Our Firm

Since being founded in 1980, Abelman Frayne & Schwab has grown and established itself as a leading law firm specializing in the protection and enforcement of all forms of intellectual property in the United States and throughout the world.  Our clients include major companies in virtually all areas of business, including apparel, alcoholic beverages, automotive, chemical, cosmetics, computers, electronics, entertainment, financial services, foods, hotel services, petroleum, pharmaceuticals, publishing, real estate, retail telecommunications, and toys. While many of our clients are Fortune 500 companies, we pride ourselves on being able to assist smaller companies and individuals in protecting and developing their intellectual property.

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Vindra Richter

Associate
212.885.9275

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Gregory S. Shatan

Partner
212.885.9253
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Douglas J. Gilbert

Partner
 
 
212.885.9381

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Our Address

 
Abelman Frayne & Schwab 10th Floor
666 Third Avenue New York, NY 10017-5621
 

Directions

 
Our offices are conveniently located in the Chrysler Center in midtown Manhattan near Grand Central Terminal.  The building entrance is located at 666 Third Avenue, between 42nd and 43rd Streets.
 

Contact Us

 
You can contact our attorneys directly using their email address or telephone number that is included on their profile page which is accessible from the "Attorneys" section of our website.  If you prefer, you can contact our switch board at 1.212.949.9022, fax us at 1.212.949.9190, send an email to the firm's general in box <e-mail@nulllawabel.com>, or complete and submit the form below (required fields are marked with an asterisk *").
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Alexander Zinchuk

Patent Agent

212.885.9383

azinchuk@nulllawabel.com

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Alex Zinchuk joined Abelman Frayne & Schwab in 2005 as a patent agent.  Prior to joining the firm, for 25 years Alex worked as a patent agent in several other patent law firms in Cleveland and in New York City.  Alex concentrates his practice on patent prosecution in the mechanical and electrical fields.

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Frank Terranella

Partner

212.885.9179

fterranella@nulllawabel.com

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Mr. Terranella specializes in U.S. and international trademark prosecution. Mr. Terranella is a member of the Trademark Office Practices Sub-committee of the International Trademark Association (INTA).

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Frank Terranella joined the firm in 2000 as an associate attorney in the trademark department. Prior to joining the firm, Frank was a partner in a general practice firm for two years. One of his clients during this time was Ingersoll Rand, for whom he acted as trademark counsel. Prior to that, he was General Counsel of Blenheim Group, Inc., a trade show producer. During his five years there, Frank brought all trademark work in-house, registered scores of trademarks and advised on the proper use of trademarks in materials produced by the company.

Frank concentrates his practice on all aspects of U.S. trademark prosecution from search to registration to maintenance. He is very familiar with the workings of the USPTO and has assisted in solving trademark registration problems for many clients over the last 12 years.

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Charles S. Stein

Associate

212.885.9366

csstein@nulllawabel.com

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Charlie Stein joined Abelman Frayne & Schwab in 2007 upon graduating law school.  Prior to entering the intellectual property practice, he gained extensive experience as a licensed Professional Engineer in the electric utility, pulp and paper, and water and waste-water treatment industries.

Charlie concentrates his practice on patent prosecution, including  U.S. and PCT applications and the management of foreign patent applications.  He also has developed extensive experience in preparing opinions of counsel, including freedom to operate, noninfringement, and invalidity.

He has worked on matters involving a wide array of electrical and electro-mechanical technologies, including power converters, regenerative drives, static reactive power production, negative sequence current injection, wind turbine blade pitch, and low voltage ride through of turbine systems.

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Theodore J. Pierson

Associate

212.885.9296

tjpierson@nulllawabel.com

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Theodore J. Pierson joined Abelman Frayne & Schwab in 2008 as an associate in the patent department.  Prior to joining the firm, Mr. Pierson was an associate at a New Jersey law firm practicing in all areas of intellectual property prosecution and litigation.

Mr. Pierson largely devotes his practice to preparing and prosecuting patent applications in various fields of technology, with an emphasis in the mechanical arts and medical devices, including power tools, fitness equipment, catheters, ports, and tissue ablation devices.  His experience includes all phases of domestic and foreign patent prosecution (including PCT prosecution).

Mr. Pierson has intellectual property litigation experience including discovery, legal research, and motion practice.  He has represented clients in the federal courts within New Jersey.  He has also been admitted to represent clients pro hac vice in courts located in other states, including federal courts in Virginia and Connecticut.

Mr. Pierson has prepared opinions of counsel for a variety of patent matters concerning infringement, validity, and patentability.  He also has experience in performing due diligence on intellectual property portfolios for mergers and acquisitions.

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Steven M. Hertzberg

Associate

212.885.9223

shertzberg@nulllawabel.com

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Steven Hertzberg specializes in patent prosecution and related matters, including infringement investigations and opinions.  Prior to entering the intellectual property practice, he gained extensive experience as an engineer in the aerospace and computer industries, and served as corporate counsel for ION Computer Systems, Inc..

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Erica R. Halstead

Associate
212.885.9236

ehalstead@nulllawabel.com

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Erica Halstead joined Abelman Frayne & Schwab in 2008 as an associate attorney in the trademark department.  Prior to joining the firm, Erica specialized in both foreign and domestic trademark practice at a NYC intellectual property boutique firm.  Additionally, Ms. Halstead managed the trademark and copyright portfolio of an education-centric software company.

Erica concentrates her practice on U.S. trademark prosecution, policing, enforcement, clearance and counseling.  This includes practice before the U.S. Trademark Trial and Appeal Board in both opposition and cancellation proceedings.  Erica also has experience in negotiating and preparing Assignments, License and Co-existence Agreements.

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Ralph J. Crispino

Partner

212.885.9358

rcrispino@nulllawabel.com

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Ralph joined Abelman Frayne & Schwab in 2008 as an associate attorney.  Prior to joining the firm, Ralph was concurrently a sole practitioner and counsel for Reveo, Inc., and between 2001 and 2006 exclusively IP counsel and Vice President for Reveo, Inc., where he managed a large, technically diverse patent portfolio.

Ralph’s practice concentrates on patent preparation, prosecution and counseling, in the areas of chemical engineering, chemistry and petrochemical processing systems and controls.

Ralph has patent related experience in various technical fields, including chemical processing, electrochemical cells and components, semiconductor processing, liquid crystal devices, mechanical devices, agricultural systems, biotechnology, encoding security systems, computer software, and various consumer products.

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Victoria T. Coleman

Associate

 
212.885.9303
 

vtcoleman@nulllawabel.com

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Victoria Coleman joined Abelman Frayne & Schwab in 2011 as an associate attorney in the litigation group.  Prior to joining the firm, Victoria was an Assistant District Attorney at the Bronx District Attorney’s Office in the Investigations Division where she prosecuted, among other things counterfeit, piracy and fraud crimes.  She also participated in a global forum on anti-counterfeiting strategies at the United States Patent Trademark Office.

Victoria’s practice is focused on litigation cases involving patent, trademark, trade secret and copyright issues on both the plaintiff and defense side.  As a member of the litigation group she strategizes to determine the best, most efficient method to obtain optimal results for clients. Victoria is involved in fact gathering, drafting pleadings, electronic discovery and preparing for trial and depositions.  Victoria also assists in counseling clients to developing an IP protection program and determine the best way to protect their IP internationally.

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Lori B. Cohen

Associate

212.885.9347

lbcohen@nulllawabel.com

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Lori Cohen joined Abelman Frayne & Schwab in 1997 where she was an associate through 2002.  After a hiatus, Lori returned to the firm in 2007.  Prior to joining the firm in 1977, Lori was in house trademark counsel at Jordache Enterprises, Inc. where she was responsible for procuring, maintaining and enforcing rights in the well known Jordache trademarks throughout the world.  Lori has also been associated with Hale and Dorr, now Wilmer Hale & Gibbons, where she practiced domestic and international trademark prosecution in industries including pharmaceuticals, wearing apparel, and technology.

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Jay S. Cinamon

Associate

 
212.885.9232

jscinamon@nulllawabel.com

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Jay Cinamon joined Abelman Frayne & Schwab in 1986 after 20 years as a Senior Patent Attorney at International Paper Company.  Jay is experienced in the preparation and prosecution of chemical, pharmaceutical, mechanical and design patent applications before the U.S. Patent and Trademark Office, the European Patent Office and various foreign patent offices, inter parties proceedings in the USPTO, and the preparation of infringement and validity opinions.

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Aimee Allen

Associate
212.885.9306
AAllen@nulllawabel.com

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Aimee Allen primarily specializes in litigation and transactional work on commercial trademark matters, principally TTAB opposition and cancellation proceedings and USPTO trademark prosecution.  She has additional expertise in copyright law and licensing for artists and arts organizations in music, photography, film, visual arts and related fields, as well as experience with the music industry licensing, publishing, and recording contracts.

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David Toren (Retired)

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212-949-9022

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dtoren@nulllawabel.com

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Davis Toren is a contributor to the Encyclopedia of Patent Law and Law for Executives and Patentrecht In den USA, in addition to contributing articles to a variety of U.S. and German legal publications. Mr. Toren taught law at Newark College of Engineering and has lectured extensively, primarily in Germany, on intellectual property.  He is fluent in German, Swedish, Danish, Norwegian and Hebrew.

 

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Thomas E. Spath

Of Counsel

212.885.9250

tespath@nulllawabel.com

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Tom Spath joined Abelman Frayne & Schwab in 1995 as Of Counsel to continue the patent and trademark practice specialties he developed over the prior 25 years as a partner in two other intellectual property specialty firms in NYC.

Tom’s current practice is focused on patent preparation and prosecution in the U.S. Patent and Trademark Office, and in international practice in numerous jurisdictions including the EPO, China, and Japan.

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Robert B. Smith

Of Counsel

 
212.885.9237

rbsmith@nulllawabel.com

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Robert B. Smith’s practice specializes in patent prosecution, litigation, and counseling, primarily in mechanical and electrical engineering, advanced materials, and computer related technologies.  He also has extensive experience in technology acquisition, opinion work, licensing, and trade secret litigation. In addition to district court litigation, he has argued a number of cases before the Court of Appeals for the Federal Circuit with a very high rate of success.

Mr. Smith’s practice has involved patents on communications satellites, tennis racquets and other sporting goods, microprocessor-based control systems, computer software, remote monitoring and control networks, medical devices, automobile engines and hybrid power plants, automobile transmissions, VVVF AC motor controls, automobile security devices, “smart” credit cards and credit card cryptogra­phy, plasma physics, elevators, razors, optics, diamond manufacture, aircraft jet engines, power plant equipment, optics, footwear, road paving machinery, hardware, tools, catalyst filters,telephone switching and communications equipment, optical devices for use in projector equipment, business methods, and wind turbines, as well as other areas.

Prior to joining Abelman Frayne & Schwab in 2009, Mr. Smith was a partner at the IP firm Brumbaugh, Graves, Donohue & Raymond.  He subsequently practiced for 10 years at White & Case, and 10 years at Skadden, Arps, Slate Meagher & Flom.

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Melvin L. Ortner

Of Counsel

212-885-9365

mortner@nulllawabel.com

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Melvin Ortner has extensive experience in advising businesses and transactional matters including licensing, distribution, sourcing, real estate, and commercial agreements.  Mel is experienced in advertising law and has successfully defended his clients’ promotional programs before the Federal Trade Commission.  He also represents executives in employment and separation agreements.

Before joining Abelman Frayne & Schwab in 2003, Mel was the Vice President and Chief Counsel of Sara Lee Branded Apparel.  Prior to that he was the Vice President and General Counsel of Playtex Apparel.  In these capacities Mel was responsible for the management of high profile litigations.  Today he serves on the board of directors of several corporations.

In the civic arena, Mel served two terms as an elected Trustee in the Village of Great Neck, where he also served as Deputy Major and Chairman of the Planning Board.

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J. David Dainow

Of Counsel

212.885.9230

jdainow@nulllawabel.com

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Jerry Dainow maintains a practice in all fields of intellectual property law with an emphasis on prosecution, licensing and counseling.  He has been involved in diverse technical and commercial areas including medical and dental devices, complex mechanical and structural engineering, manufacturing equipment, engines, toys, appliances, designs and trademarks.

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Jennifer R. Waitman

Partner

212.885.9243

jrwaitman@nulllawabel.com

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Jennifer Waitman joined Abelman Frayne & Schwab in 1998 as an associate attorney in the trademark department.  Jennifer concentrates her practice on international trademark prosecution, litigation, cancellation and opposition procedures, counterfeit goods prosecution and the management of trademark portfolios.  Her international trademark experience includes drafting of settlement and license agreements and analysis of trademark clearance reports.

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Victor M. Tannenbaum

Partner

212.885.9211

vmtannenbaum@nulllawabel.com

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Victor Tannenbaum is a founding member of the firm and specializes in licensing and distribution agreements, assignments, contracts, mergers and acquisitions, and changes in ownership, all with respect to intellectual property on a worldwide basis.

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Julie B. Seyler

Partner
212.885.9297

jbseyler@nulllawabel.com

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Julie Seyler joined Abelman Frayne & Schwab in 1988 as an associate attorney in the trademark department.  Prior to joining the firm, Julie was an attorney with the United States Trademark Office, prosecuting trademark applications as well as preparing briefs and oral arguments before the Trademark Trial and Appeal  Board.

Julie concentrates her practice on trademark counseling, prosecution and and inter party proceedings before the Trademark Trial and Appeal Board.  Her experiences includes analyzing the registrability of trademarks, preparing oppositions and cancellations and following such cases through to final briefs and oral arguments before the TTAB.

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Michael J. Schwab

Partner

212.885.9212

mjschwab@nulllawabel.com

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Michael Schwab has been with the firm since 1997 and is a partner.  Mr. Schwab specializes in trademark and copyright counseling, litigation and counseling on regulatory and other issues in the  beverage alcohol, dietary supplement and food industries.  His practice includes all aspects of a domestic and international trademark practice, including advising, searching the availability of marks, filing and prosecuting trademark applications, handling contested oppositions, cancellations and litigations, managing worldwide trademark portfolios, enforcing trademark rights, including gray market goods, anti-counterfeiting, and monitoring and preventing infringing third party trademarks, internet and related domain name use and advertising compliance.

Mr. Schwab also negotiates, drafts and interprets license and other agreements, monitors licensee compliance and manages intellectual property due diligence in connection with corporate mergers and acquisitions.

In the beverage alcohol, dietary supplement and food fields Mr. Schwab counsels clients on a wide variety of issues including federal, state, local and international regulatory compliance, international and domestic distribution agreements, federal alcoholic beverage label approval and state brand registrations, advertising compliance, trade practices and customs and international trade matters.

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Jeffrey A. Schwab

Partner

 
212.885.9215

 

jaschwab@nulllawabel.com

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Jeffrey Schwab is a founding member of the firm.  He is a patent attorney specializing in intellectual property litigation, licensing, Alternative Dispute Resolution (“ADR”), and advertising law.  Mr. Schwab has written various articles on intellectual property licensing and has been a guest lecturer on intellectual property protection at major corporations, universities and bar associations.  He was Chairman of the New York Intellectual Property Law Association subcommittee on ADR for 3 years. He has been lead counsel in a number of jury cases resulting in multi-million dollar awards for the Firm’s clients.  He is an AV rated attorney by Martindale Hubbell, and have been selected for listing for 2013 Top-Rated Lawyers in Intellectual Property by American Lawyer Media and Martindale Hubbell.

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Caridad Piñeiro Scordato

Partner

212.885.9278

cpscordato@nulllawabel.com

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Caridad Piñeiro Scordato joined Abelman Frayne & Schwab in 1980 as a clerk, attended law school at night and then worked as an attorney for a number of years before becoming a partner of the Firm in 1994.

Caridad specializes in international trademarks, computer and new media law, publishing and literary law, and international litigation. She has represented a broad range of clients in the pharmaceutical, entertainment, publishing, automotive, alcoholic beverage and food industries.

In the area of publishing and literary law, Caridad brings the unique experience and insights of being a New York Times and USA Today bestselling author, with knowledge of the inner workings of the industry.

As the Firm’s Managing Partner for IT, Caridad also has hands-on knowledge and experience in the computer and new media law areas.

Caridad is fluent in Spanish and has a working knowledge of Italian, French and Portuguese.  With those language skills she has assisted clients in a number of important overseas due diligence, litigations, and negotiations.

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Marie Anne Mastrovito

Partner
212.885.0248 

mamastrovito@nulllawabel.com

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Marie Anne Mastrovito joined Abelman Frayne & Schwab in 1999 as an associate attorney in the trademark department.  Prior to joining the firm, Marie Anne was a Trademark Examining Attorney with the United States Patent and Trademark Office and served as a Staff Attorney with the law firm of Jones Day Reavis and Pogue assisting in unfair competition litigation.

Marie Anne concentrates her practice in the field of trademark prosecution and the representation of clients in Opposition and Cancellations actions and ex parte appeals before the U.S. Trademark Trial and Appeal Board. In addition, Marie Anne has represented clients in successful appeals to the United States Court of Appeals for the Federal Circuit.

Marie Anne is also experienced in trademark clearance and investigations, preparing cease and desist letters, drafting and negotiating coexistence agreements, and assignment of marks.

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Peter J. Lynfield

Partner

212.885.9208
 

pjlynfield@nulllawabel.com

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Peter Lynfield joined the firm in 1980.  He has been a partner since 1986.  Peter concentrates his practice on U.S. and International trademark, copyright, unfair competition and related matters counseling and litigation.

He has advised clients in various industries, including automotive products, pharmaceuticals, veterinary pharmaceuticals and products, fragrances and cosmetics, beverages, real estate development, pet food music labels and groups, charitable fundraising, food additives, television and film production, personal care products, international human rights organizations and health care facilities.

Peter’s practice includes representing clients in the selection and adoption of trademarks in all countries; searching, availability, registrability and related opinions; preparation, filing and prosecution of trademark applications in all countries of the world; oppositions, litigations and related actions involving trademarks, copyrights, trade dress, unfair competition, dilution and counterfeiting worldwide.

His practice also includes negotiating and drafting license agreements related to all forms of intellectual property; conducting due diligence, opinions  and negotiating  agreements in connection with the IP aspects of acquisitions, such as purchase and sales agreements, license agreements, IP security agreements, assignments; recordal of assignments and security agreements worldwide; acquiring domain names through negotiations and alternative dispute resolution procedures; advising clients on issues relating to compliance with U.S. sanctions administered by the Office of Foreign Assets Control.

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Norman D. Hanson

Partner

212.885.9240

ndhanson@nulllawabel.com

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Norman Hanson joined Abelman Frayne & Schwab in 2011 as a partner.  Prior to joining the firm, for 12 years Norman was a partner at Fulbright & Jaworski, a partner at Felfe & Lynch for 6 years and an associate for 8 years, and an associate at Cooper & Dunham for 2 years.

Norman’s practice focuses on patent prosecution, interferences, and counseling, in the areas of biotechnology, biochemistry, chemistry, and pharmaceuticals.

He has drafted over 400 patent applications, and has served as lead or associate counsel in approximately 15 interferences.  His litigation experience includes deposition practice in the biotechnological and chemical arts, document review and preparation of pleadings.  He has argued before the Court of Appeals for the Federal Circuit and was prevailing counsel in Bosies v. Benedict, 27 F. 3d 539 (1994), and In re Gangadharam, 889 F. 2d 1011 (1989).

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Anthony J. DiFilippi

Partner

212.949.9131

ajdifilippi@nulllawabel.com

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Anthony DiFilippi joined Abelman Frayne & Schwab in 1995 as an associate attorney in the litigation department.  Anthony concentrates his practice on patent, trademark and copyright litigation and counseling.  His litigation experience includes analyzing patents and technical issues, preparing pleadings and briefs, taking and defending depositions of fact witnesses, assisting technical experts in their preparation of expert reports, conducting and defending depositions of expert witnesses, and examining witnesses at trial.

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Anthony A. Coppola

Partner
212.885.9239

aacoppola@nulllawabel.com

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Anthony Coppola joined Abelman Frayne & Schwab in 1996 and concentrates his practice in patent, trademark and copyright litigation, patent prosecution, intellectual property licensing, and transactional matters.  He has successfully litigated cases in the areas of patent infringement, trademark infringement, theft of trade secrets, trademark counterfeiting and product liability in various jurisdictions throughout the United States.

Anthony’s technical background has allowed him to analyze clients’ technologies and establish their freedom to operate.  He has prepared comprehensive opinions of counsel and successfully negotiated favorable licenses and settlements in numerous patent and trademark disputes.

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Joseph J. Catanzaro

Partner
212.885.9255 

Jjcatanzaro@nulllawabel.com

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Joseph Catanzaro is experienced in all aspects of Intellectual Property and specializes in patent practice, including preparing, filing and prosecuting patent applications, appeals, interferences and related Patent office matters; preparing, filing and prosecuting international patent applications; patentability, right-to-use and due diligence investigations and opinions; patent licensing and related matters.

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Ned W. Branthover

Partner

212.885.9376
 
nwbranthover@nulllawabel.com


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Ned Branthover is the author of “Federal Dilution Act:  Famous Marks Get Greater Protection”, Japanese Trademark Journal and has lectured on Developments in Trade Dress Protection Since Two Pesos v. Taco Cubana to the Westchester & Fairfield Corporate Counsel Association, 1995.  He has also been a lecturer on trademark matters at the INTA Annual Meetings 1996-1999.

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Michael Aschen

Partner

212.885.9207
maschen@nulllawabel.com
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Michael Aschen practices intellectual property litigation and counseling.  Michael devotes the majority of his time to litigating cases before the U.S. district courts.  His litigation experience includes analyzing patents and technical issues, preparing pleadings and briefs, taking and defending depositions of fact witnesses, assisting technical experts in their preparation of expert reports, conducting and defending depositions of expert witnesses, and bench and jury trials.

Michael has litigation experience in wide array of industries including entertainment, television, automotive, professional sports, petroleum, consumer products, apparel, jewelry, Internet, alcoholic beverages, publishing, finance, printing, telecommunications, magnetics, pet products, semiconductors, fertilizers, industrial piping, hardware, and retail.

Michael has also argued numerous appeals before the United States Courts of Appeal for the Second, Sixth, Ninth, Eleventh and Federal Circuits.

Michael provides clients with counseling regarding the development of patent portfolios, has prepared opinions of counsel, identified and resolved potential infringement disputes, and counseled clients regarding licensing opportunities.

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Practice

  • Litigation
  • Trial
  • Patent Transactions and Strategic Counseling
  • Opinions and Counseling

Industries

  • Entertainment
  • Television
  • Automotive
  • Professional sports
  • Petroleum
  • Consumer products
  • Apparel
  • Jewelry
  • Internet
  • Alcoholic beverages
  • Publishing
  • Finance
  • Printing
  • Telecommunications
  • Magnetics
  • Pet products
  • Lasers
  • Semiconductors
  • Fertilizers
  • Industrial piping
  • Hardware
  • Retail
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Lawrence E. Abelman

Partner

 
212.885.9201
 

leabelman@nulllawabel.com

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Larry Abelman is a founding member of the firm.  Mr. Abelman is well known for his expertise in international and domestic trademark protection and litigation, licensing and distributorship agreements, entertainment and media law.

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Julianne Abelman

Partner

212.885.9268

jabelman@nulllawabel.com

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Julianne Abelman specializes in all aspects of international and U.S. trademark protection and litigation, including licensing, contracts, and searches.  

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Practice Areas

trademark11.     United States and International Trademarks 2.     United States and International Patentspatent 3.      United States and International Copyrights  4.     Litigation and Enforcement 5.     Licensing and Contracts 6.     Acquisitions, Mergers and Changes in Ownership 7.     Information Technology, The Internet and New Media 8.     Entertainment and Media Law 9.    Beverage Alcohol, Dietary Supplement and Food Laws 10.  Technology and Resources 11.   Foreign Law Firms The foregoing is merely an outline of the services we provide to our clients.  We would be pleased to meet with you to discuss our capabilities in further detail.  For additional information concerning our attorneys, please visit the “Attorneys” link. Home
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Firm Profile

Since Abelman Frayne & Schwab was founded in 1980, the Firm has grown and established itself as a leader, both in the United States and overseas, in the protection and enforcement of all forms of intellectual property.  Our clients include major corporations in virtually all industries, including apparel, alcoholic beverages, automotive, chemical, cosmetics, computers, electronics, entertainment, financial services, foods, hotel services, petroleum, pharmaceuticals, publishing, real estate, retail, telecommunications, and toys.  For more information on the Firm’s areas of expertise, please click on the Practice Areas link in the menu bar above.

Our attorneys have wide ranging experience in many specialties including patents, trademarks, copyrights, licensing, contracts, mergers and acquisitions, entertainment, new media law, and Internet law.  For more information on our attorneys, their areas of expertise, and contact information, please click on the Attorneys link in the menu bar above.

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Jeffrey A. Schwab, Esq.

Amgen vs. Sandoz provides the first substantive appellate interpretation of what is generally referred to as the “patent dance” under the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  The July 21, 2015 decision by the Federal Court establishes definitive guidelines regarding patent challenge procedures under the BPCIA.

The ruling will result in “biosimilar” applicants for FDA approval considering alternative strategies in deciding how to best address potential patent challenges by the original marketer of the previously approved biologic.

BACKGROUND

BPCIA was enacted in 2010.  It established an abbreviated regulatory approval process for biological products that are “highly similar” to a previously approved product.   Traditionally, the Food and Drug Administration (FDA) approves a biological product by granting a Biologics License after an applicant has demonstrated safety and efficacy of the product.

Under the abbreviated pathway created by BPCIA, an applicant can file an abbreviated Biologics License Application for a product which is asserted to be “biosimilar” to a previously approved product.  The applicant only needs to submit information to demonstrate that its product is “biosimilar” to or “interchangeable” with the previously approved product.  The previously approved product is generally referred to as the “reference product.”  The application for the biosimilar product must include publicly available information regarding the FDA’s previous determination that the reference product is safe, pure and potent.  Therefore, under BPCIA, a biosimilar applicant is relying in part on the approved license of the reference product.

Balancing innovation and price competition BPCIA provides a four year and a twelve year exclusivity period to the original reference product.  Under BPCIA an application for a biosimilar approval cannot be submitted until a date that is four years after the date on which the reference product was first approved.  Moreover, approval of the biosimilar application may not be made effective until 12 years after the date the reference product was first approved.  Therefore, the reference product receives up to twelve years of exclusivity against follow-on products regardless of patent protection.  However, if the reference product is the subject of the patent protection those patents can be used to try and extend the exclusivity of the owner of the reference product.  Under general concepts of patent law, patents cannot be enforced until an act of infringement occurs.

BPCAI established a patent dispute resolution regimen by creating an artificial “act of infringement”, thus permitting dispute resolution earlier than might be available under general patents law concepts.  Infringement suits based on a biosimilar application can be initiated prior to FDA approval and prior to marketing of the biosimilar biological product.

As part of the BPCIA patent dispute protocol, BPCIA established a process for information exchange between the biosimilar application and the approved product patent owner.  Under that protocol, the biosimilar applicant advises the referenced product sponsor about the biosimilar applicant’s FDA application and grants confidential access to the application being made by the biosimilar applicant and also provides manufacturing information regarding the biosimilar product.  This disclosure is to take place not later than twenty days after the FDA accepts the biosimilar application for review.  The parties then exchange lists of patents each believe could reasonably be asserted by the referenced product sponsor, and each party’s position on infringement, validity and enforceability of the patents.

Following the exchange (which could take up to six months), the parties negotiate to formulate a list of patents (referred to as “listed patents”) that will be the subject of an immediate infringement action and the referenced product sponsor then sues the biosimilar applicant within thirty days.  Importantly, the legal action that can be brought for infringement can be only based upon the specific “listed patents” that the parties had negotiated.  Patents that were not agreed to be on the list —(or pending patent applications) cannot be the subject of litigation at this time.  Disputes about the non-listed patents and applications are deferred until the biosimilar applicant provides notice that it intends to commercialize market the biosimilar product.

If the biosimilar applicant discloses the information about its products and manufacturing and negotiates about “listed patents” then neither party can bring a declaratory judgment action based upon non-listed patents until after the notice of commercial marketing is given.  However, if the biosimilar applicant fails to comply with the information requirements, the reference product owner can bring legal action for infringement against the biosimilar applicant without having to wait for the Notification of Commercial Marketing.

Under BPCIA the biosimilar applicant is required to give notice of its intention to begin commercial sales.  This allows the referenced product sponsor a period of time to seek a preliminary injunction based on patents that the parties initially identified during the earlier information exchange but were not selected for immediate infringement action, as well as any newly issued or licensed patents.  This complex series of statutory provisions is generally known as the “patent dance”.

What was not clear before the Federal Circuit decision was what options are available to the biosimilar applicant about disclosing or not disclosing product and manufacturing information or whether the biosimilar applicant could provide the commercial notice to start the 180 day period before the FDA approval was received.

The Federal Circuit decision held that the initial notice and its provisions relating to disclosing of product information and manufacturing information is optional and a biosimilar applicant can opt out and choose not to follow the procedure.  On the other hand it held that the commercial marketing notification could only be given after the FDA approved the product for sale, thus assuring the referenced product sponsor the benefit of the 180 days after the biosimilar applicant received approval.

CONCLUSION

Biosimilar applicants now have a choice about how and when they wish to address patent challenges.  This will require a multi-factor analysis by the biosimilar applicant depending upon various factors, principally when is the best time to confidential information about its product and processes and when it is best to resolve potential patent disputes.

 

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Michael Schwab, Esq.

On June 4, 2015 the European Court of Justice (“ECJ”) issued a “preliminary ruling” clarifying the standard used to determine if a food label misleads consumers.  Bundesverband der Verbraucherzentralen und Verbraucherverbände v. Teekanne GmbH & Co. KG, No. C-195/14 (E.C.J., order entered June 4, 2015).  According to the ECJ, the list of ingredients on a label, even if accurate, may not be sufficient to correct an erroneous or misleading impression regarding the ingredients caused by other information on the label.

The Teekanne case concerned the interpretation of Article 2(1)(a)(i) of European Directive 2000/13/EC regarding, labeling, presentation and advertisement of foodstuffs (the “Directive”) which prohibits labeling that may mislead the purchaser as to the nature, identity, composition, quantity, durability, origin or provenance, method of manufacturer or production of a food product.  The Directive was repealed on December 13, 2014 and replaced with EU Regulation (EU) No. 1169/2011 on the provision of food information to consumers (the “Regulation”).  The language of Article 2(1)(a)(i) at issue in Teekanne appears in the Regulation. Therefore, the ECJ’s interpretation of Article 2(1)(a)(i) applies to the Regulation.

 Teekanne, a Germany company, sells a fruit tea called “Felix Raspberry and Vanilla Adventure.”  The tea does not contain vanilla or raspberry or flavorings derived from vanilla or raspberry, but its packaging has depictions of raspberries and vanilla flowers and the following statements:  “fruit tea with natural flavorings” and “fruit tea with natural flavorings – raspberry-vanilla taste.”   The list of ingredients appearing on the tea’s packaging is as follows:

 Hibiscus, apple, sweet blackberry leaves, orange peel, rosehip, natural flavoring with a taste of vanilla, lemon peel, natural flavoring with a taste of raspberry, blackberries, strawberry, blueberry, elderberry (emphasis added).

 Bundesverband der Verbraucherzentralen und Verbraucherverbände (“BVV”), a consumer protection association in Germany, filed an action to enjoin Teekanne from promoting and selling Felix Raspberry and Vanilla Adventure claiming the tea’s packaging violates Article 2(1)(a)(i) because it misleads consumers as to the composition of the tea.  According to BBV, reasonable consumers, viewing the packaging as whole, would expect the tea to contain vanilla and raspberry or flavors derived from vanilla and raspberry.  Teekanne defended on the basis that its packaging contained no explicit claim that the product contained vanilla and raspberry and the list of ingredients provided consumers with clear and unambiguous information about the ingredients. Consumers who read the list of ingredients would not be misled about the ingredients.

 The Regional Court in Dusseldorf, Germany ruled in favor of BVV and Teekanne appealed.  The Higher Regional Court reversed and BVV appealed to the Supreme Court of German which referred the following question to the ECJ for a preliminary ruling:

 Is it permissible for the labeling, presentation and advertising of foodstuffs to give the impression, by means of their appearance, description or pictorial representation, that a particular ingredient is present, even though that ingredient is not in fact present and this is apparent solely from the list of ingredients?

 (National courts in the countries of the European Union can ask the ECJ for an interpretation of a law of European Union which is at issue in a pending dispute.  The ECJ provides a “preliminary ruling” on the question of law and the national court then applies the ECJ’s legal interpretation to the facts in dispute.)

In its ruling the ECJ noted that the law requires consumers to be provided with correct, neutral, objective and non-misleading information about food products. While consumers are assumed to read the list of ingredients on a label before purchasing a food product, a label with an accurate list of ingredients may still mislead consumers if it contains other misleading, erroneous, ambiguous, contradictory or incomprehensible information. The list of ingredients may not be capable of correcting an erroneous or misleading impression about an ingredient caused when the label is reviewed as a whole.  Therefore, the ECJ concluded that the Directive “must be interpreted as precluding the labeling of foodstuffs and methods used for the labelling from giving the impression, be means of the appearance, description or pictorial representation of a particular ingredient, that the ingredient is present, even though it is not in fact present and this is apparent solely from the list of ingredient on the foodstuff’s packaging.”   In other words, a complete and accurate list of ingredients does not preclude a finding that a label, when viewed as whole, can mislead consumers about the ingredients used to make the food.

 The case has been remanded to the Supreme Court of Germany for a determination of whether the average consumer in Germany is misled by Teekanne’s label.  To make its decision the ECJ instructed the Supreme Court to “take into account the words and depictions used as well as the location, size, color, font, language syntax and punctuation of the various elements on the label.”  We are monitoring and will advise when the Supreme Court issues its decision.

The ECJ’s ruling should prompt food companies that sell products in the European Union to review their labels and packaging to ensure they could not be deemed as misleading consumers.

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Anthony A. Coppola, Esq.

On June 25th, 2015, Judge John Gleeson of the Federal District Court for the Eastern District of New York, granted a Motion for Civil Contempt filed by Abelman, Frayne & Schwab on behalf of its client, Sportco, Inc. against TRT Tactical, LLC.

In November 2014, Sportco had entered into a Consent Judgment (settlement agreement) with TRT whereby TRT agreed to cease and desist all infringing activity related to Sportco’s U.S. Patent No. 7,743,542 for magazine insertion guides for hand guns. The ‘542 Patent claims an assembly of a pair of hand gun grips and base plates (called magwells) which allow for quicker insertion of an ammunition magazine into a pistol. The magwells contain securing members which extend upwardly from its upper surface and a pair of grips that are specially machined with a contoured inner surfaces or grooves to receive the securing members and hold them properly on the gun to create the magazine insertion guide assembly.

Earlier this year, TRT attempted to sell the hand gun grip portion of the infringing magazine insertion guides on its website. Sportco discovered the activity and demanded that TRT cease its violation of the Consent Judgment. TRT refused and the Motion for Contempt was brought.

In opposing the motion, TRT claimed it was not infringing the patent or violating the Consent Judgment because it was only selling the handgun grips which were only “part” of the magazine insertion guide and not the whole device. Sportco argued that this position was not plausible for several reasons but primarily because TRT was promoting the sale of the handgun grips with language that advised visitors to the website that these grips were to be used with the magwell component previously sold to create the magazine insertion guide.

Judge Gleeson agreed with Sportco and found TRT was in contempt of the Consent Judgment and that it had to 1) immediately cease and desist from any and all activities which violate the Consent Judgment; (2) provide an independent and verified accounting of all of the violative components of the magazine insertion guide that it manufactured, sold or imported from June 24, 2014 (the time notice of infringement was given to TRT) to date; (3) provide an independent and verified accounting of all existing inventory of the violative parts; (4) surrender all existing inventory of the violative parts to Sportco’s counsel for destruction; (5) remit to Sportco all revenue it generated from the sale of the violative parts from November 25, 2014 to date; and (6) reimburse Sportco for their reasonable attorney’s fees and costs in bringing the motion for contempt.

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On July 4, 1933 the United States Patent Office issued U.S. Patent No. 1,917,099 entitled, “X-Ray Tube” to William D. Coolidge of Schenectady, New York.

William David Coolidge was an American physicist, who made major contributions to the development of X-ray machines. The ‘099 patent was one of a number of patents Coolidge received in the field of x-ray technology.  His tubes completely revolutionized the generation of X-rays and remain to this day the model upon which all X-ray tubes for medical applications are patterned.

He was the director of the General Electric Research Laboratory and a vice-president of the corporation. He was also famous for the invention of “ductile tungsten”, which found it most important use as the filament in the incandescent light bulb.

Coolidge was born in Hudson, Massachusetts. He studied electrical engineering from 1891 until 1896 at the Massachusetts Institute of Technology (MIT). He went to Germany for further study and received his doctorate from the University of Leipzig. From 1899 to 1905 he was a research assistant to Arthur A. Noyes of the Chemistry Department at MIT.

Coolidge went to work as a researcher at General Electric’s new research laboratory in 1905, where he conducted critical experiments that led to the use of tungsten as filaments in light bulbs. (Note: He received a patent on this technology in 1913. However, it was later held by a court that his 1913 patent was not valid due to obviousness).  In 1913 he invented what became known as the “Coolidge tube,” an X-ray tube with an improved cathode for use in X-ray machines that allowed for more intense visualization of deep-seated anatomy and tumors. The Coolidge tube, which also utilized a tungsten filament, was a major development in the then-nascent medical specialty of radiology, and its basic design is still in use. He filed for a patent on his x-ray tube in 1913 and it was granted as US Patent No. 1,203,495 in 1916.

Coolidge was awarded the American Institute of Electrical Engineers Edison Medal in 1927 For his contributions to the incandescent electric lighting and the X-rays art. He had rejected this prestigious award in 1926 on the basis that his ductile tungsten patent (1913) was ruled invalid.

He worked in many diverse technologies in his career and developed products ranging from high-quality magnetic steel to improved ventilating fans and the electric blanket. During World War II he contributed research to projects involving radar and radar countermeasures. Coolidge was awarded 83 patents during his lifetime.

In 1975 he was elected to the National Inventors Hall of Fame, shortly before his death at the age of 101 in Schenectady, New York.

Make some Intellectual Property History this week!

By: Anthony A. Coppola, partner Abelman, Frayne & Schwab

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Jeffrey A. Schwab, Esq.

The Federal Circuit has provided additional clarification about how “broadest reasonable interpretation” (BRI) is to be applied in Inter Partes Review (IPR) proceedings, bringing BRI claim interpretation standards closer to those applied by the courts.

In its June 16, 2015 Decision in Microsoft Corporation vs. Proxyconn, Inc., the Federal Circuit clarified the BRI standard used by the PTAB in IPR Proceedings. The Decision provides meaningful guidance and may serve to limit what many have believed to be an overly expansive application of BRI by the PTAB.

Earlier in 2015 in the case of In re Cuozzo Speed Techs, LLC, 778F.3d. 1271 (Fed. (BRI) Cir. 2015), the Federal Circuit held that the broadest reasonable interpretation standard in IPR proceeding was properly adopted by PTO regulation. In Microsoft, the Federal Circuit, for the first time placed some parameters on its breadth. The court held that the PTAB may not construe claims so broadly that its constructions are unreasonable—and what is or is not reasonable must be guided by general claim construction principles.

The Court noted that the claim should always be read in light of the specification and teachings in the underlying patents; that the PTAB should consult the patent’s prosecution history and proceedings in which the patent has been brought back to the agency for a second review; and even under BRI claim construction cannot be divorced from the specification and the record evidence and must be consistent with the one that those skilled in the art would reach. In the words of the Federal Circuit:

A construction that is “unreasonable broad” and which does not “reasonably reflect the plain language and disclosure” will not pass muster.

The case which brings claim interpretations standards closer to those used in Markman proceedings will no doubt be heavily relied upon by patent owners to prevent overly broad interpretations.

 

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