2021 research period for North America is officially open
March 24, 2021
Research team is now accepting firm submissions, due June 1
Morgan Lewis & Bockius
Morgan Lewis has purposefully developed our capabilities to serve the complete life sciences product life cycle and all aspects of the healthcare and life sciences industry. We understand and work creatively to solve the business, transactional, regulatory, intellectual property (IP), litigation, and related issues that our clients face along the product life cycle, from innovation protection and emerging business issues, through regulatory development and approval, to reimbursement, marketing, and distribution. Our lawyers handle litigation in all relevant areas (including government enforcement, fraud and abuse, product liability and IP), labor, employment, and benefits, and antitrust, and work closely with clients on mergers and acquisitions, collaborations and licensing agreements, and outsourcing.
Litigation and Dispute Resolution
Our compliance and government investigations team includes lawyers with litigation and regulatory backgrounds to assist clients with a range of criminal and civil healthcare fraud investigations and related litigation, including some of the most significant recent pharmaceutical industry–related matters in the United States. We advise clients at every stage of government enforcement activity, including responding to federal and state grand jury subpoenas and all federal government civil investigative demands and administrative subpoenas (e.g., those issued by the OIG of the US Department of Health and Human Services (HHS) and other agencies). This includes representing clients through the document production and investigation phase, settlement discussions, Corporate Integrity Agreement (CIA) negotiations, pretrial proceedings, trial, and appeal.
We routinely handle parallel criminal, civil, and administrative proceedings that occur simultaneously in multiple jurisdictions involving claims under the Anti-Kickback Statute, Healthcare Fraud Statute, HHS-OIG exclusion authorities, Civil Monetary Penalties Law, Responsible Corporate Officer Doctrine, federal and state false claims acts, and suspension and debarment authorities. Likewise, we routinely deal with state Medicaid Fraud Control Units (that are usually components of the state attorneys general) and multijurisdictional Medicaid Fraud Task Forces organized by the National Association of Medicaid Fraud Control Units.
Additionally, we regularly advise clients on all aspects of the design, negotiation, and implementation of government-mandated compliance agreements, such as CIAs, Deferred Prosecution Agreements, and state consent decrees. Morgan Lewis lawyers have negotiated and assisted dozens of large and small life sciences and healthcare companies with their most important CIA matters and have extensive knowledge of best practice compliance controls within the life sciences sector.
White Collar Litigation
Our white collar litigators regularly represent life sciences companies in Foreign Corrupt Practices Act (FCPA), UK Bribery Act (and all other forms of UK investigations and prosecutions), and other anticorruption matters, as well as US grand jury and civil investigations and criminal trial defense, state attorneys general investigations and litigation, civil False Claims Act litigation, third-party payor class action litigation, civil antitrust class action litigation, and state Bureaus of Consumer Protection actions.
Commercial Litigation
We regularly represent pharmaceutical clients in the full range of business disputes, including trade secrets and noncompete litigation, supplier/purchaser and post acquisition disputes, and consumer class actions and other consumer-related litigation. Whether they are plaintiffs or defendants in such matters, our clients benefit from our experience in these types of cases. Our work in this area has not gone unnoticed – Morgan Lewis was named a "Class Action Practice Group of the Year" by Law360 for 2013 and 2014. This accolade is in addition to two consecutive years on BTI Consulting Group's 2014 and 2015 Litigation Outlook, which ranked us as one of four "powerhouse" firms for class actions and mass torts.
Product Liability Litigation
We routinely represent our clients in medical device industry litigation, including product liability, fraud and abuse, and commercial litigation. Our long-standing, well-recognized product liability practice includes more than 50 lawyers across our US offices. For decades, we have successfully represented clients in class actions, individual lawsuits, multidistrict matters, and mass and toxic tort litigation.
When enforcement concerns have arisen, we have assisted in some of the largest and most complex government investigations and settlements of the last decade. As the FDA, Department of Justice (DOJ), Health Care Financing Administration, and HHS-OIG continue to take an aggressive enforcement stance, we regularly assist clients in responding to civil and criminal enforcement and compliance actions, including FDA Form 483 and Warning Letter responses, Import Alerts, consent decree issues, FDA's integrity policy, OIG suspension and exclusion authority, and debarment penalties from government contracting agencies.
Our deep bench of seasoned trial lawyers is capable of trying the most high-risk cases against the most aggressive adversaries, and frequently serves as US national coordinating and trial counsel to medical device companies in large-scale serial litigation. This experience consists of cases involving pacemakers, cardioverter defibrillators, neurostimulators, drug pumps, insulin pumps, therapeutic blood derivatives, breast implants, femoral knee components, and many other devices.
Fast Facts
- 300+ partners recognized, Chambers, all publications (2016)
- Most Recognized for Client Service, BTI Client Service A-Team (2016)
- More than 250 international partners and counsel focused on the life sciences industry
- More than 1,000 active life sciences clients
Honors
- Law 360: Life Sciences Practice Group of the Year (2014)
- BioPharm Insight: Top five transactional firm (2015)
- Modern Healthcare: Ranked as the largest healthcare law firm (2016)
- Legal 500: Ranked as a top 10 firm for health insurers and life sciences (2016)
- Chambers USA 2016:
- National for Life Sciences – Band 3
- Washington, DC for Healthcare: Pharmaceutical/ Medical Products Regulatory – Band 3
- Law 360 MVPs for life sciences (2012 and 2014) and healthcare (2012)
- LMG Life Sciences Award – Healthcare Pricing and Reimbursement Firm of the Year (2013) and Lifecyle Firm of the Year (2015)
Clients
- 18 of the top 20 pharma companies
- 16 of the top 20 biotechnology companies
- 11 of the top 20 medical device companies
US
Antitrust
| Competition & Antitrust — Highly Recommended |
|---|
| Arnold & Porter |
| Cleary Gottlieb Steen & Hamilton |
| Gibson Dunn & Crutcher |
| Goldman Ismail Tomaselli Brennan & Baum |
| Latham & Watkins |
| Weil Gotshal & Manges |
| White & Case |
| Competition & Antitrust — Recommended |
|---|
| Covington & Burling |
| Dechert |
| McDermott Will & Emery |
| Morgan Lewis & Bockius |
| Patterson Belknap Webb & Tyler |
| Ropes & Gray |
| Sidley Austin |
Corporate
| General Corporate — Highly Recommended |
|---|
| Cooley |
| Goodwin Procter |
| Hogan Lovells |
| Latham & Watkins |
| Ropes & Gray |
| WilmerHale |
| General Corporate — Recommended |
|---|
| Arnold & Porter |
| Covington & Burling |
| Dechert |
| Fenwick & West |
| Gibson Dunn & Crutcher |
| Jones Day |
| Morgan Lewis & Bockius |
| Sidley Austin |
| Wilson Sonsini Goodrich & Rosati |
FDA: Medical Device
| FDA: Medical Devices — Highly Recommended |
|---|
| Hogan Lovells |
| Hyman Phelps & McNamara |
| King & Spalding |
| Ropes & Gray |
| FDA: Medical Devices — Recommended |
|---|
| Arnold & Porter |
| Covington & Burling |
| McDermott Will & Emery |
| Morgan Lewis & Bockius |
| Sidley Austin |
FDA: Pharmaceutical
| FDA: Pharmaceutical — Highly Recommended |
|---|
| Covington & Burling |
| Hogan Lovells |
| Hyman Phelps & McNamara |
| Sidley Austin |
| FDA: Pharmaceutical — Recommended |
|---|
| Arnold & Porter |
| King & Spalding |
| Morgan Lewis & Bockius |
| Ropes & Gray |
General Patent Litigation
| General Patent Litigation — Recommended |
|---|
| Arnold & Porter |
| Cooley |
| Covington & Burling |
| Durie Tangri |
| Gibson Dunn & Crutcher |
| Knobbe Martens |
| Mayer Brown |
| McAndrews Held & Malloy |
| Morgan Lewis & Bockius |
| Sterne Kessler Goldstein & Fox |
| Venable |
| Weil Gotshal & Manges |
Healthcare Pricing & Reimbursement
| Healthcare: Pricing & Reimbursement — Highly Recommended |
|---|
| Arnold & Porter |
| Hogan Lovells |
| McDermott Will & Emery |
| Sidley Austin |
| Healthcare: Pricing & Reimbursement — Recommended |
|---|
| Epstein Becker Green |
| King & Spalding |
| Latham & Watkins |
| Morgan Lewis & Bockius |
| Reed Smith |
Licensing & Collaboration
| Licensing & Collaboration — Highly Recommended |
|---|
| Cooley |
| Covington & Burling |
| Goodwin Procter |
| Latham & Watkins |
| Ropes & Gray |
| WilmerHale |
| Wilson Sonsini Goodrich & Rosati |
| Licensing & Collaboration — Recommended |
|---|
| Baker McKenzie |
| Dechert |
| Fenwick & West |
| Hogan Lovells |
| Jones Day |
| King & Spalding |
| Morgan Lewis & Bockius |
| Sidley Austin |
Patent Prosecution
Patent Strategy & Management
| Patent Strategy & Management — Recommended |
|---|
| Arnold & Porter |
| Dechert |
| Fenwick & West |
| Foley & Lardner |
| Greenberg Traurig |
| Hamilton Brook Smith & Reynolds |
| Leydig Voit & Mayer |
| McDonnell Boehnen Hulbert & Berghoff |
| Morgan Lewis & Bockius |
| Venable |
| WilmerHale |
White-Collar/Govt. Investigations
| White-Collar/Government Investigation — Highly Recommended |
|---|
| Cleary Gottlieb Steen & Hamilton |
| Cooley |
| Covington & Burling |
| Gibson Dunn & Crutcher |
| Hogan Lovells |
| King & Spalding |
| Morgan Lewis & Bockius |
| Ropes & Gray |
| Sidley Austin |
| WilmerHale |
| White-Collar/Government Investigation — Recommended |
|---|
| Arnold & Porter |
| Goodwin Procter |
| Latham & Watkins |
| McDermott Will & Emery |
| Schulte Roth & Zabel |
| White & Case |
| Lawyer | Section | Practice Area | Location |
|---|---|---|---|
| Abernathy, Michael | Intellectual Property | General Patent Litigation, Hatch-Waxman Patent Litigation | Chicago |
| Altieri, Stephen | Intellectual Property | Patent Prosecution, Patent Strategy & Management | Boston |
| Beardell, Louis | Intellectual Property | Patent Strategy & Management | Philadelphia |
| Betti, Christopher | Intellectual Property | Patent Strategy & Management, General Patent Litigation | Chicago |
| Buenafe, Michele | Regulatory | FDA: Medical Device | Washington, D.C. |
| Cooney, Gordon | Non-IP Litigation & Enforcement | Product Liability, Antitrust | Philadelphia |
| Dodds, John | Non-IP Litigation & Enforcement | White-Collar/Govt. Investigations | Philadelphia |
| Frank, Steven J | Intellectual Property | Patent Prosecution | Boston |
| Glazer, David G | Financial & Corporate | Corporate, Licensing & Collaboration, Mergers & Acquisitions | Princeton |
| Johnson, Ethel | Non-IP Litigation & Enforcement | Product Liability | Houston |
| Kraeutler, Eric | Intellectual Property | Patent Strategy & Management, General Patent Litigation | Philadelphia |
| Leeds, Alan | Financial & Corporate | Licensing & Collaboration, Mergers & Acquisitions | Princeton |
| Mahinka, Stephen Paul | Regulatory , Non-IP Litigation & Enforcement | FDA: Pharmaceutical, FDA: Medical Device, Antitrust | Washington, D.C. |
| Mann, Jeffry S | Intellectual Property | Patent Prosecution, Patent Strategy & Management | San Francisco |
| McDermott, Kathleen | Non-IP Litigation & Enforcement | White-Collar/Govt. Investigations | Washington, D.C. |
| Memmott, Scott | Non-IP Litigation & Enforcement | White-Collar/Govt. Investigations | Washington, D.C. |
| Navarro, Steven A | Financial & Corporate | Corporate, Mergers & Acquisitions | New York City |
| Pensak, Benjamin | Financial & Corporate | Licensing & Collaboration, Mergers & Acquisitions | San Francisco |
| Ragosa, Emilio | Financial & Corporate | Venture Capital, Mergers & Acquisitions | Princeton |
| Reed, Steven | Non-IP Litigation & Enforcement | Antitrust | Philadelphia |
| Sanzo, Kathleen | Regulatory | FDA: Pharmaceutical, FDA: Medical Device | Washington, D.C. |
| Sitarchuk, Eric | Non-IP Litigation & Enforcement | White-Collar/Govt. Investigations | Philadelphia |
| Sonnenfeld, Marc | Non-IP Litigation & Enforcement | White-Collar/Govt. Investigations | Philadelphia |
| Stein, Mark B | Financial & Corporate | Corporate, Venture Capital, Licensing & Collaboration, Mergers & Acquisitions | Boston |
| Tom, Willard | Non-IP Litigation & Enforcement | Antitrust | Washington, D.C. |
| Vega, Julio | Financial & Corporate | Corporate, Venture Capital | Boston |
| Young, Howard | Non-IP Litigation & Enforcement | White-Collar/Govt. Investigations | Washington, D.C. |
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Financial & Corporate
Morgan Lewis & Bockius
Headquartered in Philadelphia with an additional thirty offices across the globe, Morgan Lewis & Bockius is a full-service firm with an established life sciences practice serving a variety of clients, from startups to market-leading companies. In addition to providing counseling on corporate financing, transactions, and venture capital matters, the firm has developed a particular focus on the licensing and collaborations space.
Benjamin Pensak represents a number of companies in the life sciences industry in all aspects of financial and corporate matters. He recently advised Eli Lilly in its collaboration with Evox Therapeutics to develop treatments for neurological disorders. In addition, Pensak led a Morgan Lewis team that represented Innovent Biologics in its $2.1 billion collaboration with Roche.
Working alongside Pensak is Alan Leeds, who co-chairs the firm's global life science practice and is the LMG Life Sciences Licensing & Collaborations Attorney of the Year. One peer notes Leeds is “very good, thoughtful, reasonable, and helps clients in a practical way.” In the past year, Leeds was part of a team representing Regeneron in a collaboration with Vyriad, which develops targeted cancer therapies. Leeds also led a team that advised Celgene in its collaboration agreement with Editas Medicine.
David Glazer is “fantastic” notes one peer and worked with Leeds on the Regeneron-Vyriad partnership. Glazer’s practice spans M&A, corporate transactions and licensing agreements. Among his recent matters, Glazer served as lead counsel to CRISPR Therapeutics in its licensing agreement with KSQ Therapeutics.
Mark Stein and Steven Navarro are recognized for representing both investors and companies in a variety of matters, including corporate financing, public offerings, transactions, and venture funding.
Intellectual Property
Morgan Lewis & Bockius
International firm Morgan Lewis & Bockius provides a full-service IP practice in life sciences, earning national rankings in general patent litigation, patent prosecution and strategy. The firm has been one to watch for its significant streak of lateral hires over the past two years, bolstering the firm's capabilities in the contentious and non-contentious patent arenas.
Michael Abernathy currently serves as co-head of the firm's IP litigation and life sciences groups. He was part of a Morgan Lewis team representing Praxair in one of 2020’s Impact Cases of the Year that found method of treatment claims invalid under Section 101 of the Patent Act. Abernathy was shortlisted for the Midwest Patent Litigator of the Year award for his role in the matter. Global IP head Eric Kraeutler has more than four decades of experience in law, and focuses his practice on patent litigation.
In prosecution and strategy, Jeffry Mann is one of the firm's leading practitioners for life sciences patent advice. He specializes in patent preparation and prosecution, IP portfolio monetization, due diligence and licensing. Boston-based Steven Frank focuses his practice on IP transactions, patent prosecution and strategic counseling. Stephen Altieri is versed in patent portfolio development for emerging clients in a number of areas, including biologics, diagnostics and immunotherapies.
Louis Beardell, Christopher Betti and Gargi Talukder all bring significant expertise to the firm’s patent prosecution and strategy practice. Talukder, a partner in the San Francisco office, recently assisted client Xencor with patent applications related to its antibody and protein platforms.
Life Cycle
Morgan Lewis & Bockius
Morgan Lewis & Bockius has an all-encompassing practice in the life sciences space. The firm receives national ranking for its involvement in white-collar matters, licensing and collaboration, patent litigation, regulatory counseling and general corporate work. Recently, the firm made news for its significant streak of lateral hires, particularly in the IP group.
For non-IP litigation, group chair Eric Sitarchuk is one of the firm's senior practitioners focused on white-collar and corporate investigations. He and partner Steven Reed are currently active for Teva and affiliated companies in its defense of numerous claims concerning opioid sales and distribution John Dodds has experience representing pharmaceutical and medical device companies in government investigations, bolstered by his credentials as a former prosecutor in the public sector. Among his current representations, Dodds is active for a drug maker client in an ongoing investigation. Antitrust stars Gordon Cooney and Steven Reed are representing Teva and Glenmark in a multidistrict litigation (MDL) that arose from a Department of Justice investigation involving alleged price fixing practices among generic drug makers.
In the financial and corporate group, global life sciences co-chair Alan Leeds was awarded Licensing & Collaborations Attorney of the Year. One peer notes Leeds is “very good, thoughtful, reasonable, and helps clients in a practical way.” In the past year, Leeds was part of a team representing Regeneron in a collaboration with Vyriad, which develops targeted cancer therapies. Leeds also led a team that advised Celgene in its collaboration agreement with Editas Medicine. Benjamin Pensak is a go-to for life sciences-related licensing agreements and collaborations. He recently advised Eli Lilly in its collaboration with Evox Therapeutics to develop treatments for neurological disorders. David Glazer is “fantastic” notes one peer and worked with Leeds on the Regeneron-Vyriad partnership.
The firm offers a full suite of regulatory services to clients in the industry, with the ability to advise clients at all stages of product development. Kathleen Sanzo has extensive experience assisting a number of high-profile pharmaceutical and biotechnology companies with regulatory and compliance issues. In 2020, she was shortlisted for the FDA Pharmaceutical Attorney of the Year award for her work in the area. Michele Buenafe advises both pharmaceutical and medical device clients in a host of matters, including development, manufacturing, marketing, labeling and advertising issues. Buenafe is the leader of the firm's digital health initiative and co-leader of the firm's cross-practice healthcare initiative.
In IP, the firm drew awards attention for its involvement in of the Patent Impact Cases of the Year: iNo Therapeutics v Praxair Distribution. Life sciences IP group co-head Michael Abernathy was a lead on the matter, which resulted in a Federal Circuit decision involving method of treatment claims that were found invalid under Section 101. In prosecution and strategy, Jeffry Mann is one of the firm's leading practitioners for life sciences patent advice. He specializes in patent preparation and prosecution, IP portfolio monetization, due diligence and licensing. Boston-based Steven Frank focuses his practice on IP transactions, patent prosecution and strategic counseling. LMG Life Sciences newcomers Louis Beardell, Christopher Betti and Gargi Talukder also contribute to the firm’s strong patent offering.
Non-IP Litigation & Enforcement
Morgan Lewis & Bockius
Morgan Lewis & Bockius's national rankings in government investigations and antitrust are supported by an experienced team of litigators with a deep focus on life sciences clients. The firm had a new addition to the LMG Life Sciences stars list with Ethel Johnson, who made headlines with a recent product liability verdict that reduced an $8 billion judgment against client Johnson & Johnson to $6.8 million. Johnson was shortlisted in the Non-IP Trial Lawyer of the Year category for her work in the area.
Eric Sitarchuk is a senior partner in the Philadelphia office and current chair of the firm's white-collar and corporate investigations practice. He is experienced in a diverse set of matters, including cases that involve the False Claims Act, Foreign Corrupt Practices Act and qui tam claims. He and partner Steven Reed are currently active for Teva and affiliated companies in its defense of numerous claims concerning opioid sales and distribution. In his antitrust practice, Reed was also active for Vyera and Phoenixus in a lawsuit filed by the FTC claiming two of the company’s former officers violoated antitrust laws with respect to generic competition. John Dodds has experience representing pharmaceutical and medical device companies in government investigations, bolstered by his credentials as a former prosecutor in the public sector. Among his current representations, Dodds is active for a drug maker client in an ongoing investigation.
Gordon Cooney and Steven Reed are representing Teva and Glenmark in a multidistrict litigation (MDL) that arose from a Department of Justice investigation involving alleged price fixing practices among generic drug makers, and is one of the largest MDLs to date. Howard Young is co-head of the firm's healthcare industry initiative and one of the group's experts on regulatory enforcement and investigations. He and partner Scott Memmott are currently representing device maker Joerns Healthcare in a civil False Claims Act litigation.
Regulatory
Morgan Lewis & Bockius
Morgan Lewis & Bockius is an international law firm with a broad-based life sciences regulatory practice. The firm offers a full suite of regulatory services to clients in the industry, with the ability to advise clients at all stages of product development.
Kathleen Sanzo has extensive experience assisting a number of high-profile pharmaceutical and biotechnology companies with regulatory and compliance issues. Life sciences industry group founder Stephen Paul Mahinka brings over 40 years of experience counseling clients in regulatory, compliance and antitrust issues. In addition to his practice, Mahinka often authors articles and books on FDA-related issues.
Michele Buenafe advises both pharmaceutical and medical device clients in a host of matters, including development, manufacturing, marketing, labeling and advertising issues. Buenafe is the leader of the firm's digital health initiative and co-leader of the firm's cross-practice healthcare initiative.