Arnold & Porter Kaye Scholer is the product of one of the most talked about mergers in the market last year, and further cemented life cycle firm APKS’ ability to handle life science clients’ needs across the legal spectrum. Arnold & Porter’s substantial practice in regulatory matters, government investigations and product liability combined with Kaye Scholer’s talent in IP litigation to create a law shop worth watching, if the two firms by themselves weren’t already. The firm has a handle on markets at the domestic and global scale, one peer mentioning, “Their work is very cross-border focused, and they help a lot of companies stay on the right side of the line.”
Daniel Kracov, one of the firm’s top regulatory lawyers, serves as co-chair of the Life Sciences and Healthcare Regulation Practice. He is nationally recognized as an expert in food and drug law, and has established a successful track record representing pharmaceutical, biotechnology, medical device and diagnostic companies, among other industry clients.
The IP group stands out for its patent litigation abilities, featuring David Barr and Matthew Wolf on its bench of first chair trial lawyers. One peer notes that Barr is an “excellent patent litigator for all types of biotechnology and pharmaceuticals.” Another peer calls Wolf a “great advocate in the courtroom,” and singles out his ability to comprehend his clients’ business when taking on a litigation. “He’s not just the hired gun, he understands where the case fits into their overall strategy.” Barr handles much of the firm’s Hatch-Waxman litigations, recently representing client Novartis in a set of suits related to the manufacturer’s flagship drug Gleevec, a treatment for a form of leukemia. Wolf and a team of attorneys obtained for client Hologic a post-issuance rejection of claims in two patents owned by device maker Smith & Nephew. The company had accused Arnold & Porter’s client of infringing its patents, and in response Wolf’s team filed multiple inter partes reexaminations seeking to cancel the claims. Aaron Stiefel represents high-profile branded clients like Pfizer and Novartis in Hatch-Waxman litigations, and also brings experience in matters related to product liability, breach of contract claims and alleged securities law violations.
Anand Agneshwar and Pamela Yates lead the firm’s product liability litigation practice from their New York and Los Angeles posts, respectively. Agneshwar is currently defending client Bristol-Myers Squibb in a multidistrict product liability case related to the company’s blood thinner Plavix. Yates represents Endo Pharmaceuticals and its subsidiary Auxilium in an ongoing multi-district case with 8,000 claimants related to the drug makers’ testosterone products. Trial lawyers Saul Morgenstern and Laura Shores specialize in antitrust litigations, while Arthur Brown heads a practice focused on white collar defense and product liability.
Covington & Burling is an international firm equipped to handle most aspects of life science clients’ needs. Offering robust practices in transactional, regulatory, intellectual property and litigation matters, Covington’s legal professionals are noted by peers for their strong professional reputations.
Covington’s regulatory attorneys are regarded as second to none for their ability to delve into the inter-workings of food and drug policies both domestically, and around the world. Within the life sciences realm, the firm’s regulatory and transactional specialists are particularly esteemed for work in the pharmaceutical industry, representing heavyweight clients such as AbbVie, AstraZeneca, Merck, Genentech, Allergan, Shire and Regeneron. Partners Richard Kingham and Peter Safir are two of the leading regulatory names. The highly regarded transactional attorneys are another fundamental arm of the firm’s traditional life sciences services. Amy Toro and John Hurvitz are two key partners who lead the firm’s representation in matters involving mergers and acquisitions, licensing and collaboration and other finance-driven areas.
George Pappas is a long-practicing lawyer in the intellectual property space with extensive experience litigating matters related to the biotechnology, medical device and pharmaceutical industries. In Hatch- Waxman matters, he has represented leading pharmaceutical innovators including AstraZeneca, Sanofi, Shire and UCB. Jeffrey Elikan is another partner adept in ANDA litigations battled in the district courts, with a client list consisting of Warner Chilcott, Johnson & Johnson and Shire. Christopher Sipes’ IP practice is comprised of patent litigation in both the district and appellate courts, as well as patent prosecution and Hatch-Waxman litigation counseling. Patent Office practice group leader Andrea Reister is sought after for her expertise in building patent portfolios, patent prosecution, district court litigations and PTAB proceedings. Because of her varied practice, Reister is touted by her firm as a “triple threat.” She has represented AstraZeneca, Biogen, Bristol- Myers Squibb and Eli Lilly in matters at the Patent Office.
Mark Lynch is co-chair of Covington’s pharmaceutical litigation and government investigations group. He has tried cases in a host of different venues, including the US Supreme Court. Product liability group cochair Michael Imbroscio has served as counsel for various high-profile clients, including Bayer, Boehringer Ingelheim, Eli Lilly, Genentech and Hoffmann-La Roche. Ethan Posner handles government investigation matters for major pharmaceutical clients. Previous to his time at Covington he served as Deputy Associate Attorney General at the Department of Justice, advising on antitrust and civil litigation issues.
Clients praise Goodwin Procter's life sciences group as providing “exceptional service” and “outstanding expertise across the board” for its handling of legal matters throughout a product’s life cycle. The firm maintains a level of activity in the life sciences IP space that few other firms rival. From Hatch-Waxman and general patent litigations to portfolio counseling and strategy, the IP group holds high praise from LMG Life Sciences and market peers alike. A pharmaceutical client commends the firm’s attorneys, describing them as “high-caliber lawyers who really understand our business,” while a peer notes, “I’ve been impressed with Goodwin’s group in the life sciences.” Leading the charge on the IP litigation side are Elizabeth Holland, Daryl Wiesen and David Hashmall, who in the past year were active in several Hatch-Waxman suits for generic makers. Hashmall is described by a pharmaceutical client as “very client-focused” and a “great strategic thinker.” Of the firm’s notable representations of pharmaceutical giant Teva, one client notes: “I have a lot of respect for the crew at Goodwin Procter. They have a few lawyers over there representing Teva, one of the largest generic companies. I view them as a team that has done a great job for Teva.” Holland successfully represented the company in an ANDA litigation last year concerning the six-billion-dollar drug Abilify. She and her team defeated a temporary restraining order against Teva, leading to FDA approval to market a generic and a favorable settlement for the pharmaceutical client.
Duncan Greenhalgh practices in patent prosecution and counseling, noted by one client as a “very solid life sciences lawyer.” A peer notes the firm’s increasing presence in the patent counseling space: “I see Goodwin Procter as more and more involved. We’ve turned over a few clients to them because we don’t do investor opinions.” Goodwin’s transactional practice consists of about 70% company-side representation and 30% venture capital, banking, and miscellaneous. The focus of the practice is on emerging biotech companies. Mitchell Bloom, national chair of Goodwin’s life sciences practice, specializes in financings and public offerings for later-stage private companies and public biotech companies. Kingsley Taft is a senior partner and co-chair of Goodwin’s Life Sciences practice who leads a licensing and strategic alliance practice that executes complex deals for the likes of JP Morgan.
The firm has regulatory capabilities, after bringing in a regulatory team from Wilmer- Hale several years ago led by Mark Heller. The firm also exhibits strength in non-IP litigation, notably with partner Joanne Gray who chairs the firm’s product liability and mass tort group. She has experience litigating high-profile product liability cases, and offers counseling expertise advising clients on regulatory matters, mergers & acquisitions, and litigation avoidance.
Boasting an international footprint and a full suite of legal services for life science clients, Latham & Watkins continues to establish a reputation as one of the more wellrounded firms in the practice area. The group is firmly anchored in the financial & transactional space, and in IP matters continues to be acknowledged by peers for its facility in litigation services, specifically Hatch-Waxman suits.
Judith Hasko, global Chair of the Life Sciences Licensing Group, is a leading transactional partner who was named by LMG Life Sciences as the 2015 Finance and Transactional Attorney of the Year. In just one representative matter of note, Hasko represented the biotechnology company X-Rx in reaching a collaboration agreement with Gilead to develop proprietary small molecule autotoxin inhibitors. Charles Ruck is a highly regarded name at the firm. Mark Roeder, based in the Silicon Valley office, is global Co-chair of the Life Sciences Industry Group. A substantial portion of Roeder’s practice is focused on venture capital financing and counseling clients in mergers and acquisitions.
Latham’s robust IP litigation group offers many talented attorneys specializing in general patent litigation and Hatch-Waxman matters. Kenneth Schuler is one of the firm’s most active in Hatch-Waxman suits, currently representing leading small molecule clients Mallinkrodt, Roxane and Boehringer Ingelheim in ANDA litigations. Schuler is defending Roxane in a now consolidated ANDA infringement suit brought by Vanda Pharmaceuticals regarding an anti-psychotic bioequivalent for branded drug Fanapt. Recent additions David Frazier and Mike Morin impress with their litigation capabilities, both notable for their representation of AbbVie in the ongoing high-profile case Amgen v AbbVie. “Mike is very, very good,” notes one peer. “Mike and I have a mutual admiration of one another, and I would trust him with a referral.” Global IP litigation head David Callahan focuses his practice on complex patent litigation, with a particular expertise in medical device patent disputes. In non-IP litigation, the firm is primarily known for its corporate law prowess, but also features an impressive group in the investigations and enforcement area with Daniel Meron and David Schindler. Meron is a fraud and abuse authority whom one peer complimented by saying that, “not a lot of attorneys in this field are as detailed as Dan and it shows in his accomplishments.” Schindler represented medical device manufacturer Masimo in connection with a federal criminal investigation of its medical devices. After a year-long government investigation, Schindler convinced the government not to pursue any charges against the company or its current and former employees. According to one client, Latham is “where we go when we need first-tier legal help.”
International firm Morgan Lewis & Bockius is equipped to handle legal needs across the life sciences spectrum, showing particular strength in the financial & transactional space, and capable groups dealing in IP, regulatory and compliance matters. “Morgan Lewis offers expertise in a wide range of specialties that are of use to mid-sized biotechnology companies, and has a long track record of providing excellent advice in the life sciences fields,” a biopharmaceutical client says about the firm’s varied practice. The firm expanded its reach with the absorption of Bingham McCutchen, giving Morgan Lewis a window into the Boston life sciences market.
Morgan Lewis is very active with emerging businesses in the big centers of finance and developments for life sciences companies including Boston and Silicon Valley. From the Princeton office, Randall Sunberg, Emilio Ragosa, Alan Leeds, and David Glazer are active in M&A, collaboration and licensing which is split between pharma, biotech, and medical devices. Morgan represents banks in transactions, but more often than not, life sciences companies. The firm’s FDA group is tightly knit to the corporate business and finance group, being active in pharmaceutical due diligence. Morgan Lewis has a handful attorneys in the US that focus on life sciences licensing transactions dealing with product approval processes and split territories.
In the non-IP litigation department, Kathleen “Katie” McDermott shines with a particularly active practice as of late. She recently persuaded the US Attorney’s Office in Jacksonville, Florida to decline a False Claims Act qui tam action against the Mayo Clinic and two of its physicians who performed electrophysiology procedures at Mayo. Gordon Cooney is a commercial practitioner with specific skill in class actions and is widely praised among peers in his Pennsylvania base and beyond. He achieved a favorable settlement for Merck as resolution counsel in connection to longstanding antitrust claims made by a class of direct purchasers citing they were overcharged by hundreds of millions by a Merck predecessor. John Dodds operates in the white-collar, antitrust and commercial litigation space, recently notching a win for medical device client CR Bard and subsidiary Bard Access Systems in a False Claims Act (FCA) case. Antitrust lawyer Willard Thom is singled out by a peer who says he is “a real breakout star, a great thinker and a good guy.” The regulatory practice comprises FDA, healthcare, and regulatory capabilities. Kathleen Sanzo is an FDA practice leader active in foods, drugs, combination products, and diagnostics. She is one of a handful of leading drug lawyers in the nation and, with Mahinka, she has co-written the chapter on pharmaceutical marketing and promotion for a Food and Drug Law Institute treatise.
Donna Yesner is a valuable asset to the firm’s general health-care reimbursement capabilities, specializing in government purchasing and contracting. The rising importance of e-health, telemedicine, and medical devices has raised FDA regulatory and corporate issues, as well as FCC and FTC regulation questions in the last couple of years. The Bingham merger allowed Morgan to expand into telecommunication, since Bingham has one of the leading telecommunications practice in the US. Michele Buenafe is a leading attorney in digital health issues who focuses her practice on counseling, pre-market issues, and postmarket compliance.
The firm’s global head of intellectual property Eric Kraeutler is described by a peer as a “very good lawyer,” and “an exceptional IP litigator across a variety of technologies, including biotech.” Life sciences IP practice leader Richard de Bodo shines as another one of the firm’s star trial lawyers, fronting much of the practice’s Hatch-Waxman and general patent litigations. He also offers expertise counseling clients seeking to launch biosimilars under the Biologics Price Competition and Innovation Act (BPCIA). Recently, de Bodo successfully represented Allergan, Aptalis and Forest Laboratories in three separate high-stakes Hatch-Waxman suits in the District of New Jersey related to Aptalis’ top-selling Canasa product. He is shortlisted for the 2017 LMG Life Sciences General Patent Litigator of the Year Award for California. Michael Abernathy is an expert in Section 337 ITC proceedings, currently serving as lead counsel in an ITC litigation for client Baxalta related to patents which cover its product Advate.
The firm is recognized as a leader in the fields of antitrust, product liability and white collar/investigations work, and the numerous practitioners attending to this work can be found liberally sprinkled throughout its various offices. One peer sums up the practice group’s strength by saying, “Sidley is the one to beat in life sciences litigation. They seem to attract much of this type of work and they have people that they can pull from anywhere to deal with it. They have a lot of arrows in the quiver, and some of the sharpest ones too.” Rebecca Wood is noted for her expertise in the issue of federal preemption, particularly for pharmaceutical entities dealing with the FDA. Maja Eaton and Eugene Schoon focus much of their practices on product liability litigations, both recently representing Bayer in two separate matters related to some of the manufacturing giant’s marketed products. Chicago partner John Treece is recognized as one of the firm’s top attorneys practicing in the antitrust space.
Sidley’s reputation as a mainstay litigation house certainly extends to its capabilities in the intellectual property space. The firm employs an impressive roster of patent attorneys wielding expertise in a variety of venues and industries. National IP practice leader David Pritikin is lead counsel in a patent infringement suit under the Biologics Price Competition and Innovation Act (BPCIA), representing client Amgen against Sandoz for its proposed biosimilar of Amgen’s product Enbrel. An opposing attorney speaks of Pritikin after facing him in court, saying, “For me it was an honor to go against Dave Pritikin.” Jim Badke recently represented Bayer in two litigations, one of which resulted in an affirmed verdict by the US Court of Appeals for the Federal Circuit, ruling that Glenmark infringed upon Bayer’s patents for branded drug Finacea. Jeffrey P Kushan and Vernon M Winters are two more standout litigators at the firm, who both recently sustained a win before the Patent Trial and Appeal Board (PTAB), also related to the product Enbrel. Beyond the consistent accolades for contentious IP work, Sidley’s record of success in the regulatory realm is second to none. The roster of star regulatory attorneys at Sidley includes names such as Coleen Klasmeier, Jeffrey Senger and Torrey Cope. Key partners specializing in financial and transactional work include, Sam Zucker, Deborah Marshall and Pran Jha. Jha brings more than 20 years of experience working with industry clients in M&A transactions, capital markets, joint ventures, and other transactional and corporate governance matters
WilmerHale’s life sciences practice is renowned for its range and multidisciplinary teams that counsel clients in biotechnology, pharmaceutical and medical device companies, as well as investment banks and venture capitalists.
“They do really good work,” a peer says of WilmerHale’s intellectual property practice, another simply declaring the law shop a “great firm.” The firm employs more than 120 attorneys skilled in IP matters with undergraduate and scientific degrees in scientific areas. Forty-year legal veteran William Lee maintains his status as one of the most respected litigators in the IP arena. “What can you say about Bill Lee at this point that hasn’t been said?” a peer says. “That guy is patent litigation!” Lee has tried over 200 cases to verdict, and in the life sciences focuses on pharmaceutical and medical device clients. Lisa Pirozzolo has expertise in patent litigation, licensing disputes and arbitrations. Recently, she successfully represented a major branded pharmaceutical client in a global litigation. Vice chair of the litigation & controversy practice group Amy Wigmore is involved in two ongoing cases related to the IP protection of high-profile blockbuster products. Both Pirozzolo and Wigmore are shortlisted for 2017 LMG Life Sciences Awards, in the General Patent Litigator of the Year and Hatch-Waxman Litigator of the Year categories, respectively.
While IP easily makes up much of WilmerHale’s litigation repertoire, the firm is gaining an increased amount of attention for its capabilities in the securities and enforcement area as well. The group is described by a peer as “a go-to firm for the big-bucks litigation,” and employs a few impressive practitioners on its roster. Securities- based partner Michael Bongiorno successfully represented InVivo Therapeutics Holdings, a spinal cord therapy company, in a putative class action by investors alleging it lied in public statements about drug trial opportunities, when, in January 2017, the US Court of Appeals for the First Circuit agreed with the lower court that it had rightfully dismissed all claims related to company’s disclosures about FDA communications. Howard Shapiro scored on behalf of longtime client Purdue Pharma when, in January 2016, the Fourth Circuit unanimously ruled in favor of the client in a case involving the application of the pre- 2010 public-disclosure bar of the False Claims Act.
WilmerHale has represented life sciences clients in venture capital, mergers and acquisitions, initial public offerings and other capital markets transactions, public company counseling, strategic alliances, licensing and governance matters. Since 2004, the firm has been involved in more life sciences initial public offerings in the eastern United States than any other law firm. The firm also represents life sciences companies and underwriters in follow-on public offerings and Rule 144A placements, and has experience representing issuers, placement agents and investors in PIPE financings. The firm continues to build its reputation in licensing and collaboration and M&A work. Chair of the firm’s transactional department, and 30-year veteran Steven Singer represented Editas throughout the proceedings. Partner Steven Barrett represents entrepreneurs, early-stage, and established life sciences companies in a variety of technology transactions. Belinda Juran co-chairs the firm’s life sciences industry group, advises pharmaceutical, biotechnology, and medical device companies on all phases of product development and commercialization, including technology transactions, collaboration, and joint venture agreements, among others.