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Last Updated: December 27, 2024

Details for Patent: 8,580,765


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Which drugs does patent 8,580,765 protect, and when does it expire?

Patent 8,580,765 protects EPCLUSA, HARVONI, SOVALDI, and VOSEVI, and is included in seven NDAs.

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

This patent has eighty-six patent family members in thirty-five countries.

Summary for Patent: 8,580,765
Title:Nucleoside phosphoramidate prodrugs
Abstract: Disclosed herein are phosphoramidate prodrugs of nucleoside derivatives for the treatment of viral infections in mammals, which is a compound, its stereoisomer, salt (acid or basic addition salt), hydrate, solvate, or crystalline form thereof, represented by the following structure: ##STR00001## Also disclosed are methods of treatment, uses, and processes for preparing each of which utilize the compound represented by formula I.
Inventor(s): Sofia; Michael Joseph (Doylestown, PA), Du; Jinfa (New Hope, PA), Wang; Peiyuan (Totowa, NJ), Nagarathnam; Dhanapalan (Bethany, CT)
Assignee: Gilead Pharmasset LLC (Foster City, CA)
Application Number:13/609,614
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,580,765
Patent Claim Types:
see list of patent claims
Compound; Composition; Use; Process;
Patent landscape, scope, and claims:

United States Patent 8,580,765: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,580,765, owned by Gilead Pharmasset LLC, is a significant patent in the pharmaceutical industry, particularly in the treatment of Hepatitis C Virus (HCV). This patent is part of a broader landscape of intellectual property related to HCV treatments, and its scope and claims are crucial for understanding its impact and validity.

Background

The patent in question, US 8,580,765, is one of several patents held by Gilead related to the treatment of HCV. This specific patent covers methods and compositions involving the compound GS-5885, which is a key component in the combination therapy for HCV[2].

Patent Scope

Claim Language and Metrics

The scope of a patent is often measured by the language and structure of its claims. Research suggests that metrics such as independent claim length and independent claim count can be used to assess patent scope. Narrower claims, as indicated by shorter independent claim lengths and fewer independent claims, are generally associated with a higher probability of grant and a shorter examination process[3].

Specific Claims of US 8,580,765

The patent claims of US 8,580,765 are specific to the compound GS-5885 and its use in treating HCV. These claims include:

  • The chemical structure and synthesis of GS-5885.
  • Methods of administering GS-5885 alone or in combination with other compounds for treating HCV.
  • Pharmaceutical compositions containing GS-5885.

These claims are designed to protect the innovative aspects of Gilead's HCV treatment, ensuring that the company maintains exclusivity over the use and manufacture of GS-5885[2].

Patent Claims and Examination Process

Narrowing of Claims

During the patent examination process, claims are often narrowed to ensure clarity and validity. Studies have shown that the examination process tends to reduce the scope of patent claims, making them more specific and less broad. This narrowing process is more pronounced when the examination duration is longer[3].

Examination History of US 8,580,765

The examination history of US 8,580,765 would likely involve a thorough review of prior art and the narrowing of claims to ensure that the patent does not overly broaden the scope of protection. This process would have been crucial in establishing the validity and enforceability of the patent.

Patent Landscape and Competitors

Global Patent System

The patent landscape for HCV treatments is complex and global. Patents like US 8,580,765 are part of a larger network of intellectual property that spans multiple countries. Tools like the Global Dossier and the Common Citation Document (CCD) facilitate the search and analysis of related patent applications across different intellectual property offices[1].

Competitor Actions and Litigation

The patent landscape is also marked by competitive and sometimes litigious interactions between pharmaceutical companies. For example, Gilead faced a significant challenge from AbbVie, which attempted to patent methods of treating HCV using compounds that Gilead had already developed. This led to a lawsuit where Gilead alleged that AbbVie's actions were fraudulent and intended to eliminate competition[2].

Litigation and Validity Challenges

Gilead vs. AbbVie

The litigation between Gilead and AbbVie highlights the importance of patent validity and the potential for fraudulent activities in the patent system. Gilead argued that AbbVie's patents were based on Gilead's prior pending patent applications and that AbbVie failed to inform the USPTO of this prior art. This case underscores the need for strict adherence to patent laws and the consequences of violating them[2].

Expiration and Exclusivity

Patent Expiration Dates

The patent US 8,580,765 has specific expiration dates that mark the end of Gilead's exclusivity period. After the patent expires, the technology and methods described in the patent become public domain, allowing other companies to manufacture and use the patented inventions without infringing on Gilead's rights[5].

Impact on Innovation and Market

Licensing and Litigation Costs

The breadth and validity of patents like US 8,580,765 can significantly impact innovation and market dynamics. Overly broad patents can increase licensing and litigation costs, potentially diminishing incentives for further innovation. However, well-defined and valid patents like US 8,580,765 can protect genuine innovations and encourage further research and development[3].

Conclusion

United States Patent 8,580,765 is a critical component of Gilead's intellectual property portfolio related to HCV treatments. The scope and claims of this patent are carefully defined to protect Gilead's innovations, and the patent has been subject to significant scrutiny and litigation. Understanding the patent landscape, the examination process, and the competitive environment is essential for navigating the complex world of pharmaceutical patents.

Key Takeaways

  • Patent Scope and Claims: The patent's scope is defined by specific claims related to GS-5885 and its use in HCV treatment.
  • Examination Process: The patent examination process likely involved narrowing the claims to ensure validity.
  • Global Patent Landscape: The patent is part of a global network of intellectual property related to HCV treatments.
  • Litigation and Validity: The patent was subject to litigation with AbbVie, highlighting the importance of patent validity.
  • Expiration and Exclusivity: The patent has specific expiration dates marking the end of Gilead's exclusivity period.

FAQs

What is the main subject of United States Patent 8,580,765?

The main subject of US 8,580,765 is the compound GS-5885 and its use in treating Hepatitis C Virus (HCV).

How does the patent examination process affect the scope of patent claims?

The examination process tends to narrow the scope of patent claims, making them more specific and less broad, especially when the examination duration is longer.

What was the nature of the litigation between Gilead and AbbVie regarding US 8,580,765?

Gilead alleged that AbbVie's patents were based on Gilead's prior pending patent applications and that AbbVie failed to inform the USPTO of this prior art, which Gilead claimed was fraudulent.

How does the expiration of US 8,580,765 affect Gilead's exclusivity?

After the patent expires, the technology and methods described in the patent become public domain, allowing other companies to manufacture and use the patented inventions without infringing on Gilead's rights.

What tools are available for searching and analyzing related patent applications globally?

Tools like the Global Dossier and the Common Citation Document (CCD) facilitate the search and analysis of related patent applications across different intellectual property offices.

Sources

  1. USPTO: Search for patents - USPTO.
  2. KEI Online: Gilead in 2013: AbbVie sought to eliminate competition and ...
  3. SSRN: Patent Claims and Patent Scope.
  4. Michigan Manufacturers Association: INDUSTRY5.0 - Michigan Manufacturers Association.
  5. PharmaCompass: US Patent 8580765 | Expiration | Dates - PharmaCompass.com.

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Drugs Protected by US Patent 8,580,765

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 EPCLUSA sofosbuvir; velpatasvir PELLETS;ORAL 214187-001 Jun 10, 2021 RX Yes No 8,580,765*PED ⤷  Subscribe Y ⤷  Subscribe
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir PELLETS;ORAL 214187-002 Jun 10, 2021 RX Yes Yes 8,580,765*PED ⤷  Subscribe Y ⤷  Subscribe
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-001 Aug 28, 2019 RX Yes No 8,580,765*PED ⤷  Subscribe Y ⤷  Subscribe
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-002 Aug 28, 2019 RX Yes Yes 8,580,765*PED ⤷  Subscribe Y ⤷  Subscribe
Gilead Sciences Inc SOVALDI sofosbuvir PELLETS;ORAL 212480-001 Aug 28, 2019 RX Yes No 8,580,765*PED ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,580,765

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2203462 ⤷  Subscribe 214 5029-2014 Slovakia ⤷  Subscribe
European Patent Office 2203462 ⤷  Subscribe C300704 Netherlands ⤷  Subscribe
European Patent Office 2203462 ⤷  Subscribe PA2014040 Lithuania ⤷  Subscribe
European Patent Office 2203462 ⤷  Subscribe CA 2014 00061 Denmark ⤷  Subscribe
European Patent Office 2203462 ⤷  Subscribe 1490066-6 Sweden ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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