Executive Interview with Jean Ge, Wolf Greenfield

[00:00] Transcript

[00:26] Hi everyone, and thank you for joining us. Today, I will be interviewing Jean Ge a patent attorney at Wolf Greenfield, one of the largest law firms in the US with a strong expertise in IP for biotech engineering and pharma.

[00:52] Jean will also be participating at Oxford Global's Discovery and Development event taking place on the second and third of October in San Diego. So Jean, thank you for being here and welcome.

[01:18]  So the first question from me is, for the audience, could you tell us a little bit about your role at Wolf Greenfield and your focus within the therapeutics IP space?

[01:44] Yeah, thanks, Lucia. And certainly, yeah, I can talk about that. So I am in our biotechnology practice group, and I work with companies of all sizes and at different stages in the therapeutics field, ranging from early-stage companies to established global pharmaceutical corporations, and also everything in between.

[02:10] My work covers both large and small molecules, but my real focus is on IP protection for complex Biotherapeutics. My role goes beyond just fighting patents for these client companies. It's about creating a comprehensive IP strategy that supports the company's overall business plan.

[02:36] Broadly speaking, this includes building a strong patent portfolio to protect their discoveries and enhance commercial value and also looking ahead to sort of clear paths for them by navigating the risks posed by third party patents.

[03:03] Perfect. Thank you very much. And last time we had a conversation, we touched a bit about your background, so you have a scientific background and a legal expertise background. So how would you say this comes in handy when advising clients within biopharma on their IP strategy?

[03:29] Yeah, it's an interesting question. So I often see my role as being at the intersection of science, law and business. My scientific background allows me to speak the language of the scientists so I can sit down with a team of R&D folks and have a deep conversation about their research.

[03:55]  I then translate those complex scientific discoveries into a language that the legal system understands, you know, the language of patent claims and specifications, and also, with that translated information, I design a patent strategy that and also build an integrated structure for long term protection and for value generation.

[04:21] This ensures that the fundamental scientific discoveries as they're being translated into something with commercial value is protected by equally powerful legal and business strategies.

[04:47] Thank you very much. And I guess everyone knows that it's key to start IP activity early. So what are the risks if IP strategy is delayed during the pre clinical or discovery phases?

[05:13] Yeah, that's a that's a critical point, and you're right. Starting early is definitely key, delaying IP strategy during the discovery and preclinical phases introduces a cascade of risks that can sometimes be devastating for a biopharma company, especially early stage companies, when companies don't think about IP when it's not sort of like in their mind, the risks of accidental public disclosure before you actually file a patent application to protect your technology is significantly higher.

[05:39] And of course, there is also the risks of getting scooped, which means your competitors might have filed on the same subject matter before you, especially if you're in a crowded field in which competitors are also fighting frequently.

[06:06] So now, the legal system, the patent system throughout the entire world is basically based on the first to file principle, so whoever files first gets the patent. So if you get scooped and become later, that hurts your chance of getting the patent to protect your technology.

[06:32] Also, a lack of thinking on IP also may lead to reactive filing of your own patent applications without a holistic view on the broader strategy, and again, all of these could create severe hurdles for companies to obtain defensible patents that protect their technology.

[06:58]  The other side may be that freedom to operate can also become an issue if a company, if a company goes too far without understanding the patent landscape and potential third party patent risks, and then the business risks will follow, including inability to secure funding and challenges in further business partnerships because of the lack of strong protection for your technology and or the potential patent infringement risks down the line.

[07:24] Let's see. Thank you very much. And you mentioned that you work a bit with small molecules and large molecules. Could you maybe briefly outline what a strong early IP strategy would look like for a company working on something complex, like a biologic or an ADC?

[07:50] Yeah, of course. So that's a, that's a that's a really important question, as the IP strategy for these complex modalities directly dictate their commercial potential. And here's how I would outline an IP strategy, strong IP strategy, which focus, which is focused on maximizing value and exclusivity for these molecules, for a complex modality like an ADC, it is typically not sufficient to just file a single patent to protect the molecule.

[08:16] It's about really creating a multi layered fortress for protection. The entire goal is to maximize commercial value by securing the broadest and longest market exclusivity possible. I can talk a little bit more and just break it down into a few different aspects. So the first one would be to sort of have a strategy to secure the core asset with a picket fence strategy. Foundation of all value is, you know, if you have a novel molecule, the foundation of all value is in the molecule itself.

[08:43] And by protecting only your single lead candidate with one family, one family is not sufficient, as I mentioned, a robust patent portfolio would certainly have layers of filings aligned with the development timeline of the different components of that ADC, and also the ADC as a whole, and also contain different claim scope and different focus on the different aspects of the primary structure, the production of the molecule, the formulation and the method of uses, for example, the treatment methods for your indications.

[09:09] Also if your company has a proprietary platform, you know, in the context of an ADC, for example, it could be a novel linker for ad for different types of ADCs, or some kind of a unique antibody discovery engine that you can use for the antibody side protecting the platform can also be essential, because you could also potentially monetize on that platform by licensing or future development.

[09:35] So this strategy makes it incredibly difficult for a competitor to create competing products without infringing at least some of your patents and thereby maximizing the market exclusivity. So that's one, and then the second one would be to build a defensive mode with manufacturing methods.

[10:01]  IP so unlike small molecules, protecting the manufacturing process, especially commercial scale manufacturing process, is an effective, effective strategy to extend the exclusivity of these complex about Biotherapeutics, even if you don't patent so there is also a consideration of, you know, do I want to patent them, or do I want to keep them as trade secret?

[10:27]  Either way, you will sort of create a significant barrier for entry for biosimilar competitors. Also, I would say, lastly, is to conduct proactive freedom to operate or patent landscape analysis. This is a defensive aspect of the overall strategy. This protects the commercial value you're building. You cannot maximize value if you're if you're blocked from entering the market.

[10:53]  So for an ADC or any modality that's complex with multiple components, you know, the different components could also be covered by third party patents, and maybe even the molecule as a whole.

[11:20]  So an early FTO or landscape analysis is crucial. It'll allow you to sort of de risk the program by identifying blocking patterns early, and also make strategic decisions early to either license the technology challenge the pattern or design around it before investing heavily in clinical development.

[11:46] Also This approach allows you to really act in an informed manner when you're talking to investors and or business partners, it will sort of, you know, give them a lot more comfort to want to partner with you or to invest in your company. Okay, so I think that's it

[12:12] Perfect. Thank you very much. Thank you for those very detailed and helpful insights. Definitely something new to learn. And what do you think is Wolf Greenfield's main advantage when working with innovative biotech companies? What sets you guys apart from the other law firms that are out there?

[12:38] And I'll first admit there are a lot of good law firms in IP space, in the US and also in Europe. But from my perspective, Wolf Greenfield's key advantage is that we really have a seamless integration of the technical and scientific depth with an exceptional, exceptionally broad and full service IP practice.

[13:04]  So for innovative biotech companies, this means that they don't just get a patent prosecutor. You know, it's not just about writing and prosecuting patents. What they get is a holistic.

[13:30] Like a strategic partner that's equipped to handle sort of any challenges or opportunities that arise, like will help you overcome the challenges and also maximize on the on the value of the opportunities.

[13:56] Basically, from the moment of discovery through commercialization and beyond, companies that work with us will get a team that is scientifically fluent enough to protect the most complex innovations at the molecular level, but we're also strategic, strategically broad enough to protect the business interests in, you know, boardrooms, in business negotiations, and ultimately in the courtroom, if, if there is infringement, we can cover basically the entire spectrum of their IP needs

[14:23] Perfect. Thank you very much. And final question from me, Jean is that while we are looking forward to your session at the conference on IP considerations in early discovery and development, so what are you hoping that the attendees take away from your sessions, and are there any particular conversations that you're looking forward to having at the event?

[14:49] Yeah, um, thank you. I also very much looking forward to being at the discovery and development event. I've attended a couple events Oxford Global events before and they are very comprehensive conferences with people from different functions in the in the biopharma space.

[15:15] So regarding the key takeaways from my session, I think my primary goal is to demystify intellectual property for those on the front line of discovery and development. I want to shift the mindset from sort of seeing IP as a separate late-stage legal hurdle to more viewing as an integral, proactive part of R&D life cycle and the business itself. So, you know, I look forward to, in that sense, I look forward to having conversations with scientists as to how they want to more proactively engage with engage sort of in the IP strategy process and talk to their IP console about, you know, the technology development, identifying sort of patentable subject matter, deciding you know what to file on and when to file and things along those lines to sort of make this process more, I guess, less of a remote aspect of a more of a, you know, integral piece of the R&D.

[15:41] As to the conversations I'm looking forward to having, I'm always keen to talk about the latest innovations in in these complex modalities, you know what, whether it's on new target identification or just new manufacturing or even characterisation methods, regulatory hurdles, and anything along those lines I'd be interested in. So we're hearing from the industry leaders.

[16:07] I look forward to talking to the scientists about the specific hurdles that they're facing to protecting either their platform and products from an IP perspective. And also, I want to hear from business leaders about the deal trend in the industry and their current challenges in aligning their IP strategy with corporate strategy, whether that's preparing for financing round or like seek a strategic partnership or clearing a path for commercialization,

[16:33] That's great. Thank you very much. And once again, we look forward to hosting you at the event, and I think that's all from me Jean. So thank you very much for sharing your perspectives and insights with us today. And as I said to the audience, you can hear more from Jean at Oxford Global's drug discovery and development event in San Diego on October from the second to third and for full registration, please visit the Oxford Global's event page. And thank you very much, Jean. Once again, it's been a pleasure. Thank you. Bye.