Dr. Beverly Lubit advises clients on complex intellectual property matters, focusing on the pharma, biotechnology, medical device and energy industries. She has experience in Hatch-Waxman (small molecule drugs) and BPCI Act (biosimilar drugs) issues relating to litigation and transactional matters, patent litigation, IP due diligence evaluations, opinion letters, licensing, patent prosecution, and regulatory issues with a particular emphasis on life sciences. In addition, Beverly works closely with emerging companies, venture capitalists, and company boards to develop practical IP strategies to help them bring their products and/or services to market.
Transactional and Counseling
Types of Agreements: Master Supply Agreements; Clinical Trial Agreements; Clinical Services Agreements; Compound Library Agreements; Consultant Agreements; Collaborative Research Agreements, Development or Manufacturing Services Agreements; Distributor Agreements; Informed Consents; Investigator-Initiated Clinical Research Study Agreements; Key Opinion Leader Agreements; License Agreements; Material Transfer Agreements; Non-Disclosure Agreements; Quality Agreements; Sponsored Research Study Agreements; Sponsored Clinical Research Study Agreement; Supply Agreements; Trademark Agreements; and intellectual property provisions of Merger Agreements including Disclosure Schedules. Also, U.S. regulatory advice including Compounding, Dietary Supplements, Drugs, Medical Devices, and Generic Products.
Patent Prosecution
Drafted and prosecuted U.S. and foreign patent applications including without limitation the following subject matter:
- antibody therapeutics
- bioengineered organisms
- biofuels
- biomarkers
- brain injuries affecting cerebral blood flow
- calcium channel agonists and antagonists
- cancer therapeutics
- cosmetics
- dietary supplements
- drug delivery systems, including biomedical devices
- drug formulations
- electrocardiography
- electrochemistry
- endothelin channel antagonists
- flow cytometry
- food fortifying compositions and methods
- healthcare IT
- hemostatic agents
- histone deacetylase inhibitors
- immunoinflammatory modulators and conditions
- immunotherapies
- kinase inhibitors
- Imidazolidinedione analogs to treat the appearance of skin wrinkling • lipid metabolism
- macro and nanoelectrode materials
- nanomaterials
- neurochemistry disorders and conditions
- ocular implants
- orthopedic devices
- oxidative stress
- peptides and peptide engineering
- progressive cognitive function disorders; including Alzheimer’s disease
- prostaglandin analogs
- polyisoprenyl protein inhibitors
- receptors
- recombinant biologics
- regenerative therapies
- shoulder and hip replacement medical devices
- signal transduction
- small molecules
- stem cells
- topical compositions for epithelial conditions, for treatment of topical burns and wounds, and for pain due to sports injury
- transient receptor potential channel agonists and antagonists
- 3D-nanofiber matrices for implantation delivery of differentiable stem cells isposed on or in these medical devices
