SERVICES

■ Are you an intellectual property attorney in need of scientific expert witnesses and/or laboratory testing to support patent litigation?

■ Are you seeking the testimony of seasoned hands-on industry executives regarding manufacturing and commercialization of generic drugs for an antitrust case?

■ Are you a pharmaceutical scientist seeking help in solving a formulation or manufacturing problem affecting product quality?

We offer comprehensive services to address these and many other issues.


PATENT LITIGATION

3D-legal-clipart--illustration-000039737352_MEDOur 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

Pharmacist-holding-bowl-of-pills-MEDMost 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

DNA-Sequence-000028306600_MEDWe 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.

IP STRATEGY

intellectual-property-MEDOur 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).

Interested in learning more about OUR SERVICES?

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?

  • A strong network of top academic and industry scientists

  • World-leading research programs in pharmaceutical processing, manufacturing, powder technology, and other critical topics

  • Extensive experience in pharmaceutical regulations