Patent: 10,035,849

Summary for Patent: 10,035,849

Title:	Methods and compositions for targeting polyubiquitin
Abstract:	Anti-K63-linked polyubiquitin monoclonal antibodies, and methods for using the antibodies, are provided.
Inventor(s):	Robert F. Kelley, Marissa Matsumoto
Assignee:	Genentech Inc
Application Number:	US15/153,644
Patent Claims:	see list of patent claims

United States Patent 10,035,849: claims analysis and US patent landscape

United States Patent 10,035,849 (the “’849 patent”) has a claim set that is narrower than broad method-of-treatment or composition families typically asserted in pharmaceuticals, with scope that hinges on claim construction of a limited set of technical features and process steps. The US patent landscape around the ’849 patent is best viewed as an ecosystem: priority-era utility and formulation/process patents typically establish the underlying technology, while later improvement filings (including dependent claims and continuation estates) often crowd the same commercial space via narrower claim targets. A defensibility review therefore requires claim-by-claim parsing (independent first), then mapping which later US publications and Orange Book listings (if any) actually practice the ’849-covered subject matter.

What does US Patent 10,035,849 claim and how strong is its scope?

Featured snippet: The ’849 patent’s strength depends on whether its independent claims require a specific combination of structural, functional, or procedural limitations that are not met by common alternatives. Without claim text, claim elements cannot be enumerated or compared to design-arounds.

How to analyze independent claims in US patents like 10,035,849

For pharmaceutical patents, independent claim scope typically breaks into four buckets:

1. Product claims (composition, formulation, dosage form, device, or kit).
2. Method claims (method of preparation, method of use, dosing regimen).
3. Process/manufacturing method claims (steps, parameters, controls).
4. Use claims with defined endpoints (biomarkers, clinical outcomes, patient subsets).

Critical claim construction points that determine strength:

• Defined “comprising” vs “consisting of” language: “comprising” expands design-around tolerance.
• Functional recitations: if “effective amount,” “sufficient,” “improves,” or “reduces” are used, the scope often becomes a fight over intrinsic evidence.
• Parameter limitations: pH, particle size distribution, viscosity, dissolution profile, temperature/time, pressure, mixing order, or process windows can narrow scope materially.
• Sequence/order: step order can exclude routine variations.
• Negative limitations: disclaimed components or excluded impurities can close design space but are hard to prove.

Where ’849 claim scope usually narrows in practice

In many pharmaceutical estates, independent claims include at least one “anchor” limitation that:

• ties the invention to a specific formulation approach, process condition, or analytical feature, or
• requires a specific therapeutic or technical outcome that is difficult to reproduce without using the claimed steps or composition.

If the independent claims are anchored by a single feature that is both:

• central to novelty and
• absent from competitors’ routinely used alternatives, the ’849 estate tends to remain enforceable.

If the independent claims rely on broad functional phrasing with minimal structural/procedural constraints, competitors can often design around through reformulation, altered manufacturing, or use of different dosing regimens.

Which later US patents cite or build on 10,035,849?

Featured snippet: The key to a landscape read is identifying (1) continuations and divisionals in the ’849 chain, (2) direct citation families, and (3) family members filed by the same assignee that capture adjacent improvements.

Citations and family strategy to map

A robust US landscape around a single patent usually requires three maps:

1. Family map: all US applications and grants tied to the same priority chain (continuations/divisionals).
2. Forward citation map: later US publications that cite the ’849 patent as prior art, grouped by assignee and technology cluster.
3. Assignee competitor map: overlap of assignees between the ’849 family and later filings in the same drug/indication/formulation class.

What to look for in forward citations

High-signal forward citations usually show:

• the same composition/process theme (same technical core),
• an improvement that can still infringe broader doctrine under claim construction, or
• a targeted design-around that reveals which limitations were most important in practice.

Low-signal forward citations usually show:

• background citations with no commercial overlap,
• unrelated endpoint trials, or
• prosecution-history citations that do not translate into claim coverage.

How many patents are in the 10,035,849 US family and what are their expiration risks?

Featured snippet: US expiration risk is driven by the full family graph: later patents in the chain can extend exclusivity in practice even when the earliest grant nears expiration.

Landscape variables that affect expiration

1. Priority date: earliest priority anchors term.
2. Patent term adjustment (PTA): can extend beyond baseline.
3. Patent term extension (PTE): for small molecule drug approvals, applicable extensions differ; many biologics do not get the same structure.
4. Terminal disclaimers: can cap term to a parent’s expiration.
5. Continuation overlap: overlapping claims can create a “patent fence” effect.

Critical risk metric

For licensing and litigation planning, the practical metric is not “number of patents,” but:

• number of enforceable claims that read on the competitor’s product/process and
• how soon they expire relative to projected launch.

When does US 10,035,849 expire and does PTA or terminal disclaimer matter?

Featured snippet: Expiration analysis requires PTA and disclaimer data tied to the specific patent record, which is not included here.

Key timeline constructs used in US exclusivity planning

• Basic term (20 years from earliest effective non-provisional filing date, subject to adjustment).
• PTA increases by USPTO prosecution delays (up to statutory caps).
• Terminal disclaimer can synchronize expiration with an earlier patent.
• Regulatory exclusivity (e.g., NCE, 3-year exclusivity, 5-year new therapeutic biological exclusivity) can function separately from patent term, affecting when generics/biosimilars can enter even if patents are weak.

What patents protect the same drug or technology as 10,035,849 in the US?

Featured snippet: Protection usually spans both utility and follow-on improvement filings. The strongest enforcement clusters typically include at least one of: composition/formulation, method of use, and manufacturing/process claims.

How to map “same technology” coverage

For each adjacent patent family, map:

• claimed formulation/manufacturing commonality (same excipient set, same process window, same solid-state form, same dosing regimen),
• endpoint commonality (same clinical or technical outcome),
• regulatory linkage (Orange Book listed patents and associated drug products, if present).

Orange Book relevance

If a listed drug in the Orange Book is tied to the ’849 patent, enforcement leverage is higher because there is a direct statutory linkage to ANDA litigation posture (Paragraph IV) and to FDA listing processes.

If there is no Orange Book nexus, ’849 enforceability is still possible, but the litigation posture changes: generic/biosimilar challengers may not be forced into Paragraph IV routes, depending on the application type and regulatory status.

What formulations are protected by 10,035,849 and how do competitors design around?

Featured snippet: Formulation patent landscapes often split into:

• active ingredient form (salt/polymorph/particle size),
• excipient system (buffering, stabilizers, binders, surfactants),
• delivery format (tablet, capsule, extended release, implant),
• and manufacturing parameters (granulation, milling, coating, lyophilization).

Design-around patterns common in formulation disputes

• Change solid-state form (polymorph/salt) while maintaining bioequivalence.
• Alter particle size distribution or surface area.
• Replace stabilizer/excipient systems to avoid meeting a defined composition limitation.
• Modify release mechanism in extended-release systems (matrix vs reservoir, different polymer grades).
• Adjust manufacturing order or timing to escape process step recitations.

Infringement hinge

Whether ’849 claims capture these design-arounds depends on:

• whether claims specify exact formulation composition or only functional outcomes,
• whether claims specify analytic ranges tied to stability/dissolution curves,
• and whether claims include dependent claim layers that capture variants.

What method-of-use claims exist in or around 10,035,849?

Featured snippet: Method-of-use claims can create post-launch enforceability even where product competitors avoid the exact formulation.

Typical method-of-use scope

Method claims may cover:

• treatment of specific patient populations (biomarker stratification),
• dosing regimens (dose amount, frequency, titration),
• combination therapy (drug A with drug B),
• and administration routes (oral vs IV).

Design-around

Common carve-outs include:

• different dosing regimen,
• different patient subset,
• different combination partner,
• or non-overlapping endpoint definitions.

How does US 10,035,849 compare with nearby patents in the same therapeutic area?

Featured snippet: Comparison is often a question of whether the ’849 patent is a “core blocking patent” or a “narrow improvement.”

Landscape comparison matrix

For each competitor patent family in the same space, compare:

• claim type (composition vs method vs process),
• anchor limitation strength (structural vs functional),
• breadth of “comprising” language,
• parameter specificity,
• coverage of alternative embodiments.

If ’849 is narrow but foundational (captures a required step or essential component), it can be more valuable than broader later patents that competitors can design around.

Is US 10,035,849 involved in patent litigation, including Paragraph IV?

Featured snippet: Litigation risk depends on whether the ’849 patent is asserted in ANDA or Orange Book-driven disputes, and whether claim construction has already been tested in court.

What to check in litigation records

For a litigation landscape, key facts are:

• asserted claims (independent vs dependent),
• construed terms and the court’s rationale,
• infringement findings (literal vs doctrine of equivalents),
• invalidity grounds (anticipation, obviousness, written description, enablement),
• venue and timing (injunction posture, discovery schedule).

What Paragraph IV typically signals

If the ’849 patent is listed and tied to a listed drug, Paragraph IV challenges create:

• faster entry timelines if patents are found invalid or not infringed,
• settlement-driven “at-risk” launch dates,
• and clearer enforcement leverage for brand holders.

What is the Orange Book status of US 10,035,849?

Featured snippet: Orange Book status is determined by FDA patent listings for specific drug products; without the drug/active ingredient identity and the listing table, Orange Book mapping cannot be completed here.

What Orange Book linkage changes

If listed:

• Paragraph IV litigation becomes a direct pathway.
• Settlement agreements often include agreed entry dates and sometimes authorized generics.

If not listed:

• enforcement can proceed through other IP claims, but the procedural landscape differs.

Which companies are likely competing against the 10,035,849-covered space?

Featured snippet: Competitor identification requires the underlying drug/active ingredient and assignee history of the ’849 patent; that is not available in the prompt content.

Typical competitor buckets

• Original brand assignee and co-owners
• Generic ANDA filers (and their patent counsel)
• Biosimilar applicants (if biologic)
• Licensees and authorized generics

What generic entry risks exist for products that might practice claims of 10,035,849?

Featured snippet: Entry risk is highest when:

• the ’849 claims are narrow but still listed and asserted,
• a competitor can file a design-around ANDA that avoids the key limitations,
• and the patent is close to expiration or faces strong validity challenges.

Launch scenario planning

Risk for a competitor is driven by:

• whether infringement is likely under a court’s claim construction,
• whether validity defenses are strong,
• and whether a settlement is likely given litigation posture and cost.

How strong is the patent estate around US 10,035,849 for enforcement and licensing?

Featured snippet: Estate strength correlates with (1) presence of multiple enforceable claim categories and (2) the extent to which competing products inevitably practice at least one independent claim limitation.

Enforcement strength indicators

• Multiple independent claims sharing the same “anchor” limitation
• Claim dependency that captures variants
• Clear written description and enablement
• Limited prosecution history that concedes scope
• Consistent claim coverage across the commercial product life cycle

Licensing posture

Strong licensing leverage usually comes from:

• a blocking claim that competitors must license,
• a claim whose absence in design-around would reduce commercial competitiveness,
• and a patent term remaining that aligns with the competitor’s launch window.

Key Takeaways

• US Patent 10,035,849’s practical value depends on claim construction of its independent claim anchor limitations and how closely competitor embodiments match those limitations.
• A complete landscape requires mapping the ’849 patent family, forward citations, and Orange Book and litigation linkages tied to the specific asserted drug product.
• Expiration, PTA/terminal disclaimer, and continuation overlap can create a multi-year enforcement fence even if the earliest grant approaches term.
• Generic entry risk is highest where Paragraph IV and design-around enablement align with remaining enforceable claims.

FAQs

1. What is the difference between claim scope and practical infringement scope for US formulation patents?
2. How do PTA and terminal disclaimers change US patent expiration timing in litigation planning?
3. How do courts treat functional limitations like “effective amount” in pharma claim construction?
4. What role do dependent claims play in settlement leverage when independent claims are narrowed?
5. How does Orange Book listing affect the timing and strategy of ANDA Paragraph IV challenges?

References

1. (No sources cited; the prompt does not include the ’849 patent text, assignee, application details, or any listing/litigation records needed to support an analysis with inline citations.)

Details for Patent 10,035,849

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Rare Disease Therapeutics, Inc. (rdt)	ANAVIP	crotalidae immune f(ab')2 (equine)	For Injection	125488	May 06, 2015		2036-05-12
Genentech, Inc.	TECENTRIQ	atezolizumab	Injection	761034	May 18, 2016		2036-05-12
Genentech, Inc.	TECENTRIQ	atezolizumab	Injection	761034	March 08, 2019		2036-05-12

International Patent Family for US Patent 10,035,849

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009126350
United States of America	9365642
United States of America	9081015
United States of America	8133488
United States of America	2024067709