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Crowell & Moring has developed a comprehensive collection of intellectual property and information technology practices to meet our clients' growing demand for guidance and counsel in the development and protection of assets in the regulated health care arena. We represent clients in patent litigation involving generic drugs and medical devices, as well as on a wide range of issues concerning health care information that arise in this digital age.

Hatch-Waxman Litigation Practice

Crowell & Moring is home to a growing team of patent litigators representing and advising clients in cases arising under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act, commonly referred to as the "Hatch-Waxman Act." Our Hatch-Waxman litigation group currently consists of nearly 20 intellectual property litigators who bring experience, dedication, and skill to Paragraph IV litigation.

Our group includes first-chair Hatch-Waxman and patent trial litigators (non-jury and jury), lawyers with technical degrees, including advanced degrees in the relevant disciplines, and lawyers experienced in working with experts to develop the relevant testing and opinion testimony that in many cases is critical to success. Our lawyers also have experience in the specific regulatory framework in which these cases are fought and use their knowledge to advance our clients' interests.

Our Hatch-Waxman experience also includes an understanding of the drug-approval provisions under the Food, Drug, and Cosmetic Act, and extensive history navigating the nuanced strategic considerations that often govern the desired outcomes in these litigations. Our lawyers address matters in nearly every aspect of the Hatch-Waxman arena. In addition to patent litigation, we also are experienced with citizen petitions filed with the Food and Drug Administration (FDA) on various regulatory issues under the Hatch Waxman Act that may concern approval, exclusivity, forfeiture, or other issues critical to the successful commercialization of a product.

Medical Device Industry

Medical device companies face an increasingly complex array of legal and compliance issues. Collaborating across both coasts, and between its U.S. offices and its lawyers in London and Brussels, Crowell & Moring provides to medical device industry clients extensive resources and breadth of experience.

Representative Engagements

  • Represented Gerber Scientific in a patent assertion involving ophthalmic equipment and settled on favorable terms after the Markman hearing
  • Defended C.R. Bard in a patent litigation involving coronary catheters and settled on favorable terms after two weeks of jury trial.
  • Represented Boston Scientific in offensive and defensive patent litigations relating to coronary stents
  • Represented an inventor in asserting patents directed to fiducial markers for image-guided surgical procedures
  • Advised major medical device manufacturers on new product clearances for coronary catheters, guidewires, and vascular stents, and provided formal legal opinions as appropriate
  • Designed and implemented patent portfolio strategies for medical device manufacturers for blood flow monitors, catheter guidewires, coronary catheters, coronary and vascular stents, dental implants, drug-eluting stents, electronic tissue stimulators, ophthalmic equipment, and professional and over-the-counter (OTC) diagnostic kits
  • Advised medical device companies on clearance requirements under the FDA's 510(k) premarket notification process for medical devices

Licensing / IT / E-Commerce

Crowell & Moring is a leader in the cutting edge legal issues associated with the explosive growth of health information technology. Our health care, corporate, and IP lawyers provide advice on health IT issues for clients across the entire health industry spectrum, including providers, health plans, electronic health records (EHR) vendors, device manufacturers, trade and professional associations, and health industry publishers.

Our intellectual property and IT lawyers have long worked with the firm's health care clients on a wide range of issues concerning copyright, trademark, data protection, software, services, and online liability issues in the digital age. Members of our team have negotiated content and trademark license agreements, software license agreements, collaborative IT development agreements, outsourcing and other IT services agreements, and confidentiality and non-disclosure agreements, among others, for health care industry clients.

Our attorneys have also counseled health care industry clients on Internet-related issues, including regulatory compliance, contributory and vicarious liability, the Digital Millennium Copyright Act, third-party content, website look and feel protection, and joint ownership of content. Our lawyers advise clients and speak about database protection, including new protections being considered by the U.S. government and the EU.

Representative Engagements

  • Counseling and negotiation of terms of agreements for "mining" and sharing of confidential data
  • Advising health care industry clients on anti-kickback and anti-referral hazards associated with transactions involving EHR, e-prescribing technologies, etc.
  • Negotiating content licensing for health care website, with tailored protections for credentialed medical research content
  • Negotiating joint and separate ownership of health care research and related content with the National Institutes of Health and the World Health Organization
  • Negotiating joint development agreements with software and application vendors in the health care field, including defining scope of joint ownership and providing for royalty rights for health care company/customer
  • Resolving disputes on behalf of health care service provider regarding scope of rights under application development and license agreements, including negotiation of follow-on license agreements with a vendor
  • Counseling health care industry clients on use of electronic contracting measures to satisfy HIPAA-related regulatory requirements
  • Advising health care industry clients on the privacy and security risks of using, disclosing, and accessing electronic health information (under HIPAA, Privacy Act, state privacy laws, and international data protection laws)
  • Advising health care industry clients on compliance with federal and state security breach notification laws
  • Developing protocols and procedures for electronic formation of business contracts for health care industry clients.
  • Enforcing trademark and copyright rights of health care companies and associations against unauthorized use of marks and content.
  • Performing IP due diligence in connection with mergers, acquisitions, and joint ventures of health care industry clients
  • Preparing medical related disclaimers for health care company websites
  • Preparing user agreements and policies for access to and use of health care data provided by Web-based services
  • Preparing user agreements providing a basis for protection of data compiled for Web access
  • Licensing of content of health care entities for publishing, translation, foreign exploitation, integration into electronic applications, and website use
  • Preparing rules for blogsite and discussion forum participation in services hosted by health care companies or associations
  • Advising healthcare industry clients on policies for use of social media by employees, customers, and patients, and by client itself for marketing and social community purposes
  • Advising health care industry clients on replacement of enterprise-wide core administrative IT systems
  • Negotiating IT services agreements, including business process outsourcing and hosting agreements

View More

"Payers, Providers, and Patients – Oh My!: Data Analytics and FCA Investigations," Health Care Alert (January 21, 2021). Contacts: Michael Shaheen, Joe Records, Payal Nanavati
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"Virginia Enacts Permanent COVID-19 Employee Health and Safety Requirements," Labor & Employment Law Alert - US (January 15, 2021). Contacts: Thomas P. Gies, Daniel W. Wolff, Katie Erno, Christine B. Hawes
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"HHS Finalizes SUNSET Rule, Placing Thousands of Regulations at Risk of Invalidation," Health Care Alert (January 15, 2021). Contacts: Jodi G. Daniel, Lidia Niecko-Najjum, Samuel Ruddy
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"New Legislation Eliminates Long-Standing Antitrust Immunity for Health Insurers," Antitrust Law Alert (January 14, 2021). Contacts: Shawn R. Johnson, Alexis Victoria DeBernardis, Connor Ahearn, Kate M. Watkins
Client Alert/Newsletter
"Transition 2021: The Future of Health Care under a Biden Administration," Crowell & Moring Webinar (January 12, 2021). Presenters: A. Xavier Baker, Troy A. Barsky, Jodi G. Daniel, James G. Flood, and W. Scott Douglas.
"Congress Passes Combined COVID-19 Relief and Omnibus Spending Bill," (December 23, 2020). Contacts: Jacinta Alves, A. Xavier Baker, Troy A. Barsky, Peter Eyre, James G. Flood, Glenn D. Grant, Olivia Lynch, S. Starling Marshall, Amy Laderberg O'Sullivan, Paul J. Pollock, Michael E. Samuels, Tim Shadyac
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"COVID Relief and Appropriations Legislation Includes Mental Health Parity Compliance and Oversight Requirements," Health Care Alert (December 23, 2020). Contacts: A. Xavier Baker, Michael W. Lieberman, Lauren R. Nunez, Joe Records
Client Alert/Newsletter
"Stand Up: Third Parties May Challenge False Claims Act Civil Investigative Demands," Government Contracts Bullet Points (December 22, 2020). Contacts: Brian Tully McLaughlin, Michael Shaheen, Lyndsay A. Gorton
Client Alert/Newsletter
"CMS Expands on Patient Access and Interoperability Requirements for Health Plans," Health Care Alert (December 18, 2020). Contacts: Jodi G. Daniel, Lidia Niecko-Najjum
Client Alert/Newsletter
"HHS Proposes to Modernize HIPAA to Facilitate Care Coordination and Case Management," Health Care Alert (December 17, 2020). Contacts: Jodi G. Daniel, Brandon C. Ge
Client Alert/Newsletter

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Crowell & Moring LLP is an international law firm with approximately 550 lawyers representing clients in litigation and arbitration, regulatory and policy, and transactional matters. The firm is internationally recognized for its representation of Fortune 500 companies in high-stakes litigation, as well as its ongoing commitment to pro bono service and diversity, equity and inclusion. The firm has offices in Brussels, Doha, London, Los Angeles, New York, Orange County, San Francisco, Shanghai, and Washington, D.C.

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