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About me

For more than 20 years, I have dedicated my practice to intellectual property law.  I litigate and prosecute patents and trademarks and counsel clients on a variety of intellectual property issues, both domestic and international.  As a trial attorney, my emphasis is on Hatch-Waxman ANDA litigation arising between brand and generic drug manufacturers.  My peers have awarded me an AV Preeminent rating through Martindale Hubbell.


Registered Patent Attorney specializing in pharmaceuticals and biotechnology, medical devices, Hatch-Waxman ANDA litigation, counseling and strategy, biosimilars and related FDA issues.


Languages spoken: French

Practice areas


  1. Life Sciences: 20%
    21 years
  2. Intellectual Property: 20%
    21 years
  3. Patent Application: 20%
    21 years
  4. Patent Infringement: 20%
    21 years
  5. Other: 20%
  6. More 



Fixed (sometimes), Free consultation (30 minutes)

Payment types:

Cash, Check

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Contact info

Lerner, David, Littenberg, Krumholz & Mentlik

600 South Avenue West
Westfield, NJ, 07090


NYCurrently registered 199607/11/2016
We have not found any instances of professional misconduct for this lawyer.
Avvo contributions
Legal answers
Award nameGrantorDate granted
AV Preeminent Peer Review RatedMartindale-Hubbell2010
Work experience
TitleCompany nameDuration
PartnerLerner, David, Littenberg, Krumholz & Mentlik2016 - Present
ShareholderPolsinelli PC2012 - 2015
PartnerK&L Gates2009 - 2012
PartnerHogan & Hartson LLP2004 - 2009
AssociateFrommer, Lawrence & Haug2001 - 2004
AssociateMilbank, Tweed, Hadley & McCloy LLP1998 - 2001
AssociateHopgood, Calimafde, Kalil & Judlowe1994 - 1998
Association namePosition nameDuration
American Intellectual Property Law AssociationMemberN/A
International Trademark AssociationMemberN/A
New York Intellectual Property Law AssociationMemberN/A
Intellectual Property Owners AssociationMemberN/A
American Chemical SocietyMemberN/A
Legal cases
Case nameOutcome
Luye Pharma Group Ltd. et al. v. Alkermes Pharma Ireland Ltd.pending
Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P. et al.pending
Prometheus Laboratories Inc. v. Amneal Pharmaceuticals, LLC et al.pending
See all legal cases 
Publication nameTitleDate
Law360, Portfolio Media, Inc.An Update On Hatch-Waxman Personal Jurisdiction Cases2015
Food and Drug Law Institute (FDLI)Top 20 Food and Drug Cases, 2010, & Cases to Watch, 2011; Chapter 16 AstraZeneca v. Apotex2011
K&L Gates InsightsSkinny Labeling in Question — Federal Circuit Affirms Preliminary Injunction for Inducing Infringement of Orange Book Method of Use Patent Despite Section viii Labeling Carve-Out2010
School nameMajorDegreeGraduated
New York Law SchoolLawJD - Juris Doctor1995
Rutgers UniversityEngineering, Political ScienceBA - Bachelor of Arts1992
Speaking engagements
Conference nameTitleDate
Paragraph IV DisputesParallel Proceedings Moot Court: District Court and PTAB Mock Pharmaceutical Patent Invalidity Hearings2016
Paragraph IV DisputesQuestions of Specific and General Jurisdiction in a Paragraph IV Case: Exploring Daimler's Applicability to Hatch-Waxman2015
Paragraph IV Disputes Master SymposiumThe Start of the Paragraph IV Litigation Countdown; The Paragraph IV Certication and Notice Letter2013
Paragraph IV DisputesAsserting Invalidity or Non-Infringement Under Paragraph IV: Exploring the ANDA Applicant's Pre-Litigation Obligations and Options2013
Paragraph IV DisputesThe Throwing of the Gauntlet: the Paragraph IV Notice Letter2012
Paragraph IV DisputesLitigating with Multiple ANDA Filers: Brand Name and Generic Perspectives2010
FDA Boot CampPatent and IP Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress, and More2010
10th Anniversary Maximizing Pharmaceutical Patent Life CyclesPatent and IP Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress, and More2009
Pharma/Biotech Industry Forum on Patent Portfolio ManagmentControlling Spiraling Costs as Pipelines Get Filled and Portfolios Go Global2007
Paragraph IV DisputesLet the Games Begin: The Start of the Paragraph IV Lawsuit - New Considerations, Challenges and Allegations2007
Maximizing Pharmaceutical Patent Life CyclesUpdated Guidelines for Paragraph IV Certifications and Notice Letters2006
Maximizing Pharmaceutical Patent Life CyclesPreparation and Submission of Paragraph IV Certifications and Notice Letters2005