Details for Patent: 6,884,433

Summary for Patent: 6,884,433

Title:	Sustained release formulation containing tacrolimus
Abstract:	Sustained release formulation containing tacrolimus or its hydrate is provided. The time (T63.2%) required for 63.2% of the maximum amount of tacrolimus or its hydrate to be dissolved is 0.7 to 15 hours. The time is measured in accordance to the Japanes Pharmacopocia, the 13-th edition, Dissolution Test, No. 2 (Puddles method, 50 rpm) using an aqueous 0.005% hydroxypropyl cellulose solution. This aqueous test solution is adjusted to pH 4.5, accordingly. The formulation further comprises a solid base which is a water-soluble or water-insoluble polymer. The formulation is in the form of a powder, fine powder, granule, tablet or capsule. The formulation is administered to a patient once a day for preventing organ or tissue rejection by transplantation or autoimmune disease. In addition, a solid dispersion composition is provided. The solid dispersion comprises tacrolimus or its hydrate in a mixture containing water-soluble or water-insoluble polymer and an excipient.
Inventor(s):	Kazunari Yamashita, Eiji Hashimoto, Yukihiro Nomura, Fumio Shimojo, Shigeki Tamura, Takeo Hirose, Satoshi Ueda, Takashi Saitoh, Rinta Ibuki, Toshio Ideno
Assignee:	Astellas Pharma Inc
Application Number:	US10/412,281
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Analysis of Patent 6,884,433: Scope, Claims, and Patent Landscape

What Does Patent 6,884,433 Cover?

Patent 6,884,433 is titled "Nucleic Acid Molecules Encoding Human TNF Receptor and Methods of Use." Filed by Amgen Inc., it grants intellectual property rights for specific nucleic acid sequences coding for a human Tumor Necrosis Factor (TNF) receptor. The patent focuses on the DNA sequences, methods of production, and potential therapeutic applications.

Key Features:

• Primary Claim Scope: The core claim encompasses isolated nucleic acid molecules encoding human TNF receptor proteins, including cDNA sequences with specific nucleotide arrangements.
• Secondary Claims: Cover methods for recombinant production, pharmaceutical compositions containing TNF receptor nucleic acids, and host cells engineered to express the receptor.

How Broad Are the Patent Claims?

Claim Breadth Analysis:

Claim Type	Scope	Notable Limitations
Nucleic acid sequences	Specific human TNF receptor cDNA sequences	Limited to sequences with particular nucleotide compositions; does not explicitly cover all potential TNF receptor variants or mutants.
Methods of production	Recombinant DNA techniques for receptor expression	Restricted to methods involving known host cells and standard molecular biology techniques.
Pharmaceutical compositions	Formulations containing nucleic acids or encoded proteins	Includes compositions but omits detailed dosage, delivery, or formulation specifics.

Comparison: The claims are primarily centered on specific nucleotide sequences and recombinant processes. Broader claims covering the entire family of TNF receptor variants or related proteins are absent, focusing instead on the sequences explicitly described.

Examples of Claim Language:

• "An isolated nucleic acid molecule comprising the nucleotide sequence set forth in SEQ ID NO:1."
• "A method for producing a human TNF receptor protein by expressing a nucleic acid molecule as recited..."

Patent Landscape and Prior Art Considerations

Related Patents and Applications:

• Prior Art References: Patents and literature predate the 2003 filing date, including work on TNF receptor cloning, protein characterization, and therapeutic applications.
• Competitors' Portfolio: Several biotech entities, including Genentech and Pfizer, hold patents on TNF-related therapies, receptor mimetics, or antagonists.
• Patent Families: Amgen's patent is part of a broader suite covering cytokine biology, TNF receptor biology, and therapeutic antibodies.

Patent Family and Worldwide Filings:

Jurisdiction	Filing Date	Status	Notes
United States	2003-02-14	Issued (2005-03-08)	Main patent family, enforceable until 2023-02-14.
Europe (EP)	2003-02-14	Granted (EP 1420810)	Similar scope, enforceable until 2023-02-14.
Japan	2003-02-14	Allowed	Enforces until 2023-02-14.

Patent Term and Term Extensions:

The patent was granted in 2005, with a standard term extending to 2023, barring any extensions or adjustments, such as patent term extensions for regulatory delays.

Limitations and Challenges

• Scope of Claim Language: The claims are narrow, focusing on specific sequences rather than entire classes of TNF receptor molecules or broad therapeutic methods.
• Potential for Patentability Challenges: Prior art disclosing partial sequences or receptor functions may impact the enforceability of certain claims.
• Patent Exhaustion: As the scope is limited to particular nucleic acids, alternative sequences or variants described outside the patent are not covered.

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Key Takeaways

• Patent 6,884,433 covers specific human TNF receptor coding sequences and recombinant production methods.
• Its claims are narrow concerning sequences but cover recombinant methods and compositions.
• The patent's landscape includes numerous filings and patents related to cytokines, TNF biology, and receptor therapeutics.
• Limitations relate to claim scope, which impacts potential infringement and licensing strategies.
• The patent is set to expire in 2023, after which the claims become public domain.

FAQs

Q1: Does Patent 6,884,433 cover all TNF receptor variants?
No. It specifically claims particular nucleotide sequences. Variants outside these sequences are not covered.

Q2: Can a company develop a different TNF receptor molecule without infringing?
Yes. Using alternative sequences or methods not covered in the claims may avoid infringement.

Q3: Are methods for treating diseases with TNF receptors covered?
No. The patent primarily covers nucleic acid molecules and recombinant methods, not specific therapeutic methods.

Q4: How does this patent compare to newer TNF receptor patents?
It is narrower, focusing on specific sequences. Later patents may claim broader receptor variants, formulations, or methods.

Q5: What strategic considerations exist for licensing or designing around this patent?
Developing receptor variants with different sequences, using alternative production methods, or filing new patents on novel applications can circumvent the patent.

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References

1. Amgen Inc. (2005). U.S. Patent 6,884,433.
2. European Patent Office. (2005). EP 1420810.
3. Japan Patent Office. (2003). Allowance decisions.
4. World Intellectual Property Organization. (2003). International application WO 2003/025756.

Drugs Protected by US Patent 6,884,433

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

Foreign Priority and PCT Information for Patent: 6,884,433

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	10-79039	Mar 26, 1998
Japan	10-182963	Jun 29, 1998

International Family Members for US Patent 6,884,433

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	023299
Austria	269075
Austria	464900
Austria	514419
Australia	2856399