Innovations to Improve the World's Health
With 70 lawyers on our team, we work across multiple disciplines and practice on nearly every continent to bring our perspective and help our clients grow. A snapshot of our team: 50 of us have science degrees; 22 have worked in state and federal agencies; and two have been in-house lawyers at life sciences companies. We understand the complicated environment where life sciences companies operate and assist them at every stage, from discovery to approval to marketing and beyond.
For decades, our transactional lawyers have helped build and support the pharmaceutical industry at all levels. We leverage our broad perspective of the market to provide strategic advice to companies of all sizes and in all stages of development.
Startups and IPOs. Our Technology Companies and M&A and Private Equity practice groups focus on assisting science-based businesses from organization through early financing through IPO, providing a suite of services tailored to the special needs of businesses developing cutting-edge technologies.
Licensing and Joint Ventures. Life sciences companies have unique needs for partnering to ensure the timely and effective development of new products and technologies. Our experience includes representing both large and small companies, as licensors and licensees, in transactions ranging from simple license agreements to complex and ongoing R&D and manufacturing joint ventures. A few recent representations include:
Regeneron Pharmaceuticals Inc. in a complex licensing agreement related to the development of novel gene therapy and proprietary molecules that were discovered jointly and developed using the Avalanche Ocular BioFactory, an adeno-associated virus (AAV)-based platform.
Ajinomoto Co. Inc. in numerous license and collaboration agreements, including four separate collaborative research, development, commercialization and license. agreements with Senomyx to develop and commercialize specific molecules for use as substitutes for certain flavorings, and a license agreement with Teva for technology related to a compound that could be used to treat multiple sclerosis.
Eagle Pharmaceuticals, a publicly listed specialty pharmaceutical company focused on developing and commercializing injectable products, in all of its license, collaboration and joint development transactions leading up to its IPO in 2014.
M&A. Our M&A team has counseled buyers and sellers of life sciences companies and related assets in the fields of pharmaceuticals, biotechnology and medical devices. Our global resources permit us to coordinate regulatory filings and merger reviews worldwide. Recent representations include:
Merck KGaA, a Germany-based pharmaceutical company, in its acquisition of the manufacturing rights to the vaccine Stimuvax and, through its affiliate EMD Serono Canada Inc., purchase of the current inventory and certain assets used for the manufacture of Stimuvax from Oncothyreon Inc.
Sigma-Tau Pharmaceuticals Inc., a developer of medicines for patients with rare diseases, in connection with its $327 million acquisition of the specialty products division of Enzon Pharmaceuticals Inc. and numerous joint ventures, development and licensing transactions, and pharmaceutical product acquisitions in the U.S. and Canada, and in the sale of a substantial portion of its shareholdings in SciClone Pharmaceuticals Inc.
Sequoia Capital, as a consortium member in connection with the $3.3 billion privatization of Beijing, China-headquartered WuXi PharmaTech, a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology and medical device industries.
Our industry-leading Intellectual Property practice includes lawyers who can assist life sciences companies with a full range of services designed to protect and exploit their most important assets – their ideas. In 2016, The American Lawyer named us a finalist for IP Litigation Department of the Year, and in 2015, Law360 named us IP Group of the Year for the second consecutive year. As for patent appeals, the Federal Circuit is our home court – we’ve argued 17 cases there in just the last two years. Our experience includes:
Pharmaceutical, Medical Device and Human Biotechnology Patent Infringement Litigation, Including Hatch-Waxman. Our lawyers have litigated and tried Hatch-Waxman cases for more than 20 years. We are familiar with both the strategies and tactics necessary to succeed in these cases, and have a proven record of success at trial in other infringement cases affecting life sciences patents outside of the pharmaceutical industry. Relevant representations include:
BTG and Organon in an ANDA litigation regarding the generic challenge to their Mircette™ oral contraceptive product by Barr and Duramed.
Boston Scientific and Medinol, as plaintiffs and defendants, in multiple district court cases related to bare metal and drug-eluting cardiac stents.
Siemens in a suit brought in the District of Delaware by Enzo involving a patent for nucleic acid detection technology and the use of nonporous supports in hybridization detection tests to detect the presence or quantity of certain genetic material, such as nucleotide sequences or genes.
Tekmira Pharmaceuticals Corp., obtaining a $75 million cash settlement in a multi-country patent, licensing and trade secrets dispute. Tekmira also obtained assignment of approximately 150 of the defendant’s patents and patent applications, and will receive milestones and royalties for defendant products incorporating Tekmira’s technology, including a product now in clinical trials that is projected to be a $2 billion product by 2020.
AgBiotech Patents. We have one of the most successful practices representing clients with patents covering agricultural biotechnology products. We have represented Dow AgroSciences in connection with more than 15 patent litigations in the agbiotech world, including two high-profile trials:
We secured patent protection for genetic material that provides broad-spectrum insect
resistance to commercial crops in U.S. District Court for the Southern District of California. -
We defeated infringement claims and secured our client’s freedom to operate in the field of fertile transgenic corn In U.S. District Court for the District of Delaware.
Trademark, False Advertising and Anti-Counterfeiting. We maintain an industry-leading trademark development and management practice, and have decades of experience advising companies on Lanham Act and state laws intended to prevent false advertising and unfair competition. We also have unique experience with respect to the global fight against counterfeit and illegally diverted medicines. Our representations include:
CoorsTek Medical, LLC in a pending federal district court case against CeramTec GmbH in which CoorsTek is challenging CeramTec’s claim to the color pink as trade dress for its orthopedic hip component products.
The Pharmaceutical Security Institute, the drug industry’s anti-counterfeiting trade group, which we serve as outside general counsel; we also regularly advise drug companies on measures that can be taken to address threats from the sale of counterfeit, illegally diverted, and illegal drugs and biologics.
Numerous life sciences companies, which we advise on strategies for selecting, filing, maintaining and policing and enforcing their trademarks in the U.S. and globally; we advise companies at all stages of their existence, from startups seeking to secure IP rights for purposes of financings and IPOs to global pharmaceutical companies with many thousands of trademarks to manage.
Trade Secret Protection. Life sciences companies at all stages of their development risk the loss of their IP through theft. Our Trade Secrets practice advises businesses and individuals as to steps that can be taken to deter such theft, and represents both plaintiffs and defendants where trade secret theft claims are made. Important representations include:
Dentsply Sirona, a leading dental equipment manufacturer, in connection with trade secrets litigation relating to activities in China.
10X Genomics, Inc., a leading gene-sequencing company, which we successfully defended in an arbitration claiming violation of non-compete, non-solicitation and confidentiality agreements; we are representing the company in related litigation claiming the theft of trade secrets.
Biosimilars. We field a multidisciplinary, cross-practice team to assist producers of traditional and biotechnology products in developing and readying biosimilars for the market, as well as defending their franchises against would-be biosimilars competitors. We guide our clients through complex regulatory approval processes and help them with compliance issues. Our experienced intellectual property lawyers play a large role in this area, as do our product and commercial litigators and transactional lawyers.
IPRs and Biotech and Biosimilars Patent Prosecution. We maintain an active practice before the U.S. Patent and Trademark Office, assisting companies in all phases of the IPR process and in working through the strategies necessary to coordinate such proceedings with alternatives. We also assist biotechnology companies in securing patents for their inventions.
Asian Practices. Our global IP practice is distinctive in the resources it can offer in Asia, including substantial offices in Tokyo, Beijing, Shanghai and Hong Kong. Our China team is ranked Tier 1 by Asian Legal Business.
LITIGATION AND ARBITRATION
Our lawyers worldwide are actively engaged in the representation of life sciences companies in courts and before arbitration panels, in all phases of commercial disputes and governmental investigations. Our litigators have worked with life sciences companies for decades on an array of matters, from cases determining companies’ futures to smaller, more nuanced matters that affect their businesses incrementally but strategically. We recently were identified as a Top 5 litigation “powerhouse” (Law360) and a finalist for Litigation Department of the Year in 2016 (The American Lawyer). Our lawyers have acted as trial counsel, appellate counsel, national coordinating counsel, resolution counsel, eDiscovery counsel, investigations counsel, lead arbitration counsel, and PR and communications strategists. Our experience includes:
Licensing Disputes and Other Commercial Litigation. Litigation between and among life sciences companies requires not only litigation skills but also deep industry knowledge and access to litigation and IP expertise. We offer clients this complete package, as well as credibility as trial lawyers. Recent representations include:
Merck, Sharp & Dohme Corp., as lead national counsel in more than a dozen suits nationwide brought against dozens of pharmaceutical companies by state attorneys general and Medicaid agencies alleging fraud in connection with pharmacy reimbursements based on published Average Wholesale Prices, or AWPs.
Medicis Pharmaceutical Corporation, in a dispute over product development and milestone payment issues relating to an R&D and licensing agreement.
Boiron, Inc., a leading manufacturer of homeopathic remedies, in various class actions alleging false advertising.
Schering-Plough and Merck, in guiding the companies to a successful resolution of the hundreds of consumer fraud class action cases filed against them over claims that the drug Vytorin was no more effective than an inexpensive, generic drug.
Product Liability. For decades, our lawyers have represented some of the world’s leading pharmaceutical and medical device companies. Clients such as Merck, Schering-Plough, Bausch & Lomb, Wyeth (Pfizer), American Cyanamid and others have turned to our lawyers to defend product liability lawsuits in state, federal and appellate courts. We offer the legal insight, courtroom experience, industry knowledge and practical business sense our clients need in order to prevail in cases critical to their business. We provide clients facing litigation with a strategic plan and experienced trial teams with records of success. Our experience includes the following:
Our lawyers were instrumental in litigating and resolving thousands of civil and governmental claims resulting from Merck’s withdrawal of the drug Vioxx.
In the medical device world, our lawyers have litigated matters on behalf of Bausch & Lomb in the wake of the company’s withdrawal of its ReNu with MoistureLoc contact lens solution, and also have worked with early stage companies in connection with the development and sale of mobile medical devices.
Our team served as national counsel to Wyeth (now Pfizer) throughout the United States in nearly 400 product liability cases involving claims that childhood vaccines containing the preservative thimerosal caused autism in some vaccinated children. We were largely responsible for crafting a novel pre-emption argument that the team litigated in appellate and trial courts across the country, culminating in a favorable decision by the U.S. Supreme Court. That decision, along with favorable Daubert decisions, was a central factor in Wyeth successfully resolving the litigation without an adverse judgment or monetary settlement.
We achieved a defense verdict for our client in Ramirez v. Wyeth Laboratories, a three-week state-coordinated trial, defeating product liability claims alleging permanent neurological injuries from the use of the Norplant System. The successful outcome of this trial, which was one of only three Norplant cases that was tried to verdict, was a major factor contributing to the global settlement of the nationwide litigation.
Antitrust. Our antitrust and competition lawyers worldwide represent life sciences companies that have been accused of using strong market positions to injure rivals or consumers. We are advisors as well as litigators, counseling as to compliance matters, proposed sales, marketing and strategic ventures; some have worked at the Federal Trade Commission and the U.S. Department of Justice (DOJ) Antitrust Division. We focus on high-tech issues, including the intersection of IP and antitrust and competition law, and our representation of multinational pharmaceutical clients has given us a deep and broad knowledge of the business environments and legal issues faced by such companies. Representative matters include the following:
For Merck, Sharp & Dohme Corp., and various affiliates, we provide regular antitrust counseling on a wide range of pricing and marketing issues, and provide antitrust compliance seminars targeted to the needs of different groups of employees and counsel. We have also represented these companies in antitrust litigation alleging exclusionary practices in connection with the entry of generics, and antitrust counterclaims brought in Hatch-Waxman patent litigation.
We have advised a branded drug company in connection with limitations on contractual arrangements for the manufacture of an authorized generic as part of a comprehensive set of licensing, supply and manufacturing agreements.
We were lead counsel representing affiliates for Schering-Plough Corporation in a purported antitrust class action brought in U.S. District Court for the Southern District of New York by direct purchasers of Prilosec® OTC®. The claim involved an allegation of unlawful agreements with co-defendants AstraZeneca and Procter & Gamble, and the filing of sham litigation. Our clients were dismissed based on nominal settlements.
Appellate. Our Supreme Court & Appellate team has significant experience representing pharmaceutical and life sciences companies. Clients have entrusted us with their highest-profile matters, from constitutional cases in the U.S. Supreme Court to critical IP appeals and their most significant commercial litigation. Our deep bench of appellate talent has secured victories in a wide range of subject areas, including patent, copyright, trademark, securities, antitrust, product liability, insurance, bankruptcy and constitutional law. The team has developed a reputation for breaking the mold and rebuilding appellate arguments from the ground up. We have won awards and recognition from The National Law Journal, Chambers USA, The Legal 500, Financial Times, Reuters and The American Lawyer, among many others. We recruit top talent from the Department of Justice, legal academia, other appellate practices and the most prestigious clerkships in the country – including nearly a dozen clerks from the Supreme Court alone. We have established ourselves as a marquee practice with “a deep bench, diverse cases, high-profile clients and a presence in the nation’s highest court,” as The National Law Journal has described us. Our representations include:
Merck KGaA, in its 9-0 victory in the Supreme Court allowing pharmaceutical companies to perform experiments on promising drugs before a relevant patent had expired.
Dow AgroSciences, in two appeals against Bayer Cropscience, in complex $6 billion patent litigation involving Dow’s next generation of herbicide-resistant crop technology.
Biotechnology Industry Organization, as amicus curiae, in a seminal case concerning patent eligibility.
State AG Actions. The environment for life sciences companies within state governments has never been more challenging. We maintain one of the largest state lobbying and attorney general practices in the United States. Headed by a former two-term Attorney General for the state of Washington and former President of the National Association of Attorneys General (NAAG), our Public Policy/State AG team includes members that have initiated and responded to hundreds of state AG investigations and inquiries, including antitrust issues of particular interest to large branded pharmaceutical companies, such as investigations and enforcement actions involving the allegedly improper extension of patent protection. Our AG office experience with enforcing consumer protection laws ranges from cybersecurity to tort liability, and unfair competition to Medicaid fraudulent billing matters. Our legal and policy experience includes working with state legislators and state agencies to draft, implement and amend state laws, approving indictments and negotiating settlements, and overseeing state appellate strategy, including arguing on behalf of states in significant cases before the Supreme Court.
For a major multinational pharmaceutical company, we handled a follow-on investigation to a class action in federal court. It involved claims by the Texas Attorney General that our client had violated Texas antitrust laws in connection with allegedly sham Hatch-Waxman patent infringement litigation against a generic. The litigation was ultimately dismissed and the investigation was closed, with no enforcement action taken.
We represented a different major multinational pharmaceutical company in connection with lobbying to forestall potential antitrust claims in connection with an M&A transaction that had been publicly announced.
Criminal Investigations and Prosecutions. Our White Collar practice routinely represents life sciences companies and their executives and employees in federal and state criminal investigations involving claimed violations of federal and state False Claims Acts, the Foreign Corrupt Practices Act, the UK Bribery Act, and U.S. money laundering statutes, as well as Medicare and Medicaid fraud and abuse. In addition, we serve as court-appointed compliance monitors and counsel to federal agency compliance monitors and counsel clients on the development and implementation of compliance policies. Our work has included the following:
We represent a multinational medical device company before the DOJ and SEC in an ongoing FCPA enforcement action.
We conducted an internal investigation on behalf of a hospital concerning Medicare and Medicaid reimbursement issues.
We represented the former General Counsel of a medical device company in connection with a DOJ investigation concerning the off-label promotion of a medical device used in sinus surgery.
We conducted a global ABC risk assessment for a health care company, focusing on distributor relationships, product registrations, travel and hospitality, HCP consultants, sponsorships, and discounts/rebates.
Labor & Employment Law. We are known for winning some of the biggest employment cases in the country, often disposing of these complex disputes long before trial. Employers turn to our team when they are headed to trial and their reputations are on the line. Each of our employment partners has broad experience before judges and juries, defending clients in single-plaintiff and multi-plaintiff trials and arbitrations. In selecting us as Employment Group of the Year, Law360 reported that our “preference for the most complex labor disputes makes Orrick stand out from the pack of employment practices.” Recent representations include:
Genentech, in various matters:
Defeated claims of race discrimination, retaliation, harassment, negligent supervision and retention, infliction of emotional distress and wrongful termination, and for punitive damages brought by a former employee.
Obtained a unanimous defense verdict and directed verdicts against a former sales representative who claimed disability discrimination.
Succeeded in three matters involving claims brought by former employees under ERISA regarding the denial of their respective long-term disability claims under the applicable corporate benefits plan.
Allergan, on the potential enforcement of non-competes in California and other states.
Varian Medical Systems, in a broad-spectrum of employment litigation matters including cases involving discrimination and harassment, trade secrets, wrongful termination, failure to pay wages, and meal and rest period violations.
eDiscovery and Discovery Management. Our eDiscovery and Discovery Management team is a destination practice for companies navigating the increasingly technical and expensive demands of litigation. We offer Orrick Analytics, a unique cost-effective analytical and review operation based in our Global Operations Center in Wheeling, West Virginia. We also provide advice about document retention triggers and standards, and the representation of companies as counsel of record to defend claims of spoliation.
We serve as spoliation counsel to a major pharmaceutical company faced with thousands of product liability cases in which sanctions for alleged failures to produce and maintain documents were a central issue.
Risk Management. Our years of experience working on behalf of life sciences companies enables us to help our clients avoid litigation when possible. To that end, we regularly advise companies on matters relating to emerging safety issues, commercialization issues, IP protection, pricing issues and compliance. Similarly, we assist companies located outside the U.S. with managing these risks and avoiding U.S. litigation.