Big Molecule Watch

Goodwin Releases Comprehensive Guide to Biosimilars Litigation and Regulation in the U.S. 

New publication is a go-to reference on all things biosimilars

Goodwin has released its Guide to Biosimilars Litigation and Regulation in the U.S., 2020-2021 ed., a comprehensive reference guide authored by a group of lawyers from Goodwin’s Intellectual Property, Life Sciences, FDA, Products Litigation + Counseling, Antitrust + Competition and Appellate Litigation practices and published by Thomson Reuters.

To purchase from Thomson Reuters, click here.

Other Publications

Below is a sampling of articles and other publications authored by members of the Big Molecule Watch blog team and other Goodwin attorneys and law clerks on issues relating to biosimilars, pharma or biotech more generally.

• Adam Houldsworth, Latest Humira Dispute Highlights Biosimilar Trade Secrets Dangers, Intellectual Asset Management (Mar. 30, 2021)
• Tony Hagen, Biosimilars Litigation: When Safe Harbor Is Not Safe, The Center for Biosimilars (Mar. 12, 2021)
• Alexandra Valenti, Rob Cerwinski, Not So Different: Goodwin Attorneys Discuss Updates to Biosimilars Litigation Guide, The Center for Biosimilars (Mar. 7, 2021)
• Adam Houldsworth, Major Biosimilar Patent Issues Are Coming to the Boil in the US — Here’s What You Need to Know, Intellectual Asset Management (Mar. 2, 2021)
• Huiya Wu, Freddy Yip, Goodwin Lawyers Discuss How Foreign Companies Can Break Into China’s Biosimilar Market, The Center for Biosimilars (Feb. 20, 2021)
• Manasi Vaidya, AbbVie’s Successful Hard-Ball With Humira Legal Strategy Unlikely to Spawn Similar Efforts; Potential Appeals Outcome Unclear, Pharmaceutical Technology (Feb. 19, 2021)
• Not So Different: The Race to the Top: Does China Have What it Takes?, The Center for Biosimilars (Feb. 7, 2021)
• Tony Hagen, China Pulls Out Stops for Biosimilar Development, The Center for Biosimilars (Jan. 25, 2021)
• Anna Rose Welch, Will These Big Biosimilar Questions Be Answered In 2021?, Biosimilar Development (Dec. 23, 2020)
• Adam Houldsworth, Rare ED Texas Pharma Lawsuit May Be A Sign of Things to Come for Biosimilars, Intellectual Asset Management (Dec. 4, 2020)
• Tony Hagen,Goodwin Lawyers Discuss Hospira-Amgen Infringement Case, The Center for Biosimilars (Sep. 15, 2020)
• Biggest Influencers in Biosimilars in Q2 2020: The Top Individuals and Organizations to Follow, Pharmaceutical Technology (Sep. 14, 2020)
• Introduction to Biosimilars and Labeling Issues, For the Defense (Sep. 3, 2020)
• Skylar Jeremias, Expert Opinion Roundup: New Insulin and Biosimilar Regulation, The Center for Biosimilars (Aug. 26, 2020)
• John Bennett, Brian Drummond, Kline Moore, Janssen v. Celltrion Federal Circuit Judgment: What Biosimilar Makers Need To Know, BioProcess Online (Aug. 25, 2020)
• John Bennett, Brian Drummond, Kline Moore, Genentech v. Amgen Federal Circuit Judgment: What Did We Learn?, BioProcess Online (Aug. 18, 2020)
• Fed. Circ. Keeps Sandoz’s Enbrel Biosimilar Off The Market, Law360 (Jul. 1, 2020)
• European Pharmaceutical Review, Five Patent Issues That European Biosimilar Developers Should Consider Before Entering The US Market, European Pharmaceutical Review (Jun. 22, 2020)
• Nick Mitrokostas, Nick Mitrokostas Discusses New Biosimilar Approval and the Outlook for 2020, The Center for Biosimilars (Jun. 21, 2020)
• Brenda Sandburg, COVID – 19 Impacting Patent Litigation, From Exclusivity Forfeiture to Launch Delays, Pink Sheet (Apr. 28, 2020)
• Alexandra Valenti, Doing the ‘Patent Dance:’ Untangling Biosimilar Litigation for Physicians, Healio Rheumatology (Mar. 20, 2020)
• Fed. Circ. Grapples With Double-Patenting In Enbrel Case, Law360 (Mar. 5, 2020)
• FDA Moves to Speed Up Supplemental Biosimilar Reviews, Politico (Feb. 10, 2020)
• Stephen M. Hahn, FDA, Federal Trade Commission to target ‘anti-competitive’ practices to support biosimilars, Healio (Feb. 3, 2020)
• Tony Hagen, Biosimilar Makers Must Plan for Originator Firms Gaming the Patent System, Panel Says, The Center for Biosimilars (Jan. 22, 2020)
• Biosimilar Patent Litigation May Be On The Rise In 2020,Law360 (Jan. 14, 2020)
• Robert Cerwinski, Alexandra Valenti, Goodwin Attorneys Give a Look at Biosimilar Litigation, Not So Different Podcast (Jan. 6, 2020)
• Adam Houldsworth, What We Have Learned From the Early Years of Biosimilar Litigation, IAM Magazine (Dec. 10, 2019)
• Joshua Whitehill, Natasha Daughtrey, US Launch: Five litigation strategies European biosimilar developers should know, Pharma IQ (Nov. 12, 2019)
• Alexandra Valenti, Regulatory Scrutiny and Biosimilar Settlements, The Center for Biosimilars (Oct. 18, 2019)
• Joshua Whitehill, Alexandra Valenti, Biosimilar IP Dispute Heats Up—’Notice of Commercial Marketing’, Bloomberg Law (Oct. 16, 2019)
• Alexandra Valenti, The 2020 Transition of Insulins to Regulation as Biologics, The Center for Biosimilars (Oct. 11, 2019)
• Alexandra Valenti, Common Features of Lawsuits Filed Against AbbVie Over Humira, The Center for Biosimilars (Sept. 27, 2019)
• Elaine Herrmann Blais, The FDA and Communications About Biosimilars, The Center for Biosimilars (Sept. 20, 2019)
• Alexandra Valenti, Experience With BPCIA Litigation, The Center for Biosimilars (Aug. 28, 2019)
• Elaine Herrmann Blais, The Potential for US Patent Reform, The Center for Biosimilars (Aug. 21, 2019)
• Natasha Daughtrey, Khurram Naik, Medicare Negotiation and Competitive Licensing Act: An Ambitious Challenge to Biologic Patents, Biosimilar Development (May 21, 2019)
• Frederick Rein, Aviv Zalcenstein, Kathleen McGuinness, Amgen v. Sanofi: The fall of the newly characterized antigen test (if it ever truly, jurisprudentially existed in the first place), Journal of Generic Medicines (May 20, 2019)
• Elaine Herrmann Blais, Nicholas Mitrokostas, Khurram Naik, Increasing Biosimilar Competition: Trends In Government Responses, Biosimilar Development (Mar. 12, 2019)
• Joshua Whitehill, Kevin DeJong, Alexandra Valenti, ‘Biosimilar V. Biosimilar’ Patent Case May Be First Of Many, Law360 (Mar. 4, 2019)
• Joshua Whitehill, Michael Cottler, The US Biosimilars Patent Litigation Outlook For 2019, Law360 (Jan. 18, 2019)
• Elaine Herrmann Blais, Scott Lassman*, Alexandra Valenti, Biosimilars Market Update Webinar, Goodwin Procter LLP (Nov. 6, 2018) (recap)
• Frederick Rein, Aviv Zalcenstein, Ilana Saltz**, Time To Remove Patent Barriers To US Drug Manufacturing, Law360 (Aug. 6, 2018)
• Keith Zullow, Michael Cottler, Joshua Whitehill, The Ongoing Debate About Disclosing Manufacturing Process Information in the Patent Dance, Bloomberg Law (July 2, 2018)
• Frederick Howard Rein, Aviv A. Zalcenstein, Kathleen McGuinness, Amgen v. Sanofi: Can an injunction contrary to the public health interest ever properly be granted?, Journal of Generic Medicines (June 22, 2018)
• Alexander Varond, Julie Tibbets, Scott Lassman*, Expanded Access Policy Disclosure and Federal Right-to-Try Law, Goodwin Procter LLP (June 6, 2018)
• Keith Zullow, Michael Cottler, Alexandra Valenti, Turning tide on diagnostic method claims, Intellectual Property Magazine (May 2018)
• Theresa Kavanaugh, Effective IP Habits for Early Stage Life Science Companies, Goodwin Procter LLP (May 2, 2018)
• Michael Cottler, Natasha Daughtrey, Does Indication-Specific Pricing Fit Generics With Carveouts?, Law360 (Dec. 15, 2017)
• Michael Cottler, Joshua Whitehill, Alison Siedor, The 2018 biosimilar litigation landscape: A primer, BioPharma Dive (Dec. 14, 2017)
• Robert Cerwinski, VIDEOS: Robert Cerwinski Sits Down With the Center for Biosimilars, The Center for Biosimilars (Dec. 12, 2017)
• Frederick Rein, Aviv Zalcenstein, Vineeta Nangia**, Incentivizing Brand Pharma Cos. To Manufacture In The US, Law360 (June 29, 2017)
• William Jay, Brian Burgess, Webinar: TC Heartland’s Impact on Hatch-Waxman, Goodwin Procter LLP (June 15, 2017)
• Alexandra Valenti, Alexandra Lu, Elaine Herrmann Blais, Robert Cerwinski, Dance Fever: A Recap of Recent BPCIA Litigation, Bloomberg Law (Apr. 28, 2017)
• Frederick Rein, Aviv Zalcenstein, Making America Manufacture Drugs Again: Can President Trump Level The Pharmaceutical Playing Field?, Law360 (Mar. 2, 2017)
• Michael Cottler, Joshua Whitehill, Jacqueline Genovese Bova, The Biosimilars Litigation Landscape For 2017, Law360 (Jan. 6, 2017)
• Alexandra Valenti, Joshua Whitehill, Elaine Herrmann Blais, Robert Cerwinski, Biosimilars and the Mensing Product Liability Shield: A Primer for Patent Litigators, NYIPLA: The Report (Feb./Mar. 2016)
• Nicholas Mitrokostas, Webinar: Pharmaceuticals at the Patent Trial and Appeal Board, Goodwin Procter LLP (Oct. 8, 2015)
• Elaine Herrmann Blais, Robert Cerwinski, Webinar: Amgen v. Sandoz on Appeal: The Federal Circuit Construes the BPCIA, Goodwin Procter LLP (Aug. 12, 2015)
• Elaine Herrmann Blais, Robert Cerwinski, Alexandra Lu, Order in Amgen v. Sandoz Provides First Judicial Interpretations of the BPCIA Patent Dispute Resolution Provisions, Goodwin Procter LLP (Mar. 20, 2015)
• Elaine Herrmann Blais, Alexandra Lu, Webinar: The Impact of Amgen v. Sandoz, Goodwin Procter LLP (Mar. 18, 2015)
• Theresa Kavanaugh, Daryl Wiesen, Brian Drummond, Recent Ruling Clarifies Patent Litigation Timing Under Biosimilars Act, Goodwin Procter LLP (Nov. 26, 2013)
• Brian Fairchild, Duncan Greenhalgh, Douglas Klein, In Myriad, Supreme Court Declares Isolated, Naturally Occurring DNA Not Patent Eligible, Goodwin Procter LLP (June 24, 2013)
• Brian Fairchild, Duncan Greenhalgh, Federal Circuit Reconfirms Isolated DNA Is Patent-Eligible; Mental Processes Are Not, Goodwin Procter LLP (Aug. 31, 2012)

 

*Former Goodwin attorney
**Law clerk