Life Sciences | Industries

Transactions

Clients rely on us to guide them through structuring, managing, and documenting their transactions, especially those that are complex, time-sensitive, and critical.

We have assisted both domestic and multinational clients in various forms of transactions including mergers and acquisitions, divestitures, contested transactions, management and other buyouts, recapitalizations, reorganizations, tender offers, and joint ventures. Our team is adept at handling all aspects of transactions, such as marketing and promotion arrangements, product development alliances, clinical trial agreements, licenses, site separation mechanics, shared facility agreements, business and other service agreements, lease agreements, toll and contract manufacturing agreements, supply agreements, power arrangements, and IP-related agreements.

Our expertise extends to competition and antitrust advice for cross-border transactions, ensuring adherence to regulations in the United States, Europe, and Asia. Leveraging our litigation experience, we help companies evaluate potential product and commercial liability risks through formal and informal due diligence, covering risks from existing or emergent toxic torts, product liability, and commercial disputes.

We collaborate with many Fortune 100 companies, leading global banks, and significant broker-dealers, asset managers, and insurance companies, offering legal knowledge and market experience in financial products central to these institutions. Our clients benefit from thoughtful, innovative solutions to challenges in capital markets transactions.

With our extensive experience in life sciences, we adeptly address regulatory, disclosure, and commercial issues in capital markets transactions. Having lawyers who thoroughly understand your business can make a substantial difference in deal outcomes.

Equipped with multi-jurisdictional skills and in-depth knowledge of capital markets and structured finance, we are positioned to offer counsel on global project finance. Our award-winning Project Finance Group frequently engages in large and innovative projects across the globe, with experience spanning sectors and countries in Europe, Asia, and the Middle East.

Our domestic and international teams are skilled in risk assessment, project appraisal, and documentation, including concession and development agreements, partnership and joint venture agreements, acquisition agreements, management agreements, and sub-contracting arrangements for a diverse clientele, including developers, sponsors, investors, contractors, operators, commercial and investment banks, governments, and public agencies.

Intellectual Property

Our IP practice offers a wide range of services, including litigation, enforcement, counseling, patent and trademark prosecution, transactional support, and agreement drafting. Our global IP capabilities and adept handling of evolving issues in IP asset protection are well-suited for life sciences companies.

We provide comprehensive assistance from key business centers worldwide. Many of our US IP lawyers are admitted before the US Patent and Trademark Office and possess technical degrees in various fields such as biochemistry, chemistry, pharmacy, microbiology, electrical, mechanical, and chemical engineering, and computer science. Several have professional backgrounds as scientists and engineers, enhancing their legal expertise.

Our European lawyers manage cross-border patent issues and significant global brands. Our highly experienced team in Asia has practiced in Hong Kong, China, and the broader region for many years, combining knowledge of IP law with practical application.

Hatch-Waxman Counseling and Litigation

We have a successful track record in Hatch-Waxman and other patent litigation, representing innovator pharmaceutical companies against generic manufacturers and others alleging non-infringement, patent invalidity, inequitable conduct, and antitrust violations. Our creative strategies in these cases have been upheld by the Federal Circuit.

Given that new drug products are often subject to generic attacks, we provide routine counseling on Hatch-Waxman and product management issues, recognizing the critical role of IP in the life sciences sector. Our activities include:

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• Pre-litigation analysis of Orange Book listed patents to identify risks early.
• Assessing extension of FDA and patent exclusivities.
• Conducting due diligence for Hatch-Waxman and antitrust litigation.
• Creating detailed timelines and scenario planning.
• Providing strategic advice on patent term extensions.
• Analyzing non-Orange Book eligible patents.
• Offering representation before the FTC and courts in ANDA litigation settlements.

Licensing

Our team excels in representing major pharmaceutical companies and academic research institutions in negotiating IP licenses for a variety of technologies.

Our European offices manage a range of licensing and regulatory issues, including centralized and decentralized drug licensing procedures with the EMEA, orphan drug designation licenses, and related proceedings. We also provide advice on marketing, sales, and regulatory matters in collaboration with national authorities.

Similarly, our Asian offices protect trademarks and other IP rights across Southeast Asia, offering a strong presence in China through our Beijing office.

Dispute Resolution

We handle a spectrum of litigation affecting life sciences companies, from civil and criminal enforcement actions to IP litigation, environmental litigation, products liability, and mass tort actions. Our experience includes defending against various consumer and product liability claims and working on high-profile pharmaceuticals and devices.

Our Supreme Court & Appellate practice has significant experience in preemption, shaping the defense for life sciences companies in numerous Supreme Court cases. Our integrated trial approach involves assisting at the trial level and in appellate strategy.

We provide advice on various commercial disputes, including breach of contract, qui tam litigation, securities and ERISA disputes, and employment litigation.

Our team is also experienced in international and domestic arbitrations and mediations, supported by leadership in electronic discovery and records management.

Antitrust and Competition

We address a broad range of antitrust and competition issues in life sciences, from mergers and acquisitions to internal and government investigations. We represent clients before major antitrust authorities and in private damages actions.

Our combination with JSM enhances our advisory capacity concerning China's new competition regime. We also navigate the intersection of pharmaceutical IP and antitrust law, representing patent-owning clients credibly in investigations and litigation, managing related risks.

Risk Management, Investigations, and Compliance

Our expertise identifies weaknesses in controls and activities that could lead to enforcement actions. We develop compliance practices aligned with evolving regulations, conduct internal investigations, and suggest corrective measures to mitigate enforcement actions.

We advocate for "product stewardship" to spot potential issues early and advise on insurance coverage for product liability claims.

We offer risk management advice to help clients reduce litigation and claims risks, develop supplier agreements, review product labels, draft compliance programs, and assess processes for potential risks.

Government and Global Trade

Our Government and Global Trade practices combine political experience with legal knowledge to shape policy and regulations globally. Our team aids clients in advancing their domestic and global objectives.

Tax and Transfer Pricing

With over 100 tax lawyers, our tax practice is comprehensive. We advise a significant portion of the Pharmaceutical Research and Manufacturers of America members and several of the world's largest pharmaceutical companies.

We counsel on domestic and cross-border restructurings, corporate transactions, and tax disputes. Our transfer pricing advice covers the entire value chain, emphasizing coordination with non-tax personnel to protect valuable assets.

We address common industry tax issues such as:

• Value chain considerations: research, manufacturing, marketing, and life cycle management;
• Taxation of government payments and settlements;
• Handling of fees, royalties, and deferred income;
• R&D tax credits;
• Strategies for outbound migrations and intangible cost sharing;
• Domestic manufacturing deductions;
• Repatriation under the Homeland Investment Act.

Regulatory

The life sciences industries are heavily regulated, especially at early stages.

Our team has vast experience with regulating drugs, biologics, medical devices, combination products, and veterinary drugs. We guide clients through product life cycles, from research and development to compliance, government inspections, recalls, regulatory audits, labeling, and Good Manufacturing and Clinical Practices.

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Antiplatelet Drugs Market Growth Analysis 2024

Yes. As the COVID-19 and the Russia-Ukraine war are profoundly affecting the global supply chain relationship and raw material price system, we have definitely taken them into consideration throughout the research, and in Chapters 1.7, 2.7, 4.X.1, 7.5, 8.7, we elaborate at full length on the impact of the pandemic and the war on the Antiplatelet Drugs Industry.

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