Lauren Katzeff

LAUREN KATZEFF is a trial litigator with deep knowledge of the complex intellectual property and regulatory challenges facing pharmaceutical and technology clients. As a member of Sidley’s IP Litigation and Global Life Sciences groups, 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 Patent Trial and Appeal Board, the International Trade Commission, the American Arbitration Association, and at the Federal Circuit. She brings a strategic vision to litigation, rooted in her understanding of the broader landscape of issues surrounding the highly-regulated life sciences industry. Clients rely on her courtroom acumen, depth of scientific and legal analysis, and compelling communication style. Lauren translates complex concepts when presenting and cross-examining fact and expert witnesses in jury and bench trials, in written motions and submissions, and through argument at Markman, evidentiary, and discovery hearings.

Her practice also includes strategic advising across Sidley’s Global Life Sciences platform, including 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.

Prior to joining the firm, Lauren served as a judicial law clerk for multiple federal judges whose courts’ dockets frequently include complex technical proceedings and/or regulatory appeals. She clerked for The Honorable David B. Sentelle of the U.S. Court of Appeals for the D.C. Circuit, as well as for The Honorable William L. Osteen, Jr. and The Honorable Catherine C. Eagles, both in the U.S. District Court for the Middle District of North Carolina.

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.

Lauren's representative experience includes:

IP Litigation

• Representing biopharmaceutical company in multi-district litigation asserting patents under the Biologics Price Competition & Innovation Act (BPCIA) against manufacturers seeking to market biosimilar versions of antibody to treat osteoporosis. After a multi-day evidentiary hearing on a motion for preliminary injunction, case against initial biosimilar manufacturer settled (D.N.J.; E.D.N.C.; N.D. Ill.).
• Representing biotechnology 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 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 (CAFC).
• Representing anti-arrythmia drug manufacturer in district court and arbitration involving issues of patent ownership, inventorship, and FDA regulatory requirements, obtaining a decision that opponent breached contract (N.D. Ill.; AAA).
• Defending a consumer electronics company in litigation involving noise-cancellation technology, including a bench trial that resulted in a finding of no violation by the company (ITC).
• Representing innovator manufacturer of radioactive diagnostic agent in Hatch-Waxman litigation, securing early settlement (D.N.J.).
• Representing small molecule innovator in an abbreviated new drug application (ANDA) appeal involving a treatment for hyperparathyroidism, securing a reversal on claim construction and non-infringement judgment against one generic manufacturer and an affirmance of infringement judgment against another (CAFC).
• Representing biopharmaceutical manufacturer in patent litigation involving blockbuster fusion protein biologic to treat rheumatoid arthritis and psoriasis (D.N.J.), including successfully defending an inter partes review challenge (PTAB). Representing developer of genomic sequencing platforms in patent litigation involving library preparation kits for next-generation and high throughput sequencing, obtaining rapid settlement (S.D. Tx.).
• Representing biopharmaceutical innovator in patent litigation involving the first anti-PD-1 antibody approved for cancer treatment in the United States, securing a favorable global settlement against major competitor (D. Del., D.N.J.).
• Representing global biotechnology company in pre-suit diligence and declaratory judgment action to invalidate an antibody patent under license, securing a settlement that resulted in significant royalty payment savings (E.D. Va.).
• Defending patent covering the use of anti-CD20 antibody in inter partes review challenge where the Board declined to institute trial proceedings (PTAB).
• Representing a major biotechnology company in a patent interference proceeding involving an antibody to amyloid-beta used in the treatment of Alzheimer’s disease, resulting in favorable settlement (USPTO).
• Representing the manufacturer of a once-daily tablet used to treat ADHD in Hatch-Waxman litigation, settling cases against numerous defendants in multiple jurisdictions (N.D.W. Va., E.D. Pa.).

Healthcare Litigation and Investigations

• Defending biopharmaceutical company against False Claims Act allegations of fraudulently procuring a patent to improperly inflate the price of a drug (D.N.J).
  Representing multinational pharmaceutical company in criminal and civil investigations by the U.S. Attorneys’ Offices of alleged fraud on U.S. Patent &Trademark Office as a predicate to False Claims Act liability (D. Mass.).
• Representing a publicly traded cell therapy company in connection with an internal investigation into potential diversion of intellectual property 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 (S.D. Fl.).

Strategic, Regulatory, and Diligence Counseling

• Providing strategic patent portfolio advice and pre-suit diligence in advance of potential Hatch-Waxman and BPCIA litigation against manufacturers of generics and biosimilars.
• 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.
• Providing 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.