Life Sciences

Today, life sciences companies are exploring expanded opportunities created by advances in genetics knowledge, research design, computer modeling, big data analytics, mobile devices and apps, global communications, personal communications, cloud-based processing and storage and other technologies. Those opportunities raise new types and levels of risk through increased complexity of products and product delivery systems, as well as expanded regulation, compliance enforcement and litigation.

Our Clients

We have professionals who represent fast-growing clients that use life science technology to create products for health and wellness, healthcare, food production, environmental and other applications. Examples are those in the following sectors: small-molecule pharmaceuticals, biologicals, vaccines, biotechnology, medical devices, diagnostics, veterinary products, foods, nutritional supplements, medical and nonmedical research, personal care products, pharmacies and other distributors of pharmaceutical and medical device products.

Our Services

Our attorneys team with clients to advance opportunities and mitigate risks in all product lifecycle phases — from early development and registration through approval, marketing and disposal. We regularly join forces to work with life sciences clients on matters involving the activities and entities listed below.

Business
  • Corporate formation
  • Mergers and acquisitions
  • Venture capital
Regulatory counseling and litigation
  • Centers for Medicare & Medicaid Services (CMS)
  • Controlled-substance regulation
  • Food and Drug Administration (FDA)
  • Federal Trade Commission (FTC)
  • Government relations and policy advocacy
  • Healthcare
  • International trade (U.S. customs, import, and export)
  • Medicare and Medicaid issues
  • Office of Inspector General (OIG)
  • Pharmacy regulation, licenses, and permits
  • Real estate transactions
  • Securities regulation, compliance, and enforcement
  • Trade associations
  • U.S. taxation
More »
Employment law
  • Employment litigation
  • Family and Medical Leave Act (FMLA) issues
  • Wage and hour litigation
  • Whistleblower and compliance
Intellectual property
  • Patent procurement
  • Patent litigation (including Patent Office trials)
  • Patent strategy and portfolio management
  • Privacy and data protection
  • Purchase, sale and licensing of technology
  • Trademark prosecution and licensing
  • Domain names and Internet issues
Litigation
  • Antitrust and price-fixing investigations and litigation
  • Class action defense
  • Complex commercial litigation
  • Distribution and franchise litigation
  • False advertising litigation
  • Products liability litigation
  • Securities, shareholder and corporate litigation
Our Professionals

Our attorneys and other professionals have long-standing experience representing life sciences clients. That experience has given them deep understanding and a practical view of client needs. More than 50 attorneys have advanced degrees in legal and nonlegal areas that give them insight into highly technical legal issues. Examples of these advanced degrees are Ph.D., organic chemistry; Ph.D., chemical engineering; Ph.D., biophysics; Ph.D., molecular biopharmacology; and Doctor of Veterinary Medicine (DVM). Many are highly ranked by Chambers, Best Lawyers, and other legal directories.

Select Experience

  • Provided tax counsel to the Archer Daniels Midland Company (ADM), a Fortune 27 U.S.-based diverse agribusiness. Due to our strong technical structuring skills and deep knowledge of the company’s business, ADM routinely relies on us for tax structuring-related advice around the globe. For example, we recently advised the company on tax issues in connection with their acquisition and integration of Wild Flavors GmbH, the German-based multinational food ingredients business; their disposition of a fertilizer business in Brazil and Paraguay; and tax issues associated with the formation of a joint venture with Asia’s leading agricultural group.
  • Represent Cardinal Health, one of our long-standing clients, in many of the company’s deal activities and litigation matters, as well as in a variety of specialty areas.
  • Represent Johnson & Johnson on patent prosecution matters, spanning a wide array of therapeutics and medical devices. In addition to patent prosecution, we provide all forms of counseling related to patents and technology, including the purchase, sale and licensing of technology, as well as corporate acquisitions. Our portfolio management includes monitoring competitor products and patents, and providing advice regarding product clearance and patent enforcement.
  • Assisted an Indian pharmaceutical manufacturing company with an OIG self-disclosure involving government pricing of an FDA-regulated product. The company turned to our team based on our experience with the FDA and CMS elements of the project. We drafted documents and interacted with the government for the company. We specifically reviewed the company’s pricing and government reporting compliance policies, advised on enhancing these policies, drafted a disclosure to OIG explaining the compliance lapse involving the price reporting to CMS, discussed the conflict between CMS regulations and FDA’s authorized generic drug regulations, and assisted with OIG negotiations. We also drafted compliance policies for the company that addressed CMS and FDA-authorized generic drug price reporting issues.
  • Defend a major international pharmaceutical company in multiple lawsuits, Equal Employment Opportunity Commission (EEOC) charges, investigations and other administrative matters across several states. Claims range from whistleblower allegations, wage and hour claims, age discrimination, gender discrimination, race discrimination, retaliation, to alleged FMLA violations. In federal court, we defended the company in a whistleblower lawsuit alleging retaliation under the False Claims Act and other counts. The plaintiff, a former pharmaceutical sales representative, alleged retaliatory termination due to her reports of alleged off-label marketing and alleged kickbacks and false claims. We obtained dismissal of the wrongful discharge, breach of contract, and punitive damages claims.
More »

Professionals

Name Title Office Email
Goodarz T. Agahi Partner Costa Mesa
Ron B. Birnkrant Associate Costa Mesa
Barry E. Bretschneider Of Counsel Washington, D.C.
Jessica Captain Novick Partner Orlando
Donna S. Clark Partner Houston
Clayton W. Coley Partner Atlanta
Payal P. Cramer Counsel Atlanta
Thomas W. Dekleva Ph.D. Partner Philadelphia
Geraldine E. Edens Partner Washington, D.C.
Joseph E. Ezzie Partner Columbus
David N. Farsiou Partner Philadelphia
Elizabeth Price Foley Of Counsel Washington, D.C.
Wanda D. French-Brown Counsel New York
John M. Gherlein Partner Cleveland
Matthew D. Graban Partner Cleveland
Michael David Graham Patent Agent Washington, D.C.
Felicity E. Groth Partner Philadelphia
Susan Feigin Harris Partner Houston
David B. Hoffman Counsel Philadelphia
Lindsay P. Holmes Associate Washington, D.C.
Benjamin C. Hsing Partner New York
Irene E. Hudson Partner New York
David P. Kardian Associate Washington, D.C.
Elyssa S. Kates Associate New York
Ronald C. Kern Jr., Ph.D. Associate Philadelphia
Kevin W. Kirsch Partner Cincinnati
Peter J. Knudsen Partner Seattle
Mark H. Krietzman Partner Costa Mesa
Laurice Rutledge Lambert Associate Atlanta
Jacqueline M. Lesser Counsel Philadelphia
Gary H. Levin Partner Philadelphia
Stephanie A. Lodise Ph.D. Partner Philadelphia
Joseph Lucci Partner Philadelphia
Krista L. Lynch Counsel Washington, D.C.
David A. Mancino Partner Cincinnati
Samuel A. McMahon Associate Philadelphia
James L. Moore Partner Houston
John F. Murphy Partner Philadelphia
Francis B. Palumbo Of Counsel Washington, D.C.
Tayan B. Patel Partner Washington, D.C.
Janis M. Penman Partner Washington, D.C.
Aaron B. Rabinowitz Partner Philadelphia
Lee H. Rosebush Partner Washington, D.C.
Jeffrey H. Rosedale Ph.D. Partner Philadelphia
Kathleen P. Rubinstein Healthcare Policy Analyst Houston
Lynn Sessions Partner Houston
Lance L. Shea M.S., J.D. Partner Washington, D.C.
Hans P. Smith Associate Costa Mesa
Christopher J. Swift Partner Cleveland
S. Maurice Valla Partner Philadelphia
Jennifer P. Whitton Associate Atlanta
Alec Wightman Partner Columbus
Kristen McDermott Woodrum Partner Atlanta

Experience

  • Provided tax counsel to the Archer Daniels Midland Company (ADM), a Fortune 27 U.S.-based diverse agribusiness. Due to our strong technical structuring skills and deep knowledge of the company’s business, ADM routinely relies on us for tax structuring-related advice around the globe. For example, we recently advised the company on tax issues in connection with their acquisition and integration of Wild Flavors GmbH, the German-based multinational food ingredients business; their disposition of a fertilizer business in Brazil and Paraguay; and tax issues associated with the formation of a joint venture with Asia’s leading agricultural group.
  • Represent Cardinal Health, one of our long-standing clients, in many of the company’s deal activities and litigation matters, as well as in a variety of specialty areas.
  • Represent Johnson & Johnson on patent prosecution matters, spanning a wide array of therapeutics and medical devices. In addition to patent prosecution, we provide all forms of counseling related to patents and technology, including the purchase, sale and licensing of technology, as well as corporate acquisitions. Our portfolio management includes monitoring competitor products and patents, and providing advice regarding product clearance and patent enforcement.
  • Assisted an Indian pharmaceutical manufacturing company with an OIG self-disclosure involving government pricing of an FDA-regulated product. The company turned to our team based on our experience with the FDA and CMS elements of the project. We drafted documents and interacted with the government for the company. We specifically reviewed the company’s pricing and government reporting compliance policies, advised on enhancing these policies, drafted a disclosure to OIG explaining the compliance lapse involving the price reporting to CMS, discussed the conflict between CMS regulations and FDA’s authorized generic drug regulations, and assisted with OIG negotiations. We also drafted compliance policies for the company that addressed CMS and FDA-authorized generic drug price reporting issues.
  • Defend a major international pharmaceutical company in multiple lawsuits, Equal Employment Opportunity Commission (EEOC) charges, investigations and other administrative matters across several states. Claims range from whistleblower allegations, wage and hour claims, age discrimination, gender discrimination, race discrimination, retaliation, to alleged FMLA violations. In federal court, we defended the company in a whistleblower lawsuit alleging retaliation under the False Claims Act and other counts. The plaintiff, a former pharmaceutical sales representative, alleged retaliatory termination due to her reports of alleged off-label marketing and alleged kickbacks and false claims. We obtained dismissal of the wrongful discharge, breach of contract, and punitive damages claims.

Recognition

  • BTI Client Service 30: BakerHostetler advanced 19 positions to #9 (2016)

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