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De, Sona

Sona De

パートナー
  • 商取引に関する訴訟及び紛争処理
  • 知的財産権訴訟

Biography

SONA DE is a nationally recognized trial lawyer who has led numerous victories in both bench and jury trials through appeal. She has also argued before the Federal Circuit Court of Appeals and the Multidistrict Litigation Panel, represented clients in arbitration, and defended witnesses overseas under the Hague Convention. She has over 23 years of practice across a range of cases in various technology sectors, with a focus on biologics, pharma/Hatch-Waxman litigation, medical devices/med-tech, crop science/agribusiness, chemicals, tech, and consumer goods. Her work is well recognized, has received several awards, and has been widely reported in the press. Sources in Chambers USA 2022 describe her as “a sophisticated trial lawyer who knows how to get her point across,” with a “notable track record” and “the best cross-examination of an expert witness” they have seen.

In biologics, Sona represented Bayer HealthCare in its jury trial and appeal wins against Baxalta’s flagship hemophilia product. Her segment of the closing argument addressed Baxalta’s non-infringement and invalidity defenses. The jury handed Bayer a complete victory across every liability issue and awarded the largest damages verdict in Delaware for a biologic. The District Court awarded supplemental damages through final judgment, bringing the award to US$182 million. In a sweeping 37-page precedential opinion, the Federal Circuit recently affirmed in Bayer’s favor on every issue that Baxalta appealed. It cited Sona’s direct examination of various experts and cross examination of Baxalta's primary technical expert from the trial record. The case was inducted into The National Law Journal’s “Verdicts Hall of Fame, won LMG Life Sciences’ 2019 “Patent Impact Case of the Year,” and was selected as a “Legal Lion” by Law360 for continued success in post-trial motions.

Sona also represented Amgen/Immunex in its trial win against Sandoz’s biosimilar of Enbrel®, the first time a biologics maker has fully succeeded in blocking a biosimilar under the Biologics Act through the courts. Following a stipulation on infringement and a nearly month-long trial on numerous validity challenges, the district court found in Amgen’s favor across the board. The Federal Circuit affirmed. The case won LMG Life Sciences’ 2020 “Impact Case of the Year.”

In the medical device/med-tech space, Sona was featured as “Litigator of the Week” by The American Lawyer and received the Financial Times’ highest ranking for her role in the innovative strategies and success in the landmark Therasense case involving glucose metering technology. Therasense created a new legal standard for the inequitable conduct doctrine and has been named as one of the top 10 patent decisions of this decade by Law360.

In Hatch-Waxman litigation, she was profiled by InsideCounsel for her role in Bayer HealthCare’s trial win on a formulation patent based on the doctrine of equivalents. Her work for the University of Texas and Purdue in serial trials against multiple generics on three different patent families also won LMG Life Sciences’ 2013 “Hatch-Waxman Impact Case of the Year.”

Sona is ranked by Chambers USA in Intellectual Property for her “notable track record” in life sciences litigation (2021–2025); is recommended by The Legal 500 US (Healthcare: Life Sciences); is recognized for her patent litigation work by the IAM Patent 1000 (2017–2025); is recommended by Who’s Who Legal IP (2023); is ranked among “The Top Women Attorneys in the New York Metro Area”; is recognized in the 2019–2024 LMG Life Sciences guides for Patent Litigation; was shortlisted for LMG Life Sciences’ 2017 “General Patent Litigator of the Year” in New York; and has received In Motion’s “Commitment to Justice Award.” Her prior work experience in the pharmaceutical industry enables Sona to represent clients on various patent issues with an understanding of how companies operate with an eye toward their business needs.

Experience

Representative Matters

  • Bayer Healthcare LLC v. Baxalta Inc., et al. (D.Del): Represented plaintiff Bayer in a US$182 million biologics jury trial win against Baxalta’s flagship hemophilia drug, Adynovate®. Following a six-day trial involving 18 witnesses, the jury found in favor of Bayer across the board on infringement and validity of all asserted claims and issued a damages award that ranks among the top 10 largest Delaware patent verdicts in the last decade.
  • Bayer Healthcare LLC v. Baxalta Inc., et al. (CAFC): Represented appellee Bayer to secure unanimous affirmance on every issue Baxalta appealed. The opinion addressed the scope of disclaimer in claim construction, use of FDA submissions to establish infringement, use of the trial record to overcome enablement challenges, the ability to present a range of potential royalty rates for damages to the jury without specifying a number therein, and a district court’s ability to apply the jury’s chosen rate from within that range for supplemental damages without violating the Seventh Amendment.
  • Sandoz Inc. v. Amgen Inc. et al. (D.N.J.): Represented plaintiff Amgen and its subsidiary Immunex in a patent trial win against a biosimilar to Enbrel®, the first FDA-approved TNF receptor fusion protein. The court found in favor of Amgen/Immunex on all issues. Affirmed on appeal.
  • Baxalta Inc., Baxalta US, and Nektar Therapeutics v. Bayer HealthCare LLC (D.Del.): Represented defendant Bayer HealthCare in a high-stakes competitor case involving the assertion by Nektar Therapeutics and Baxalta of two patent families comprising 12 patents against Bayer for the sale of Bayer’s Jivi® biologic for the treatment of hemophilia. Settled after asserted claims were significantly reduced through depositions and successful summary judgment and the court denied Plaintiffs’ serial motions to dismiss Bayer’s inequitable conduct, unclean hands, and antitrust counterclaims.
  • Amgen v. Amneal et al. (Fed. Cir.): Represented plaintiff-appellant Amgen in serial appeals before the Federal Circuit in abbreviated new drug application (ANDA) litigation concerning Sensipar® for secondary hyperthyroidism against numerous generic defendants. Secured reversal of a claim construction and non-infringement judgment against competitor while affirming infringement against another.
  • Boston Scientific Corp. et al. v. Nevro Corp. (D. Del): Represented Nevro in multi-patent and trade secret litigation relating to high-frequency spinal cord stimulation technology to treat pain. First trial in series of cases resulted in non-infringement verdict in Nevro’s favor on two patents. The parties then reached settlement that concludes all of the existing litigations and includes a net payment from Boston Scientific to Nevro of US$85 million.
  • Merck & Co., Inc. et al. v. Merck KGaA (D.N.J.): Representing Merck & Co., Inc. in a trademark and breach of contract case regarding the use of the name “Merck” in the United States. 
  • Huvepharma EOOD et al. v. Koninklijke DSM et al. (D.Del.): Lead counsel for defendants in patent case involving animal feed additives alleged to be made overseas via patented biologic process. Dismissed with prejudice.
  • Illumina Inc. v. APExBIO Technology LLC (S.D. Texas): Represented Illumina in patent case involving methods for modifying nucleic acids. Competitor sold kits and instructed customers on method of kit use. Obtained injunction against future infringement and favorable settlement on past claims.
  • Beckman Coulter v. Gen-Probe (TTAB): Lead counsel for Beckman Coulter in trademark opposition regarding the use of the mark “Access” in connection with nucleotide and molecular assays. Secured settlement following entry of Beckman’s case-in-chief in trial phase.
  • Therasense, Inc. (Abbott Laboratories) v. Becton, Dickinson & Co. and Nova Biomedical Corp. (N.D. Cal.):* Represented defendants in successful six-year patent suit on four different patents involving diabetes blood glucose monitors that culminated in back-to-back trials. Won summary judgments of non-infringement and/or invalidity on the first two patents and summary judgment of no literal infringement on the third patent. Won the bench trial finding the third patent invalid and unenforceable and secured attorney’s fees. Won the jury trial finding the fourth patent invalid and not literally infringed. Judgment on all patents affirmed in BD/Nova’s favor on appeal. Won remand following en banc rehearing on inequitable conduct of third patent.
  • Roche Diagnostics Operations, Inc. et al. v. Abbott Diabetes Care, Inc. et al. (D. Del.; Fed. Cir.): Represented defendant Nova Biomedical Corp. in a patent suit involving diabetes blood glucose monitors. Won summary judgment dismissing all patent issues based on a successful claim construction. The case was appealed and remanded for further proceedings. Secured successful claim construction again on remand and through second appeal. Affirmed on appeal.
  • Bayer Healthcare Pharmaceuticals et al. v. Glenmark Generics Ltd. et al. (D. Del): Represented plaintiffs in a successful ANDA trial involving topical gel. Defendants had substituted out two of the claimed ingredients in the accused product to avoid literally infringing the patent-in-suit, rendering this a doctrine of equivalents case from the start. Defendants raised non-infringement, estoppel, ensnarement, and obviousness defenses. Won the trial finding the patent valid and infringed. Affirmed on appeal.
  • Leo Pharmaceutical v. River’s Edge Pharmaceutical (D. Atl.): Represented plaintiff in an ANDA case involving a topical dermatological medication. Settled after a successful evidentiary hearing on claim construction. 
  • Arbitration (UNCITRAL): Successfully represented claimant in international dispute involving distribution agreements for analytic medical device. Obtained early judgment dismissing respondent’s counterclaims, leaving no dispute against client’s claims.
  •  Purdue Pharma L.P. et al. v. Watson Laboratories. Inc. et al. and related cases (S.D.N.Y.):* Represented plaintiffs in a series of three trials, each of which involved multiple generic drug manufacturers, on abuse-deterrent oral analgesic. Won infringement issues at trial. Affirmed on appeal.
  • Purdue Pharma Products L.P. et al. v. Par Pharmaceutical, Inc. et al. (D. Del.):* Represented plaintiffs in an ANDA trial involving a 24-hour oral analgesic. Won infringement and enforceability issues at trial. Affirmed on appeal.
  • Multidistrict Litigation No. 2126: In re Tramadol Hydrochloride Extended-Release Tablets Patent Litigation (J.P.M.L.):* Successfully argued for plaintiffs before the Multidistrict Litigation Panel to consolidate ANDA suits against various generics involving a 24-hour oral analgesic.
  • King Pharmaceuticals, Inc. et al. v. Teva Parenteral Medicines, Inc. et al. (D. Del.):* Represented plaintiffs in an ANDA trial involving an automatic injector device for epinephrine. Settled following trial.
  • Arbitration (JAMS):* Successfully represented respondent/counter-claimant in dispute involving supply agreement for analytic medical device.
  •  Sanyo Electric Co., Ltd. v. MediaTek, Inc. et al. (C.D. Cal.):* Represented the plaintiffs in a patent suit involving chips for CD and DVD drives. Won summary judgment dismissing the counterclaim patent based on a successful claim construction. Settled on the eve of trial.
  • Purdue Pharma L.P. v. Endo Pharmaceuticals Inc. et al. (S.D.N.Y.):* Represented plaintiffs in a successful nine-year patent litigation against multiple generic drug manufacturers involving an oral analgesic. Focused on antitrust issues. Defended foreign witnesses on patent liability issues under the Hague Convention. 
  • AstraZeneca Pharmaceuticals v. Mayne Pharma (USA) Inc. (S.D.N.Y.):* Represented plaintiff in a successful ANDA trial involving an anesthetic. Won the trial finding patents infringed, enforceable, and valid. Affirmed on appeal.
  • Zeneca v. Rhone Poulenc (D.Del):* Represented Zeneca in patent litigation involving corn herbicide and chemical safener. Settled favorably on eve of trial.
  • Monsanto v. Zeneca (D.Del):* Litigation involving patent license to Roundup Ready seeds. Settled following discovery.
  • Catheter Flushing LLC v. AngioDynamics et al. (D. Utah):* Represented defendant Becton, Dickinson in a multiparty patent litigation involving catheters. Settled following Becton’s assertion of laches and non-infringement defenses.

*Select matters were handled by Sona prior to joining Sidley. Full case list available on request.

Community Involvement

Membership & Activities

Professional Organizations:

  • Member, Sidley’s Inclusion Committee
  • Member, New York Intellectual Property Law Association (NYIPLA)
  • NYIPLA Women in IP Law co-chair (2011–2015)

Honors & Awards:

  • LMG Life Sciences (General Patent Litigation)
  • The New York Times Magazine’s “Top Women Attorneys in the New York Metro Area” 
  • The American Lawyer’s “Litigator of the Week”
  • IAM Patent 1000
  • The Legal 500 US — Healthcare: Life Sciences
  • Financial Times’ Standout “Lawyers to the Innovators”
  • In Motion’s Commitment to Justice Award
  • New York Super Lawyers

Credentials

Admissions & Certifications
  • U.S. Supreme Court
  • U.S. Court of Appeals, Federal Circuit
  • U.S. District Court, N.D. of California
  • U.S. District Court, C.D. of California
  • U.S. District Court, E.D. of New York
  • U.S. District Court, N.D. of New York
  • U.S. District Court, S.D. of New York
  • California
  • ニューヨーク州
Education
  • University of Southern California Gould School of Law, 法務博士, 1997, Senior Notes Editor, Interdisciplinary Law Journal
  • University of California, Los Angeles, B.S. in Biochemistry, 1992

News & Insights

Articles and Book Chapters:

In the News:

  • Quoted in, “Another Stacked Week of Litigator of the Week Runners-Up and Shout Outs,” The AmLaw Litigation Daily, March 5, 2021.
  • Quoted in, “Bayer's $182 Million Judgment Against Takeda Unit Upheld in Hemophilia Drug Fight,” Reuters, March 1, 2021.
  • “Bayer's $181 Million Patent Win Over Adynovate Upheld,” Bloomberg Law, March 1, 2021.
  • “Fed. Circ. Backs US$173M Bayer Patent Win on Hemophilia Drug,” Law360, March 1, 2021.
  • Quoted in, “After Lull in Biosimilar IP Litigation, 2021 Could Bring Influx,” Law360, January 7, 2021.
  • “Judges Mull Whether Word 'Random' Kills Bayer Patent Win,” Law360, August 31, 2020.
  • Quoted in, “Law360’s Weekly Verdict: Legal Lions & Lambs,” Law360, August 29, 2019.
  • “Takeda Unit Can't Undo $155M Loss In Bayer IP Row,” Law360, August 23, 2019.
  • Quoted in, “Takeda Loses Bid to Nix $155 Million Bayer Win in Drug Case,” Bloomberg Technology, August 23, 2019.
  • Quoted in, “Skilled in the Art: Sidley Gives Amgen a $10 Billion Boost + PTAB Still Leery of Ride Hailing Patent,” Law.com, August 14, 2019.
  • Quoted in, “Amgen Wins Patent Validity Ruling Worth $10 Billion,” Law.com, August 14, 2019.
  • Quoted in, “Why This IBD Stock Of The Day Is No Longer Sweating $5 Billion In Sales,” Investor’s Business Daily, August 13, 2019.
  • Quoted in, “Amgen Could Block Enbrel Biosimilars For Another Decade As Court Rules Stealth Patents Valid,” Pink Sheet | Pharma Regulatory and Policy Insights, August 12, 2019.
  • Quoted in, “Amgen’s Court Win Could Mark ‘a New Dawn’ for the Stock,” Barron’s, August 12, 2019.
  • Quoted in, “Amgen Patents Beat Sandoz Validity Check In Biosimilar Fight,” Law360, August 9, 2019.
  • Quoted in, “Health Care Roundup: Market Talk,” The Wall Street Journal August 9, 2019.
  • Quoted in, “Bayer gets welcome win in US court,” The Pharma Letter, June 2, 2019.
  • Quoted in, “Bayer v. Baxalta,” Global Legal Chronicle, March 29, 2019.
  • Quoted in, “Jury Awards $155M in Damages for Infringement of Bayer Hemophilia Treatment,” Law.com, February 7, 2019.
  • Quoted in, “Jury Awards $155 Million in Damages for Infringement of Bayer Hemophilia Treatment,” Delaware Business Court Insider, February 7, 2019.
  • Quoted in, “Jury Says Takeda Unit Owes Bayer $155 Million Over Hemophilia IP,” IP Law360, February 6, 2019.
  • Quoted in, “Takeda Ordered to pay Bayer $155 for Patent Infringement,” FiercePharma, February 6, 2019.
  • Quoted in, “Takeda’s Hemophilia A Drug: New Data and a $155 Million Patent Infringement Settlement,” BioSpace, February 6, 2019.
  • Quoted in, “Baxalta Owes Bayer $155M for Infringing Hemophilia Drug Patent,” Bloomberg Law, February 5, 2019.
  • Quoted in, “U.S. Jury Orders Takeda to Pay Bayer $155 Million over Hemophilia Drug,” Reuters, February 5, 2019.
  • “Jury Says Takeda Unit Owes Bayer $155M Over Hemophilia IP,” Law360, February 5, 2019.
  • Quoted in, “Patent Lawyers See a Surge in Brand-Name Drug Company Lawsuits,” Law.com, December 13, 2016.
  • Quoted in, “Federal Circuit Affirms J&J Win in Roche Blood Test Case,” IP Law360 , September 23, 2016.
  • Quoted in, “Federal Circuit Rules Glenmark Infringed Bayer’s Finacea Patent,” IP Law360, May 16, 2016.
  • Quoted in, “Glenmark Tells Federal Circuit Bayer Fell Short in Finacea IP Suit,” Law360, January 8, 2016.
  • Quoted in, “How America Invents: Inter Partes Review Explained,” Commercial Dispute Resolution, January–February 2016.
  • Featured in, “IP litigation partner Sona De helped Bayer Healthcare Pharmaceuticals Inc. Notch a Win in its Patent Suit,” InsideCounsel, September 17, 2015.
  • Quoted in, “Glenmark Infringed Bayer’s Finacea Patent, Judge Rules,” IP Law360, July 28, 2015.
  • Quoted in, “SCOTUS Goes Hybrid on Claim Construction; May Lead to Evidence Games Played at Trial,” Bloomberg BNA’s Patent, Trademark & Copyright Law Daily, January 21, 2015.
  • Quoted in, “Supreme Court Overhauls Federal Circuit’s Standard of Claim Construction Review,” Managing Intellectual Property, January 21, 2015.
  • Quoted in, “High Court Claim Construction Ruling Set To Spur New Fights,” Law360, January 20, 2015.
  • Quoted in, “Lawyers Weigh In On High Court Claim Construction Ruling,” Law360, January 20, 2015.
  • Author, “Seeking Attorneys’ Fees in Exceptional Patent Cases,” Inside the Minds: The Impact of Recent Patent Law Cases and Developments, 2015.
  • Quoted in, “Biosimilars – Blood on the Patent Dance Floor,” Managing Intellectual Property, December 9, 2014.
  • Quoted in, “CAFC Affirms Sandoz’s Enbrel Biosimilar Suit Against Amgen Not Ready for Litigation,” Patent, Trademark & Copyright Journal, Life Sciences Law & Industry Report, December 12, 2014; Bloomberg Law, December 5, 2014.
  • Quoted in, “Patent Troll Bill Killed In Senate,” Law360, May 22, 2014.
  • Quoted in, “Supreme Court Patent Rulings Shift Reform Debate,” Corporate Counsel, May 1, 2014.
  • Quoted in, “Supreme Court Reverses Federal Circuit On Exceptional Case Merit, Review Standards,” Bloomberg BNA’s Patent, Trademark & Copyright Journal, April 30, 2014.
  • Quoted in, “Lawyers Weigh In On High Court’s Patent Rulings,” Law360, April 29, 2014.
  • Quoted in, “Patent Trolls To Think Twice After High Court Rulings,” Law360, April 29, 2014.