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When Your Life Sciences Are on the Line Podcast Ep. 14: IP Disputes

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Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s...

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<p><em>When Your Life Sciences Are on the Line </em>Podcast Ep. 14: IP Disputes</p>

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<p dir="ltr">Katherine (Kate) Driscoll is a partner in Morrison Foerster’s Investigations + White Collar Defense Practice Group. Kate focuses her practice on investigations, enforcement actions, and compliance, representing companies and senior business executives. Kate has extensive experience in a wide range of criminal and civil cases, with an emphasis on pharmaceutical and life sciences clients, related to healthcare fraud, the Anti-Kickback Statute (AKS), the False Claims Act (FCA), and the Foreign Corrupt Practices Act. Kate routinely consults with clients on all manner of compliance matters, including providing risk assessments, gap analyses, and maturity evaluations. Kate also recently completed a secondment with a global consulting firm, leading government-facing investigations relating to healthcare matters.</p><p dir="ltr">Prior to joining Morrison Foerster, Kate served as an Assistant United States Attorney in the U.S. Attorney’s Office for the Eastern District of Pennsylvania. Kate has significant trial experience, obtaining multiple jury and bench trial verdicts. As a federal prosecutor, Kate ran large-scale white-collar investigations, including complex wiretap and forensic financial investigations, involving healthcare fraud, illegal distribution of prescription drugs, money laundering, wire fraud, bank fraud, and tax fraud. Kate conducted parallel investigations with the Civil Division related to potential False Claims Act violations, and the SEC for potential violations of securities laws. Among her experience, Kate led the criminal prosecution of one of the largest theft of trade secrets cases in United States history, involving a leading multinational pharmaceutical company, and also led COVID-19-related government fraud investigations, involving the CARES Act and the Paycheck Protection Program.</p><p dir="ltr">Kate received the 2019 Inspector General’s Award for Excellence in Fighting Fraud, Waste, and Abuse for the successful prosecution and conviction of healthcare professionals who illegally distributed millions of dollars in prescription drugs. She was also part of the prosecution team that was awarded the Prosecutor of the Year Award for 2021 from the Coalition Against Insurance Fraud regarding work on a significant arson, healthcare fraud, and tax fraud prosecution that impacted hundreds of victims and caused significant damage to the City of Philadelphia. Kate has advised and worked closely with a variety of federal and local law enforcement agencies.</p><p dir="ltr">Kate is a lecturer at Yale University, teaching a course on white-collar investigations and prosecutions. Earlier in her career, Kate clerked for the Honorable Pamela K. Chen of the U.S. District Court Eastern District of New York. Kate earned her J.D. from the University of Pennsylvania Law School and her A.B. summa cum laude from Bryn Mawr College.</p><h4 dir="ltr">Representative Experience</h4><p dir="ltr"><strong>Defense Experience</strong></p><ul><li dir="ltr">Represented McKinsey & Company in negotiating a $650 million five-year deferred prosecution agreement and civil False Claims Act settlement with DOJ and Corporate Integrity Agreement with HHS-OIG arising from McKinsey’s past work for opioid manufacturers, including Purdue Pharma.</li><li dir="ltr">Representation of Anthony Ornato, a former senior career civil servant who recently served as White House Deputy Chief of Staff of Operations, in the January 6 Select Committee investigation and related government investigations.</li><li dir="ltr">Representation of a multinational pharmaceutical and medical device manufacturer in various internal investigations relating to employees’ alleged kickback violations, submission of false claims, bribery, collusion with business partners, and corporate governance issues across North America.</li><li dir="ltr">Representation of a multinational holding company in a DOJ investigation arising from the client’s investment into a telehealth company under investigation for the unlawful prescription of controlled substances involving potential violations of the Controlled Substances Act (CSA) and the FCA.</li><li dir="ltr">Advising a pharmaceutical company seeking to mitigate AKS risk in supporting commercially insured patients in the transition to a new biosimilar therapy.</li><li dir="ltr">Representation of a global manufacturing company in reviewing and enhancing their anti-corruption and bribery codes of conduct, third-party due diligence protocols, and procurement policies.</li><li dir="ltr">Internal investigation in the U.S., Europe, and Latin America on behalf of a financial institution, which involved over US$1.3 billion in potential liabilities.</li></ul><p dir="ltr"><strong>Government Experience</strong></p><ul><li dir="ltr">Matter involving scientists employed by a multinational pharmaceutical company who were criminally charged for conspiracy, theft of trade secrets, wire fraud, and money laundering, all relating to theft of cancer research platforms, valued at more than US$550 million.</li><li dir="ltr">Matter involving a scientist who was extradited from Switzerland after indictment for conspiracy to steal trade secrets related to the theft of research and other confidential information from several multinational pharmaceutical companies.</li><li dir="ltr">Matter involving physicians criminally charged for prescribing more than US$5 million in prescription drugs used to treat opioid addiction outside the course of professional practice and not for legitimate medical purposes.</li><li dir="ltr">Matter involving a financial advisor who was criminally charged for diversion of client funds through bank, mail, and wire fraud, and aggravated identity theft.</li><li dir="ltr">Matter involving arson that displaced hundreds of victims and injured several firefighters. Obtained convictions for all defendants and US$22 million in restitution for the victims. Brought related indictments charging additional criminal conduct, including healthcare fraud, tax fraud, and federal benefits fraud.</li></ul><h4 dir="ltr">Memberships</h4><ul><li dir="ltr">National LGBTQ+ Bar Association</li><li dir="ltr">Philadelphia LGBTQ Bar Association</li><li dir="ltr">Pennsylvania Association Criminal Defense Lawyers (Planning Committee)</li><li dir="ltr">Federal Criminal Law Committee in the Eastern District of Pennsylvania (Executive Committee)</li><li dir="ltr">University of Pennsylvania Inn of Court</li><li dir="ltr">Women’s White Collar Defense Association</li></ul>

Kate Driscoll

Partner

<p><span>Nathaniel (Nate) Mendell is a partner in Morrison Foerster’s Investigations + White Collar Defense and </span>Data, Cyber + Privacy<span> practice groups and was the former Acting U.S. Attorney for the United States Attorney’s Office for the District of Massachusetts. He represents companies, financial institutions, boards, and executives through all phases of investigation and litigation involving allegations of corporate healthcare fraud, securities and other financial fraud, public corruption, criminal intellectual property theft, data breach or disclosure, and international money laundering. Nate leverages his two decades of service in the U.S. Department of Justice to offer clients an invaluable insider perspective on white collar defense, internal investigations, cyber breaches, and government enforcement actions.</span></p><p>Prior to joining Morrison Foerster, Nate served as First Assistant U.S. Attorney and Senior Litigation Counsel advising the U.S. Attorney. As Acting U.S. Attorney, Nate led over 135 prosecutors and reported directly to the Attorney General. Before serving as First Assistant, Nate was Chief of the Narcotics and Money Laundering Unit, where he led more than a dozen prosecutors investigating and prosecuting money laundering cases across the United States, Colombia, Europe, and the Middle East. He also contributed to the creation of the District Court’s RISE Program and was an Assistant U.S. Attorney in the Southern District of Florida.</p><p>Nate earned his B.A., cum laude, from Amherst College and earned his J.D. from Harvard Law School where he served as the Editor in Chief of the<span> </span><em>Harvard Latino Law Review</em>.  He has also served on the <em>Law360</em> Massachusetts editorial board since 2024.</p><h4>Representative Experience</h4><h5>Defense Experience</h5><ul><li>Representation of a multinational holding company in a DOJ investigation arising from the client’s investment into a telehealth company under investigation for the unlawful prescription of controlled substances involving potential violations of the Controlled Substances Act (CSA) and the False Claims Act (FCA).</li><li>Advising a pharmaceutical company seeking to mitigate Anti-Kickback Statute (AKS) risk in supporting commercially insured patients in the transition to a new biosimilar therapy. While providing support to commercially insured patients and carving out federally insured patients is not prohibited, such arrangements can draw government scrutiny if they are intended to induce or “pull through” federally insured patients to use medical services or products. We are helping formulate practical parameters for a program that will assist commercially insured patients, meet business goals, and comply with applicable laws and regulations. </li><li>Advising pharmaceutical company whose trade secrets and confidential information were used as the basis for a patent application filed by a competitor and former employees.</li><li>Advising a commercial bank on the acquisition of a medical records company under investigation by DOJ for alleged violations of the FCA.</li><li>Advising an investment management company on the acquisition of a medical device manufacturer under investigation by the DOJ for alleged violations of the FCA.</li><li>Provided training to an online market place regarding the legal framework of the AKS, recent enforcement trends, and compliance best practices.</li></ul><h5>Government Experience</h5><ul><li>Violations of the AKS against a variety of major pharmaceutical companies, which culminated in settlements involving nearly $1,000,000,000 in fines and restitution to resolve the improper use of “patient assistance programs” to subsidize patient co-pays.</li><li>Violations of the CSA against the founder and chief executive officer of a publicly‑traded pharmaceutical company related to the opioids epidemic.</li><li>FCA matters involving improper inducements, insurance pull-through schemes, and improper billing and coding practices.</li><li>Fraud and tax fraud charges against a professor suspected of stealing trade secrets and intellectual property from U.S. interests for a foreign government.</li><li>Conspiracy to obtain unauthorized access to computers and to commit wire fraud and securities fraud charges against a Russian businessman.</li><li>Charges of mail fraud, money laundering, bribery, conspiracy to commit mail and wire fraud, and racketeering conspiracy against coaches, administrators, and parents who fraudulently obtained test scores and college admissions for students related to the Varsity Blues scandal.</li><li>Six-week mail and wire fraud trial against an American businessman involved in a multi-million dollar Ponzi scheme.</li></ul>

Nathaniel R. Mendell

<p class="MoFoBioBodyTextLead">Fitz Collings is an IP litigator who puts science first to develop innovative litigation strategies for life sciences and technology companies.</p><p class="MoFoBodyText">Fitz counsels some of the largest pharmaceutical, biotechnology, and technology companies in the world on complex intellectual property matters. His experience over the past decade includes high-profile patent litigation involving immunotherapies for autoimmune diseases and cancer, for which he was recognized by <em>Who’s Who Legal: Life Sciences</em> in 2017 and 2018; trade secret proceedings in district courts and before the International Trade Commission; numerous Hatch-Waxman Act cases in district courts around the country; and representation of life sciences, biotechnology, and technology companies before the Patent Trial and Appeal Board (PTAB). Fitz also regularly serves as a trusted advisor to emerging companies—for whom IP is often their greatest asset—in structuring their growth and preparing for future litigation.</p><p class="MoFoBodyText">Fitz maintains an active pro bono practice in which he represents clients in Medicaid coverage disputes and immigration matters. His recent pro bono work involved representing some of the most vulnerable members of our communities in partnership with Maryland Disability Law Center, Children’s Law Center, Public Counsel, and Southern Poverty Law Center.</p><p class="MoFoBodyText">Fitz earned his B.A. in biology from Cornell University. He received his J.D. from the College of William & Mary, where he served as the technical editor of the <em>Environmental Law and Policy Review</em> and as president of both the American Constitution Society and the Student Intellectual Property Society. Prior to law school, Fitz worked as a scientific researcher at Brigham and Women’s Hospital and the Cleveland Clinic, and he draws on this experience to provide legal advice grounded in science to all of his clients.</p><h4>Representative Experience</h4><div><ul><li>A major technology company in a complex intellectual property case involving trade secret, copyright, patent, and antitrust claims.</li><li>A global pharmaceutical company in worldwide patent litigation and PTAB proceedings involving a first-in-class antibody immunotherapy product.</li><li>A global pharmaceutical company in district court patent litigation under the Biologics Price Competition and Innovation Act and PTAB proceedings involving a prominent biologic product.</li><li>A global pharmaceutical company in numerous district court litigations under the Hatch-Waxman Act involving a small-molecule product.</li><li>Global pharmaceutical companies in district court litigation involving a blockbuster small-molecule product.</li><li>A global pharmaceutical company in litigation to invalidate an antibody patent under license, securing a highly favorable settlement.</li><li>A biotechnology company in district court litigation and PTAB proceedings regarding microfluidic devices.</li><li>A chemical manufacturer in a trade secret dispute before the International Trade Commission.</li><li>A global pharmaceutical company in a trademark infringement and counterfeiting dispute.</li></ul></div><div style="position: absolute;left: -10000px;top: 0px;width: 1px;height: 1px;overflow-x: hidden;overflow-y: hidden;" id="_mcePaste"><p class="MoFoBioBodyTextLead">Fitz Collings is an IP litigator who puts science first to develop innovative litigation strategies for life sciences and technology companies.</p><p class="MoFoBodyText">Fitz counsels some of the largest pharmaceutical, biotechnology, and technology companies in the world on complex intellectual property matters. His experience over the past decade includes high-profile patent litigation involving immunotherapies for autoimmune diseases and cancer, for which he was recognized by <em>Who’s Who Legal: Life Sciences</em> in 2017 and 2018; trade secret proceedings in district courts and before the International Trade Commission; numerous Hatch-Waxman Act cases in district courts around the country; and representation of life sciences, biotechnology, and technology companies before the Patent and Trademark Appeal Board (PTAB). Fitz also regularly serves as a trusted advisor to emerging companies—for whom IP is often their greatest asset—in structuring their growth and preparing for future litigation.</p><p class="MoFoBodyText">Fitz maintains an active pro bono practice in which he represents clients in Medicaid coverage disputes and immigration matters. His recent pro bono work involved representing some of the most vulnerable members of our communities in partnership with Maryland Disability Law Center, Children’s Law Center, Public Counsel, and Southern Poverty Law Center.</p><p class="MoFoBodyText">Fitz earned his B.A. in biology from Cornell University. He received his J.D. from the College of William & Mary, where he served as the technical editor of the <em>Environmental Law and Policy Review</em> and as president of both the American Constitution Society and the Student Intellectual Property Society. Prior to law school, Fitz worked as a scientific researcher at Brigham and Women’s Hospital and the Cleveland Clinic, and he draws on this experience to provide legal advice grounded in science to all of his clients.</p><p class="MsoNormal"> </p></div>

Fitz Collings

Life Sciences + Healthcare

Investigations + White Collar Defense

Patent Litigation