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  • IAM Patent 1000 (2018)

Education

  • J.D., New York Law School, magna cum laude, 1998
  • M.B.A., Fairleigh Dickinson University, Finance, 1992
  • Ph.D., Columbia University, Microbiology, 1977
  • M.Phil, Columbia University, 1975
  • M.A., Columbia University, 1975
  • B.S., New York University, cum laude, 1972

Bar Admissions

  • New Jersey
  • New York
  • U.S. Patent & Trademark Office

Court Admissions

  • U.S. Court of Appeals, Federal Circuit
  • U.S. District Court, District of New Jersey
  • U.S. District Court, Southern and Eastern Districts of New York

Memberships & Affiliations

AIPLA, Biotechnology Committee, Subcommittee on PTO Issues

American Association for the Advancement of Science

American Bar Association

American Chemical Society

Association of the Bar of the City of New York, Science and Law Committee

New Jersey State Bar Association

New York State Bar Association

Languages

  • French
  • Spanish

Beverly W. Lubit, Ph.D.

  • |
Partner
  • T: 973.639.7992
    F: 973.297.3896
    • Four Gateway Center
      100 Mulberry St.
      Newark, NJ 07102

Beverly W. Lubit, Ph.D. 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.

On behalf of life science, medical device and technology companies, Beverly negotiates key intellectual property agreements including: 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.

Dr. Lubit has been named New Jersey Law Journal's "Top Women in Law" (2016); IAM Patent 1000, New Jersey (2016, 2018); Client Choice Award, Intellectual Property: Patents for New Jersey, Lexology (2013, 2015-2017) and Chambers USA, New Jersey Intellectual Property (2013-2016). IAM Patent 1000 is published by Globe Business Media Group. Chambers is published by Chambers and Partners. A description of their selection process can be found in the respective links above. No aspect of this advertisement has been approved by the Supreme Court of New Jersey.

Transactional and Counseling

Types of Agreements: Master Supply Agreements with CROs; Clinical Trial Agreements; Clinical Services Agreements; Compound Library Agreements; Consultant Agreements; Development or Manufacturing Services Agreements; Distribution Agreements; Informed Consents; Investigator-Initiated Clinical Research Study Agreement; 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 IP provisions of Merger Agreements, including Disclosure Schedules.

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
  • hemostatic agents
  • histone deacetylase inhibitors
  • immunoinflammatory modulators and conditions
  • kinase inhibitors
  • Imidazolidinedione analogs to treat the appearance of skin wrinkling
  • lipid metabolism
  • macro and nanoelectrode materials
  • nanomaterials
  • neurochemistry disorders and conditions
  • orthopedic devices
  • oxidative stress
  • peptides and peptide engineering
  • progressive cognitive function disorders; including Alzheimer’s disease
  • prostaglandin analogs
  • polyisoprenyl protein inhibitors
  • receptors
  • recombinant biologics
  • 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  

Representative Matters

Prepared IP due diligence assessment, including freedom to operate analyses, relating to potential M & A with small molecule targets.
Prepared IP due diligence assessment related to potential acquisition of biofuel technology.
Prepared litigation opinions related to patent validity and patent infringement related to therapeutic monoclonal antibodies.
Prepared patent invalidity analysis and strategy related to knock-out/knock-in animals and recombinant stem cells.
Prepared IP audits related to implantable medical devices.

Speaking

06/27/18
3rd Annual Precision Medicine Leaders Summit