Jason Balich was previously an associate at Axinn, Veltrop & Harkrider, where he assisted in the representation of both plaintiffs and defendants in both patent litigation before US District Courts and also in inter partes reviews before the US Patent Office (USPTO). Jason has performed intellectual property counseling and patent due diligence, particularly in mechanical, chemical, pharmaceutical, and biologic industries. Jason has also counseled clients on regulatory matters before the Federal Drug Administration (FDA).

Jason also previously worked for General Electric in their Global Patent Operation and is the co-inventor of four US patents, obtained while working at 3M Company.

  • Performed case management and assisted in litigation strategy for seven patent litigations in the Districts of Delaware and Eastern District of Virginia:
    • Represented five generic pharmaceutical companies as defendants in Hatch-Waxman generic drug litigation
    • Represented a branded pharmaceutical company as a plaintiff/patentee
    • Represented a Massachusetts-based medical device company as defendant
  • Drafted sections of a summary judgment brief, prompting settlement to the satisfaction of the medical device client
  • Assisted in drafting two Markman briefs and produced a technology tutorial video on polymorphs as part of a Markman hearing
  • Worked with experts in the fields of crystallography, biomechanical engineering, pharmaceutical formulations and medical doctors
  • Drafted three inter partes review (IPR) petitions being filed with the USPTO challenging patents on monoclonal antibody pharmaceutical formulations
  • Drafted patent licensing agreements and settlement agreements
  • Drafted an opinion letter regarding noninfringement of clients products and invalidity of competitor’s patents in the field of protein antagonists
  • Drafted over a dozen notice letters for P-IV certifications in abbreviated new drug applications (ANDAs) in connection with Hatch-Waxman litigations
  • Assisted a client with addressing an FDA deficiency regarding an ANDA for a generic transdermal patch by coordinating magnetic resonance imaging (MRI) testing on the client’s proposed patch for submission to FDA
  • Performed pre-acquisition due-diligence to determine likely antitrust concerns for four potential mergers and acquisitions
  • Performed several patent landscape evaluations for human tissue based products
  • Evaluated whether eight different drugs undergoing clinical trial would qualify for “new chemical entity” (NCE) exclusivity upon approval
  • Director, Sandy Point Sailing Association, Beverly, MA
  • Private pilot
  • Races J/80 sailboats in regional, national and international competitions
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Jason Balich was previously an associate at Axinn, Veltrop & Harkrider, where he assisted in the representation of both plaintiffs and defendants in both patent litigation before US District Courts and also in inter partes reviews before the US Patent Office (USPTO). Jason has performed intellectual property counseling and patent due diligence, particularly in mechanical, chemical, pharmaceutical, and biologic industries. Jason has also counseled clients on regulatory matters before the Federal Drug Administration (FDA).

Jason also previously worked for General Electric in their Global Patent Operation and is the co-inventor of four US patents, obtained while working at 3M Company.

  • Performed case management and assisted in litigation strategy for seven patent litigations in the Districts of Delaware and Eastern District of Virginia:
    • Represented five generic pharmaceutical companies as defendants in Hatch-Waxman generic drug litigation
    • Represented a branded pharmaceutical company as a plaintiff/patentee
    • Represented a Massachusetts-based medical device company as defendant
  • Drafted sections of a summary judgment brief, prompting settlement to the satisfaction of the medical device client
  • Assisted in drafting two Markman briefs and produced a technology tutorial video on polymorphs as part of a Markman hearing
  • Worked with experts in the fields of crystallography, biomechanical engineering, pharmaceutical formulations and medical doctors
  • Drafted three inter partes review (IPR) petitions being filed with the USPTO challenging patents on monoclonal antibody pharmaceutical formulations
  • Drafted patent licensing agreements and settlement agreements
  • Drafted an opinion letter regarding noninfringement of clients products and invalidity of competitor’s patents in the field of protein antagonists
  • Drafted over a dozen notice letters for P-IV certifications in abbreviated new drug applications (ANDAs) in connection with Hatch-Waxman litigations
  • Assisted a client with addressing an FDA deficiency regarding an ANDA for a generic transdermal patch by coordinating magnetic resonance imaging (MRI) testing on the client’s proposed patch for submission to FDA
  • Performed pre-acquisition due-diligence to determine likely antitrust concerns for four potential mergers and acquisitions
  • Performed several patent landscape evaluations for human tissue based products
  • Evaluated whether eight different drugs undergoing clinical trial would qualify for “new chemical entity” (NCE) exclusivity upon approval

  • Director, Sandy Point Sailing Association, Beverly, MA
  • Private pilot
  • Races J/80 sailboats in regional, national and international competitions