General and Pqatent Counsel in Life Science
Resume:
JOHN A. CARUSO
** ****** ******, *********, ** **825
(***********@***.***)
PROFESSIONAL SUMMARY
. General Counsel, and Vice President- Regulatory Affairs, Patents and
Business Development, in the biotechnology, medical device and
pharmaceutical industries, and Of Counsel to a law firm
. CEO of a patent licensing and litigation company which obtained $
Millions from infringers of computer software/system patents
. B.S., Physiology, and member of New York and U.S. Patent and Trademark
Office bars (recently retook Patent Office exam covering America Invents
Act)
. Prepared and prosecuted patent applications in the medical device,
biotechnology and mechanical arts
. Advised on FDA matters and compliance requirements, and completed
clinical trial, research, license, and other contracts
. Member of multiple company committees that approved drug marketing and
sales promotion for publication and for presentation to FDA Office of
Prescription Drug Promotion
. Completed several due diligence projects and acquisitions of products,
technologies and companies, and led team implementing drug development
joint venture
EXPERIENCE
Icahn School of Medicine at Mount Sinai, New York, NY
3/2014-9/2014
Senior Licensing Consultant
Worked with Mount Sinai physicians and scientists in negotiating,
drafting and licensing-out their inventions, patents and
technologies, to industry partners and their spin-out companies
. Completed sponsored research, institutional collaboration, material
transfer and other research
agreements
Sunovion Pharmaceuticals, Inc., Marlborough, MA
10/2013-2/2014
Promotional Review Consultant-New Drug Project
. Reviewed and modified marketing and promotional materials for new CNS
drug
. Legal member of company committee that approved, published and
presented such materials to FDA Office of Prescription Drug Promotion
. Worked with Manufacturing on new PV, QA and other manufacturing
agreements
Iroko Pharmaceuticals Inc., Philadelphia, PA
7/2013-10/2013
Healthcare and Regulatory Counsel-First Drug Launch Project
. Set up managed care network of agreements in connection with first
drug approval
. Reviewed and modified marketing and promotional materials for first
drug
. Legal member of company committee that approved, published and
presented such
materials to FDA
DataTern, Inc., New York, NY
2010-2013
Managing Director (Patent Monetization Company)
. Monetized value in patents through litigation and licensing against
multiple infringers
. Settled several litigations and brought in $ Millions in revenue
. Managed team of contingency litigators and technical consultants to
evaluate patents,
create compelling infringement positions, and implement strategies to
achieve settlements
Ohlandt, Greeley, Ruggiero & Perle, L.L.P., Stamford, CT
2009-2010
Of Counsel-Law Firm
. Advised Life Science clients on freedom to operate, validity and other
patent matters
. Evaluated Hatch-Waxman patent challenges by generic drug companies
. Prepared and prosecuted patent applications in the medical and
mechanical arts
Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA
2007-2009
FDA/Compliance Counsel
. Member of Reckitt committee responsible for approval of drug promotion
and marketing, and advised on FDA and Compliance requirements
. Incorporated Compliance into new " Here To Help " treatment program to
improve treatment outcomes, doctor-patient relationship, and adherence
to label and DEA requirements for controlled substance drug
General/ Patent Counsel
. Completed significant acquisition of drug delivery assets and
technology
. Conducted several due diligence projects and negotiations for Business
Development to license-in and acquire new drugs and technologies
. Created drug life cycle management strategies involving improvement
patents on Company's most important drug
VivoQuest, Inc., Valley Cottage, NY
2002-2006
Lifeblood Medical, Inc., Freehold, NJ
2002-2007
Business Development/Legal Consultant
. Closed screening/license agreement for VivoQuest, a startup biotech,
with
a large pharmaceutical company, which led to a merger
. Consultant to and Director of Lifeblood Medical (2002- 2007)
. Negotiated material transfer and joint development agreements
with institutions to use
VivoQuest technology for their partner relations
. Evaluated with technical people molecule screening technologies for
potential license-in as
Business Development tools
. Aided Lifeblood CEO in selling improved tissue preservation solutions
to companies conducting
organ transplant studies
. Developed with Lifeblood team applications for grants and
financing proposals to fund clinical
trials of oxygen carrying solutions
Enzon Pharmaceuticals, Inc., Piscataway, NJ
1987-2001
General Counsel (1990-2001)
. Completed acquisition of Genex Corp., working with Board, investment
bankers, and outside counsel
. Secretary to Board of Directors and responsible for Legal requirements
in several public and private financings
. Managed inside and outside general, regulatory and patent counsel
VP Regulatory Affairs (1998-2001)
. In view of publicized, potential recall, established monitoring
program with FDA to make and sell an immune deficiency drug, until
manufacturing issues were resolved, which resulted in no recall
. In connection with publicized, potential recall of a leukemia drug,
led Enzon Regulatory and Manufacturing people, our pharma partner and
FDA people in modifying manufacturing protocols, which avoided a
recall and led to my promotion as VP-Regulatory Affairs
VP Business Development (1994-1998)
. To meet NASD minimum cash requirement, completed timely contract with
Sanofi-Aventis including satisfactory upfront cash payment
. Successfully handled arbitration with Green Cross Corp. about
royalties due Enzon under Single Chain Antibody technology license
agreement
. Closed joint venture for Single Chain Antibody technology, which
resulted in multiple out-license agreements for the joint venture
. Thereafter promoted to head Business Development
VP Patents (1987-2001)
. Led Genex Corp. acquisition of antibody business from Cambridge
Antibodies
. Developed with scientists patent strategy leading to license with
Schering-Plough for hepatitis drug, which today provides Enzon with a
reported $60 Million in annual royalties
Baxter Healthcare, Inc., Deerfield, IL
1980-1987
General and Patent Counsel for IV Product and Medical Device Divisions
. Provided general and patent legal services and supervised in-house and
outside counsel in patent prosecution, litigation and contract matters
. Prepared and prosecuted patent applications in the medical device arts
. Worked with Veterans Administration and outside counsel to favorably
settle a publicized investigation into compliance with Medicaid Rebate
Act pricing requirements, which averted a significant potential
problem without unearned liability to Baxter
EDUCATION/BAR
ADMISSION
J.D., Law
Cleveland State University
B.S., Physiology
Ohio State University
License to practice Law
New York
Member of U. S. Patent and Trademark Office Bar
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