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 U.S. and in Canada.

To date, Acumen scientists have participated in litigations involving approximately 30 different patents. The following were found invalid:

  • US 7776314
  • US 8309060
  • US 8714383
  • US 8337888
  • US 9675610

Other critical patent cases include: US 9095614, US 9095615, US 9084816, US 8529948, US 8808740, and US 7968119.

Three of our expert witnesses (Dr. Muzzio, Dr. Somma, and Dr. Cuitino) have provided reports, deposition testimony, and trial testimony regarding a wide range of topics involving claim construction, patent infringement (both literal and under doctrine of equivalents), and patent invalidity (anticipation, obviousness, indefiniteness, lack of written description, and lack of utility in Canada).

Acumen has also supported a wide range of laboratory services to provide critical data points. These measurements have included testing commercial products for five specific attributes to determine whether commercial tablets of the innovator and generic company fell within the patent specifications. These attributes include:

  • Tablet “hardness” or crushing strength, which was tested using a standard hardness tester, a hammer, and an Instron system;
  • Tablet density before and after heat treatment;
  • Tablet dissolution, which was tested four different times using USP I and II apparatuses and three different times in dissolution media (SGF, SIF, standard buffer);
  • Viscosity of tablets dissolved in a small amount of aqueous fluid; and
  • Injectability of dissolved tablets

In addition to commercial tablets, laboratory tablet samples were prepared by Acumen scientists to examine whether (1) prior art tablets anticipated the patents in suit, and (2) the claims of the patents where indefinite. The Acumen scientists prepared tablets using the following five methods: hot-melt extrusion, direct compression without heat, direct compression with subsequent application of heat, direct compression with simultaneous heat, and direct compression with preceding heat.

Finally, the internal structure and coating characteristics of both commercial tablets and laboratory-prepared samples were examined using a variety of methods, including Scanning Electron Microscopy (SEM), Energy Dispersive X-ray spectroscopy (EDS or EDX), X-ray computer tomography (X-ray CT), 3D Raman scanning microscopy, and Near-Infrared Scanning microscopy.

All tests were carried out following protocols developed by Acumen scientists, and documented using laboratory notebooks, spreadsheets, photographs, and movies. The team also supported this work with literature searches and analysis of prior art literature, scientific publications, NDA and ANDA documents, batch records, and numerous other files.

Results from these and other laboratory tests were incorporated into expert reports and court demonstratives, and laboratory results were cited by multiple judges as being highly relevant to court decisions.