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David A. Fazzolare

Associate

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David Fazzolare is a biotech, pharma and medical device patent attorney in the Intellectual Property practice of Morse, Barnes-Brown & Pendleton. David’s practice centers on preparing and prosecuting patent applications, developing and managing patent portfolios, and counseling clients (e.g., universities, research institutions, mulitnational biopharmaceutical companies, medical device companies, startups, etc.) on patentability, infringement, and freedom-to-operate during all phases of a product’s lifecycle, from concept to commercialization.

David’s patent experience covers a variety of complex and innovative inventions involving small molecule drugs, biologics, cell-based technologies (e.g., stem cells, reprogramming, differentiation, regenerative medicine, etc.), nutritional supplements, compositions of matter, medical devices (e.g., catheters, stents, grafts, etc.), drug delivery devices and formulations, nucleic acid- and protein-based technologies (e.g., gene, peptide, antibody, and RNA therapeutics (e.g., antisense, siRNA, miRNA, mRNA, etc.), mutant proteins, genome editing, etc.) and diagnostic tests. David also has experience counseling clients on the Hatch-Waxman Act and is closely following developments involving biosimilars under the Biologics Price Competition and Innovation Act.

David’s technological experience spans fields as diverse as immunology, oncology, cardiology, neurology, genetics, cell biology, molecular biology, and indications such as diabetes, metabolic disorders, cancer, neurodegenerative disorders (e.g., motor neuron diseases, such as spinal muscular atrophy and amyotrophic lateral sclerosis, multiple sclerosis, Alzheimer’s disease), and pain.

Prior to joining MBBP, David worked as a patent attorney and associate at Greenberg Traurig, LLP, and as a patent agent at Myriad Genetics, Inc. David received his J.D. cum laude from J. Reuben Clark Law School, and received his B.S. summa cum laude in Pharmacology from SUNY at Stony Brook. David received his M.S. cum laude in Biotechnology from Johns Hopkins University in May 2012.

Publications by David A. Fazzolare

Second Biosimilar Application Filed Under BPCI Act by Celltrion

FDA Releases Guidance for Determining Biologic Exclusivity Under the BPCI Act

Biosimilars Developers Watch Closely as FDA Accepts First Biosimilar Application from Sandoz

USPTO Guidance On Patentable Subject Matter: Impediment to Biotech Innovation?
Journal of Commercial Biotechnology

Obtaining Early Biosimilar Patent Certainty in the Aftermath of Sandoz v. Amgen

Trends: Top 10 Intellectual Property Developments of 2013

SCOTUS Fails to Clear the Murky Hatch-Waxman Act Safe Harbor Waters

Trends: Top 10 Intellectual Property Developments of 2012

FDA to Partner with Industry to Help Expedite Medical Device Development

Federal Circuit Finds Myriad’s Isolated DNA Claims Patentable Despite Mayo

USPTO to Hold a First-Inventor-to-File Roundtable on Thursday, September 6, 2012

FDA to Hold Public Hearing on May 11th, 2012 to Obtain Input on Draft Biosimilars Guidance

FDA Releases Long-Awaited Draft Guidance on Biosimilars

FDA to Meet on December 16 to Discuss Proposed User Fee Program for Biosimilar and Interchangeable Biologic Product Applications

Mass Life Sciences Center Accepting Applications for Accelerator Loan Program

Biotech Patent Battles Looming: The Only Certainty Provided By The Biosimilars Act

Will the Biosimilars Act Encourage Manufacturers to Bring Biosimilars to Market?
Food and Drug Policy Forum

Gaming the Biosimilars Act: Loopholes Allow Authorized Interchangeable Settlement Agreements to Delay Authentic Generic Competition up to 18 Months
FDA Udpate (July-Aug. 2010)

Strategic Management of International Life Sciences Patent Portfolios: Filing Strategies (Part I of III), J. Biolaw & Bus., Vol. 12, No. 3 (Oct 2009)

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)

A Common Sense Approach to Authorized Generics, J. Biolaw & Bus., Vol. 11, No. 3 (Sep 2008)

 

Maura Malone

Office Locations:
Waltham
Cambridge

Practice Areas:
Intellectual Property
Patent Prosecution
IP Diligence
Trade Secrets

Recent Honors:

Unique Experience:
Teaches an elective course, Intellectual Property and Patent Law for Researchers, for the online MS in Pharmacology and Toxicology at Michigan State University

Recent Articles:
Obtaining Early Biosimilar Patent Certainty in the Aftermath of Sandoz v. Amgen

Top 10 Intellectual Property Developments of 2013

Education:
SUNY at Stony Brook
J. Reuben Clark Law School
Johns Hopkins University

Bar Admissions:
Massachusetts
USPTO