Goldberg Segalla LLP

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Hatch-Waxman ANDA Litigation and Counseling

Goldberg Segalla’s Pharmaceutical ANDA Litigation team brings together highly accomplished attorneys with broad and interdisciplinary technical and scientific training as well as decades of high-stakes patent litigation experience. Our lawyers serve as trusted advisors to generic pharmaceutical companies and their executives at every stage of pharmaceutical product selection, patent due diligence, litigation, and monetization involving the federal Drug Price Competition and Patent Term Restoration Act (or Hatch-Waxman Act). Our Hatch-Waxman litigation and lead trial experience covers scores of patents and products in jurisdictions across the U.S.

But we also understand that patent litigation is a means and not an end. We do not chase every potential defense. We do not believe in old-school “scorched-earth” litigation tactics. The practice of law has changed and we understand that. The days of wasteful and duplicative billable hours are gone. We believe in delivering value and peace-of-mind to our clients. We stick to our budgets and can also offer alternative billing arrangements. We make it our standard practice to learn everything we can about each client’s business practices, immediate needs, and long-term goals, so we can better tailor our services and strategies to provide the most comprehensive and cost-efficient representation.

With a keen understanding of not only the legal issues related to the Abbreviated New Drug Application (ANDA) process, but also of the pharmaceutical regulatory environment and the business, legislative, and political pressures our clients face, we have developed an approach that covers the whole lifecycle of individual products and groups of products — through selection, litigation and agency review, and commercialization and marketing — that promises the advice and lawyering our clients deserve and are entitled to.

Our Experience
Collectively, our team has handled pharmaceutical product selection and Hatch-Waxman litigation for various products including:

  • Abiraterone
  • Alosetron
  • Amphetamine
  • Aripiprazole
  • Atorvastatin
  • Bendamustine
  • Bivalirudin
  • Calcium acetate
  • Canagliflozin
  • Capecitabine
  • Cilastatin/Imipenem
  • Clozapine
  • Dextroamphetamine
  • Esmolol
  • Esomeprazole
  • Famotidine
  • Fentanyl
  • Gabapentin
  • Guaifenesin
  • Hyoscyamine
  • Levofloxacin
  • Linagliptin
  • Macitentan
  • Metformin
  • Omeprazole
  • Pemetrexed
  • Polyethylene glycol
  • Prasugrel
  • Sodium picosulfate
  • Terfenadine
  • Zolpidem
Selection and Counseling
Drawing on the resources of both the Intellectual Property and Life Sciences Practice Groups, this team brings together highly experienced trial attorneys possessing academic degrees in a range of scientific disciplines, practical experience in the technology and life science industries, decades of experience in patent litigation, and invaluable fluency with corporations’ internal business and litigation strategies — meaning we bring to each client, product, and matter a global understanding of the pharmaceutical patent landscape. We take a strategic and comprehensive approach to ANDAs based on up-front discussions with our clients and decisions on overall objectives, risk tolerance, and financial standing. We help our clients anticipate risk and position themselves for success — long before litigation and other product development concerns commence.

Pharmaceutical product selection — We assist companies in searching for, evaluating, and choosing the right products to pursue, offering an informed and comprehensive assessment accounting for financial projections, the anticipated number of companies pursuing the same product, and potential litigation issues and costs. We also advise on formulation design (including development of design-around strategies), licensing and marketing, and other technical, scientific, and logistical concerns.

Pre-litigation support — We frequently provide pre-litigation patent evaluations, offer counsel on non-infringement and validity, conduct necessary prior art searches, and prepare freedom to operate (FTO) opinions for pharmaceutical patents and products.

Paragraph IV certification letters and detailed statements/FLBs — In analyzing the potential non-infringement of virtually any product and the invalidity of any patent, we advise on Paragraph IV certification letter strategies and regularly prepare accompanying detailed statements/FLBs to ensure compliance with the Food, Drug, and Cosmetic Act.

ANDA Litigation
Our lawyers have a long history of success litigating patent cases, including complex multi-district litigation (MDL), in U.S. District Courts all over the country, frequently in hotbeds of patent litigation in Delaware, New Jersey, Texas, and California; as well as before the U.S. Patent and Trademark Office, the U.S. Court of Appeals for the Federal Circuit, and the International Trade Commission.

Clients rely on our strong relationships with leading experts in pharmacology, drug formulation, therapeutic uses of drugs, synthetic and medicinal chemistry, polymorphism, and all forms of analytical testing. We win cases by combining their clout and technical expertise with our litigators’ abilities to translate hard science into compelling narratives that make it easy for courts to side with our clients — sometimes beginning long before anticipated litigation has commenced, continuing through claim construction and the discovery process, and culminating in favorable summary judgments or victories at trial.

Our vast range of scientific and legal experience allows us to handle Hatch-Waxman litigation, no matter the product or venue, with a holistic approach to ensure that we meet all of our clients’ needs — with one eye on immediate concerns and the other on future risks and liabilities. We also work with all parties constructively to find a business solution outside the courtroom when that offers the best path to achieving the client’s objectives.

A Different Approach
Choosing the right pharmaceutical product to genericize and bring to market is an art rooted in science and patent law. Generic pharmaceutical companies, operating in a uniquely challenging business environment, have to take into account their long-term financial investment, technological requirements, and the burdens of litigation. In addition, U.S. federal laws set strict and complicated timetables for ANDA filings, related litigation, exclusivity, and marketing. Pharmaceutical patent trials and appeals are an expensive endeavor. And the cases that settle have to pass antitrust review, which can jeopardize significant investment and years of effort.

Goldberg Segalla’s collaborative culture and value system are shifting the paradigm of pharmaceutical patent litigation. Our attorneys work together across diverse practice areas to provide the most comprehensive and efficient defense or counsel possible. For example, our litigators, backed by the firm’s pioneering E-Discovery Practice Group, can cut down and manage discovery and e-discovery demands — which can be extraordinarily taxing in pharmaceutical and ANDA litigation — to minimize litigation’s impact on day-to-day business operations and the bottom line. Fluid collaboration among our Antitrust and Competition, Mergers and Acquisitions, and Cybersecurity and Data Privacy teams helps us to guide our clients more effectively through the lifecycle of the drug, from product selection to filing an ANDA, potential litigation, packaging and promotion, and management in the marketplace.

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  • 5.0/5.0 Review for John M. Allen by a Associate on 05/04/16 in General Liability

    John is an excellent civil defense attorney. Most importantly, he seeks resolutions that are fair to the parties. This is a trait not often found in litigation matters. Given that John and I were on opposite sides of the fence in a recent case, my... Read more

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    John is an excellent civil defense attorney. Most importantly, he seeks resolutions that are fair to the parties. This is a trait not often found in litigation matters. Given that John and I were on opposite sides of the fence in a recent case, my comments stem from personal knowledge of this gentleman. Read less

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Both within our own firm and across the wider business and legal communities, Goldberg Segalla’s commitment to diversity is strong, sincere, and a critical component of our firm’s mission and culture. Our philosophy has always been that we hire people who are excellent at what they do, and even better human beings. Period. We feel we would be doing a disservice to our firm and to our clients if we didn’t include contributions from every available resource.

We are extremely proud that our commitment has received regional and national recognition for the innovative programs we have developed and the results we have been able to achieve. The following is a sampling of the firm-wide or individual honors we have received for implementing initiatives that make a difference:

  • George B. Vashon Innovator Award, Minority Corporate Counsel Association
  • MCCA Firm Affiliate Network
  • Vault/MCCA Commitment to Diversity
  • Community Service Award, Defense Research Institute
  • Good Works Award, American Bar Association Section of Litigation
  • Outstanding Committee Chair, ABA Section of Litigation
  • Diversity Trailblazer Award, New York State Bar Association
  • Legal Service Award, Minority Bar Association of Western New York
  • Lawyer of the Year, Bar Association of Erie County
  • Legal Community Leader Award, National Federation for Just Communities of Western New York
  • Diversity Excellence Award, Buffalo Niagara Human Resource Association
  • Value Award for Diversity, Leadership Buffalo
  • Western New York Game Changers, Buffalo Spree magazine

What we are most proud of, though, is that our efforts have shown significant results and continue to make a lasting impact on the lives of many.

Leadership and Action

To put our philosophy and commitment into practice, we have a Diversity Task Force, which includes our managing partner, in place to conceptualize and implement diversity-focused programs as well as give diversity a voice in our decision-making at the highest level. The individuals on this task force share the firm’s strong commitment to increasing diversity, and they use their unique experiences and backgrounds to support and advance that goal. The team meets regularly to create programs, schedule events, establish diversity initiatives both inside and outside of the firm, set long-term goals, and develop the strategy to recruit and retain people from diverse backgrounds.

The chair of our Diversity Task Force, Joseph M. Hanna, has spearheaded numerous diversity initiatives in various organizations and outreach programs, serves on several diversity-related committees, and is a frequent author and speaker on diversity. Among other positions, he is co-chair of the American Bar Association (ABA) Young Lawyer Leadership Program, former chair of the association’s Minority Trial Lawyer Committee and its Special Committee on Human Rights, and former editor-in-chief of the ABA’s Minority Trial Lawyer; a 2014 fellow of the Leadership Council on Legal Diversity (LCLD); a past president of the Minority Bar Association of Western New York (MBAWNY) and the MBAWNY Foundation; and the Diversity Liaison for several committees at the 22,000-member DRI.

For more than a decade, Goldberg Segalla has proudly supported the ABA’s Judicial Internship Opportunity Program, which provides racial and ethnic minority law students, along with members of other groups underrepresented in the legal profession, opportunities to serve as an intern with a judge during the summer after their first or second year of law school. Joe Hanna — an alumni of the program himself — acts as a mentor and leader in the program, through which he has conducted more than 100 interviews for students across the country.

In 2017, Goldberg Segalla participated in the Thurgood Marshall Summer Law Internship Program, the New York City Bar Association’s flagship pipeline program for high school students. As a participating legal employer, we hosted high-achieving inner-city students for the summer and collaborate with the NYC Bar to provide them with additional programming before, during, and after the summer designed to help them prepare for a legal career.

Each summer, Goldberg Segalla proudly welcomes interns through a formal Diversity Clerkship Program that was conceived by Joe while he served as president of the MBAWNY. The program was developed in collaboration with the MBAWNY and the SUNY Buffalo Law School to provide opportunities for minority UB Law students to gain firsthand experience in the legal system. Since it was launched in 2011, the program has placed more than 100 students in clerkships in area courts as well as in several area law firms, with more judges and law firms asking to participate every day. It provides participants with an in-depth look at the legal process and the interaction between the bench and the bar that they would not otherwise get. At our firm, a dedicated team of partners monitors the work of these law clerks and ensures they obtain valuable experience to help develop important legal research, writing, case management, and client service skills critical to their long-term success. Our program earned the firm the Minority Corporate Counsel Association’s 2012 George B. Vashon Innovator Award.

We also have sponsored Success in the City, an annual diversity networking and mentoring event developed by Joe that brought together students, legal and business professionals, educators, nonprofits, and political leaders to make lasting partnerships. Many employment, business, and mentoring relationships resulted from this event. Past events have drawn more than 500 political and business leaders, legal professionals, and students. Success in the City has influenced the development of similar programs in Baltimore, Cleveland, Birmingham, Dallas, and elsewhere.

Our firm is committed to spreading the message throughout the broad legal and business communities that embracing diversity contributes to greater overall success. We conduct training sessions for in-house counsel at Fortune 500 corporations on increasing and promoting diversity. Our attorneys have authored articles and delivered presentations on diversity for various legal organizations, including DRI and the ABA, and our efforts and accomplishments in this area have been profiled in publications such as Law360, the New York State Bar Association’s State Bar News, Business First of Buffalo, the Buffalo Law Journal, and others.

In one example of our work to provide inspiration and raise awareness of diversity and women’s issues in the legal community, Caroline Berdzik, chair of our Employer and Labor Practice Group, spoke to Law360 for the publication’s “Female Powerbrokers” series. In the interview, Caroline discussed her career, the challenges of being a woman at a senior level at a law firm, the work-family life balance, and the importance of taking risks. She also offered guidance to female attorneys on moving their careers forward and advice to law firms on both increasing the number of women partners and retaining top female talent. Her longtime advocacy for women (at her previous firm, she served on the Women’s Business Development Committee and was a member of what became the national Women’s Presidents Organization) helped earn her a spot on the 2015 NJBIZ list of New Jersey’s Best 50 Women in Business.

Joe Hanna also was featured by Law360 in its “Minority Powerbrokers” series, in which he shared his perspective on breaking the glass ceiling in the legal industry, the challenges of being a lawyer of color at a senior level, how law firms can increase diversity in their partner ranks, and Goldberg Segalla’s core commitment to diversity.


Goldberg Segalla is proud to be a member of the Minority Corporate Counsel Association Firm Affiliate Network, which was created by the MCCA to assist and acknowledge law firms that are committed to advancing diversity and inclusion in the legal profession.

We are also a member of the Leadership Council on Legal Diversity (LCLD), a national organization of leaders in law firms and corporate legal departments dedicated to creating a truly diverse legal profession. As noted earlier, Joe Hanna was a fellow of the LCLD in 2014. In this position, he played a critical role in organizing the first-ever New York City LCLD Fellows Roundtable event, and he was instrumental in establishing a mentorship program in Hartford for local diverse first-year law students.

We support the diversity efforts of numerous organizations, including:

  • American Bar Association
  • Asian American Bar Association of New York
  • Columbian Lawyers Association
  • Defense Research Institute
  • Federal Bar Association
  • Korean American Association of Greater New York
  • League of First Nations
  • Minority Bar Association of Western New York
  • National Bar Association
  • Native American Rights Fund
  • National Association of Asian American Professionals
  • National Congress of American Indians
  • New York State Bar Association
  • Seneca Free Trade Association
  • SUNY Buffalo Law School
  • Women’s Bar Association of the State of New York

Our outreach efforts led to the creation of a comprehensive database of more than 500 minority law organizations throughout the United States. Contact between these organizations takes place in anticipation of bringing CLE and legal programs together. This group of minority bar associations includes both local and national organizations, such as:

  • National Association of Women Lawyers
  • National Association of Muslim Lawyers
  • Hispanic National Bar Association
  • National Asian Pacific American Bar
  • Black Women Lawyers Association of Los Angeles
  • South Asian Bar Association of Philadelphia
  • Vietnamese American Bar Association of North Carolina

A Talented and Diverse Team

Diversity is further evident within our firm through the many languages and dialects spoken by members of our team, including Albanian, Arabic, Croatian, French, German, Greek, Hebrew, Hindi, Italian, Korean, Malayalam, Mandarin, Marathi, Norwegian, Portuguese, Punjabi, Russian, Spanish, Swedish, Tagalog, Tamil, Thai, and Urdu.

Goldberg Segalla’s culture is one that values team-spiritedness, collegiality, and interpersonal harmony within our working community. We are a firm that believes in diversity in the workplace, and we are proud to offer a professional and positive work environment for each and every member of our team.

On these values, and on our commitment to diversity, we will never waver. We are proud of what we have accomplished thus far, but we also realize that this is a long-term mission. We will continue to innovate and to improve diversity in law and business — both within Goldberg Segalla and across the communities in which we live and work.

Diversity Matters — Join the Conversation

If you have questions regarding any of the firm’s diversity initiatives or would like to discuss ideas regarding increasing diversity in the legal profession, please contact Joe Hanna (716.566.5447; [email protected]) or another member of our Diversity Task Force:

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