We have expertise in drafting, negotiating and enforcing U.S. and global commercial and operational agreements, including master service agreements, clinical supply agreements, collaborative research agreements, data privacy agreements, SaaS agreements, joint ventures, license agreements and non-disclosure agreements.
We counsel healthcare clients on data privacy and data security issues and compliance, including HIPAA, GDPR, and CCPA.
We provide advice on corporate governance and compliance issues, including FCPA, Stark, anti-kickback statutes, and FDA promotional issues.
We specialize in clearance opinions and Biologics Price Competition and Innovation Act (BPCIA) for generic and biosimilar products, Paragraph IV opinions, pre-litigation strategies, exclusivity/forfeiture strategies, Citizen Petitions and regulatory strategies for generic pharmaceutical companies.
We also represent pharmaceutical companies in Hatch-Waxman litigation, particularly in subsequent filer actions and in IPR proceedings.
We have expertise in due diligence, freedom to operate analyses and opinions, pre-litigation analyses, reexaminations, strategic advice and appeals from Board decisions.
As registered patent attorneys with significant experience in patent litigation in district courts and the Federal Circuit, we are uniquely qualified to handle post-grant proceedings before the Patent Office, including Inter Partes Review (IPR), Covered Business Method review (CBM) and Post-Grant review.
We represent large and small companies in patent litigation in district courts and on appeal in the Federal Circuit. Our approach is streamlined, cost-efficient, and effective. We design litigation strategies with our clients’ business interests firmly in mind, and with the goals of minimizing disruption to the company organization and day-to-day operations, narrowing the issues early in the case, limiting fact discovery (particularly electronic discovery), and achieving early favorable resolutions without the expense of trial. We have particular expertise in medical device litigation, Hatch-Waxman litigation, and biosimilars litigation under the BPCIA. We also have developed considerable expertise in defense of patent infringement actions brought by Patent Assertion Entities. We have advised clients on IPR proceedings as an alternative or complement to patent litigation to address invalidity issues, and view IPR as an important addition to patent litigation strategy.
We provide a variety of legal services to start-up and small companies with limited in-house counsel capabilities, including IP counseling, patent portfolio development and management, due diligence, litigation and discovery management, licensing and transactional services and strategic advice. We are also available for interim engagements to provide ongoing in-house counsel support.
Copyright © 2019 Jellins Christensen LLP - All Rights Reserved.