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Andrew Berdon is a Partner in the New York office of Quinn Emanuel Urquhart Oliver & Hedges, LLP.  Mr. Berdon is a litigator and trial lawyer with extensive experience in the area of ANDA litigation under the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act.  Mr. Berdon also represents clients in complex litigation matters, including: business disputes, antitrust, regulatory enforcement and white collar criminal investigations, internal corporate investigations, and corporate governance matters.

Within the pharmaceutical industry, Mr. Berdon has represented the following clients in significant litigation and counseling matters: 
 
Stiefel Laboratories/Connetics Corp.
Medicis Pharmaceutical Corporation
Actavis Group
Wockhardt USA, Inc.
Mutual Pharmaceutical Company
Reliant Pharmaceuticals
Par Pharmaceuticals/Kali Laboratories
Barr Laboratories/Pliva, Inc.
SkyePharma plc
Purepac Pharmaceutical Co./Faulding Pharmaceuticals

Represented Reliant Pharmaceuticals as lead counsel in FDA regulatory proceedings and related patent litigation regarding competing branded cholesterol lowering agents.  Successfully opposed a Citizen's Petition asking FDA to block approval of Reliant's product and then served as lead counsel in a declaratory judgment action brought under the patent laws seeking to hold four of its competitors' patents not infringed, invalid and unenforceable.  Prior to trial, the matter was settled on terms that permitted the Reliant product to remain on the market without the payment of past royalties.
 

Represented Kali Laboratories, a subsidiary of Par Pharmaceuticals, as lead counsel in ANDA patent litigation relating to the anti-epilepsy treatment Diastat(R).  Following the completion of discovery and filing of the parties' joint pre-trial order, the plaintiff agreed to a settlement that will provide Kali with the right to market a generic version of Diastat and Diastat AccuDial three years prior to patent expiration.
 

Represented Purepac Pharmaceutical Co. as lead counsel in two FDA regulatory litigation matters adverse to Apotex Corp. regarding the right to 180-day generic market exclusivity for gabapentin tablets.  In both cases, Purepac was granted summary judgment in favor of its position as the sole holder of this exclusivity, which allowed Purepac to form the generic market for a $2.4 billion branded drug.  Both holdings were later upheld on appeal.
 

Represented Mutual Pharmaceutical Co. as lead counsel in FDA regulatory and related patent litigation relating to Mutual's ANDA seeking approval to market a generic version of the drug Periostat(R).  After litigating two motions for preliminary injunctions, Mr. Berdon was successful in opposing the plaintiffs' motion to stay discovery on Mutual's defense that the patents in suit were unenforceable due to the inequitable conduct of the named inventors.  Prior to the depositions of the named inventors, the plaintiffs agreed to a settlement that provided Mutual with the immediate right to enter the market with its own branded version of the product, and a fully-paid, royalty free license to market a generic version of the product upon the formation of the generic market.
 

Mr. Berdon has also conducted numerous internal corporate investigations and provided confidential advice to the boards of publicly traded corporations regarding internal compliance and corporate integrity matters.