Betsy Flanagan

About Betsy

Publications

“Keeping Up With Life Sciences Appeals: 1Q2020,” Fish Litigation Blog (April 10, 2020).

“Section 101: Cert. Denied … Now What?” Fish Litigation Blog (April 2, 2020).

“Coping With A Pandemic,” Q&A with Law360 (March 2020).

“Life Sciences Litigation Heats Up Around Patent Eligibility And Generics,” Corporate Counsel Business Journal (March 2020).

“Federal Circuit Holds Life Sciences Claims Eligible in Illumina v. Ariosa,” Fish Litigation Blog (March 24, 2020).

“Method of Treatment Claims Pass Mayo Test,” Fish Litigation Blog (June 15, 2018).

“Mixed Results When New Attribution Standard is Put to the Test with Life Science Divided-Actor Method Claims,” co-author, Fish Litigation Blog (March 3, 2017).

“US Solicitor Sides With Sandoz In Biosimilar Case,” co-author, Law360 (December 20, 2016).

“Solicitor General Claims Error in Federal Circuit’s Sandoz Holding,” co-author, Fish Litigation Blog (December 14, 2016).

Speaking Engagements

“Hatch-Waxman: How to Prepare for the Paragraph IV Letter,” Fish Life Sciences Webinar (June 3, 2021).

“The Business of the Hatch-Waxman Act,” Fish Life Sciences Webinar, (May 20, 2020).

“The IPR Landscape in 2020: Adopting the Phillips Standard, Bars, and More,” Intellectual Property Law Spring Seminar 2020, (March 5, 2020).

“2019 Year in Review,” Fish’s Boston Seminar Series, (January 29, 2020).

“The Section 101 Landscape,” Midwest IP Institute, (September 27, 2019).

“2018 Year in Review,” Fish’s Boston Seminar Series, (January 22, 2019).

“Patent Infringement Litigation,” Patent Resources Group (PRG) Advanced Courses Program (Spring & Fall 2018).

“2017 Year in Review,” Fish’s Boston Breakfast Series, (January 10, 2018).

“Enjoining Life Sciences Competition:  A Review and Discussion,” Fish Litigation Webinar (November 9, 2017).

“Biosimilars:  A Mid-Year Review,” Fish Litigation Webinar (August 16, 2017).

“Equitable Defenses in Patent Cases,” Patents on Tap (September 15, 2016).

Defended a major diagnostic clinic after a competitor accused our client of infringing a patent on a test for diagnosing a rare autoimmune disorder. The judge ruled that the claimed methods of testing relied on a law of nature, which cannot be patented. In arriving at the ruling, the judge cited the Supreme Court’s 2012 landmark ruling in Mayo v. Prometheus. On appeal, the Federal Circuit affirmed the ruling of the District Court and denied the opposing party’s petition for en banc review in a precedential order. The Fish team then successfully opposed its certiorari petition to the Supreme Court by noting that the Court had already provided adequate guidance in its 2012 Mayo ruling.

Exela Pharma Sciences LLC v. Eton Pharmaceuticals Inc., No. 1:20cv365 (D. Del.). Represents Exela Pharma Sciences in Hatch-Waxman litigation against Eton Pharmaceuticals, Inc., involving three patents related to Exela’s L-cysteine hydrochloride injection product ELCYS®. After Eton filed petitions for post-grant review of all three patents at the PTAB, the Fish team successfully obtained decisions of non-institution on all three petitions.

Gilead Sciences Inc. v. Merck & Co., No. 5:13cv4057 (N.D. Cal., June 6, 2016). Served as trial and appellate counsel on an all-women oral argument team for client Gilead Sciences. The matter was ultimately resolved in a unanimous Federal Circuit opinion that affirmed a June 2016 post-trial wipe-out of a $200 million jury verdict against Gilead. The Fish team mounted and proved, in a bench trial, an “unclean hands” defense against Merck. The Federal Circuit affirmed Judge Beth Labson Freeman’s finding of unclean hands, holding that the case involved clear misconduct by Merck in breaching commitments to a third party and clear misconduct in litigation, which “infected this entire case.”

Coherus BioSciences Inc. v. AbbVie Biotechnology Ltd., No. IPR 2016-00172 (PTAB, May 16, 2017). Served as a key member of the team that won three inter partes reviews (IPRs) for Coherus BioSciences, which invalidated three patents in the AbbVie Biotechnology blockbuster drug Humira® patent family. The PTAB found that the patents were obvious and unpatentable, and the result was upheld on appeal. 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. The cases were among the most closely watched life sciences IPRs in 2017, given the broader implications for the biosimilar industry.

iCeutica Ltd. et al v. Lupin, Ltd., et al., No. 1:14cv1515 (D. Del. February 9, 2017). Represented iCeutica as trial team leader in Hatch-Waxman litigation over the pain medication ZORVOLEX®. The Fish team successfully resolved this litigation for branded pharmaceutical clients Iroko and iCeutica, which sued generic pharmaceutical company Lupin in December 2014 after it sought to bring generic versions of Iroko/iCeutica’s Zorvolex® drug to market. The case was settled amicably one week before trial.

Cephalon Inc. et al v. Mylan Pharmaceuticals Inc. et al. (D. Del.). Served as trial counsel for plaintiffs in Hatch-Waxman litigation involving the pain medication FENTORA®; won an injunction that was entered against the generic entry.

Immunex Corporation, et al. v. Samsung Bioepis Co. Ltd., Civil Action No. 19-11755 (D.N.J.). Representing Samsung Bioepis in Biologics Price Competition and Innovation Act (BPCIA) litigation concerning the SB4 biosimilar to Enbrel.

Named Managing Principal of Fish & Richardson’s Twin Cities Office (2021).

Named “Litigation Practitioner of the Year – Minnesota” by Managing Intellectual Property (2021).

Named “Attorney of the Year” group award winner by Minnesota Lawyer (2020).

Named a “Local Litigation Star” by Benchmark Litigation (2020).

Named a “Life Science Star” by LMG Life Sciences (2017-2020).

Named to “Top 250 Women in Litigation” list by Benchmark Litigation (2018-2020).

Named a “Leading Patent Professional” by IAM Patent 1000 in 2020.

Named to “Best Lawyers” by Best Lawyers in America in 2020 and 2021.

Named a “Rising Star” by Law360 in 2019.