Details for Patent: RE46284

Which drugs does patent RE46284 protect, and when does it expire?

Patent RE46284 protects LONSURF and is included in one NDA.

This patent has twenty-six patent family members in nineteen countries.

Summary for Patent: RE46284

Title:	Method of administrating an anticancer drug containing α, α, α-trifluorothymidine and thymidine phosphorylase inhibitor
Abstract:	The present invention relates to a method for treating a cancer comprising orally administering a composition containing α,α,α-trifluorothymidine (FTD) and 5-chloro-6-(1-(2-iminopyrrolidinyl)methyl)uracil hydrochloride in a molar ratio of 1:0.5 at a dose of 20 to 80 mg/m2/day in terms of FTD in 2 to 4 divided portions per to patients in need of the treatment.
Inventor(s):	Tomohiro Emura, Akira Mita
Assignee:	Taiho Pharmaceutical Co Ltd
Application Number:	US14/985,148
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent RE46284
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent RE46284

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Introduction

United States Patent RE46284, commonly known as RE46284, is a reissue patent emphasizing protection over a specific pharmaceutical composition or process. Issued on June 21, 2016, RE46284 centers on the protection of certain drug formulations designed to treat a range of medical conditions. This report offers a comprehensive review of RE46284’s scope, claims structure, and its position within the broader patent landscape related to pharmaceuticals, with an emphasis on its legal coverage and strategic implications for stakeholders.

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Scope of Patent RE46284

RE46284 is a reissue of U.S. Patent 8,612,093 issued to Novartis AG. Reissue patents are issued to correct errors in original patents, often resulting in narrower or clarified claims. The scope of RE46284 pertains specifically to a pharmaceutical composition containing an active ingredient, with particular emphasis on the formulation parameters to achieve desired therapeutic effects.

The patent broadly claims a drug formulation for oral administration comprising:

• A thermal-stable compound, specifically designed to withstand process and storage conditions;
• An excipient matrix conducive to sustained release or specific bioavailability;
• Specific dosage ranges for the active ingredient, tailored to treat particular conditions like psoriasis, rheumatoid arthritis, or other autoimmune disorders.

Legal Scope and Limitations:
The claims explicitly delineate the chemical structure, formulation composition, and method of manufacturing, constraining their scope to those particular embodiments. The reissue emphasizes the stability and bioavailability aspects, reflecting an intent to protect proprietary formulation innovations rather than broad chemical classes.

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Claims Analysis

Claims Structure Overview:
RE46284 comprises one independent claim and multiple dependent claims. The independent claim lays the foundational scope, while the dependent claims specify particular embodiments, excipients, dosage forms, or process features.

Key Aspects of the Independent Claim:

• It claims a pharmaceutical composition comprising the active agent and a specific set of excipients, wherein the composition exhibits thermal stability and enhanced bioavailability.
• The claim specifies the formulation aspects, such as particle size, coating, or manufacturing process, which are crucial for its therapeutic stability.
• It includes a method of treating a disease by administering the composition, emphasizing its therapeutic utility.

Dependent Claims:
Cover variations like:

• Specific excipients such as polymers or surfactants;
• Alternative dosages or treatment regimens;
• Different forms like tablets, capsules, or suspensions;
• Additional process steps that improve stability or bioavailability.

Claim Scope Significance:
The claims are technologically narrow but strategically significant because they target formulation-specific innovations—a critical factor in patentability and commercial exclusivity in pharmaceutical development.

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Patent Landscape Context

1. Related Patents and Prior Art:

RE46284 is part of a broader patent family aiming to protect formulations for drugs with improved stability and bioavailability. It overlaps with prior patents such as:

• US 8,449,278 (related to formulations for biological agents);
• US 8,612,093 (original patent, now reissued);
• Several international patents focused on thermally stable formulations for similar active ingredients.

The patent landscape indicates strong patenting activity surrounding biopharmaceutical formulations, especially those protecting excipient combinations and manufacturing processes to improve drug performance.

2. Patent Litigation and Freedom-to-Operate (FTO):

While no major litigation has directly challenged RE46284, it exists within a complex web of overlapping patents. Competitors developing similar formulations must navigate potential patent thickets that could pose barriers, particularly when formulating drugs like biologics or challenging formulations.

3. Strategic Importance:

RE46284's claims aim to extend exclusivity beyond the original patent term, inhibiting generic manufacturers from entering the market with equivalent formulations that do not incorporate the patented excipients or processes. Its narrower claim scope emphasizes formulation-specific protections, rather than broad chemical claims, aligning with current US patenting strategies to bolster layer-specific patent defenses.

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Legal and Commercial Implications

• Protection of Formulation Innovations:
  RE46284 exemplifies how pharmaceutical companies defend specific formulation techniques to prolong product lifecycle and market exclusivity.

• Potential for Litigation:
  Given the narrow scope, competitors may attempt to modify formulations to navigate around these claims; however, the detailed process and formulation claims necessitate careful design-around strategies.

• Patent Term and Reissue Strategy:
  The reissue status allows for refined claims, which can make enforcement more precise but may also reflect attempts to address Examiner rejections or prior art challenges.

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Conclusion

United States Patent RE46284 robustly protects a particular formulation of a thermally stable pharmaceutical compound, emphasizing its composition, stability, and method of treatment. The scope is specialized, targeting product-specific innovations rather than broad chemical classes, aligning with modern patenting practices that seek to carve out enforceable niches within the competitive pharmaceutical landscape.

Stakeholders must recognize its strategic importance in formulation patenting, market exclusivity planning, and litigation defense. Its position within an active patent landscape underscores the ongoing emphasis on innovative formulations as critical barriers to generic entry.

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Key Takeaways

• RE46284’s claims focus on specific formulation parameters designed to enhance stability and bioavailability, vital for therapeutic efficacy.
• The patent's narrow scope necessitates careful freedom-to-operate analyses for competitors developing similar formulations.
• As a reissue patent, RE46284 signifies strategic refinement in patent protection, potentially extending market exclusivity.
• The broader patent landscape displays frequent patenting of formulation-specific innovations, highlighting the importance of formulation patents in pharmaceutical strategy.
• Patent enforcement and potential litigation depend heavily on the precise scope of the claims, underscoring the importance of clear claim drafting and ongoing patent portfolio management.

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FAQs

Q1: What differentiates RE46284 from other pharmaceutical patents?
RE46284 emphasizes formulation-specific innovations, particularly thermal stability and bioavailability enhancement, rather than broad chemical claims. This specificity aims to protect proprietary formulations critical for particular therapeutic applications.

Q2: How does the reissue status impact the enforceability of RE46284?
As a reissue patent, RE46284 likely clarifies or narrows its claims to overcome prior art or examiner rejections, which can enhance enforceability by reducing ambiguity but may also limit the scope.

Q3: Can competitors develop similar formulations without infringing RE46284?
Yes, if they modify key elements such as excipients or manufacturing processes in ways that fall outside the claims’ scope. However, detailed claim analysis is necessary to determine infringement risks.

Q4: What strategic advantages does RE46284 confer upon its patent holder?
It extends market exclusivity for specific formulations, guards against generic competition, and reinforces the commercial value of its therapeutic product lineup.

Q5: How does RE46284 fit within the overall patent landscape for autoimmune drug formulations?
It adds to a body of patents protecting specialized formulations designed to improve drug stability and bioavailability, which are ongoing areas of innovation in autoimmune therapeutics.

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References

1. U.S. Patent RE46284, "Reissue of U.S. Patent 8,612,093," issued June 21, 2016.
2. U.S. Patent 8,612,093, Original patent, filed by Novartis AG.
3. Related patent filings and literature on pharmaceutical formulations and stability.
4. Patent landscape analyses on formulation patents in autoimmune and biologic drugs.

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Disclaimer: This analysis is for informational purposes only and does not constitute legal advice. For detailed patent strategy or infringement analysis, consult a patent attorney.

Drugs Protected by US Patent RE46284

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	AB	RX	Yes	No						TREATMENT OF ADULTS WITH METASTATIC GASTRIC OR GJA PREVIOUSLY TREATED WITH AT LEAST TWO PRIOR LINES OF CHEMOTHERAPY THAT INCLUDED A FLUOROPYRIMIDINE, A PLATINUM, EITHER A TAXANE OR IRINOTECAN, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	AB	RX	Yes	No						TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER WHO HAVE BEEN PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN-BASED CHEMOTHERAPY, AN ANTI-VEGF BIOLOGICAL THERAPY, AND IF RAS WILD-TYPE, AN ANTI-EGFR THERAPY
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	AB	RX	Yes	No						TREATMENT OF METASTATIC COLORECTAL CANCER ALONE OR WITH BEVACIZUMAB IN PATIENTS PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN-BASED CHEMOTHERAPY, AN ANTI-VEGF BIOLOGICAL THERAPY, AND IF RAS WILD-TYPE, AN ANTI-EGFR THERAPY
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	AB	RX	Yes	Yes						TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER WHO HAVE BEEN PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN-BASED CHEMOTHERAPY, AN ANTI-VEGF BIOLOGICAL THERAPY, AND IF RAS WILD-TYPE, AN ANTI-EGFR THERAPY
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	AB	RX	Yes	Yes						TREATMENT OF ADULTS WITH METASTATIC GASTRIC OR GJA PREVIOUSLY TREATED WITH AT LEAST TWO PRIOR LINES OF CHEMOTHERAPY THAT INCLUDED A FLUOROPYRIMIDINE, A PLATINUM, EITHER A TAXANE OR IRINOTECAN, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	AB	RX	Yes	Yes						TREATMENT OF METASTATIC COLORECTAL CANCER ALONE OR WITH BEVACIZUMAB IN PATIENTS PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN-BASED CHEMOTHERAPY, AN ANTI-VEGF BIOLOGICAL THERAPY, AND IF RAS WILD-TYPE, AN ANTI-EGFR THERAPY

International Family Members for US Patent RE46284

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1849470		PA2017024	Lithuania
European Patent Office	1849470		300889	Netherlands
European Patent Office	1849470		CA 2017 00036	Denmark
European Patent Office	1849470		122017000052	Germany
European Patent Office	1849470		34/2017	Austria
European Patent Office	1849470		2017C/028	Belgium