How big is our practice group?
More than 100 professionals.

Amanda Austin (Harvard Law School '05) is involved with biotech and pharmaceutical companies in connection with various licensing and corporate partnering transactions.

What do we do?
Ropes & Gray's Life Sciences Practice Group is one of the leading life sciences practices in the nation and worldwide (Ranked in Band 1, according to the 2007-2010 editions of Chambers USA, and recognized as a leading international practice in the 2009-2011 editions of Chambers Global). We represent every type of life sciences company from pharmaceutical, biotechnology and medical device manufacturers to research institutions. Our multi-disciplinary team of lawyers and technical specialists with expertise in FDA regulatory, government enforcement, intellectual property, private equity, securities and corporate law, work together in a coordinated fashion. We have expertise and experience to resolve virtually any legal problem facing life sciences companies. Our work covers a full rage of legal areas, including financings, IPOs, licensing, M&A, patent due diligence, prosecution and litigation, FDA regulation, research compliance, medical product reimbursement, health care compliance, government enforcement defense, and life sciences-related public policy.

• Ropes & Gray represented Biogen Idec in its aquisition of worldwide rights to three pre-clinical immunotherapy programs from Neurimmune Holding AG for approximately $430 million.
• Ropes & Gray is Genzyme Corporation’s principal outside counsel on securities, mergers and acquisition and certain licensing matters. Over the past year, we have represented Genzyme in:
• its sale to sanofi-aventis SA for $20.1 billion;
• its divestiture of three global business units with 2009 worldwide revenues of over $500 million, including the $925 million sale of the Genzyme Genetics business unit to Laboratory Corporation of America, the $260 million sale of the Genzyme Diagnostics business unit to Sekisui Medical Ltd., and the sale of its pharmaceutical intermediates business to International Chemical Investors Group (ICIG); and
• its $1.0 billion debt offering.
• In 2010, Ropes & Gray represented Ironwood Pharmaceuticals, Inc. in its $202 million IPO.
• Ropes & Gray represented Johnson & Johnson in
  • its co-promotion agreement with Japan-based Takeda Pharmaceutical Company (“Takeda”), the largest pharmaceutical company in Japan, granting Takeda the right to co-promote VELCADE(R) (bortezomib) for Injection, a treatment for patients with multiple myeloma, in Japan; and
  • its collaboration agreement with Takeda to co-market Galantamine in Japan for the treatment of Alzheimer’s disease once Johnson & Johnson affiliate’s application is approved by Japan’s regulatory authorities.
• As one of a select number of law firms that comprise the Pfizer Legal Alliance (“PLA”), Ropes & Gray represented Pfizer, Inc. in:
  • the Wyeth  merger, which included a detailed review and summary of all of Wyeth’s ongoing drug research agreements and major commercial agreements worldwide, including in-licenses, collaborations and other research program agreements (a total of more than 5,000 agreements).  This project helped facilitate a smooth integration of Wyeth's operations with Pfizer’s immediately following consummation of their $68 billion merger. For a description of an associate’s role in this transaction, click here.
  • an assignment and license agreement with Ergonex Pharma GmbH relating to Terguride, a drug in development for the treatment of pulmonary arterial hypertension (PAH), which included Pfizer obtaining worldwide (except in Japan) commercialization rights to the product for the PAH indication. For a description of an associate’s role in this transaction, click here; and
  • its acquisition of FoldRx Pharmaceuticals, Inc., a drug development company focusing on first-in-class, disease-modifying, small molecule therapeutics to treat diseases of protein misfolding.
• Ropes & Gray represented Stryker Corp. in the sale of its bone growth therapies product line (including OP-1 Implant, OP-1 Putty, Opgenra and Osigraft) as well as a manufacturing plant in New Hampshire, to Olympus for $60 million. For a description of an associate’s role in this transaction, click here.

FDA Practice: Our regulatory and governmental affairs lawyers regularly provide counsel, representation, and strategic advice to companies subject to food and drug law. Our wide-ranging experience includes representation before the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Federal Trade Commission (FTC), as well as before grand juries and state and federal courts. For a representative description of the associate’s role in this work click here.

Our recent FDA work includes:

• Ropes & Gray provides ongoing strategic and regulatory advice to Shire Pharmaceuticals on its full range of products including to both the Specialty Pharmaceuticals and Human Genetic Therapies business units.  In addition, we have advised Shire in responding to various FDA enforcement letters that raised a variety of issues ranging from Internet promotion, to procedural concerns related to submission of marketing materials, to allegations of misbranding.
• In 2004, Ropes & Gray assisted Johnson & Johnson in drafting a citizen petition to FDA outlining potential safety and efficacy issues associated with the approval of generic versions of one of its drugs. The petition focused on unique bioequivalence issues implicated by the product, and much of the analysis was ultimately adopted by the agency.
• Ropes & Gray provides Pfizer, Inc. ongoing FDA regulatory advice and counsel on a wide range of matters.
• Ropes & Gray’s significant work for GlaxoSmithKline LP in 2010 included:
  • counseling FDA approval standards for potential generic versions of important GSK drug products; and
  • assisting the company in the preparation and submission of a major citizen petition urging FDA to adopt certain bioequivalence standards before approving generic versions of Advair – one of GSK’s leading products.  

Other matters include:

• Ropes & Gray advised and represented a client in regard to questions of bioprospecting and its regulation under the Convention for Biological Diversity. As part of this engagement, we represented the client before the State Department on issues concerning the international implications of this regime and we have been involved in continuing negotiations involving agreements governing access to genetic resources.
• Ropes & Gray represents a coalition of pharmaceutical, biotech and device companies regarding FDA’s policies concerning off-label dissemination. We were involved in helping obtain the Reprint Guidance from FDA, we have submitted comments asking for an advisory opinion process for promotional issues, and we are seeking clarity in several other areas that are of concern to the entire industry.
• Our regulatory and transactional attorneys collaborated to negotiate a Material Transfer Agreement (MTA) and a Pharmacovigilance Agreement (PVA) on behalf of a global pharmaceutical client. Under these agreements, the client provided drugs to another global pharmaceutical company preparing to undertake a clinical trial in the United States and several foreign jurisdictions. The project involved providing advice on safety reporting obligations and clinical trial practices, among other issues, across multiple jurisdictions.