IP & Legal Support
The discovery of new physical forms after product launch is an ongoing, expensive problem for innovator companies; such as the cases of ritonavir and rotigitine. However, opportunities exist to extend exclusivity rights through solid state patents. Exploitation of physical forms to generate new intellectual property is a popular strategy for generic drug manufacturers.
Wide-ranging experience in patent prosecution and litigation
Our scientific litigation and prosecution support team have lectured at the European Patent Office on solid state issues. They have access to the expertise found across the entire Almac Group; esteemed professors and over 200 highly skilled PhDs in solid state chemistry, organic chemistry, formulation science, and analysis.
- Expert witness services (testifying / non-testifying)
- Paragraph IV
- Technical consultancy
- Advice and support for successful patent prosecution in Europe and the US
- Case-by-case scientific strategy
‘Robustness of form’ screening
Polymorph screening on all new drug substances has been required by the regulatory authorities since the publication of ICH Q6A in 1999. However, drug products launched prior to this date may not have had a rigorous investigation into their tendency to change physical form. As a result, the unexpected appearance of new forms can appear years after product launch or after seemingly minor changes to processes. Alterations of form can lead to batch failures, reductions in efficacy and even product withdrawal.
We can provide ‘robustness of form’ screening for older drugs, to mitigate the risk of physical form change and allow for the implementation of control measures during changes in manufacturing or formulation. Our screening method is designed to identify the solid forms of the API most likely to be produced during the stresses of processing and on exposure to formulation components.