From potential legal challenges to Chinese biopharma supply chains, Europe’s new Unified Patent Court (UPC), landmark decisions in life sciences, pharma’s Orange Book listings, design patent rejections, and likely shifts at the USPTO, 2024 provided plenty of important and often global changes and clarifications in intellectual property law. Wolf Greenfield attorneys discuss 2024’s most important IP news, and what to look for in 2025 and beyond.
LIFE SCIENCES
In 2024, the Federal Circuit heard oral arguments in University of California v. Broad Institute regarding invention of the groundbreaking CRISPR-Cas9 gene-editing technology, which allows researchers to manipulate and modify DNA with exacting precision – the court’s decision is expected in early 2025.
Chelsea Loughran, Shareholder, Litigation Practice:
“What will be interesting in 2025 is not only the expected decision regarding who invented the CRISPR-Cas-9 technology first, but how disputes over license agreements and indemnification clauses surrounding the technology will move forward. In the number of years in which the litigants engaged in legal battles regarding who first invented the technology, the field has been using the CRISPR-Cas-9 technology, and engaging in a whole host of different licensing agreements and contractual frameworks for its use. In 2025, we are likely to see a number of disputes regarding license agreements and provisions that parties have used to shield themselves from liability and reduce risk.”
BIOTECHNOLOGY
The BIOSECURE Act (H.R. 8333) aims to prevent federally-funded US drug companies from collaborating and contracting with certain Chinese biotechnology companies due to concerns involving alleged national security threats, data, and IP theft by the Chinese government. While the bill has seen strong bipartisan support, due process concerns regarding naming specific companies has made its future less certain.
Gabe McCool, Counsel, Biotechnology Practice: 
“Given the uncertainty of the passage of the BIOSECURE Act, it’s impossible to know its full impact. That said, many companies have already begun making decisions to cut ties with Chinese CDMOs in favor of sourcing other domestic and foreign supply chain options. Such pivoting may come with higher costs and constraints on biopharma supply chains for US drug companies, as China has for the last decade grown to be a significant powerhouse as a provider of biomanufacturing and biopharma supply. Time will tell, but given the expected continued concerns over perceived risks of data and IP theft by the Chinese government, companies are expected to continue the trend of pivoting away from Chinese firms throughout 2025, with possible strengthening of CDMO and biomanufacturing industries elsewhere, including in the US – whether or not the BIOSECURE Act becomes law.”
PHARMACEUTICAL
2024 saw continued Federal Trade Commission activity regarding Orange Book listings, and the threat of enforcement surrounding alleged improper patent listings, and was capped by a significant decision from the Federal Circuit Court of Appeals regarding what patents must, and must not, be listed.
Jon Roses, Shareholder, Pharmaceutical Practice:
“As a late holiday gift, the Federal Circuit issued a decision in the Teva v. Amneal case that provided a little bit of clarity around Orange Book listing of patents for drug device combinations. The crux of that decision is that a patent that covers the device or its components, which is part of an approved drug device combination product, is not properly listable in the Orange Book if it does not include a claim to the active ingredient of that product. This is important and is something that medical device companies had asked the FDA to clarify, and now we have at least a little bit of clarity around the issue from the Federal Circuit. This is, of course, subject to change if the case moves through the Supreme Court.”
Jon also offered some thoughts on the incoming administration and Congress, and the changes that may bring to the life sciences industry:
“In 2024, we saw some proposals from the legislative and executive branches that all ultimately stalled, including efforts from the USPTO, such as proposed changes to terminal disclaimer rules, and increases in certain patent fees. The situation is likely to be the same in 2025 because Congress and the second Trump administration will be focused on other priorities. That said, legislative efforts are likely to continue, and we may see more action in 2025 and 2026.”
ELECTRICAL & COMPUTER TECHNOLOGIES
After coming into full force in 2023, the UPC saw a number of lawsuits filed in 2024. While there have been no significant UPC decisions in the standard essential patent space or in the area of fair, reasonable, and non-discriminatory royalties, this is an important area that needs to be followed closely in 2025.
Zach Piccolomini, Shareholder, Electrical & Computer Technologies Practice:
“In 2025, we’ll start to see these UPC cases play out, and can start to understand which of the UPC local courts will become lawsuit hotspots. Globally, we will likely start to see new and different standard-based technologies emerge as the basis for lawsuits. For example, a few decades ago, a big focus was what was new at the time: DVD discs and Blu-ray disc technologies. After that, we saw a lot of litigation in the wireless and cellular space. Now, we are starting to see even more technologies emerge - things like video coding, connector-based standards, and the internet of things-type standards. It will be interesting to see not only how the global and European case law evolves, but also how the technologies evolve, and what we see with different technologies giving rise to standard essential litigation.”
DESIGN PATENTS
2024 delivered a highly anticipated Federal Circuit decision in LKQ v. GM Global Technologies, overturning a 40 year-old test for design patents. The LKQ decision’s new test will likely lower the bar for examiners to reject design patents, making designs more susceptible to obviousness rejections.
Jennifer Wang, Shareholder, Mechanical Technologies Practice:
“If examiners make an obviousness rejection in designs, they still have to provide a reason for the modification. So first, it’s essential to make sure that the examiner has in fact addressed every single part of the claim. This is similar to utility patents. Sometimes examiners just leave out whole parts of the claim, and that’s not a proper rejection: they have to address every piece. Secondly, they must make sure they are actually providing an adequate reason or motivation to modify the primary reference. With utility cases, oftentimes examiners will hand wave and not provide a real concrete reason for their modification. This may also happen with designs, where examiners just say, ‘I found one feature in one reference and another feature in another, and it’d be obvious to put them together.’ That would not be a sufficient motivation. There needs to be something a little bit more concrete than that, so it’s important to carefully review rejections.”
PATENT TRIAL AND APPEAL BOARD (PTAB) / UNITED STATES PATENT AND TRADEMARK OFFICE (USPTO)
2024 saw changes in practices relating to terminal disclaimers, and as the new administration begins in January 2025, there is likely to be marked movement at the USPTO, particularly after a new director is installed.
Scott McKeown, Shareholder, Post-Grant Proceedings Practice:
“The most noteworthy development in the USPTO arena was the attempt to reign in or recalibrate practices relating to terminal disclaimers. Over the years, the USPTO position has become more and more political, and it seems that politicians have learned that you can sell certain themes to the American public by using patent policy as your base. In 2024, one theme that was pushed with the American public was that drug pricing is a problem, and that the way to get to drug pricing is through patent policy.”
Scott also noted some potential changes in leadership at the USPTO, making predictions for 2025 and beyond:
“The expectation here in the short term is that we will have an interim director for most, if not all, of 2025. In 2026, I’m expecting the Republican appointee to come in, and while he or she is likely to follow the game plan of the former director in some of the procedural mechanisms used to drive policy, I expect the new policies will also be opposite in many ways to those driven by Director Vidal. For patent owners in particular, the new director may offer some opportunity to go back once again to the discretionary practices of former Director Iancu (who preceded Director Vidal), and those policies were somewhat pro patentee in that they mostly benefitted patent owners in finding ways to avoid the PTAB or lawsuits in districts with more aggressive trial schedules.”
TRADEMARK & COPYRIGHT
In trademark law, 2024 provided a highly anticipated decision in Vidal v. Elster, in which the Supreme Court found that a provision of the Lanham Act regarding trademarks using the name of living individuals without their consent does not violate the free speech clause of the First Amendment. In 2025, the Supreme Court will issue a decision in Dewberry Group v. Dewberry Engineers – a long-running dispute over similar names.
John Strand, Shareholder, Trademark & Copyright Practice:
“In Dewberry, an important issue before the Supreme Court is what damages can be recovered from affiliates of an infringer or defendant. In Dewberry, the district court allowed for the plaintiff to recover not only the profits of the actual defendant, but also profits from the defendant’s affiliates. The question before the Supreme Court is whether it is possible to reach beyond the actual parties of the case to get damages under the Lanham Act. I think this has a lot of bigger implications beyond the Lanham Act regarding how far the federal courts can go in stretching their power to right what a jury or judge has seen as a wrong where a plaintiff was harmed by a defendant and its affiliates, with regard to how much damages the plaintiff can be awarded from non-parties.”