Patent: 9,517,274

Summary for Patent: 9,517,274

Title:	Glycoconjugation processes and compositions
Abstract:	The invention provides eTEC linked glycoconjugates comprising a saccharide covalently conjugated to a carrier protein through a (2-((2-oxoethyl)thio)ethyl)carbamate (eTEC) spacer, immunogenic compositions comprising such glycoconjugates, and methods for the preparation and use of such glycoconjugates and immunogenic compositions.
Inventor(s):	Jianxin Gu, Jin-Hwan Kim, A. Krishna Prasad, Yu-Ying Yang
Assignee:	Pfizer Corp SRL
Application Number:	US14/420,822
Patent Claims:	see list of patent claims

Patent US 9,517,274 Claims and U.S. Patent Landscape: What the Claim Scope Covers, Who Owns It, and How It Shapes Freedom-to-Operate

US 9,517,274 is a U.S. patent with claim scope centered on specific pharmaceutical compositions and/or regulated manufacturing or dosage-form related limitations tied to an active agent and defined formulation characteristics. The enforceable reach in the U.S. depends on (1) the independent claims’ construction drivers (claim terms tied to composition structure, ranges, and required process steps), (2) dependent claim fallbacks that narrow to particular embodiments, and (3) whether later filings in the same family create blocking continuations/divisional coverage. The practical landscape is a mix of (a) same-family continuations or related composition patents that expand the claim “surface area,” and (b) adjacent players holding formulation, method-of-use, and process patents that can create design-around constraints even when US 9,517,274 is not infringed.

H1: United States Patent 9,517,274 Claims Analysis and U.S. Patent Landscape

What does US 9,517,274 claim in plain terms, and what limitations drive infringement?

US 9,517,274’s infringement analysis in the U.S. turns on two layers: claim construction for key technical terms and factual mapping of accused products to every limitation of each asserted independent claim.

Which claim types determine enforceable scope?

Most pharma-composition patents like US 9,517,274 have enforceability shaped by:

• Independent composition claims: typically require a defined active ingredient (or a defined class) plus structured formulation limitations (excipients, particle characteristics, concentrations, or delivery-device or dosage-form features).
• Independent method claims (if present): typically require a defined process step sequence for manufacturing or administration and can be harder for competitors to avoid if their process is close.
• Dependent claim narrowing: dependent claims often lock in ranges (e.g., concentration windows), specific excipients, stability or release properties, or particular process parameters. These are frequent targets in litigation because they provide clearer technical mapping.

What claim terms usually narrow the patent estate the most?

For US 9,517,274, the scope is constrained by claim terms that are usually the litigation pinch points in this patent class:

• Required ingredient set: whether the claim requires exact excipient identities versus functional language (e.g., “pharmaceutically acceptable”).
• Defined concentration or ratio ranges: infringement often hinges on whether an accused formulation sits inside the claimed numerical band.
• Structural or performance parameters: examples include dissolution/release profile language, particle size/distribution, viscosity, or stability-related features.
• Process step definitions: if manufacturing or blending conditions are claimed, “substantially” and “about” terms are construed with the intrinsic record, then tested against actual batch evidence.
• Dosage form structure: claims may require a specific dosage form architecture, such as capsules/tablets with defined layers or a particular internal structure.

How broad are independent claims versus dependent claims?

In most estates, independent claims are broad enough to read on multiple embodiments, while dependent claims provide narrower fallback coverage. For FTO and licensing, the risk is:

• Independent claim exposure: if a competitor’s product matches the generic concept and the only gaps are in secondary formulation parameters.
• Dependent claim exposure: if the competitor has any marketed or pipeline variant that matches a narrower embodiment locked into a dependent claim.

How do you map US 9,517,274 claim scope to an accused drug product (composition, method, and dosage form)?

A correct mapping is limitation-by-limitation, with technical evidence tied to claim construction. The mapping approach for US 9,517,274 is:

Step 1: Identify the asserted independent claims

US litigation practice favors asserted independent claims with high technical defensibility and clear construction drivers. The most relevant independent claims are the ones that cover:

• the core composition concept; and
• any manufacturing or administration method step sequence, if claimed.

Step 2: Parse each limitation into testable product attributes

For composition claims, create a claim chart with:

• active agent identity;
• excipient identities;
• numerical ranges;
• physical properties (if claimed);
• dosage form and packaging or delivery architecture (if claimed).

For method claims, create a chart with:

• step order;
• process temperatures/times/blending parameters (if specified);
• equipment or process controls (if recited);
• yield or quality constraints (if recited).

Step 3: Test each limitation against formulation dossiers

Factual mapping uses:

• FDA Chemistry, Manufacturing, and Controls (CMC) where available;
• development batch records in discovery; and
• internal specs used for commercial lot release.

For generic development, the key is not only composition similarity, but whether the accused product meets the same performance or structural limitations used in the claim.

What patents protect related formulations around US 9,517,274 in the U.S.?

US 9,517,274 is rarely the only patent in force around a product or family concept. The U.S. landscape typically includes:

• Same-family continuations: added claims with slightly different formulation limits or process steps.
• Divisional continuations: carve-outs that can extend coverage even after some claims fall or are narrowed.
• Terminal-disclaimer-connected continuations: still enforceable but with expiration tethering.
• Neighbor patents from other assignees: competing formulation approaches, delivery technologies, and method-of-use claims.

How to treat “same family” versus “adjacent estate” risk

• Same family risk is higher because claim terms are often consistent across continuations, and the prosecution history may bind construction.
• Adjacent estate risk arises when competitors independently claim:
  • alternate excipient systems;
  • alternate particle engineering;
  • alternate release-control technologies; or
  • alternate method-of-manufacture steps.

In practice, a product can avoid infringement of US 9,517,274 while still landing inside a different active patent that blocks market entry.

When does US 9,517,274 lose exclusivity in the U.S. (expiration and terminal disclaimers)?

Enforceability and exclusivity depend on:

• the patent’s statutory expiration (generally 20 years from earliest effective nonprovisional filing, subject to adjustments);
• any Patent Term Adjustment (PTA) granted by USPTO;
• any terminal disclaimer linking expiration to an earlier patent in the chain; and
• any regulatory exclusivity that may affect generic or biosimilar timing (rarely controls patent infringement directly, but it governs FDA eligibility for approval pathways).

For a precise exclusivity timeline, you would need the patent’s filing history, PTA figures, and disclaimer status as recorded in the USPTO patent document and INPADOC legal status. Without those inputs, a definitive expiration date cannot be stated in an actionable way.

What Orange Book status would govern generic launch risk if US 9,517,274 covers an approved drug?

For a U.S. small molecule pharmaceutical patent, Orange Book listings often determine:

• whether Paragraph IV notice is triggered for the exact listed patent(s);
• which claims are asserted during litigation; and
• the automatic stay mechanics under Hatch-Waxman.

If US 9,517,274 is listed for an FDA-approved NDA/ANDA, then its enforceability typically matters directly to generic timing. If it is not listed, it may still be enforceable, but FDA launch timing and Paragraph IV strategy differ.

A complete Orange Book status analysis requires the listed NDA/ANDA product mapping for US 9,517,274, which cannot be reliably produced without the underlying FDA listing record.

How many patents in this family or around this technology are likely to be co-pending or co-listed?

Patent family density is usually high in pharma formulation and process spaces because:

• prosecution invites continuation to refine claims;
• competitors file around core features, leading to multiple overlapping estates; and
• later variants (strengths, dosage forms, stability upgrades) get separate claims.

A defensible count requires assembling:

• all U.S. family members (continuations/divisionals);
• their grant status and expiration alignment; and
• their legal status (active, expired, lapsed, disclaimed).

That dataset is not provided here, so a quantified count cannot be produced.

What litigation risks does US 9,517,274 create for generics, and what Paragraph IV scenarios are plausible?

A Paragraph IV risk scenario for a composition or method-of-use patent generally depends on:

• whether it is Orange Book listed;
• whether the generic certification targets the same active ingredient and dosage form; and
• whether the generic formulation can design around the claim limitations without losing bioequivalence or stability.

Common litigation patterns include:

• asserting dependent claims that are easier to map to batch specs;
• arguing equivalence for “about” and functional limitations;
• attacking prosecution history for claim scope narrowing; and
• focusing on whether the generic process steps match claimed sequences (if method claims exist).

A case-by-case scenario requires actual Paragraph IV notices, dockets, and settlement dates, none of which are specified here.

How strong is the patent estate for US 9,517,274: claim breadth, validity posture, and design-around barriers?

Assessing “strength” requires:

• prosecution history review (claim amendments and surrender);
• prior art analysis against key limitations; and
• enforceability status (lapse, terminal disclaimer, reexamination, PTAB outcomes).

Without the text of the claims and specification, plus the cited references during prosecution, strength cannot be evaluated in a rigorous, business-actionable way.

Still, the decision framework is clear:

• High strength if independent claims have clean, nonfunctional limitations anchored to objective parameters and the specification provides detailed support for those limits.
• Medium strength if claims rely on ranges, “about,” and functional language that are more susceptible to validity and noninfringement arguments.
• Lower strength if claims are broad but depend on narrow, contested construction terms, making claim charts more dependent on expert interpretation.

What are the likely design-around routes that competitors use versus US 9,517,274?

Competitors typically design around by changing:

• excipient system while retaining the same active;
• concentration ranges to move outside claimed numerical bands;
• particle engineering parameters if structural or performance attributes are required;
• process steps if method claims require strict sequence or operating windows;
• dosage architecture if the claim requires defined physical structure.

Design-around success depends on whether US 9,517,274 claims are limited to exact structural/performance characteristics or whether they cover broad functional outcomes. The patent text is required for this determination.

How does US 9,517,274 compare with neighboring patents held by major pharma and generic companies?

In pharma patent landscapes, competition typically clusters among:

• originator formulation/process portfolios;
• generic formulation improvements; and
• specialty delivery technology owners.

Comparative value analysis requires:

• identifying the assignee(s);
• listing contemporaneous family members and competitor patents with overlapping claim elements; and
• mapping which elements are common across estates.

This requires the identity of the patent’s active ingredient coverage and its claim set, which is not included in the prompt.

What licensing strategies are most compatible with US 9,517,274 (portfolio licensing versus product-specific licensing)?

For a patent covering a composition and possibly manufacturing constraints, the typical licensing strategy choices are:

• Product-specific license: targeted to the marketed dosage form and manufacturing process.
• Portfolio cross-license: used when both parties have blocking patents across process and formulation.
• Field-of-use license: if method claims and specific embodiments can be carved by therapeutic indication or dosage form.

Whether US 9,517,274 supports these options depends on claim breadth and the number of co-owned blocking patents.

Key Takeaways

• US 9,517,274’s enforceable scope is determined by the independent claim limitations and construction of high-impact technical terms (ingredient identity, concentration/range, structural/performance parameters, and any recited process steps).
• A complete U.S. patent landscape analysis requires: claim text, family membership, legal status (PTA, terminal disclaimer), and Orange Book or litigation mapping. Those data are not present in the prompt.
• For FTO and generic launch risk, the core questions are whether an accused product matches every limitation of the asserted independent (and likely dependent) claims, and whether adjacent patents create alternative blocking coverage.

FAQs

1. How do courts construe “about” and range limitations in composition patents like US 9,517,274?
2. What evidence most often decides infringement for formulation patents: product specs, stability data, or manufacturing batch records?
3. When does a continuation or divisional in the same family extend practical enforcement risk around an issued patent?
4. How does Orange Book listing change Paragraph IV strategy for generics facing a composition patent?
5. What are common validity attack pathways for pharma composition patents: anticipation, obviousness, indefiniteness, or written description?

References

1. USPTO Patent Information for US 9,517,274.

Details for Patent 9,517,274

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Wyeth Pharmaceuticals Llc	PREVNAR 20	20-valent pneumococcal conjugate vaccine	Injection	125731	June 08, 2021	9,517,274	2033-08-12

International Patent Family for US Patent 9,517,274

Country	Patent Number	Estimated Expiration
South Africa	201500493
World Intellectual Property Organization (WIPO)	2014027302
United States of America	10583187
United States of America	11110160