How we can help
Product Development with an Eye on Patents
Before filing an ANDA, the ANDA product must be developed. By involving us at that stage, we can provide strategic guidance with respect to Orange Book patents for which certification will later be required. Choosing a proper strategy can help reduce cost and effort later, potentially leading to faster ANDA approval.
Notice Letters with Technical Finesse
Once the product is developed and the ANDA filed with Paragraph IV certifications, it is time to prepare a notice letter for the Paragraph IV patents. This requires a deep understanding of both patent law and technology, which our team has. Dmitry Shelhoff has a Ph.D. in biochemistry and molecular biology, and Cathy Chin Eng has a degree in chemical engineering. From structural obviousness of chemical compounds to pharmaceutical formulations to methods of treatment, we have the technical knowledge to interpret the prior art and develop strong invalidity and non-infringement positions.
Work with Experts and State-of-the-Art Testing
The question of infringement often depends on chemical and physical characteristics of the proposed ANDA product and its active pharmaceutical ingredient (API). We work with leading experts in their respective fields who have access to state-of-the-art instruments, such as XRPD (including synchrotron radiation), 13C/1H NMR, Raman, FTIR, TGA, and DSC, to characterize proposed ANDA products and active ingredients and develop non-infringement positions.
Efficient Litigation with the End Goal in Mind
We litigate each case with our client's budget and goals at the forefront. We expend our effort where it can have the greatest impact. Whether the target is a pretrial resolution or taking the case to trial and beyond, we represent our clients' interests faithfully.