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.
LABORATORY TESTING, CONTROLLED SUBSTANCES MANAGEMENT, LITERATURE SEARCHES
Antitrust laws also referred as “competition laws” are intended to ensure that there is fair competition in an open-market economy to protect consumers. This is not protection from competition, but instead through competition, the antitrust laws serve as a core component of U.S. economic policy. Intellectual Property litigation between the innovator product (branded) company and generic manufacturers with PIV filings may end in settlements between the players that may potentially infringe antitrust laws. Some types of pharmaceuticals antitrust cases include:
- Reverse payment or pay-for-delay
- “Product hopping” through the introduction of new versions of brand name products facing generic competition
- Drug product price fixing practices
Our industry leading experts have extensive experience in pre and post pharmaceutical product Life Cycle Management and Loss of Exclusivity (LOE) strategies, as well as commercialization of PIV and 505 B2 generics. The cross functional operational team has been closely involved in the planning and execution of generic and branded product launches including:
- Regulatory compliance
- Manufacturing site readiness strategies
- Inventory management
- Product pricing
- Market access strategies
Our hands-on consultants provide objective and thorough analysis of data to support clients in the assessment of the industry practices and procedures applied by the parties of the antitrust litigation. All service follows Acumen principles and values that are built on the highest level of integrity and objectivity.
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).