As the legal lifeline of the life sciences industry, Kaye Scholer’s nationally recognized Life Sciences Group successfully addresses issues and exploits opportunities for leading pharmaceutical, medical device, biotech and health tech firms. Our actions help define our clients as leaders by aiding every stage of their products’ life cycle. From initial licensing and commercialization stages through disputes concerning those agreements, and all marketing, intellectual property, and product liability point in between, our full-service, multidisciplinary focus securest the very foundations of your business. Whether it’s the structuring of a complex drug development deal, negotiating an acquisition, protecting intellectual property, minimizing exposure to mass tort liability, resolving complex biotech disputes or defending high-stakes government investigations, the business of life sciences and the development and commercialization of health technology is deeply ingrained in our DNA.
In the Market
- Boston, Vicari to Participate in DRI’s Drug and Medical Device Seminar May19-20, 2016 • Seminars
- Who’s Who Legal 2016 Honors Kaye Scholer Lawyers February 2016 • Recognitions
- Kaye Scholer Secures Seventh Circuit Generic Preemption Win February 3 • Client Successes
- Excluding Expert Opinion Impugning Corporate Ethics, Motive and State of Mind January 27 • Articles
- Deconstructing Plaintiffs’ Peer-Reviewed
Scientific Literature January 27 • Articles
- Excluding or Limiting FDA Regulatory Expert Opinion January 27 • Articles
- Taking a Science Expert Deposition to Set
Up a Daubert Motion January 27 • Articles
- Mastery in the MDL: Maximizing the MDL
Daubert Process January 27 • Articles
- Social Media Trends in the Promotion of Pharmaceuticals, Biologics and Medical Devices January 14 • Articles
The Numbers: Our Accomplishments
- 30 Percentage of the world’s top 10 pharma companies that are our clients—and have been for multiple decades
- 7 Recommended Life Sciences practices in the LMG Life Sciences (2014)
- 15 Life Sciences partners recognized as “Life Science Stars” in the LMG Life Sciences (2014)
- 1 of 4 Our position on Novartis’ list of preferred firms to serve the full range of their US legal needs.
Capabilities: How We Do It
When it comes to the life sciences sector, we offer full services, with deep experience and expansive capabilities in the following areas:
- Government Enforcement Actions
- Treble Damages Lawsuits
- M&A Advice & Agency Clearance
- Compliance Counseling
- Breach of Contract Actions
- Early Litigation Assessments
- Complex Settlements
- Mergers & Acquisitions
- R&D and Commercialization Collaborations
- IP Licensing Arrangements
Investigations & Compliance
- Government & Internal
- FCPA & Export Violations
- Qui Tam Suits under the False Claims Act
- White-Collar Defense
- Capital Markets
- PE/VC Financing
- Debt Financing
- ANDA & Other Patent Litigation
- IP Due Diligence
- Trademark, Copyright & False Advertising
- Trade Secrets
- Product Liability & Mass Tort Defense
- End Game Strategies
- Risk Mitigation
- Disclosure & Securities
- Counseling Boards
- 10-b Litigation
- Shareholder Derivative Suits
- King Pharmaceuticals (a subsidiary of Pfizer): In a cluster of class actions brought on behalf of direct purchasers, indirect purchasers for resale and end-payor purchasers of Skelaxin®, a brand name prescription drug, in which the plaintiffs allege that King and co-defendant Mutual Pharmaceuticals conspired to prevent or delay generic competition for Skelaxin®.
- AstraZeneca: Secured and upheld a motion to dismiss on all nine claims in a $1.28 billion contract litigation brought by Verus Pharmaceuticals.
- Purchaser: Representation of a $2.5 billion health group in litigation regarding whether approximately $50 million in Value Added Tax receivables were included as assets in the Asset Purchase Agreement.
- Novartis: Advised on the intellectual property-related aspects of a series of strategic deals totaling $30 billion, including the landmark acquisition of GlaxoSmithKline’s (GSK) oncology unit for up to $16 billion. In exchange, GSK will acquire Novartis’ vaccine business, excluding its flu products, for up to $7.1 billion, plus royalties. The two companies will also form a joint venture in consumer healthcare products, combining Novartis’ over-the-counter pharmaceuticals business with GSK’s consumer operations.
- Pfizer Inc.: In the acquisition of InnoPharma, Inc., a privately held sterile product development company focused on developing complex generic and innovative specialty pharmaceutical products in injectable and ophthalmic dosage forms, for an upfront cash payment of $225 million, with up to $135 million of contingent milestone payments.
- Pfizer Inc.: In a worldwide licensing agreement with OPKO Health Inc., granting Pfizer exclusive rights to develop and commercialize OPKO’s long-acting human growth hormone (hGH-CTP) for the treatment of growth hormone deficiency in adults and children, for an upfront payment of $295 million with up to $275 million of contingent milestone payments plus undisclosed royalties.
Corporate Counseling, Investigations & Compliance
- Novartis: Convinced federal prosecutors not to pursue allegations of off-label promotion of Novartis’s anti-eczema drug Elidel, won a dismissal of the underlying qui tam litigation in federal court, and negotiated a favorable settlement with Texas, the only state to pursue the allegations.
- Novartis: In a matter involving the Assistant US Attorneys in the Southern District of New York (SDNY) and various other state Attorneys General Offices.
- Novartis: In IT and business process outsourcing transactions to manage regulatory compliance.
- Complete Genomics: Obtained the complete dismissal with prejudice of all claims filed against our client, whose groundbreaking technology has driven the cost of human genome sequencing below $5,000 per genome. The settlement represented a total victory for Complete Genomics, who made no payment and took no license to any of the four patents asserted in the two lawsuits.
- Pfizer: As a charter member of Pfizer’s Legal Alliance, we advised the pharma giant on myriad matters, including the high-profile victory before the U.S. District Court for the Eastern District of Virginia when Pfizer defeated Teva Pharmaceutical’s attempt to bring a generic version of Viagra® to the market, thereby preserving Pfizer’s patent exclusivity for its blockbuster drug through 2019.
- Endo Pharmaceuticals Inc.: National counsel in product liability litigation, including an MDL, involving testosterone products regarding claims of heart attack, stroke and related cardiac issues.
- Pfizer (and its subsidiaries): National coordination counsel on all hormone therapy (HT) litigation matters, including defending subsidiaries Wyeth, Pharmacia and Upjohn in West Virginia—classified by the American Tort Reform Foundation as a “judicial hellhole”—winning a jury verdict that the clients’ HT products did not cause the plaintiffs’ breast cancer.
- Pfizer and Wyeth: National counsel in the Reglan litigation. Plaintiffs claim that Reglan caused patients to develop movement disorders. The litigation involves the cutting edge theory of innovator liability. Virtually all of the plaintiffs ingested generic versions of Reglan, but plaintiffs argue that the brand manufacturer can be liable for injuries associated with that ingestion because of their control of the label.