Few industries have such life changing impact on both a macro and a micro level as the pharmaceutical industry. With stakes high and many competing interests, all levels of government are heavily invested in making sure that pharmaceutical products are developed, tested and subject to the highest degrees of scrutiny when attempting to bring them to market.
As an increasing number of blockbuster drugs’ patents are set to expire, the market is inundated with opportunity and challenge. The race to bring lower priced generic equivalents to market has grown heated, and law suits are rising exponentially. Large pharmaceutical firms are seeking to extend patents as up-and-coming companies strive for approvals in this increasingly contentious space.
Amin Talati Upadhye’s attorneys are embedded in the industry and offer keen insight into the changes in both the marketplace and in the legislative and regulatory space. We understand the issues from all sides: we provide counseling both to generic companies seeking to challenge patents and overcome regulatory obstacles to bring drugs to market, and to brand name pharmaceutical companies seeking to strategically patent and protect brand name products. We are particularly adept at navigating the intersections of FDA, IP, and antitrust laws.
We guide our clients through the evolution of their products, from initial development and testing through approval and challenges. In addition to acting as a strategic partner at inception, we remain with our clients when challenged by competitors and governmental agencies: we provide clients with experienced counsel in Paragraph IV litigation, False Claims Act (whistleblower) suits and patent disputes to name a few. Our attorneys have strong relationships with the regulatory bodies in the pharmaceutical sector, and our expertise is recognized by industry associations and peers.
We concentrate a large part of our work helping clients to solve legal problems when dealing with FDA compliance. Particularly, we help clients comply with the myriad of FDA statutes, regulations, and policies as they relate with drugs and devices. This includes helping with financial, operational, marketing, and investigatory/enforcement issues.