You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Details for Patent: 7,803,788


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 7,803,788
Title:Prodrugs of phosphonate nucoleotide analogues
Abstract: A novel method has led to the identification of novel mixed ester-amidates of PMPA for retroviral or hepadnaviral therapy, including compounds of structure (5a) ##STR00001## having substituent groups as defined herein. Compositions of these novel compounds in pharmaceutically acceptable excipients and their use in therapy and prophylaxis are provided.
Inventor(s): Becker; Mark W. (Redwood City, CA), Chapman; Harlan H. (La Honda, CA), Cihlar; Tomas (Foster City, CA), Eisenberg; Eugene J. (San Carlos, CA), He; Gong-Xin (Cupertino, CA), Kernan; Michael R. (Pacifica, CA), Lee; William A. (Los Altos, CA), Prisbe; Ernest J. (Los Altos, CA), Rohloff; John C. (Boulder, CO), Sparacino; Mark L. (Morgan Hill, CA)
Assignee: Gilead Sciences, Inc. (Foster City, CA)
Application Number:12/110,829
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,803,788
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 7,803,788

Introduction

United States Patent 7,803,788, hereafter referred to as the '788 Patent, is a crucial component of Gilead Sciences' intellectual property portfolio, particularly in the realm of pharmaceuticals. This patent, along with others, plays a significant role in protecting Gilead's innovative drugs, including those containing tenofovir alafenamide (TAF). Here, we delve into the details of the patent's scope, claims, and the broader patent landscape.

Background of the Patent

The '788 Patent is one of the prodrug patents asserted by Gilead Sciences in various legal proceedings. It is closely related to other patents such as U.S. Patent Nos. 7,390,791, 8,754,065, and 9,296,769, which collectively form a protective umbrella for Gilead's TAF-based products like VEMLIDY®, DESCOVY®, and ODEFSEY®[2].

Claim Construction

The claims of the '788 Patent are subject to specific constructions that define their scope and applicability. In a recent court ruling, the District of Delaware clarified the meanings of several disputed claim terms:

  • Diastereomerically Enriched: This term means "enriched relative to all other diastereomers" and applies to claims 1 through 7 of the '788 Patent[1].

This construction is critical because it specifies the purity and composition requirements for the compounds claimed in the patent, ensuring that any generic versions must meet these standards to avoid infringement.

Patent Scope and Claims

The '788 Patent, like other patents, is evaluated based on its claim language, which includes independent and dependent claims.

  • Independent Claims: These are the broadest claims in a patent and define the overall scope of the invention. The length and count of independent claims can be metrics for measuring patent scope. Research indicates that narrower claims, often resulting from the examination process, are associated with a higher probability of grant and a shorter examination process[3].

  • Dependent Claims: These claims build upon the independent claims and provide additional specificity. They often limit the scope of the independent claims by adding further requirements or features.

Prosecution History

The prosecution history of a patent, including any amendments, arguments, and communications with the patent office, can significantly influence the interpretation of its claims. For the '788 Patent, any changes or clarifications made during the prosecution process would be considered when determining the patent's scope and validity[1].

Relationship with Other Patents

The '788 Patent is part of a larger patent family that includes other patents like the '791, '065, and '769 Patents. These patents collectively protect various aspects of Gilead's TAF-based products, including the chemical composition, formulation, and methods of use. The interplay between these patents ensures comprehensive protection against generic competition[2].

Market Exclusivity and Generic Competition

The '788 Patent, along with other related patents, contributes to the market exclusivity of Gilead's products. The timing of generic entry into the market is influenced by the expiration dates of these patents and any associated exclusivities. A study by the USPTO and FDA highlights the complexity of calculating market exclusivity, which includes both patent protection and FD&C Act exclusivities[4].

Litigation and Enforcement

Gilead Sciences has been involved in several legal battles to enforce the '788 Patent and other related patents against generic manufacturers. These lawsuits aim to prevent the early market entry of generic versions of their products, ensuring that Gilead maintains its market share and revenue streams[2].

Impact on Innovation and Competition

The breadth and validity of patents like the '788 Patent can have significant implications for innovation and competition in the pharmaceutical industry. Broader patents can sometimes be criticized for stifling innovation by increasing licensing and litigation costs. However, they also provide the necessary protection for innovators to recoup their investment in research and development[3].

Key Takeaways

  • Specific Claim Construction: The '788 Patent's claims are subject to specific constructions that define their scope, particularly regarding terms like "diastereomerically enriched."
  • Patent Scope Metrics: The length and count of independent claims are important metrics for evaluating the scope of the patent.
  • Prosecution History: The patent's prosecution history is crucial for interpreting its claims and determining its validity.
  • Market Exclusivity: The patent contributes to the market exclusivity of Gilead's TAF-based products, affecting the timing of generic competition.
  • Litigation: Gilead has actively enforced the '788 Patent in legal proceedings to protect its market share.

FAQs

  1. What is the significance of the term "diastereomerically enriched" in the '788 Patent?

    • This term specifies that the compounds claimed in the patent must be enriched relative to all other diastereomers, ensuring a certain level of purity and composition[1].
  2. How does the '788 Patent relate to other Gilead patents?

    • The '788 Patent is part of a larger patent family that includes other patents like the '791, '065, and '769 Patents, collectively protecting various aspects of Gilead's TAF-based products[2].
  3. What impact does the '788 Patent have on generic competition?

    • The patent contributes to the market exclusivity of Gilead's products, delaying the entry of generic versions into the market until the patent expires or is successfully challenged[4].
  4. How is the scope of the '788 Patent measured?

    • The scope can be measured using metrics such as independent claim length and count, which are validated by their explanatory power for several correlates of patent scope[3].
  5. Why is the prosecution history of the '788 Patent important?

    • The prosecution history, including any amendments and communications with the patent office, is crucial for interpreting the claims and determining the patent's validity[1].

Sources

  1. District of Delaware Memorandum Order - Gilead Sciences, Inc. v. Apotex, Inc., et al., C.A. No. 20-189-MN[1].
  2. United States District Court for the District of Delaware - Gilead Sciences, Inc. v. Apotex, Inc., et al., C.A. No. 20-189 (MN)[2].
  3. SSRN Paper on Patent Scope - "Patent Claims and Patent Scope"[3].
  4. USPTO-FDA Report on Drug Patent and Exclusivity - "USPTO-FDA Report on Drug Patent and Exclusivity"[4].

More… ↓

⤷  Subscribe


Drugs Protected by US Patent 7,803,788

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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 7,803,788

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1301519 ⤷  Subscribe 2016/014 Ireland ⤷  Subscribe
European Patent Office 1301519 ⤷  Subscribe PA2016009 Lithuania ⤷  Subscribe
European Patent Office 1301519 ⤷  Subscribe 300803 Netherlands ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.