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.
- Alexandra Valenti, The 2020 Transition of Insulins to Regulation as Biologics, Center for Biosimilars (Oct. 11, 2019)
- Alexandra Valenti, Common Features of Lawsuits Filed Against AbbVie Over Humira, Center for Biosimilars (Sept. 27, 2019)
- Elaine Herrmann Blais, The FDA and Communications About Biosimilars, Center for Biosimilars (Sept. 20, 2019)
- Alexandra Valenti, Experience With BPCIA Litigation, Center for Biosimilars (Aug. 28, 2019)
- Elaine Herrmann Blais, The Potential for US Patent Reform, 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, INSIGHT: 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, 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