C. Kyle Musgrove is a patent trial and appellate lawyer. While he is experienced in many types of patent litigation, his primary goal is helping pharmaceutical companies navigate the patent litigation process and bring their products to market pursuant to either an ANDA or a 505(b)(2) application. Kyle also helps and assists clients with advice and litigation relating to biosimilar and biologics applications as well as the medical device industry.

Perhaps most significantly, clients appreciate Kyle’s understanding that the ultimate goal of any engagement is to aid his clients in the pursuit of their business interests. Litigation is often part of that process, but, ultimately, it is merely a component of the process. And, as such, Kyle crafts litigation strategy in close consultation with clients to best achieve the client’s business goals.

In that regard, for nearly a quarter of a century, Kyle has litigated under the Hatch-Waxman Act, particularly in the United States District Courts of Delaware and New Jersey. A number of his cases have involved products with sales exceeding $1 billion per year. Despite the high stakes, Kyle has successfully obtained judgments invalidating and/or holding non-infringed the asserted claims of patents alleged to cover those products. In some instances, his strategic approach has facilitated favorable settlements for his clients while avoiding the uncertainties and expense associated with protracted litigation.

Kyle has litigated cases in a variety of technologies in addition to pharmaceuticals, including medical devices, nutritional supplements, vaccines, and other types of biotechnology. Additionally, Kyle has practiced before the United States International Trade Commission and litigated antitrust violations relating to allegations of “sham” litigation brought by patentees.

Kyle also handles appellate proceedings before the United States Court of Appeals for the Federal Circuit. His experience includes briefing and arguing appeals where the underlying district court litigation was handled by other counsel.

Yet further aspects of Kyle's practice include counseling clients regarding possible infringement or invalidity issues and transactional work relating to intellectual property (including negotiating both license and settlement agreements).

Many of Kyle’s clients are based in countries outside the U.S. Kyle is a frequent author and is often quoted in various media outlets.

Bar Admissions
District of Columbia
New York
North Carolina
U.S. Patent and Trademark Office

Education
J.D., University of North Carolina at Chapel Hill, 1995, with honors; Order of the Coif; Holderness Moot Court Bench; Journal of International Law and Commercial Regulation
B.S., Chemical Engineering, Tulane University, 1992, Omega Chi Epsilon Honor Society

Significant Accomplishments
Biogen Int’l GmbH v. Banner Life Sciences LLC (D. Del. 2018) (Case dismissed)

Bristol-Myers Squibb Co. v. Impax Labs. (D. Del. 2017) (Case dismissed)

Merck Sharp & Dohme Corp. v. Savior Lifetec Corp. (E.D.N.C. 2015) (Case dismissed)

Otsuka Pharmaceutical Co., Ltd. v. Stason Pharmaceuticals Inc. et al. (D.N.J. 2015) (Settled favorably)

Takeda GmbH et al. v. Breckenridge Pharmaceutical, Inc. (D.N.J. 2015) (Settled favorably)

Sanofi-Aventis U.S. LLC v. Breckenridge Pharmaceutical, Inc. (D.N.J. 2015) (Settled favorably)

Otsuka Pharmaceutical Co., Ltd. v. Prinston Pharmaceutical Inc. et al (D.N.J. 2014) (Settled favorably)
Teijin Limited et al v. Prinston Pharmaceutical Inc. (D. Del. 2014) (Settled favorably)

Astrazeneca Pharmaceuticals LP et al. v. Pharmadax USA, Inc. et al (D.N.J. 2014) (Settled favorably)

Eisai Inc. v. Banner Pharmacaps, Inc. (D. Del. 2011) (Settled favorably)

Shionogi Pharma et al v. Impax Labs (D. Del. 2010) (Settled favorably)

Abbott Labs. et al. v. Impax Labs. and Elan Pharma et al. v. Impax Labs. (D.N.J. 2009) (Settled favorably)

Pfizer Inc. et al. v. Impax Laboratories, Inc. (D.N.J. 2008) (Settled favorably)

Purdue et al. v. Impax Laboratories, Inc. (D. Del. 2008) (Dismissed)

Wyeth v. Watson Pharmaceuticals, Inc. and Watson Laboratories, Inc. (D. Del. 2008) (Dismissed)

Abbott Laboratories v. Impax Laboratories, Inc., (D. Del. 2007) (Settled favorably)

Certain Endodontic Instruments, No. 337-TA-610 (ITC 2007) (Investigation Dismissed)

Elan Corp., PLC v. Andrx Pharmaceuticals, Inc. (S.D. Fla. 2005) (Settled favorably)

Abbott Laboratories, et al. v. Impax Laboratories, Inc. (D. Del. 2003) (Infringement portion of case dismissed with prejudice; client's antitrust counterclaims settled favorably)

On-Line Technologies, Inc. v. Perkin-Elmer Corp., et al. (D. Ct. 1999) (Settled favorably after partial summary judgment of invalidity granted on behalf of client)

Alcon Labs. v. Bausch & Lomb (N.D. Tex. 1999) (Settled favorably after preliminary injunction was granted on behalf of client)