Edwards Wildman Palmer LLP

Peter J. Manso is a registered patent attorney and has over twenty-five years experience in the field of intellectual property and technology-related law. He has developed extensive patent prosecution experience in a wide range of complicated technologies, particularly in the life sciences, 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, monoclonal and polyclonal antibodies; and medical devices. Pete has developed and prosecuted patent portfolios for several pharmaceutical products now in clinical use. He currently serves as intellectual property counsel to a number of leading U.S. pharmaceutical companies. Pete also has prosecuted domestic and foreign patent applications in other technology areas including specialty chemicals, foods, flavors and a variety of mechanical inventions.

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, infringement, availability and enforceability studies concerning trademarks, service marks and trade dress, is involved in drafting and negotiating license, acquisition or asset purchase, confidentiality disclosure, technology and material transfer, research, employment, non-compete, 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 to found to be valid, enforceable and infringed.

Our Firm has been recognized by IP Worldwide as one of the ten best U.S. firms in prosecuting small chemical entity/pharmaceutical/biotechnology patents.

• Pete was part of the litigation team that brought successful suit on behalf of Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America, Inc. against four generics to enforce U.S. Patent No. 4,687,777. The '777 patent covers the blockbuster oral anti-diabetic branded drug Actos®. In the decision, dated 2/21/2006, the U.S. District Court for the SDNY found the '777 U.S. patent to be both valid and enforceable. See Takeda Chem. Indus. v. Mylan Labs., Inc., 417 F. Supp. 2d 341 (S.D.N.Y. 2006). On March 13, 2006, the U.S. District Court entered an order finding that the '777 patent was valid and enforceable, Defendants Mylan, Alphapharm and Genpharm infringed claims 1, 2 and 5 of the '777 patent, and Ranbaxy and Watson would infringe claims 1, 2 and 5 of the '777 patent had they not certified under paragraph III and if they were to commercialize pioglitazone hydrochloride tablets as described in their respective ANDAs. See Takeda Chem. Indus. v. Mylan Labs., Inc., 2006 WL 618424; 2006 LEXIS _____; 03 CIV. 8250 (DLC), 03 CIV. 8253 (DLC), 03 CIV. 8254 (DLC), 04 CIV. 1966 (DLC) (S.D.N.Y., March 13, 2006). As a result, entry of a generic version of Actos® into the U.S. market is blocked until at least January 17, 2011, the date upon which the '777 U.S. patent will expire.
  
  
• Pete was part of the litigation team that brought successful suit on behalf of Scott Paper Co. and Chester Davis against Moore Business Forms, Inc. to enforce U.S. Patent Nos. 3,193,404 and 3,278,327, which were reissued as Reissue Patents 30,797 and 30,803, respectively. The Reissue patents cover methods of printing using carbonless copy paper systems and transfer and manifolding sheets. In the decision, dated 09/05/1984, the U.S. District Court for the District of Delaware found the '797 and '803 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., 594 F. Supp. 1051; 224 U.S.P.Q. (BNA) 11 (D. Del., September 5, 1984).
  
  
• Pete was invited by the Sarnoff Corporation as an IP consultant to sit on three separate panels at a "Bugs-to-Drugs" program, which was sponsored by the U.S. Department of Defense and organized on behalf of the DOD by the Sarnoff Corporation, to address the national defense needs to (a) shift from a chemical and nuclear-orientated paradigm to include a biological-orientated paradigm, (b) develop and deploy technologies for disease surveillance, electronic medical records and field-ready DNA fingerprinting technologies, and (c) 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. The Bugs-to-Drugs program was chaired by Brigadier General Klaus Shafer, who at the time was the Deputy Assistant to Secretary of Defense Donald H. Rumsfeld in the Chemical and Biological Program, within the Office of the Secretary of Defense (OSD) and served as the single focal point within the Office of the Secretary of Defense (OSD) for oversight, coordination, and integration of the chemical biological defense and counterproliferation support.
  
  
• Pete has prepared and/or prosecuted key U.S. patents to issuance for clients in the pharmaceutical industry, which cover successful pharmaceuticals currently selling annually in excess of $500,000,000/year. Notable commercially successful drugs patented by Pete include Niaspan®, Pepcid Complete® and Levoxyl®.
  
  
• Pete has conducted due diligence to assess numerous pharmaceutical and biotechnical patent portfolios in acquisitions that have been valued at $650 million or more.
  
  
• Pete has development extensive patent portfolios for clients to maximize exclusivity, including the Niaspan® patent portfolio, which patents were recently admitted by the generic in a Paragraph IV litigation, to be valid, infringed and enforceable.
  
  
• Pete has successfully negotiated and concluded multinational licensing arrangements in the pharmaceutical and biotechnology field.
  
  
• Pete was successful in obtaining 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).
  
  
• Pete practices in an IP group, that is recognized as one of the ten best U.S. firms, in prosecuting pharmaceutical/biotechnology patents, IP Worldwide, 2002.
  
  HATCH-WAXMAN (FDCA), FDA ORANGE BOOK and ANDA PATENT PRACTICE
  Extensive experience counseling and developing IP strategy and portfolios for clients to maximize patent protection, market exclusivity and longevity for branded drugs. More particularly, Pete specializes in complex legal intellectual property issues that concern all four phases of the drug development process, i.e., research, pre-clinical, clinical and post-launch, and he has counseled clients on: (a) Hatch-Waxman and regulatory schemes and exclusivities, including pediatric, orphan drug, new chemical entity, new clinical investigation (use) and data exclusivities, FDA Orange Book listings, paragraph I, II, III and IV and Section viii certifications, citizens petitions before FDA, patent extensions, and indications and labeling; (b) U.S. provisional patent rights; (c) first and multi-generation patent strategies, namely, protection for compounds, compositions of matter, processes, indications, research tools, formulations, metabolites, intermediates, friability characteristics, pharmacokinetic characteristics (cMax, tMax, AUC, rates of dissolution, rates of disintegration, rates of absorption, urinary elimination rates, gastric emptying rates, rates and extent of permeation, absorption profiles, blood and plasma profiles, urinary metabolite profiles, Wagner-Nelson profiles and methods, acid-ionization constants (Ka), negative logs of the acid-ionization constants (pKa), etc.), polymorphs, routes of administration, scaled-up processes, combinations, times of administration, delivery systems, dosage forms, stabilization techniques and products, packaging and distribution systems and methods; (d) USP, monographs, dosage form, dosage strength, safety and warning considerations and strategies; (e) antitrust and recent Federal Circuit considerations; and (f) licensing and acquisition strategies and considerations.
  
  LITIGATION
  Takeda Chem. Indus. v. Mylan Labs., Inc. (Actos® - an insulin sensitizer for treating Type 2 diabetes); Scott Paper Co. v. Moore Business Forms, Inc. (printing methods using carbonless copy paper, and transfer and manifolding sheets); Becton Dickinson v. Syntron (home pregnancy tests); Technical Chemicals & Products, Inc. v. Unilever (European Opposition - home pregnancy test); Americare Transtech, Inc. et al. v. Technical Chemicals & Products, Inc. (transdermal glucose patches and tests); Technical Chemicals & Products, Inc. v. HDI, Inc. (home diagnostic tests); Werner Pump Co. (trade secret litigation - pump technology); Americare Transtech, Inc. et al. v. Technical Chemicals & Products, Inc. (trade secret litigation, patent Infringement litigation - saliva collector and transdermal technology); Acushnet v. Birdie Golf (counterfeit and reconditioned Titleist® golf balls); and Stihl v. Bailey's (gray market goods - Stihl® chisel chain), etc.
  
  PATENTS
  Biotech - Separation technology, including affinity chromatography to separate proteins, e.g., HCV antigens, HIV antibodies, interferon proteins,, HPV antibodies, rotaviruses and hCG antigens, stem cells, anti-obesity and Type II diabetic agents, transgenic mice, insects and plants, cell lines (megakaryocyte), antibodies, constructs, ELISA assays, methods, interferon, vaccines, e.g., HPV HCV and rotaviruses, APRT, transgenic milk, transgenic tobacco plants, natural and recombinant thrombin, surfactant proteins, 2-5A system, PCR, GIP antagonists, GIP antibodies, etc. Pharmaceuticals - home pregnancy tests and other diagnostics (glucose, cholesterol, pregnancy, lactic acid), antibiotics, anti-inflammatories, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), heartburn medications, muscle relaxants, thrombin, tuberculosis, urinary tract medications, anti-nausea medications, muscle relaxants, selective serotonin uptake inhibitors (SSRIs), proton pump inhibitors (PPIs), transdermals, ophthalmics, anti-atherosclerotics, anti-hyperlipidemics, chemotherapeutics, thyroxines, anti-cholesterol agents, imaging agents, NMR imaging, drug delivery systems, pharmacokinetic profiles, e.g., cMax, tMax, AUC and metabolites, etc.
  
  Chemicals - plastic films, combinatorial chemistry, detergents, fertilizers, corona discharge, NMR, laser dyes, plastic materials, perfluorocarbons, artificial bloods, microencapsulations, etc. Foods and Flavors - tomato products, caffeinated products, macadamian products, vanilla flavors, etc.
  
  Mechanical - laboratory equipment, bottle caps, bottles, orthotics, rectal devices, implants, shoe inserts, clothing, pediatric IV vests, transdermal patches, display devices, contact lenses, hands-free cellular telephone devices and holsters, outboard jet drives for boats, laser alignments for race cars, espresso and cappuccino machines and devices etc.
  
  Recent Licenses and Acquisitions
  Pharmaceuticals and biotechnologicals by major drug companies, including NCEs, patent portfolios and families, cell lines, transdermals, combinations, formulations, modified release and other delivery systems, stem cells, etc.

Peter J. Manso is a registered patent attorney and has over twenty-five years experience in the field of intellectual property and technology-related law. He has developed extensive patent prosecution experience in a wide range of complicated technologies, particularly in the life sciences, 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, monoclonal and polyclonal antibodies; and medical devices. Pete has developed and prosecuted patent portfolios for several pharmaceutical products now in clinical use. He currently serves as intellectual property counsel to a number of leading U.S. pharmaceutical companies. Pete also has prosecuted domestic and foreign patent applications in other technology areas including specialty chemicals, foods, flavors and a variety of mechanical inventions.

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, infringement, availability and enforceability studies concerning trademarks, service marks and trade dress, is involved in drafting and negotiating license, acquisition or asset purchase, confidentiality disclosure, technology and material transfer, research, employment, non-compete, 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 to found to be valid, enforceable and infringed.

Our Firm has been recognized by IP Worldwide as one of the ten best U.S. firms in prosecuting small chemical entity/pharmaceutical/biotechnology patents.

Notable Experience

• Pete was part of the litigation team that brought successful suit on behalf of Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America, Inc. against four generics to enforce U.S. Patent No. 4,687,777. The '777 patent covers the blockbuster oral anti-diabetic branded drug Actos®. In the decision, dated 2/21/2006, the U.S. District Court for the SDNY found the '777 U.S. patent to be both valid and enforceable. See Takeda Chem. Indus. v. Mylan Labs., Inc., 417 F. Supp. 2d 341 (S.D.N.Y. 2006). On March 13, 2006, the U.S. District Court entered an order finding that the '777 patent was valid and enforceable, Defendants Mylan, Alphapharm and Genpharm infringed claims 1, 2 and 5 of the '777 patent, and Ranbaxy and Watson would infringe claims 1, 2 and 5 of the '777 patent had they not certified under paragraph III and if they were to commercialize pioglitazone hydrochloride tablets as described in their respective ANDAs. See Takeda Chem. Indus. v. Mylan Labs., Inc., 2006 WL 618424; 2006 LEXIS _____; 03 CIV. 8250 (DLC), 03 CIV. 8253 (DLC), 03 CIV. 8254 (DLC), 04 CIV. 1966 (DLC) (S.D.N.Y., March 13, 2006). As a result, entry of a generic version of Actos® into the U.S. market is blocked until at least January 17, 2011, the date upon which the '777 U.S. patent will expire. 
  
  
• Pete was part of the litigation team that brought successful suit on behalf of Scott Paper Co. and Chester Davis against Moore Business Forms, Inc. to enforce U.S. Patent Nos. 3,193,404 and 3,278,327, which were reissued as Reissue Patents 30,797 and 30,803, respectively. The Reissue patents cover methods of printing using carbonless copy paper systems and transfer and manifolding sheets. In the decision, dated 09/05/1984, the U.S. District Court for the District of Delaware found the '797 and '803 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., 594 F. Supp. 1051; 224 U.S.P.Q. (BNA) 11 (D. Del., September 5, 1984). 
  
  
• Pete was invited by the Sarnoff Corporation as an IP consultant to sit on three separate panels at a "Bugs-to-Drugs" program, which was sponsored by the U.S. Department of Defense and organized on behalf of the DOD by the Sarnoff Corporation, to address the national defense needs to (a) shift from a chemical and nuclear-orientated paradigm to include a biological-orientated paradigm, (b) develop and deploy technologies for disease surveillance, electronic medical records and field-ready DNA fingerprinting technologies, and (c) 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. The Bugs-to-Drugs program was chaired by Brigadier General Klaus Shafer, who at the time was the Deputy Assistant to Secretary of Defense Donald H. Rumsfeld in the Chemical and Biological Program, within the Office of the Secretary of Defense (OSD) and served as the single focal point within the Office of the Secretary of Defense (OSD) for oversight, coordination, and integration of the chemical biological defense and counterproliferation support. 
  
  
• Pete has prepared and/or prosecuted key U.S. patents to issuance for clients in the pharmaceutical industry, which cover successful pharmaceuticals currently selling annually in excess of $500,000,000/year. Notable commercially successful drugs patented by Pete include Niaspan®, Pepcid Complete® and Levoxyl®. 
  
  
• Pete has conducted due diligence to assess numerous pharmaceutical and biotechnical patent portfolios in acquisitions that have been valued at $650 million or more. 
  
  
• Pete has development extensive patent portfolios for clients to maximize exclusivity, including the Niaspan® patent portfolio, which patents were recently admitted by the generic in a Paragraph IV litigation, to be valid, infringed and enforceable. 
  
  
• Pete has successfully negotiated and concluded multinational licensing arrangements in the pharmaceutical and biotechnology field. 
  
  
• Pete was successful in obtaining 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). 
  
  
• Pete practices in an IP group, that is recognized as one of the ten best U.S. firms, in prosecuting pharmaceutical/biotechnology patents, IP Worldwide, 2002.