The Team at Emery Pharma comes with decades of experience in pharmaceutical, chemical, and medical device industries. We understand intellectual property prosecution and litigation support. Emery Pharma is a FDA registered, GLP/cGMP complaint, and DEA licensed contract research lab with experts that can help with your case.
Scientific Litigation Support
Intellectual Property and Patent Infringement Cases
Emery Pharma scientists are experts on numerous solid form patents and patent applications. Drawing from experience with the United States and European patent offices, our team at Emery Pharma fully recognizes the value of high-quality, scientifically valid data and data interpretation.
We also fully understand the value of Intellectual Property Support. With a combined 75+ years of laboratory research support, our unique research offerings can be used to enhance the client’s value during the patent application/patent protection process. We also regularly assist attorneys/agents with the science and technical expertise needed to provide clear support throughout the entire prosecution process.
ANDA (Abbreviated New Drug Applications) Litigation
We work closely with the most prominent law firms and pharmaceutical companies to provide testing on a variety of issues related to pharmaceutical litigation. We provide cutting edge testing and method development on a variety of pharmaceutical technologies including formulation, bioavailability, chemical analysis, solid solution and solid dispersions, excipient interactions, and have the capability to reproduce steps from the formulation process from Abbreviated New Drug Applications (“ANDA”) or Drug Master Formulary (“DMF”). We specialize in providing method development and testing for cases involving analytical chemistry, chemical analysis, organic reactions, polymorph testing, purity analysis, melting point and glass transition. Our scientists have subject matter expertise in a variety of fields ranging from analytical chemistry to FDA regulatory issues and have served on numerous cases as experts charged with opining on validity and infringement issues related to pharmaceutical patents. We have a strong track record of consulting and providing expert testimony in Federal Court related to the complex web of laws related to the Hatch Waxman Act.
In the field of life sciences, Emery Pharma has the capability to measure an active pharmaceutical ingredient (API) in human tissue and bodily fluids samples using the most sophisticated equipment.
Product Liability Cases
We can design analytical investigations to determine the root cause for various product liability cases, including product failures, liability, misbranded products, defects, and contamination in cases ranging from pharmaceutical drugs to consumer products. Our team can also design proactive testing programs to minimize risk and potential failures.
Commercial Claim Evaluation Cases
A claim for the best product requires the backing of scientifically valid evidence, especially when the claim is being challenged. Our team of scientists and technical experts at Emery Pharma can assist with claim evaluations where proper scientific expertise is needed. This includes offering critical review of opposing data, interpretation of technical results, and conclusions.
If the competition is making outrageous claims, yet the customer feedback does not bear those claims, Emery Pharma can also evaluate the validity of the competitors’ claims. Utilizing our extensive experience in pharmaceutical products analysis, Emery Pharma can help your organization develop a strategy that will help prevent counterfeit samples of your product from reaching the market.
When conducting appropriate tests on the evidentiary material, we ensure that all clients fully understand the test result interpretation and its significance to the case. We can observe the trace of controlled substances or other known samples in tissue, blood, hair, bone, and nail.
Drug Chemistry Tests
The team at Emery Pharma is able to extend its techniques into the field of “Forensic Chemistry,” which, in the broadest sense, refers to using various analytical procedures while utilizing traditional chemical principals and instrumentation in a forensic manner.
We perform the identification and quantification of controlled substances, pharmaceutical preparations, and unknown substances. Emery Pharma has an extensive list of methods that can be used in these forensic investigations including: TLC, HPLC, LC/-MS/MS, NMR, and colorimetry.
Depositions and Trial Testimony
Once an analytical investigation has been completed, resulting data may need an expert interpretation and its significance of lack thereof be highlighted. Emery Pharma’s scientists have the capability to serve as an expert witness in claims cases where a recognized specialist in the field is needed to demonstrate the validity of a claim.