We serve our clients by offering legal skill steeped in scientific and industry knowledge, tapping a multidisciplinary team of practitioners to provide the life sciences industry with a full suite of government and internal investigations, class action, product liability and mass tort, patent, trade secret, antitrust, securities, compliance, capital markets, and corporate services. With lawyers deeply entrenched in the pharmaceutical and medical technology sectors—many of whom are themselves former scientists with advanced degrees in medicine, chemistry, and biology—we help clients stave off challenges to their devices, medications, and intellectual property while working alongside them to capitalize on opportunities unique to the industry.
Class Action and Product Liability Litigation
We have unmatched experience defending against—and defeating—high-stakes, multi-defendant, multi-jurisdictional litigation involving pharmaceuticals and medical devices. We have litigated individual suits, mass torts, and class actions in nearly all 50 states as well as dozens of multi-district proceedings involving allegedly defective products. Our comprehensive, forward-thinking approach sets us apart. We are known for developing early, creative, and uniform approaches to overarching legal issues, involving our nationally recognized appellate practitioners at the outset to help shape strategy and achieve results that benefit our clients beyond a single dispute, dramatically reducing risk well into the future.
Intellectual Property Litigation
Our life sciences IP litigators harness the resources that companies expect from an elite global litigation firm, but with the client-centric approach of an intellectual property boutique. Some of the nation’s preeminent practitioners and thought leaders in branded pharmaceutical, biotechnology, and medical device patent litigation call O’Melveny home, including two MDs and several PhDs in the field. Our IPR team is led by a former Vice Chief Judge of the Patent Trial and Appeal Board and Senior Legal Advisor to the Director of the USPTO. And our trade secrets lawyers are published authorities on this evolving field of law, including one litigator who was asked to testify before Congress on the subject.
With boots on the ground in the US, Europe, and Asia, our antitrust capabilities span the globe. At local, regional, national, and international levels, we advocate for industry leaders entangled in high-stakes cartel investigations and litigation—from initial agency query to resolution and through appeal when necessary to vindicate our clients’ interests. We have prevailed in some of the most significant antitrust matters affecting the life sciences industry in the last two decades, capturing public and political attention. We shepherd mergers through global clearance processes, and we design antitrust-compliant corporate agreements—all with a clear eye to the economic realities that face life sciences companies.
Compliance and Government Investigations
Utilizing our extensive experience defending life sciences clients before prosecutors and regulators, and the knowledge gained by our many lawyers who have served in government positions, we guide clients, their audit committees, directors, corporate officers, and executives through myriad legal issues. These include investigations by the DOJ, state attorneys general, SEC, HHS-OIG, FDA, Congress, and other regulators, as well as sensitive internal investigations, compliance matters (domestic and foreign), and voluntary disclosures.
Capital Markets and Corporate
Our transactional lawyers have strong ties to the entrepreneurs, scientists, and venture capital firms that drive innovation in the life sciences sector. This allows us to unlock and maximize the value of life sciences companies around the globe and across the spectrum. We have lawyers on the ground in the key scientific and commercial centers in the US, including in New York/New Jersey’s pharmaceutical corridor and in San Francisco, the Silicon Valley, and Newport Beach, servicing California’s northern and southern biotechnology hubs. We are also well known in China’s burgeoning biotechnology market, particularly for bringing the best life sciences and biotech companies in China to the public markets in Hong Kong and the United States. Sophisticated and experienced, our counselors advise companies on all aspects of corporate governance, strategic transactions, and capital-raising transactions.
Secured an injunction for Allergan protecting its market for Botox® in a trade secrets case against Merz Pharmaceuticals.
Prevailed at trial and secured a US$39 million jury verdict enforcing a patent covering the eyelash growth drug, Latisse®.
Brought Hatch-Waxman cases to enforce patents covering Corlanor®, a prescription medicine used for the symptomatic management of stable heart-related chest pain and heart failure; we negotiated favorable settlements with all seven generic defendants, including consent judgments in our clients’ favor.
Brought four waves of Hatch-Waxman litigation involving AstraZeneca’s breast cancer treatment Faslodex®. Several matters resolved just prior to or during trial. We also defeated seven IPRs, and managed the company’s worldwide patent litigation on the product.
- Negotiated a global resolution of claims from 48 states and more than 3,000 municipalities accusing pharmaceutical manufacturers of causing the opioid-abuse crisis.
- With US$50 billion on the line, we convinced a California judge that four local governments could not expand public-nuisance laws to address alleged opioid-related harms.
- Convinced the Oklahoma Supreme Court to reverse a trial court’s ruling that called for our client to pay US$465 million for nuisance abatement.
Among our many victories serving as national appellate counsel in the massive pelvic mesh product liability litigation, we overturned a US$15 million verdict against our client and its subsidiary in an opinion that has the potential to reshape how medical device litigation is tried in New Jersey and beyond.
Obtained a crucial victory for Novartis in a retaliatory antitrust suit brought by Regeneron Pharmaceuticals in the Northern District of New York, winning dismissal of the complaint in full without leave to amend.
Won at trial in Hatch-Waxman patent infringement litigation involving Onyx’s multiple myeloma cancer drug Kyprolis®–all Onyx patent claims found valid and infringed; affirmed on appeal.
Achieved a highly favorable settlement in an investigation by the US Attorney’s Office for the District of Massachusetts and DOJ Civil Frauds of alleged violations of the Anti-Kickback Statute and the False Claims Act.
Secured a complete declination from the government on relator's claims against our client in a two-year federal FCA investigation by the US Attorney’s Office for the Southern District of New York, the DOJ, and the District of Rhode Island.
Led Pharmaron’s Hong Kong IPO followed by multiple acquisitions of US companies, strengthening Pharmaron’s global end-to-end chemistry and manufacturing service offerings.
Represented Progenics in multiple significant capital-raising deals and in its ultimate acquisition by Lantheus Medical Imaging, Inc.
Scored a significant victory for Samsung Bioepis in the nation’s first antitrust “reverse-payment” case involving biologics and biosimilars, defeating allegations that an anticompetitive scheme injured purchasers of arthritis drug Humira®.
Brought Hatch-Waxman cases to enforce patents relating to our clients’ blockbuster, multi-billion dollar a year drugs for the treatment of HIV, Tivicay® and Triumeq®. We prevailed on claim construction before the cases successfully settled.
O’Melveny “is known for its broad portfolio of work, advising pharmaceutical companies on core transactions and representing them in litigations, alongside supplementing M&A with a focus on venture capital clients, with a presence in multiple pharmaceutical development markets.”
—The Legal 500 US
“Admired for its dynamism in intellectual property, O’Melveny & Myers vigorously represents top innovators in urgent patent litigations threatening their core technologies and business and is consistently successful in doing so. Life sciences companies make a beeline for the outfit…”
—IAM Patent 1000
Product Liability Firm of the Year
—LMG Life Sciences (2022)