Details for Patent: 8,822,430

Which drugs does patent 8,822,430 protect, and when does it expire?

Patent 8,822,430 protects HARVONI and is included in two NDAs.

Protection for HARVONI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has one hundred and thirty-nine patent family members in thirty-nine countries.

Summary for Patent: 8,822,430

Title:	Antiviral compounds
Abstract:	The invention is related to anti-viral compounds, compositions containing such compounds, and therapeutic methods that include the administration of such compounds, as well as to processes and intermediates useful for preparing such compounds.
Inventor(s):	Bacon; Elizabeth M. (Burlingame, CA), Canales; Eda (San Mateo, CA), Cho; Aesop (Mountain View, CA), Cottell; Jeromy J. (Redwood City, CA), Desai; Manoj C. (Pleasant Hill, CA), Graupe; Michael (Pacifica, CA), Guo; Hongyan (San Mateo, CA), Halcomb; Randall L. (Foster City, CA), Kato; Darryl (San Francisco, CA), Kim; Choung U. (San Carlos, CA), Kirschberg; Thorsten A. (Redwood City, CA), Krygowski; Evan S. (Belmont, CA), Lazerwith; Scott E. (San Francisco, CA), Link; John O. (San Francisco, CA), Liu; Hongtao (Foster City, CA), Liu; Qi (Union City, CA), Mackman; Richard L. (Millbrae, CA), Mitchell; Michael L. (Heyward, CA), Parrish; Jay P. (Redwood City, CA), Pyun; Hyung-Jung (Fremont, CA), Saugier; Joseph H. (Livermore, CA), Schroeder; Scott D. (Foster City, CA), Sun; Jianyu (Surrey, CA), Taylor; James G. (San Mateo, CA), Trenkle; James D. (Oakland, CA), Tse; Winston C. (Redwood City, CA), Vivian; Randall W. (San Mateo, CA), Watkins; William J. (Saratoga, CA), Xu; Lianhong (Palo Alto, CA)
Assignee:	Gilead Pharmasset LLC (Foster City, CA)
Application Number:	13/956,195
Patent Claim Types: see list of patent claims	Compound; Composition; Use;

Understanding the Scope and Claims of United States Patent 8,822,430

Introduction

United States Patent 8,822,430, assigned to Gilead Pharmasset LLC, is a significant patent in the pharmaceutical industry, particularly for the drug HARVONI. This patent protects a combination therapy used for the treatment of hepatitis C. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.

Patent Overview

Patent Number and Assignee

• The patent number is 8,822,430, and it is assigned to Gilead Pharmasset LLC, based in Foster City, California[1].

Application and Filing Details

• The patent was filed under application number 13/956,195. It involves a team of inventors from various locations in California, including Redwood City, Fremont, Livermore, Foster City, San Mateo, Oakland, and Palo Alto[1].

Scope of the Patent

Protected Drug: HARVONI

• This patent specifically protects HARVONI, a drug combination of ledipasvir and sofosbuvir, used for the treatment of hepatitis C virus (HCV) infection. The protection includes the compound, composition, and use of this combination therapy[1].

International Protection

• The patent has a broad international reach, with 139 patent family members in 39 countries. This extensive coverage ensures global protection for the drug[1].

Claims of the Patent

Types of Claims

• The patent includes various types of claims such as compound claims, composition claims, and use claims. These claims define the scope of protection for the invention, ensuring that any similar or identical combinations of ledipasvir and sofosbuvir fall under the patent's purview[1].

Claim Language and Scope

• The claims are crafted to be specific yet broad enough to cover various aspects of the drug combination. For instance, the claims might include the specific chemical structures of the compounds, the method of preparing the composition, and the therapeutic uses of the drug[3].

Patent Expiration and Extensions

Original Expiration Date

• The original expiration date of the patent would typically be 20 years from the filing date of the application. However, patent expiration dates can be influenced by various factors such as extensions and supplementary protection certificates[1].

Pediatric Extension

• The patent has been extended by six months due to pediatric studies, as indicated by the PED designation. This extension is a common practice to incentivize pharmaceutical companies to conduct pediatric studies, which can provide valuable data on the safety and efficacy of drugs in children[1].

Supplementary Protection Certificates (SPCs)

European and Other Jurisdictions

• In addition to the U.S. patent, the invention is also protected by Supplementary Protection Certificates (SPCs) in various European countries. These SPCs extend the patent protection beyond the original expiration date, providing additional market exclusivity for the drug in these regions[1].

Patent Landscape and Global Dossier

Global Patent Family

• The patent is part of a large global patent family, with related applications filed in multiple countries. The Global Dossier service provided by the USPTO allows users to access the file histories of these related applications, including classification, citation data, and office actions[4].

Common Citation Document (CCD)

• The CCD application consolidates prior art cited by all participating IP offices for the family members of a patent application. This tool helps in visualizing the search results for the same invention produced by several offices on a single page, facilitating a more integrated global patent system[4].

Inventorship and Ownership

Inventors and Assignees

• The patent lists multiple inventors from Gilead Pharmasset LLC. Correctly identifying the true and only inventors is crucial under U.S. patent law to ensure the patent remains enforceable[2].

Legal and Policy Considerations

Patent Quality and Scope

• The debate over patent quality and scope is relevant here. Metrics such as independent claim length and count can measure patent scope, and narrower claims are often associated with a higher probability of grant and a shorter examination process[3].

Future Implications and Challenges

Litigation and Licensing

• Broad patents, including those with overly broad claims, can lead to increased licensing and litigation costs. This can diminish incentives for innovation. Therefore, the scope and claims of Patent 8,822,430 must be carefully managed to balance protection with the need for continued innovation in the pharmaceutical sector[3].

Key Takeaways

• Patent Protection: Patent 8,822,430 protects the drug HARVONI, a combination of ledipasvir and sofosbuvir, used for treating hepatitis C.
• International Coverage: The patent has extensive international coverage with 139 patent family members in 39 countries.
• Claims and Scope: The patent includes compound, composition, and use claims, ensuring broad protection for the drug combination.
• Expiration and Extensions: The patent has been extended by six months due to pediatric studies and may be further extended by SPCs in European jurisdictions.
• Global Dossier and CCD: Tools like Global Dossier and CCD facilitate the management and analysis of the global patent family.

FAQs

1. What drug does Patent 8,822,430 protect?

   • Patent 8,822,430 protects HARVONI, a combination therapy of ledipasvir and sofosbuvir used for treating hepatitis C[1].

2. Who is the assignee of Patent 8,822,430?

   • The assignee of Patent 8,822,430 is Gilead Pharmasset LLC[1].

3. How many patent family members does this patent have globally?

   • This patent has 139 patent family members in 39 countries[1].

4. What is the significance of the PED designation for this patent?

   • The PED designation indicates that the patent has been extended by six months due to pediatric studies[1].

5. How can one access the global patent family and related documents for this patent?

   • One can use the Global Dossier service and the Common Citation Document (CCD) application provided by the USPTO to access the file histories and citation data for the global patent family[4].

Sources

1. Drug Patent Watch - Patent 8,822,430
2. Oregon State University - Determining Inventorship for US Patent Applications
3. SSRN - Patent Claims and Patent Scope
4. USPTO - Search for patents
5. ACUS - U.S. Patent Small Claims Court

Drugs Protected by US Patent 8,822,430

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-001	Aug 28, 2019		RX	Yes	No					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-001	Oct 10, 2014		RX	Yes	Yes					Y

International Family Members for US Patent 8,822,430

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2430014		CA 2016 00006	Denmark
European Patent Office	2430014		PA2016002	Lithuania
European Patent Office	2430014		300796	Netherlands
European Patent Office	2430014		16C0005	France
European Patent Office	2430014		232 5001-2016	Slovakia