Becoming more than a pipeline feeder
Ventures with the ambition to evolve into principals will have the IP to match, designing their way round roadblocks. Armin K Bohmann reviews the prospects in biotech
The model for up-and-coming biotechs was clear for a generation. Bear the cost of exploring compounds on new technology platforms. Partner with a big pharma and let them take the lead with your IP. Then hope for payments against milestones and royalties without expecting to exercise any control of your own. Press repeat and continue exploring.
As a model, it could be highly lucrative, but it did keep you swimming with the small fry. Now biotech ventures are harbouring wider ambitions towards becoming principals in their own right. They are continuing to license the generic IP in their platform to their partners in big pharma, while retaining specific rights that they can commercialise as their own clinical candidates.
This space has opened up because big pharma is in intense competition for new products. When a venture can negotiate with two to three of them, it gives them more scope to retain rights beyond the main application. It’s a trend that is being reinforced as we enter the age of personalised medicine and diagnosis of individual patients.
Big pharma will still expect to be in the driving seat about how the claims in this IP are defined and defended. Any concessions or limitations on its scope are likely to be in its favour. So the horror scenario for biotech ventures is that they are at risk of losing whatever rights they have been able to negotiate for themselves. Big pharma may still have an attitude of grab and run, but what are the alternative solutions for ventures aiming to move up the biotech pecking order?
Spheres of interest
It is better not to to have a single patent that relies on big pharma defining the future rights of developers. Separate patents will ideally govern each sphere of interest: a generic one that additionally contains the big pharma’s clinical candidates in an individualised form that is licensed and one specifically related to those compounds to which the developer retains the commercialisation rights.
The options for ventures then, essentially, extend to divisionals and disclaimers. Neither of them are perfect, although the room for manoeuvre in Europe gives some room for comfort. Elsewhere the status of these rights can vary widely. In weighing them up, the questions are: how separate is separate enough and when should separation occur?
Divisionals
Ventures are typically inclined to defer IP-related costs into the future. A single patent application is frequently filed first and maintained as a single application throughout the international phase prior to the national and regional phases. Divisional applications are then filed to reflect the spheres of interest. What sounds like a standard procedure under European practice may turn into a challenge given the diversity of national patent laws in those jurisdictions where patent protection is subsequently sought.
Disclaimers
If a case allows, it is preferrable to file separate applications rather than divisionals, creating one licensed parent case and, at least, one separate application specifically related to those compounds to which the developer retains the commercialisation rights. The consequences are twofold:
The claims of the divisional or separate application depend on the parent case and, consequently, the licensor has to establish freedom to operate in light of the exclusively licensed parent case.
Quite a number of patent offices prohibit two patents being granted to the same applicant with claims directed to the same subject-matter. To overcome this objection, the claims of the parent case are amended.
Unfortunately, the legal landscape regarding the admissibility of a disclaimer is diverse. Even if a disclaimer is allowable, the legal validity of a parent claim containing one could be vulnerable.
Summary
These questions are becoming more and more pertinent. In the past, the small fries developed a compound and handed it over. It was more or less file and forget. Nowadays, more and more ventures want to take a couple of steps up in the hierarchy of pharmaceutical companies, rather than only being a pipeline feeder. It’s a long way from when there was next to no interest in retaining any specific compounds as proprietary clinical candidate, which has far-reaching consequences for how IP is now set up and negotiated.
· The full article by Armin Bohmann, ‘Beyond the IP pipeline: becoming more than a developer’ appears in Managing Intellectual Property Today, 2026/27 edition.. More details here or at novaropublishing.com/ip.
