Case Studies - Acumen BioPharma

Our expert witnesses have extensive background, integrity, and uncompromising credibility in pharmaceutical formulation, dosage form manufacturing, process design, characterization of pharmaceutical materials and powder blends, liquids, suspensions and solutions, films technology, capsules, tablets and more.

With a working knowledge of patent law and a deep understanding of infringement and validity issues, they have considerable experience working as background consultants and testifying witnesses

This practical acumen complements their strong technical knowledge, creating a powerful combination in support of litigation services.

Read about some of our case studies.

Case Study 1 – The internal structure of a pharmaceutical product

The Challenge:

The case required elucidation of the internal structure of capsules manufactured by wet granulation followed by blending. Litigation required high-resolution testing of the capsules to determine which ingredients were in contact with other ingredients.

The Acumen Approach:

Acumen BioPharma formed a team of three senior academic experts supported by three laboratory researchers working in four different laboratories, using a combination of experimental methods (Scanning Electron Microscopy, Energy Dispersive Spectroscopy,Raman Scanning Spectroscopy, X-Ray Computer Tomography) and computer models to examine the frequency of ingredient contacts within capsules. These techniques were used to acquire high-resolution pictures of the internal structure of the particles within the capsule.

The Result:

Results demonstrated a high number of contacts between critical ingredients; case was settled in client’s favor.

Case Study 2 – Abuse deterrent opioid products litigation, 2013

The Challenge:

The case required replicating Hot Melt Extrusion tablets to examine their hardness.

The Acumen Approach:

Acumen formed a team of three experts and five laboratory researchers from academia to:

Implement a hot melt extrusion tablet manufacturing process per prior art description and use the process to manufacture tablets for a variety of testing conditions.
Test the hardness of tablets manufactured according to the prior art process.
Test the prior art tablets to determine whether the tablets infringed patent claims.
Perform multiple literature searches in support of expert reports.
Assist attorneys in preparing trial demonstratives.
Provide court testimony.

The Result:

Case was won by Acumen client and two patents were invalidated.

Case Study 3 – Abuse deterrent opioid products litigation, 2013 (same case as above)

The Challenge:

The case required examining the ability of commercial formulations to form threads when dissolved in a small amount of water and injected into a second fluid.

The Acumen Approach:

Acumen BioPharma designed and performed experiments to test the rate at which liquids would mix when a viscous solution was formed by dissolving a commercial tablet in 10 ml of water and then injecting the solution into a container of aqueous liquid maintained at a controlled temperature. Results demonstrated that the behavior of the injected liquid depended strongly on stirring conditions.

The Acumen team also performed multiple literature searches in support of expert reports, assisted customers in preparing trial demonstratives and provided court testimony.

The Result:

Case was won by Acumen client and two patents were invalidated.

Case Study 4 – Abuse deterrent opioid products litigation, 2014

The Challenge:

The case required replicating prior art Hot Melt Extrusion tablets and examining the viscosity of solutions obtained when dissolving the tablets in 1 to 10 ml of water.

The Acumen Approach:

Acumen worked with two defendants, using the same team as in the 2013 litigation to provide services that included:

Manufacturing additional tablets using hot melt extrusion and direct compression.
Testing the viscosity and syringeability of solutions prepared using both hot melt extrusion tablets and direct compression tablets.
Demonstrating that the language in the patent regarding viscosity testing was indefinite.
Supporting claim construction arguments.
Performing multiple literature searches to complement expert reports.
Assisting attorneys in preparing trial demonstratives.
Providing court testimony.

The Result:

Case was won by Acumen client and a patent was invalidated.

Case Study 5 – Internal structure of tablets manufactured by direct compression and by hot melt extrusion

The Challenge:

The case required examining the internal structure of hot melt extrusion and direct compression tablets to determine whether the processes were equivalent.

The Acumen Approach:

Acumen formed a team of four senior academic experts and six laboratory researchers working in four different laboratories to:

Test the internal structure of tablets using Scanning Electron Microscopy, Energy Dispersive Spectroscopy, Raman Scanning Spectroscopy, and X-Ray Computer Tomography.
Test product performance and compare it to the attributes of the claimed products.
Articulate sound technical arguments demonstrating that the processes generated products with very different attributes.
Support clients in building claim construction arguments.
Provide deposition testimony.

The Result:

Case was settled favorably post-deposition without going to trial.

Case Study 6 – Internal structure of tablets manufactured by alternative methods

The Challenge:

The case required evaluating the equivalence of pharmaceutical formulations and manufacturing methods involving alternative ways to enhance bioavailability.

The Acumen Approach:

Acumen assembled a team of four academic experts to:

Complete a comprehensive literature review and analysis of prior art in support of a doctrine of equivalents infringement case.
Develop sound technical arguments to defend patents against invalidity attacks (anticipation, indefiniteness, lack of written description).
Provide deposition testimony.

The Result:

Case was settled favorably post-deposition without going to trial.

Case Study 7 – Comparative analysis of tablets with different coatings

The Challenge:

The case required the analysis of tablets coated with an enteric polymer, both with and without sub-coats. Infringement was based on whether the sub-coat effectively separated the drug substance from the enteric coating material.

The Acumen Approach:

The Acumen expert witness team came together to provide:

Comprehensive literature review.
Analysis of prior art regarding the role of coating materials and methods to examine the accused process from the perspective of the patents en suit.
Sound technical arguments and court testimony to defend the client against untrue infringement allegations.

The Result:

Case was settled in favor of the client.

Case Study 8 – Internal structure of a tablet

The Challenge:

The case required the analysis of the internal structure of tablets manufactured by direct compression and their potential infringement of a patent that claimed that the drug substance was coated by an insoluble polymer.

The Acumen Approach:

Acumen assembled a team involving a senior academic expert supported by two additional laboratory researchers to:

Perform a comprehensive literature review and analysis of prior art regarding the role of insoluble polymers acting as sustained release agents.
Perform microtoming and SEM/EDX measurements of the accused tablets to demonstrate that the drug substance was indeed coated by the insoluble polymer within the tablet matrix.
Develop sound technical arguments to support the infringement allegations.
Provide court testimony supporting the infringement allegations.

The Result:

Case was won by Acumen client, an innovator company, with the product proven to infringe the patents en suit.

If you are ready to find out how Acumen BioPharma can help you – Click here to contact us today