Brand Drug Practice
(NDA and 505(b)(2) Applications)
We are I.P. & FDA Regulatory Lawyers
We are lawyers for your life cycle management of brand drug products
Creative, Strategic, and Experienced Lawyers Who Understand the Pharma Company’s Concerns and Business
For 20+ years our lawyers have been representing brand and generic drug companies. We understand the intricacies of the drug development process from product inception to launch management. We have handled countless cases for clients in patent office, federal trial, and appeal courts.
We know the importance of drug products, regardless of the sales values of that drug product. Even small drug products are important to a client’s business goals. We help brand companies build a long-term strategy by helping focus on patents, FDA regulatory, and their interplay.
Patent acquisition is not enough. Rather, the patent portfolio must be strategically tailored to provide long-term benefit. Because of this need, we work alongside the company to develop creative and value-added strategy. We make interactions with internal personnel as seamless as possible.
We represent brand companies in Hatch Waxman Act/Paragraph IV litigation against other brand companies and generic companies.
We literally wrote the book on pharmaceutical patent and FDA law. The 2020 Edition is more than 1400+ pages and is packed with legal understanding, scenarios and situations, and strategy. The book is available in paper, on Westlaw, and as a fully interactive e-book. Click HERE for more information.
As Shashank says, “[b]ecause we worked with generic companies, we help you put together the IP, FDA, and operational strategy to protect you from us.”
Lawyers With The Science Background
Myth: Patents are only about science.
Truth: Patents are legal documents that provide legal protections. If a patent was a scientific document, then there’s no need to enforce it in courts.
Why It Matters: It’s the difference of whether the patent professional is a scientist with a law degree or a lawyer with a science degree.
Patent acquisition is a function of its later enforceability in licensing and court. We use our deep scientific knowledge as a basis to formulate a winning legal strategy. Our attorneys are USPTO registered, engage in patent application work, and in litigation. Each team member has one or more degrees in chemistry, pharmacology, molecular biology, biology, or engineering.
Proactive Planning & Advanced Preparation
Whether the client is planning for licensing, sales, M&A, or life cycle management, we can help a client at each stage of the development cycle. While it’s true that many of our lawyers cut their teeth helping generic companies, these skills are formidably transferred to helping our brand-side clients.
We help clients plan for:
– corporate goal setting; knowing expectations
– infringement of API, formulations, packaging, PK/PD/AUC
– “method of use” (MOU) patent infringement and Section viii Statements (e.g., the “carve-out” or skinny label); inducement
– invalidity; inoculating the patent from attack
– API and importation of formulations; using Customs and the ITC; cutting off supply in foreign countries
– marketing materials to establish the nexus between patents and commercial success
– personnel – for potential exit by inventors, former employees, experts, marketing/finance/regulatory, collaboration partners, etc.
Working with the FDA
Rarely do brand drug products escape competition from other branded drugs or eventually generic competitors. Knowing the FDA regulatory process, like we do, helps clients strategize the life cycle management of drugs. We work with our clients to understand unique aspects of the drug product. If there are such unique aspects, we then work the FDA to develop appropriate guidelines for follow-on companies.
We help draft citizen petitions, product-specific guidance documents that influence the bioequivalency standards or ANDA approvability.
We harmonize patent strategy with the FDA standards to ensure that the barriers to entry can be appropriately heightened, such as through the USP Monograph, bioequivalence, purity standards, size/shape/color and other physical attributes, and maximizing any relevant FDA marketing exclusivity.
How We Are Different
As a specialized boutique, we are not beholden to wooden big law firm bureaucracy. We are nimble, flexible, and very cost-effective. We use flexible fee arrangements. We believe that being more affordable allows us to put in more valuable work for the same price as other firms. Our firm is singularly focused on meeting the client’s goals. Our attorneys are not evaluated on billable hours. UT does not strive for AMLAW 100 status to maximize PPP.
To learn more about our Philosophy on Legal Fees, please click HERE.
Planning for Exit or M&A
We can help prepare for future Exit or M&A by:
– working with management on talking points for roadshows
– validating timelines of patent expirations, regulatory exclusivities, launch, and brand/generic competition
– ensuring strategy is aligned with management vision
– reviewing SEC filings
505(b)(2) Specialist – Drug Reformulation and Re-positioning
We also maintain a robust practice with drug re-positioning and life cycle management. We help pharmaceutical clients with the 505(b)(2) NDA process, with an emphasis on creating savvy business and legal strategies around intellectual property, FDA, and supply chain. We can assist 505(b)(2) applicants to interpret the “innovative change” and “conditions of approval” standards and whether a 505(b)(2) will be blocked by an exclusivity.
Given our background in drug development and Para. IV litigation, we help 505(b)(2) applicants formulate a patent portfolio strategy, identify gaps in the pending patent portfolio, map the patent strategy onto the FDA regulatory strategy, work with the FDA on obtaining data or market exclusivity, and planning for generic competition. We help protect the franchise for longevity.
The Fully Integrated Approach
Talk to us about how we can work alongside you as a trusted partner. Our fully integrated approach helps us to help you with matching legal, regulatory, and technical expertise.
For Generic Companies seeking ANDA or 505(b)(2) approvals, please see our in-depth practice description HERE.
For Medical Device Companies, please see our in-depth practice description HERE.
To learn more about our FDA & GMP practice, please see our in-depth practice description HERE.