Matthew V. Anderson

Matthew V. Anderson is a partner at Rakoczy Molino Mazzochi Siwik LLP. He is registered to practice before the United States Patent and Trademark Office and holds a Master of Science in biotechnology.

Litigation

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

Mr. Anderson has experience representing clients in proceedings before numerous U.S. District Courts as well as the Federal Circuit Court of Appeals. Specifically, Mr. Anderson has experience in a number of stages of litigation, including pre-suit strategy development, fact and expert discovery, the pre-trial and trial phases of federal litigation, and at the federal appellate level.

Mr. Anderson has experience with respect to a wide range of pharmaceutical technologies, including with respect to small molecule chemistry, biologic or biosimilar products, pharmaceutical compounds, pharmaceutical formulations, polymorphic forms of active pharmaceutical ingredients, immediate and extended release dosage forms, injectable dosage forms, inhalation dosage forms, topical dosage forms, and/or pharmaceutical dosing methods and devices.

Practice Before the U.S. Patent and Trademark Office

Mr. Andersonis registered to practice before the United States Patent and Trademark Office and also has significant experience with inter partes‘review petitions, including preparation of IPR petitions, related discovery, and oral argument before the PTAB.

Opinion Work and Patent Counseling

Mr. Andersonhas experience in the firm’s patent counseling practice group. In this context, Mr. Anderson has prepared opinions of counsel for clients on a variety of intellectual property issues and with respect to a wide range of pharmaceutical technologies, including with respect to small molecule chemistry, pharmaceutical compounds, pharmaceutical formulations, polymorphic forms of active pharmaceutical ingredients, immediate and extended release dosage forms, inhalation dosage forms, and pharmaceutical dosing methods.

Mr. Anderson has also prepared a number of detailed statements in support of a number of different regulatory filings including with respect to Abbreviated New Drug Applications and abbreviated Biologics License Applications.

Mr. Anderson has also prepared a number of freedom to operate opinions and has assisted clients with their due-diligence efforts.

Regulatory Counseling

Mr. Anderson also has significant experience in the firm’s regulatory counseling practice, including statutory and regulatory issues arising under the Hatch-Waxman Act, the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), and/or the Biologics Price Competition and Innovation Act (BPCIA)).

Representative Matters

Mitsubishi Tanabe Pharma Corp., et al. v. Aurobindo Pharma USA, Inc., et al. (D.N.J. 2021): Represented Lupin Limited and Lupin Pharmaceuticals, Inc. in Hatch-Waxman litigation concerning patents related to INVOKANA® (canagliflozin), INVOKAMET® (canagliflozin / metformin hydrochloride), and INVOKAMET XR® (canagliflozin / metformin hydrochloride extended-release). Case resolved by settlement with favorable terms for client.

In re Copaxone 775 Patent Litigation (D. Del. 2019):‘Represented Sandoz Inc. in Hatch-Waxman litigation concerning patent related to filtration manufacturing process of glatiramer acetate. Case resolved by settlement with favorable terms for client.

In re Copaxone 40 mg Consolidated Cases (Fed. Cir. 2018): Represented Sandoz Inc. in a Hatch-Waxman litigation concerning patents related to COPAXONE® (glatiramer acetate injection). Part of trial and appellate team that obtained decision in favor of client finding all asserted claims not infringed and/or invalid.

Merck Sharp & Dohme Corp. (f/k/a Schering Corp.) v. Apotex Inc., et al.(D.N.J. 2018; Fed. Cir. 2013;): Member of team that successfully representedApotexInc. andApotexCorp. at trial and on appeal in patent litigation against Merck Sharp &DohmeCorp. (f/k/aScheringCorp.) concerning patents related toNASONEX® (mometasone furoate monohydrate), an inhaled nasal steroid product. On appeal, the Federal Circuit affirmed the decision of non-infringement by the United States District Court for the District of New Jersey.

ViiV Healthcare UK Ltd., et al. v. Lupin Ltd., et al.(D. Del. 2014): RepresentingLupinLtd. andLupinPharmaceuticals, Inc. in patent litigation againstViiVHealthcare UK Ltd. concerning patent related toTRIZIVIR® (abacavir/lamivudine/zidovudine). Part of team that obtained decision in favor of client finding all asserted claims not infringed.

Previous Experience

Prior to joining Rakoczy Molino Mazzochi Siwik LLP as an associate, Mr. Anderson worked as in-house Patent Counsel at the Oklahoma Medical Research Foundation and as a Disease Specialist for Merck & Co., Inc. He also worked as a summer law clerk at an intellectual property and regulatory boutique law firm.

Prior to attending law school, Mr. Anderson worked at Rush University Medical Center as a Research Assistant.