Dorothy Whelan is a Senior Principal in the Twin Cities office of Fish & Richardson P.C. and co-chair of the firm’s Post-Grant Practice Group. Under her co-leadership, Fish’s post-grant practice grew to become the most active at the Patent Trial and Appeal Board (PTAB) and was the first to appear in at least 1,000 proceedings. She was one of the earliest attorneys to appear before the PTAB at the birth of the practice in 2012 and has been among its most prolific and successful practitioners ever since, having been involved in numerous landmark post-grant matters.
Dorothy’s practice focuses primarily on post-grant proceedings at the PTAB, where she represents clients ranging from startups to Fortune 100 companies on both the petitioner and patent owner sides. She has broad technical expertise in the life sciences and chemicals industries, including the technological fields of pharmaceuticals, medical devices and materials, polymer processing, batteries, and fuel cells. Her practice also encompasses patent counseling, due diligence, and patent portfolio management for both budding entrepreneurs and established companies. When the patents at issue are the subject of co-pending litigation, Dorothy works closely with Fish’s litigation team to design and implement holistic strategies for success.
When clients come to Dorothy, she works with them to ensure that she understands their business objectives on a fundamental level and how their post-grant matter fits into the big picture. She develops strategies designed to help her clients meet their objectives by using post-grant matters to get them where they need to go. Clients trust her business-savvy approach and know that she will advise them on the overall best course of action for them, even if that means foregoing a post-grant matter.
Dorothy writes and speaks extensively on topics related to post-grant proceedings and is a recognized national thought leader in the field. She is a regular speaker at Fish’s Post-Grant for Practitioners webinar series and a prolific contributor to the wider body of post-grant scholarship. By staying plugged in to the latest developments in post-grant jurisprudence, she keeps her clients one step ahead of the frequent changes in post-grant practice.
Education
J.D., magna cum laude, Boston College Law School (1987)
Member, Boston College Law Review
S.M., Polymers, Massachusetts Institute of Technology (1984)
B.S., Chemistry, Yale University (1981)
Admissions
- U.S. Patent and Trademark Office 1989
- Massachusetts 1987
- Minnesota 1995
Recognitions
- Named a “Leading Patent Professional” and recommended for post-grant proceedings by IAM Patent 1000 (2012-2013, 2016-2021)
- Recognized as a notable practitioner in Intellectual Property, Chambers USA: Minnesota (2020-2021)
- Named a “Life Science Star” by LMG Life Sciences (2017-2020)
- Named to the “Top 50 Women in PTAB Trials” by the PTAB Bar Association (2019)
- Named a “IP Star” by Managing Intellectual Property (2013-2020)
- Named “Post Grant Proceedings Attorney of the Year” by LMG Life Sciences (2018)
- Named “Attorney of the Year” by Minnesota Lawyer (2017-2018)
- Named to the “Top 250 Women in IP” by Managing Intellectual Property (2016-2020)
- Named “Life Sciences MVP of the year” by Law360 (2017)
- Named to The Best Lawyers in America– Intellectual Property (2014, 2013, 2011, 2008, 2007) and Patent Law (2021, 2020, 2019, 2016, 2015, 2011), and Minneapolis Patent Law Lawyer of the Year (2014 and 2020)
- Named to the “Top 250 Women in IP” by Euromoney (2013)
- Named a “Top Patent Prosecutor” by Patent Research Review/Patent Buddy (2011)
- Received “Women in Business/Industry Leader Award” Minneapolis/St. Paul Business Journal (2010)
- Named a Super Lawyer (2003, 2006-2013)
Experience
- Coherus BioSciences v. AbbVie Biotechnology, IPR 2016-00172: Dorothy led post-grant strategy for the Fish team that won three much-heralded IPRs for Coherus BioSciences invalidating three patents in the blockbuster drug Humira® patent family. These were the first-ever IPR decisions that invalidated patents for AbbVie’s biologic, which was the highest-selling drug in 2016 with $16 billion in global sales. At the time, Humira accounted for over 60% of AbbVie’s sales. The Coherus case was the most closely watched life sciences IPR of the year, not only because there was so much at stake for the parties, but because of the broader implications for the entire biosimilar industry. Fish’s work is now a model for how other biosimilar patents can be successfully attacked and challenged.
- I-MAK, v. Gilead Sciences, IPR 2018-00120, -00119, -0000103, -00122, -00121, -00125, -00126, 00123, -00211, -00390: Gilead hired Fish to thwart an attack by Initiative for Medicines, Access & Knowledge Inc. (I-MAK), the billionaire-backed nonprofit that sought to invalidate at the PTAB Gilead’s patents covering its hepatitis C drugs Sovaldi, Harvoni and related sofosbuvir-based drugs. I-MAK filed 10 inter partes review (IPR) petitions at the PTAB against seven Gilead Orange Book patents, and Dorothy and the Fish team (along with co-counsel at WilmerHale) successfully obtained denial of all 10 petitions. The IPRs were coordinated with other proceedings as part of a larger dispute that involved multiple U.S. federal court cases, hearings at the Opposition Division of the European Patent Office, and trials in Norway, the UK, Canada, Germany, and Australia.
- Eton Pharmaceuticals v. Exela Pharma Sciences, PGR-00064, -00068, -00086: Fish filed a Hatch-Waxman lawsuit for client Exela Pharma Sciences in March 2020 in the District of Delaware against Eton Pharmaceuticals over its intent to produce a generic version of Exela’s patented ELCYS® (cysteine hydrochloride injection) drug. Eton responded by filing three post-grant reviews (PGRs) petitions on Exela’s ELCYS® patents in May, June, and September 2020 in an attempt to invalidate Exela’s patents in the district court litigation. Dorothy led the Fish team that successfully stopped the institution of the PGRs – a huge win for Exela – with the PTAB refusing to institute the post-grant reviews in November 2020, December 2020, and April 2021.
Publications
- “IPR and PGR: A Complex and Shifting Landscape,” Managing Intellectual Property (July 29, 2019)
- “Recent Developments in Biopharma PTAB Practice,” NYIPLA (February/March 2017)
- “Post-Grant Pushes Forward in Life Sciences,” Metropolitan Corporate Counsel (September 17, 2015)
- Validity Challenges: District Court Vs. Patent Office, Law360 (December 18, 2013)
Media Mentions
- Quoted, “Looming Judge Fight Threatens Generics’ Favored Patent Forum,” Bloomberg Law (January 7, 2021)
- Interview, “Breaking the Ice: Practice reinvented with patent challenges,” Minnesota Lawyer (November 12, 2020)
- Quoted, “6 PTAB Issues That CameTo A Head in 2019,” Law360 (December 23, 2019)
- Quoted, “Reviewing ‘A Tremendous Year of Change’ for the PTAB,” Managing Intellectual Property, (January 22, 2019)
- Quoted, “The Unintended Consequences of IPR,” Life Sciences Intellectual Property Review (June 16, 2015)
Speaking Engagements
- “Post-Grant for Practitioners Webinar | After Arthrex: What the Supreme Court’s Decision Means,” Fish Post-Grant Webinar (June 23, 2021)
- “Post-Grant: 2020 Year in Review,” Fish Post-Grant Webinar (January 14, 2021)
- “Post-Grant: 2019 Year in Review,” Fish Post-Grant Webinar (January 8, 2020)
- “SAS and Oil States: One Year Later,” Fish Webinar (May 8, 2019)
- “Hatch-Waxman and IPR Strategy,” Fish Webinar (March 27, 2019)
- “2018 Post-Grant Year in Review,” Fish Webinar (January 9, 2019)
- “BioPharma Patents at the PTAB,” Fish Webinar (July 11, 2018)
- “Looking Ahead: Practical Implications of Oil States Energy Services and SAS Institute,” Fish Webinar (April 26, 2018)
- “2017 Post-Grant Year in Review,” Fish Webinar (January 10, 2018)
- “Ethical Issues at the PTAB,” Fish Webinar (May 10, 2017)
- “2016 Post-Grant Year in Review,” Fish Webinar (January 11, 2017)
- “Midyear Review of Decisions and Developments at the PTAB,” Fish Webinar (July 13, 2016)
- “Biosimilars & IPR,” Fish Webinar (March 24, 2016)
- “2015 Post-Grant Year in Review,” Fish Webinar (January 13, 2016)
- “Hot Issues in PTAB Trials,” AIPLA/USPTO Road Show Series – Enhancing Patent Quality and Conducting AIA Trials at the USPTO, San Jose, CA (August 24, 2015) and Alexandria, VA (August 28, 2015)
- “Making Sense of Inter Partes Review Proceedings,” Cantor Fitzgerald’s Inaugural Healthcare Conference (July 8, 2015)
- “Hatch-Waxman and Biosimilars: A Total Immersion Course Encompassing Strategies for Prosecution, FDA Regulation, Post-Grant Challenge, Litigation and Appeal,” Patent Resources Group Advanced Patent Law Course (April 16-18, 2015)
- “Post-Grant Patent Challenges: What Bio-Pharma Practitioners Need to Know,” Boston Breakfast Series (October, 2014)
- “Post-Grant Executive Roundtable” Consero Group (September, 2014).
- “PTAB AIA Trial Roundtable,” USPTO (May, 2014)
- “Inter Partes Review: Patent Owner’s Perspective,” West Legal Education (March, 2014)
- “Examining the Impact of Patent Reform on Hatch-Waxman Litigation and the Brand/Generic Wars,” ACI Patent Reform (January, 2014)
- “Understanding New Proceedings for Challenging Patent Validity (IPR, PGR, CBM),” Thomson Reuters Patent Disputes 2013, Santa Clara, CA (November, 2013)
- Ms. Whelan hosts and regularly speaks at the Post-Grant for Practitioners Webinar Series covering issues, statistics, strategy, and practice tips for those looking to learn the basics of these proceedings or gain an advanced understanding of the post-grant landscape.
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