We represent leading pharmaceutical companies in Hatch-Waxman and BPCIA patent litigation and Patent Office proceedings, including recent district court cases, appeals, and inter partes reviews on behalf of Pfizer, Hospira, Actavis, Allergan, Amneal, and Array Biopharma. We appear regularly in the courts most often associated with Hatch-Waxman and biologics patent litigation, including the District of New Jersey and the District of Delaware, and are quite familiar with the judges and practices in those courts. We regularly handle appeals in the Federal Circuit, and have a track record of success at the district and appellate level.

We have a robust practice counseling clients in pharmaceutical patent matters, from advising on product development and patent clearance matters to navigating the interface of patent and regulatory exclusivities to preparing for litigation or adversarial Patent Office proceedings on a developed product that has not yet been subject to a lawsuit.

We represent patent holders as well as developers of biosimilar and generic drugs. For example, we represented Hospira and Orion in obtaining a district court judgment against Sandoz protecting the validity and enforceability of the patent for the active ingredient in the sedative Precedex. We represented Nautilus in ANDA litigation against two generic challengers on four patents related to novel formulations and methods of treating migraines using diclofenac.

In addition, we have been working on biologics patent matters for many years. We are currently handling one of the first cases to be litigated under the BPCIA, involving recombinant erythropoietin, and are at the forefront of this actively developing area. We also provide strategic advice and patent counseling to clients on confidential matters involving pending biosimilars.

We represent clients in patent litigation in a variety of diverse areas, including: online software, encryption algorithms, network and telecommunications, financial trading systems, digital signal processors, automated external defibrillators, and other medical devices.

We also handle more than just patent litigation. For example, we have significant experience in bankruptcy litigation for high-tech companies involving IP. We represented the Board of the UK Pension Protection Fund and the trustees of the Nortel Networks UK Pension Trust Limited, which is a pension plan involving 40,000 former employees of Nortel with a funding deficit in the billions of dollars. As such, our client was one of the largest creditors in the global bankruptcy proceedings involving the Nortel companies. We worked with our bankruptcy and litigation departments in this multi-jurisdictional bankruptcy that was the subject of an unprecedented joint US/Canadian trial. Our team focused on the allocation of proceeds from the sale of Nortel’s assets, including a $4.5 billion portfolio of telecommunications patents. We received favorable trial decisions from the Delaware and Canadian courts, and settled the case favorably on appeal.

Our team has experience in copyright, trademark, and trade secret litigation, including the cases below.  We also handle additional matters for clients before the U.S. Patent & Trademark Office Trademark Trial and Appeal Board. We have also coordinated the handling of trademark infringement litigation abroad for clients such as Bloomberg L.P. and GFI.  The Willkie IP Team has also worked on copyright litigation, including significant victories at the trial and appellate level.

In many transactions, the intellectual property and the related products, services and technology are often the most crucial asset.  Maximizing the value and minimizing business risk requires an understanding of the technology and the business. Our intellectual property lawyers counsel clients on a full range of legal services related to the acquisition, development, commercialization, protection, and enforcement of intellectual property rights and related technology assets.  We have a diverse client base, for whom we regularly handle complex intellectual property transactions world-wide that often necessitate cutting edge and novel approaches in order to get the deal done.  We act as trusted counsel and strategic advisors to our clients on patents, trademarks, copyrights, trade secrets and other issues related to high-technology, such as outsourcing, cybersecurity, and management of open source software.  

Our intellectual property transactional services include the negotiation and drafting of all major documents affecting the use, acquisition, and disposition of intellectual property, including joint ventures, joint-development and strategic alliances, inbound and outbound license agreements, development agreements (e.g., application development and related support), vendor agreements from both a vendor and customer perspective, outsourcing, offshoring and shared services agreements, R&D agreements, co-promotion and marketing agreements, IP acquisition/disposition agreements, commercial-facing IP agreements (e.g., manufacturing, sourcing/supply, service provider and distribution agreements), and M&A-related technology agreements (e.g., transition services agreements). We help our clients evaluate and manage intellectual property risks, develop and implement strategies to protect and enforce their intellectual property to achieve their business goals, restructure their intellectual property assets or acquire intellectual property assets from distressed situations, and evaluate and implement branding and licensing strategies.