- Harold H. Fox, Ph.D.
+1 202 429 6284
- John J. Molenda, Ph.D.
+1 212 378 7540
- FCPA / Anti-Corruption
- Intellectual Property
- International Regulation & Compliance
- IP Litigation
- Trade Secrets
Pharmaceuticals & Biotechnology
Steptoe’s intellectual property practice assists clients in the pharmaceutical and biotechnology industries in identifying IP assets, and successfully enforcing and protecting those assets through the legal experience and technical understanding that the lawyers and specialists in our practice possess. Steptoe counsels clients in both:
Our patent litigation practice blends Steptoe’s noted litigation strength—the firm is ranked by Chambers USA and The National Law Journal cites us as one of the most frequently used outside litigation counsel by Fortune 500 companies—with strong scientific and technological experience. Our pharmaceutical and biotech litigation team has asserted and defended patent rights in over 30 Hatch-Waxman and 505 (b)(2) litigations, trials, and appeals.
Steptoe lawyers also have considerable experience at the US Court of Appeals for the Federal Circuit, the appellate court that hears all patent cases, and has represented clients in all manners of appeals from the US Patent and Trade Office (USPTO), Federal District Courts, and the International Trade Commission (ITC). Our lawyers have experience at the court through prior clerkships, the Court’s Advisory Council, and leadership roles at the Federal Circuit Bar Association.
We help companies build pharmaceutical and biotechnology patent portfolios through identifying and protecting IP assets, performing IP due diligence of acquisition targets, advancing and managing new discoveries, and strategically analyzing others patent holdings. We assist research institutions, pharmaceutical companies, and biotechnology companies in formulating corporate policy on the development, acquisition, and exploitation of their biomedical assets, including patents. In addition, we provide:
- ANDA—pre FDA and pre-litigation diligence
- FDA Citizen petitions, controlled correspondence
- Enforceability, Infringement, and Validity Opinions
- Patent Preparation and Prosecution
- Patent Licensing, Support, and Negotiation
- Patent Landscape Analysis
We also negotiate and draft agreements for collaborative arrangements, including joint ventures and strategic alliances.
In addition, we work closely with PBMs on multiple matters including significant ERISA issues.
Select News & Events
- Steptoe Further Expands Intellectual Property Practice in New York
- Steptoe Expands IP Practice in New York with Patent Litigator John Molenda
- ERISA Attorneys Win Twice for Caremark
- “US Biosimilars” ACI
- Planning Committee, "Lex Mundi Intellectual Property Practice Group and Life Sciences Practice Group Joint Global Meeting"
- After Ariad v. Lilly: Implications and Best Practices