Rachel L. Pernic Waldron

Rachel Pernic Waldron is a partner at Rakoczy Molino Mazzochi Siwik LLP.

Rachel Pernic Waldron is a partner at Rakoczy Molino Mazzochi Siwik LLP, serving clients in the life sciences industry.

Patent and Complex Commercial Litigation

Ms. Waldron’s legal career has been largely focused on complex patent litigation, with a particular focus on Hatch-Waxman litigation.  Ms. Waldron has extensive experience in every facet of litigation, including pre-filing investigations and notice letters, fact and expert discovery, claim construction, mediations, dispositive motion practice, pre-trial and trial practice, and appellate practice.  Ms. Waldron’s broad litigation experience spans a variety of technologies; within the Hatch-Waxman space, her cases have concerned pharmaceutical compounds, pharmaceutical formulation strategies, methods of use, devices, and dosing regimens.  Ms. Waldron also has extensive experience with BPCIA matters, as well as APA matters. 

Representative Matters​

• Boehringer Ingleheim Pharmaceuticals Inc. et al. v. Apotex Inc. et al., No. 23-685-CFC (D. Del.) (linagliptin) (ongoing)
• Janssen Pharmaceuticals, Inc. et al. v. Alkem Laboratories Ltd. et al., No. 23-2939 (D. N.J.) (esketamine) (ongoing)
• Astellas Pharma Inc., et al. v. Sandoz Inc. et al., No. 20-1589-JFB (D. Del.) (mirabegron) (invalidated U.S. Pat. No. 10,842,780)
• Leo Pharma A/S et al. v. Glenmark Pharmaceuticals Ltd., No. 20-1359-CFC (D. Del.) (betamethasone-calcipotriene) (confidential settlement)
• Sun Pharma Global FZE et al. v. Lupin Ltd. et al., No. 18-2213-FLW (D. N.J.) (bromfenac) (invalidated U.S. Pat. No. 8,778,999)
• Teva Pharmaceuticals USA, Inc., et al. v. United States Food and Drug Administration, No. 20-0808-BAH (D. D.C.) (successfully defended FDA’s decision to not transfer Copaxone to a BLA)
• In Re: Copaxone 775 Patent Litigation, No. 16-1267-CFC (D. Del.) (manufacture of glatiramer acetate) (confidential settlement)
• In Re: Copaxone Consolidated Cases, No. 14-1171-GMS (D. Del.) (dosing regimens of glatiramer acetate) (invalidated U.S. Pat. Nos. 8,232,250, 8,399,413, 8,696,302, and 9,155,776 invalid), aff’d In Re: Copaxone Consolidated Cases, No. 17-1575 (Fed. Cir.)
• AstraZeneca Pharmaceuticals LP et al. v. Sandoz Inc. et al., No. 14-cv-03547-RMB (fulvestrant) (confidential settlement)
• ViiV Healthcare UK Ltd. et al. v Lupin Ltd. et al., No. 11-cv-00576-RGA (D. Del.) (abacavir, lamivudine, and zidovudine) (U.S. Pat. No. 6,417,191 not infringed), aff’d ViiV Healthcare UK Ltd. et al. v Lupin Ltd. et al., Nos. 14-1303, -1304, and -1315 (Fed. Cir.)
• Cadence Pharmaceuticals, Inc. et al. v. Sandoz Inc., No. 13-278 (S.D. Cal.) (acetaminophen) (confidential settlement)
• Shire LLC et al. v Mylan Pharmaceuticals et al., No. 11-00055 (N.D. W. Va.) (guanfacine) (confidential settlement)
• Pronova Biopharma Norge AS v. Apotex Corp. et al., No. 09-304-SLR (D. Del.) (omega-3) (confidential settlement)

Previous Experience

Prior to joining RMMS in 2010, Ms. Waldron was a partner at Kirkland & Ellis LLP.