On July 9, 2021, President Biden issued “Executive Order on Promoting Competition in the American Economy” (the “Executive Order”). The Executive Order was billed by the White House as “historic” and comparable to Teddy Roosevelt’s trust-busting and Franklin Roosevelt’s “supercharged antitrust enforcement”. Asserting that a “fair, open, and competitive marketplace has long been the cornerstone of the American economy,” the Executive Order sets forth 72 initiatives across over a dozen federal agencies.

Notably, a number of these initiatives focus on the healthcare sector, among them, a direction to the Secretary of Health and Human Services to:

  1. lower the prices of and improve access to prescription drugs and biologics, [and] continue to promote generic drug and biosimilar competition,” including by: (a) clarifying the approval framework for generic drugs and biosimilars, and the standards for interchangeability of biological products; (b) “supporting biosimilar product adoption;” (c) facilitating “the development and approval of biosimilar and interchangeable products;” and (d) “identifying and addressing any efforts to impede generic drug and biosimilar competition, including but not limited to false, misleading, or otherwise deceptive statements about generic drug and biosimilar products and their safety or effectiveness;”
  2. ensure that the patent system, while incentivizing innovation, does not also unjustifiably delay generic drug and biosimilar competition,” and, by August 23, 2021, “write a letter to the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office enumerating and describing any relevant concerns;” and
  3. support the market entry of lower-cost generic drugs and biosimilars.”

As part of the effort to address competition matters in the healthcare space, the Executive Order also “encourage[s]” the Attorney General and the Secretary of Commerce to “consider whether to revise their position on the intersection of the intellectual property and antitrust laws.” It further instructs the Federal Trade Commission to exercise its statutory rulemaking authority with respect to “anticompetitive conduct or agreements in the prescription drug industries, such as agreements to delay the market entry of generic drugs or biosimilars.”

Although the Executive Order is potentially significant, its impact will depend on the extent and timing of concrete actions that the affected agencies ultimately take. Indeed, by its own terms, the Executive Order does not “create any right or benefit, substantive or procedural, enforceable at law or in equity.” With respect to the patent system, more will be known once the Secretary of Health and Human Services releases his letter to the Under Secretary of Commerce for Intellectual Property and Director of the USPTO on or before August 23, 2021. Industry stakeholders should monitor this space for updates, including opportunities to provide public comments on any proposed rules and regulations.

Print:
Email this postTweet this postLike this postShare this post on LinkedIn
Photo of Michelle M. Ovanesian Michelle M. Ovanesian

Michelle Ovanesian is an associate in the Litigation Department, where she focuses on intellectual property and life sciences. Michelle has worked on a range of matters in federal district courts, including serving on the trial team in the Amgen Inc. v. Sanofi remand.…

Michelle Ovanesian is an associate in the Litigation Department, where she focuses on intellectual property and life sciences. Michelle has worked on a range of matters in federal district courts, including serving on the trial team in the Amgen Inc. v. Sanofi remand.

In addition to intellectual property and life sciences, Michelle’s practice has encompassed a variety of other legal matters, including pro bono veterans services, commercial disputes and bankruptcy.

Photo of Siegmund Y. Gutman Siegmund Y. Gutman

Siegmund (“Sige”) Gutman is chair of the Life Sciences Patent Practice, a partner in the Litigation Department, and a member of the Patent Law and Intellectual Property Groups.

Sige is an accomplished patent litigator, frequently representing clients before trial and appellate courts, as…

Siegmund (“Sige”) Gutman is chair of the Life Sciences Patent Practice, a partner in the Litigation Department, and a member of the Patent Law and Intellectual Property Groups.

Sige is an accomplished patent litigator, frequently representing clients before trial and appellate courts, as well as arbitration panels. In the life sciences area, his practice focuses on developing and executing market exclusivity and freedom-to-operate strategies, including patent office and FDA regulatory strategies, for leading biologics, pharmaceutical, biotechnology, and medical device clients. He has extensive experience successfully litigating biologic drug patent and Hatch-Waxman cases, and has frequently spoken and written about issues relating to biosimilars and generic drugs. Sige’s background combines a graduate degree in molecular and cell biology and biophysical chemistry with more than 20 years of industry experience, including serving as senior patent litigation counsel for Amgen, the world’s largest biotechnology company.

He advises clients on patent matters involving a wide range of technologies, including therapeutic proteins such as monoclonal antibodies, antibody-drug conjugates, nucleic acids, gene therapy, stem cells, expression systems, screening methodologies, purification processes, DNA microarrays, small molecules and polymer chemistry.

Sige also has extensive experience in inter-partes patent office actions, including oppositions, and providing strategic patent counseling, including addressing product life cycle management and patent portfolio development issues, as well as preparing third-party patent landscape analyses.

Prior to joining Proskauer, Sige was a partner at another Am Law 100 firm.

While in graduate school, Sige worked on elucidating the 3-D structure of an auto-catalytic RNA using molecular biological, biochemical and biophysical techniques. He also previously worked for a major manufacturer of photocopiers and printers, where he helped develop novel color toner particles using electrochemical, photochemical and polymer chemical techniques.