Daniel Knauss

Dan is an experienced life sciences intellectual property litigator. He counsels clients regarding disputes in a wide variety of technology areas – including cancer and antiviral medicines, biosimilars and antibody drugs, agricultural technology and biofuels, and medical devices. Dan represents branded pharmaceutical companies in abbreviated new drug application (ANDA) litigation and both reference product and biosimilar companies in Biologics Price Competition and Innovation Act (BPCIA) litigation. He has litigated cases to trial in various district courts and at the Patent Trial and Appeal Board (PTAB), the Delaware Court of Chancery and the International Trade Commission (ITC).

Dan has a PhD in microbiology and cancer biology from the University of Wisconsin–Madison. He earned a JD, with distinction, from Stanford Law School, where he was an editor of the Stanford Technology Law Review. He externed in the Santa Clara County District Attorney’s Office. Before attending law school, Dan was director of intellectual property at Third Wave Technologies, where he managed a large international patent portfolio, product licensing and litigation matters.

Dan’s representative past matters include:

• Genentech v. Amgen (D. Del.) – Represented Amgen in Biologics Price Competition and Innovation Act (BPCIA) litigation regarding trastuzumab biosimilar; defeated temporary restraining order/preliminary injunction enabling Amgen to launch its trastuzumab biosimilar Kanjinti; affirmed by federal circuit; obtained global settlement
• Genentech, et al. v. Celltrion, et al. (D. Del.) – Represented Celltrion and Teva in BPCIA litigation regarding rituximab biosimilar Truxima; invalidated method of treatment patent in inter partes review (IPR) proceedings prior to settlement
• Central Valley Seeds v. Vilmorin North America (N.D. Cal.) – Represented Vilmorin in patent litigation concerning proprietary vegetable varieties; obtained settlement securing product launch
• Butamax Advanced Biofuels v. Gevo (D. Del.) – Represented Gevo in multipatent disputes relating to production of isobutanol biofuel in microorganisms, including defeat of a preliminary injunction threatening Gevo’s operations
• Shareholder Representative Services v. Celldex Therapeutics (Delaware Chancery) – Represented Shareholder Representative Services on behalf of former shareholders in a merger agreement milestone payment dispute relating to antibody technologies
• Journey Medical Corp. (D. Del.) – Represented Journey Medical in a variety of Hatch-Waxman (abbreviated new drug application) litigations concerning Journey Medical’s dermatology products
• Elekta, et al. v. Varian Medical Systems (E.D. Mich.); Varian Medical Systems v. Elekta (ITC); Varian Medical Systems v. Elekta, et al. (PTAB) – Represented Varian in a three-fora patent battle, including in defense of the first suit filed by Elekta in district court, as well as in ITC and IPR countersuits for Varian; obtained settlement with no payments exchanged between plaintiffs and defendants and no future financial obligations
• Hoffmann-La Roche v. Gilead Sciences (American Arbitration Association arbitration, International Centre for Dispute Resolution) – Obtained complete defense verdict in favor of Gilead in a contract and patent dispute for exclusive rights to Sovaldi
• Onyx Pharmaceuticals v. Bayer (N.D. Cal.) – Represented Onyx in a collaboration agreement dispute relating to regorafenib (Stivarga)
• Horus Vision v. Applied Ballistics (N.D. Cal.) – Represented optical technology company Horus Vision in a patent infringement action; obtained complete claim construction victory and licensing outcome for client
• Meta Platforms, Inc. v. Palo Alto Research Center Inc. (PTAB) – Represented Meta (Facebook) in two IPRs; all challenged claims were found unpatentable
• Microsoft Corp. v. Windy City Innovations, LLC (PTAB) – Represented Facebook in three IPRs after joinder; all challenged claims were found unpatentable
• Tele-Publishing Inc. v. Facebook, Inc., et al. (D. Mass and Fed. Cir.) – Represented Facebook in a patent case; won on claim construction briefing and motion to invalidate all of Tele-Publishing’s asserted claims based on indefiniteness and unpatentable subject matter

Publications and media

• Co-author of “UPOV Releases Explanatory Notes Further Defining Protection for Essentially Derived Varieties,” Cooley alert, February 2024
• Co-author of “Two Recent Federal Circuit Opinions Illustrate Risk of Product Demonstrations for Patent Validity,” Cooley alert, August 2023
• Co-author of “Supreme Court Affirmance in Amgen v. Sanofi Leaves Legal Standard for Patent Enablement Undisturbed,” Cooley alert, May 2023
• Co-author of “Illegality Doctrine Rejected in Legal Cannabis Patent Case, Confirming Patent Enforceability,” Cooley alert, February 2023, published in IP Litigator, March/April 2023
• Noted in “Facebook Gets Patent Axed After Citing Inventors’ Paper,” Law360, January 2023
• Co-author of “ Circ. Teva Ruling May Shake Up Skinny Label Strategies,” Law360, September 2021
• Co-author of “GSK v. Teva: Federal Circuit Opinion After Rehearing Confirms Induced Infringement Liability Despite Skinny Label,” Cooley alert, August 2021
• Co-author of “IP Protection for Vegetatively Reproduced Plants: New Paths Forward,” Journal of the Patent and Trademark Office Society, June 2021
• Co-author of “GSK v. Teva– Induced Infringement Liability Despite Skinny Label,” Cooley alert, October 2020
• Co-author of “EPO: Plants and Plant Materials Not Patentable if Exclusively Obtained by Essentially Biological Process,” Cooley alert, May 2020
• Co-author of “Federal Circuit Report: Syngenta Ruling Impacts Process Patent Owners,” IP Litigator, March/April 2020
• Co-author of “Syngenta Confirms Section 271(g) Infringement Does Not Require Single Entity Perform All Steps of Patented Method,” Stanford Intellectual Property Association Newsletter, January 2020 (also published as a Cooley alert in December 2019)
• Co-author of “Protecting Plant Innovation,” American Bar Association Landslide magazine, July/August 2019
• Co-author of “Ensuring a Bountiful IP Yield from Plant Sales,” Managing Intellectual Property, February 2019
• Co-author of “2018 Farm Bill Enacted With Important Provisions for Plant IP and Cannabis-Related Business,” Cooley alert, January 2019
• Co-author, “Helsinn Confirms Longstanding Law Concerning ‘On-Sale’ Bar,” Cooley alert, January 2019
• Co-author of “Shoots, Leaves and Money Trees,” Intellectual Property Magazine, December 2018
• Co-author of “Major Judicial Decisions Impacting Pharmaceutical and Biotech Patents,” Practicing Law Institute, July 2015

Speaking engagements

• Invited speaker, “Patent Protection and Litigation Strategy,” in conjunction with the University of California, Davis, Seed Biotechnology Center course, Hemp Breeding and Seed Production, December 2024
• Invited speaker, “US IP Landscape Update,” International Conference on IP Protection for Plant Innovation, June 2024
• Invited speaker, “Claim Construction,” Consero IP Forum for Life Sciences, December 2023
• Invited speaker, “Patent Protection and Litigation Strategy,” in conjunction with the University of California, Davis, Seed Biotechnology Center course, Hemp Breeding and Seed Production, December 2023
• Invited speaker, “CRISPR-Cas Patent Landscape Update,” International Conference on IP Protection for Plant Innovation, December 2022
• Invited speaker, “Getting Your House in Order – Preparing for IP Diligence,” 5th International Cannabinoid-Derived Pharmaceuticals Summit, September 2022
• Invited speaker, “IP Considerations for Global Seed Companies,” American Seed Trade Association 61st Vegetable & Flower Seed Conference, January 2022
• Invited speaker, “IP Update: CRISPR, New Gene Editing Technologies and US Caselaw,” American Seed Trade Association Annual Meeting, Seed Innovation and Protection Alliance seminar, December 2021
• Invited speaker, “Genome Editing and New Breeding Technologies – IP Considerations,” International Conference on IP Protection for Plant Innovation, December 2021
• Co-presenter, “Patent Protection and Litigation Strategy,” in conjunction with the University of California, Davis, Seed Biotechnology Center course, Hemp Breeding and Seed Production, November 2021
• Roundtable co-host, “Protecting Your Work With Strong Intellectual Property Strategy,” 4th International Cannabinoid-Derived Pharmaceuticals Summit, September 2021
• Roundtable host, “IP Enforcement in the Emerging Cannabis Market,” World Agri-Tech Innovation Summit, March 2021
• Co-presenter, “Patent Protection and Litigation Strategy,” in conjunction with the University of California, Davis, Seed Biotechnology Center course, Hemp Breeding and Seed Production, October 2020
• Co-presenter, “America’s Newest Crop: IP Protection, Product Development, and Enforcement for Hemp Innovation,” Lawline webinar, June 2020
• Co-presenter, “Agtech IP Enforcement and Litigation,” American Seed Trade Association Annual Meeting, Seed Innovation and Protection Alliance seminar, December 2019
• Co-presenter, “Patent Protection and Litigation Strategy,” University of California, Davis, Seed Biotechnology Center Plant Breeding Academy program, October 2019
• Co-presenter, “Agtech Plant IP Prosecution and Litigation,” California Seed Association Annual Convention, Seed Innovation and Protection Alliance seminar, October 2019
• Co-presenter, “Protecting Plant Innovation: Hemp, CBD & Plant IP Laws Under the 2018 Farm Bill,” Lawline webinar, May 2019