Cynthia Lambert Hardman, a partner in Goodwin's IP Litigation Group and chair of the firm’s PTAB Practice, is a go-to patent litigator for complex patent cases in U.S. district courts, the U.S. International Trade Commission (ITC), and the U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB).

Ms. Hardman represents clients in the pharmaceutical, biosimilar, medical device, nutritional supplement, and consumer product industries. She has deep experience in ANDA cases under the Hatch-Waxman Act and in inter partes reviews (IPRs), having appeared in over 30 pharma and biosimilars-related IPRs. She also litigates cases involving a wide range of other technologies and products such as spinal fixation devices, home pregnancy tests, and video content analysis systems and software.

Ms. Hardman's practice also extends to pre-litigation counseling, including rendering opinions on to patentability, infringement, validity and freedom-to-operate issues.

Ms. Hardman co-founded and co-authors Goodwin’s PTAB newsletter, The PTAB Trial Tracker, which analyzes PTAB, district court, and Federal Circuit decisions that impact post-grant review proceedings. Ms. Hardman is also an editor and regular contributor to the firm’s biosimilars blog, Big Molecule Watch. Ms. Hardman is also an active participant in the firm’s Cannabis practice.

 

Experience

ERFAHRUNG

工作经历

Recent PTAB victories include:

  • Successfully prevented institution of IPR on client's patent directed to certain deuterated drug compounds.
  • Achieved victory for IPR petitioner on patent to a method of using an anti-cancer biologic. The decision helps clear our client's path to launching a biosimilar.
  • Achieved victory for patent owner in IPRs involving patents on a novel drug dosing regimen. The decisions help protect our client's innovative drug.
  • Achieved victory for IPR petitioner on patents to methods of using a nitrogen-scavenging drug. The decisions help clear our client's path to launching a generic drug.

Significant Hatch-Waxman and other litigation victories include:

  • Invalidated five patents involved in an ANDA bench trial relating to an extended release ADHD suspension. The decision helps clear our client's path to launching its generic drug.
  • Represented a pharmaceutical company against a multi-billion dollar damages claim in a jury trial concerning an epilepsy drug.  Case settled during trial, resulting in a favorable settlement. 
  • Invalidated five patents involved in an ANDA bench trial for a client sued for infringing patents for treatment of overactive bladder. The Federal Circuit affirmed.
  • Defended a specialty supplements company concerning their krill oil products before the ITC, in a case that extended to the PTAB. A favorable settlement was reached.
  • Obtained a $5.7M award at summary judgment for a nutritional supplements company in a trademark and copyright counterfeiting case. 
  • Represented a patent licensee in a patent infringement suit concerning mobile video technology used by spectators at sporting events.
  • Represented a respondent in an ITC patent infringement trial concerning patents covering video analytics technology.
  • Represented a pharmaceutical company in an action involving patents for an extended release formulation of an antibiotic. Helped overturn a preliminary injunction, allowing client to market its generic equivalent of the drug.
 
Professional Activities

Ms. Hardman is a contributor to the firm’s Biosimilars Reference Guide, Guide to the Biosimilars Patent Dance, and Big Molecule Watch blog.

She is a member of the Patent Trial and Appeal Board Bar Association and the William C. Conner Inn of Court.

Ms. Hardman’s recent pro bono work includes assisting a student in obtaining special education services.

Professional Experience

Prior to joining Goodwin in 2014, Ms. Hardman was a partner at Kenyon & Kenyon LLP in New York City, where her practice focused on patent litigation and counseling matters.

Recognition

Ms. Hardman has been recognized as a “Rising Star” by Super Lawyers New York (2012-2014). In law school, she served as articles editor for the Journal of Science & Technology Law. In college, she received the Chancellor’s Undergraduate Research Award.

In The News

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在新闻中

Credentials

WERDEGANG

专业资格

Education

J.D., 2001
Boston University School of Law
B.S., Molecular Biology, 1996
University of Pittsburgh
(cum laude)

Admissions

Bar

New York
U.S. Patent and Trademark Office (USPTO)

Courts

U.S. District Court for the Eastern District of New York
U.S. District Court for the Southern District of New York
U.S. Court of Appeals for the Federal Circuit
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