David A. Fazzolare J.D, M.S.,

Practice Areas

David counsels clients in all areas of intellectual property including patents, trademarks, copyrights, and trade secrets. David has over 15 years of experience advising clients, including startups, prominent university and research institutes, and Fortune 500 companies in the life sciences sector on the strategic development and management of their patent portfolios worldwide. David also advises clients on mitigating third party intellectual property risks throughout all phases of product development, including providing freedom to operate, non-infringement, and invalidity opinions, as well as performing due diligence to assess patent portfolios for venture capital investment, mergers and acquisitions, and licensing opportunities. David has also counseled clients on the Hatch Waxman Act.

With a background in pharmacology and biotechnology, and in-depth knowledge of regulatory affairs, David helps clients maximize product lifecycles and revenue streams in the biotechnology, chemicals, materials sciences, medical devices, pharmaceuticals, and specialty chemicals areas. David’s diverse patent experience includes artificial cells and organs, bioassays, bioinformatics, biologics, cellular therapy and regenerative medicine, control systems, diagnostics, drug formulations and delivery systems, enzymes and microorganisms, gene editing, immunotherapy, industrial bioprocesses, nucleic acid synthesis and therapeutics, nutraceuticals, research tools, small molecules, and vaccines.

David leverages his significant in-house patent experience to provide cost-effective, practical, and business-focused solutions to his client’s complex legal problems. Before joining Casimir Jones, he served as inhouse patent counsel at Novozymes for over 7 years, where he helped their first-generation biofuels business maintain their dominant market share by engaging in competitive patent drafting and prosecution with awareness of competitor’s products and using available USPTO procedures to challenge competitor filings, helping cross-functional product development teams to harvest inventions and work around competitor’s patents, counseling commercial teams on the negotiation and drafting of intellectual property provisions in partnering agreements, and collaborating with internal and external litigation teams on strategies for enforcing patents and defending against patent infringement lawsuits and IPRs. During law school, David worked as a patent agent for Myriad Genetics where he conducted prior art searching and patentability assessments, reviewed and drafted non-disclosure agreements, performed due diligence for acquisition and in-licensing of patent portfolios and devised strategies for staving off generic competition under the Hatch-Waxman Act.

Professional Experience

Shareholder, Casimir Jones S.C., 2024-present

Senior Patent Attorney, Novonesis (formerly Novozymes) 2016-2024

Attorney, Ward and Smith, P.A., 2015-2016

Associate, Morse, Barnes-Brown & Pendleton, 2011-2015

Instructor, Intellectual Property and Patent Law for Researchers, Michigan State University, 2011-Present

Associate, Greenberg Traurig, LLP, 2009-2010

Summer Associate, Greenberg Traurig, LLP, 2008

Myriad Genetics, Inc. 2007-2008

Education

Johns Hopkins University, M.S., Biotechnology, Concentration in Regulatory Affairs, 2012

Brigham Young University, J. Reuben Clark Law School, J.D. (cum laude), 2009
SUNY Stony Brook, B.S. Pharmacology (summa cum laude), 2005

Admitted

State Bar of North Carolina
State Bar of Massachusetts
United States Patent and Trademark Office

Professional Affiliations

Association of University Technology Managers (AUTM)

North Carolina Bar Association (NCBA): Intellectual Property Law Section

10^th Judicial District Bar
National Association of Muslim Lawyers (NAML)

Honors and Distinctions

 Rising Stars (Issued by Super Lawyers), 2013
Senior Editor, International Law & Management Review, 2008-2009
Undergraduate Influenza Vaccine Research, New York Medical College, Department of Microbiology and Immunology, Spring 2005

Legal Publications and Presentations

1. Patent Strategy for Companies in the Biotechnology and Pharmaceutical Industries, Editor, CRC Press; 1st edition (June 15, 2017)
2. Global Medical Device Regulatory Strategy, co-author, Chapter 20 Patents and Intellectual Property, Regulatory Affairs Professional Society (RAPS), 2016
3. What the Patent Dance of the Biosimilars Act Means for Biosimilars, J. Commercial Biotechnology (Oct 2014)
4. Biosimilars Market Entry Barriers in Emerging Markets, Business of Biosimilars Conference (Oct 2014)
5. Quoted in Biosimilar ‘Patent Dance,’ Litigation Could Coincide With Possible Approval, InsideHealthPolicy.com’s FDA Week Vol. 20, No. 32 (2014)
6. USPTO Guidance On Patentable Subject Matter: Impediment to Biotech Innovation?, J. Commercial Biotechnology, Vol. 20, No. 3, (Jul 2014).
7. Harvard University Guest Lecturer, Harvard School of Public Health, Adj. Prof. Joanna Brougher, Intellectual Property & Public Health Policy, Resolving Patent Conflicts between Brand-name and Generic Companies under the Hatch Waxman Act and the Biologics Price Competition and Innovation Act, Oct. 2012
8. Will the Biosimilars Act Encourage Manufacturers to Bring Biosimilars to Market?, Food and Drug Policy Forum, Vol. 1, No. 5 (2011).
9. Gaming the Biosimilars Act: Loopholes Allow Authorized Interchangeable Settlement Agreements to Delay Authentic Generic Competition up to 18 Months, FDA Update (July-Aug. 2010).
10. Strategic Management of International Life Sciences Patent Portfolios: Filing Strategies, J. Biolaw & Bus., Vol. 12, No. 3 (Oct 2009).
11. Comment, Wielding the Double-Edged Sword: Creating the Perception of a Chinese Enterprise to Obtain and Enforce Patent Protection in China, 5 BYU INT’L L. & MGMT. REV. 207 (2009).
12. A Common Sense Approach to Authorized Generics, J. BIOLAW & BUS., Vol. 11, No. 3 (2008).