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Laura A. Lydigsen

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Areas of Focus

Overview

Laura A. Lydigsen is an intellectual property litigator with over 15 years’ experience representing clients in patent litigation before the federal courts. She particularly focuses on Federal Circuit appeals and district court litigation involving pharmaceuticals, biotechnology, and medical devices.

Laura has extensive experience representing generic pharmaceutical companies in pharmaceutical litigation under the Hatch-Waxman Act and Biologics Price Competition and Innovation Act (BPCIA). She has appeared in litigations and/or Patent Trial and Appeal Board (PTAB) proceedings involving dozens of distinct drug products and assisted clients with regulatory and pre-litigation strategy for many others. Laura is more than a litigator for her pharmaceutical clients; she recognizes that a winning litigation strategy must be paired with good regulatory and business strategies and assists her clients in achieving all three.

Laura has a deep knowledge of appellate practice before the Federal Circuit. Before joining private practice, Laura clerked for the Honorable Alvin A. Schall at the Federal Circuit, and she has updated the Federal Circuit treatise Patents and the Federal Circuit for over a decade. She has been involved in all stages of appeals before the Federal Circuit across a wide range of technologies, including appeals involving pharmaceuticals, biotechnology, medical devices, automotive technology, and insurance. She has successfully argued before the court and written briefs in dozens of appeals, including complex multi-patent appeals stemming from decisions of the PTAB in post-grant proceedings established under the America Invents Act. Laura also has experience representing pro bono a U.S. veteran and a widow of a U.S. veteran in appeals from adverse benefits decisions of the U.S. Court of Appeals for Veterans Claims.

Laura is a co-chair of Crowell & Moring’s Patent and ITC Litigation Group. Prior to joining Crowell, she was a shareholder at Brinks Gilson & Lione, where she served as the chair of the firm’s appellate practice.

Career & Education

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    • U.S. District Court for the Northern District of Illinois
      Law Clerk to the Honorable Ruben Castillo, September 2006–December 2006
    • U.S. Court of Appeals for the Federal Circuit
      Law Clerk to the Honorable Alvin A. Schall, September 2005–August 2006
    • Loyola University School of Law
      Coach for Saul Lefkowitz Moot Court Team, 2014–2016 and Giles Rich Moot Court Team, 2013–2014
    • U.S. District Court for the Northern District of Illinois
      Law Clerk to the Honorable Ruben Castillo, September 2006–December 2006
    • U.S. Court of Appeals for the Federal Circuit
      Law Clerk to the Honorable Alvin A. Schall, September 2005–August 2006
    • Loyola University School of Law
      Coach for Saul Lefkowitz Moot Court Team, 2014–2016 and Giles Rich Moot Court Team, 2013–2014

    • Wellesley College, B.A., cum laude, biological sciences, 2002
    • Washington University in St. Louis School of Law, J.D., first in class, 2005
    • Wellesley College, B.A., cum laude, biological sciences, 2002
    • Washington University in St. Louis School of Law, J.D., first in class, 2005

    • Illinois
    • Supreme Court of the United States
    • U.S. District Court for the Northern District of Illinois
    • U.S. District Court for the Southern District of Indiana
    • U.S. Court of Appeals for the Federal Circuit
    • U.S. Court of Appeals for Veterans Claims
    • Illinois
    • Supreme Court of the United States
    • U.S. District Court for the Northern District of Illinois
    • U.S. District Court for the Southern District of Indiana
    • U.S. Court of Appeals for the Federal Circuit
    • U.S. Court of Appeals for Veterans Claims

  • Professional Activities and Memberships

    • Federal Circuit Bar Association, Vice-Chair Rules Committee, 2011–2014; Co-Chair Rules Committee, 2014–2017; Vice-Chair Amicus Committee, 2017–2020; Co-Chair Amicus Committee 2020–2022 Board 2022-present.
    • Linn Inn of Court, Secretary, 2011–2013
    • Intellectual Property Law Association of Chicago

    Professional Activities and Memberships

    • Federal Circuit Bar Association, Vice-Chair Rules Committee, 2011–2014; Co-Chair Rules Committee, 2014–2017; Vice-Chair Amicus Committee, 2017–2020; Co-Chair Amicus Committee 2020–2022 Board 2022-present.
    • Linn Inn of Court, Secretary, 2011–2013
    • Intellectual Property Law Association of Chicago
Laura is a popular pick among pharmaceutical and biotechnology companies, which she represents rigorously in their most important disputes; a former Federal Circuit clerk, she is also in her element handling appeals.

— IAM Patent 1000, 2022

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Representative Matters

  • Trudell Med. Int’l v. D.R. Burton Healthcare, LLC, No. 23-1777 (Fed. Cir. 2023-present). Counsel for client appealing a jury verdict in a patent infringement suit involving a patented device for improving breathing via oscillatory positive expiratory pressure (“OPEP”).
  • Astellas Pharma Inc. v. Sandoz Inc., No. 2:23-cv-1214 (D.N.J. 2023-present). Counsel for client in a challenge to an Orange Book-listed patent for the anti-cancer drug gilteritinib, which Astellas markets as Xospata®.
  • Array Biopharma, Inc. v. Sandoz Inc., No. 1:22-cv-1316 (D. Del. 2022-present). Counsel for client in a challenge to Orange Book-listed patents for the anti-cancer drug binimetinib, which Array markets as Mektovi®.
  • Carnegie Institution of Washington v. Fenix Diamonds LLC, No. 20-cv-200, 21-2249 (S.D.N.Y., Fed. Cir. 2022-present). Counsel for client on appeal in defending a grant of summary judgment of non-infringement at the Federal Circuit and in subsequent proceedings on return to the district court.
  • Genentech, Inc. v. Tanvex BioPharma USA, Inc., No. 3:22-cv-809 (S.D. Cal.) (2022). Counsel for the maker of a biosimilar to the breast and gastric cancer drug Herceptin®.  Crowell assisted the client with navigating the so-called “patent dance” under the Biologics Price Competition and Innovation Act of 2009 and subsequent litigation.
  • Merck Sharp & Dohme Corp. v. Sandoz Inc., No. 20-cv-783 (D.N.J. 2020). Counsel for client in patent infringement litigation involving posaconazole oral suspension, which Merck markets as Noxafil® for the the treatment of oropharyngeal candidiasis.  Merck voluntarily agreed to dismiss the suit after Crowell filed a motion to dismiss.
  • Otsuka Pharm. Co. et al. v. Sandoz Inc. et al., No. 19-2080 (D. Del. 2019–2022). Counsel for client in a challenge to Orange Book-listed patents for brexpiprazole, which is marketed by Otsuka as Rexulti®.
  • Vifor (International) AG, et al. v. Sandoz Inc., et al., No. 19-13955 (D.N.J. 2019–2022). Counsel for client in a challenge to five Orange Book-listed patents for ferric carboxymaltose, which is marketed by American Regent as Injectafer®.
  • Boston Scientific Scimed, Inc. v. Cook Group Inc., Nos. 2019-1370, -1372, -1377, -1412, -1413, -1422, -1594, -604, -1605 (Fed. Cir. 2019–2020). Counsel for medical device company in appeals from a series of four inter partesreview appeals concerning hemostatic clips. The Federal Circuit upheld the PTAB’s holdings of unpatentability as to all claims held unpatentable before the PTAB and vacated several findings that the client, which was the petitioner before the PTAB, had not met its burden of proving other claims unpatentable.
  • Par Pharm., Inc. v. Sandoz Inc., No. 3:18-cv-14895 (D.N.J. 2018–2020). Counsel for client in challenge to six Orange Book-listed patents for vasopressin IV, which is marketed by Par as Vasostrict®.
  • Lundbeck et al. v. Apotex Inc. et al., No. 18-88 (D. Del. 2018–present). Counsel for client in challenge to crystal polymorph patents listed in the Orange Book in connection with the antidepressant vortioxetine hydrobromide, which Takeda markets as Trintellix®.
  • Janssen Prods., L.P. et al. v. Amneal Pharms., LLC et al., No. 2:18-cv-17585 (D.N.J. 2018–2019). Counsel for client in challenge to patents related to darunavir ethanolate, which Janssen markets as Prezista®.
  • Celgene Corp. v. Sandoz Inc., No. 18-cv-11026 (D.N.J. 2018–2020). Counsel for client in challenge to Orange Book-listed patents for apremilast, which Celgene markets as Otezla®.
  • In re Jublia, No. 18-cv-13635 (D.N.J. 2018–2020). Counsel for client in challenge to patents listed in the Orange Book in connection with efinaconazole, which Bausch markets as Jublia®.
  • Mitsubishi Tanable Pharma Corp. et al. v. Sandoz Inc., No. 3:17-cv-5219, -5005 (D.N.J. 2017–2020). Counsel for client in challenge to Orange Book-listed patents for canagliflozin, which Janssen markets as Invokana® and Invokamet®.
  • AstraZeneca LP et al. v. Sandoz Inc., No. 08-cv-1512 (D.N.J. 2017–2018). Counsel for client in bond proceedings related to ANDAs for budesonide inhalation suspension, which AstraZeneca markets as Pulmicort Respules®.
  • Eli Lilly & Co. v. Sandoz Inc., IPR2016-00318 (PTAB 2015–2018). Counsel for client in challenge to an Orange Book-listed patent for pemetrexed, which is marketed by Eli Lilly & Co. as Alimta®.
  • Mitsubishi Tanabe Pharma Corp. et al. v. Sandoz Inc. et al., No. 3:17-cv-5319 (D.N.J. 2017–present). Representing claim in Hatch-Waxman litigation related to canagliflozin, which is sold by Janssen as Invokana® and Invokamet®.
  • Horizon Pharma Ireland Limited et al. v. Actavis Laboratories UT, , No. 14-7992 (D.N.J. 2014–2017). Represented client in Hatch-Waxman litigation related to diclofenac sodium topical solution 2% w/w, which is sold by Horizon as Pennsaid 2% w/w.
  • Sanofi-Aventis U.S. LLC et al. v. Sandoz Inc., No. 3:16-cv-5678 (D.N.J. 2016–present). Representing client in Hatch-Waxman patent litigation relating to cabazitaxel, which is sold under the brand name Jevtana®.
  • In re LifeWatch Technologies Ltd., No. 2017-1652 (Fed. Cir. 2017–2018). Represented client in appeal from ex parte reexamination decision at the Patent Trial and Appeal Board.
  • Gramm v. Deere & Co., 3:22-cv-10 (S.D. Iowa), Nos. 2017-1252, -1253 (Fed. Cir. 2017–present). Representing client in defending decisions of the Patent Trial and Appeal Board invalidating a patent and in subsequent patent infringement litigation in the S.D. Iowa.
  • Leak Surveys, Inc. v. FLIR Systems, Inc., No. 2016-1299 (Fed. Cir. 2015–2017). Represented client in successfully defending the Patent Trial and Appeal Board’s judgment of invalidity for two patents relating to infrared (IR) camera systems that can be used in the detection and identification of chemicals, gas, and petroleum products. The Federal Circuit issued an affirmance in favor of the client under Fed. Cir. R. 36 on January 10, 2017.
  • Wasica Finance GmbH et al. v. Continental Automotive Systems, Inc. et al., 853 F.3d (Fed. Cir. 2017). Represented patent challenger in appeal from Patent Trial and Appeal Board involving a system for detecting tire pressure. The Federal Circuit affirmed the PTAB’s decision invalidating claims 1-5, 10-19 and 21, and reversed-in-part in invalidating an additional claim (claim 9) that the PTAB had found not invalid.
  • AstraZeneca Pharmaceuticals LP v. Burwell, No. 1:16-cv-1336 (D.D.C. 2016). Representing intervenor in defending against a motion for a temporary restraining order in which AstraZeneca sought to enjoin approval of the client’s ANDA for rosuvastatin calcium, which AstraZeneca markets as Crestor®, based on issues related to labeling carve outs related to orphan drug exclusivity and pediatric indications.
  • Sequenom, Inc. v. Ariosa Diagnostics, Inc., No. 15-1182 (S. Ct. 2016). Submitted amicus brief to the Supreme Court on behalf of client in support of Sequenom, Inc.’s petition for certiorari.
  • AstraZeneca LP et al v. Hisun Pharmaceutical (Hangzhou) Co., Ltd. et al., No. 1:15-cv-1042 (D. Del. 2015–2016). Represented client in Hatch-Waxman patent litigation relating to ticagrelor, which is sold under the brand name Brilinta®.
  • Boehringer Ingelheim Pharma GmbH et al. v. Sandoz Inc. et al., No. 1:15-cv-7461 (D.N.J. 2015–2016). Represented client in Hatch-Waxman patent litigation relating to extended release dipyridamole/acetylsalicylic acid (aspirin) capsules, which are sold by Boehringer Ingelheim under the brand name Aggrenox®.
  • Indivior Inc. et al. v. Sandoz Inc., No. 1:15-cv-1051 (D. Del. 2015–2016). Represented client in Hatch-Waxman patent litigation relating to buprenorphine HCl/naloxone HCl sublingual film, which is sold by Indivior under the brand name Suboxone® film.
  • AstraZeneca AB v. Actavis Laboratories FL, Inc. et al., No. 14-664 (D. Del. 2014–2017). Represented client in multi-defendant Hatch-Waxman patent litigation involving the diabetes drug saxagliptin, sold by AstraZeneca as Onglyza® and Kombiglyze®.
  • Ateliers De La Haute-Garonne v. Broetje Automation, USA Inc., et al., No. 1:09-cv-598 (D. Del. 2014–2016). Counsel for client in suit involving trademark and patent issues pertaining to riveting systems.
  • Eli Lilly & Co. v. Sandoz Inc., No. 14-2008 (S.D. Ind. 2014–present). Counsel for client in Hatch-Waxman litigation involving pemetrexed, which is marketed by Eli Lilly & Co. as Alimta®.
  • Lawson v. Gibson, No. 14-7059 (Fed. Cir. 2014–2016). Lead counsel for a veteran appealing a benefits decision of the United States Court of Appeals for Veterans Claims.
  • Liberty Mutual Insurance Co. v. Progressive Casualty Insurance Co., Nos. 2014-1538, -1549 (Fed. Cir. 2014–2015). Represented client in appeals from Patent Trial and Appeal Board involving online servicing technology, which stem from some of the first covered business method patent review (“CBMPR”) proceedings instituted under the America Invents Act.
  • Liberty Mutual Insurance Co. v. Progressive Casualty Insurance Co., Nos. 2014-1446, -1586, -1636, -1637, -1639, -1656 (Fed. Cir. 2014–2015). Represented client in appeals from Patent Trial and Appeal Board involving usage based insurance, which stem from some of the first covered business method patent review (“CBMPR”) proceedings instituted under the America Invents Act.
  • Roche Palo Alto LLC et al. v. Actavis Laboratories FL, Inc., No. 1:13-cv-1533 (D. Del. 2013–2015). Represented client in Hatch-Waxman patent litigation related to valganciclovir hydrochloride sold by Genentech as Valcyte®.
  • Salberg v. Gibson, No. 14-7049 (Fed. Cir. 2014–2015). Successfully obtained a remand for a veteran’s widow appealing a denial of benefits from the United States Court of Appeals for Veterans Claims.
  • Trading Technologies International Inc. v. Stellar Trading Systems, Ltd. et al., No. 2012-1583 (2013–2014). Lead counsel for one defendant group in an appeal involving patents pertaining to electronic trading. The client settled during pendency of the appeal.
  • Apple Inc. v. Samsung Elecs. Co., No. 14-1335 (Fed. Cir. 2014), No. 15-777 (S. Ct. 2015). Filed amicus briefs on behalf of client in support of Samsung at the Federal Circuit and Supreme Court.
  • Northgate Techs., Inc. v. Stryker Corp., et al., No. 12-7032 (N.D. Ill.) (2012–2014). Counsel for client in litigation involving a patent for an improved laparoscopic insufflator. The case settled prior to trial scheduled before Judge Richard Posner.
  • Noven Pharmaceuticals, Inc. v. Watson Laboratories, Inc. et al., No. 11-cv-5997 (D.N.J. 2011–2014). Represented generic client in Hatch-Waxman patent litigation related to a methylphenidate transdermal patch sold by Noven as Daytrana®. Obtained partial summary judgment rulings of non-infringement and invalidity due to inadequate written description. The parties’ settlement permits a 2015 launch notwithstanding the 2018 expiration of the patents-in-suit.
  • Avanir Pharmaceuticals, Inc. et al. v. Watson Pharmaceuticals, Inc. et al., 11-cv-704, 12-cv-258 (D. Del. 2011–2013). Represented clients in patent litigation under the Hatch Waxman Act related to dextromethorphan hydrobromide quinidine sulfate sold by Avanir as Nuedexta®.
  • McDavid, Inc., et al. v. Nike USA, Inc. et al., Nos. 1:08-cv-6584, 13-cv-1137 (N.D. Ill.) (2013–2014). Counsel for client in patent litigation involving reissue patents pertaining to athletic apparel.
  • Abbott Laboratories, et al. v. Watson Laboratories, Inc.-Florida, et al., No. 2:10-cv-2139 (D.N.J. 2010–2012). Represented generic client in Hatch-Waxman patent litigation related to choline fenofibric acid sold by Abbott as Trilipix®. The case settled prior to trial.
  • Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc., No. 2011-1555 (Fed. Cir. 2011), No. 13-43 (S. Ct.). Represented appellee in appeal from grant of judgment as a matter of law of non-infringement and invalidity, involving patents for deepwater drilling technology. In response to appellee’s petition for certiorari, the Supreme Court called for the views of the Solicitor General (CVSG). The case settled prior to the release of the SG’s brief.
  • In re Parker, No. 2011-1421 (Fed. Cir. 2011). Represented appellant in appeal from United States Patent Board of Patent Appeals and Interferences decision of unpatentability of patent application for a catheter sheath.
  • Abraxis Bioscience Inc. v. Navinta LLC, 625 F.3d 1359 (Fed. Cir. 2010). Successfully represented appellant in an appeal from a judgment of infringement of three patents. The Federal Circuit held that Abraxis did not have standing to bring suit and remanded with instructions to dismiss.
  • Boss v. Cabilly, No. 2009-1264 (Fed. Cir. 2010) (Interference No. 105,531). Successfully represented client in an appeal of the decision by the U.S. Patent and Trademark Office Board of Patent Appeals and Interferences that Genentech’s “Cabilly” patent application (No. 08/422,187) has priority over UCB Pharma’s “Boss” patent application (No. 08/450,727) covering recombinant DNA techniques for manufacturing antibodies. The technology is now a foundation for many top-selling cancer-treatment drugs such as Avastin®, Herceptin® and Rituxan®.
  • Lexion Medical, LLC v. Northgate Techs., Inc., No. 2009-1494 (Fed. Cir. 2009). Represented appellant in seeking review of grant of summary judgment of infringement.
  • Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc., 610 F.3d 1296 (Fed. Cir. 2010). Assisted appellee in seeking rehearing en banc based on the panel’s decision holding that the location of a contemplated sale controls whether an allegedly infringing act occurs within the United States under 35 U.S.C. § 271.
  • Pfizer v. Sandoz Inc., No. 09-cv-2052 (D.N.J. 2009–2011). Litigated patents under the Hatch Waxman Act related to pregabalin sold by Pfizer as Lyrica®.
  • Eli Lilly & Co. v. Sandoz, Inc., No. 1:08-cv-1548 (S.D. Ind. 2008–2011). Represented generic pharmaceutical client in Hatch-Waxman litigation involving duloxetine sold by Eli Lilly as Cymbalta®
  • Aventis Pharma S.A. v. Sandoz Inc., Nos. 2008-1560, -1563, -1591 (Fed. Cir. 2008). Represented appellee in an appeal from the grant of summary judgment of unenforceability based on inequitable conduct.
  • Abbott Labs. v. Sandoz Inc., 566 F.3d 1282 (Fed. Cir. 2009) (en bancin part), cert. denied, No. 09-335 (2010). Counsel in an appeal involving patents related to the antibiotic Omnicef® and generic cefdinir.
  • Janssen, L.P., et al. v. Sandoz, Inc., No. 08-2892 (D.N.J. 2008–2009). Represented generic client in obtaining favorable claim construction decision. Following claim construction, the parties stipulated to dismissal.
  • Lexion Med., LLC v. Northgate Techs., Inc., 292 Fed. Appx. 42 (Fed. Cir. 2008). Represented appellant in an appeal of a district court decision on claim construction and alleged infringement of a patent concerning medical devices related to endoscopic surgery.
  • Seirus Innovative Accessories v. Do-Gree Fashions Ltd., No. 2:05-cv-355 (D. Utah 2007–2008). Represented client in multiple-patent case relating to skiwear, which settled shortly after the client received a favorable claim interpretation ruling, but before the pending motions for summary judgment of non-infringement were decided.
  • Herman Miller, Inc. v. Teknion Corp. and Okamura Corp., No. 05-cv-2761 (N.D. Ill. 2007–2008). Represented client in a patent infringement action against Teknion and Okamura relating to Herman Miller's iconic Aeron® chair. Herman Miller obtained summary judgment that the accused chair literally infringed. The case settled shortly thereafter.
  • Pequignot v. Solo Cup Co., No. 1:07-cv-897 (E.D. Va. 2007–2008). Represented client against a false patent marking claim during discovery and preparation of a summary judgment motion. The claims eventually were dismissed on summary judgment.
  • Abbott Labs. v. Sandoz Inc., 486 F. Supp. 2d 767 (N.D. Ill. 2007). Successfully defended client against request for temporary restraining order and preliminary injunction by Abbott and Astellas before Judge Wayne R. Andersen over patents relating to a polymorph of crystalline cefdinir, an antibiotic also sold as Omnicef®.

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Recognition

  • Crain's Chicago Business: Notable Women in Law 2020
  • 40 Illinois Attorneys Under 40 to Watch: Honoree, 2017
  • Illinois Super Lawyers: Intellectual Property Law, Rising Stars, 2010–2017
  • Intellectual Asset Management Patent 1000: Leading Patent Practitioner, 2018–2020
  • Washington University School of Law: Alumni Association Prize for the highest overall G.P.A. in graduating class
  • Washington University School of Law: Order of the Coif
  • Giles Rich Moot Court Team: Midwest Regional Winner 2004
  • Samuel M. Breckinridge Practice Court Prize for excellence in moot court
  • Breckinridge Book Award for outstanding performance in Legal Research and Writing
  • CALI Excellence Awards: Legal Research and Writing, Patent Law, Patent Drafting, Bankruptcy, Constitutional Law, Civil Procedure, and Torts

Laura's Insights

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Insights

Speaking Engagement | 10.29.24

"Intellectual Property Rights When Contracting with the U.S. Government." 2nd Annual Midwest Government Contracts Seminar, Chicago, IL.

Client Alert | 6 min read | 10.23.24

Unfinished Business in Congress on Drug Patents and Competition

Press Coverage | 09.09.24

FTC Backs Teva Orange Book Delisting At Fed. Circ.

Firm News | 2 min read | 06.18.24

Crowell Attorneys and Practices Recognized in Managing IP’s 2024 IP Stars Guide
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