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ANDA and Pharmaceutical Patent Litigation Practice

LeClairRyan offers a comprehensive national and international ANDA and pharmaceutical patent litigation practice. We have represented generic and brand companies in disputes relating to numerous pharmaceuticals, including several billion-dollar drug products. LeClairRyan’s team of experienced litigators, patent attorneys, and patent agents apply their keen technical knowledge to provide clients with an integrated approach to ANDA and pharmaceutical patent litigation.

Our team includes professionals who have advanced degrees in chemical engineering, chemistry, biology, toxicology, biophysics, structural biology, biophysical and computational chemistry, microbiology, and immunology. This technical depth combined with our extensive pharmaceutical litigation experience allows us to offer the full range of services necessary to manage and successfully prosecute pharmaceutical patent litigations.

Our distinctive ANDA and pharmaceutical patent litigation strengths include:

  • Patent portfolio analysis and opinions
  • Paragraph IV certification letters 
  • Pleadings and motion practice
  • Expert reports, depositions and testimony 
  • Claim construction analysis, briefing and Markman hearings
  • Patent trials
  • Federal Circuit appeals
  • International Trade Commission (ITC) proceedings
  • Discovery
  • International patent enforcement
  • Licensing and settlement strategies

Patent Portfolio Analysis and Opinions
Our attorneys are routinely asked to evaluate the patent landscapes and provide non-infringement, validity, and/or freedom to operate opinions with respect to pharmaceutical patents and products, including Orange Book patents. With our deep technical capabilities, our team is well equipped to analyze the formulation, method of use, polymorph, compound, and process of making patents relevant to pharmaceutical products.

Paragraph IV Certification Letters
Members of our team have extensive experience analyzing certification letters, including Paragraph IV certification letters, to determine compliance with the Federal Food, Drug and Cosmetic Act.

Pleadings and Motion Practice
Our team has prepared every variety of complaints, counterclaims, discovery requests, discovery motions, dispositive motions, and pre-trial motions in ANDA and pharmaceutical patent litigations. We combine legal acumen and technical knowledge in drafting pleadings, discovery motions, and dispositive motions. In drafting pleadings and handling motion practice, we maintain our focus on the facts, the law, and our client’s business objectives, and work to effectively manage legal costs. We strive to avoid pointless motion practice, engaging in discovery battles only when it significantly benefits a client’s case.

Expert Reports, Depositions and Testimony
Members of our team are experienced working with national and international experts in drug formulation, synthetic chemistry, polymorphism, pharmacology, industrial chemistry, analytical testing, and many more disciplines. We have drafted scores of expert reports and defended dozens of expert depositions, both in the U.S. and overseas. We have worked with leading experts in the U.S., Canada, Europe, and Australia, including experts whose innovative forensic techniques have proven beneficial for our clients.

Claim Construction Analysis, Briefing and Markman Hearings
Claim construction can be the crux of patent litigation and frequently is the difference between winning and losing. Our team is well versed in claim construction discovery, briefing and Markman hearing strategies. From the outset of every case, our team focuses on the key claim construction issues, and we craft our case strategy to maximize the strength of our claim construction positions.

Patent Trials
We have successfully conducted numerous patent trials on a full spectrum of technologies through the development of solid case theory, thorough preparation and sound execution. Our trial attorneys understand not only patent law, but the science behind case facts, and use that knowledge to develop and skillfully execute winning trial strategies. In addition, our substantial trial experience in a variety of legal venues enables us to persuasively present complex technology issues in a way that a lay judge or jury can understand, and prevail at trial.

Federal Circuit Appeals
Members of our team have successfully represented numerous clients in Federal Circuit appeals of preliminary injunction, claim construction, and summary judgment decisions as both appellants and appellees. Underlying our appellate success are the tenets that thorough understanding of the facts and the law, strong brief writing and precise oral advocacy win appeals.

ITC Proceedings
Our team is experienced in Section 337 cases at ITC proceedings, which address intellectual property disputes involving imported goods. These ITC proceedings involve rules very different from federal court litigation and expedited schedules. Our lawyers apply their combined knowledge of the ITC’s procedures and patent law to give our clients an edge in ITC proceedings.

Discovery Solutions
Modern litigation is increasingly influenced by the demands of electronic discovery. The cost, business disruption, and complexity of electronic discovery, particularly within the complex legal and technological framework of pharmaceutical litigation, requires a unique, multidisciplinary skill. LeClairRyan’s pharmaceutical patent litigation team is backed by a depth of experience in electronic discovery, including management of multiple litigations involving productions in excess of one million documents. We effectively use the latest technology and leading contract attorney services to achieve the highest quality electronic discovery service at the lowest cost.

International Discovery
ANDA and pharmaceutical patent litigations often involve international parties and frequently play out on a global scale. Our attorneys have managed letters rogatory, overseas plant inspections, European seizure proceedings, and conducted international document and deposition discovery. We have developed a network of highly qualified and experienced foreign counsel who aide us in these efforts.

International Patent Enforcement
Our team has crafted international patent strategies for numerous clients, including coordination of international patent procurement, international discovery, managing international patent enforcement action, and overseeing patent trials in foreign jurisdictions in Europe, Canada, India, Japan, New Zealand and Australia.

Licensing and Settlement Strategies
We have successfully negotiated favorable licensing and settlement agreements for generic and brand companies in the context of pharmaceutical disputes. When licensing or settlement opportunities are presented, our team can employ broad experience in intellectual property licensing to achieve the best possible business resolutions for our clients.

Representative Matters

ANDA, Pharmaceutical and ITC

  • Abbott Labs. et al. v. Biovail Labs. Int’l. SRL et al. (Valeant), No. 09-0005 (D.N.J.)
  • New York University v. Lupin, No. 09-483 (D. Del.)
  • Albany Molecular Research, Inc. v. Sandoz Inc., No. 09-4639 (D.N.J.)
  • Evonik Degussa GmbH v. Materia, Inc., No. 09-636 (D.Del.)
  • Aventis Pharmaceuticals Inc. v. Dr. Reddy’s Laboratories, Ltd., No. 04-1075 (D.N.J.)
  • Depomed, Inc. v. Lupin Pharmaceuticals, Inc., No. 09-5587 (D.N.J.)
  • Aventis Pharmaceuticals Inc. v. Impax Laboratories, Inc., No. 04-1076 (D.N.J.)
  • New York University v. Sandoz, No. 11-162 (D.Del.)
  • GlaxosmithKline Biologicals S.A. v. Novartis Vaccines, No. 10-1620 (D. D.C.)
  • Aventis Pharmaceuticals Inc. v. Mylan Pharmaceuticals, Inc., No. 04-1077 (D.N.J.)
  • New York University v. Impax, No.09-703 (D. Del.)
  • Aventis Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., No. 04-1078 (D.N.J.)
  • Elan Pharma Int’l. Ltd. et al. v. Biovail Labs. Int’l. SRL et al. (Valeant), No. 08-5412 (D.N.J.)
  • Aventis Pharmaceuticals Inc. v. Sandoz Inc., Civil No. 04-3944 (D.N.J.)
  • Applied Medical Resources Corp. V. Covidien, No. 11-01406 (S.D.C.A.)
  • Albany Molecular Research, Inc. v. Dr. Reddy’s Laboratories, Ltd., No. 09-4638 (D.N.J.)
  • Nycomed US Inc., et al. v. Tolmar, Inc., No. 10-2635 (D.N.J.)
  • New York University v. Mylan, No. 09-184 (D.Del.)

International Patent Disputes 

  • AMR Technology, Inc. v. Novopharm, Ltd., File No. 5119 0002 (Canada)
  • AMR Technology, Inc. v. DiPharma Francis s.r.l., Docket Role No. 78929/06 (Italy)
  • AMR Technology, Inc. v. Alphapharm Pty Ltd., Civil No. VID 219/2007 (Australia)
  • AMR Technology, Inc. v. Arrow Pharmaceuticals Pty Ltd., No. VID 883/2007 (Australia) 


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  • 804.916.7160