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Jenny Shmuel, Ph.D. Photo

Background

 

Dr. Jenny Shmuel represents clients on a range of intellectual property matters, with an emphasis on medical device and pharmaceutical technologies. She has extensive experience in pre-suit diligence, case management, expert and fact discovery, and brief writing, and has examined and cross-examined witnesses at trial.

Over the last several years, Dr. Shmuel has helped successfully defend Gilead’s HCV franchise and secured a significant damages award for a medical device manufacturer. Dr. Shmuel has represented pharmaceutical clients in competitor litigation, Hatch-Waxman litigation, and biosimilar litigation. Since joining the firm, Dr. Shmuel has worked to build Fish’s biologics/biosimilar practice. She is a frequent contributor to Fish’s Litigation Blog and regularly presents seminars and webinars on hot topics in biosimilar litigation.

Dr. Shmuel earned her Ph.D. in Materials Science and Engineering from MIT in 2009. Her doctoral work focused on biological applications for polymer thin films.

Education

J.D., Harvard Law School 2012
cum laude


Ph.D., Massachusetts Institute of Technology 2009
Materials Science & Engineering


B.S., Massachusetts Institute of Technology 2004
Materials Science & Engineering

Admissions

  • Connecticut 2012
  • Massachusetts 2012
  • U.S. District Court for the District of Massachusetts

Memberships & Affiliations

​Women's Bar Association of Massachusetts​

Other Distinctions

Selected Presentations

Shmuel, JA, Whelan, DP, Francis, TM “Hot Topics in Biologics/Biosimilar Disputes,” West LegalEdcenter Webcast, July 19, 2018.

Shmuel, JA, Adkisson, JC, Francis, TM, “Biosimilars – A Year in Review,” Fish & Richardson Presentation, January 18, 2018.

Shmuel, JA, Adkisson, JC, “Boston Seminar Series: Biosimilars Litigation – A Mid-Year Review,” Fish & Richardson Presentation, August 9, 2017.

Shmuel, JA, Adkisson, JC, Francis, TM, “Webinar Series: Biosimilars – Recent and Upcoming BPCIA Guidance from the Federal Circuit and the Supreme Court,” Fish Webinar, May 23, 2017.

Selected Publications

Shmuel, JA, Francis, TM, “Focus on Competition in U.S. Biosimilars Market Heats Up in Summer of 2018,” Fish Litigation Blog, August 31, 2018.

Shmuel, JA, Francis, TM, “FDA Releases Biosimilars Action Plan,” Fish Litigation Blog, July 20, 2018.

Shmuel, JA, Francis, TM, “Live from the 9th Annual Summit on Biosimilars,” Fish Litigation Blog, June 28, 2018.

Shmuel, JA, Francis, TM, “Senator Hatch: Choose IPR or an Abbreviated Regulatory Pathway, But Not Both,” Fish Litigation Blog, June 25, 2018.

Shmuel, JA, Francis, TM, “New Draft Guidance on FDA Meetings, But Nothing Further on Substantive Requirements for Biosimilars and Interchangeables,” Fish Litigation Blog, June 20, 2018.

Shmuel, JA, Francis, TM, “No Declaratory Judgment Jurisdiction in Dispute Over Avastin® Biosimilar Launch Date; Questions Remain,” Fish Litigation Blog, April 27, 2018.

Shmuel, JA, Francis, TM, Murphy, BF, “Declaratory Judgment Litigation Brought by Biosimilar Manufacturers,” Fish Litigation Blog, February 26, 2018.

Shmuel, JA, Francis, TM, Chamberlin, BL, “Biosimilars 2017 Year in Review,” Bloomberg Law, February 6, 2018.

Shmuel, JA, Francis, TM, “Federal Circuit Simplifies BPCIA Disputes by Finding State Remedies Preempted,” Fish Litigation Blog, December 20, 2017.

Shmuel, JA, Francis, TM, Kraning-Rush, CM, “The Herceptin® Battle Moves into the District Court,” Fish Litigation Blog, November 22, 2017.

Shmuel, JA, Francis, TM, “Federal Circuit Provides Guidance on Probative Value of “Patent Dance” Letters and aBLA Parameters in an Infringement Analysis,” Fish Litigation Blog, November 15, 2017.

Shmuel, JA, Francis, TM, “BPCIA At Fed. Circ.: Awaiting Guidance On Patent Dance,” Law360, October 12, 2017.

Shmuel, JA, “List it or Lose it: The Federal Circuit Weighs in on the Amgen v. Hospira Discovery Dispute,” Fish Litigation Blog, August 11, 2017.

Shmuel, JA, Francis, TM, “The Ramifications of Leaving the Patent Dance Floor,” Fish Litigation Blog, August 3, 2017.

Shmuel, JA, Kraning-Rush, C, “PTAB Splits on Instituting Challenges to Herceptin® Patents,” Fish Post-GrantAugust 2, 2017.

Shmuel, JA, Vogel, RF, “The Amgen v. Sandoz Disclosure Disputes Continue,” Fish Litigation Blog, July 27, 2017.

Shmuel, JA, Kraning-Rush, C, “Pfizer Takes Aim at Herceptin® Patent at the PTAB,” Fish Post-Grant, July 12, 2017.

Shmuel, JA, Francis, TM, “Thought Leaders Gather at 8th Annual ACI Biosimilars Summit,” Fish Litigation Blog, June 14, 2017.

Shmuel, JA, Francis, TM, “SCOTUS Unravels Some of the BPCIA Enigma — But Questions Remain,” Fish Litigation Blog, June 13, 2017.

Kraning-Rush, C, Shmuel, JA, Francis, TM, “The Last “Cabilly” Challenge Quietly Settles,” Fish Post-Grant, May 25, 2017.

Shmuel, JA, Francis, TM, “Justices Struggle With BPCIA Enigma,” Law360, April, 28, 2017.

Shmuel, JA, Francis, TM, Torabi, NZ, “Protective Agreements Before and During BPCIA Litigation: Prosecution and Regulatory Bars,” Fish Litigation Blog, April 7, 2017.

Shmuel, JA, Vogel, RF, Francis, TM, “First Biosimilar Monoclonal Antibody in Oncology Granted EU Approval: Implications for the U.S. Market,” Fish Litigation Blog, March 14, 2017.

Shmuel, JA , Nellesen, GF, “Dismissal Demonstrates Need for Clarity on BPCIA Disclosure Steps,” Fish Litigation Blog, March 13, 2017.

Shmuel, JA, Kraning-Rush, C, Francis, TM. “Rituxan® Patents Resurface at the PTAB,” Fish Post-Grant Alerts, March 10, 2017.

Shmuel, JA, Nellesen, GF, “REMICADE® Cell Powder Trial Postponed While Court Addresses Standing and BPCIA Remedies,” Fish Litigation Blog, March 3, 2017.

Shmuel, JA, Nellesen, GF, “Biosimilar Litigants Dispute Probative Value of Statements Exchanged During the Patent Dance,” Fish Litigation Blog, February 27, 2017.

Shmuel, JA, Francis, TM, Nellesen, GF, “Genentech Seeks “Urgent” Relief from Amgen’s Alleged BPCIA Violations,” Fish Litigation Blog, February 17, 2017.

Shmuel, JA, Francis, TM, Nellesen, GF, “Biosimilar Litigants Square Off Before the Supreme Court,” Fish Litigation Blog, February 16, 2017.

Shmuel, JA, De Cock, JM and Francis, TM, “Dance Partners Janssen and Celltrion Face Off in Trial Scheduled for February 2017Fish Litigation Blog, February 07, 2017.

Shmuel, JA, Francis, TM, “Janssen Files Opening Appeal Brief in Attempt to Revive Remicade® PatentFish Litigation Blog, February 02, 2017.

Shmuel, JA, Francis, TM, “Biosimilars: What to Expect in 2017,Fish Litigation Blog, January 23, 2017.

Shmuel, JA, Francis, TM, Nellesen, GF, “Patent Challengers Must Show Harm to Appeal Final PTAB Decisions,” Fish Post-Grant Blog, January 20, 2017.

Shmuel, JA, Francis, TM, Nellesen, GF, “Biosimilars: Looking Back and Looking Ahead,” Bloomberg Law: Pharmaceutical Law & Industry Report, January 18,  2017.

Shmuel, JA, Francis, TM, “Amgen v. Sandoz: SCOTUS to Solve the Riddle Wrapped in a Mystery Inside an Enigma,” Fish Litigation Blog, January 17, 2017.

Shmuel, JA, Francis, TM, Wheatley, KE, “Confidentiality in BPCIA Cases,” Fish Litigation Blog, January 05, 2017.

Shmuel, JA, Francis, TM, Nellesen, GF, “Amgen Opposes Apotex’s Petition for Certiorari,” Fish Litigation Blog, November 18, 2016.

Shmuel, JA, Francis, TM, Nellesen, GF, “Amgen Crystallizes Disagreement in Appeal of Discovery Row,” Fish Litigation Blog, November 17, 2016.

Shmuel, JA, Francis, TM, Terhufen, TN, “New Developments in AbbVie’s BPCIA Suit Targeting Amgen’s Humira® Biosimilar,” Fish Litigation Blog, November 14, 2016.

Shmuel, JA, Nellesen, GF, “Hospira Fires Back in Appeal of BPCIA Discovery Dispute,” Fish Litigation Blog, October 31, 2016.

Shmuel, JA, Nellesen, GF, and Francis, TM, “Mylan and the Biosimilars Council Urge Supreme Court to Overturn Amgen v. Apotex,” Fish Litigation Blog, October 21, 2016.

Shmuel, JA, Kraning-Rush, CM, and Francis, TM, “Biogen Dodges IPR Bullet on Key Tysabri® Patents,” Fish Litigation Blog, October 20, 2016.

Shmuel, JA, Rubin, EJ, and Francis, TM, “Amgen Appeals Loss of Neulasta® and Neupogen® Litigation,” Fish Litigation Blog, October 7, 2016.

Shmuel, JA, and Rubin, EJ, “Court Orders Entry of Final Judgment of Invalidity in Ongoing Janssen v. Celltrion BPCIA Dispute,” Fish Litigation Blog, September 30, 2016.

Shmuel, JA, Chamberlain, HC, and Francis, TM, “Amgen’s Humira Biosimilar Becomes the Fourth FDA Approved Biosimilar,” Fish Litigation Blog, September 27, 2016.

Shmuel, JA, Chamberlain, HC, and Francis, TM, “Amgen Argues “Entire Balance of BPCIA” in Jeopardy unless Federal Circuit Discovery Ruling,” Fish Litigation Blog, September 20, 2016.

Shmuel, JA, WJ, and Francis, TM, “The Dance Continues: Apotex Petitions the Supreme Court for Review,” Fish Litigiation Blog, September 19, 2016.

Shmuel, JA and Francis, TM, “Amgen Loses BPCIA Suit Against Apotex’s Neulasta® and Neupogen® Biosimilars,” Fish Litigation Blog, September 8, 2016.

Shmuel, JA and Francis, TM, “FDA Approves Sandoz’s Biosimilar of Enbrel®,” Fish Litigation Blog, August 31, 2016.

Shmuel, JA, and Bandli, RM, “Court Invalidates Janssen Remicade® Patent for Double Patenting; Celltrion Seeks Speedy Appeal,” Fish Litigation Blog, August 25, 2016.

Shmuel, JA, “Federal Circuit Denies Motion to Dismiss Appeal of BPCIA-Related Discovery Order,” Fish Litigation Blog, August 15, 2016.

Shmuel, JA, and Francis, TM, “Amgen Can Enforce Notice of Commercial Marketing for Epogen® Biosimilar,” Fish Litigation Blog, August 8, 2016.

Shmuel, JA, and Francis, TM, “Amgen DJ to Compel Patent Dance Dismissed ,” Fish Litigation Blog, July 26, 2016.

Shmuel, JA, Francis, TM, and Pechette, AM, “Fall-Out from the Federal Circuit’s Decision in Amgen v. Apotex,” Fish Litigation Blog, July 14, 2016.

Shmuel, JA, and Francis, TM, “Notice of Commercialization is only Effective After FDA-Approval Regardless of Whether Parties Dance,” Fish Litigation Blog, July 11, 2016.

Shmuel, JA, and Francis, TM, “You Can’t Patent Dance Your Way Out of Biosimilar Notice,” Law360, July 8, 2016.

Shmuel, JA, Francis, TM, and Pechette, AM, “Janssen Uses Manufacturing Info Obtained in BPCIA Litigation to Target Supplier,” Fish Litigation Blog, June 17, 2016.

Shmuel, JA, Francis, TM, and Jack, SE, “Amgen v. Sandoz—The Biosimilars Battle Continues,” Fish Litigation Blog, June 15, 2016. 

Shmuel, JA, Francis, TM, and Pechette, AM, “Janssen Continues BPCIA Litigation Against Celltrion But Eyes New Target,” Fish Litigation Blog, June 10, 2016.

Shmuel, JA and Francis, TM, “Janssen Seeks Expedited Trial Following FDA Approval of Remicade Biosimilar,” Fish Litigation Blog, April 13, 2016. 

Shmuel, JA and Francis, TM, “Biosimilar Law May Head to the Supreme Court,” Fish Litigation Blog, February 17, 2016. 

Shmuel, JA and Chacon, MA, “Diagonostics Patent Eligibility: A Turning Point Approaches,” Life Sciences Intellectual Property Review, February 16, 2016.

Shmuel, JA and Iwanicki, JP, “The Attack on Patentable Subject Matter: ACLU v. Myriad Genetics as a Harbinger of Things to Come,” BNA Patent, Trademark & Copyright Journal, August 27, 2010.

Lichter JA, et al. “Design of antibacterial surfaces and interfaces: Polyelectrolyte multilayers as a multifunctional platform,” Macromolecules, 42 (22), 8573–8586, 2009.

Hajicharalambous CH, Lichter JA, et al. “Nano- and sub-micron porous polyelectrolyte multilayer assemblies: biomimetic surfaces for human corneal epithelial cells,” Biomaterials, 9 (23-24), 4029-4036, 2009.

Lichter JA and Rubner MF “Polyelectrolyte Multilayers with Intrinsic Antimicrobial Functionality: The Importance of Mobile Polycations,” Langmuir, 25 (13), 686–7694, 2009.

Lichter JA, et al. “Substrata Mechanical Stiffness Can Regulate Adhesion of Viable Bacteria,” Biomacromolecules, 9 (6), 1571–1578, 2008.

Thompson MT, Berg MC, Tobias IS, Lichter JA, Rubner MF, Van Vliet KJ. “Biochemical functionalization of polymeric cell substrata can alter mechanical compliance,” Biomacromolecules, 7 (6), 1990-1995, 2006.

What's trending with Jenny

Filter by
News
February 23, 2018
Fish & Richardson Wipes Out $2.5 Billion Patent Verdict Against Gilead Sciences on JMOL
Press Release
Fish Litigation Blog
August 31, 2018
Focus on Competition in U.S. Biosimilars Market Heats Up in Summer of 2018
Focus on Competition in U.S. Biosimilars Market Heats Up in Summer of 2018
Authors: Jenny Shmuel, Ph.D., Tasha M. Francis, Ph.D.
IP Litigation
Life Sciences
Fish Litigation Blog
July 20, 2018
FDA Releases Biosimilars Action Plan
FDA Releases Biosimilars Action Plan
Authors: Jenny Shmuel, Ph.D., Tasha M. Francis, Ph.D.
Fish Litigation Blog
June 28, 2018
Live from the 9th Annual Summit on Biosimilars
Live from the 9th Annual Summit on Biosimilars
Authors: Jenny Shmuel, Ph.D., Tasha M. Francis, Ph.D.
IP Litigation
Life Sciences
Fish Litigation Blog
June 25, 2018
Senator Hatch: Choose IPR or an Abbreviated Regulatory Pathway, But Not Both
Senator Hatch: Choose IPR or an Abbreviated Regulatory Pathway, But Not Both
Authors: Jenny Shmuel, Ph.D., Tasha M. Francis, Ph.D.
IP Litigation
Life Sciences
Fish Litigation Blog
June 20, 2018
New Draft Guidance on FDA Meetings, But Nothing Further on Substantive Requirements for Biosimilars and Interchangeables
New Draft Guidance on FDA Meetings, But Nothing Further on Substantive Requirements for Biosimilars and Interchangeables
Authors: Jenny Shmuel, Ph.D., Tasha M. Francis, Ph.D.
IP Litigation
Life Sciences
Fish Litigation Blog
April 27, 2018
No Declaratory Judgment Jurisdiction in Dispute Over Avastin® Biosimilar Launch Date; Questions Remain
No Declaratory Judgment Jurisdiction in Dispute Over Avastin<sup>®</sup> Biosimilar Launch Date; Questions Remain
Authors: Jenny Shmuel, Ph.D., Tasha M. Francis, Ph.D.
IP Litigation
Life Sciences
Fish Litigation Blog
February 26, 2018
Declaratory Judgment Litigation Brought by Biosimilar Manufacturers
Declaratory Judgment Litigation Brought by Biosimilar Manufacturers
Authors: Brendan Murphy, Jenny Shmuel, Ph.D., Tasha M. Francis, Ph.D.
Life Sciences
Fish Litigation Blog
February 9, 2018
Biosimilars 2017 Year in Review
Biosimilars 2017 Year in Review
Authors: Brianna Chamberlin, Jenny Shmuel, Ph.D., Tasha M. Francis, Ph.D.
IP Litigation
Life Sciences
Event
January 18th, 2018 | 1:00 pm EST
Biosimilars - A Year In Review
Biosimilars - A Year In Review
Webinar
Fish Litigation Blog
December 20, 2017
Federal Circuit Simplifies BPCIA Disputes by Finding State Remedies Preempted
Federal Circuit Simplifies BPCIA Disputes by Finding State Remedies Preempted
Authors: Jenny Shmuel, Ph.D., Tasha M. Francis, Ph.D.
IP Litigation
Life Sciences
Fish Litigation Blog
November 22, 2017
The Herceptin® Battle Moves into the District Court
The Herceptin® Battle Moves into the District Court
Authors: Casey M. Kraning, Jenny Shmuel, Ph.D., Tasha M. Francis, Ph.D.
IP Litigation
Life Sciences
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