Abstract
This chapter deals with pharmaceutical solid forms and solid form patents. The two principal criteria – novelty and obviousness – for a patent for a solid form (polymorph, salt, solvate, hydrate, amorphous) are defined and discussed from scientific and legal points of view. Following a number of landmark historical developments, several examples of the role of serendipity in the discovery of solid forms are presented. Examples of typical ex post facto arguments for and against the obviousness of crystal forms are cited from recent patent litigations, providing a framework for defining current case law for patents on solid forms.
| Original language | English |
|---|---|
| Title of host publication | Polymorphism in the Pharmaceutical Industry |
| Subtitle of host publication | Solid Form and Drug Development |
| Publisher | wiley |
| Pages | 469-483 |
| Number of pages | 15 |
| ISBN (Electronic) | 9783527697847 |
| ISBN (Print) | 9783527340408 |
| DOIs | |
| State | Published - 1 Jan 2018 |
| Externally published | Yes |
Keywords
- Historical developments
- Legal opinions
- Novelty
- Obviousness
- Patents
- Polymorphs
- Recent litigations
- Serendipity
- Solid forms
ASJC Scopus subject areas
- General Chemistry
- General Chemical Engineering