Ellie F. Steiner

Now a seasoned patent litigator, Ellie F. Steiner was once an undergraduate studying molecular biology and found the complexities of the field fascinating, which naturally led to an interest in intellectual property law.

Over the years, she has represented pharmaceutical companies in numerous high-stakes legal battles.

A notable case involved representing Viatris (formerly Mylan) against Sanofi's patents for Lantus (insulin glargine) products.

After a week-long trial, Judge Stanley Chesler of the U.S. District Court of New Jersey ruled the sole remaining device patent invalid for lack of written description and not infringed by Mylan's proposed product.

"Our team's victory, along with our success in parallel IPR proceedings at the PTAB, allowed for approval of the first interchangeable biosimilar," Steiner said.

Pharmaceutical patent litigation couples complex scientific and technical subject matter with multiple fields of law, including patent law, regulatory law and potentially antitrust, she added.

"Even while aware of the layers of knowledge and strategy in a case, effectiveness in litigation requires clarity of communication," Steiner continued. "This is true when we communicate within a team, with clients, with experts and with judges and juries. One recurring challenge in these patent cases is to capture the essential issues with accuracy but to maintain enough simplicity to allow understanding -- the balance will differ depending on context."

When asked about recent IP trends, she said she is seeing more patent validity challenges arising at the claim construction stage.

For example, Steiner continued, questions of claim breadth that used to fall within the Section 112 enablement requirement now appear in the guise of indefiniteness.

"The idea behind enablement is that a person of ordinary skill in the art should be able to make and use what is claimed in a patent based on that person's knowledge as well as the patent's disclosure. If a claim is not enabled, then that claim is invalid," she said.

This is a question that involves expert discovery, Steiner said.

"Indefiniteness is a little different -- it relates to ambiguous language in a patent claim that prevents an infringement defendant from knowing what conduct would fall within the patent scope," she continued. "When these indefiniteness challenges arise early in cases, i.e., at claim construction, there is the potential for the court to invalidate a patent prior to expert discovery and trial."