Dr. Beverly W. Lubit has decades of experience as IP counsel, deal advisor and litigator, helping her clients to realize the potential of their technologies, products and services. She advises clients on complex intellectual property and regulatory compliance matters.
Dr. Lubit has drafted and successfully prosecuted hundreds of biotechnology patents. From cutting edge cancer, stem cell, immunology and neurochemistry therapies to orthopedic devices, to dietary supplements, to biofuel development, Dr. Lubit’s practice has touched an extraordinarily broad array of groundbreaking work at the nexus of science and business.
Dr. Lubit provides comprehensive counsel and guidance on intellectual property and regulatory compliance issues and has structured and negotiated all manner of transactions – from operational, production, and distribution-related contracts to clinical trial agreements, funding agreements, consulting and research agreements to master services and supply agreements, among others. She has prepared patent noninfringement, validity, and freedom to operate opinions and conducted due diligence examinations of potential merger, investment and partnering targets.
Dr. Lubit’s strong research, project management, strategic planning and communication skills enables her to work closely with emerging companies, venture capitalists and company boards to develop practical IP and regulatory strategies to help them bring their products and/or services to market.
Honors
- New Jersey Law Journal’s Top Women in Law (2016)
- IAM Patent 1000, New Jersey (2016-present)
- Client Choice Award, Intellectual Property: Patents For New Jersey, Lexology (2013, 2015-2017)
Various biotechnology clients – prepared patent-related opinions: prepared patent noninfringement, validity, and freedom to operate opinions related to, for example, polymer chemistry, cellular therapies, and therapeutic antibodies.
Regulatory compliance: Provided U.S. regulatory advice relating to compliance with the framework for human drug compounding; the Drug Supply Chain Security Act (DSCSA); Federal Food, Drug and Cosmetics Act, and Medical Device Amendments; regulatory due diligence under 505(b)(2), 21 CFR 312 (IND), and 21 CFR 314 (NDA); prepared INTERACT brochure; prepared terms and conditions for medical device launch
Hospital entity: Preparation and negotiation of joint venture agreements and IP management plan: Prepared clinical trial agreements, funding agreements, and subaward agreements related to multisite grant-funded clinical trials. Prepared and negotiated IP Management Plan; Affiliation Agreement; Joint Venture and Strategic Partnership Agreements between the involved hospital entities.
Various medical centers, early stage companies, and biotech start-ups – drafted and successfully prosecuted U.S. and ex-U.S. patent applications including the following technologies:
- Antibody therapeutics
- Biofuels
- Biomarkers
- Brain injuries
- Cancer therapeutics
- CAR-T cells
- Catheters
- Cell engineering
- Cell therapies
- Drug delivery systems
- Drug formulations
- Electrocardiography
- Exosome therapeutics
- Healthcare IT
- Hemostatic agents
- Histone deacetylase inhibitors
- Immunoinflammatory modulators and conditions
- Immunotherapies
- Kinase inhibitors
- Ocular implants
- Peptides and Peptide Engineering
- Polymer chemistry
- Recombinant biologics
- Signal transduction
- Small molecule therapeutics
- Stem cells
- Topical compositions for epithelial conditions; for treatment of topical burns and wounds, and for pain due to sports injury
- Wound healing
Negotiation of research provisions and agreements: negotiated IP related provisions of sponsored research and option agreements relating to a patent portfolio of medical devices; provided strategic advice regarding optioning patents; and IP advice regarding ongoing patent prosecution of involved patents
Medical practice: joint venture, consulting and IP agreements: prepared uniform consulting terms and conditions for medical practices and policies regarding outside activities and assignments; negotiate web based services HIPAA and HITECH vendor compliant agreements; negotiate physician consulting agreements that govern consulting relationships
Start-up biotechnology companies: lead in-licensing negotiations with major U.S. universities; prepared and negotiated master services agreements with Clinical Research Organizations for clinical development and discovery