About Jitty Malik, PhD

Dr. Jitendra "Jitty" Malik has a wide-ranging patent practice, which includes patent litigation, post-grant patent practice before the US Patent and Trademark Office, patent counseling and patent prosecution. With particular experience in the drug approval process under the Hatch-Waxman and Biologics Price Competition and Innovation Acts, he helps clients in developing strategies for marketing drug and biologic/biosimilar products, and challenging patents pursuant to the Hatch-Waxman Act and BPCIA.

Patent counsel informed by scientific knowledge

Jitty's practice encompasses patent litigation, post-grant patent review, opinions, IP due diligence, licensing and prosecution. He is experienced in handling matters in which patents are challenged post grant before the US Patent & Trademark Office, including inter partes review and post-grant review process, ex-parte reexaminations and reissues.

His scientific knowledge includes chemistry, biochemistry, organometallic chemistry, polymer chemistry, physics and electrochemistry. Prior to law school, Jitty was a project supervisor for a leading chemical materials manufacturer. He has been published many times in scholarly scientific and legal publications and is a frequent speaker on legal matters.

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Practice Focus

  • Patent litigation
  • Pharmaceutical and life sciences litigation
  • Intellectual property litigation
  • Post-grant patent practice before the USPTO
  • Patent counseling
  • IP licensing
  • Patent prosecution

Representative Experience

  • Litigation in the US District Court for the District of Delaware involving multiple patents associated with the treatment of early-stage idiopathic Parkinson’s disease and moderate-to-severe restless legs syndrome using rotigotine.
  • Lead trial counsel in the US District Court for the District of Delaware involving patents associated with a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma using melphalan for injection.
  • Lead trial counsel in the US District Court for the District of Delaware involving patents associated with the treatment of patients with metastatic colorectal cancer using regorafenib.
  • Litigation in the US District Court for the District of New Jersey involving multiple patents directed to methylnaltrexone bromide formulation for subcutaneous injection.
  • Lead trial counsel in the US District Court for the District of New Jersey involving patents associated with the treatment of adults with multiple myeloma using lenalidomide.
  • Litigated in the US District Court for the District of Delaware involving five patents directed to a controlled release of budesonide. *
  • Litigated in the US District Court for the District of New Jersey involving multiple patents directed to treating schizophrenia, bipolar disorder, depression and autism spectrum disorders with aripiprazole.  *
  • Litigated in the US District Court for the District of Delaware involving multiple patents directed to treating moderate to severe dementia of the Alzheimer’s type with memantine.  *
  • Litigated in the US District Court for the District of New Jersey involving two patents directed to the reduction of elevated total cholesterol using ezetimibe and simvastatin.  *
  • Section 505(b)(2) Hatch-Waxman litigation in the US District Court for the District of New Jersey involving two patents directed to an intravenous formulation of acetaminophen. *
  • Litigated in the US District Court for the District of New Jersey involving numerous patents associated with the treatment of post-operative inflammation and reduction of ocular pain in patients who have undergone cataract surgery using a bromfenac ophthalmic solution.  *
  • Represented one of the largest pharmaceutical companies in the world as plaintiff in patent infringement action involving medical foods before the US District Court for the Eastern District of Texas.  *
  • Represented developer of direct bonding technology for 3D integration as plaintiff in patent infringement action involving image sensors before the US District Court for the Northern District of California.  *
  • Represented one of the world’s largest chemical producers as plaintiff in patent infringement action involving animal health products before the US District Court for the Middle District of North Carolina.  *
  • Defended developer of cardiovascular treatments in patent infringement action involving medical devices before the US District Court for the Northern District of California.  *
  • Defended an integrated textile company in patent infringement action involving fabric technology before the US District Court for the Southern District of New York.  *
  • Defended industrial valve manufacturer in patent infringement action involving industrial petrochemical equipment before the US District Court for the Central District of California.  *
  • Represented fiber optics developer as plaintiff in patent infringement action before the US District Court for the Northern District of Georgia. *
  • Defended one of the largest petrochemical companies in the Americas in patent infringement action involving systems for petrochemical refining before the US District Court for the Western District of Texas. *
  • Represented developer of nutrient-use efficiency technologies as plaintiff in litigation involving patent directed to substances that improve plant growth.  *
* Experience prior to Katten

News

Publications

  • 2016
    USPTO Post-Grant Trials Handbook
  • May 2015
    A Second Bite of the Apple? Potential to Expand an Invalidity Argument in an IPR is Not Precluded by Joinder

Presentations and Events

  • June 21, 2016
    The Defend Trade Secrets Act
    Co-presenter
  • April 17, 2015
    Biotechnology Industry Organization (BIO)
    Moderator | Recent Developments in IPR and Their Effect on the Life Sciences | Bio IP Counsels Committee Conference
Practices
Education
  • Wake Forest University School of Law, JD
  • University of Cincinnati, PhD, Polymer Science and Engineering
  • University of Cincinnati, MBA
  • The University of North Carolina at Charlotte, MS, Chemistry
  • The University of North Carolina, BS, Chemistry
Bar Admissions
  • North Carolina
Community Involvements
  • Intellectual Property Owners Association, Pharmaceutical & Biotechnology Issues Committee
Recognitions
Recognized or listed in the following:
  • ANDA Litigation Intelligence Report
    Best Performing ANDA Attorneys Representing Defendants, 2021–2022; Top 1, 2023
    Best Performing ANDA Attorneys Overall (Representing Plaintiffs or Defendants), Top 3, 2023
    Most Active ANDA Attorneys Representing Defendants, Top 100, 2021; Top 10, 2023
    Most Active ANDA Attorneys Overall (Representing Plaintiffs and Defendants), Top 100, 2021–2023
  • BTI Client Service All-Stars
    2020
  • IAM Patent 1000
    Recognized Individual, United States, 2023
    Recognized Individual, North Carolina, 2020–2023
  • IPR Intelligence Report
    Top 100 Best Performing IPR Attorneys Representing Petitioners
Award Methodologies