We have 30 years of expertise in developing drug discovery assays and methods for regulatory (e.g. FDA, EU) approvals. MarinBio ensures that our clients’ IP and patent-related challenges are expertly managed to achieve successful outcomes. At MarinBio, we recognize the significant impact that Intellectual Property (IP), have on the healthcare, diagnostics, medical device, pharmaceutical, and biotech industries.
These disputes often lead to litigation, particularly over issues such as the validity of patent claims, the reproducibility of results using contemporary methods and equipment, and the uniqueness and commercial application of specific methods. Our comprehensive understanding of both the scientific and legal aspects of drug development and IP disputes positions us as a valuable partner for pharmaceutical, biotech, and healthcare companies seeking to protect their innovations and resolve IP-related challenges.
MarinBio offers comprehensive support to navigate the complex landscape of drug development and IP protection. MarinBio’s services are particularly relevant in addressing several key areas of IP disputes:
Patent Validity and Reproducibility: MarinBio’s expertise in cell-based assays and potency testing can be crucial in validating patent claims and demonstrating reproducibility of results. This is especially important in cases where the validity of a patent is challenged based on the methods and equipment available at the time of patent issuance. Some of these methods were employed during the 1990’s or earlier. MarinBio’s scientists have supported other patent validity involving molecular biology (mRNA expression) biochemistry (protein expression) as well as cell biology (cell expression and differentiation).
Trade Secret Protection: In cases where patenting may not be feasible or desirable, MarinBio can assist in developing strategies to protect valuable trade secrets.
Litigation Support: MarinBio’s scientists are well-versed in the importance of confidentiality, record-keeping, and patent law in litigation contexts. They have provided expert witness testimony in trials and depositions and support in IP disputes, offering professional insights based on their extensive experience in drug discovery and development.
Regulatory Compliance: The company’s expertise in developing validated potency cell-based assays and other assays is crucial for meeting FDA requirements and supporting regulatory approvals. This capability can be instrumental in defending the uniqueness and commercial applicability of patented methods.
Strategic IP Management: MarinBio can assist clients in determining the best approach to protect their innovations, whether through patents or trade secrets, based on the specific characteristics of the technology and the current legal landscape.
Data Generation and Analysis: The company’s capabilities in generating high-quality, meticulously validated data can provide critical support in patent disputes or in demonstrating the uniqueness of a method.
There is more to working in the litigation area than just the results of the lab work.
Our experience at MarinBio, in supporting the entire litigation effort, enhances the outcomes of our client’s litigation requirements. Our scientists are fully aware of the importance of secrecy, confidentiality, record keeping and patent law for client litigation issues. Through our initial MarinBio conversations with you and your legal representatives, you control how communications occur, whether through emails, phone calls, videoconferences, in person meetings or written or other types of interactions and records. We understand what is discoverable. Our professional Ph.D. scientists have been deposed and have testified in trials as expert witnesses on behalf of our clients.
Contact us to discuss the specifics of your project. Our team of experienced scientists is ready to assist you with tailored solutions to meet your unique needs. Whether you need help with assay development, FDA IND, stability study, lot release approval, or other scientific endeavors, we are here to support you.
Contact us to learn more about our cell based assay services
We will initiate your project as soon as the proposal is approved and signed by you. Our streamlined process ensures a quick start, minimizing delays and maximizing efficiency. Fill out the form below to email us or click our live chat option to speak with a MarinBio Scientist and get your project underway.
Yes, we have over 30 years of expertise in developing and validating cell based assays for FDA IND, lot release or stability study approval. Our team can also liaise directly with the FDA on your behalf, ensuring a smooth and compliant process. Please contact us to learn more about how we can assist you with your assay development and FDA approval needs.
MarinBio scientists are experienced and creative in designing, developing, validating assays. Some of the assays we perform are listed below, but there are many more that we created, developed and validated. Give us call so that we may help you.
Give us a call at 415-883-8000
For More Information about our Litigation services, please use the following informational form
