LAUREN KATZEFF focuses her practice on litigation and regulatory issues facing life sciences and technology clients, primarily in the areas of biologics, pharmaceuticals, medical devices, biotechnology and consumer electronics.
As a member of the Global Life Sciences team, which was awarded “Practice Group of the Year” 2019 by Law360, Lauren’s experience includes district court litigation, inter partes review proceedings (on behalf of both petitioner and patent owner), interference proceedings, and litigation before the International Trade Commission. Lauren has represented several major pharmaceutical and technology companies in a variety of stages of patent litigation, including in cases arising under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act.
Recent representative intellectual property engagements include:
- Representing a major pharmaceutical company in multiple patent suits involving replacement Factor VIII products used to treat hemophilia, including obtaining a jury trial victory on behalf of the patent owner, who was awarded more than $150 million in damages after a finding that the patent is valid and infringed on all asserted claims (D. Del., D. Del.). This victory was the largest damages verdict from a Delaware jury for a biologic and won LMG Life Sciences’ 2019 “Patent Impact Case of the Year.”
- Representing a global pharmaceutical company in pre-suit diligence and litigation to invalidate an antibody patent under license, securing a highly favorable settlement (E.D. Va.).
- Representing Merck in patent litigation involving KEYTRUDA®, the first anti-PD-1 antibody approved for cancer treatment in the United States (D. Del., D.N.J.). Case favorably settled.
- Representing Amgen in patent litigation involving Amgen’s blockbuster rDNA biologic Enbrel® (D.N.J.), and part of team successfully defending an inter partes review challenge to an Enbrel® patent (USPTO).
- Defending a consumer electronics company in litigation before the International Trade Commission, resulting in a finding of no violation (ITC).
- Part of team successfully defending patent covering the use of anti-CD20 antibody rituximab in inter partes review challenge (USPTO). Patent Trial & Appeal Board declined to institute IPR proceedings.
- Representing a major pharmaceutical company in interference proceeding involving an antibody to amyloid-beta used in the treatment of Alzheimer’s disease (USPTO). Case favorably settled.
- Representing Johnson & Johnson in Hatch-Waxman litigation involving CONCERTA®, a once-daily tablet used to treat ADHD (N.D.W. Va., E.D. Pa.). Case favorably settled.
Lauren maintains an active regulatory practice on aspects of healthcare law impacting life sciences clients, including healthcare reform; fraud and abuse; federal healthcare program enrollment, coverage, and reimbursement issues; healthcare compliance programs; and federal and state transparency and reporting laws.
Recent representative regulatory engagements include:
- Representing a publicly traded biotechnology company in connection with a government investigation regarding fraud and abuse allegations.
- Representing a durable medical equipment supplier in connection with federal healthcare program enrollment and numerous state licensure issues.
- Analysis and advice in connection with a variety of federal and state requirements, policies, risks and opportunities for numerous healthcare items and services, including counseling with respect to diligence.
In 2020, Lauren was selected to serve as the Associate Deputy Washington, D.C. Co-Chair for Sidley’s Committee on Retention and Promotion of Women. Before practicing law, Lauren spent several years working in the Pediatric Blood & Marrow Transplant Program and the Carolinas Cord Blood Bank at Duke University Medical Center, generating umbilical cord blood transplants for patients’ use worldwide.