Last Updated: May 12, 2026

Profile for Japan Patent: 2010522773


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US Patent Family Members and Approved Drugs for Japan Patent: 2010522773

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.
US Patent Number US Expiration Date US Applicant US Tradename Generic Name
10,570,453 Mar 28, 2028 Vanda Pharms Inc BYSANTI milsaperidone
9,074,254 Dec 28, 2031 Vanda Pharms Inc BYSANTI milsaperidone
9,074,254 Dec 28, 2031 Vanda Pharms Inc FANAPT iloperidone
>US Patent Number >US Expiration Date >US Applicant >US Tradename >Generic Name

Key insights for pharmaceutical patentability - Japan patent JP2010522773

Last updated: May 1, 2026

JP2010522773: Scope, Claims, and Japan Patent Landscape

JP2010522773 is a Japan national-phase publication of a PCT application that entered Japan, and it is used in the Japanese patent record as a “drug” family node linked to a broader global filing set. The scope of protection and the practical landscape in Japan are determined by (1) the independent claim structure in the published Japanese document, (2) how the claims are construed against Japanese written-description and support requirements, and (3) where later filings in the same pharmacological “series” fall on the same compound versus use-versus-method axes.

What is the claim scope architecture in JP2010522773?

Patent families covering drugs typically present one of three claim architectures in Japan:

  1. compound claims (specific chemical entity), sometimes with salt/polymorph variants;
  2. composition claims (formulations, dosage forms); and
  3. use claims (medical use, method of treatment, and sometimes patient subpopulations).

For JP2010522773, the scope is analyzed along four protection levers that map directly to infringement risk in Japan:

  • Molecule definition: whether the independent claim is limited to a single compound by name/structure, or instead covers a genus defined by structural Markush features.
  • Substituent and salt coverage: whether the claim explicitly covers salts, solvates, tautomers, prodrugs, or crystal forms.
  • Therapeutic subject matter: whether it is a method-of-treatment claim (action steps) or a medical-use claim (indication).
  • Dosage/formulation constraints: whether the claims limit route, dose range, regimen schedule, or excipients.

In practice, Japan courts and examiners focus on whether the claim language requires a specific pharmacological action tied to the claimed structure, and whether the written description supports each claim element.

What claims drive enforceable coverage in Japan?

In the Japan published record for JP2010522773, the enforceable value typically concentrates in the independent claim set that covers either:

  • the active ingredient identity (compound claim), or
  • the claimed therapeutic use tied to the active ingredient (use claim), or
  • both, depending on the breadth strategy in the PCT and how the Japanese national phase was prosecuted.

Because Japan claim interpretation is element-by-element and novelty/obviousness depend on claim scope at filing, the “best” claims for business purposes are those that:

  • are broad on structure or salts, and
  • have fewer dosing/regimen limitations, and
  • avoid overly narrow patient or regimen qualifiers that later design-arounds can bypass.

How does JP2010522773 map into the compound-use landscape in Japan?

A robust Japan infringement/clearance analysis for a drug patent family uses three overlays:

  1. Same-compound filings: later patents claiming the same molecule for different uses, combinations, or formulations.
  2. Same-therapeutic-class filings: patents covering “class” variants, prodrugs, metabolites, analogs, and salt/polymorph variants.
  3. Manufacturing and formulation filings: process, particle size, amorphous/crystalline form, and dosage form patents that may still block generic entry even when the core compound claim falls.

For JP2010522773, the practical landscape in Japan typically includes at least one of the following within the family:

  • companion patents directed to salt or polymorph variants,
  • later filings for specific indications within the same drug scaffold, or
  • formulation patents covering dosage forms and stability.

Those companions matter because they determine whether an at-risk generic can rely on a non-covered form (or different salt/crystal) or must design around the use claim or composition claim.

What is the Japan patent landscape around this family node?

The Japan drug landscape is assessed using:

  • Cited prior art relationships (to infer claim vulnerability),
  • family expansion into Japan (to infer residual coverage), and
  • later Japanese continuations (to infer how much room exists for restriction to narrower embodiments).

For a PCT-to-Japan national phase like JP2010522773, the landscape in Japan is generally structured as:

  • Core Japanese national-phase publication (JP2010… series) covering the earliest priority compound/use disclosure.
  • Possible later Japanese publications within the same INPADOC family, covering improvements or narrower subsets (formulations, salt forms, dosing regimens, combination therapy).
  • Independent parallel applications in Japan by third parties (originators, challengers, and generic manufacturers) that may pursue around-the-edge claims.

In this case, the business implication is that clearance in Japan cannot rely on a single document. The correct approach is to check all Japan publications and granted patents in the same family as JP2010522773 and then run a second pass for third-party patents that claim:

  • alternate salts/polymorphs,
  • alternate routes of administration, or
  • alternate combinations with other actives.

What are the claim-design-around vectors in Japan for a JP2010 drug family?

For Japan drug patent families with compound or use claims, the most frequent design-around vectors are:

  • Salt/prodrug substitution: if JP2010522773 covers only a free base, salt variants can fall outside the literal claim while still being close for doctrine-of-equivalents arguments.
  • Crystal form selection: if the claim does not specify polymorphs, generic strategies can select non-covered forms; if the claim does specify forms, generics often need an alternate solid-state form plus a non-infringing formulation.
  • Indication switching: if the claim is use-limited to a specific therapeutic indication, generic entry may still be blocked for other indications through other patents.
  • Regimen/dose constraints: if dosage ranges and dosing schedules appear in independent claims, generics can design around dosing steps while maintaining therapeutic effect.

For business planning, the risk assessment hinges on whether JP2010522773 contains explicit limits on these vectors.


Japan Practical Enforcement and Validity Considerations

How does Japan prosecution affect the enforceable scope of JP2010522773?

Japanese national-phase prosecution often narrows claim breadth through:

  • amendments to satisfy novelty (Kokoku/Kokai prior art) and inventive step,
  • insertion of structural limitations when examiners find “broad genus” lack of support, and
  • conversion between compound and use claim types.

The resulting enforceable scope is therefore not just what the PCT claims looked like in the earliest draft, but what survived in the published Japanese claims. That is why the publication’s claim language is the controlling dataset.

How does Japan written description and support apply to drug claims?

Japan requires support in the specification for claimed subject matter. For drug families this interacts with:

  • breadth of Markush ranges,
  • coverage of salts/polymorphs and prodrugs, and
  • whether the specification contains examples tied to the full claimed genus.

If JP2010522773’s claims are broad, support and enablement determine whether later invalidation arguments can narrow or wipe out portions of claim scope in practice.


Competitive Landscape for Generics and New Entrants (Japan)

What does JP2010522773 imply for generic entry timing in Japan?

Entry timing in Japan depends on:

  • whether the relevant claims cover the specific marketed form of the originator drug (compound, salt, and dosage form),
  • whether later family members still block entry even if one patent family element expires, and
  • the Japanese patent term status (pending, granted, and whether claims were narrowed).

From a business perspective, JP2010522773 should be treated as a baseline coverage document. The real “entry barrier” is the set of active Japan rights that include at least one claim type likely to be asserted against generics: compound, medical use, or composition/formulation.

Where are litigation targets likely to cluster?

Litigation exposure in Japan for drug families clusters around:

  • the active ingredient (literal chemical coverage),
  • the intended medical use (use-claim coverage against label/indication),
  • the dosage form (formulation patents that overlap with approved product presentations).

So if JP2010522773 is compound-centric, generic attackers typically target alternate salts/forms or challenge claim validity. If JP2010522773 is use-centric, label and indication become the battlefield.


Key Takeaways

  • JP2010522773 is a Japan national-phase node that defines enforceable scope via its published claim architecture (compound versus use versus composition levers).
  • The Japanese enforcement landscape depends on whether the claims explicitly cover salts, solid-state forms, dosing regimen constraints, and indication limits.
  • Generic design-around vectors in Japan for such families usually run through salt/prodrug/crystal changes, indication switching, and regimen changes.
  • Clearance planning must extend beyond JP2010522773 to other Japan filings in the same family and adjacent third-party filings that claim improvements in salts, polymorphs, formulations, or combinations.

FAQs

1) Does JP2010522773 primarily protect the compound, the use, or the formulation?
It protects whichever independent claim set in the published Japanese document is compound-, use-, or composition-focused; practical enforcement risk usually concentrates in that independent claim language.

2) Can generics enter Japan by switching to a different salt form if JP2010522773 is a compound claim?
Only if the salt/prodrug/crystal variants are outside the literal claim scope and not captured by the claim’s explicit salt or solid-state coverage.

3) If JP2010522773 has an indication-limited use claim, can competitors relabel for a different indication?
Competitors may avoid that particular use claim only for indications not covered by that specific claim; other family member patents can still block the new indication.

4) Why does Japan require considering the full family, not just JP2010522773?
Because other Japan filings in the same family often cover salts, polymorphs, formulations, or secondary uses that remain enforceable even after narrower claim elements are bypassed.

5) What claim elements most affect invalidation risk in Japan for drug patents?
Breadth of Markush ranges, support for genus coverage, and whether the specification enables the full claimed scope tied to the asserted therapeutic effect.


References

[1] Japan Patent Office (JPO). JP2010522773 (published patent application record).
[2] WIPO. PCT publication record corresponding to JP2010522773 family entry.
[3] INPADOC / EPO family metadata databases indexing the JP2010522773 family links.

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