Natasha L. White

Natasha L. White is a partner at Rakoczy Molino Mazzochi Siwik LLP.

Litigation

Ms. White’s practice focuses on intellectual property litigation, with an emphasis on patent infringement suits arising under the Biologics Price Competition and Innovation Act (BPCIA) and the Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act.

Ms. White has extensive experience in all stages of pharmaceutical litigation including pre-litigation strategy development and diligence, fact and expert discovery, motion practice, preliminary injunction proceedings, Markman hearings, pre-trial and trial, and appeals. Ms. White has represented clients in proceedings before U.S. District Courts and the Federal Circuit. Additionally, Ms. White has experience with proceedings before the Patent Trial and Appeal Board.

Ms. White’s broad litigation experience includes a variety of technological fields including biosimilar drug products, devices and manufacturing processes with respect to the same, small molecule chemistry, pharmaceutical compounds, pharmaceutical formulations, polymorphic forms of active pharmaceutical ingredients, extended release dosage forms, injectable dosage forms, inhalation dosage forms, topical dosage forms, and pharmaceutical dosing methods.

Ms. White also assists clients with negotiating favorable settlement and licensing arrangements in connection with pending litigation.

Regulatory and Legislative Counseling

Ms. White is also involved in the firm’s regulatory counseling practice, helping clients navigate various statutory and regulatory issues arising under the Hatch-Waxman Act, the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), and the Biologics Price Competition and Innovation Act (BPCIA)). Specifically, Ms. White has experience with administrative submissions to the U.S. Food and Drug Administration and U.S. Patent and Trademark Office, including comments to proposed regulations and rules.

Additionally, Ms. White assists clients with evaluating federal legislative proposals affecting the pharmaceutical sector, including amendments to the Hatch-Waxman Act, the BPCIA, and patent reform under the America Invents Act (AIA).

Representative Matters

• AstraZeneca LP et al. v. Breath Ltd. et al. (D.N.J.) (Fed. Cir.), Pulmicort® (budesonide) represented generic manufacturer Breath in successful district court and appellate litigation ultimately finding all asserted patents not infringed or otherwise invalid
• Amgen Inc. v. Mylan Inc. et al. (W.D. Pa.), Neulasta® (pegfilgrastim) (represented Mylan in district court litigation granting motion to dismiss for non-infringement with respect to Mylan’s biosimilar)
• Purdue Pharma L.P. v. Mylan Pharms. Inc. (S.D.N.Y. 2013) (Fed. Cir.), Oxycontin® (oxycodone) represented Mylan in Federal Circuit appeal upholding motion to dismiss
• Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, 13-cv-00391 (D.N.J.), Xyrem® (sodium oxybate)
• Kowa Co., Ltd. et al. v. Mylan, Inc. et al. (S.D.N.Y.), Livalo® (pitavastatin)‘
• Indivior Inc. et al v. Aveva Drug Delivery Systems, Inc., 19-cv-60757 (S.D. Fl.), Suboxone® (buprenorphine and naloxone)
• Mylan Pharmaceuticals, Inc. v. Genentech, Inc. & City of Hope (PTAB), Herceptin® (trastuzumab)
• Ferring Pharms. Inc. v. Lupin Inc. (D. Del.), Clenpiq® (sodium picosulfate / magnesium oxide / anhydrous citric acid oral solution)

Previous Experience

Prior to joining Rakoczy Molino Mazzochi Siwik LLP as an associate, Ms. White worked at as a Judicial Extern for the Honorable Ronald A. GuzmÁn and also worked at Fermilab National Laboratory.