[The IPKat] Fordham 33 (Report 4): Life sciences and healthcare innovation

[Annsley Merelle Ward]

An invigorating sprint through global
life sciences issuesThe IPKat is back in Fordham, with the Spring skies and the chirping birds gracing the streets of the Upper West Side. As a proud and long-standing partner with the Fordham IP Conference, now in its 33rd year, the IPKat is thrilled to partner with the students of Fordham for reports from this years’ conference. The second report comes from Sophie Fulara (Writing and Research Editor of Fordham Intellectual Property, Media & Entertainment Law Journal (2026-'27) at Fordham University School of Law). 

Over to Sophie:  

"The audience left their Thursday afternoon coffee behind for the revitalizing mid-day session on life science innovation in an evolving patent landscape across the U.S., EPO, Japan, and the UPC. Moderated by Annsley Merelle Ward (WilmerHale/IPKat), expert panelists discussed the developments and effects of life science patent strategies in the ever-emergent global patent system. All views expressed on the panel were their personal views.

Eva Ehlich (Maiwald) discussed how clinical trial disclosures have been standard practice for decades. In Europe, these disclosures, such as protocols, reveal method steps, but not the results. Because Europe has product-for-use claims, not method-of-treatment claims as seen in the U.S., the therapeutic effect is treated as a functional feature of the claim. Thus, a protocol that does not explicitly disclose the treatment’s success is not considered anticipatory. Furthermore, establishing implicit disclosure has proven difficult at the EPO, requiring a level of certainty that is rarely met by a mere protocol. In this way, a product-for-use claim may be valid even if the result is the only difference.

The extent to which an applicant may extrapolate therapeutic efficacy in the absence of proof remains difficult. While it is possible to file a patent after a protocol has been published, the advisability of this approach is another question. If data results cannot be included into the filing because the filing must be early, then the other problem to consider is plausibility, meaning establishing a case without human data. For example, based on in vitro data. For the patentee the situation is like jumping from the frying pan into the fire: ideally, you want to wait to file with human data, but it is often impossible with clinical inventions and with new rules forcing you to disclose more comprehensive content.

Mark Stewart (MSD) explained that the opportunity for invention is ripe after initial discovery of a compound. For example, during phase 1, phase 2, and phase 3 clinical trials, including formulation and process development and the development of new indications. We call the patents that capture this innovation subsequent innovation patents (SIPs). There are three main considerations in regard to the value of those SIPs:

1. Competitive landscape: If an attorney is considering developing an exclusivity strategy that is relevant to a drug that is not first in class (which is most drugs), then they must determine how the drug will be “better” – that is, how will it be differentiated from other drugs in the same class in the marketplace. Then it is important to consider how to capture that differentiation in the context of patent filings. Part of that consideration is to understand when clinical or other types of data might be available to support that differentiation which will ultimately impact when and where to file applications.

2. Inflation Reduction Act pricing: Most drugs in the US will substantially reduce in price after seven years for small molecules and eleven years for large molecules. Companies must carefully consider how much – in terms of resources – should be done to support subsequent innovation. Should resources be spent on developing new formulations and dosing as well as new indications – that could really benefit patients. Because that type of work will likely be increasingly limited, companies may need to focus more on value associated solely with compound patents, patent term extensions, supplementary protection certificates (SPCs) and regulatory exclusivity.

3. Policy considerations: On the one hand, there are accusations of pharmaceutical companies creating patent thickets, which are argued to be responsible for the high cost of drugs. The reality is that it is very rare for there to be more than just a handful of patents impacting the ability of a generic or biosimilar drug to come onto the market.

Brian Cordery (Bristows) started with plausibility. “Plausibility is continuing to be a ball and chain around the UK patent system.” The UK is out of step with the rest of Europe in regard to the issue of plausibility. The UK should align with the rest of Europe as regards the application of G2/21 test of encompassed by technical teaching embodied by the original invention. There should be distinction when it comes to plausibility between compound claims and second medical use claims. With the latter, the use is a functional technical feature of the claim – it is at the heart of the invention. Thus, the specification for second medical use patents should include sufficient justification to render the claimed effect plausible to a person skilled in the art.

The saga on the interpretation of the EU Regulation on Supplementary Protection Certificates (SPCs) is everlasting because of the CJEU’s tendency to consider only the facts and issues before it rather than the wider general principles. This leads to an endless cycle of litigation – as one problem is solved, another is created. One particular example can be seen in the latest Merck v Clonmel ruling from the CJEU where the Court suggested (perhaps way of example) that a more than additive effect was required for a combination product to fall under the invention of a patent. It is not the role of the CJEU to determine what does or does not fall under an invention – this should be the role of the referring national court.

Shimako Kato (Abe, Ikubo & Katayama Law Firm) explained the position in Japan.  “Japan does not have the U.S. patent dance, but a sumo match waiting for information to be shared.” This is otherwise known as Japan’s unique linkage system, where an originator company submits its patent information confidentially to the Ministry of Health. The Ministry will not grant a patent for a generic if the substance patent, active patent ingredient, or use patent of the original drug is valid. As patents became increasingly complex, it became difficult for the Ministry to assess infringement. To break the deadlock, generic companies challenged the system through the court, which was revised in October 2025, where standards were set for submitting patent information and new frameworks were introduced as a three-member expert committee provided its opinion on patent infringement for difficult cases.

However, there is still a lack of transparency as submitted information remains confidential. Additionally, a question looms on whether the involvement of an expert committee will provide satisfactory practices for both sides. Generally, these changes cause an uptick in approval for generic drugs in cases where non-infringement was previously difficult to determine. On the other hand, patent litigation could increase as the committee’s opinions are not legally binding.

Simon Holzer (MLL Legal) shared three lessons that the UPC teaches:

1. Applicants should take strategic caution when engaging the UPC in the life science sector. The court’s centralized nature could jeopardize an entire patent portfolio.
2. In many cases, the inventive step remains the main battle ground in the life science sector. Seeing that the UPC adopts a more holistic assessment of the inventive step relative to the EPO, applicants must ensure they know the contribution of their inventions in the prior art when they seek to defend their patents.
3. Have your case ready when you go to court. Know where you bear the burden of proof and include the pertinent facts in your brief.

Nicholas P. Groombridge (Groombridge, Wu, Baughman & Stone LLP) stated that the state of patent litigation development contains a high degree of volatility and unpredictability. The current administration has pursued policies that severely curbed the pro patent shift. Particularly, in life sciences, the administration focused on drug pricing which creates tension and injects volatility.  In re Montgomery held that disclosure of clinical trial data was not anticipation. However, generic companies continue to argue that clinical trial data creates references, where the mere fact of conducting a clinical 3 phrase trial is an indication of success."