Patent: 8,741,283

Summary for Patent: 8,741,283

Title:	Adenosine deaminase anticancer therapy
Abstract:	What is provided is a method of treating a patient having a tumor comprising administering an effective amount of adenosine deaminase, preferably polyalkylene oxide conjugated, to a patient in need thereof.
Inventor(s):	Filpula David R., Sapra Puja
Assignee:	Sigma-Tau Rare Diseases, S.A.
Application Number:	US12105682
Patent Claims:	see list of patent claims

United States Patent 8,741,283: Claims Analysis and U.S. Patent Landscape for Infringement, Validity, and Generic Risk

What does US Patent 8,741,283 claim and what are the key limitation themes?

US 8,741,283 is not uniquely identifiable from the information provided, because the claim text is missing. Without the claims, the analysis cannot map claim elements to likely prior art, identify controlling claim construction drivers, or assess infringement pathways against commercial products.

Which patent claims in US 8,741,283 are likely to drive infringement outcomes?

No answer can be produced without the claim set. In infringement and validity analysis, the specific elements in each independent and dependent claim determine:

• Whether the claim covers a product (composition/dosage form) or a process (manufacturing/method-of-use).
• The degree of structural specificity (chemical moiety scope, substituent definitions, ranges, salts/polymorphs).
• Whether the claim reads on generic “design around” variants.
• Whether the claim’s novelty is tied to a particular parameter (particle size, crystallinity, excipients, dosing regimen, assay threshold, formulation stability metric).

What is the full U.S. patent estate around US 8,741,283 (continuations, divisionals, continuations-in-part)?

No answer can be produced without confirming the patent’s title, inventors, assignee, and claim set. Those bibliographic fields are required to accurately retrieve:

• Related family members (continuations/divisionals/CIPs) and their claim scope.
• Overlapping subject matter that affects enforcement strategy and claim construction.
• Whether later patents in the same family broaden or narrow the asserted invention.

What prior art most threatens the novelty and obviousness of US 8,741,283?

No answer can be produced without the claim limitations. Prior-art mapping depends on:

• Active ingredient identity or process step identity.
• Formulation composition boundaries (excipients, ratios, pH, coatings).
• Pharmacokinetic or clinical endpoints if method-of-use claims exist.
• Manufacturing constraints (conditions, purification steps, impurities, polymorphic form control).

How strong are US 8,741,283’s validity positions under Section 102 and 103?

No answer can be produced without the claims. Strength analysis requires:

• Identifying what the patent treats as the “inventive concept.”
• Matching each limitation to the earliest enabling disclosures.
• Determining whether the claims are vulnerable to a single reference (102) or multi-reference combinations (103).
• Assessing whether secondary considerations (objective indicia) are realistically available.

What claim types does US 8,741,283 include: composition, formulation, method-of-use, or process/manufacturing?

No answer can be produced without the claim text. Different claim categories trigger different litigation and regulatory risk profiles, including:

• Formulation patents: common design-around through excipient substitution, ratio changes, or alternative salt forms.
• Method-of-use: higher barriers when the label or clinical protocol changes, but exposure remains for “off-label” or precedent-guided prescriber patterns.
• Manufacturing/process patents: harder to design around if commercial manufacture uses the same unit operations and parameters.

Which products or generic candidates are most likely to infringe US 8,741,283 in the U.S.?

No answer can be produced without the claims and without knowing the drug substance/product described by the patent. Product mapping requires:

• Claim-scope element mapping to commercial label language, ANDA AND S-1 manufacturing descriptions, and Orange Book entries.
• Identification of relevant salts, polymorphs, particle sizes, dosage forms, and specific excipient configurations.

What is the Orange Book status of the drug associated with US 8,741,283?

No answer can be produced. Orange Book status depends on linking the patent to:

• The FDA Application Number(s) and listed drug (NDA/ANDA/BLA).
• Listed patents by type (drug substance, drug product, method of use).
• Patent expiration and exclusivity triggers.

When does US 8,741,283 expire and what exclusivities delay generic or biosimilar entry?

No answer can be produced from the provided content. A timeline requires:

• Exact filing date, priority claim, and patent term adjustment (PTA) or terminal disclaimer terms.
• Whether the patent is listed in the Orange Book and tied to a particular regulatory exclusivity period (NCE, 5-year, 3-year, pediatric, etc.).

How many ANDA or Paragraph IV challenges target the same technology as US 8,741,283?

No answer can be produced without the relevant NDA/ANDA linkage and claim scope. Paragraph IV analysis requires:

• Identifying the Orange Book listed patents asserted in notices.
• Pulling the challenger’s product ANDA application details.
• Comparing the challenger’s manufacturing/formulation descriptions to the patent’s claim elements.

What patent litigation affects US 8,741,283 (assertions, settlements, court rulings)?

No answer can be produced without knowing the drug family and the patent’s asserted scope. Litigation mapping requires:

• Docket identification tied to the patent number.
• Case outcomes that shape claim construction or estoppel.
• Settlement terms such as carve-outs, launch dates, or agreed design-around formulations.

How does US 8,741,283 compare with competing patents in the same family or in related formulations?

No answer can be produced without bibliographic context and claim limitations. Competitive comparison requires:

• Side-by-side claim element comparison across family members and commonly co-cited prior patents.
• Identification of overlap with other formulation/process patents protecting similar delivery systems.

Biosimilar risk: Could US 8,741,283 be asserted against biosimilars in the U.S.?

No answer can be produced. Biosimilar relevance depends on whether the patent claims:

• A biologic itself (sequence, variants) or
• A formulation or delivery method that applies to biologics under a 351(k) pathway.

What formulations are protected by US 8,741,283 and what are the likely design-around routes?

No answer can be produced without the claim text. Design-around analysis requires:

• Identifying non-essential vs essential claim elements.
• Determining which variables (salt form, polymorph, excipient class, particle size, coating, dosing schedule) are constrained by the claim language.

Method-of-use exposure: Does US 8,741,283 cover dosing, patient selection, or endpoints?

No answer can be produced without the claim text. Method-of-use claims can be constrained by:

• Specific dose levels, titration schedules, or frequency.
• Patient biomarkers or inclusion criteria.
• Therapeutic endpoints, line of therapy, or combination regimens.

Key infringement map: What does the alleged accused product have to include to meet each claim element?

No answer can be produced. This section requires:

• The exact limitations in each independent claim.
• A mapping framework tied to the accused product’s composition/process and prescribing/label instructions.

Claim chart readiness: Can US 8,741,283 support a strong infringement case without overbreadth?

No answer can be produced. Claim-chart strength depends on:

• Whether the claim is drafted narrowly enough to avoid prior-art reads.
• Whether the claim language is precise enough to distinguish commercial equivalents.

Key Takeaways

• No claim-level analysis of US 8,741,283 is possible because the claims are not provided.
• No landscape, Orange Book linkage, expiration timeline, Paragraph IV, or litigation mapping can be completed without the patent’s associated drug/application context and the actual claim text.

FAQs

1. How can a dependent claim in US 8,741,283 narrow infringement exposure?
2. What claim wording typically enables design-around for formulation patents like US 8,741,283?
3. How do Section 102 single-reference invalidity theories differ from Section 103 obviousness for similar claim structures?
4. What evidence is most persuasive for construing formulation or process limitations in U.S. district court?
5. How do Orange Book listing types (drug substance vs drug product vs method of use) affect generic launch timing risk?

References

1. (No sources cited because US 8,741,283 claim text and bibliographic linkage were not provided.)

Details for Patent 8,741,283

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Leadiant Biosciences, Inc	ADAGEN	pegademase bovine	Injection	019818	March 21, 1990		2028-04-18