Lauren Katzeff

LAUREN KATZEFF is a litigator with deep knowledge of the complex intellectual property and regulatory challenges facing pharmaceutical and technology clients. As a member of Sidley’s Global Life Sciences group, she leverages her scientific background to counsel manufacturers of biologics and small molecules—from major brands to pre-clinical and clinical stage companies—as well as biotechnology, medical device, and consumer electronics corporations.  

Lauren has significant experience in all stages of high-impact intellectual property proceedings before U.S. district courts, the U.S. Patent & Trademark Office, the International Trade Commission, and the Federal Circuit. Clients rely on her courtroom experience—which includes presenting and cross-examining fact and expert witnesses in jury and bench trials, as well as arguing at Markman, evidentiary, and discovery hearings—and the depth of her analysis in preparation for litigation. Lauren’s litigation strategy is rooted in her understanding of the broader landscape of issues surrounding drugs, biotechnology, and devices. Her practice includes portfolio and pipeline assessment and planning; regulatory counseling; diligence advice in high-value transactions; and representation in internal and government investigations involving healthcare and intellectual property issues.

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. She has undergraduate degrees in Biochemistry and Biological Sciences.

Representative experience includes:
Litigation and Investigations

• Representing Bayer 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 US$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 it won LMG Life Sciences’ 2019 “Patent Impact Case of the Year.” The verdict was increased to US$182 million with supplemental damages and interest, and was upheld on appeal before the U.S. Court of Appeals for the Federal Circuit (CAFC).
• Defending a consumer electronics company in litigation before the International Trade Commission (ITC), including a bench trial that resulted in a finding of no violation by the company.
  Representing a publicly traded cell therapy company in connection with an internal investigation of intellectual property licensing and related opportunities.
• Representing a publicly traded biotechnology company in connection with a government investigation of healthcare fraud and abuse allegations related to physician speaker programs, including preparation of witnesses for grand jury testimony.
• Representing Amgen in an abbreviated new drug application (ANDA) appeal involving Sensipar®, securing a reversal on claim construction and non-infringement judgment against one generic manufacturer and an affirmance of infringement judgment against another (CAFC).
• Representing Amgen in patent litigation involving Amgen’s blockbuster rDNA biologic Enbrel® (D.N.J.), including successfully defending an inter partes review challenge to an Enbrel® patent (USPTO).
• Representing Illumina in patent litigation involving library preparation kits for next-generation and high throughput sequencing (S.D. Tx.). Case favorably settled.
• 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 Takeda in pre-suit diligence and litigation to invalidate an antibody patent under license, securing a highly favorable settlement (E.D. Va.).
• 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 inter partes review (IPR) proceedings.
• Representing a major pharmaceutical company in an 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.

Strategic, Regulatory, and Diligence Counseling

• Providing strategic patent portfolio advice and pre-suit diligence in advance of potential Hatch-Waxman and Biologics Price Competition & Innovation Act (BPCIA) litigation against generics and biosimilars manufacturers.
• Conducting patent diligence for a publicly traded biotechnology company in connection with an acquisition involving microfluidics and electrowetting.
• Conducting patent diligence for a special purpose acquisition company (SPAC) in connection with evaluating a clinical-stage biopharmaceutical company focused on developing and commercializing transformative therapies for oncology, neurology, and immunology diseases.
• Counseling a durable medical equipment supplier in connection with federal healthcare program enrollment and numerous state licensure issues, including negotiations with various regulatory agencies.
• Analysis and advice in connection with a variety of federal and state healthcare requirements, policies, risks and opportunities for numerous healthcare items and services, including transparency and reporting laws.

Lauren maintains an active pro bono practice in which she frequently represents veterans in disability benefits appeals and discharge upgrade review hearings.