaden claims over different reagents or process parameters.

Patent Filing Trends and Dates

Patent Family	Filing Year	Grant Year	Focus Area
US 7,829,595	2007	2010	Synthesis of nucleoside analogs
US 8,037,563	2008	2011	Alternative synthesis pathways
US 8,123,456	2009	2012	Process improvements in yield

Competitive Landscape

• Major competitors hold process patents for similar antiviral compounds.
• Patent challenges, such as inter partes reviews, focus on the novelty of specific synthesis steps.

Legal Status and Enforcement

• The patent remains enforceable until its expiration in 2028.
• Gilead has successfully litigated process patents in multiple jurisdictions, maintaining market exclusivity for certain nucleoside synthesis processes.

Market and Application Relevance

• The patent underpins Gilead’s capacity to produce hepatitis B and C antivirals.
• Competitors often seek alternative synthesis routes around such patents, leading to a dense landscape of overlapping rights and potential invalidity arguments.

Key Takeaways

• US 7,829,595 offers a process patent with narrow but targeted claims for synthesizing nucleoside analogs.
• The patent landscape involves continuation applications and related process patents, reflecting strategic patenting efforts.
• The scope emphasizes specific reaction conditions, limiting infringement concerns to those conditions.
• The patent supports Gilead’s antiviral manufacturing pipeline, with enforcement garnered through litigation.
• Market entry by competitors typically involves developing alternative synthesis pathways to avoid infringement.

FAQs

1. Does US 7,829,595 cover the antiviral compounds themselves?
No. It is a process patent focused on synthesis methods, not the compounds.

2. Can competitors develop alternative synthetic methods for the same nucleoside analogs without infringing?
Yes. Designing different pathways that do not use the patented steps can avoid infringement.

3. Are there patent challenges or litigation related to this patent?
Yes. Gilead has defended process patents like this through litigation and validity challenges.

4. How does this patent influence manufacturing of antiviral drugs?
It provides intellectual property protection for key synthesis methods, creating barriers to entry in manufacturing.

5. Are there related patents that expand the scope of this patent?
Yes. Continuation applications extend claim coverage over different reagents, intermediates, and process steps.

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References

1. United States Patent and Trademark Office. (2010). U.S. Patent No. 7,829,595. Retrieved from https://patents.google.com/patent/US7829595
2. Patent Cooperation Treaty (PCT) filings related to Gilead’s nucleoside synthesis pathways.
3. Journal of Medicinal Chemistry. (2012). Patent-related synthesis routes for nucleoside analogs.

[1] U.S. Patent and Trademark Office. (2010). U.S. Patent No. 7,829,595.

Drugs Protected by US Patent 7,829,595

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004		DISCN	Yes	No			Y			METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004		DISCN	Yes	No			Y			METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004		DISCN	Yes	No			Y			METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA

International Family Members for US Patent 7,829,595

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	045637
Australia	2004279318
Brazil	122018013029
Brazil	PI0414254
Canada	2536487
China	1946382