Health Care Intellectual Property

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" or "Hatch-Waxman." Our Hatch-Waxman litigation group currently consists of nearly twenty IP group litigation partners, counsel and associates, 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 expertise in the specific regulatory framework in which these cases are fought and use that expertise 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 expertise in navigating the nuanced strategic considerations that often govern the desired outcomes in these litigations. Our attorneys 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 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 attorneys in London and Brussels, Crowell & Moring provides to medical device industry clients both extensive resources and breadth of expertise. Attorneys in Crowell & Moring's Intellectual Property practice have experience working with medical device companies in the following areas:

Represented Gerber Scientific in a patent assertion involving ophthalmic equipment. Case settled on favorable terms after the Markman hearing.
Defended C.R. Bard in a patent litigation involving coronary catheters. Case settled on favorable terms after two weeks of jury trial.
Represented Boston Scientific in offensive and defensive patent litigations relating to coronary stents.
Represented 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 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

Our Intellectual Property attorneys have long worked with the firm’s healthcare clients on a wide range of issues concerning copyright, trademark, data protection, software, and online liability issues in the digital age. Our experts have negotiated content and trademark license agreements, software license agreements, collaborative IT development agreements, and confidentiality and non-disclosure agreements, among others, for healthcare industry clients.

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

Our recent experience for healthcare industry companies and associations includes the following:

Counseling and negotiation of terms of agreements for “mining” and sharing of confidential data
Negotiation of content licensing for healthcare website, with tailored protections for credentialed medical research content
Negotiations regarding joint and separate ownership of healthcare research and related content with the National Institutes of Health and the World Health Organization
Negotiation of joint development agreements with software and application vendors in the healthcare field, including defining scope of joint ownership and providing for royalty rights for healthcare company/customer
Resolving disputes on behalf of healthcare service provider regarding scope of rights under application development and license agreements, including negotiation of follow-on license agreements with vendor
Counseling healthcare industry clients on use of electronic contracting measures to satisfy HIPAA-related regulatory requirements
Developing protocols and procedures for electronic formation of business contracts for healthcare industry clients
Enforcing trademark and copyright rights of healthcare companies and associations against unauthorized use of marks and content
Performing IP due diligence in connection with mergers, acquisitions, and joint ventures of healthcare industry clients
Preparation of medical related disclaimers for healthcare company websites
Preparation of user agreements and policies for access to and use of healthcare data provided by web-based services
Preparation of user agreements providing a basis for protection of data compiled for web access
Licensing of content of healthcare entities for publishing, translation, foreign exploitation, integration into electronic applications, and website use
Preparation of rules for blogsite and discussion forum participation in services hosted by healthcare companies or associations
Advised 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