Alex Lu is a partner in the litigation department of Goodwin and a member of its Intellectual Property practice. She focuses her practice on patent matters and has litigated patent infringement suits in areas spanning from biotechnology and pharmaceuticals to network technology. Alex has focused a significant portion of her practice on legal and regulatory issues concerning biosimilars and biologics, and is a founding member and editor of the Big Molecule Watch, an award-winning blog that reports real-time analysis and updates on regulatory issues, litigation, legislation and other news in the developing world of biosimilars (or “big molecules”). Alex is also a contributing author of Goodwin’s biosimilar resource: Biosimilars: A Guide to Regulatory and Intellectual Property Issues.
Alex has extensive experience in all phases of patent litigation from pre-suit patent analysis through trial and appeal, including experience with federal bench and jury trials, summary judgment proceedings, preliminary injunction proceedings, and Federal Circuit appeals.
Alex also has experience working on arbitrations involving contract disputes in the life sciences space, and inter partes review proceedings before the U.S. Patent Trial and Appeal Board.
Representative matters include:
- GlaxoSmithKline v. Teva Pharmaceuticals USA, Inc., No. 14-878-LPS (D. Del.) – Represented Teva in patent litigation, including jury trial, concerning Teva’s generic version of Coreg® (carvedilol) tablets
- Indivior Inc. v. Dr. Reddy’s Laboratories, S.A., No. 17-7111 (D. N.J.) – Representing Dr. Reddy’s in patent infringement litigation, including a hearing on motion for a preliminary injunction, concerning Dr. Reddy’s applications to market generic versions of Suboxone® (buprenorphine hydrochloride and naloxone hydrochloride) sublingual films
- Reckitt Benckiser Pharmaceuticals Inc. v. Dr. Reddy’s Laboratories, S.A., No. 14-1451-RGA (D. Del.) – Represented Dr. Reddy’s in patent infringement litigation, including bench trial, concerning Dr. Reddy’s applications to market generic versions of Suboxone® (buprenorphine hydrochloride and naloxone hydrochloride) sublingual films. After trial, the court found that Dr. Reddy’s proposed generic product did not infringe any of the asserted patents
- Genentech, Inc. v. Celltrion, Inc., No. 18-cv-0574 (D. N.J.) – Represented Celltrion and Teva in patent infringement litigation under the BPCIA, including preparations for hearing on motion for a preliminary injunction, concerning Celltrion’s and Teva’s proposed biosimilar rituximab product
- Sophos, Inc. v. RPost Holdings, Inc., No. 13-12856-DJC (D. Mass.) – Represented Sophos in declaratory judgment action regarding Sophos’s network security and email security products. The court granted Sophos’s motion for summary judgment of invalidity on two independent grounds
- Genzyme Corp. v. Dr. Reddy’s Labs., Ltd., No. 13-1506-GMS (D. Del.) – Represented Teva Pharmaceuticals USA, Inc. in patent infringement litigation, including trial, regarding Teva’s application to market a generic version of Genzyme’s stem cell mobilizing agent, Mozobil® (plerixafor)
Alex is also committed to pro bono work, in which she has focused on matters representing unaccompanied minors seeking asylum and Special Immigrant Juvenile status in immigration and related state court proceedings. Alex was also an active member of a team that successfully challenged, on First Amendment grounds, city ordinances banning charitable solicitation in public places, and a team that successfully won an immigration case before the Supreme Court concerning the correct interpretation of the stop-time rule for cancellation of removal.
While in law school, Alex was a student and student director in the Immigration Legal Services Clinic at Yale Law School, and an editor for the Yale Law Journal. She also worked as a summer intern at the Department of Justice Civil Rights Division, Housing and Civil Enforcement Section.
Yale Law School
- U.S. District Court for the District of Massachusetts
- U.S. Court of Appeals for the Federal Circuit
- U.S. Supreme Court
Recognition & Awards
Alex was recognized by the American Immigration Lawyers Association as part of the Pereira Litigation Team with the 2019 Jack Wasserman Memorial Award for excellence in litigation in the field of immigration.
- Contributor, “Guide to Biosimilars Litigation and Regulation in the U.S., 2022-2023 ed.,” published by Thomson Reuters, 2012
- Speaker, “BPCIA Patent Dance Disclosures: Discovery During the Patent Dance and Beyond,” Goodwin Webinar, 2020
- Contributor, “Guide to Biosimilars Litigation and Regulation in the U.S., 2019-2020 ed.,” published by Thomson Reuters, 2019
- Speaker, “The Impact of Amgen v. Sandoz,” Goodwin webinar, 2015
- Co-Author, “Plants and Potions,” Intellectual Property Magazine, 2015
- Co-Author, “Order in Amgen v. Sandoz Provides First Judicial Interpretations of the BPCIA Patent Dispute Resolution Provisions,” 2015
- Media mention, “Goodwin Procter Launches Big Molecule Watch Blog for Biosimilars Industry,” 2015
- Media mention, “Enbrel Biosimilar Market In Sandoz's Grasp; Will Cost, Litigation Derail It?,” Scrip, 2016
- Co-Author, “Dance Fever: A Recap of Recent BPCIA Litigation,” Bloomberg Law, 2017
- Co-Author, “Sanctuary Cities: Distinguishing Rhetoric From Reality,” Boston Bar Journal, 2017
- Co-Author, “Goodwin Trial Win Clears Patent Hurdle for Dr. Reddy’s Generic Suboxone®,” 2017
- Co-Author, “No Child Stands Alone,” 2017
- Co-Author, “KIND Pro Bono Attorney Spotlight,” 2018