LSPN chair: Uncertainty lies ahead for life sciences

Ahead of the upcoming LSPN North America-Spring 2025 conference, chair Eldora Ellison shares insights on emerging innovations in AI and gene editing, and offers advice for thriving in a competitive environment.

In less than a month, the life sciences community will converge in Boston for LSIPR's seventh annual LSPN North America–Spring 2025 conference.

The event, running May 6-7, will bring together experts to tackle the most pressing IP issues facing pharmaceutical, biotechnology, and medical technology industries.

The conference, chaired by Eldora Ellison of Sterne Kessler, promises to deliver vital insights on a diverse range of topics—from understanding the difficulties of US patent eligibility under Section 101 to protecting innovations involving big data, artificial intelligence (AI), and machine learning.

Sessions will also explore the changing responsibilities of IP lawyers, developments in China's patent landscape, updates on the Unified Patent Court, and the emerging field of Femtech patents.

With 29 years of experience, Ellison brings expertise to her role as chair, having represented clients in over 80 inter partes review and post-grant review proceedings, more than 15 patent interferences, and numerous re-examinations and district court cases.

Her technical background spans biotechnology, pharmaceuticals, molecular biology, therapeutic methods, diagnostics, immunology, and vaccines.

In an exclusive interview with LSIPR ahead of the event, Ellison shared what’s on her radar at the moment.

LSIPR: What are the top concerns for in-house counsel in the life sciences patent space right now, and how are they adapting to and overcoming these concerns?

Ellison: The life sciences industry finds itself in a period of increased uncertainty in view of shifting policies at the US Patent and Trademark Office (USPTO), reductions in the workforce at US federal agencies, funding cuts that impact the innovation pipeline, looming potential cuts to Medicare and Medicaid, and a growing ‘trade war’.

It’s now more important than ever to re-evaluate how a company’s assets fit into the IP landscape and marketplace, and to partner with counsel that stay abreast of the latest developments.

What  emerging innovations are you are most excited about, and how do you see them affecting the industry?

I’m excited to see how AI is being used in the life sciences industry.

For example, in accelerating drug discovery and design, analysing large data sets, identifying biomarkers, and developing diagnostics.

I’m also excited to see how carefully crafted and judiciously implemented AI tools can be used in the practice of law to better serve our clients.

But multiple issues may arise when AI is used.

For example, inventorship issues can come into play when seeking protection for inventions developed with the help of AI technologies.

Also, it is important to consider developing a comprehensive IP portfolio (eg, patents, trademarks, copyrights, trade secrets) to protect AI-based inventions.

Finally, confidentiality issues may arise when using AI tools; so, it’s important that the entire team understand how any AI tools are being used and the potential consequences of their use.

In addition to being excited about AI, I am excited to see further developments in mRNA-based vaccines and therapies, cell-based therapies, and CRISPR and other forms of gene editing.

What are the biggest challenges/risks when it comes to patent protection?

The written-description and enablement requirements continue to pose a challenge for many patent applicants seeking claims with significant breadth.

For parties seeking claims to formulations and dosing regimens, the USPTO’s views on obviousness also can create hurdles that must be overcome.

And for parties who develop diagnostic methods, patent eligibility remains an ongoing concern that warrants skilful patent drafting.

For start-ups and small businesses: Don’t go it alone.

I encourage such businesses to partner with experienced counsel who have strong technical backgrounds that allow them to understand the company’s technology and help them mitigate risks while capitalising on opportunities.

What key trends are you seeing at present?

We are closely watching developments at the USPTO.

Already, we are seeing that the Patent Trial and Appeal Board is exhibiting a greater willingness to deny inter partes reviews and post grant review petitions, as well as taking longer to grant such petitions a filing date in the first place.

This appears to reflect both a shift in policy as well as increased work-load pressures.

Similarly, the examining corps is facing increased productivity pressures, and we are watching for any impact on prosecution, eg,increased backlog or change in the time it takes to prosecute a matter.

What are you most looking forward to at LSPN Boston?

I am very much looking forward to connecting with in-house and outside counsel colleagues from around the globe.

LSPN is unparalleled in its ability to attract speakers who will address the cutting-edge issues affecting patents in the life sciences.

And it is unparalleled in the networking opportunities the conference provides. I can’t wait to gather in Boston again!

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