We are posting a series of articles describing different ways to perform pharmaceutical product and ingredient testing that are relevant to a wide range of litigation and prosecution issues.
Find the first three here, focusing on the role of drug release testing (dissolution testing), viscosity testing, and tablet hardness testing on patent litigation and prosecution. you and your colleagues might find this useful.
Areas of Expertise
Our technical and business experts combine consulting for litigation experience with a deep knowledge of pharmaceutical materials, products, processes, and commercial operation business practices to support IP and antitrust litigation. They provide outstanding performance with high integrity and impartiality.
PIV Pharmaceutical Operations/Commercialization of Brand and Generic Products/Life Cycle Management/PIV Generics Product Launch StrategiesProduct Launch Strategies
Our experts are industry leaders with experience in Life Cycle Management and Loss of Exclusivity strategies of innovator (branded) pharmaceutical products, as well as launching PIV and 505B-2 products. Read more…
Ingredients and Finished Product Testing for Quality Assurance and Regulatory Compliance
Materials and products are tested during process development, commercial manufacturing, and litigation. Read more…
Pharmaceutical Product and Process Design/ Analysis of Patent Infringement
Pharmaceutical formulations and manufacturing processes are evolving rapidly. New materials and processing methods, innovative testing technologies and changing regulatory expectations combine to create a dynamic intellectual property landscape. Are you infringing someone’s patent? Or is someone infringing yours? Read more…
Analysis of Patent Infringement
Abuse Deterrent Formulations and Technologies
Acumen Biopharma has been involved in opioid IP litigations since 2012, working with 7 clients in 9 different cases, both in the US and in Canada.
To date, Acumen scientists have participated in litigations involving approximately 30 different patents. Read more …
Determination of Product Structure
Brand and generic versions of a medicine often contain similar ingredients and are supposed to perform in the same manner.
Are the products the same, or are they different?
It often boils down to particles, and how they are assembled to form the product. Read more…
FROM OUR CLIENTS
“Acumen BioPharma has been instrumental for my practice in intellectual property litigation in the identification of cutting edge technology to conduct scientific analysis. Acumen’s process emphasizes detailed coordination focused on customer deadlines.”
– Patent Litigator, Washington DC
“As a patent litigator involved in Hatch Waxman related cases, I have been very satisfied with the excellence of services and consistent timely delivery received from Acumen BioPharma. Acumen brings together top scientists from different disciplines in pharmaceutical manufacturing technology to conduct in-depth scientific assessment of patents and provide technical advice based on solid scientific grounds.
– Patent litigator, California based law firm
“ In my patent litigation practice, Acumen has consistently been able to provide excellent technical advice, comprehensive laboratory testing services (including re-creation of critical prior art examples) and has done so on very challenging timelines.”
– Patent litigator, major New York area law firm
WHY CHOOSE US?
Connect with and engage experts that will make a meaningful difference.
Work with a “deep bench” of experts supported by highly trained technical personnel who can perform testing, literature searches, computer modeling, statistical data analysis, and many other relevant services.
Leverage the expertise developed by industry leaders.
Reduce the time, expense and risks associated with searching for the right expert, information, analytical technology or laboratory facility.