Patent: 8,986,693

Summary for Patent: 8,986,693

Title:	Use of TNF.alpha. inhibitor for treatment of psoriasis
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), Taylor; Lori K. (Boston, MA), Chartash; Elliot K. (Marietta, GA), Yan; Philip (Vernon Hills, IL), Granneman; George R. (Marco Island, FL)
Assignee:	AbbVie Biotechnology Ltd. (Hamilton, BM)
Application Number:	14/510,821
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,986,693
Patent Claims:	see list of patent claims

United States Patent 8,986,693: Claims, Strength, and US Patent Landscape for Adalimumab Dosing to Achieve PASI Responses in Plaque Psoriasis

US Patent 8,986,693 is a US method patent directed to a specific adalimumab induction-plus-maintenance regimen for moderate to severe chronic plaque psoriasis and tied performance outcomes at defined timepoints using PASI thresholds. The core claim set is built around (i) an 80 mg subcutaneous induction dose, (ii) 40 mg every other week (EOW) starting one week after induction, and (iii) response-rate and individual response gates (PASI 90 at week 12; PASI 75 at week 24; and population gates at week 12 or week 24).

This landscape analysis focuses on where the patent meaningfully differentiates versus earlier adalimumab psoriasis disclosures, where it is exposed to obviousness and anticipation, and how the claims are likely to be treated by US courts and by a freedom-to-operate (FTO) posture.

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What do the claims actually cover (and what do they not)?

Claim architecture and what is materially limiting

The claims define treatment as a method with four limiting elements:

1. Patient population: “adult patient having moderate to severe chronic plaque psoriasis.”
2. Dosing scheme:
   • First dose: 80 mg adalimumab subcutaneously
   • Then 40 mg adalimumab every other week
   • Starting one week after the 80 mg dose
3. Administration form (dependent claims only): “pre-filled syringes for subcutaneous injection.”
4. Efficacy gates:
   • Claim 1: PASI 90 at week 12 (individual-level)
   • Claim 3: PASI 75 at week 24 (individual-level)
   • Claim 5: population-level: at least 47% achieve PASI 75 at week 12
   • Claim 7: population-level: at least 53% achieve PASI 75 at week 24

Notably absent from the independent claim language are restrictions on:

• prior therapy status (naive vs experienced),
• concomitant therapies (topicals, phototherapy, methotrexate),
• stratification by baseline PASI or body weight,
• immunogenicity management,
• treatment duration beyond the stated endpoints.

This means enforceability and design-around will turn on whether infringing dosing and PASI outcomes are achieved under the claim’s metric framing, not on broader clinical management choices.

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How strong is the efficacy linkage given prior art dosing?

Why PASI endpoints matter legally

In US method patents, tying a dosing regimen to a quantified clinical response can:

• help distinguish versus prior art that discloses the dosing but does not disclose the particular PASI endpoint at the specified timepoint or population rate, and
• create a “new result” argument under obviousness analysis when the regimen was not expected to yield that specific magnitude or timing.

What the claims still risk

The efficacy gates here are not broad biomarkers; they are classic plaque psoriasis endpoints (PASI 75 and PASI 90). If earlier disclosures:

• already disclose the same induction and maintenance schedule, and
• report PASI outcomes at week 12 or week 24 at a level that overlaps the claim thresholds,

then the claims can be anticipated or rendered obvious with less work than if endpoints were novel.

The population-rate elements (47% and 53%) also create a double-edged structure:

• They may distinguish if prior art results sit below those exact thresholds.
• But they also invite a “substantial overlap” attack: if prior art trials or pooled analyses produce outcomes statistically consistent with the claimed cutoffs, then the thresholds may not confer patentable difference.

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Claim-by-claim critical assessment

Claim 1

• Regimen: 80 mg SQ induction, then 40 mg EOW starting 1 week after induction
• Endpoint: patient achieves PASI 90 at week 12

Key enforceability points

• This is the most specific endpoint (PASI 90, week 12). Courts often scrutinize whether such outcomes were routine or predictable from earlier studies.
• If the same regimen was previously studied in plaque psoriasis with PASI 90 at week 12 reported, this claim is vulnerable. If not, it is a better candidate for differentiation.

Claim 2 (dependent)

• Adds only the formulation: adalimumab in pre-filled syringes.

Practical effect

• Dependent claims narrow infringement to a particular presentation. If the drug is marketed in that format (as it typically is), the limitation may not reduce infringement risk for generic or channel-specific design-arounds unless the product form changes.

Claim 3

• Regimen: same as claim 1
• Endpoint: patient achieves PASI 75 at week 24

Critical risk

• PASI 75 at week 24 is a standard endpoint used in psoriasis pivotal trials for anti-TNF therapies. If earlier adalimumab dosing disclosures report PASI 75 at week 24 for comparable populations, this claim is exposed.

Claim 4 (dependent)

• Pre-filled syringes limitation.

Claim 5

• Endpoint: population gate: at least 47% of patients achieve PASI 75 at week 12

Critical risk

• “At least” thresholds can still be anticipated if earlier trials’ week 12 PASI 75 proportions meet or exceed the cutoff.
• If earlier art reports PASI 75 at week 12 but with different inclusion criteria (e.g., baseline severity, prior biologic exposure), then a differentiation argument exists, but it depends on how directly those inclusion criteria map onto “adult moderate to severe chronic plaque psoriasis.”

Claim 6 (dependent)

• Pre-filled syringes limitation.

Claim 7

• Endpoint: population gate: at least 53% achieve PASI 75 at week 24

Critical risk

• If earlier studies of adalimumab show PASI 75 at week 24 above 53% for the relevant regimen and population, this claim becomes the easiest to attack.

Claim 8 (dependent)

• Pre-filled syringes limitation.

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What does the patent landscape imply for obviousness and anticipation?

The central “dosing-schedule” question

The claims are built around what is essentially a two-step regimen: 80 mg once, then 40 mg every other week starting 1 week later.

In US patent practice, if earlier publications or regulatory materials disclose this same dosing schedule for plaque psoriasis and report PASI outcomes at week 12 and/or week 24, then the novelty may collapse quickly:

• Anticipation requires each claim limitation be disclosed in a single prior art reference.
• Obviousness allows combination, but courts still demand a reason to combine or a rational basis for expecting the claimed efficacy.

The “regimen expectation” problem for the applicant

Even when endpoints are quantified, US obviousness can hinge on predictability:

• PASI 75 and PASI 90 are well-established in psoriasis drug development.
• Adalimumab’s pharmacology and class effect make efficacy at week 12 and week 24 plausible.

So the patent’s strongest position typically comes from demonstrating that:

• the precise schedule timing (start at week 2 relative to the 80 mg induction) was not previously disclosed for psoriasis at this strength, or
• the specific PASI threshold proportions at those endpoints were not previously disclosed, or
• the claimed results were unexpectedly high relative to prior art.

If the record shows the same regimen and similar endpoints were already disclosed, the patent’s practical life for enforcement narrows to niche settings (different populations, different measurement definitions, or differences in how PASI response is assessed).

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Where are design-arounds most likely to work?

Because all independent claims lock the dosing schedule, the most straightforward design-arounds are typically those that alter one of the schedule elements or the measurement framing. For an FTO posture, the main “moving parts” are:

Schedule-level changes

• Use a different induction dose (not 80 mg) or a different induction structure.
• Change the maintenance schedule (not 40 mg EOW).
• Change the timing of when maintenance begins (not “starting one week after” induction).

Any of these can break infringement literally.

Endpoint-level changes (harder for compliance)

Because the claims are tied to achieving certain PASI outcomes “wherein the patient achieves…,” simply targeting the same regimen while measuring endpoints differently is not always a clean escape. In litigation, the relevant issue becomes what happens clinically, not what the sponsor says the goal is.

Formulation-level changes (dependent claims only)

Claims 2, 4, 6, 8 add “pre-filled syringes” limitations. If an operator uses another adalimumab presentation that is not “pre-filled syringes,” the dependent claims may not apply, though the independent claims (1, 3, 5, 7) still can.

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US patent landscape: typical claim coverage layers you should expect

Even without reproducing the entire reference set here, method patents in this space commonly fragment coverage into layers:

1. Dose and schedule (induction and maintenance timing)
2. Patient selection (baseline severity, prior biologic exposure, comorbidities)
3. Endpoint/timepoint performance (PASI at week 12, week 24)
4. Formulation/administration device (pre-filled syringe vs vial)
5. Combination therapy (MTX, topicals, phototherapy)
6. Treatment line and durability (retreatment, discontinuation rules)

US 8,986,693 sits heavily in layers 1 and 3, with a small dependent layer in 4.

Business implication: if a generic or biosimilar plan intends to use the standard commercial adalimumab psoriasis regimen, this type of patent is often only partially effective against broad market entry because schedule-level disclosures are usually widely circulated via scientific literature and regulatory documents. Its value tends to concentrate against a specific “induction-then-EOW” schedule variant or a very specific PASI-response profile that earlier disclosures do not match.

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Potential litigation posture: where the claims are most attackable

Attack vector 1: same regimen already disclosed for plaque psoriasis

If earlier references show the exact induction and maintenance schedule for adult moderate-to-severe chronic plaque psoriasis, then the remaining differentiator is the PASI performance at the specified week markers.

Attack vector 2: PASI outcomes overlap the asserted thresholds

If earlier references report PASI 75 and PASI 90 proportions at week 12 and week 24 that meet or exceed the claimed thresholds, then the claims face anticipation or a tight obviousness case.

Attack vector 3: measurement and population comparability

Because claims describe “adult moderate to severe chronic plaque psoriasis” without further constraints, prior art that uses overlapping inclusion criteria (for example, baseline PASI range typical to psoriasis trials) can be treated as sufficiently aligned for legal purposes. That reduces the space for arguing the population was meaningfully different unless inclusion criteria diverged strongly.

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Commercial relevance: what the claims would mean for competitors

If a biosimilar or competitor uses a regimen consistent with the standard adalimumab plaque psoriasis regimen, the decision points become:

• Does the competitor’s induction and maintenance schedule match exactly?
  Claims are schedule-specific.

• Are PASI endpoints consistent with the thresholds in the claim?
  Clinical practice and trial endpoints can differ, but if the regimen reproduces the same response patterns, the “achieves PASI” element supports infringement risk.

• Can the competitor steer clear of dependent “pre-filled syringe” limitations?
  That helps only against dependent claims, not independent ones.

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Key Takeaways

• US 8,986,693 is built on a specific adalimumab dosing schedule (80 mg SQ induction followed by 40 mg EOW starting one week later) plus PASI performance gates at week 12 (PASI 90) and week 24 (PASI 75), with additional population thresholds (47% at week 12; 53% at week 24).
• The claims’ enforceability likely depends less on novelty of endpoints (PASI 75/90 are standard) and more on whether the precise induction-timing schedule and the claimed PASI cutoffs were not previously disclosed for plaque psoriasis.
• The highest-probability design-arounds are schedule changes (dose, EOW cadence, or the “start one week after” feature). Changing endpoints alone is less likely to avoid infringement because the claims track what outcomes patients achieve.
• Dependent claims limited to pre-filled syringes narrow infringement only for that formulation layer and do not address the main schedule-based independent claims.

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FAQs

1) What regimen is required for US 8,986,693 claim coverage?

The claims require 80 mg adalimumab subcutaneously first, then 40 mg adalimumab every other week, with maintenance starting one week after the 80 mg dose.

2) Do the claims require PASI 90 and PASI 75 in the same patient?

No. Claim 1 requires PASI 90 at week 12. Claim 3 requires PASI 75 at week 24. Claims 5 and 7 use population PASI 75 thresholds at week 12 and week 24, respectively.

3) Can a competitor avoid dependent claims by using a non-pre-filled syringe presentation?

Dependent claims (2, 4, 6, 8) add the limitation “pre-filled syringes.” Changing presentation may help against those dependent claims, but it does not remove risk under independent claims that do not include the formulation limitation.

4) Is the method patent dependent on a particular trial or study design?

No. The claim language is outcome-based (PASI thresholds at specified timepoints), but it does not tie infringement to a specific study protocol. In litigation, what matters is whether the regimen in an accused method yields the claimed PASI outcomes.

5) What is the most direct way to design around the patent?

Change at least one schedule element: induction dose (not 80 mg), maintenance (not 40 mg EOW), or maintenance start timing (not “starting one week after” induction).

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References

[1] United States Patent and Trademark Office. US Patent 8,986,693. (Patent number as provided by user).

Details for Patent 8,986,693

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	December 31, 2002		2034-10-09
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	February 21, 2008		2034-10-09
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	April 24, 2013		2034-10-09
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	September 23, 2014		2034-10-09
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	November 23, 2015		2034-10-09

International Patent Family for US Patent 8,986,693

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