Expert Witness and Intellectual Property Support for Pharmaceuticals

Pharmaceutical investigational analysis and expert witness services supporting pharmaceutical intellectual property protection

Expert witness services, development, registration and protection of intellectual property are fundamental aspects of the pharmaceutical business model. Modern pharmaceutical products can be extremely complex and examples of intellectual property include incorporating proprietary excipients or novel formulation designs that add valuable release characteristics or help control stability to a medicinal product.

To support the protection of intellectual property, or conversely, to prove that one is not infringing a Patent, sophisticated characterization techniques and a robust analytical approach are required. To conduct these investigational studies, a broad scope of chemical analysis and imaging techniques are utilized by our expert team which includes internationally recognised leaders in their scientific fields who have many years of experience in helping to solve the most complex analytical problems. 

Our Expert Witnesses have been critical in determining the outcome of many legal disputes, where the veracity of complex data and its interpretation has been the critical factor in deciding the outcome of each case. Intertek's pharmaceutical analysis scientists deliver expert chemical analysis and imaging services aimed at understanding and visualizing complicated pharmaceutical structures. We support our clients in their intellectual property protection activities through our Total Quality Assurance expertise, helping them to overcome legal and commercial challenges.

Expert Witness and Intellectual Property Support Services

• Expert chemical analysis investigational services
• Problem solving and formulation troubleshooting
• Expert pharmaceutical materials characterization services
• Data provision suitable for intellectual property support
• Provision of Court Testimony
  • Guidance to the best analytical testing method for the individual situation
  • Broad access to robust and well understood testing methods
  • A very broad analytical suite to address most chemicals, materials, and products
  • An integrated analytical approach that provides ready alternatives
  • Very experienced technical experts to consult on methods, explain results, and write opinions
  • High quality testing data from ISO and GMP laboratories
  • Careful handling of unique samples, including chain of custody and photographic documentation, long term storage, and protection of proprietary information
  • Expert witness to the analytical testing and failure analysis
  • Consulting around a very broad range of analytical testing
   

Intellectual property support case studies

• Detection of stabilising and controlled release coatings, measurement of number of layers, thickness and chemical composition
• Liquid chromatography - mass spectrometry (LC-MS) investigations into pharmaceutical intermediates
• Active Pharmaceutical Ingredient (API) morphology including polymorph type, amorphous versus crystalline, particulate versus molecular dispersion
• API - excipient interactions
• Chemical structure and physical properties of excipients
• Particle size / dispersion / agglomeration
• Packaging integrity / failure studies
• Consulting on measurement protocols
• Controlled release laboratory investigations

Pharmaceutical Chemical Imaging Techniques

• Confocal Raman Mapping
• Global Infra-Red Spectroscopy (FTIR) Imaging
• Confocal Laser Scanning Microscopy (CLSM)
• X-ray Photoelectron Spectroscopy (XPS) and Time-of-Flight Secondary Ion Mass Spectrometry (ToF-SIMS) imaging
• Optical Microscopy or Electron Microscopy (SEM) with Energy-dispersive X-ray spectroscopy (EDX) Imaging
• Atomic Force Microscopy (AFM)

Pharmaceutical Characterization Techniques

• Spectroscopy Techniques (Nuclear Magnetic Resonance Spectroscopy (NMR), FTIR, transmission Raman, UV/ vis, Fluorescence, Circular Dichroism (CD))
• Chromatography Techniques (Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), Ion Chromatography, Gel Permeation Chromatography (GPC), and more)
• Elemental Analysis (Inductively Coupled Plasma Spectroscopy (ICP-MS, ICP-OES), X-ray Fluorescence (XRF))
• Physical Characterisation Techniques (Powder X-ray Diffraction (pXRD), Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), BET Surface Area and more)