Details for Patent: 7,709,682

Which drugs does patent 7,709,682 protect, and when does it expire?

Patent 7,709,682 protects LIVDELZI and is included in one NDA.

This patent has thirty-one patent family members in twenty-five countries.

Summary for Patent: 7,709,682

Title:	Lysine salts of 4-((phenoxyalkyl)thio)-phenoxyacetic acid derivatives
Abstract:	The present invention is directed to a novel lysine salts, pharmaceutical compositions containing them and their use in the treatment of disorders and conditions modulated by PPAR delta. The present invention is further directed to a novel process for the preparation of said lysine salts.
Inventor(s):	Ahmed F. Abdel-Magid, Steven J. MEHRMAN, Armin Roessier
Assignee:	Janssen Pharmaceutica NV
Application Number:	US11/531,464
Patent Claim Types: see list of patent claims	Compound;

Scope and Claims of US Patent 7,709,682 and the US Patent Landscape Around the Crystalline L-Lysine Salt (R)-{4-[2-Ethoxy-3-(4-trifluoromethyl-phenoxy)-propylsulfanyl]-2-methyl-phenoxy}-acetic acid

US 7,709,682 is a solid-state crystalline-patent focused on a specific API stereochemical core and a specific counterion: an L-lysine salt of (R)-{4-[2-Ethoxy-3-(4-trifluoromethyl-phenoxy)-propylsulfanyl]-2-methyl-phenoxy}-acetic acid. The claims are defined entirely by crystalline X-ray diffraction peak sets (powder XRD), with multiple peak-list variants. As drafted, the US exclusion is strongest against products that practice the claimed crystalline form(s) and weaker against salt-forms that change polymorph peak identities, swap the counterion away from L-lysine, or reformulate via different crystalline forms.

What exactly is claimed in US 7,709,682: crystalline L-lysine salt defined by XRD peaks?

Claim scope (core chemistry). Every independent claim you provided recites the same chemical entity: a crystalline L-lysine salt of (R)-{4-[2-Ethoxy-3-(4-trifluoromethyl-phenoxy)-propylsulfanyl]-2-methyl-phenoxy}-acetic acid.

Claim scope (solid-state definition). Each claim then limits the scope to a crystalline material that has a defined powder X-ray diffraction fingerprint.

Key practical point. These are not “functional” crystallinity claims. They are sequence-of-2θ peak list claims. In enforcement and validity arguments, the contested issue typically becomes whether an accused product’s diffraction pattern matches the claimed peaks within the patent’s implicit/typical tolerance used in the US (often defined in practice by expert methodology and instrument conditions, though the patent language itself does not provide tolerance in the excerpt you supplied).

How broad are the four peak-list claim variants you provided?

Your excerpt shows four claim versions, each defined by a different subset of XRD peaks. That structure usually indicates the specification describes multiple crystalline “forms” (or multiple peak-identification sets that are considered equivalent for claim purposes).

• Claim 1 (long peak list): contains the broadest peak set in your excerpt (more peaks listed).
• Claim 2 (shorter peak subset): lists a reduced set (fewer peaks).
• Claim 3 (expanded variant list): includes a different set of peaks with a broader number of entries than claim 2 and fewer than claim 1 in your snippet.
• Claim 4 (intermediate subset): uses the reduced subset like claim 2 but with different peak entries.

Enforcement consequence. When multiple peak lists exist, the patentee can often assert that an accused crystal form infringes at least one claim variant, even if it does not match every peak listed in the longest list. Conversely, a generic or new salt/crystal developer can sometimes design around by selecting a crystalline form whose XRD peaks omit one or more required peaks in all claim variants.

How do the XRD-peak claims define “infringement” risk for generics and crystal engineers?

Featured snippet answer. Infringement hinges on whether the accused crystalline L-lysine salt’s powder XRD pattern includes the claimed peak positions (2θ) and corresponding d-spacings that match the claim sets.

What makes these claims difficult to design around?

1. Specific stereochemical API core is fixed. The claims do not cover the racemate or other stereoisomers by name. A design-around could attempt a different stereochemistry or a different absolute configuration; but that is usually not trivial for a chiral drug.
2. Counterion is fixed to L-lysine. Switching from L-lysine to another lysine enantiomer (D-lysine) or another base changes salt identity and is a direct non-infringement path on its face.
3. Multiple crystalline forms are already captured via multiple peak lists. The presence of several peak subsets makes it harder for a challenger to find a “near neighbor” polymorph that avoids all lists.

What makes these claims easier to challenge?

1. XRD reproducibility and peak assignment. Accused materials can be tested under different measurement conditions. While infringement does not normally rely on measurement artifacts alone, peak shifting and intensity variability can support non-infringement arguments when the claim language is strict about peak positions.
2. Potential overlap with known crystals or mixtures. If prior art crystals exist that already match one of the listed peak subsets, the claims can be attacked as not novel or not inventive (depending on what the patent cites and what the prior art actually shows).
3. Indefiniteness risk (often litigated). Peak-list claims can be attacked for lack of clear boundaries if the patent does not define tolerances. Whether that argument succeeds depends on the exact US claim language and prosecution history, neither of which is included in your excerpt.

What patents protect this compound class in the US: how to think about the US “estate” around a crystalline salt?

Even without the rest of the patent family data, a crystalline-salt estate in the US typically clusters into four patent layers:

1. Core active ingredient patents
   Cover the (R)-{...}-acetic acid scaffold, stereochemistry, and routes to make it.
2. Salt formation patents
   Cover L-lysine salt formation, sometimes including multiple counterion salts (and salts with different stoichiometries).
3. Polymorph/crystal form patents
   Cover specific crystalline forms via XRD peaks, DSC, Raman, solid-state IR, and sometimes preparation conditions.
4. Formulation and method-of-use patents
   Cover dosage forms (tablets, capsules), excipients, controlled release, and therapeutic uses.

Where US 7,709,682 usually sits: the claim text you provided is squarely in layer 3: polymorph/crystal form coverage for a particular salt of a fixed chiral API.

How many “other” patents typically share the same target?

For a crystalline salt like this, common estate outcomes in the US are:

• One family member for the salt itself (broader),
• One or more family members for particular polymorphs (narrower but enforceable),
• Additional family members for preparation methods or seed crystals (often used in manufacturing disputes),
• Separate later filings for formulations.

Without the citation list and family members, a precise “how many” count cannot be produced from your excerpt alone.

When does US exclusivity end and when do generic risks rise: how to map this patent to launch timing?

A correct exclusivity/timing analysis requires:

• the priority date(s),
• application filing date,
• patent term adjustments,
• any pediatric extensions,
• whether an Orange Book listing exists for the same active,
• whether the patent is listed as method-of-use or drug-substance/drug-product.

Your excerpt does not provide priority/filing dates, Orange Book status, or FDA product mapping. Under the constraints, a complete exclusivity timeline cannot be generated.

What is the Orange Book status of US 7,709,682?

To answer Orange Book status, the patent number must be tied to:

• an approved drug listing,
• an FDA application number (NDA/BLA/ANDA/505(b)(2)),
• listed patent type (drug substance, drug product, method of use),
• and whether it lists a crystalline form of the salt.

No Orange Book listing data is included in your excerpt; therefore, a factual status statement cannot be made.

What generic entry risks exist for the crystalline L-lysine salt: do Paragraph IV challenges matter?

Paragraph IV risk depends on:

• whether this patent is listed in the Orange Book,
• whether an ANDA is pending or approved with a section viii carve-out/design-around,
• and the scope of the generic’s manufactured solid state.

A Paragraph IV “risk” assessment cannot be stated as fact from the claim excerpt alone.

What formulation patents or method-of-use claims could be adjacent to US 7,709,682?

Crystalline salt patents often pair with:

• preparation method patents (seeded crystallization, specific solvent systems)
• particle size / micronization patents (if not identical to crystallinity claims)
• tablet formulation patents (binder, disintegrant, coating)
• stability patents (humidity/temperature stability of the crystalline salt)
• bioavailability patents (solid state affecting dissolution)

However, no related US patent numbers, assignees, or citations are provided with your prompt. Without that, a mapped adjacent landscape cannot be produced in a factual, numbered form.

How strong is the patent estate for blocking alternatives: crystal-form claims vs salt/counterion substitutes

Strength profile of US 7,709,682 (based on your claim language):

• High leverage against direct crystal-form copying of the claimed L-lysine crystalline material.
• Moderate leverage against “same salt, different polymorph” if at least one claim variant matches the accused pattern.
• Lower leverage against counterion swaps (e.g., D-lysine, other amines, different stoichiometries) and against different crystalline forms that do not include at least one required peak from each claim variant.
• Lower leverage against non-crystalline forms (amorphous solids) if they avoid the defined crystalline peaks.

Potential validity friction:

• If earlier literature or earlier filings describe identical crystalline peak sets for the same salt, novelty and inventive step can be challenged.
• If the patent’s disclosed experimental data does not support all peak-list variants as distinct, or if alternative forms overlap, the claims may face construction issues.

Claim construction: how courts typically read peak-list crystalline claims

In US practice, peak-list claims generally get construed with attention to:

• The measurement method (Cu Kα radiation is typical but not guaranteed unless specified)
• Calibration and instrument alignment
• Whether peaks are required exactly or within a stated/implicit tolerance
• How to treat absent peaks with low intensity

Because the tolerance and method are not included in your excerpt, the only defensible statement is that the claims require the presence of the listed peaks as defined in the claim.

Key claim-by-claim breakdown (from your excerpt)

Claim 1

Crystalline L-lysine salt of (R)-{4-[2-Ethoxy-3-(4-trifluoromethyl-phenoxy)-propylsulfanyl]-2-methyl-phenoxy}-acetic acid comprising XRD peaks at:

• 5.270, 7.882, 9.683, 10.370, 11.611, 19.561, 19.921, 20.652, 21.963, 23.162, 23.710, 23.883, 23.969

(Full peak list in your text also includes the 2θ values 11.2170, 9.1342, 8.5312, 7.6218, 4.5383, 4.4571, 4.3009, 4.0471, 3.8403, 3.7527, 3.7228, 3.7188 with corresponding d-spacings.)

Claim 2

Crystalline L-lysine salt comprising XRD peaks at:

• 5.270, 9.683, 19.921, 23.162 (and in your excerpt only the reduced subset through 23.162; plus listed d-spacings 4.4571 and 3.8403).

Claim 3

Crystalline L-lysine salt comprising XRD peaks at:

• 5.285, 9.255, 9.501, 9.976, 15.017, 18.417, 18.799, 19.102, 19.430, 19.990, 20.327, 20.643, 21.276, 21.989, 22.693, 23.187, 23.931, 24.084, 25.642, 26.462, 27.973 (with corresponding d-spacings as listed in your text).

Claim 4

Crystalline L-lysine salt comprising XRD peaks at:

• 9.255, 18.799, 19.102, 20.643, 21.989, 23.187 (again with d-spacings as provided).

What is the actionable decision impact for R&D, licensing, and litigation?

For R&D (solid-state development):

• If the commercial strategy requires freedom to operate, the development target must be a crystalline form whose powder XRD does not meet any of the listed peak sets for the L-lysine salt.
• Counterion and stereochemistry design-around is more direct than attempting to “shift” peaks slightly, because peak-list claims are strict.

For licensing and diligence:

• Treat US 7,709,682 as a crystal-form bottleneck: it can block manufacturing even if you have freedom on core API synthesis and general salt formation, unless your product avoids the specific peak fingerprints.

For litigation posture:

• The central infringement issues are powder XRD matching and claim construction of peak presence.
• The central invalidity issues are prior art that already discloses the same crystalline L-lysine salt peak sets or renders them obvious.

Key Takeaways

• US 7,709,682 protects a specific chiral API scaffold as an L-lysine salt and restricts coverage to crystalline materials defined by powder XRD peak lists.
• The patent’s practical enforcement scope is driven by whether an accused product matches at least one of the claimed XRD peak variants.
• Design-around is most feasible via counterion changes (away from L-lysine) or selecting different crystalline forms that omit required peaks across all claim variants.
• A full US landscape mapping (expiration, Orange Book status, Paragraph IV, litigation) cannot be stated from the claim excerpt alone.

FAQs

1. Can a different polymorph of the same L-lysine salt avoid US 7,709,682?
   Yes if its powder XRD does not match the required peak sets in all asserted claim variants.

2. Does using D-lysine instead of L-lysine avoid the claims?
   Yes on the face of claim scope because the claims require an L-lysine salt.

3. Are formulation tablets or capsules automatically covered by a crystalline salt patent?
   Not automatically. If the crystalline form is the same and the claims cover the crystalline drug substance, the product may still infringe, but formulation-specific defenses depend on claim boundaries and product evidence.

4. What is the main technical test for infringement for peak-list crystalline claims?
   Powder XRD on the accused solid under comparable measurement conditions to determine presence of the claimed 2θ peaks.

5. How do multiple peak-list claims affect generic design-around strategies?
   They broaden the infringement net, so design-around must avoid matching the peak sets in each claim variant the patentee may assert.

References

1. US Patent 7,709,682 (claims provided in prompt text).

Drugs Protected by US Patent 7,709,682

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Gilead Sciences Inc	LIVDELZI	seladelpar lysine	CAPSULE;ORAL	217899-001	Aug 14, 2024		RX	Yes	Yes				Y

International Family Members for US Patent 7,709,682

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1937065		C20253005	Finland
European Patent Office	1937065		CA 2025 00024	Denmark
Argentina	058044
Australia	2006291006