Proven expertise in solid-state chemical analysis to support patent application, prosecution, and litigation matters!
The team has extensive experience in pharmaceutical, fine chemical, and medical device intellectual property support - our experts have served as expert and fact witnesses in more than 200 matters worldwide. We routinely provide expert services to innovator and generic pharmaceutical companies in Paragraph IV ANDA Litigation.
By the time a medicinal product reaches the market, an average of 12-13 years will have elapsed since the first synthesis of the new active substance and many other patents likely have been filed for protection of both drug substance and drug product. The patent protection landscape is often complex and scientifically confusing. We assist your legal teams in building scientifically sound claims for patent prosecution. We help pharmaceutical, fine chemical, and medical device companies, large and small, uncover the scientific facts needed to form a strategic response and determine whether to litigate.Triclinic experts can support your patent prosecution and litigation teams with strong, chemistry-based approaches and clear, authoritative opinions and testimony.
Those cases typically required difficult analyses of solid mixtures (e.g. drug products) to determine the presence or properties of individual components and whether infringement is occurring. To meet the unique analytical needs of each situation, Triclinic Labs has developed a wide variety of mapping, imaging, and chemometric techniques.
Experience and offerings include:
- Consulting Expert Witnesses
- Litigation Support (Testifying and Non Testifying Experts)
- Reproduction of Prior Art
- Infringement Analysis
- Patent Prosecution Support
- Paragraph IV ANDA Litigation Support
- Reverse Engineering
- Scientific Demonstrative Consulting
- Organic Chemistry Services
- Analytical Chemistry Services
- Computational Chemistry Services
- Chiral Chemistry Services
- Synthetic Chemistry Services
- Vibrational Spectroscopy Services
- Physical Chemistry Services
Physical and Chemical Analysis for IP Support:
- Design of Experiment
- Chemical Imaging and Mapping
- Contaminant Analysis
- Polymorph Analysis and Infringement Investigations
- Counterfeit and Tampering Investigations
- State-of-the-art Materials Analysis and Identification
- Product Failure Analysis
Our Team Leaders:
David E. Bugay, Ph.D.
An AAPS Fellow, has over 22 years of experience in pharmaceutical development and associated intellectual property support. Since receiving a Ph.D. in Physical Chemistry, he held advancing positions in the Analytical R& D Department of Bristol-Myers Squibb, was Senior VP of Analytical Chemistry at SSCI, Inc., and was Managing Director of the Legal Services group of Aptuit Consulting. Dr. Bugay is recognized world-wide as a leading expert in the area of solid-state analytical chemistry. His expertise includes vibrational and NMR spectroscopy, thermal analysis, x-ray diffraction, microscopy, chemometrics, and scientific aspects of patent litigation. Dr. Bugay has been an invited speaker at dozens of conferences and has taught numerous courses. In addition, he has published many peer-reviewed scientific papers, written book chapters, authored his own book, and served on the USP General Chapters Expert Committee from 2005 to 2010.
Email Dave Bugay or request David Bugay's CV and Case History
Andy Gilkison, Ph.D.
Dr. Gilkison received his Ph.D. in Physical Chemistry from Purdue University in 2005, where his research focused on the investigation of intra molecular relaxation dynamics in super-excited states of small molecules using muli-resonance optical spectroscopy. Dr. Gilkison spent 9 years, prior to joining Triclinic Labs, as a research Investigator at SSCI, Inc., where he later advanced to the position of Senior Research Investigator. There he served as a subject matter expert for vibrational spectroscopy, and developed and validated GMP solid state analytical methods for pharmaceutical.
Email Andy Gilkison or request Andy's CV and Case History
Aeri Park, Ph.D.
Dr. Park received her Ph.D. from the University of Oklahoma and is a recognized industry expert in API solid form screening and selection, solid-state characterization of APIs, intermediates, and drug products, crystallization method development, patent prosecution support, and frequently acts as an expert witness in Paragraph IV litigation matters both domestically and internationally. Dr. Park leads Triclinic’s efforts in physical and analytical chemistry services as well as contributes to its patent prosecution and litigation expert services practice. Dr. Aeri Park, was formerly Director of US Operations for Almac Group and established and grew a US-based analytical laboratory for the firm. Prior to joining Almac, Dr. Park was instrumental in the growth and scientific success of SSCI, a solid-state development group. She is a registered US Patent Agent and routinely consults in patent claim strength assessment projects.
Email Aeri Park or request Aeri Park's CV and Case History
Stephan (Steef) Boerrigter, Ph.D.
Dr. Boerrigter received his Ph.D. in Computational Materials Science from Nijmegen University, The Netherlands, where his research focused on Crystal Morphology Prediction. Prior to joining Triclinic Labs, Dr. Boerrigter spent 12 years at AMRI (formerly SSCI, Inc.), where he advanced to the position of Senior Research Investigator. There he served as a group leader in materials science, focusing on polymorph, salt, and cocrystal screening, applying computational methods for solid-state characterization and phase transitions, as well as structure elucidation by single-crystal diffraction. At Triclinic, Dr. Boerrigter leads the Materials Modeling group in both organic and inorganic analysis and advanced method development and validation capabilities.
Email Steef Boerrigter or request Steef's CV and Case History
Our experts are supported by a team of experienced scientists, and a fully equipped analytical, physical, and organic chemistry laboratory. Our team consists of a large number of other Testifying and Non-Testifying Experts.
Triclinic Experts have been repeatedly tested under Daubert...
The Daubert standard is a rule of evidence regarding the admissibility of expert witnesses' testimony during United States federal legal proceedings. The U.S. Supreme Court in a 1993 case determining the standard for admitting expert testimony in federal courts suggested that the following factors be considered:
-
Has the technique been tested in actual field conditions (and not just in a laboratory)? [e.g.
fingerprinting has been extensively tested and verified not only in laboratory conditions, but even in
actual criminal cases. So it is admissible. Conversely, Polygraphy has been well tested in
laboratories but not so well tested in field conditions]
- Has the technique been subject to peer review and publication?
- What is the known or potential rate of error?
- Do standards exist for the control of the technique's operation?
- Has the technique been generally accepted within the relevant scientific community? [this test was earlier the only relevant criterion under Frye]
Although trial judges have always had the authority to exclude
inappropriate testimony, prior to Daubert, trial courts often preferred to let juries hear evidence proffered by both sides. Once certain evidence has been excluded by a Daubert motion, it will likely be challenged when introduced again in another trial.