Litigation & Dispute Resolution

Our litigators have clerked for judges and bring seasoned trial depth. We know how to prepare a case for trial, have tried patent cases to verdicts before judges and juries, and regularly handle major patent-related arbitrations. We have successfully litigated cases in most significant patent jurisdictions in the country. We also have a depth of experience before the International Trade Commission (ITC). We have a longstanding, highly successful appellate litigation practice. We also regularly appear before the Patent Trial and Appeal Board (PTAB) in Inter Partes Review (IPR), Covered Business Method (CBM), and Post Grant Review (PGR) proceedings, while efficiently managing simultaneous litigation.

• Litigation in Federal District Court, State Court, and at the
  International Trade Commission (ITC)
• Hatch-Waxman (ANDA) litigation
• Appellate Advocacy before the Federal Circuit (CAFC)
• AIA Dispute Proceedings at the Patent Trial and Appeal
  Board (PTAB)

Intellectual Property

Our IP team assists clients with a wide range of issues, including litigation and transactions.  A hallmark of our transactional practice is our experience structuring, negotiating, and drafting strategic collaboration, licensing, co-development, co-promotion, technology transfer and various types of commercial agreements, ranging from highly-complex global alliances to more standard licensing agreements.  We work collaboratively with our clients to develop pragmatic, flexible agreements that promote productive and lasting relationships by focusing on the shared business goals of all parties.

Corporate Transactions

Our experienced corporate attorneys assist clients with a wide range of transactional issues, including structuring, negotiating, and drafting strategic collaboration, licensing, co-development, copromotion, technology transfer and various types of commercial agreements. We help companies form domestic and global alliances and advance business operations. We work collaboratively with our clients to develop pragmatic, flexible agreements that promote productive and lasting relationships by focusing on the shared business goals of all parties.

• Leveraging IP and other Corporate Assets
• Negotiations with Business Partners
• Drafting Contracts (Settlement Agreements, Licenses,
  Non Disclosure Agreements, Confidentiality
  Agreements, Non-Compete Agreements)
• Drafting and Negotiating Clinical Trial Agreements and
  Contracts with Institutional Review Boards (IRB)
• Transactional Due Diligence and Opinion Letters
• Non-dispute Licensing

Regulatory Compliance

Our Regulatory Compliance Practice encompasses the full range of pharmaceutical, biotechnology, medical device, food and beverage, dietary supplement, and cosmetics issues.  We represent pharmaceutical, biotechnology, and medical device clients on matters spanning the product life cycle, from product development and clinical trials, through the FDA premarket review process, to post-marketing compliance, including pharmacovigilance, adverse event reporting, Good Manufacturing Practice (GMP) and Quality System requirements, and sales and marketing. We also advise clients on complex issues relating to Hatch-Waxman, biosimilars, and orphan products. We assist clients in all aspects of product development, safety, labeling, and promotion.