Madison C. Jellins is an experienced transactional and IP legal strategist with expertise in advising health tech, digital health, biopharma, medical device and tech clients on global transactional, patent, regulatory, compliance and privacy issues. She has significant experience drafting, negotiating and enforcing U.S. and global commercial, operational and collaborative research agreements. She advises clients on privacy issues including HIPAA, GDPR and CCPA. She also advises clients on compliance issues such as anti-kickback, Stark, FCPA, and FDA promotional issues.
Madison has significant experience in patent litigation and strategic counseling for biopharmaceutical and medical device clients. She has served as lead counsel in patent cases in multiple district court jurisdictions and at the Federal Circuit. She is a registered patent attorney and has particular expertise in patent and regulatory strategy, including the FDA approval process for small molecules, biologics, biosimilars, and combination products.
Madison also handles appellate matters before the Federal Circuit and frequently lectures on Federal Circuit case law developments and patent/regulatory issues. She has a particular expertise in claim construction and Markman proceedings.
She clerked for the Hon. Helen W. Nies, former Chief Judge of the Federal Circuit. She has been recognized as a Northern California Super Lawyer in IP Litigation in 2009-2019.
Madison was formerly a partner in the IP litigation group of Alston & Bird LLP and a partner in the patent litigation group at Townsend LLP.
Direct: (650) 241-0192
Sarif Biomedical LLC v. Accuray Inc. Lead counsel for defendant in patent infringement case in D. Delaware.
Radiation Stabilization Solutions, LLC v. Accuray Inc. Lead counsel for defendant in patent infringement case in N.D. Illinois.
Best Medical Int'l, Inc. v. Accuray Inc. Lead counsel for defendant in patent infringement case in W.D. Pa.
PDL BioPharma Inc. v. Sun Pharmaceutical Industries Ltd. Lead counsel for plaintiff in ANDA patent infringement action in D.N.J. concerning intravenous calcium channel blocker for treatment of hypertension.
E-Pass v. Visa Int'l Serv. Ass'n, Visa USA Inc. Represented defendant in patent infringement action in N.D. Cal. concerning smart card technology. Summary judgment of non-infringement granted. 2006 U.S. Dist. LEXIS 95914 (N.D. Cal. 2006). Court awarded attorney fees based on exceptional case under 35 U.S.C. § 285.
IDEC Pharm. Inc. v. Corixa Corp. Represented defendant in patent infringement action in S.D. Cal. concerning radio-labeled antibody for treatment of non-Hodgkin's lymphoma.
Genentech v. Amgen, Inc. Represented defendant in patent infringement action in N.D. Cal. concerning recombinant cloning vehicles and methods of microbial expression of polypeptides. Summary judgment of non-infringement granted. Judgment precluding infringement under doctrine of equivalents affirmed. 289 F.3d 761 (Fed. Cir. 2002).
SmithKline Beecham Corp. v. Excel Pharm. Inc. Represented defendant in ANDA patent infringement action in E.D. VA concerning generic drug for treatment of depression. Defendant's motion for summary judgment of non-infringement granted. 214 F.Supp.2d 581 (E.D. Va. 2002).
Telectronics Pacing Sys., Inc. v. Ventritex Inc., Intermedics v. Ventritex Inc. Represented accused infringer in two declaratory judgment/patent infringement actions in N.D. Cal. on 35 U.S.C. Â§ 271(e)(1) exemption to patent infringement concerning cardiac defibrillators. Summary judgment of non-infringement granted.
Intervet, Inc. v. Merial Ltd. Represented appellant in appeal to the Federal Circuit from summary judgment of non-infringement concerning a porcine vaccine. Claim construction reversed, summary judgment of non-infringement vacated, case remanded to determine infringement under correct claim construction. (Fed. Cir. 2010).
E-Pass v. Visa Int'l Serv. Ass'n, Visa USA Inc. Represented defendant-appellee in appeal to Federal Circuit. Summary judgment affirmed. 473 F.3d 1213 (Fed. Cir. 2007).
Lead counsel for appellee in appeal to the Federal Circuit from an award of attorney fees based on exceptional case under 35 U.S.C. § 285. Affirmed without opinion.
Translogic Technology, Inc. v. Hitachi Ltd. Represented appellant in appeal to Federal Circuit from final judgment in patent infringement action, overturning an $86 million judgment and permanent injunction. 250 Fed. Appx. 988 (Fed. Cir. 2007), reh'g denied, 2008 U.S. App. LEXIS 13886 (Fed. Cir.), cert. denied (December 1, 2008).
In re Translogic Technology, Inc. Represented intervenor in appeal to Federal Circuit from Board of Patent Appeals and Interferences decision on reexamination finding all claims unpatentable for obviousness. Board decision affirmed. 504 F.3d 1249 (Fed. Cir. 2007), reh'g denied, 2008 U.S. App. LEXIS 2755 (Fed. Cir.), cert. denied (October 7, 2008).
Brown v. Barbacid. Represented junior party in appeal to Federal Circuit from BPAI decision on interference. 436 F.3d 1376 (Fed. Cir. 2006).
Merck KGaA v. Integra Lifesciences, Inc. Represented San Diego Intellectual Property Law Association on Amicus brief to U.S. Supreme Court concerning 35 U.S.C. § 271(e)(1) exemption to patent infringement and its implication for research tools.
Philips v. AWH Corp. Represented amici on Amicus brief to Federal Circuit concerning claim construction.
University of Rochester v. G.D. Searle. Represented eleven public and private universities on Amicus brief to U.S. Supreme Court on written description requirement under 35 U.S.C. § 112.
University of Rochester v. G.D. Searle. Represented University of California and University of Texas on two Amicus briefs to the Federal Circuit on written description requirement under 35 U.S.C. § 112.
Telectronics Pacing Sys., Inc. v. Ventritex Inc., Intermedics v. Ventritex Inc. Represented defendant-appellee in two appeals to the Federal Circuit from grant of summary judgment of non-infringement based on 35 U.S.C. § 271(e)(1) exemption to patent infringement .Decisions affirmed. 982 F.2d 1520 (Fed. Cir. 1992); 1993 U.S. App. LEXIS 3620 (Fed. Cir. 1993).
Representative Speaking Engagements:
PLI Fundamentals of Patent Litigation, San Francisco, 2011-2016
Speaker: "The Markman Process and Hearing"
AAPS 2013 National Biotechnology Conference, San Diego, May 2013
Speaker: Patent and Regulatory Issues for Biosimilars
Licensing Executives Society, San Francisco, August 2012
LA IPLA Spring Seminar, La Jolla , June 2012
Panelist: Patentable Subject Matter
ACI Hatch-Waxman Boot Camp, San Diego, June 2012
ALM IP Counsel Forum, San Jose, March 2012
Panelist: Implications of Recent Case Law
ACI PIV Disputes, San Francisco, December 2011
Co-Chair, Panelist: "No Holds Barred – Fighting for or Defending Against the Coveted 180-Day Exclusivity"
ACI Hatch-Waxman Boot Camp, San Diego, July 2011
Featured Speaker: Master Class: "Biosimilars Strategy Session"
ACI Biosimilars, NYC, June 2011
Panelist: "Debating the Practical Implications of a 12-Year Exclusivity Period – Striking a Balance Between Innovator and Biosimilar Interests"
ACI PIV Disputes, NYC, May 2011
Scheduled Moderator and Panelist: "Forfeiture of Exclusivity Dilemmas for PIV Litigation;" Submitted presentation: "Shared Exclusivity, Relinquishment, Selective Waiver, and Parking of Exclusivity"
BIO IPCC Spring Meeting, Seattle, April 2011
Panel Chair and Speaker: "Biosimilars"
ACI Medical Device Patent Litigation, Boston, January 2011
Panelist: "Patent Litigation for Drug and Device Combination Products: Preparing for the Intersection between Medical Devices and Hatch-Waxman Litigation"
AHLA Life Sciences Practice Group Luncheon, Washington D.C., January 2011
Featured Speaker: "New Approval Pathway for Biosimilars: Next Steps, Open Issues and Implications for Biotech and Generic Industries"
ACI Paragraph IV Disputes, San Francisco, December 2010
Panelist: "Recent Decisions Impacting PIV Challenges and Motion Practice"
IIR Business of Biosimilars, Boston, September 2010
Speaker: "Assessing the Impact of Past and Present Cases on the Biopharmaceutical Industry"
ACI FDA Boot Camp, San Francisco, August 2010
Speaker: "Spotlight on Follow-On (Comparable or Biosimilar) Biologics and the 2010 Healthcare Reform Act"
ACI Hatch-Waxman Boot Camp, San Diego, July 2010
Panelist: "How the Dynamics of Follow-On Biologics Will Change the Hatch-Waxman Landscape;" Teacher,
Master Class: "Follow-On Biologics"
ACI Follow-On Biologics, NYC, June 2010
Panelist: "Patentability of Diagnostics and Gene Sequencing in Light of AMP v. Myriad;" Featured Speaker: Workshop: "Patent Term Extensions and Adjustments to Optimize Biologic Patent Lifecycle"
BIO IPCC Spring Meeting, New Orleans, April 2010
Panel Chair: "Patent Law Updates: Ariad v. Eli Lilly; AMP v. Myriad; Bilski v. Kappos"
Silicon Valley Intellectual Property Law Association Meeting, Silicon Valley, 2010
Featured Speaker: "Written Description Requirement after Ariad v. Eli Lilly"
API China, Beijing, November 2009
Speaker: "Basics of Hatch-Waxman Litigation"
Tianjin Institute of Pharmaceutical Research, Tianjin, November 2009
Speaker: "Strategies in Paragraph IV Litigation"
Tasly Pharmaceuticals 2-Day Training Seminar, Tianjin, November 2009
Speaker: "Strategies in Paragraph IV Litigation and Opportunities in Biosimilars"
Duke Univ. School of Law, Raleigh, Hot Topics in Intellectual Property, February 2009
Speaker: "Stumbling Blocks to Approval of A Regulatory Regime for Follow-On Biologics"
ACI Paragraph IV Disputes, NYC, 2008
Panelist: "Identifying and Analyzing How the Latest Trends in CAFC Decisions, PTO Rules and Patent Reform Legislation Impact Paragraph IV Motion Practice and Litigation Strategies"
Lecturer Santa Clara University School of Law
Intellectual Property Litigation (Summer 2012, Summer 2011)
Janice's practice focuses on corporate transactions, intellectual property, privacy, regulatory and compliance matters for clients ranging from well established, large and midsize publicly traded corporations to young, privately held start-ups. She regularly advises biopharma, medical device, health tech, digital health, financial services and tech companies on global transactional, patent, copyright, trademark, privacy, regulatory and compliance issues.
Janice's legal expertise includes drafting, negotiating and enforcing global commercial, software as a service (SaaS), collaborative research and technology licensing and transfer agreements.
She frequently counsels clients on privacy issues including HIPAA, GDPR and CCPA. She also counsels clients on compliance issues such as anti-kickback, Stark, FCPA, and FDA promotional issues.
Janice has an extensive litigation background from her years at AmLaw 100 firms. She has litigated patent infringement suits in the U.S. District Courts, the U.S. Court of Federal Claims, and the ITC, and appeals to the U.S. Courts of Appeals for the Federal Circuit and the Second Circuit. Her experience includes advising clients on FDA regulatory filings under the Hatch-Waxman Act and litigating patent infringement suits under the Hatch-Waxman Act.
Janice is a registered patent attorney and also has significant experience analyzing issues of patent infringement and validity prior to litigation. She has rendered opinions on these issues (including freedom to operate, product clearance and Paragraph IV opinions) in a variety of technical fields.
Janice is admitted to the New York bar and currently practices in New York.
Prior to joining Jellins Christensen LLP, Janice was counsel in the New York IP Litigation Group of Alston & Bird LLP. Janice began her legal career as associate at the IP boutique firm Morgan & Finnegan LLP in New York.
Direct: (347) 394-5349
Best Medical Int'l Inc. v. Accuray, Inc., Case No. 10-cv-1043 (W.D. Pa.)
Radiation Stabilization Solutions, LLC v. Accuray, Inc., Case No. 11-cv-7700 (N.D. Ill.)
Sarif Biomedical LLC v. Accuray, Inc., Case No. 13-151- (D. Del.)
Takeda Pharmaceuticals Co. Ltd. et al. v. Mylan Pharmaceuticals, Inc., Case No. 11-cv2506 (D.N.J.)
Medicis Pharma. Co. et al. v. Actavis Mid Atlantic LLC, Case. No. 11-cv-00409 (D. Del.)
Cima Labs Inc. et al. v. Mylan Pharmaceuticals, Inc., Case No. 10-cv-625 (D. Del.)
Orion Corp. v. Mylan Pharmaceuticals, Inc., Case No. 11-cv-0078 (D. Del.)
Cephalon Inc. et al. v. Teva Pharmaceuticals USA Inc. et al., Case No. 09-cv-0918 (D. Del.)
In Re: Armodafinil Patent Litigation, MDL No. 10-md-2200
San Francisco Technology, Inc. v. Maybelline LLC et al., Case No. 10-cv-5931 (S.D.N.Y.)
Mallinckrodt, Inc. et al. v. E-Z-EM, Inc. et al., Case No. 07-cv-262 (E.D. Tex.)
Mallinckrodt, Inc. et al. v. E-Z-EM, Inc. et al., Case No. 09-cv-228 (D. Del.)
Nokia Corp. v. InterDigital Inc. et al., Case Nos. 11-3040-cv and 10-c1358-cv (2d Cir.)
Travel Tags, Inc. v. UV Color, Inc. et al., Case No. 09-cv-1619 (D. Mn.)
Clear With Computers, LLC v. Belkin Int’l Inc., Case No. 08-cv-0188 (E.D. Tex.)
Kollmorgen Corporation v. United States of America, Case No. 04-cv-1661 C (U.S. Ct. Cl.)
Medinol, Ltd. v. Guidant Corp. et al., Case No. 03-cv-2604 (S.D.N.Y.)
Medtronic Vascular, Inc. v. Boston Scientific Corp., Medinol, Ltd. et al., Case No. 98-cv-47 (D. Del.)
IPC Information Systems, LLC v. The Odyssey Group, Inc., Case No. 04 CV 9822 (S.D.N.Y.)
Casco Products Corp. v. Valeo Vision S.A.S., Case No. 02-cv-2327 (S.D.N.Y.)
In re: Products and Pharmaceutical Compositions Containing Recombinant Human Erythropoietin, No.
337-TA-568 (Represented Respondent Hoffman-La Roche in ITC Section 337 Investigation related to recombinant human erythropoietin)
Representative Speaking Engagements:
NYIPLA Fall 2014 Patent CLE Seminar, "Legal Update: Patent Trial and Appeal Board"
November 20, 2014 at the Princeton Club
"The PTAB in 2014: Highlights from the Second Year of Post - Issuance Proceedings"
published in the New York Intellectual Property Law Association Bulletin, February/March 2015
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