Background - Practices (Details)

Intellectual Property - Life Sciences

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Crowell & Moring meets the diverse needs of clients in the life sciences industry by drawing from a wealth of intellectual property and information technology experience.  Our lawyers have excellent technical and legal credentials and, in many cases, have worked directly in the life sciences, chemistry, and biotechnology spaces. Our services encompass everything from providing guidance in the development, protection, and monetization of assets to enforcing and defending clients’ IP rights.

Given the growing IP issues in digital health, we assist clients with prosecution, litigation, counseling, licensing, and data rights involving health care information. Identifying the default IP terms regarding the ownership and use of data and innovations is critical for our life sciences industry clients— specifically how any anticipated jointly developed health technology will be owned and utilized—and we work with clients to craft detailed descriptions, determine IP ownership cadences, create cost-sharing frameworks for prosecution and maintenance, and grant license rights. We represent clients ranging from start-ups to the largest Fortune 500 companies in life sciences areas including biotechnology, pharmaceuticals/biopharmaceuticals, biomanufacturing, medical devices, and digital health assets.

Biotechnology

Crowell & Moring’s biotechnology team handles litigation for a wide variety of clients in technologies such as genetic engineering tools and pluripotent stem cells, while also addressing client needs with patent procurement and licensing.  In addition, our team has extensive experience in biomanufacturing of biologics and the processes, procedures, and protocols to scale up benchtop to manufacturing.

Hatch-Waxman, BPCIA, and Biotechnology Litigation Practice

Crowell & Moring is home to a team of nearly 20 intellectual property litigators representing and advising clients in cases arising under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act (BPCIA).  Our group includes first-chair life sciences patent trial litigators (both non-jury and jury), lawyers with advanced degrees and other technical 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. We have been victorious in courts throughout the country, including Delaware, New Jersey, and Maryland. 

Our lawyers also have experience in the specific regulatory framework in which these cases are fought, and they use their knowledge to advance our clients’ interests.  In addition to patent litigation, we 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, and with patent term extensions under 35 U.S.C. §156 for both drug and medical device products.

With offices internationally, Crowell & Moring regularly coordinates and handles international litigations on specific products, thereby ensuring clients are able to leverage the knowledge gained in each jurisdiction and disseminate it to other jurisdictions litigating the same product.  This not only provides key consistency in arguments made across jurisdictions, but also helps client reduce costs of international litigation by using the same counsel in multiple jurisdictions worldwide. 

Inter Partes Review

Our combination of patent procurement, counseling, and litigation experience makes us particularly effective in handling post-grant proceedings, including interferences, inter partes reviews, ex parte reexaminations, and other administrative proceedings before the U.S. Patent and Trademark Office. Our team works closely with clients to develop and implement cost-effective strategies to challenge or defend patents during inter partes review and other post grant proceedings and includes attorneys who have handled IPRs in various industries, such as pharmaceutical, biotechnology, biologics, and medical devices.

Medical Device Industry

Medical device companies face an increasingly complex array of legal issues in the intellectual property arena.  Our attorneys have experience advising solo inventors, start-ups, venture capital entities, and publicly traded companies on patent prosecution and in-licensing, portfolio growth, licensing, and enforcing or defending intellectual property.  We have succeeded in high-stakes patent litigation in the medical device field, which have been subsequently affirmed at the Federal Circuit. 

Licensing and Monetization

The intellectual property team at Crowell & Moring helps clients across the United States and abroad realize the full value of their intellectual property and defend against unauthorized use of their ideas— assets often described as “today’s international currency.” Successful strategy, protection, and management of intellectual property rights can play a significant role in the broader success or failure of a business venture, especially where substantial effort and capital investment are devoted to the development of new technology or new ideas.

Innovations typically involve a broad range of technologies, and our IP team has in-depth experience in the full spectrum of scientific disciplines and the products and processes to which they give rise. Our lawyers apply their technical backgrounds and experiences to guide clients in a variety of industries, including biotechnology, chemical engineering, pharmaceuticals and life sciences.

Lawyers from our Intellectual Property and Corporate Groups work together closely to structure, negotiate, and implement IP transactions involving patents, trademarks, copyrights, trade secrets, know-how, and most other forms of intellectual property. As a benefit of our close working relationship with the firm’s Government Contracts Group, we have substantial knowledge and extensive experience with issues arising when licensing IP to governmental entities, including patent and technical data rights issues.

Data Rights in Life Sciences

Crowell & Moring is a leader in the cutting-edge legal issues associated with the explosive growth of health information technology. Our cross-discipline team of intellectual property and IT lawyers have long worked with the firm’s 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 life sciences industry clients.

Our attorneys have also counseled 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.