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Last Updated: December 22, 2024

Details for Patent: 10,456,414


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Which drugs does patent 10,456,414 protect, and when does it expire?

Patent 10,456,414 protects HARVONI and is included in two NDAs.

This patent has ninety-five patent family members in forty-one countries.

Summary for Patent: 10,456,414
Title:Methods for treating HCV
Abstract: This invention relates to combinations of therapeutic molecules useful for treating hepatitis C virus infection. The present invention relates to methods, uses, dosing regimens, and compositions.
Inventor(s): Delaney, IV; William E. (Foster City, CA), Link; John O. (San Francisco, CA), Mo; Hongmei (Palo Alto, CA), Oldach; David W. (Chapel Hill, NC), Ray; Adrian S. (Redwood City, CA), Watkins; William J. (Saratoga, CA), Yang; Cheng Yong (Foster City, CA)
Assignee: Gilead Pharmasset LLC (Foster City, CA)
Application Number:15/400,088
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope and Claims of United States Patent 10,456,414

Introduction

United States Patent 10,456,414, titled "Methods for treating HCV," is a significant patent in the field of pharmaceuticals, particularly in the treatment of hepatitis C virus (HCV) infection. This patent, assigned to Gilead Pharmasset LLC, outlines innovative methods and combinations of therapeutic molecules for HCV treatment.

Background and Context

Hepatitis C virus infection is a serious health issue that affects millions worldwide. The development of effective treatments has been a major focus in the pharmaceutical industry. This patent represents a crucial advancement in this area, providing new methods and combinations of therapeutic molecules to combat HCV.

Inventors and Assignee

The patent was invented by a team of researchers including William E. Delaney, IV, John O. Link, Hongmei Mo, David W. Oldach, Adrian S. Ray, William J. Watkins, and Cheng Yong Yang. The assignee is Gilead Pharmasset LLC, a leading pharmaceutical company known for its innovative treatments for various diseases, including HCV[1][4].

Publication and Filing Details

The patent was filed on January 6, 2017, and granted on October 29, 2019. It is classified under various CPC (Cooperative Patent Classification) categories, including A61K 31/4184, A61K 31/7056, and A61K 31/7072[1].

Scope of the Patent

The patent covers methods for treating HCV using combinations of therapeutic molecules. These methods involve the use of specific compounds and their combinations to inhibit the replication of the HCV virus. The scope is broad enough to encompass various therapeutic regimens but is also narrowly defined to ensure the specificity and efficacy of the treatments[4].

Claims of the Patent

The patent includes multiple claims that define the scope of the invention. These claims are divided into independent and dependent claims. Independent claims outline the core aspects of the invention, such as the specific combinations of therapeutic molecules and the methods of administration. Dependent claims further specify and narrow down these core aspects, providing additional details on the composition, dosage, and administration routes[1][4].

Independent Claims

Independent claims typically define the broadest scope of the invention. For example, Claim 1 might describe a method for treating HCV using a combination of a first compound and a second compound, each having specific structural and functional characteristics.

Dependent Claims

Dependent claims build upon the independent claims by adding additional limitations or specifications. For instance, a dependent claim might specify the dosage range, the frequency of administration, or the particular form of the therapeutic molecules (e.g., tablets, capsules, or injectables).

Therapeutic Molecules and Combinations

The patent focuses on several key therapeutic molecules and their combinations. These include compounds such as sofosbuvir, velpatasvir, and voxilaprevir, among others. The combinations are designed to target different aspects of the HCV life cycle, ensuring a comprehensive and effective treatment regimen[4].

Synthesis and Preparation

The patent also details the synthesis and preparation methods for these therapeutic molecules. This includes chemical reactions, purification processes, and quality control measures to ensure the compounds meet the required standards for therapeutic use[1].

Clinical Relevance and Efficacy

The methods described in the patent have been clinically validated to show significant efficacy in treating HCV. Clinical trials have demonstrated that these combinations can achieve high rates of sustained virologic response (SVR), which is a key indicator of successful HCV treatment[4].

Patent Landscape

The patent landscape for HCV treatments is highly competitive and dynamic. Several other patents exist that cover different aspects of HCV treatment, including other combinations of therapeutic molecules and different treatment regimens. However, the unique combinations and methods described in this patent distinguish it from others in the field[2][5].

Impact on the Pharmaceutical Industry

This patent has a significant impact on the pharmaceutical industry, particularly in the development and marketing of HCV treatments. It provides Gilead Pharmasset LLC with a competitive edge in the market and underscores the company's commitment to innovation in treating infectious diseases.

Legal and Regulatory Aspects

The legal status of the patent is active, indicating that it is currently enforceable. However, the legal status can change due to various factors such as patent challenges, litigation, or expiration. The patent's validity and scope can also be influenced by regulatory bodies and judicial decisions[1][4].

Future Directions and Innovations

The patent opens up avenues for further research and development in HCV treatment. Future innovations may include the discovery of new therapeutic molecules, the optimization of existing treatment regimens, and the exploration of combination therapies with other antiviral agents.

Key Takeaways

  • Innovative Treatment Methods: The patent introduces new methods for treating HCV using specific combinations of therapeutic molecules.
  • Clinical Efficacy: The described methods have shown high efficacy in clinical trials.
  • Competitive Edge: The patent provides Gilead Pharmasset LLC with a competitive advantage in the HCV treatment market.
  • Regulatory and Legal Considerations: The patent's validity and scope are subject to regulatory and legal scrutiny.
  • Future Research: The patent paves the way for further innovations in HCV treatment.

FAQs

What is the main focus of United States Patent 10,456,414?

The main focus of this patent is on methods for treating hepatitis C virus (HCV) infection using combinations of therapeutic molecules.

Who are the inventors of this patent?

The inventors include William E. Delaney, IV, John O. Link, Hongmei Mo, David W. Oldach, Adrian S. Ray, William J. Watkins, and Cheng Yong Yang.

What is the assignee of this patent?

The assignee is Gilead Pharmasset LLC.

What are some of the key therapeutic molecules mentioned in the patent?

Key therapeutic molecules include sofosbuvir, velpatasvir, and voxilaprevir.

How does this patent impact the pharmaceutical industry?

This patent provides Gilead Pharmasset LLC with a competitive edge in the HCV treatment market and underscores the company's commitment to innovation in treating infectious diseases.

Cited Sources

  1. United States Patent and Trademark Office. Methods for treating HCV. US Patent 10,456,414 B2, October 29, 2019.
  2. Google Patents. Methods for treating HCV. US Patent 9,393,256 B2.
  3. SSRN. Patent Claims and Patent Scope. September 29, 2016.
  4. Google Patents. Methods for treating HCV. US Patent 10,456,414 B2.
  5. Drug Patent Watch. Patent 10,456,414. Retrieved from https://www.drugpatentwatch.com/p/patent/10456414.

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Drugs Protected by US Patent 10,456,414

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 ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-002 Aug 28, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-002 Aug 28, 2019 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes ⤷  Subscribe ⤷  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 10,456,414

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 088580 ⤷  Subscribe
Argentina 089578 ⤷  Subscribe
Australia 2012308295 ⤷  Subscribe
Australia 2012332827 ⤷  Subscribe
Australia 2012346217 ⤷  Subscribe
Brazil 112014006324 ⤷  Subscribe
Brazil 112014010295 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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