A coverage matrix organized by relevant solid-form class, patent application or family, and available scientific evidence.
Identify solid-form patent coverage gaps before they become portfolio risks
This assessment is intended for innovator pharmaceutical companies, solid-state and chemistry, manufacturing, and controls (CMC) teams, portfolio leaders, and patent counsel who need to know whether a patent application or portfolio adequately addresses the solid forms that could matter during development. Triclinic reviews the available screening and characterization record across polymorphs, salts, cocrystals, hydrates, solvates, amorphous forms, and amorphous solid dispersions, then identifies scientific, experimental, and documentation gaps.
The work is normally performed before litigation and before a potential generic abbreviated new drug application (ANDA). It is a proactive scientific coverage review, not an infringement or validity opinion. Counsel remains responsible for claim strategy and legal conclusions.
The content of this page has been scientifically reviewed by Aeri Park, Ph.D., COO at Triclinic Labs · Updated 8/1/2026
When this service is the right starting point
Review coverage while there is still time to address the gaps
- An innovator or development team is preparing a patent application, expanding a patent family, or reviewing the scientific strength of an existing portfolio.
- The team needs to determine which relevant solid-form classes have been screened, characterized, and supported—and which remain unevaluated or weakly documented.
- A coverage review is needed before filing, licensing, a major development commitment, or a future generic challenge makes missing evidence more difficult or costly to obtain.
How Triclinic evaluates solid-form patent coverage
The assessment begins with the target product, disclosed forms, screening history, analytical record, planned claims, and the development or portfolio decision the review must support.
Triclinic organizes the record into a coverage matrix spanning relevant polymorphs, salts, cocrystals, hydrates, solvates, amorphous forms, and amorphous solid dispersions. Each area is classified as adequately supported, partially supported, not evaluated, or in need of additional evidence.
Where gaps matter, Triclinic recommends targeted experiments rather than automatically repeating a full development program. Orthogonal evidence may be needed to establish form identity, stoichiometry, hydration or solvation, purity, crystallinity, structure, reproducibility, stability, and development relevance.
The result is a clear scientific record of what has been covered, what the data support, what remains uncertain, and which gap-closing work should be prioritized. Triclinic supplies scientific findings and recommendations; patent counsel determines claim strategy and legal conclusions.
Questions the coverage review should answer
- Which solid-form classes are relevant to the molecule, product, route of administration, and development strategy?
- Which relevant forms have been screened, prepared reproducibly, and characterized with appropriate analytical controls?
- Where is the current record incomplete, and which additional evidence would close the highest-value gaps?
Techniques commonly considered
- XRPD
- DSC
- TGA
- Raman
- FTIR
- NMR
- chromatography
- microscopy
- SCXRD
- MicroED
- DVS
- Karl Fischer where relevant
What the solid-form coverage review examines
The review is tailored to the molecule and product. Not every theoretical form requires the same level of work; the objective is to identify the areas most likely to affect development value and patent coverage.
| Solid-form area | Coverage questions | Potential gap-closing work |
|---|---|---|
| Polymorphs | Was the screening space broad enough, were forms reproduced, and are form relationships and controls understood? | Targeted polymorph screening, orthogonal characterization, stability studies, and form-conversion testing. |
| Salts | Were relevant ionizable sites and counterions evaluated, and are the selected salt and any salt polymorphs adequately supported? | Counterion screening, salt characterization, disproportionation testing, and comparative property studies. |
| Cocrystals | Was a scientifically relevant coformer space considered, and can cocrystals be distinguished from salts and physical mixtures? | Targeted cocrystal screening, phase assessment, structural characterization, and stability testing. |
| Hydrates and solvates | Are water- or solvent-containing forms known, reproducible, and understood under relevant storage and processing conditions? | Humidity, slurry, desolvation, and variable-temperature studies. |
| Amorphous forms and solid dispersions | Are amorphous material, polymer selection, drug loading, recrystallization risk, and physical stability adequately addressed? | Amorphous and dispersion screening, glass-transition, miscibility, and stability studies. |
| Supporting evidence | Does the record establish reproducibility, analytical distinction, relevant properties, and the limits of prior work? | Repeat preparations, orthogonal characterization, comparative testing, and documentation of successful and unsuccessful conditions. |
Typical deliverables
The output is designed to help development leaders and patent counsel decide what is adequately covered and what should happen next.
Examples and Publications.
These examples and publications provide useful, verifiable context. Each example lists the author, publication date, and a descriptive abstract rather than relying on vague claims.
Other services available
Common Questions
When is a solid-form patent coverage assessment most useful?
It is most useful before an initial filing, continuation or divisional strategy, licensing diligence, portfolio review, or a major development commitment. Performing the review before a generic ANDA or litigation allows more time to address important scientific evidence gaps.
Which solid forms are reviewed?
The scope may include polymorphs, salts, cocrystals, hydrates, solvates, amorphous forms, and amorphous solid dispersions. The molecule, dosage form, route of administration, development history, and planned patent strategy determine which areas are relevant.
Does the assessment provide a legal opinion?
No. Triclinic identifies scientific coverage, evidence strengths, uncertainties, and gaps. Patent counsel remains responsible for claim strategy and legal opinions, including validity and infringement.
Can Triclinic perform experiments to close identified gaps?
Yes. Triclinic can design staged screening, characterization, comparative-property, and stability studies that focus on the highest-priority gaps identified during the review.
How much material is needed?
Material requirements depend on the number and type of gaps, the techniques required, and whether existing samples or data can be used. Triclinic can often stage the work around limited material and confirm quantities after the initial record review.
Review solid-form patent coverage before gaps become costly
Share the relevant patent application or portfolio, compound and product information, form-screening reports, analytical data, development stage, and upcoming filing or portfolio decision. Triclinic will help define a focused coverage review and any priority gap-closing work.
