Life Sciences

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Andrea L.C. Reid

Partner Boston +1 617 728 7131

David S. Rosenthal

Partner New York +1 212 698 3616

Mélanie Thill-Tayara

Partner Paris +33 1 57 57 81 04

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Hatch-Waxman Litigation

Digital Health

Excellence Across the Product Life Cycle

In today's competitive landscape, innovative leaders in the healthcare and life sciences industry rely on Dechert to navigate their most complex and demanding transactional, intellectual property and litigation matters anywhere in the world.

We represent clients through all stages of the product life cycle  – from discovery through development, clinical testing, promotion and sales. We draw on our antitrust, corporate, dispute resolution (litigation and arbitration) intellectual property, product liability, securities, tax and white collar defense, FCPA and corruption investigations lawyers to provide comprehensive solutions to the industry’s most sophisticated challenges.

With dedicated resources deployed at major life sciences hotbeds across the U.S., Europe and Asia, our global team of lawyers collaborates seamlessly to help clients establish or expand their international presence.

Whether guiding a start-up biotech through its first round of commercially significant funding, executing a strategic acquisition for a large pharmaceutical company, licensing a medical device company’s patents or winning antitrust, securities or patent disputes, our lawyers approach every matter with the resources of a major international firm and the focus and depth of a life sciences boutique.

We routinely advise on complex cross-border and domestic transactions. Our clients range from start-ups to multinationals in pharmaceuticals, biotechnology, drug discovery, genomics, diagnostics, medical devices, biosimilars, and digital health – as well as the life sciences industry’s most active investment banks, venture/growth capital firms and research institutions.

Our life sciences transaction lawyers enhance the development and commercialization of new technologies and scientific breakthroughs by negotiating mergers, acquisitions, spin-offs and joint ventures, advising on licensing options, partnerships and strategic alliances, and guiding clients through related antitrust and litigation issues. Our team efficiently delivers value to stakeholders by structuring commercially successful transactions, ensuring swift execution and protecting clients’ interests in all phases of the transaction. We also help clients structure capital to support the development and commercialization process, ranging from early-stage venture financings and strategic equity investments to complex public offerings of equity and debt.

During the planning phase, we work in multidisciplinary teams to analyze legal, tax and regulatory implications and conduct risk assessments. As companies prepare for transition, we, in close collaboration with our clients, facilitate the exploration of strategic alternatives and advise on competitive negotiations. A core aspect of our efforts is to support our clients’ teams in managing the details of closing transactions while simultaneously operating their businesses and advising on a range of integration issues.

We collaborate with Dechert specialists in tax, intellectual property, antitrust, real estate, environmental, litigation and labor to provide clients with the full range of advisory expertise they need to get the deal done.  

When life sciences disputes arise, our cross-practice litigation team works to preserve clients’ interests, assets and reputations, obtaining successful outcomes in litigation and arbitrations across the globe. Drawing on our antitrust/competition, intellectual property, international arbitration, litigation, product liability, regulatory, securities and white collar

LIFE SCIENCES TRANSACTIONS

LIFE SCIENCES LITIGATION

defense lawyers, we provide comprehensive advice in the most complex life sciences disputes.

We regularly take on bet-the-company litigation for pharmaceutical, biotechnology and medical device companies. Our deep bench of trial lawyers are lead counsel in many of the most significant cases that challenge the healthcare and life sciences industry.

Dechert’s antitrust lawyers pilot deals through the Federal Trade Commission and European Commission, navigating competition investigations and defending private litigation, including class actions. Our IP practice has a dedicated Hatch-Waxman litigation team with extensive experience in preparing for and litigating Abbreviated New Drug Application (ANDA) disputes. We defend our clients in product liability and consumer fraud claims of all kinds, drawing on the skills of one of the leading product liability practices in the U.S. 

Our lawyers also have extensive experience representing life sciences companies in a broad range of securities litigation matters, including claims arising out of the development, commercialization, sale and marketing of pharmaceutical products. We advocate on behalf of clients in disputes, including in litigation and arbitration, arising out of licensing, collaboration, asset purchase and other agreements. We also advise life sciences companies and their boards, audit committees and executives through complex internal and external investigations and related civil litigation.

From defending branded products against generic challenges and coordinating mass tort defenses to protecting companies and their boards from challenges by shareholders, we guide clients through the entire array of contentious issues that arise in the life sciences sector.

Our intellectual property counseling team advises on strategies that achieve life sciences clients’ business goals while balancing risk through all stages of the product life cycle. Working alongside start-ups and multinationals in pharmaceuticals, biotechnology and drug discovery – as well as the industry’s most active venture/growth capital firms and research institutions that fund them – we help clients assess business opportunities, avoid regulatory problems and keep their business momentum energetic and on track. 

Recognizing the dual imperative of maximizing patent portfolio value and aggressively protecting client products worldwide, we strive to enhance our clients’ value and afford them the strongest protection. Our services include strategic portfolio management and patent prosecution, IP due diligence associated with M&A deals, joint ventures and other commercial transactions, and post-grant and ex parte proceedings, including interferences, reviews, opinions, re-examinations, re-issues and oppositions.inter partes

Many members of our team hold a Ph.D. or other advanced degrees in the sciences and have either postdoctoral or industrial experience above and beyond their experience as lawyers, enhancing collaboration with our clients’ scientists, executives and legal teams.

LIFE SCIENCES COUNSELING

CVS Health, a pharmacy innovation company, in a series of antitrust-sensitive billion dollar deals, including its US$70 billion acquisition of Aetna. This is the largest healthcare services transaction in history, the largest announced deal of 2017, and the second largest deal to close in 2018. The antitrust implications were analyzed by the Department of Justice (DOJ), Congress, state attorneys general, state departments of insurance, and many private groups. The companies obtained approval from DOJ despite loud opposition seeking to block the deal based on vertical foreclosure concerns.

Ipsen, a global specialty-driven pharmaceutical group, in its US$1 billion cross-border acquisition of the global oncology assets from Merrimack Pharmaceuticals, including its key marketed product ONIVYDE® (irinotecan liposome injection) for the treatment of patients with metastatic pancreatic cancer. Under the terms of the agreement, Ipsen gained exclusive commercialization rights for the current and potential future indications for ONIVYDE® in the U.S. as well as the current licensing agreements with Shire for commercialization rights outside the U.S. The transaction also includes Merrimack’s commercial and manufacturing infrastructure. Analysts say the deal gives Merrimack the resources to fund the development of three new compounds targeting pancreatic, lung and other types of cancers, while boosting Ipsen’s portfolio, which has traditionally focused on endocrinology.

BioAtla, a global clinical stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, in its worldwide collaboration with BeiGene, a commercial-stage biopharmaceutical company, for the development and commercialization of CAB-CTLA-4. BioAtla will receive an upfront payment of US$20 million and a milestone payment upon reaching the defined early clinical objectives. BioAtla is also eligible to receive up to US$249 million in subsequent development and regulatory milestones globally and commercial milestones in the BeiGene territory, together with tiered royalties on sales in the BeiGene territory.

Celgene Corporation, a global biopharmaceutical company, in the acquisition of a 10% stake in Juno Therapeutics, Inc. as part of a 10-year collaboration for the development and commercialization of immunotherapies worth approximately US$1 billion. This acquisition represents the largest up-front sum for a biotechnology licensing agreement ever, according to Bloomberg Intelligence. As many analysts have noted, this collaboration has the potential to eradicate many forms of cancer over the next 10 years. Dechert has also represented Celgene in several other domestic and cross-border multibillion-dollar licensing and M&A transactions.

Endo Pharmaceuticals, a global specialty pharmaceutical company, in a series of related Hatch-Waxman patent infringement actions filed against seven generic companies regarding its OPANA® ER tablets, which at its peak, was Endo’s second highest-selling product with US$300 million in annual sales. The Dechert team prevailed in a five-week trial in New York against seven generic companies, and later, secured Federal Circuit affirmance of its hard-fought patent trial victory, so that none of the generic versions of OPANA® ER involved can come to market before Endo’s patents expire in 2023. Dechert also prevailed in two separate patent trials in the District of Delaware with respect to an additional patent that Endo exclusively licensed from Mallinckrodt. The cases are currently on appeal, and the defendants are enjoined from selling their generic products through 2029.

EXPERIENCE

Nimbus Apollo, Inc., a biotherapeutics company that develops drugs to treat non-alcoholic steatohepatitis, in developing and implementing a drug discovery patent strategy and, later, a focused patent strategy protecting the lead drug candidate in human clinical trials. Subsequently, the company was acquired by Gilead Sciences for US$1.2 billion. In 2016, Dechert was honored by the Financial Times in the "Legal Expertise" category entitled "Enabling Clients to Innovate" for the innovative IP strategy work done on behalf of the drug discoverer to underpin the deal with Gilead.

Pfizer, a global biopharmaceutical giant, in a multidistrict litigation (MDL) related to the company’s anti-cholesterol drug, Lipitor. In June 2018, the U.S. Court of Appeals for the Fourth Circuit handed Pfizer a resounding victory by upholding a lower court’s dismissal of a MDL alleging that Lipitor had caused Type 2 diabetes in thousands of patients. The court’s decision was also a triumph for Dechert partner Mark Cheffo, who for more than a decade has been national counsel to the company in litigation involving Lipitor. Beginning in 2015, Mark led a team that prevailed on a series of Daubert motions and prevented the plaintiffs from bringing a single case to trial. The federal MDL court excluded all general causation evidence at all doses (other than the highest dose), which affected thousands of cases that represented about 90% of the docket. The court excluded virtually all of plaintiffs’ experts’ opinions that Lipitor is not effective for women and dismissed their core “no efficacy” claims as pre-empted. Also excluded were significant portions of the plaintiffs’ regulatory and marketing opinions and their specific causation experts in the first two trial cases. The MDL was closed less than three years after it was created.

Johnson & Johnson (J&J) and its affiliate , a medical equipment developer Ethiconwithin the J&J family of companies, in its strategic collaboration with Google, working with the Life Sciences team on advancing surgical robotics to benefit surgeons, patients and health care systems. The companies will bring together capabilities, intellectual property and expertise to create an innovative robotic-assisted surgical platform capable of integrating advanced technologies with the goal of improving health care delivery in the operating room. The companies seek to develop new robotic tools and capabilities for surgeons and operating room professionals that integrate best-in-class medical device technology with leading-edge robotic systems, imaging and data analytics.

Bristol-Myers Squibb (BMS), a global biopharmaceutical company, in an important victory by securing the reversal by the Pennsylvania Supreme Court of a lower court’s US$28 million judgment against BMS for violating Pennsylvania’s Unfair Trade Practices and Consumer Protection Law. The decision was significant as at least 26 other states had filed similar lawsuits citing unfair and deceptive practices by pharmaceutical companies.

The underwriters, led by Citigroup Global Markets Inc. and JefferiesLLC, in the initial public offering and cross-border listing of French radiopharmaceutical company (AAA) on NASDAQ. AAA was Advanced Accelerator Applications S.A. seeking to advance the molecular nuclear therapy branch of its business, to heighten its corporate profile and to diversify its investor base by gaining access to the U.S. capital markets. AAA accomplished these goals by capitalizing on the positive results from the pivotal Phase 3 trial for its novel lead therapeutic candidate, Lutathera, for the treatment of patients with positive midgut neuroendocrine tumors to conduct a successful US$86.5 million initial public offering of American Depositary Shares and listing on the NASDAQ Global Select Market. AAA’s IPO priced within its anticipated range despite uneven market conditions. AAA’s U.S. IPO not only enabled AAA to access U.S. investors, but AAA used a portion of the

proceeds of the offering to establish a permanent Lutathera manufacturing facility in Millburn, New Jersey; further establishing a favorable profile for future capital raising transactions in the U.S.

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SAMUEL B. ABRAMS

PartnerIntellectual Property(more)New YorkT +1 212 641 5684samuel.abrams@dechert.comvCard

ARIF H. ALI

PartnerInternational Arbitration(more)Washington, D.C.T +1 202 261 3307LondonT +44 20 7184 7557arif.ali@dechert.comvCard

SHEILA L. BIRNBAUM

PartnerProduct Liability and Mass Torts(more)New YorkT +1 212 698 3625sheila.birnbaum@dechert.comvCard

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PartnerLitigation(more)PhiladelphiaT +1 215 994 2205steven.bizar@dechert.comvCard

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PartnerIntellectual Property(more)PhiladelphiaT +1 215 994 2664martin.black@dechert.comvCard

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