Shashank Upadhye and Joseph (Joe) Cwik proudly announce the formation of the Upadhye Cwik LLP law firm along with the best team members they know.
We intend to build upon our decades of intellectual property, litigation, and FDA counseling success focused on serving our industry leading pharmaceutical and medical device clients.
We will continue to deliver superb results cost-effectively, while providing hard hitting, innovative and responsive client service. This move allows us to be more nimble and better able to focus on what really matters to clients – solving their most complex problems efficiently and effectively.
Our Areas of Practice
At Upadhye Cwik LLP, we practice IP & FDA law individually and the intersection between the two. We collaborate with pharmaceutical companies providing advisement during all stages of pharmaceutical product development. Our attorneys are well known in the representation of drug companies in Hatch Waxman Act/ Paragraph IV litigation.
We provide legal representation at the highest professional level by advising effective solutions in the following areas:
Our Hatch-Waxman team has deep experience in leading the largest and smallest generic drug companies in Abbreviated New Drug Application (ANDA) cases. We understand the keen aspects of generic drug development and provide a full range of counseling and litigation services to our clients.
We help brand companies build a long-term strategy by helping focus on patents, FDA regulatory, and their interplay. Our attorneys understand the intricacies of the development process from product inception to launch management.
For FDA’s GMP compliance, we work with clients on responses to Form 483 Observations, Warning Letters, and Import Alerts. We work with GMP consultants to ensure that remediation efforts are going well, effectively, and cost-efficient.
Our Litigation practice group steps in when our clients face adversarial challenges from government entities, competitor corporations, and from consumers in class actions alleging labeling, advertising and safety violations. We have deep experience in FDA, USDA, FTC disputes, patent and trademark infringement, commercial breach of contract claims and Paragraph IV challenges.
Our intellectual property litigation experience includes prosecution and defense of patent and trademark infringement actions and competitor false advertising litigation under 43(a) Lanham Act. We seek to craft patent applications that look beyond mere patentability to meaningful enforceability when tested in litigation or in other contexts.
Committed to first understanding our client needs and then aiding them in achieving their business goals, Upadhye Cwik consists of four attorneys, with decades of experience. Our attorneys are experienced in navigating the intersections FDA, IP, and antitrust laws that impact generic and name brand pharmaceutical companies. Learn more about our attorneys’ profiles.
Shashank Upadhye has one of the most recognizable brands in the world of brand and generic drug development. As the former chief in-house counsel at three leading pharmaceutical companies, he is known for spearheading innovative business and legal strategies to protect existing drug or device patents.
Joe Cwik is the litigator you want in your corner when your product is under attack. Serving as lead trial lawyer at Upadhye Cwik, LLP, Joe heads all litigation (Intellectual Property and commercial) for the firm’s clients. Joe is focused entirely on achieving successful results for his clients within the court system and before regulatory agencies.
Dr. Yixin combines a creative and assertive litigation style with superb technical training (molecular biology, bio-engineering, microbiology) in his legal practice. For more than a decade, Dr. Yixin has argued in court and obtained successful results for his clients.
Brent Batzer primary focus is the pharmaceutical industry. Brent brings experience in brand and generic pharmaceutical companies as a patent lawyer, and litigating patents. Clients lean heavily on Brent for quick answers when available, detailed analysis when called for, and a pragmatic approach befitting an attorney with an engineering background.
For industry leading pharmaceutical and medical device companies, our goal at Upadhye Cwik LLP law firm is to continue to deliver cost-effective results while providing hard hitting, innovative and responsive client service.
Our attorneys have decades of experience in Intellectual property, litigation, and FDA counseling successfully solving the complex problems our clients face efficiently and effectively.
We are proud to announce Upadhye Cwik LLP and look forward to serving you.