Patent: 9,085,620

Summary for Patent: 9,085,620

Title:	Use of TNF.alpha. inhibitor for treatment of psoriatic arthritis
Abstract:	The invention describes methods of treating erosive polyarthritis comprising administering a TNF.alpha. antibody, or antigen-binding portion thereof. The invention also describes a method for testing the efficacy of a TNF.alpha. antibody, or antigen-binding portion thereof, for the treatment of erosive polyarthritis.
Inventor(s):	Hoffman; Rebecca S. (Wilmette, IL), Weinberg; Mark (Northbrook, IL), Banerjee; Subhashis (Princeton, NJ), Taylor; Lori K. (Boston, MA), Spiegler; Clive E. (Skillman, NJ), Tracey; Daniel E. (Harvard, MA), Chartash; Elliot K. (Marietta, GA), Barchuk; William T. (San Diego, CA), Yan; Philip (Vernon Hills, IL), Murtaza; Anwar (Westborough, MA), Salfeld; Jochen G. (North Grafton, MA), Fischkoff; Steven A. (Short Hills, NJ), Granneman; George R. (Marco Island, FL)
Assignee:	AbbVie Biotechnology Ltd. (Hamilton, BM)
Application Number:	14/681,713
Patent Claims:	see list of patent claims

United States Patent 9,085,620 (Adalimumab Psoriatic Arthritis) Claim Scope and US Patent Landscape Analysis

Executive summary: US 9,085,620 is drafted to method coverage around (i) subcutaneous 40 mg adalimumab “every other week” for psoriatic arthritis, (ii) specific presentation constraints tied to “filling adalimumab into vessels” including syringes, (iii) concentration and fill-volume limitations (50 mg/mL, 40 mg per syringe), and (iv) effect/endpoint limitations tied to erosive polyarthritis, structural damage inhibition, symptom reduction, and high-threshold response metrics (ACR at week 24, PASI at week 24). The most practical invalidity/avoidance risks for competitors typically arise from whether these limitations read on already-approved adalimumab labeling and earlier adalimumab uses or from whether the “filling vessels/syringes” and concentration/fill constraints are novel over prior commercial product/formulation and prior art manufacturing disclosures. The most practical enforcement leverage for the patent owner typically comes from locking around specific administration regimens and product-specific container/concentration constraints, which can be harder for generic biosimilar entrants to avoid if they are forced into the same dosing and same dose strength.

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What does US Patent 9,085,620 claim for adalimumab in psoriatic arthritis?

Direct claim answer: The patent claims a method of administering adalimumab to patients with psoriatic arthritis using a subcutaneous 40 mg dose every other week, tied to “filling adalimumab into vessels,” with dependent claims narrowing to 50 mg/mL concentration, 40 mg per vessel, and the vessels being syringes. Additional dependents narrow the patient phenotype (erosive polyarthritis associated with psoriatic arthritis) and include clinical-effect limitations (inhibiting progression of structural damage; reducing/inhibiting symptoms; achieving response thresholds using ACR and PASI at week 24).

Claim set structure (independent vs. dependent)

• Independent claim 1 (method of administration):
  • Administer adalimumab for psoriatic arthritis
  • “Filling adalimumab into vessels”
  • Subcutaneous 40 mg every other week
• Independent claim 13 (method of preparation):
  • Preparing/dispensing adalimumab for treatment by filling into vessels
  • Same dosing regimen: subcutaneous 40 mg every other week

Core limitations across most claims

1. Therapeutic indication: psoriatic arthritis (with later dependents specifying erosive polyarthritis).
2. Dose strength and interval: 40 mg subcutaneously every other week.
3. Container/vessel act: “filling adalimumab into vessels” (and in dependents, “vessels are syringes”).
4. Formulation concentration and fill:
   • 50 mg/mL concentration
   • vessels/syringes each contain 40 mg (implies 0.8 mL fill volume if 50 mg/mL is used).
5. Clinical outcome gates:
   • inhibits progression of structural damage
   • reduces/inhibits symptoms
   • achieves ≥70% ACR at week 24 (claim 27)
   • achieves ≥90% PASI at week 24 (claim 29)

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How broad are the “filling into vessels/syringes” limitations, and what do they do to claim scope?

Claim scope impact: The “filling adalimumab into vessels” language shifts claim coverage toward the act of dose preparation/dispensing and could capture practices that occur at manufacturing, kit assembly, pharmacy dispensing, or provider preparation, depending on how infringement is argued. The narrower syringe-based dependents further anchor the claim to a specific presentation type.

Vessel language: why it matters legally

• A “method of administering” claim can still be infringed by actors upstream in the supply chain if the patent owner ties “filling” to their operations and the remaining administration elements are satisfied by the downstream provider/patient.
• The “method of preparing” claim (claim 13) is aimed at upstream conduct. That makes it more actionable against:
  • label-compliant packaging operations
  • outsourcing fill-finish activities
  • distribution/dispensing systems that prepare prefilled syringes or kits

Syringe and dose-form constraints

• Claims 4–6, 16–18, 21–24, 26–28, 30: require that the vessels are syringes and specify concentration and fill.
• If a competitor uses an alternative delivery format (for example, autoinjector vs syringe, different concentration/dose strength presentation, or a device that does not match “syringe” as argued), the dependent claims can become harder to read on.

Formulation constraints: 50 mg/mL and 40 mg per syringe

• These numerical constraints are high-friction for entrants because many biosimilar products are marketed in fixed strengths and volumes. If a competitor’s syringe concentration differs (even if the injected dose is still 40 mg), dependent claims may avoid infringement.
• If competitors are forced into the same standard prefilled syringe strength commonly used for adalimumab 40 mg dosing regimens, these dependents become easier for a rights-holder to assert.

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Does US 9,085,620 read on adalimumab labeling for psoriatic arthritis dosing (40 mg every other week)?

Featured snippet answer: If 9,085,620’s dosing regimen matches the FDA-approved adalimumab schedule for psoriatic arthritis, the dosing portion (40 mg subcutaneously every other week) is likely not the differentiating novelty; the novelty would have to come from the “filling into vessels/syringes at 50 mg/mL in 40 mg per syringe” and the specific outcome limitations.

Practical claim-drafting logic visible in the claim text

• The regimen is broad (independent claims 1 and 13).
• Dependent claims add product-form constraints and explicit concentration/fill requirements.
• Additional dependents add outcome gates (ACR and PASI thresholds), which can further narrow infringement but also raise proof burdens.

Litigation consequence

• For an enforcement strategy, the patent owner’s strongest position is usually where the competitor’s product is used exactly as claimed, including:
  • prefilled syringe type
  • concentration
  • fill content
  • regimen timing
• For a defense/avoidance strategy, a competitor typically looks for:
  • a different concentration in the syringe
  • a different device term that is not a “syringe” under claim construction
  • different dosing interval
  • different patient selection/outcome endpoints (hard to control in real-world use)

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What patient and efficacy limitations are included (erosive polyarthritis, structural damage, ACR 70, PASI 90)?

Direct answer: Dependent claims escalate specificity by adding:

• erosive polyarthritis associated with psoriatic arthritis (claim 7)
• inhibition of progression of structural damage (claim 10)
• symptom reduction/inhibition (claim 25)
• at least 3 swollen joints and 3 tender joints plus erosive polyarthritis (claim 19)
• achieving:
  • ≥70% ACR at week 24 (claim 27)
  • ≥90% PASI at week 24 (claim 29)

How efficacy endpoints change infringement proof

• Outcome-based limitations can reduce the number of infringing cases if infringement is tied to clinical measurement thresholds at week 24.
• In litigation, the rights-holder may need clinical-response evidence for the asserted patient cohort. That can be easier if the label or pivotal trials used the same endpoints, but harder if real-world outcomes vary.

Cross-indication signal in claim set

• PASI is a psoriasis skin measure. Including PASI in a psoriatic arthritis method claim suggests the method targets combined or overlapping psoriasis activity or a trial design that measured both joint and skin endpoints.
• This can matter in an obviousness/anticipation argument because prior adalimumab studies in psoriatic disease often track both ACR and PASI, but those studies will still need to match the specific product and dosing constraints.

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How many independent claim pathways exist for infringement (administration vs preparation)?

Direct answer: Two independent claim anchors:

• Claim 1: method of administering (includes “filling into vessels” + subcutaneous dosing)
• Claim 13: method of preparing (includes filling into vessels and providing for treatment)

Why two pathways matter

• A generic/biosimilar entrant can try to argue noninfringement for one claim pathway by shifting operational roles. The presence of both administration and preparation claims increases the chance that some actor in the supply chain is captured.

Dependent claim overlays

• Dependent claims add the same numerical product constraints across both pathways:
  • 50 mg/mL
  • 40 mg per vessel
  • syringe vessel type
• So the product presentation is central across both infringement theories.

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What patent landscape issues typically dominate for adalimumab biosimilars vs method-of-use container claims?

Featured snippet answer: For adalimumab-related patents, the main landscape typically includes:

1. originator composition/manufacturing patents
2. formulation and device/prefilled syringe patents
3. method-of-use patents for specific indications and endpoints
4. regulatory exclusivity and settlement-driven entry timing (biosimilar/generic pathways)

For US 9,085,620 specifically, the decisive landscape question is whether earlier prior art (clinical studies, regulatory submissions, manufacturing fill-finish disclosures, or commercial product presentations) already described the same regimen with the same concentration and syringe fill content, and whether outcome thresholds were known and achievable.

Typical invalidity theories under a claim like this

• Anticipation: prior disclosure of dosing regimen + container fill characteristics + indication.
• Obviousness: combination of known adalimumab psoriatic arthritis dosing with known prefilled syringe concentration/fill practices and known outcome measurements.
• Indefiniteness/enablement (rare but possible): if “inhibits progression” or endpoint claims require specific assay definitions not described in the patent. (This is claim-construction and proof-dependent.)

Typical infringement-avoidance strategies

• change syringe concentration while preserving 40 mg dose
• switch to a different device that is argued not to be a “syringe”
• adjust dosing interval away from every other week
• contest patient selection and endpoint-based limitations (week 24 thresholds)

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When does US 9,085,620 likely expire, and how does that interact with biosimilar entry timelines?

Direct answer: A hard expiration date cannot be derived from the claim text alone. Expiration depends on filing date, priority chain, patent term adjustments, and potential extensions. With only the claims provided, no valid expiration schedule can be computed.

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What Orange Book status applies to US 9,085,620 for adalimumab products?

Direct answer: Orange Book eligibility and listing depend on whether the drug is an FDA-approved small-molecule ANDA product (Orange Book) versus a biologic license (Biologics License Application) listed in the Purple Book. Adalimumab is a biologic; listing and exclusivity are handled via the biologics licensing framework, and any patent-linking would be in the biosimilar context rather than the Orange Book. With only the patent claim text, no definitive listing status can be established.

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Which companies are likely affected by US 9,085,620 in the US market?

Direct answer: The likely affected parties are adalimumab biosimilar makers and sponsors selling US-labeled adalimumab products for psoriatic arthritis using a 40 mg every-other-week subcutaneous regimen in prefilled syringe formats. However, the patent landscape for US 9,085,620 cannot be mapped to specific companies without the patent’s bibliographic data, assignee, and any Orange Book/Purple Book linking and litigation docket numbers.

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What patent litigation risk does a “container concentration + dosing regimen” claim create for biosimilars?

Direct answer: It increases litigation leverage around product presentation and labeling use. A biosimilar that sells a 40 mg/0.8 mL (or equivalent) syringe at 50 mg/mL concentration and is used every other week in psoriatic arthritis can become difficult to design around without changing concentration, dosing interval, or device category.

Proof and discovery dynamics

• Container constraints can be satisfied with product specifications, labeling, and manufacturing records.
• Administration constraints require evidence that the regimen was used as claimed.
• Endpoint limitations require patient-response data, often contested, but sometimes supported by clinical trial data or post-marketing evidence.

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How does US 9,085,620 compare with other adalimumab patents in psoriatic arthritis (method-of-use vs formulation)?

Direct answer: This patent is closer to a method-of-use plus preparation container-configuration than a pure formulation patent. It is not limited to adalimumab composition parameters beyond concentration and fill volume in the syringe. Compared with broader composition-of-matter or manufacturing-process patents, it is narrower in chemical scope but potentially broader in real-world method enforcement if the product presentation and dosing match.

Practical comparison dimensions

• Method-of-use dominance: strong on dosing interval and indication.
• Presentation dependence: strong on syringe + concentration + fill content.
• Outcome-specific narrowing: reduces reach but raises proof burdens.

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Commercial exposure: where would infringement arguments concentrate?

Direct answer: The commercial exposure is concentrated in:

• commercially used psoriatic arthritis regimens featuring adalimumab 40 mg every other week
• prescriber and payer settings where adalimumab prefilled syringe usage is standardized
• biosimilar switching scenarios where the biosimilar’s product presentation mirrors the claimed concentration and dose-per-syringe

Without the patent’s assignee, priority and prosecution history, and known asserted counterparties, revenue exposure cannot be quantified to specific competitors.

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Key Takeaways

• US 9,085,620 is structured around a psoriatic arthritis adalimumab dosing regimen (40 mg subcutaneously every other week) coupled to dose presentation constraints (50 mg/mL; 40 mg per vessel; vessels are syringes in dependents).
• The strongest technical enforcement hooks are the numeric concentration/fill content and syringe requirement, because those can be attacked or avoided only through meaningful product changes.
• The patient phenotype and efficacy endpoint dependents (erosive polyarthritis; structural damage inhibition; ACR 70 at week 24; PASI 90 at week 24) can narrow infringement scope but also create contested proof requirements in litigation.
• The patent includes both an administration claim and a preparation claim, increasing enforcement surface across supply-chain actors.

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FAQs

1. What happens if an adalimumab biosimilar uses a different syringe concentration but still injects 40 mg every other week?
2. Can “every other week” dosing be found equivalent if real-world schedules vary by a few days?
3. Do outcome-based limitations like “ACR 70 at week 24” make enforcement harder for post-marketing use claims?
4. How do “syringe” claim terms affect differentiation vs autoinjectors or other delivery devices?
5. Is the “method of preparing” claim more useful for enforcement against fill-finish or packaging contractors than against prescribers?

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References

1. (No sources cited. The request provides the claims text only, and no patent bibliographic data, prosecution history, assignee, filing/priority dates, or litigation/regulatory record was included to support an evidence-based landscape analysis.)

Details for Patent 9,085,620

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	December 31, 2002		2035-04-08
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	February 21, 2008		2035-04-08
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	April 24, 2013		2035-04-08
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	September 23, 2014		2035-04-08
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	November 23, 2015		2035-04-08

International Patent Family for US Patent 9,085,620

Country	Patent Number	Estimated Expiration
Argentina	040603
Argentina	045710
Argentina	077474
Argentina	077573
Argentina	098173