Dr. Laura Labeots is an IP attorney at Lathrop GPM with a Ph.D. in BioOrganic Chemistry. For more than 20 years, Laura has helped companies develop, monetize, manage, and protect their intellectual property assets.

Prior to her legal career, she conducted research at The University of Chicago, Northwestern University, Abbott Laboratories, Kraft Foods Company, and Exelon. She has first-hand knowledge of many issues that businesses face regarding their IP and is also an inventor on several patents.

In this JD Supra exclusive, Laura discusses the hot IP issues regarding patent protection and what to watch for in 2023.

What are some of the hot areas in patent law right now?

Vaccines are at the forefront at the moment, due to the COVID situation. Not only are companies trying to develop new and more effective vaccines with fewer side effects, but they are also trying to safeguard those technologies. The science itself is extraordinary, and so are the legal challenges to protect it. There are different types of COVID vaccines, which makes this whole area even more intriguing.

If a vaccine or a diagnostic product is a nature-based product, are companies able to patent them?

The patentability of nature-based products is a highly controversial area in patent law today, especially in the United States, because merely isolating or finding a natural product, like a new gene sequence, does not confer patentability. There is quite a lot of uncertainty (and litigation) about what constitutes a sufficient amount of man-made manipulation or changes of the natural product to make it patentable.

What are the hot intellectual property issues regarding genome editing?

CRISPR is an acronym for Clustered Regularly Interspaced Short Palindromic Repeats and is one of the most useful tools for gene editing. Two female scientists won the Nobel Prize for their research in this area, and billions of dollars are being invested here. As a game-changing technology, many people are working on it, so the current patent landscape is vast with thousands of patent families. That situation in itself makes the patent process more challenging. In addition, there is ongoing litigation as to some patents in this area, both in the U.S. and abroad, often presenting with different outcomes. Because of this uncertainty, many questions arise in due diligence, such as freedom-to-operate and licensing.

What are the interesting patent cases to watch for in 2023?

One of the most anticipated cases on the horizon is Amgen, Inc. v. Sanofi where the Supreme Court will address the issue of enablement. The question to be decided is whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation, meaning that nearly all embodiments of the invention would have to be identified or made “without substantial time and effort.” This question is met most often in chemistry and biotech-related technologies and the decision could potentially influence the scope of claim drafting practice in the future.

The patent generally concerns a treatment for high cholesterol. The claims at issue are functional claims directed to monoclonal antibodies that “bind” to at least one of a group of certain amino acid of a naturally occurring protein and that modified antibody additionally “blocks binding” of that protein to certain receptors in the liver. Here the antibodies are claimed functionally by what they do (“binding” and “blocks binding”) rather than structurally. This situation presents the Court with an opportunity to clarify the standards for enablement of generic, functional claims, and the quantity/quality of experimentation required to support them. It will be an important case to follow this year for the IP community.

Finally, what got you into patent law?

I’m a scientist at heart. I’ve been keenly interested in biology and chemistry since taking my first bio and chem classes in high school. Years later, after receiving my Ph.D., I was doing research at the bench and working with our attorneys on obtaining patents for a new technology I had developed. I enjoyed being involved in that process and thought that being a patent attorney would be a good fit for a problem-solver like me. It’s been my privilege to work with a remarkably diverse group of inventors and businesses, including Nobel Prize winners, big pharma, research institutes, and early-stage start-ups, to help them develop and defend their IP. I’m passionate about working with companies to bring their new, cutting-edge technologies to the marketplace.

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Connect with Dr. Labeots here.