Peter "Pete" Manso is an attorney in the Fort Lauderdale office at Lewis Brisbois and a member of the Corporate and Intellectual Property & Technology Practices. Pete is a registered patent attorney with more than 30 years of IP and patent prosecution experience involving complex technologies, particularly in the life sciences. He serves as intellectual property counsel to a number of leading US pharmaceutical companies, and leverages significant legal and technical insight to develop strategies that maximize the patent protection, market exclusivity, and longevity and value of branded drugs.
Pete has developed and prosecuted patent portfolios for several pharmaceutical products that have gone through and are now in clinical use. He has worked with technologies including small molecule pharmaceuticals and pharmacokinetic properties and profiles; biotechnology inventions, such as cloning systems and recombinant proteins; transgenics, stem cells, cell lines, various assays, vaccines, probes, and monoclonal and polyclonal antibodies; and medical devices.
Pete’s focus includes complex legal intellectual property issues that concern all four phases of the drug development process: research, preclinical, clinical, and postlaunch. Over the years, Pete has counseled life sciences clients on HatchWaxman and regulatory schemes and exclusivities, FDA Orange Book practice inclusive of patent listing and use code strategies; patent term exclusivity (PTE) and patent term adjustment (PTA) practice and strategies; US and foreign patent practice and strategies; first and multigeneration lifecycle management (LCM) practice and strategies, including protection for compounds, compositions of matter, processes, methods, syntheses, scaleups, indications, formulations, metabolites, intermediates, polymorphs, pharmacokinetic characteristics, stabilization techniques and characteristics, mono and combination Rx and OTC therapies, delivery systems, dosage forms, e.g., enterals (tablets, capsules, capsules, lozenges, troches, sublingual, orally disintegrating, buccal, chewable, fast acting, slow release, controlled release, enteric coated, film coated, powders, and liquids), parenterals (intravenous, subcutaneous, intramuscular, intraocular), topicals (cream, ointment, gel, foam, liquid, and cryotherapy), transdermals, nasals (sprays and gels), inhalants (liquid and powder), ophthalmics, otics and rectals, dosage strengths, treatment regimens, implants, packaging and distribution systems and methods; FDA monograph patent practice and strategies, including USP and other national pharmacopeia considerations; regulatory patent practice and strategies, including 505(b)(1), 505(b)(2), ANDA, 510K, clinical, safety warning, toxicity, and labeling patent practice and strategies; citizens petitions patent practice and strategies; clinical trial patent practice; patent misuse and antitrust practice and strategies; licensing practice and strategies; IP due diligence practice and strategies; and merger, acquisition, and divestment patent practice and strategies.
In addition to patenting a very wide variety of biotechnology and pharmaceutical products, including everything from HIV antibodies to home pregnancy and HCV tests and other diagnostics, Pete has prosecuted domestic and foreign patent applications in other technology areas, including specialty chemicals, foods, flavors, and a variety of mechanical and cellular inventions, such as handsfree cellular smartphone and tablet devices.
Pete also has extensive experience in evaluation, licensing, acquisition, and enforcement of all types of intellectual property rights. He regularly conducts IP due diligence, including infringement and validity studies of patents; infringement and validity studies concerning public offerings and SEC filings; and infringement, availability, and enforceability studies concerning trademarks, service marks, and trade dress. He is also involved in drafting and negotiating a wide variety of agreements, including licensing, acquisition, asset purchase, confidentiality disclosure, technology and material transfer, research, employment, noncompete, assignment, and joint venture agreements.
Pete also has a significant amount of litigation experience, including patent infringement litigations in which the patents on which suits were brought were found to be valid, enforceable, and infringed.
He was invited to sit on three panels at a "BugstoDrugs" program sponsored by the US Department of Defense and organized by the Sarnoff Corporation. The program addressed the need to shift to a national defense paradigm with a more biological orientation; develop and deploy technologies for disease surveillance, electronic medical records, and fieldready DNA fingerprinting technologies; and accelerate the development, manufacture, and distribution of novel and effective biological and/or chemical countermeasures — namely drugs, vaccines, and biologics — in the event of biological attack or pandemic.
Prior to embarking on his career as an IP attorney, Pete was a hospital and retail pharmacist at the University of Maryland shock trauma unit.
Primary Area(s) of Practice
- Intellectual Property & Technology
- Italy Practice
United States Patent and Trademark Office
US District Court for the Southern District of Ohio
- Member, American Bar Association
- Member, American Intellectual Property Law Association
- Member, South Florida Intellectual Property Law Association
- Board member, BioFlorida (2014 – present)
- Member, Parkland Parks and Recreation Board, Parkland, Florida (2007 – 2011)
- Sponsor of Parkland Baseball Buddies program for handicapped and autistic children, Parkland, Florida (2006 – present)
- Founder and president, Parkland Traveling Baseball Club, Parkland, Florida (1997 – present)
- President, Cardinal Gibbons High School Baseball Booster Club, Ft. Lauderdale, Florida (1999 – 2002)
- Board member, Parkland Little League Board, Parkland, Florida (1993 – 1995)
- Cofounder, sponsor and/or coach of Parkland girls’ fast-pitch softball travel program and Parkland boys’ soccer travel program, Parkland, Florida (1992 – 1995)
University of Cincinnati
University of Maryland
Bachelor of Science, Pharmacy
Florida State University
Bachelor of Science, Biology & Chemistry
- Part of a litigation team that brought successful suit on behalf of Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America, Inc. against four generics to enforce a US patent covering ACTOS®, the blockbuster oral antidiabetic drug. In the 2006 decision, the US District Court for the Southern District of New York found the patent to be valid and enforceable (see Takeda Chem. Indus. v. Mylan Labs, Inc.), thereby blocking the entry of a generic version of the drug into the US market.
- Part of a litigation team that brought successful suit on behalf of Scott Paper Co. and Chester Davis against Moore Business Forms, Inc. to enforce two reissued US patents covering methods of printing using carbonless copy paper systems and transfer and manifolding sheets. In the 1984 decision, the US District Court for the District of Delaware found the reissue patents to be valid, enforceable, and willfully infringed and awarded actual and punitive damages in excess of $25 million. (See Scott Paper Co. v. Moore Business Forms, Inc.)
- Prepared and/or prosecuted key US patents covering successful pharmaceuticals — among them Niaspan®, Pepcid Complete®, and Levoxyl® — currently selling annually in excess of $500,000,000/year.
- Conducted due diligence to assess numerous pharmaceutical and biotechnical patent portfolios in acquisitions valued at $650 million or more.
- Developed extensive patent portfolios to maximize exclusivity. The patents in one such portfolio, the Niaspan® patent portfolio, were recently admitted by the generic in a Paragraph IV litigation to be valid, infringed, and enforceable.
- Successfully negotiated and concluded multinational pharmaceutical and biotechnology licensing arrangements.
- Obtained insurance coverage for defense legal fees under the advertising injury provisions of General Commercial Liabilities policies to defend against trademark infringement actions in Acushnet v. Birdie Golf (counterfeit and reconditioned Titleist® golf balls) and Stihl v. Bailey's (gray market goods — Stihl® chisel chain).