The Legal 500

Covington & Burling LLP has the ‘top lawyers in the industry: excellent in response times, business acumen and industry knowledge’. The group’s regulatory practice was strengthened by the addition of two former government officials at its main Washington DC office: of counsel Demetrios Kouzoukas, who served as deputy general counsel at the Department of Health and Human Services; and former chief counsel of the FDA Gerald Masoudi, who co-chairs the firm’s food and drug regulatory practice. The firm represented Genentech in a high-profile FDA hearing on whether to withdraw accelerated approval of the breast cancer indication for the Avastin drug. In M&A, it represented King Pharmaceuticals on its $3.6bn definitive merger agreement with Pfizer. The group has significant strength in antitrust and litigation, with substantial patent litigation and product liability practices. Masoudi’s ‘knowledge of the FDA, its people and their workings is extremely helpful on difficult issues’. Richard Kingham ‘has worked with most major pharma companies and his knowledge of the industry, the business and the law is second to none – including UK and EU regulations’; and Peter Safir’s ‘knowledge of Good Manufacturing Practices is really superb’. Transactions specialist John Hurvitz is also highly regarded. Kingham, Safir and Hurvitz are all based in the capital.

Hogan Lovells US LLP ‘covers the full range of issues’ with the ‘highest level of professional service, excellent response times and easy access to specialists in many areas’. Clients include Cephalon, GE Healthcare and Merck. Its highly regarded regulatory group – noted for its expertise ‘in the substance and the politics’ – advises numerous medical device, pharma and biotech companies on potential FDA approval. Particularly busy on the medical devices side, the firm is advising Siemens on clearance for a new product, and Janice Hogan – ‘a wonderful resource on FDA issues’ – is part of a team representing Stryker Corporation on quality submissions, reimbursement and compliance. The firm advised Merck on the cross-border acquisition of its biomanufacturing network by Fujifilm, utilising attorneys in London, Japan and Moscow. Baltimore-based Asher Rubin advised Tesaro on a Series B financing in one of the largest-ever venture capital rounds for a biotech company. Baltimore corporate partner William Intner is ‘extremely competent in all matters related to SEC reporting’; and practice co-head Rubin is ‘invaluable’. Also based in the capital, antitrust expert Robert Leibenluft and former FDA associate chief counsel Robert Brady are very highly regarded.

Latham & Watkins LLP provides ‘outstanding service’ in FDA and CMS regulatory work, M&A, securities offerings and litigation. The firm serves as outside FDA counsel to the Medical Device Manufacturers Association, and represented it and Boston Scientific in negotiations to reauthorize the Medical Device User Fee Act. On the CMS side, it successfully acted for two device manufacturers in challenges to denials of Medicare claim adjudications and standards for device distributors, respectively. John Manthei advised Advanced Biohealing on its acquisition by Shire plc; and Stuart Kurlander acted on several transactions, including for IntegraLifeSciences on its acquisition of SeaSpine Inc. Both attorneys are based in the Washington DC office, from where the bulk of the firm’s regulatory and corporate work is handled. In California, the firm acted for Clarient in class action merger litigation, successfully arguing a non-monetary settlement in principle on the eve of the tender offer closing. Practice co-chair and FDA expert Manthei is ‘extremely responsive’, ‘conscientious’ and ‘very strategic’. Silicon Valley emerging company expert Alan Mendelson is ‘absolutely a preeminent lawyer’. The group also has a sizeable product liability and patent litigation practice.

A leading presence in the space, Ropes & Gray LLP offers life sciences coverage across the full spectrum of needs in the US and from offices in Shanghai, Tokyo, Hong Kong and London. With an already robust foothold on the East Coast, the firm recently added to its West Coast capability with the addition of Ryan Murr from Goodwin Procter LLP to its San Francisco office. It is principal outside counsel to Genzyme Corporation, and represented the company in its hostile tender offer defense and ultimate sale to Sanofi-Aventis for $20.1bn. A mixed team of Boston corporate and New York IP attorneys, led by Marc Rubenstein, is assisting Biogen Idec in its $300m joint venture with Samsung Biologics to develop biosimilars. The firm is instructed by both Pfizer and Johnson & Johnson in relation to corporate and FDA regulatory matters; Boston-based Steven Wilcox advised on Pfizer’s development and marketing agreement with Puma Biotechnology for a breast cancer inhibitor; and Mike Sexton, also based in Boston, led a team acting for Johnson & Johnson on its settlement agreement with Merck amending global distribution rights for two autoimmune antibodies. In California, Murr acts as outside general corporate counsel for nano-medicine company Arrowhead Research, and advised it on its acquisition of therapeutics assets from Roche. Rubinstein and Washington DC-based Greg Levine co-chair the group.

Sidley Austin LLP has ‘outstanding ability to provide practical legal advice that takes into account the legal/regulatory environment’; and is ‘at the top in FDA drug-related litigation’. The firm has key offices in Washington DC, Chicago and Silicon Valley, and international capabilities with life science groups in London, Brussels and Shanghai. It is acting for Allergan on regulatory issues, often adversarial, across all the company’s products; and for Bayer as launch counsel for three new products, advising on importation, distribution and reimbursement. GE Healthcare remains a key corporate client for transactional and licensing matters, with recent deals including its $590m acquisition of Clarient. On the contentious side – where it also has a significant product liability and IP practice – the group acted for Genentech, Johnson & Johnson and Novo Nordisk. Washington DC-based Scott Bass and Jim Stansel – co-heads of the global life sciences team – are ‘outstanding advisors’; Ray Bonner, also based in the capital, is ‘an absolute industry expert, savvy and business aligned’; Chicago-based corporate partner Pran Jha is ‘incredibly responsive, and gives intelligent and business-savvy advice’; and Washington DC -based Jeff Senger has ‘regulatory expertise that is broad and deep’.

A transactional powerhouse which represents pharma, biotech and medical device companies on middle-market transactions and mega-deals, Cooley LLP has a firm foothold in the corporate space with 70 attorneys in its life sciences practice. The firm is highly regarded for its work in public offerings, and represented major companies including Exilixis, Optimer and Cerus on a range of IPOs and follow-ons. In M&A, a three-office team acted for AMAG Pharmaceuticals on its $686m merger with Allos Therapeutics; and Barbara Kosacz represented Gilead Sciences in its $225m acquisition of Arresto Biosciences. Partnering and licensing is another significant practice area: highlights included acting for Synosia Therapeutics in a $745m deal with UCB; and for Xencor in a $500m option deal with Amgen to co-develop an antibody for autoimmune diseases. In Silicon Valley, Robert Jones has been ‘around for a long time doing licensing work’, and is ‘a great lawyer’. Practice head Kosacz, also based in Palo Alto, attracts widespread praise, and has been ‘immersed in the industry for many years’. The group has a regulatory practice based in Washington DC, and patent litigation capability.

Highly regarded in the Boston life sciences market, Goodwin Procter LLP has since 2006 also had a presence on the West Coast, opening offices in San Francisco, San Diego and Silicon Valley. In common with other Boston firms, it is known for its work in private equity – especially PIPE deals – and venture capital, but also has a significant FDA practice; the team includes a former FDA associate chief counsel in its co-chair, Washington DC-based Mark Heller. The firm represented biotech company Avila Therapeutics in its $350m merger agreement with Celgene Corporation, a deal worth up to an additional $575m in milestone payments. In California, a team from the San Diego office advised Cleave Biosciences on its $42m Series A financing from various investors including Astellas Venture Management. Other corporate highlights included advising biopharma company Aegerion on its £48m IPO to finance development of its lead product, Iomitapide.

Kaye Scholer LLP’s highly regarded life sciences group represents several multinational pharma companies in antitrust matters, commercial litigation and corporate transactions. Recent work includes winning a Second Circuit ruling affirming the dismissal of a $1.28bn claim in damages for fraud and breach of contract against client AstraZeneca. It also successfully represented two subsidiaries of key client Pfizer at the District Court, with a jury rejecting claims that hormone therapy medicines manufactured by the companies caused plaintiff breast cancer. On the transactional side, the firm acted for Novartis on the divestiture of global rights to manufacture eczema treatment Elidel to Meda AB. The opening of the firm’s Silicon Valley office in 2010 has significantly strengthened its already well-respected product liability and IP practice.

McDermott Will & Emery LLP’s lawyers are ‘creative, inventive, and very smart’. The wide-ranging practice includes a highly regarded countrywide patent prosecution practice, notably in the major life centers of California, Washington DC and Boston. The firm has a longstanding relationship with Allergan, acting as outside reimbursement and compliance counsel. It represented a coalition of companies, including Brahms and Siemens, in securing a Medicare reconsideration determination for the laboratory fees associated with the diagnostic tool procalcitonin. The firm is representing long-time litigation client Amgen in a qui tam action seeking over $1bn in damages in the Boston Federal Court. In corporate, highlights included acting for Endo Pharmaceuticals on a $900m private offering of senior notes; and on a restructuring and Series B financing deal for Versartis. Government enforcement defense attorney David Rosenbloom is ‘responsive and pragmatic, and has a good relationship with the government’. Former AstraZeneca general counsel Glenn Engelmann joined the Washington DC office in September 2011.

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is highly regarded for its longstanding representation of biotech companies, acting for start-ups and large-caps across corporate, IP, regulatory and tax matters. Clients have included Massachusetts-based biotech companies such as Pulmatrix, Biogen Idec and Paratek. Among its corporate transactions, highlights included advising imaging and detection specialist Caliper Life Sciences on its $600m acquisition by PerkinElmer, and ARIAD Pharmaceuticals on a $258m public offering. The practice has some capability on the West Coast, with life science lawyers in its San Diego and Palo Alto offices.

Primarily known for its position in the important life sciences market of Boston, Morgan Lewis also has international capability, with experience in cross-border matters for major European and Asian clients. The firm represented Japanese multinational Asahi Kasei in its action for alleged sabotage of a licensing agreement against Swiss company Actelion in the California State Court, winning $577m (including $30m in punitive damages). Princeton partner Randall Sunberg advised Japanese pharma company Takeda on its commercialisation agreement with Intra-Cellular Therapies to develop inhibitors of the central nervous system. Regulatory highlights included advising Pfizer on its negotiations with the Department of Justice regarding a Corporate Integrity Agreement; and assisting EMD Serono with US and EU compliance issues for various product lines. M&A clients included Alacer Biomedical, Orchid Cellmark and AxoGen, which it represented in multiple transactions closing with a reverse triangular merger between it and a subsidiary of LecTec Corporation. Sunberg is a ‘licensing guru’, and San Francisco corporate partner Ben Pensak is also recommended. The Washington DC-based FDA practice made three new hires, including Arianne Callender, a former senior counsel at the Department of Health and Human Services. It also re-hired Alexis Reisin Miller, a former FDA Regulatory Counsel, in September 2011.

Skadden, Arps, Slate, Meagher & Flom LLP advises on high-value M&A, litigation and regulatory matters, and is particularly active in FDA investigations and qui tam action defense. Among several transactions for Endo Pharmaceuticals, the firm acted on its $2.9bn acquisition of American Medical Systems Holdings and the related $2.7bn acquisition financing. It also represented the company on a $900m high yield offering of senior notes. In litigation, it is representing KCI USA, a subsidiary of Kinetic Concepts, in two pending qui tam suits brought under the False Claims Act; and represented Amylin in an antitrust claim against Eli Lily. On the regulatory side, John Bentivoglio assisted EMD Serono in negotiations with the Department of Health and Human Services regarding kickback allegations, achieving a civil settlement and a three-year corporate integrity agreement.

Known for its strength in M&A and IP litigation, WilmerHale’s Boston office houses the bulk of its substantial life science team. The firm covers all aspects of the industry including real estate, private financings and alliances. M&A highlights included acting for Thermo Fisher Scientific on its $3.5bn acquisition of Phadia; and for BioVex group on its acquisition by Amgen in a deal that could include up to $575m in contingent milestone payments. Clients on the issuer side of numerous private financings included Agios Pharmaceuticals, Cerulean Pharma and Verastem, raising a total of $409m across all transactions. In Washington DC, the group has been active in government enforcement defense – particularly in relation to allegations of off-label marketing. Other clients included Novartis, Cephalon and Abbott Laboratories. Steve Singer in New York and David Redlick in Boston co-chair the practice group. Redlick is ‘top tier in both biopharma collaborations and corporate finance’.

West Coast mainstay Wilson Sonsini Goodrich & Rosati represents a wide range of companies from its main life sciences base in Palo Alto, primarily on corporate matters. IPOs are a significant area of strength; it raised a total of $653m in the first half of 2011 on behalf of clients. The group has a robust reputation for its advice to start-ups attempting to secure venture capital finance. In other corporate work, it advised Rinat Neuroscience on its acquisition by Pfizer; and acted on the commercialisation alliance between GlaxoSmithKline and Xenoport for Horizant, a drug that treats restless leg syndrome. Other clients have included Cholostech, Barosense and Align Technology. Casey McGlynn is highly regarded for his work with start-ups and on IPOs, and licensing expert Kenneth Clarke is also recommended; both are based in Palo Alto.

Corporate giant Cravath, Swaine & Moore LLP focuses on high-profile M&A, capital markets and financing work. The firm is representing longstanding client Johnson & Johnson on the largest transaction in the company’s history – the $21.3bn acquisition of orthopaedic device manufacturer Synthes. It also represented Novartis, another long-time client, in its $470m acquisition of Genoptix. In capital markets, the group regularly acts for the underwriters in senior debt offerings by major pharmaceuticals companies. It recently represented Merrill Lynch, Wells Fargo and JPMorgan in an offering by service company AmerisourceBergen.

Dechert LLP’s ‘response time is fast’, and its ‘industry knowledge, level of service and value for money all high – especially in relation to the negotiation of pharma licensing deals’. The firm acts primarily for mid to large-cap pharma companies in mass tort, product liability and IP matters; and also in antitrust litigation and transactional matters. In antitrust it represented Elan Corporation in class and opt-out actions alleging illegal delayed market entry of a generic drug, finalising the settlement with both sets of plaintiffs in March 2011. Corporate highlights included advising Covance in relation to its ten-year strategic alliance with Sanofi-Aventis, potentially worth $2.2bn in payments to the client; and advising for Janssen Pharmaceuticals on its non-binding cooperation agreement with Skolkovo Foundation, a non-profit organization developing scientific innovation in Russia. George Gordon and David Schulman co-chair the practice from Philadelphia and Washington DC respectively.

Foley & Lardner LLP is ‘cost competitive’, with an ‘ability to discern the “real” issue beyond the smokescreen’. The group has corporate and regulatory practices, with an emphasis on venture capital, licensing and private equity on the corporate side. It represented biotech company SynthRx in the negotiation of its all-stock merger into Adventrx Pharmaceuticals; and PregLem in the negotiation of a product licence and development agreement. In regulatory, Washington DC-based practice co-chair David Rosen is assisting H&P Industries and Spectra on FDA issues, obtaining late-stage marketing clearance for a medical device for Spectra. In San Francisco, co-chair Judith Waltz advises on government enforcement, and is noted for her ‘strong people interactions’ and ‘first-hand experience with individuals in government agencies’.

A product liability and IP litigation heavyweight, O’Melveny & Myers LLP’s 12-partner life sciences group also has a substantial corporate practice. The firm assisted Advance Medical on the establishment of a Cayman Islands/Brazil/US international structure and closing of a Series A financing, and continues to advise on the company’s expansion into the Brazilian aesthetic market. Particularly strong in capital markets, the firm acted on a variety of complex financings. It represented Nektar Therapeutics on a public offering of common stock which netted proceeds of $220m for the company; and Silicon Valley-based Brophy Christensen acted for Cell Therapeutics on a series of direct offerings worth more than $110m of Series 3 preferred stock. Highly regarded practice chair Sam Zucker, also based in Silicon Valley, is a ‘very good corporate practitioner’. In May 2012, Stanton Lovenworth joined from Dewey & LeBoeuf LLP.

Shearman & Sterling LLP represents multinational biotech companies, medical device manufacturers and large-cap pharma companies in high-value deals, white-collar litigation and antitrust matters. The firm is acting for Synthes on its $21.3bn acquisition by Johnson & Johnson: a cross-border transaction requiring Hart-Scott-Rodino clearance, European Commission approval and regulatory approval in other jurisdictions. In litigation, it acted for Élan Corporation in gaining the dismissal of two actions for securities fraud in the New York and California Courts. The group’s co-heads are based in San Francisco, Washington DC and New York.

With a strong transactions and litigation practice, California stalwart Sheppard, Mullin, Richter & Hampton LLP has been doing some significant work in emerging markets. It represented the Serum Institute of India in several matters relating to drug development, including a licensing agreement with Merck to market a new variety of pneumococcal conjugate vaccine. It also has a relationship with Indian pharma giant CIPLA, which has been active in attempting to reduce the cost of HIV treatments in developing markets. Domestically the group advised across a wide range of transactional matters, particularly M&A and financings, including representing Aduro BioTech in a $19.25m Series B financing; and Luitpold Pharmaceuticals in its acquistion of PharmaForce Inc. The litigation practice is oriented towards IP, and the group has a strong record in licensings and collaborations. Less well known on the regulatory side, it nevertheless has life science attorneys in Washington DC and New York.

Baker & McKenzie’s life sciences group includes 23 partners solely or mainly focused on the area. The firm’s global reach has assisted in generating a flow of large international deals over the past year, and advice to multinationals on compliance with new universal jurisdiction legislation such as the UK Bribery Act. A Chicago-based team led the advice to Abbott Laboratories on its $3.7bn acquisition of Indian branded generics manufacturer Primaral Healthcare, a deal that involved 44 offices and required approval from Indian state government for land transfers. In capital markets, the New York office advised Fresenius Medical Care on a $962m dual currency offering of 6.50% senior unsecured notes.

A single-office firm based in Boston, Choate, Hall & Stewart’s ‘overall level of service is outstanding’. Primarily a patent litigation and licensing practice, the firm has also been busy in trade secrets litigation, and is currently defending a pharma company in an ongoing action seeking damages of $100m. On the corporate side, the team acted for Vitality on its $20m acquisition by Global Health Grid; and Pappa Life Science Ventures and other investors on their investment in Canadian research business Milestone Pharmaceuticals.

Among several matters for K-V Pharmaceutical, Dentons acted on a False Claims Act/qui tam action alleging medicare fraud; and advised on negotiations with Congress, the FDA and CMS on the rollout of lead brand product Makena. The firm also serves as regulatory counsel for several divisions of Abbott Laboratories, and is advising on investigations under the Foreign Corrupt Practice Act. In transactions, the firm represented Topaz Pharmaceuticals on its merger with Sanofi-Pasteur, the vaccines division of Sanofi-Aventis; and advised bio-defense company PharmAthene on a $19.5m restructure of convertible debt and a $30m underwritten public offering. The group has strong IP and product liability practices.

Gibson Dunn has been very active on the patent litigation and transactional fronts. Among numerous corporate highlights, the firm acted for Covidien on a $1.5bn revolving credit facility; St. Jude Medical on its $1.5bn acquisition of AGA Medical Holdings; and niche life science investors Bio*One Capital on a Series D investment into device manufacturer TriReme Medical. Other clients included Accuray, Quidel and I-Flow Corporation. Litigators Daniel Thomasch and Mark Perry head the group.

A cross-practice team at Morrison & Foerster LLP represented Abraxis Bioscience in its acquisition by Celgene Corporation; the deal had a significant IP element with the pending approval of breast cancer drug Abraxane for other types of cancer potentially increasing the deal’s value to $3.5bn, and the firm has subsequently been retained by Celgene to advise on the Abraxis patent portfolio. Other clients have included Catalyst Biosciences, Terumo Corporation and Acambis. Patent prosecution and product liability defense remain the basis of the firm’s reputation in the area.

Better known for its work in healthcare, Proskauer Rose LLP also represents life sciences clients, primarily on transactional and licensing matters. The firm acted for Grifols on its $4bn acquisition of Talecris Biptherapeutics, including IP agreements. In licensing, the firm advised Biocryst Pharmaceuticals on a collaboration agreement with a UK pharma company for an oncology drug. Celgene and Novocure are longstanding clients.

With significant strength in antitrust and patent litigation, White & Case LLP acts for three large-cap pharma companies among other clients. It is representing Pfizer in a complaint alleging Walker Process fraud and sham litigation, and advised the company on the $2.3bn multi-jurisdictional sale of its Capsugel division to a private equity company. The firm also acted for Sandoz in 18 separate False Claims Act cases alleging inaccurate reporting of pricing benchmarks; and for Novartis in the high-profile antitrust case RxUSA Wholesale Inc v Alcon Laboratories Inc et al. All the work referred to was handled by attorneys in the firm’s New York office. In May 2012, Bryan Luchs joined from Dewey & LeBoeuf LLP.