Founded in 1819, Cravath, Swaine & Moore LLP is widely recognized as one of the preeminent law firms in the world. Each of its practices is highly regarded and its lawyers are recognized for their commitment to the representation of their clients' interests in the United States and internationally.
Cravath represents some of the largest and most highly regarded companies in the life sciences industry on a variety of corporate and litigation matters. We have played a leading role in critical and complex transactions and cases that have defined the life sciences industry, including handling one of the first suits to proceed under the Biologics Price Competition and Innovation Act, in which we represented Amgen in a lawsuit arising from its anticipated introduction of the first biosimilar to AbbVie's biologic drug, Humira®.
Our attorneys bring to the table an understanding of the life sciences industry coupled with extensive corporate and litigation experience handling high-level matters in other areas, giving us both the depth and breadth of expertise to creatively and effectively solve problems affecting all aspects of our clients' businesses.
The Firm represents pharmaceutical, biotechnology, healthcare services and medical device companies in significant intellectual property and antitrust litigation; complex shareholder derivative and securities suits; breach of contract and licensing disputes; and arbitrations. We also handle government and internal investigations; regulatory enforcement; and compliance matters for life sciences clients, as well as regulatory clearance and antitrust advice relating to mergers and acquisitions.
On the corporate side, we advise life sciences companies and their boards of directors in mergers and acquisitions; corporate governance matters, including defense against activist hedge funds; capital markets offerings and banking and credit transactions; financial restructuring and reorganization; tax; and executive compensation and benefits matters. Cravath's environmental lawyers work with its life sciences clients on acquisition and disposition strategies as well as financings and advise on the challenges and opportunities associated with environmental, social and governance ("ESG") issues, sustainability concerns and climate change. Our corporate IP lawyers advise on acquisitions and divestitures; multiparty joint ventures and strategic investments; licensing agreements; and portfolio development and exploitation.
Cravath's clients in this area have included: Abiomed, Actelion, Akorn, Amgen, Chemed, Insys Therapeutics, Johnson & Johnson, Medinol, Merck & Co., Mylan Laboratories, Novartis Pharmaceuticals, OrbusNeich, RedHill Biopharma, Roivant Sciences and Vitaworks.
Founded in 1978 and based in Washington, D.C., Sterne Kessler is a premier law firm dedicated exclusively to the protection, transfer, and enforcement of intellectual property rights. The firm has more than 160 lawyers, registered patent agents, students, and technical specialists number over 170 and include some of the country’s most respected practitioners of IP law. Most of these professionals hold an advanced level degree, including more than 50 masters degrees and more than 50 doctorate degrees in science or engineering -- credentials wide and deep enough to fill the faculty of a science oriented university.
For over 40 years, the patent prosecution group has been preparing and prosecuting patent applications. This renowned group prosecutes and enforces utility and design patents for Fortune 500 companies with extensive, active patent portfolios, as well as small startup companies that rely on the patent system to obtain funding and to head off competition.
The trial & appellate group practices before Federal District Courts throughout the United States in complex IP cases involving software, biotech products, medical devises, pharmaceuticals, electronics, and consumer products. With more than 50 PhDs on staff, the group seamlessly blends disciplines to ensure the right team is handling the legal and technical challenges specific to the IP dispute at hand. The group provides counsel across a broad spectrum of IP issues, including patent infringement actions, trademark and copyright issues, licensing disputes, breach of contract, trade secrets and Lanham Act matters to name a few.
Since the inception of the U.S. America Invents Act (AIA) in 2012, the patent office litigation practice has worked on more AIA reviews than any other law firm at the United States Patent and Trademark Office Patent Trial and Appeal Board -- the PTAB. The group has handled more than 1000 IPRs and other post-grant reviews on behalf of both patent owners and third party requesters. The PTO litigation group represents both petitioners and patent owners, in a wide range of the PTAB’s technology centers-- biotech and chemical, electrical, and mechanical.
The appellate litigation practice handles appeals to the U.S. Court of Appeals for the Federal Circuit, as well as circuit courts around the U.S. The practice handles appeals from district courts, the U.S. International Trade Commission, and the PTAB.
International Trade Commission:
The ITC Section 337 investigations team represents complainants and respondents of international companies before the US International Trade Commission (ITC). The team uses its technical expertise and proximity to the ITC headquartersin Washington, DC to assist clients in navigating the multifaceted process related to Section 337 investigations. These complex, fast-paced matters require a unique and essential blend of skills in litigation, administrative law, and patent law, as well as technical skills. The team’s clients include commercial manufacturers and importers, in addition to retailers of accused products. The team is highly experienced in managing the fast track nature of the ITC proceedings, the complex issues involved in accused technologies, and following the precise agency rules associated with investigations. Sterne Kessler has more experience at the ITC than 95% of firms appearing there since 2015, and the firm successfully took 5 investigations through trial throughout 2018-19.
Trademark & Brand Protection:
The Trademark & Brand Protection Practice draws on more than 30 years of experience meeting the intellectual property needs of companies developing and maintaining strong brands around the world. Comprehensive and strategic IP protection and enforcement helps businesses both differentiate their product and service offerings from those of competitors, and helps them achieve their full market potential.
The practice’s well-thought-out IP strategies guard against patent, trademark, and copyright infringers, knock-offs and counterfeiting, online fraud, and idea theft by competitors, insiders, partners, and manufacturers – all of which can harm the reputation and brand of companies large and small.
Paul Hastings is an IP litigation powerhouse, protecting the interests of life sciences, healthcare, and technology clients in patents and trade secrets litigation with litigation and trial success at all levels in key forums and venues.
We are strategic, nimble, efficient, and dedicated to our clients, with a deep bench of diverse, award-winning attorneys who excel in high-stakes life sciences IP enforcement and defense. Our approaches to cases and seamless integration of strategy for Patent Trial and Appeal Board (PTAB) proceedings, as well as district and appellate court proceedings, has propelled us to represent innovator life sciences companies including in bet-the-company cases.
Chambers and Partners has individually ranked six of our IP Partners, and our New York life sciences team is ranked for "Intellectual Property: Patent." Chambers also reports that we are known for "renowned counseling and representation of innovator pharmaceuticals and biotechnology companies." The Legal 500, U.S. News & World Report & Best Lawyers, Benchmark Litigation, and Managing IP all rank our practice as Tier 1 Nationally for IP and Patent Litigation. BTI Consulting lists us each year as a "Go-To Litigation Firm" and "Best for Complex IP Litigation" in its annual Intellectual Property Outlook report.
In addition to the rankings mentioned above, our IP practice as a whole has been recognized by third-parties and rankings organizations including:
Intellectual Asset Management recognizes us as among "The World's Leading Patent Professionals" each year for patent litigation, Federal Circuit appeals, ITC 337 Investigations;
Law360 recognized us as "Most Valuable Players" for Life Sciences, Technology, and IP as well as "Practice Group of the Year" for Life Sciences;
The American Lawyer recognized us as 2018 "IP Transatlantic Team of the Year" for work we performed for a branded pharmaceutical company; and
National Law Journal named several IP partners "Intellectual Property and Litigation Trailblazers."
We offer clients the following four key benefits–present in combination–which we believe differentiate us from the relatively small group of other life sciences IP practices with whom we compete:
Substantial experience handling parallel proceedings before the PTAB:
Our Patent Office practice has extensive experience with post-grant challenges, including post-grant review (PGR) and inter partes review (IPR) proceedings, resulting in a strategic and cost-efficient defense to litigation. Our attorneys have been involved in over 500 post-grant proceedings, and are undefeated at the PTAB in life sciences matters. Managing both district court and Patent Office proceedings, we are able develop efficient, coordinated strategies that take account of the differences between the two venues, while maintaining consistency in positions and taking the approach most likely to protect key patents through all proceedings.
Third parties have recognized us as a go-to-firm for post-grant proceedings. Chambers and Intellectual Asset Management recognizes us as experts in PTAB practice. In fact, we helped form the PTAB Bar Association and maintain professional relationships with other members of the Bar and Judges.
Diverse bench of nearly 40 legal professionals and PH.D.-trained scientific advisors: Besides being skilled trial lawyers, nearly all of our life sciences IP attorneys hold technical degrees, including advanced degrees in the life sciences, chemistry, materials science, or engineering, and many have hands-on experience from work at leading research institutions and large life sciences companies. Our technical acumen allows us to field efficient litigation teams that possess deep insight into the technology and understand how to present technical issues in the most persuasive way. We work efficiently and closely with inventors and experts to develop the strongest legal positions backed up by solid scientific positions. We are deeply committed to diversity, equity, and inclusion, and nearly half of the attorneys in our life sciences intellectual property practice are diverse, beginning with our award winning partner and of-counsel ranks. We recruit the best and brightest from leading law schools and work with a range of organizations to build our diverse and inclusive talent base, which has resulted in our being consistently recognized for our commitment to advancing diverse leaders.
Unwavering commitment to innovator clients: We are dedicated to seamless client communication, and we promise that our lead counsels give focused attention to matters throughout the course of the case. We do not have conflicts being adverse to generics. We are experts in the nuances of Hatch-Waxman and biotech patent litigation, including strategies to win cases in federal district court while navigating intersecting regulatory issues involving the FDA. We have litigated against virtually every generic drug company and generic law firm. We look to outmaneuver the generics' firms, including by staying attuned to the trends and tactics evolving in the generic corps. We also have substantial experience in biosimilars patent litigation practice under the BPCIA, providing key strategic advice and representing both reference product sponsors and biosimilar applicants companies in litigation and related PTAB proceedings involving multi-billion dollar biologics products.
Proven track record of success: Whether judge or jury–we know how to try case–and we win. And because our opposition knows we are not afraid to go to trial we are able to leverage our skill and reputation to deliver successful results through settlements where beneficial for our clients. Our success does not end at trial. Leveraging Federal Circuit clerkships and deep appellate experience, we partner with our clients through appeal.
Our clients trust Paul Hastings to protect their most important products and processes. Together, our nationally ranked IP litigation and appellate practices shape a formidable team that serves our clients well.
RMMS consists of over 30 attorneys focused exclusively in the field of pharmaceutical and biopharmaceutical patent and regulatory counseling, and litigation under Hatch-Waxman, the Medicare Modernization Act (MMA), the Biologics Price Competition and Innovation Act (BPCIA), as well as post-grant review before the Patent Trial and Appeal Board.
RMMS attorneys embrace the science of a case, and make it an integral part of our winning strategy. Indeed, a majority of our attorneys have technical degrees or backgrounds in a variety of areas and disciplines, including chemistry, biochemistry, biology, molecular biology, microbiology, genetics, bacteriology, bioengineering, biomedical engineering, chemical engineering and pharmacy, and many of our attorneys are registered with the USPTO. RMMS also employs full-time Ph.D. technical advisors specializing in chemistry, biological sciences, and pharmaceutics/pharmacy.
Our experience is unparalleled in the industry. Since the firm’s inception over 15 years ago, RMMS has handled over 300 Hatch-Waxman/BPCIA and related pharmaceutical litigation matters (including declaratory judgment, patent infringement, Administrative Procedure Act (APA), and commercial dispute matters) involving at least 160 different drug products for over 25 pharmaceutical clients. In addition to our substantial litigation experience, our attorneys also have extensive regulatory and legislative experience.
We understand that patent litigation is not an end-game, and that the business decisions made throughout the entire product and patent evaluation, regulatory review, litigation, and commercialization process are equally critical to the company’s strategic plans involving any one product or group of products. Our goals are aligned with those of our clients: to ensure that each client obtains value from its applications, whether through the eventual commercial marketing of the product, the sale or assignment of the asset, or relationship-building with other companies through joint development agreements, active pharmaceutical ingredient (API) and finished dosage form supply agreements, licensing agreements, and co-promotion and marketing agreements.