Abstract: | The present invention is directed to a class of substituted 5-hydroxy-3,4,6,9,9a,10-hexahydro-2H-1-oxa-4a,8a-diaza-anthracene-6,10-di- ones useful as anti-HIV agents. The compounds have the formula: ##STR00001## Z.dbd.O; R.sup.20, R.sup.21, R.sup.22, R.sup.23, R.sup.24 and R.sup.25 independently are hydrogen, C.sub.1-C.sub.8 alkyl, (C.sub.6-C.sub.14)aryl-(C.sub.1-C.sub.8)alkyl, C.sub.6-C.sub.14 aryl, or alkoxy; the stereochemistry of an asymmetric carbon represented by * shows R- or S-configuration, or a mixture thereof; R.sup.X is hydrogen; R.sup.14 is hydrogen or optionally substituted lower alkyl; R.sup.3 is hydrogen; R.sup.1 is hydrogen or lower alkyl; R is halogen; and m is 1, 2 or 3; or a pharmaceutically acceptable salt thereof. |
Patent landscape, scope, and claims: |
United States Patent 8,129,385: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction to Patent 8,129,385
Patent 8,129,385 is a significant intellectual property asset that protects several pharmaceutical compounds used in the treatment of HIV. The patent was granted to Shionogi & Co., Ltd. and GlaxoSmithKline LLC on March 6, 2012, and it covers the inventions of Brian Alvin Johns, Takashi Kawasuji, Teruhiko Taishi, and Yoshiyuki Taoda [2].
Protected Drugs
The patent protects several drugs, including TIVICAY PD, TRIUMEQ PD, DOVATO, JULUCA, TIVICAY, and TRIUMEQ. These drugs are integral to the treatment of HIV and have been extended for pediatric studies with the PED designation [2].
Patent Family and International Coverage
Patent 8,129,385 has 125 patent family members across 33 countries. This extensive international coverage underscores the global significance of this patent in the pharmaceutical industry [2].
Inventors and Assignees
The inventors behind this patent are Brian Alvin Johns from Research Triangle Park, NC, and Takashi Kawasuji, Teruhiko Taishi, and Yoshiyuki Taoda from Osaka, Japan. The assignees include Shionogi & Co., Ltd. and GlaxoSmithKline LLC [1][2].
Patent Claims and Scope
The patent claims cover compound and composition aspects, specifically focusing on substituted 5-hydroxy-3,4,6,9-tetrahydro-2H-1-oxa-4a,8a-diazantracene-6,10-diones [1]. The scope of the patent is defined by its claims, which are crucial for determining the boundaries of the protected invention.
Patent Litigation and Infringement Cases
There have been notable patent infringement cases involving this patent. For instance, ViiV Healthcare Company and Shionogi & Co., Ltd. filed a lawsuit against Gilead Sciences, Inc., alleging that Gilead's HIV drug product Bictegravir infringed claims 2 and 6 of the '385 patent under the doctrine of equivalents [4][5]. This litigation highlights the competitive landscape in the pharmaceutical industry and the importance of patent protection.
Disclosure-Dedication Rule
The disclosure-dedication rule is significant in understanding the scope of this patent. This rule states that what is not claimed in a patent is dedicated to the public. Therefore, any subject matter disclosed in the written description but not claimed cannot be used as a basis for infringement [5]. This principle ensures that patentees do not extend their exclusive rights beyond what was examined by the PTO.
Patent Examination Process
The examination process for patents like 8,129,385 involves evaluating the scope of claims. Research has shown that narrower claims at publication are associated with a higher probability of grant and a shorter examination process than broader claims [3]. This indicates that the PTO tends to narrow the scope of patent claims during the examination process.
Key Takeaways
- Protected Drugs: TIVICAY PD, TRIUMEQ PD, DOVATO, JULUCA, TIVICAY, and TRIUMEQ.
- Inventors: Brian Alvin Johns (Research Triangle Park, NC), Takashi Kawasuji (Osaka, JP), Teruhiko Taishi (Osaka, JP), Yoshiyuki Taoda (Osaka, JP).
- Assignees: Shionogi & Co., Ltd. (Osaka, JP) and GlaxoSmithKline LLC (Philadelphia, PA).
- International Coverage: 125 patent family members across 33 countries.
- Patent Claims: Compound and composition aspects focusing on substituted 5-hydroxy-3,4,6,9-tetrahydro-2H-1-oxa-4a,8a-diazantracene-6,10-diones.
- Patent Litigation: Notable cases involving infringement under the doctrine of equivalents.
FAQs
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What drugs are protected by Patent 8,129,385?
- TIVICAY PD, TRIUMEQ PD, DOVATO, JULUCA, TIVICAY, and TRIUMEQ [2].
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Who are the inventors of this patent?
- Brian Alvin Johns (Research Triangle Park, NC), Takashi Kawasuji (Osaka, JP), Teruhiko Taishi (Osaka, JP), Yoshiyuki Taoda (Osaka, JP) [1][2].
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Who are the assignees of this patent?
- Shionogi & Co., Ltd. (Osaka, JP) and GlaxoSmithKline LLC (Philadelphia, PA) [1][2].
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What is the significance of the disclosure-dedication rule in this context?
- The disclosure-dedication rule ensures that what is not claimed in a patent is dedicated to the public, preventing patentees from extending their exclusive rights beyond what was examined by the PTO [5].
-
How does the patent examination process affect the scope of claims?
- Narrower claims at publication are associated with a higher probability of grant and a shorter examination process than broader claims [3].
Conclusion
Patent 8,129,385 is a critical intellectual property asset in the pharmaceutical industry, protecting several key drugs used in HIV treatment. The patent's extensive international coverage and significant litigation history underscore its importance. Understanding the scope and claims of this patent is essential for navigating the complex landscape of pharmaceutical patents and ensuring compliance with intellectual property laws.
Cited Information:
- Patent Images - United States Patent 8,129,385 [1].
- DrugPatentWatch - Information on drugs covered by patent 8,129,385 [2].
- Hoover Institution - Paper on patent claims and patent scope [3].
- District of Delaware - Case involving patent infringement of Bictegravir [4].
- District of Delaware - Memorandum opinion on patent infringement case [5].
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