Our senior experts have been involved in pharmaceutical IP litigation for over 15 years, and have participated in numerous cases involving patent invalidity and infringement. Clients have included developers and manufacturers of both branded and generic products.
Available services include:
- Scientific strategy consulting
- Identification and referral of the most capable experts
- Expert witness testimony
- Literature searches
- Laboratory testing at one of our six partner universities and specialty labs
- Project management
Recent cases have typically included one or more expert witnesses supported by a laboratory team with assistance from additional team members performing documentation and literature search services, and managed by an Acumen BioPharma project manager.
Most of our cases were settled out of court and their records remain confidential, preventing Acumen BioPharma from describing our role in those cases (attorney references available on request). However, two high-profile cases in which Acumen BioPharma participated and that were litigated to completion have been the Oxycodone 2013 and 2014 cases in NY federal court. Links to the Judge Alfred Stein decisions in both cases can be found in the links below.
SAMPLE PREPARATION & TESTING
Most of our cases require the preparation and testing of samples to determine whether a product or a material infringes a patent claim. In order to provide these services with accuracy, integrity, and maximum speed, we have developed comprehensive master service agreements with six major US universities.
Available services include:
- Preparation and testing of samples: ingredients, blends, unit dosage forms, and commercial products
- Testing for a wide range or material properties for ingredients and blends: particle size distribution, powder flow, wettability/hydrophobicity, electrostatics, blend homogeneity, segregation tendency, agglomeration tendency, solubility, chemical partition and saturation, gas permeability through polymers
- Capability to prepare many types of dosage forms: tablets, capsules, films, solutions, suspensions
- A wide range of dosage form preparation technologies: blending, wet granulation, roller compaction, fluid bed processing, hot melt extrusion, tableting, capsule filling, dry and wet coating
- Extensive capabilities to test prepared dosage forms and commercial products: content uniformity, dissolution, disintegration, chemical imaging and determination of product structure via SEM, EDS (EDX), X-ray CT, NIR imaging, Raman imaging
Testing services are conducted using state-of-the-art technology and industry-standard documentation protocols, including chain-of-custody procedures, laboratory notebooks, electronic data generation, storage, and transfer, and technical reports designed to meet client needs. Results are reported with maximum speed and integrity. Testing is conducted in non-cGMP facilities.
LEGAL SUPPORT SERVICES
We strive to support our clients in a comprehensive and efficient manner. Our operational processes are continuously adapted to maximize our clients’ effectiveness:
- Project management services, supporting multi-functional teams comprising client representatives, multiple expert witnesses, technical experts, laboratory personnel, and support personnel at Acumen BioPharma
- Materials management capabilities, including purchasing, transferring, and storing controlled substances, sample preservation, and materials disposal
- Literature searches conducted by PhD scientists who are capable of performing comprehensive and thorough searches in a minimum amount of time, providing clients with highlighted technical references and an analysis of their relationship to the case matter
Testing services are conducted using state of the art technology and industry-standard documentation protocols. Results are reported with maximum speed and integrity.
PROCESS TROUBLESHOOTING, QUALITY COMPLIANCE AND TECHNICAL TRAINING (FOR PHARMACEUTICAL SCIENTISTS)
Our extensive experience in pharmaceutical product and process development and regulatory compliance is also extensively utilized by pharmaceutical companies to address a number of needs:
- Conceptual design of pharmaceutical products and manufacturing processes
- Process troubleshooting: overcoming product failures, identification of failure causes, designing product testing plans, and supporting companies in their efforts to achieve and maintain quality compliance
- Technical training: formulation methodologies, manufacturing methods, implementation of continuous manufacturing systems, characterization of material properties, QbD, PAT, and statistical methodologies
Our experts have pioneered the use of process modeling methods that are becoming increasingly useful in product and process development and regulatory filings:
- Discrete element modeling of powder processes
- Computational fluid mechanics modeling of liquids, gases, and suspensions
- Population balance models of granulation, drying, milling, and blending processes
- Statistical modeling methodologies including DOE, RSM, PCA, PLS, and many others
- Residence time distribution and flowsheet process models for continuous manufacturing systems
Our services in this area focus on proactive management of IP issues. We help innovators to identify opportunities for developing IP. This includes analyses of the patent landscape, identification of opportunities for innovative development, help in articulating inventive concepts, and critical analysis of patent language to identify and mitigate weaknesses, resulting in stronger patents.
We also help clients determine whether they are infringing a patent (or whether a competitor is infringing their patent) by performing a technical analysis of the accused product, method, or process relative to the relevant patents.
Also, we advise clients that seek to minimize the probability of infringing an existing patent. This includes an analysis of the scope of existing patents, and identification of product design methodologies that reduce the probability of infringement (whether literally, or under doctrine of equivalents).