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Life Sciences



We help clients keep up and thrive in a constantly shifting landscape. Our attorneys are at the forefront of industry trends, advising clients on everything from adopting new business models and navigating the regulatory landscape, to devising innovative IP protection and monetization strategies.

Our approach

The global life sciences industry is advancing rapidly. Increased generic competition, the changing patent landscape, evolving regulations, and pricing pressures present new challenges and opportunities for companies across the sector.

Our cross-disciplinary team can steer you through every phase of your life cycle, helping you carefully consider all of your options, and execute effective growth strategies—whether through licensing, M&A deals, or other types of transactions.

And while we have a lot of experience with transactions and litigation for large public companies, we have a passion for helping mid-market and startup companies grow.

The rapidly changing life sciences ecosystem presents a lot of exciting opportunities. We’re focused on helping clients leverage those opportunities and make strategic decisions that maximize their business potential.

Who we work with

  • Biotech companies
  • Medical device companies
  • Pharmaceutical companies
  • Academic medical centers
  • Leading universities

Representative Corporate, Regulatory, and Transactional Matters:

  • Representing a Canadian company in coordinating the research, development and licensing of medical isotope technology with a U.S. Government laboratory and state university.
  • Representing a startup company developing a care model for diabetes in the licensing of intellectual property from a university and the formation of a joint venture with a bioinformatics company to develop and commercialize the technology.
  • Represented the world's largest biological resource center and the most comprehensive source of reference cultures and reagents used by researchers, in negotiating and drafting numerous distribution and development agreements with companies throughout the world.
  • Counseling a large biologics company, providing an opinion on the eligibility of its new drug product for marketing exclusivity and patent term extension.
  • Representing a medical device company in responding to an FDA import detention and refusal involving products made by its contract manufacturer in China, and responding to a Form FDA-483, Inspectional Observations, regarding compliance with Current Good Manufacturing Practice (“CGMP”) requirements.
  • Assisting a large biologics manufacturer on the preparation of a challenge to an FDA decision awarding orphan drug exclusivity to a competitor.
  • Represented a biologics company in preparing and obtaining a successful response to a citizen’s petition from the FDA. The problem involved limits on orphan drug designation.
  • Advised a biopharmaceutical company focused on new drugs candidates targeting GPCR, in a multi-million dollar financing.
  • Advised a company specializing in proton therapy treatment, in its $10 million financing from existing shareholders.
  • Advised a French biopharmaceutical company in its fund raising from seed to Series A, B and C rounds, and on a broad range of matters such as build-up operations, mergers, spin-off, asset deals, employment and executive management remuneration and incentive packages, joint venture agreements, and partnerships.
  • Represented a biotechnology company focused on novel pharmaceutical therapies that seek to exploit RNA editing and DNA editing enzymes, in negotiating a license into the company relating to its core technology, and represent the company with regard to the creation and maintenance of its stock option plan and other general legal matters.
  • Represented a growth-stage medical device company focused on the development of biodegradable silk-based scaffolds for use in tissue regeneration in numerous therapeutic areas in its sale to a multi-specialty health care company that develops pharmaceuticals, biologics, medical devices and over-the-counter consumer products.
  • Represented a Swedish medicinal and analytical chemistry company in the acquisition of two product lines and associated business from a leading provider of cutting-edge technologies in the life science industry.
  • Represent a well-known biopharmaceutical company in a variety of real estate transactions including leasing, permitting, construction contracting, and financing, related to multiple client facilities and offices.
  • Handle leasing work on behalf of a large manufacturer of analytical and medical instruments.

Representative Litigation Matters:

  • Represented the plaintiff, a well-known medical device company, in a patent infringement case in the U.S. District Court for the District of Massachusetts. Our client was awarded a multi- million dollar verdict for lost profits and a 16% royalty (on sales not included in lost profits).
  • Represented one of the largest healthcare companies in the world in connection with the company’s global settlement of three separate government investigations for $3 billion—the largest health care fraud settlement in U.S. history. Of the three investigations, Nixon Peabody attorneys were the primary counsel for the company in the defense of an investigation by the Department of Justice relating to the company’s Medicaid “best price” reporting. Our attorneys were also significantly involved in the defense of the investigation by the U.S. Attorney’s Office for the District of Massachusetts relating to the government’s allegations of off-label promotion and anti-kickback violations. The case settled favorably for our client.
  • Represented the plaintiff, a leading medical device company, in a patent infringement case in the U.S. District Court for the Northern District of Illinois. The case was settled on terms favorable to our client.
  • Served as Counsel for over 66 pharmaceutical companies in role as liaison counsel for Average Wholesale Pricing matters venued in commercial court in New York. The case was favorably resolved for our clients.
  • Currently defending Shire Human Genetic Therapies in a Lanham Act false advertising case brought by Genzyme.
  • Represented a pharmacy chain and a national grocery store and in a putative class action in the Northern District of California involving alleged inflation of average wholesale pricing (AWP) for prescription drugs by national pharmacy chains Supervalu Inc., New Albertson’s Inc., Walgreens Co., Longs Drugs Stores Corp., The Kroger Co., Safeway Inc., Wal-Mart Stores Inc., CVS Caremark Corp., and Rite Aid Corp. In January 2010, the case was dismissed with prejudice by the trial court for failure to state a claim. On February 9, 2012, the Ninth Circuit Court of Appeals unanimously affirmed the trial court’s dismissal.

Awards & Rankings

  • The Legal 500 United States
    • Recommended as a leader in the Healthcare: Life Sciences industry
  • Managing IP magazine’s World IP Survey
    • Recognized as a national leader in the patent category for bio life sciences
  • IAM Magazine
    • Ranked in the top ten for securing high quality patents in the healthcare (pharma/bio) category

UC Expands Patent Lawsuit Against Retailers and Manufacturers

Supply Chain Brain | October 05, 2020

The following article covers the U.S. International Trade Commission’s second investigation into leading retailers and suppliers of filament LED lighting products, based on a complaint filed by Nixon Peabody on behalf of the Regents of the University of California (UC). Supply Chain Brain quotes Los Angeles Intellectual Property partner Seth Levy extensively on the expanded patent enforcement campaign. The NP team representing UC is led by Seth and Los Angeles Intellectual Property partner Shawn Hansen.

Standing Apart

Intellectual Property Magazine | October 01, 2020

Intellectual Property partner and Life Sciences Practice co-chair Seth Levy and Intellectual Property counsel Peter Wied, both of Los Angeles, contributed this article, based on their alert, which examines the Gensetix Inc v Baylor College of Medicine case and a recent ruling to allow an infringement case to proceed without the state university patent owner’s involvement.

Nixon says ITC probes retailers in patent infringement case

Bloomberg Law | September 30, 2020

This article covers the U.S. International Trade Commission’s institution of a second investigation into leading retailers and suppliers of filament LED lighting products, based on a complaint NP filed on behalf of the Regents of the University of California (UC). Los Angeles Intellectual Property partners Seth Levy and Shawn Hansen are leading the NP team in UC’s LED patent enforcement campaign.

USITC targets Ikea and GE in bulb investigation

World IP Review | September 30, 2020

The following article covers the U.S. International Trade Commission’s second investigation into leading retailers and suppliers of filament LED lighting products, based on a complaint filed by Nixon Peabody on behalf of the Regents of the University of California (UC). Supply Chain Brain quotes Los Angeles Intellectual Property partner Seth Levy extensively on the expanded patent enforcement campaign. The NP team representing UC is led by Seth and Los Angeles Intellectual Property partner Shawn Hansen.

Takeda Subsidiary Seeks $130M for Drug Firm's Spinoff Fraud

Law360 | September 22, 2020

This article covers a trial to consider the amount of damages to be awarded to Millennium Pharmaceuticals for being fraudulently induced into investing more than $100 million into a spinoff of Harpoon Therapeutics. The story mentions Chicago Complex Commercial Disputes partners John Ruskusky and Lisa Sullivan for representing Millennium.

Hospitals can transfer patients’ medical debt to RIP Medical Debt, regulators say

Modern Healthcare | July 28, 2020

In this article on the Department of Health and Human Services Office of Inspector General’s advisory opinion that will expand national nonprofit and client RIP Medical Debt’s services, Long Island Health Care partner Michele Masucci is quoted on the legal nuances of the advisory opinion and anti-kickback concerns.

Aetna Blasts Conformis For Using Patient To Force Coverage

Law360 | July 24, 2020

Complex Commercial Disputes co-practice group leader and Boston partner Steve LaRose and Manchester associate Kierstan Schultz were mentioned in this article for representing Aetna in a suit regarding coverage for medical device manufacturer Conformis’ customized total knee implants.

Microbiome therapeutics and patent protection

Nature Biotechnology | July 08, 2020

Boston Intellectual Property partner Mark FitzGerald co-authored this journal article on microbiome therapeutics, and how two U.S. Supreme Court decisions have redefined the scope of which natural phenomena—including microbiome therapeutics—are patent eligible.

Bayer Ducks Suit Over Birth Control Device Defect Claims

Law360 | June 25, 2020

This article, covering a federal judge’s dismissal of claims against NP client Bayer Corp. related to the company’s Essure birth control device, mentions Buffalo Complex Commercial Disputes partner Vivian Quinn and counsel Tracey Scarpello for representing Bayer.

Gut Check: Microbiome Patent Update

Intellectual Property & Technology Law Journal | May 01, 2020

Intellectual Property partner Mark FitzGerald in Boston and associate Matt Kitces in Washington, D.C. contributed this article examining the post-grant review challenge of a U.S. patent related microbiomes and the treatment of cancer. The result could provide an indication of how microbiome-related patents will fare when challenged for validity. Click here for the full article.

Validity Attack on US Patent for Bifidobacetrium Combo-Therapy: What can we learn?

Microbiome Times | April 29, 2020

Boston Intellectual Property partners Mark FitzGerald and David Resnick co-authored this article analyzing a recent decision by the U.S. Patent Trial and Appeal Board to invalidate a University of Chicago U.S. microbiome patent. The authors note some positive aspects of that decision within the microbiome community, as it provides increased definition around what they can protect with patents.

Patent opportunities and dangers in the microbiome revolution

IAM | April 02, 2020

Boston Intellectual Property partner Mark FitzGerald discusses how the microbiome—the collection of microbes that occupy the human body—has become an increasingly fruitful source of insights for life sciences researchers looking to develop new therapeutics.

Doctors say no secret info used in FCA suit against J&J

Law360 | March 06, 2020

This article mentions Boston Government Investigations and White-Collar Defense partners Hannah Bornstein and Mark Seltzer for their representation of the defendants in a False Claims Act suit centering on faulty hip replacement devices. The defendants have argued the suit should be dismissed on the grounds that confidential information was used in the complaint.

A Year Out and a Supreme Court Case Still Leaves Patent Questions Unanswered

Intellectual Property & Technology Law Journal | December 05, 2019

Intellectual Property associates Sydney Pritchett, Ben Rosborough and Ravi Braich authored this patent alert about remaining questions and uncertainty following the U.S. Supreme Court ‘s ruling in Helsinn Healthcare S.A. v. Teva Pharmaceuticals U.S.

21st Century Cures Act driving FDA changes

Modern Healthcare | September 07, 2019

This article discussing the 21st Century Cures Act’s ongoing impact on the Food and Drug Administration’s approval process quotes Boston Government Investigations and White Collar Defense partner Hannah Bornstein and Chicago Health Care partner Valerie Montague.

“Ascertainability” in pharmaceutical and medical device cases

Defense Research Institute | September 04, 2019

Complex Commercial Disputes partner Vivian Quinn and associate Tracey Scarpello, both of the Buffalo office, co-wrote this article in the Defense Research Institute’s publication, analyzing the impact of the ascertainability requirement on pharmaceutical and medical device class actions.

Microbiome biotechs grapple with how to protect their IP

Boston Business Journal | August 08, 2019

This story quotes Boston Intellectual Property partner David Resnick on best practices and challenges facing microbiome companies, which create novel disease-fighting treatments from naturally occurring substances, as they try to patent their innovations.

GSK wins access to records on researcher’s link to Zofran plaintiffs’ lawyers

Reuters Legal | July 25, 2019

This story mentions Boston Government Investigations and White Collar Defense partner Mark Seltzer for his representation of GlaxoSmithKline in an ongoing matter regarding the drugmaker’s antinausea medication, Zofran.

GSK gets 2nd chance to argue preemption in Zofran MDL

Law360 | July 10, 2019

The following articles mention Boston Government Investigations and White Collar Defense partners Mark Seltzer and Brian French for their representation of GlaxoSmithKline in an ongoing matter related to the pharmaceutical company’s anti-nausea drug Zofran. One of the issues is whether federal law pre-empts state law in the case.

Judge to seek FDA’s views on Zofran birth defect cases against GSK

Reuters Legal | July 10, 2019

The following articles mention Boston Government Investigations and White Collar Defense partners Mark Seltzer and Brian French for their representation of GlaxoSmithKline in an ongoing matter related to the pharmaceutical company’s anti-nausea drug Zofran. One of the issues is whether federal law pre-empts state law in the case.

GSK renews Zofran birth defect dismissal bid after Supreme Court ruling

Reuters Legal | June 04, 2019

This article mentions Boston Government Investigations and White Collar Defense partner Mark Seltzer for his representation of GlaxoSmithKline in an ongoing matter related to its anti-nausea medication Zofran.

Don't Miss It: Simpson, Latham guide week's hot deals

Law360 | May 10, 2019

Boston Corporate partner David Martland and Chicago Corporate partner Brian Krob are mentioned in this roundup of notable deals for advising Merck in its acquisition of Intermolecular.

GSK fights to subpoena publisher of Zofran study by plaintiffs' consultant

Reuters Legal | April 02, 2019

Boston Government Investigations & White Collar Defense partner Mark Seltzer is mentioned in this story for his representation of pharmaceutical company GlaxoSmithKline in an ongoing matter related to the company’s anti-nausea drug Zofran.

Chinese biotech company pulls back suit over biased H-1B denials

Law360 | March 07, 2019

Manchester Complex Commercial Disputes associate Nate Warecki is quoted in this article discussing the positive outcome for his client, Chinese biotech firm Vcan, in a dispute with the U.S. Department of Homeland Security.

GSK accuses Zofran plaintiffs' law firms of funding academic study

Reuters | March 05, 2019

Boston Government Investigations and White Collar Defense partner Mark Seltzer is mentioned in this article for representing GlaxoSmithKline in an ongoing dispute related to the company’s anti-nausea drug Zofran.

$4.8B Akorn ruling more outlier than shift at Chancery

Law360 | October 14, 2018

In the following coverage, Rochester Corporate partner Lori Green, Complex Commercial Disputes partners Rick McGuirk and Carolyn Nussbaum, and New York City Complex Commercial Disputes partner Chris Mason analyze a key ruling by the Delaware Chancery Court that affirmed the existence of a material adverse event allowing German pharmaceutical company Fresenius to back down from a merger with Akorn, Inc.

Delaware Chancery Court issues rare decision finding Material Adverse Effect justifying termination of merger

Law360 | October 14, 2018

In the following coverage, Rochester Corporate partner Lori Green, Complex Commercial Disputes partners Rick McGuirk and Carolyn Nussbaum, and New York City Complex Commercial Disputes partner Chris Mason analyze a key ruling by the Delaware Chancery Court that affirmed the existence of a material adverse event allowing German pharmaceutical company Fresenius to back down from a merger with Akorn, Inc.

AngioDynamics says rival must stay in $145M damages row

Law360 | September 18, 2018

Albany Complex Commercial Disputes partner Bill Reynolds is mentioned in this story for his representation of AngioDynamics Inc. in an ongoing dispute with Biolitec AG.

FDA never saw birth-defect tests on GSK drug, families say

Law360 | September 12, 2018

Boston Government Investigations & White Collar Defense partners Mark Seltzer and Brian French are mentioned in this article for their ongoing representation of GlaxoSmithKline in a suit regarding their drug Zofran.

Consumer protection – preemption – eyedrops

Massachusetts Lawyers Weekly | August 27, 2018

Litigation Department head Scott O’Connell is mentioned in this case summary for his role as co-counsel for a group of pharmaceutical companies. The companies successfully defended a suit by a class of customers seeking to force changes to the design of the companies’ eyedrops bottles.

1st Circuit says challenge to Rx eyedropper size preempted

Law360 | August 26, 2018

Nixon Peabody is mentioned in this article as co-counsel for a group of pharmaceutical companies who won dismissal of a First Circuit class-action suit regarding the design of their eyedrop bottles.

Senate approves legislation to crack down on patent trolls

The Boston Globe | July 27, 2018

Boston Intellectual Property co-practice group leader Jason Kravitz is quoted in this article analyzing legislation approved by the Massachusetts Senate to reduce patent infringement claims made by “patent trolls.”  Jason says such legislation is important in a state with a strong entrepreneurial economy.

GSK Zofran users bicker over scope of patient discovery

Law360 | April 24, 2018

Boston government investigations and white collar defense partners Mark Seltzer and Brian French are mentioned in this story for their representation of pharmaceutical company GlaxoSmithKline in a lawsuit brought by users of its anti-nausea medication Zofran.

U.S. Supreme Court declines to review whistleblower case against J&J's DePuy

Reuters Legal | April 15, 2018

In the following coverage, Boston government investigations and white-collar defense partners Mark Seltzer and Hannah Bornstein are mentioned for their ongoing representation of Johnson & Johnson and its subsidiary DePuy Orthopaedics Inc. in a False Claims Act case. The Supreme Court recently declined to review the First Circuit’s ruling in the case.

J&J won't get high court look at FCA 'particularity' rule

Law360 | April 15, 2018

In the following coverage, Boston government investigations and white-collar defense partners Mark Seltzer and Hannah Bornstein are mentioned for their ongoing representation of Johnson & Johnson and its subsidiary DePuy Orthopaedics Inc. in a False Claims Act case. The Supreme Court recently declined to review the First Circuit’s ruling in the case.

J&J unit wants whistleblower docs in hip implant FCA suit

Law360 | April 11, 2018

Boston government investigations and white-collar defense partners Mark Seltzer and Hannah Bornstein are mentioned in this article for representing Johnson & Johnson Services Inc. and its subsidiary DePuy Orthopaedics in a suit alleging violations of the False Claims Act.

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Contacts

Seth D. Levy

Partner
Co-chair, Life Sciences Practice

slevy@nixonpeabody.com

Phone: 213-629-6161

Jill H. Gordon

Partner
Co-chair, Life Sciences Practice

jgordon@nixonpeabody.com

Phone: 213-629-6175

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