Since drug polymorphs are considered susceptible to patent protection in most of the world, they have been used for several decades as a tool to create valuable IP by either innovative companies seeking to delay market introduction of generics, or by generic companies seeking to capture increased market share. This is facilitated, among other factors, by the fact that a polymorphic form of an API used to formulate a final dosage form may be unequivocally identified by using proper analytical techniques.
For a generic company, the IP activities are performed in two directions:
- Activities to ensure freedom to operate (FTO)
- Activities to obtain patents on proprietary crystal forms (IP creation)
A generic company seeking differentiation from other generic players may combine these activities by turning the challenge presented by innovator crystal form patents into an opportunity to create its own IP as a valuable differentiator in the highly competitive arena of generic pharmaceutical manufacturers.
Familiarity with the legal attitudes, combined with scientific expertise, creates the winning interface for a strong position in all IP matters.
In the field of polymorph/solid state, Oriento offers highly qualified scientific support for any legal activity, such as:
- Patent litigations
- Patent oppositions
- Analyses of solid-state patent and scenarios, for selected products
- Strategies for intellectual property enhancement
- Broad polymorph patent analyses for marketing purposes
- Patent prosecutions
- FTO analyses
- Upon customer request, services may be added, modified, or tailor-made.