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LIFE SCIENCES
Nixon Peabody offers a highly integrated, cross-practice approach to serving the complete legal needs of life sciences companies. Consistent with the firm’s emphasis on collaboration and team work, more than 50 attorneys across the firm work seamlessly on the full range of transactional, regulatory, and litigation challenges faced by pharmaceutical, biotechnology, and medical device companies.
Our approach to serving the life sciences industry is to consider legal services in the context of the company life cycle. Whether developing devices or drug formulations, life sciences companies face unique challenges:
- Start-up: Concerns about time-to-market limiting pool of potential investors
- Financing: Keep promising, but unproven, technologies funded
- Research & Development: Increasing regulatory scrutiny by the FDA
- IP Protection: Patentability questions associated with emerging technologies
- Sales & Marketing: Investigations focused on sales force management, labeling, and marketing practices
Recognizing that the legal issues faced at each stage of the company life cycle can be complex, Nixon Peabody’s corporate, regulatory, and litigation attorneys work together to bring diversity of perspectives and experience to solutions:
- University research centers are connected to capital that bridges the funding gap between seed money and private equity through a team experienced in intellectual property, tax exempt financing, and charitable trusts.
- Emerging companies secure financial backing in tandem with needed patent protection from our team of corporate and intellectual property attorneys.
- Venture capital firms work with corporate, FDA, and intellectual property lawyers who perform necessary regulatory and intellectual property due diligence as part of the investment and financing transaction.
- Established companies work with an interdisciplinary sales and marketing team that addresses pricing, advertising, privacy, and regulatory enforcement concerns to assure compliance with marketing products.
At Nixon Peabody, we understand that to be effective, we need to consider your company’s place in its life cycle, the issues you face in advancing to the next stage, and which of our attorneys and professional specialists bring the most relevant resources to your team. This highly industry-focused, client-centric approach is unusual among law firms, and differentiates our life sciences services.
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 start-up 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.
Thought Leadership/AlertsCMS to hold town hall teleconference for physicians and teaching hospitals regarding the Physician Payment Sunshine Act
Health Alert | May 10, 2013 Hospitals and other providers of medical services and devices may find themselves subject to federal contractor requirements
Health Law Alert | April 25, 2013 . . . View all . . .
Recall or product enhancement? Medical device manufacturers invited to comment on proposed FDA guidance
Pharmaceutucal, Medical Device & Life Sciences Alert
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February 26, 2013
Webinar Recording: The New World of Raising Capital in Life Sciences
Originally recorded December 13, 2012
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December 14, 2012
Webinar Recording: The First Amendment and Off-Label Promotion: Understanding the Implications of U.S. v. Caronia
Originally recorded December 5, 2012
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December 6, 2012
Personalized Medicine Patent Watch
Intellectual Property Alert
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October 31, 2012
Nixon Peabody's 2012 MAC Survey
October 22, 2012
Webinar Recording: Leveraging Philanthropic Capital to Fund Life Science Companies and University Spin-outs
Originally recorded September 24, 2012
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September 26, 2012
Personalized Medicine Patent Watch Update
Intellectual Property Alert
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July 9, 2012
Webinar Recording: Avoiding the Glare of Government Scrutiny: Understanding the implications of the Physician Payment Sunshine Act
Originally recorded June 28, 2012
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July 2, 2012
Supreme Court holds that pharmaceutical reps meet the outside sales exemption to the FLSA
Employment Law Alert
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June 18, 2012
HHS releases proposed rule on Stage 2 requirements for meaningful use of EHRs
Health Law Alert
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March 9, 2012
FDA issues biosimilar draft guidance
FDA Alert
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February 28, 2012
Claims to investment tool too "abstract" to be patent eligible under 35 USC § 101
Intellectual Property Alert
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February 28, 2012
FDA's draft guidance on social media and off-label communications
FDA Alert
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January 26, 2012
At the Brink of Transformation: What Stephen Berger's report means for health care system board members
Health Law Alert
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January 26, 2012
Crafting personalized medicine IP protection—walking the thin line between patent eligibility and enforcement
Intellectual Property Alert
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January 10, 2012
FAQs on the final ACO regulations
Health Law Alert
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December 28, 2011
First true induced pluripotent stem cell (iPSC) patent issued by the USPTO
Intellectual Property Alert
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November 2, 2011
California Court of Appeal affirms award of pre- and post- statutory settlement offer expert witness fees and the reasonableness of a relatively low pretrial settlement offer
Product Liability Alert
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November 1, 2011
CMS Releases Final ACO Rule!
Health Law Alert
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October 24, 2011
California Supreme Court clarifies limits on recovery of medical expenses in tort actions
Products Liability Alert
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August 23, 2011
Ninth Circuit clarifies jurisdiction rules in intellectual property cases brought against out-of-state companies operating on the Internet
Intellectual Property Alert
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August 16, 2011
Seeing red: NY court refuses to enforce single color trademark for shoe design
Intellectual Property Alert
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August 15, 2011
First Induced Pluripotent Stem Cell (iPSC) Patent Approved by the EPO
Intellectual Property Alert
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August 2, 2011
Federal Circuit issues opinion in ACLU v. Myriad
Intellectual Property Alert
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July 29, 2011
OCR begins HIPAA compliance auditing program – Are you prepared?
HIPAA Law Alert
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July 29, 2011
New Texas health care privacy law more stringent than HIPAA
HIPAA Law Alert
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July 21, 2011
Patent reform primer
Changes to the grace period
Intellectual Property Alert
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July 14, 2011
IRS issues Notice and request for comments on the community health needs assessment requirements for certain tax-exempt hospitals
Health Law Alert
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July 14, 2011
OCR settles HIPAA violations with UCLA Health System for $865,500
HIPAA Law Alert
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July 13, 2011
Legislation headed to Governor’s desk granting health care providers additional rights in OMIG audits
Health Law Alert
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July 8, 2011
Personal jurisdiction: Is no news from the Supreme Court good news for foreign product manufacturers?
Products Liability Alert
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June 30, 2011
Immigration compliance: What Every Employer Needs to Know; Audits, Audits, Everywhere
Immigration Law Alert
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June 29, 2011
New .XXX domain name tentatively scheduled to launch September 7, 2011 — clients are advised they may be able to block certain domains to prevent future use
Intellectual Property Alert
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June 21, 2011
U.S. PTO Restriction Practice: Personalized medicine claims with SNPs
Intellectual Property Alert
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June 13, 2011
FATCA as applied to investment funds: suggested fund agreement provisions
Private Equity Alert
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June 10, 2011
Employers (particularly universities): check your invention assignment agreements!
Intellectual Property Alert
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June 7, 2011
Webinar Recording: 2011: The Stem Cell Odyssey Continues
June 3, 2011
Therasense decision highlights specific intent requirement for inequitable conduct determinations
Intellectual Property Alert
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June 1, 2011
HHS issues notice of proposed rulemaking for new standards for accounting of disclosures of protected health information including the right to an access report
HIPAA Law Alert
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June 1, 2011
U.S. Supreme Court upholds Arizona E-Verify law
Immigration Law Alert
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May 31, 2011
Follow-on Biologics legislation has immediate impact on patent holders
Intellectual Property Alert
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May 25, 2011
Recent New York Court of Appeals decision addresses disclosure and use of patient medical records in Assisted Outpatient Treatment proceedings
HIPAA Law Alert
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May 24, 2011
I-9 Central: A new user-friendly, online resource for employers and employees
Immigration Law Alert
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May 18, 2011
Protecting personalized medicine innovation in China and India: Are diagnostic methods patentable?
Intellectual Property Alert
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May 17, 2011
New York general hospitals, nursing homes, home care services agencies, special needs assisted living residences, enhanced assisted living residences, attending physicians, and nurse practitioners now obligated to provide palliative care information to terminally-ill patients
Health Law Alert
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April 27, 2011
OASAS proposes significant changes to its standards for chemical dependence outpatient and opioid treatment providers
Health Law Alert
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April 22, 2011
Analysis of Proposed ACO Regulations Issued March 31, 2011
Health Law Alert
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April 20, 2011
A patent in 12 months? But it will cost you!
Intellectual Property Alert
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April 6, 2011
Federal Circuit hears oral argument on Myriad ”gene patents”
Intellectual Property Alert
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April 4, 2011
Opportunity to comment on implementation of new home care program
Health Law Alert
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April 4, 2011
Amnesty period to unwind laboratory EHR donations ends April 15, 2011
Health Law Alert
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April 1, 2011
U.S. Supreme Court declines to adopt bright-line rule that adverse drug reaction reports are not material unless they are statistically significant
Securities Litigation Alert
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March 28, 2011
The Federal Circuit holds that the heightened pleading standards of Rule 9(b) apply to false patent marking claims, finding general allegations of “sophistication” and “knowledge” to be insufficient to state a claim under Section 292
Intellectual Property Alert
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March 15, 2011
New York State Medicaid Redesign Team marches forward and issues recommendations
Health Law Alert
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March 1, 2011
Strong message from HHS/OCR with two HIPAA privacy rule enforcements within one week
HIPAA Law Alert
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February 28, 2011
U.S. Supreme Court decides that all design-defect claims are preempted by the Childhood Vaccine Injury Act
Products Liability Alert
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February 22, 2011
Constitutional challenges to the Patient Protection and Affordable Care Act
Health Law Alert
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February 3, 2011
New York Medicaid Redesign Team
Health Law Alert
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January 14, 2011
CMS soliciting comments on the EMTALA’s applicability to inpatients
Health Law Alert
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January 10, 2011
Food Safety Legislation Signed Into Law
Food Safety and Litigation Alert
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January 6, 2011
Canada enacts sweeping consumer products safety law
Products Liability Alert
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December 21, 2010
Webinar Recording: The Foreign Corrupt Practices Act (FCPA): Spotlight on the Pharmaceutical and Medical Device Industries One Year After the Warning
December 1, 2010
U.S. Supreme Court to revisit personal jurisdiction over foreign manufacturers
Products Liability Alert
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November 16, 2010
CMS posts notice soliciting comments on initial regulations for ACOs
Health Law Alert
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November 16, 2010
Restrictions on the beneficial use of software
Intellectual Property Alert
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November 16, 2010
The NCQA and AMGA issue statements on accountable care organization
Health Law Alert
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November 15, 2010
Stricter duty hour rules for medical residents effective July 1, 2011
Health Law Alert
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October 6, 2010
HHS regulations allow suspension of Medicare, Medicaid, and CHIP Payments following credible fraud allegations
Health Law Alert
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October 4, 2010
Significant changes in New York HIV testing law
Health Law Alert
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September 29, 2010
It’s the Department of State calling
Immigration Law Alert
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September 17, 2010
OSHA enters the duty hours debate as the ACGME prepares to vote on revisions to its duty hour standards later this month
Health Law Alert
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September 10, 2010
In Stauffer decision, Federal Circuit finds that qui tam relator has standing to pursue false marking claims under Patent Act
Intellectual Property Alert
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August 31, 2010
Impact of the Dodd-Frank Wall Street Reform and Consumer Protection Act on Private Equity Funds and Other Private Pools of Capital
Private Equity Alert
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August 19, 2010
The U.S. Food and Drug Administration Releases a Comprehensive Preliminary Assessment on the Regulation of Medical Devices
FDA Alert
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August 4, 2010
HHS withdraws breach notification rule from administrative review
HIPAA Law Alert
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August 4, 2010
HHS announces Final Rule on meaningful use of EHRs
Health Law Alert
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July 13, 2010
HHS/ONC proposed rulemaking expands HIPAA privacy and security rules
Health Law Alert
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July 9, 2010
CMS issues proposed regulations that outline criteria for certification of EHR technology
Health Law Alert
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July 7, 2010
According to the Patent Office, the machine-or-transformation test is alive and well
Intellectual Property Alert
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July 2, 2010
New tax credit or cash grant for qualifying therapeutic discovery projects
Pharmaceutical, Medical Device, and Life Sciences Alert
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July 1, 2010
Supreme Court affirms Federal Circuit’s judgment that risk hedging claims not patent eligible; rejects “machine-or-transformation” test as sole test of patent eligibility of process claims
Intellectual Property Alert
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June 28, 2010
American Board of Internal Medicine sanctions 139 physicians and sues 5
Health Law Alert
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June 15, 2010
In Solo Cup decision, Federal Circuit affirms district court’s ruling on burden of proof for intent to deceive and false marking with expired patents, and confirms the definition of “offenses”
Intellectual Property Alert
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June 11, 2010
Federal Trade Commission delays enforcement of Red Flags Rule until December 31, 2010
Health Law Alert
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June 1, 2010
Office of Inspector General (OIG) posts Advisory Opinion (AO) on proposed referrals incentive program offered by a continuing care retirement community
Health Law Alert
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June 1, 2010
Provisions of the Senate bill to enact reforms in federal regulation of the financial industry would affect private investment funds and their advisers
Private Equity Alert
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May 26, 2010
. . . Hide Thought Leadership. . . PressChambers Recognizes Leading Nixon Peabody Attorneys and Practices
March 14, 2013 Health Services Partner Jill Gordon Joins Nixon Peabody's Los Angeles Office
May 17, 2012 . . . View all . . .
New Partner Seth Levy and Three Associates Join Los Angeles Office
May 7, 2012
Experienced Government Contracts Attorney Joins Nixon Peabody
February 23, 2012
Corning Broadens its Life Sciences Product Offerings with Acquisition of VA-based Corporation
December 5, 2011
Nixon Peabody Adds FDA Insider to Leading Life Sciences Practice
November 28, 2011
Nixon Peabody Advises in $20M Med Device Financing
October 21, 2011
Nixon Peabody Partners Earn Top Recognition from Best Lawyers
October 18, 2011
Merck Serono Acquires Multiple Sclerosis Drug
October 13, 2011
Nixon Peabody Partner Joins Personalized Medicine Coalition Policymaking Body
September 27, 2011
IP Team Joins Nixon Peabody, Growing Firm's Intellectual Property, Patent Litigation, and Life Sciences Practices
September 12, 2011
Nixon Peabody Taps New Intellectual Property Leaders; Experienced IP Partners to Lead Litigation and Patents-Focused Practice
March 15, 2011
Nixon Peabody 2010 Annual MAC Survey Finds More “Seller-Friendly” Market; Results of 2010 Survey Examine Clauses in M&A Transactions
December 7, 2010
Nixon Peabody Advises in Exclusive Cancer Drug Licensing Agreement
June 28, 2010
. . . Hide Press . . . Media Clips- FDA Cracking Down on Compounders at Historic Pace
Law360 | April 22, 2013
Washington, DC, health services and life sciences partner Areta Kupchyk provides commentary in this feature article discussing the U.S. Food and Drug Administration’s efforts to police the compounding pharmacy sector. - Medical App Makers Await Regulator Checkups
The Recorder | March 15, 2013
Silicon Valley Global Business & Transactions partner Mavis Yee and Washington, DC, Health Services and Life Sciences partner Areta Kupchyk are featured throughout this article noting that the mobile medical app industry is awaiting formal regulatory guidelines from lawmakers. - Social Media and the De-Identification of Protected Health Information
Bloomberg BNA Social Media Law & Policy Report | March 12, 2013
This article, co-authored by partner & leader of the health services practice Michele Masucci and Long Island health services associate Carly Eisenberg, addresses the rising popularity of social media bring new challenges for health care providers. Click here to read the article. . . . View all . . .
EventsWebinar: The New World of Raising Capital in Life Sciences
December 13, 2012 Webinar: The First Amendment and Off-Label Promotion: Understanding the Implications of U.S. v. Caronia
December 5, 2012 Webinar: Leveraging Philanthropic Capital to Fund Life Science Companies and University Spin-outs
September 24, 2012 . . . View all . . .
Webinar: The FDA and Medical Products: Practices and Proposals for Internet and Social Media
July 10, 2012
Webinar: Avoiding the Glare of Government Scrutiny: Understanding the implications of the Physician Payment Sunshine Act
June 28, 2012
Webinar: Recent Developments in the Regulation of
Off-Label Communications
January 10, 2012
Patent Reform in the U.S.
November 14, 2011
2011: The Stem Cell Odyssey Continues
May 20, 2011
Rochester CLE Program
November 19, 2010
Parliamentary Debate II—Biotech & Pharma: Towards a virtuous circle for financing health care by 2020?
October 8, 2010
Stem Cells: 2010 Update
October 7, 2010
Second Annual Supplier Quality Management Congress
August 18, 2010
Webinar: Bilski v. Kappos: What Does it Mean for Biotech?
July 19, 2010
. . . Hide Events . . .
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