ATTORNEYS & LEGAL STAFF


Clifford M. Davidson

Partner, New York Office

phone  +1 (212) 736-1940 x101

email  cdavidson@ddkpatent.com

phone  Profile (.pdf)


CLIFFORD M. DAVIDSON, Patent Attorney, received his B.S. in Pharmacy from Rutgers University College of Pharmacy in 1983 and his Juris Doctor degree from Rutgers University School of Law-Camden in 1986, where he received the American Jurisprudence Award for excellence in property Law. He is a member of the New York, New Jersey and Pennsylvania State Bars. He is a member of the New York Patent, Trademark & Copyright Law Association, and the New Jersey Patent Law Association. Mr. Davidson is also a Registered Pharmacist in New Jersey, and is a member of the American Pharmaceutical Association, and Controlled Release Society Pharmaceuticals. Prior to the creation of Davidson, Davidson & Kappel, LLC in 1998, Mr. Davidson was a name partner at Steinberg, Raskin & Davidson, P.C., and prior to that, Mr. Davidson was an attorney at Kenyon & Kenyon.

Mr. Davidson has particular expertise in the area of pharmaceuticals, and has prepared and prosecuted numerous patent applications covering virtually all areas of drug development, including new chemical entities, new pharmaceutical formulations (immediate release, controlled release, and multiphasic release; oral dosage forms; injectables; implantables; inhalations, intranasal, sublingual, buccal, suppository and topical formulations; transdermal devices; and opthalmics), new combinations of previously known drugs; new modes of administration of previously known drugs; methods of treatment, pharmaceutical excipients, and methods of preparing pharmaceutical dosage forms. Mr. Davidson has also focused on methods of treatment and compositions directed to the pharmacokinetic profiles of drugs/drug formulations, pharmacologic activity of drugs/drug formulations. Mr. Davidson has a great deal of experience meeting with his clients' drug development, research, clinical, marketing, and business development departments, as well as in-house counsel, in order to elucidate patentable aspects of his clients' drug development programs and develop a useful strategy to maximize patent protection opportunities. In conjunction with the development of patent portfolios, Mr. Davidson advises his clients and assists them in developing strategies concerning offensive and defensive patent filings, obtaining adequate coverage for new developments and creating patent strategies/claims that cannot be readily designed around.

Mr. Davidson also represents clients involved with the development of branded generic formulations and generic pharmaceutical formulations subject to Abbreviated New Drug Applications (ANDA) that must be filed with the United States Food & Drug Administration. Mr. Davidson's participation included evaluating proposed formulations with respect to Orange Book patent issues; evaluation of the additional patent landscape; paragraph IV submissions for ANDA filings.

Mr. Davidson is also routinely involved in transactional work (due diligence) concerning patent portfolios, trade secrets and know-how. Mr. Davidson is often asked to evaluate patent portfolios for business acquisitions, initial public offerings, start-ups, and capitalizations. Such work often involves evaluations of a product(s) with respect to such patents that are involved in the transactional work and consideration of patentability issues, and infringement avoidance.

In addition to his expertise in pharmaceuticals, Mr. Davidson has had a great deal of experience in the preparation and prosecution of patent applications in other technologies including mechanical (including food processing equipment, paper machinery, military equipment and automotive equipment); and food technology (including preparation of patent applications directed to a wide variety of diary-based products, juice-based products, dietary products, snack foods, and processes for preparing the same).

Mr. Davidson has participated in the litigation of complex pharmaceutical and chemical patent situations. He also has expertise with respect to ex-parte and inter-partes proceedings before the United States Patent Office, including Appeals, Reexamination, Reissue Proceedings, and Interference Proceedings.

Mr. Davidson has significant experience in the prosecution of patent applications throughout the world, and has actively participated in Opposition proceedings and Appeals before the European Patent Office, the Australian Patent Office, and the Japanese Patent Office.

Mr. Davidson has been awarded an AV® rating from Martindale-Hubbell, confirming Mr. Davidson's status as a highly respected, ethical member of the Bar, with his legal abilities being rated very high to preeminent.

Mr. Davidson has been a featured speaker at American Conference Institute Seminars concerning pharmaceutical patent life cycle management; product development and commercialization; and the effect of Hatch-Waxman reforms on the patent endgame. He has written an article on patent issues for BusinessWeek, and regularly contributes articles concerning patent law to a pharmaceutical industry magazine, Drug Delivery Technology®.


Honors and Awards

AV® rating, Martindale-Hubbell

Featured Speaker, American Conference Institute Seminars Concerning Pharmaceutical Patent Life Cycle Management (2001-2003)

Featured Author, Drug Delivery Technology® Magazine

Editorial Board and Featured Author, Specialty Pharma7 Magazine

American Jurisprudence Award for Excellence in Property Law

Featured Speaker, Sino-American Pharmaceutical Association Conference June 2006

Featured Speaker, 2nd Annual Specialty Pharma Global

Summit: Growth Opportunities for Pipeline & Business Development - Strategic Research Institute (SRI) May 2006

Featured Speaker, AAPS Conference At West Point (formerly Arden House): Oral Controlled Release Development and Technology, January 2006

Featured Speaker, World Pharmaceutical Congress May 2005

Featured Speaker, Sino-American Pharmaceutical Association (SAPA) Generic Drug and Biopharmaceutical Conference March 2005


Publications

"The FTC On Pharmaceutical Patent Litigation Settlements: Not Walking Softly, But Still Carrying a Big Stick" Drug Delivery Technology® Magazine, Vol x No x April 2006, pp xx-yy.

The "Disclosure-Dedication Rule - Are Your Patents Affected?" Specialty Pharma® Magazine, Vol x No x May 2006, pp xx-yy.

"Patent Infringement - Understanding Patent Claims", Drug Delivery Technology® Magazine, Vol x No x January 2006, pp xx-yy.

"More Than One Year Later: MMA's Effect on Hatch-Waxman", Specialty Pharma ® Magazine, Vol x No x September 2005, pp xx-yy.

"The Long-Awaited Merck v. Integra Decision: Where Does it Leave Us?", Drug Delivery Technology® Magazine, Vol x No x July/August 2005, pp xx-yy.

"When Does "A Little" Equal "Enough"?, Drug Delivery Technology® Magazine, Vol x No x April 2005, pp xx-yy.

"U.S. Patent Filings and the Pitfalls of Claiming Small Entity Status", Drug Delivery Technology® Magazine, Vol x No x February 2005, pp xx-yy.

"Generics Beware: Pre-Marketing Infringement Suits On Use Patents", Drug Delivery Technology® Magazine, Vol 4 No 8 October 2004, pp 30-34.

"Loss of Patent Rights - "Experimental Use" v. On-Sale/Public Use Bar", BusinessWeek7 Magazine, July 26, 2004.

"The Safe Harbor Provision of Hatch-Waxman: Is There a Hole in the Safety Net?",Drug Delivery Technology® Magazine, Vol 4 No 5 June 2004, pp 26-30.

"Product Lifecycle Management Through Patents" , Drug Delivery Technology® Magazine, Vol 4 No 2 March 2004, pp 26-29.

"The Effect of Proposed Legislative Reforms on the Patent Endgame" presented at American Conference Institute Legal Strategies for Maximizing Pharmaceutical Patent Life Cycles, April 2003.

"Patent Life Cycles: What's the Right Strategy?" presented at The Canadian Institutes Conference on Pharma Patents, October 2002.


"The Generic Perspective: Getting onto the Market" presented at American Conference Institute Legal Strategies for Maximizing Pharmaceutical Patent Life Cycles, May 2002; September 2002.


Inventions

U.S. Patent No. 6,866,867 ("Process for preparing a directly compressible solid dosage form containing microcrystalline cellulose")

U.S. Patent No. 6,395,303 ("Process for preparing a directly compressible solid dosage form containing microcrystalline cellulose")

Other patent applications pending.