Kyle Musgrove

Practices

Industries

Education and Clerkships

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

Admissions

North Carolina

District of Columbia

New York

U.S. Patent and Trademark Office

Court Admissions

U.S. Court of Appeals for the Federal Circuit

U.S. District Court for the District of Columbia

Profile

C. Kyle Musgrove is a patent trial and appellate lawyer. While he is experienced in many types of patent litigation, his primary focus is on representing life sciences companies. One typical representation involves 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. Other types of representations include providing advice and litigating cases 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.

Professional Recognition

  • Recognized as a leading patent litigator by Intellectual Asset Management (IAM) Patent 1000, Globe Business Media Group, 2019
  • Recognized as a “Life Science Star” by LMG Life Sciences, Euromoney Institutional Investor PLC, 2012-2019

Honors

IAM Patent 1000

Haynes and Boone Lawyers Featured in 2019 IAM Patent 1000 Directory

Intellectual Asset Management (IAM) Patent 1000 has recognized Haynes and Boone and 11 lawyers in the 2019 edition of the independently researched legal directory.

Selected Client Representations

  • 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).

Professional and Community Activities

  • American Bar Association
  • Federal Circuit Bar Association
  • New York State Bar Association
  • District of Columbia Bar Association
  • Mecklenburg County Bar Association
  • North Carolina State Bar Association

Trial Experience

  • Sebela Int’l Ltd. v. Prinston Pharmaceutical Inc. et al. (D.N.J. 2014)
  • GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. (D. Del. 2011) 
  • Alza Corp. and McNeil-PPC, Inc. v. Andrx Pharmaceuticals, LLC and Andrx Corp. (D. Del. 2007)  
  • Pfizer, Inc. v. Synthon Holdings BV, et al. (M.D.N.C. 2006)  
  • SmithKline Beecham Corp. v. Teva Pharmaceuticals USA, Inc. (D.N.J. 2005)  
  • Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline, PLC (E.D. Va. 2002)

Appellate Work

  • Eurand Inc. v. Impax Laboratories, Inc., No. 2012-1280 (Argued) 
  • Alza Corp. and McNeil-PPC, Inc. v. Andrx Pharmaceuticals, LLC and Andrx Corp., No. 2009-1350, 603 F.3d 935 (Fed. Cir. 2010) (Argued) 
  • Impax Laboratories, Inc. v. Aventis Pharmaceuticals, Inc., 545 F.3d 1312 (Fed. Cir. 2008); earlier opinion reported at 468 F.3d 1366 (Fed. Cir. 2006) (Argued)  
  • On-Line Technologies, Inc. v. Bodenseewerk Perkin-Elmer GmbH, 386 F.3d 1133 (Fed. Cir. 2004)  
  • Geneva Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline, PLC, 349 F.3d 1373 (Fed. Cir. 2003)  
  • Evans Medical Ltd. v. American Cyanamid Co., 215 F.3d 1347 (Fed. Cir. 1999) (Unpublished)

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