Articles

The Patent Cliff Is an Opening for Central and Eastern Europe Biotech — Readiness Will Decide Who Benefits

Sterne, Kessler, Goldstein & Fox October 29, 2026
Author: Olga A. Partington, Ph.D.

The patent cliff driving a wave of dealmaking is not new. What matters now is which assets stand out, and why some preclinical programs attract serious investment before human data while others do not. For Central and Eastern Europe, that distinction is where the opportunity lies.

The Wave of Dealmaking Is Real.

The looming loss of exclusivity on many blockbuster drugs, referred to as the patent cliff, is widely cited as the catalyst behind pharma’s growing appetite for external innovation. EY,[1] PwC,[2] and IQVIA[3] have all made some version of the case. They are right, and the numbers are not subtle.

Evaluate, a pharma data company, estimates that products generating more than $300 billion in prescription-drug revenue will lose exclusivity between 2025 and 2030, and projects a $94 billion growth gap for large pharma by 2030.[4] This timing is worth note — rarely have so many blockbuster products faced loss of exclusivity in so compressed a window, and the result is a synchronized scramble for growth across the industry.

The money is already moving. By J.P. Morgan’s count, first-half 2026 biopharma M&A reached $96 billion in upfront cash across 80 deals, alongside far larger licensing totals that are mostly contingent milestones.[5] On IQVIA’s narrower measure, qualifying acquisitions came to $130 billion, nearly matching all of 2025 in half the time.[3] Different methods, but the same direction.

Acknowledging this current wave, the question is no longer whether the buying wave is coming, but which assets it will reach and why some will attract serious interest while others will not. For founders outside of the established hubs, including much of Central and Eastern Europe, those questions decide whether good science from a less familiar place gets into this cycle at all.

Two Horizons

The pressure to replace lost revenue does not push buyers in one direction. Read it as two currents: one pulls buyers toward clinically de-risked assets that can add revenue soon, and the other pushes a few of them earlier, toward assets that have no human data yet. For an early-stage company, the difference between them is what matters.

The near-term horizon is about revenue, and it is where most of the money goes. A company facing a loss of exclusivity has a strong incentive to favor assets that can contribute revenue sooner rather than later. The fiercest competition and the highest prices are for clinically de-risked assets — late-stage programs, near-commercial products, things with human data and a visible path to approval. Most 2026 M&A transactions have been concentrated in clinical-stage assets, and that is exactly what the near-term horizon predicts. BioCentury’s analysis of the top pharma deals show the shape of it: acquisitions cluster at Phase II, where buyers can see data at or near proof of concept, and deal values climb steadily with each later phase.

The longer-term horizon is narrower and more selective. When everyone is bidding for the same de-risked clinical assets, those assets get expensive, and a few buyers respond by reaching earlier, before the human data exists and before the price reflects it. But this is a narrow phenomenon, not a broad one: the aggregate numbers show no surge in early-stage deal counts, and none is claimed here.

When preclinical assets do draw interest, it comes mostly through licensing rather than acquisition. BioCentury found preclinical programs rising to 44% of product partnerships, up from 35% a year earlier, a tick rather than a wave, while they stayed scarce among outright buyouts.[6] The buyers reaching early are few, too. Eli Lilly signed close to a fifth of the deals in BioCentury’s set of top-pharma dealmaking, which is reason to read the upstream moves as selective rather than industry-wide.[6] Still, in specific cases, a buyer will pay real money for a preclinical asset, and what those cases have in common is not accidental.

What Makes a Buyer Look Early

So what distinguishes those cases? A handful of features recur, and the assets that draw serious early interest tend to show several at once.

The first is breadth. A buyer paying before human data rarely wants a single molecule. Sometimes it buys the platform itself: when Bristol Myers Squibb agreed to pay $1.5 billion for Orbital Therapeutics, it was buying OTX-201, still preclinical and in IND-enabling studies, together with the RNA platform behind it, circular and linear RNA engineering, lipid-nanoparticle delivery, and AI-guided design.[7] The lead program was one asset and the platform was a way to make more. Other times it takes a portfolio instead: Lilly took an exclusive license to a set of Insilico’s preclinical oral therapeutics,[8] and Madrigal licensed six preclinical siRNA programs from Ribo.[9] Those buyers did not acquire the platform behind the programs, but each still came away with several early assets rather than a single molecule. Whether through a platform or a portfolio, the buyer gets more than one program.

Next is a differentiated mechanism aimed at biology that is already validated or strategically important. Novelty on its own does not sell. It becomes easier to underwrite when applied to biology that the buyer already considers validated or strategically important. Novartis paid $1.1 billion upfront for Myricx Bio, a preclinical company, because Myricx pairs a new antibody-drug-conjugate payload mechanism with two lead programs against B7-H3 and HER2, both validated ADC targets.[10] The payload is the differentiation; the validated targets are what let a buyer underwrite it.

A third signal is technology that makes an existing modality better, such as drug delivery. Alector’s deal with Genentech turned on a blood-brain-barrier delivery platform, and Genentech paid $100 million upfront for worldwide rights to a program that had not reached the clinic.[11],[12] Madrigal’s deal turned on liver-targeted siRNA delivery.[9] Myricx’s on a payload that works where current ADC payloads fail, including in models resistant to the standard classes.[10] Each one improves a modality buyers already want to use.

Then there is validation. “Preclinical” is not one thing. An asset in IND-enabling studies with clean data in the right disease models, activity in resistant models, or convincing non-human-primate results is a different proposition from a slide deck. Orbital’s lead program had non-human-primate data showing full B-cell depletion in blood, spleen, and lymph nodes.[13] Myricx’s preclinical data suggested activity in tumor models resistant to the standard ADC payloads.[10] That kind of evidence is what lets a buyer move before the clinic.

Finally, there is optionality. The same asset can be met with very different structures, an outright acquisition like Orbital or Myricx, or a license, option, or milestone-weighted deal like Alector, Insilico, and Madrigal, depending on how much risk a buyer wants to carry and how much control it needs. Readiness does not guarantee a choice of structures, but it preserves more of them. Loose ends do the opposite: they push the deal toward whatever structure best protects the buyer, usually on worse terms.

None of this means early money is easy to get. The bar is high, and it is specific, but it is legible. These are not mysterious deals, but ones a founder can reverse-engineer.

Noticed Is Not the Same as Buyable

Suppose a founder has all of it: a real platform, a validated target, a component technology, and strong preclinical data. The asset may deserve attention, but still may not be buyable.

Here is the distinction that decides the deal. Pharma does not buy discoveries; it buys assets it can own, control, diligence, defend, and one day sell. A buyer willing to pay nine figures for a program with no human data is not buying a result; it is buying the opportunity to pursue one, for years, through development it will fund. And it has to believe it can take that opportunity, hold it, and eventually monetize what it becomes. That belief is transaction readiness. Intellectual property is not the whole of it, but for academically rooted preclinical companies it is often where much of the avoidable transaction risk sits, and it has little to do with whether patents were simply filed. Plenty of companies with patents are not buyable.

None of this creates buyer demand where strategic fit is absent. Clean ownership cannot rescue weak biology, an undifferentiated program, an impractical path to the clinic, or a market the buyer does not care about. Nor can it answer what a buyer always asks about the people: can this team be trusted with capital to run the program, hit its milestones, and not damage the asset? IP readiness sits alongside the strength of the science and the credibility of the team, not above them. What readiness does is narrower and real: it keeps an otherwise compelling asset from losing to a more controllable one, and it gives a buyer room to move before every scientific risk is gone.

This is where a CEE company can face an added disadvantage, and the reason is institutional, not scientific. The science is often genuinely good. The harder problem is underwriting unfamiliarity. A global buyer prices what it can recognize: the institutions behind an asset, the ownership rules that govern it, the technology-transfer practices that produced it, the financing history, and the development infrastructure around it. Where those are less familiar, more of the asset has to be explained from the ground up, which makes it harder to underwrite even when the science is strong. Much of that unfamiliarity is a headwind no single founder can fix.

Part of that unfamiliarity is historical. Modern technology-transfer and commercialization systems, clear ownership rules, functioning transfer offices, a working market for turning science into a transferable asset, developed later across much of the region than in the United States and parts of Western Europe, and they remain uneven between countries and between institutions. They work; they are simply younger in places, and less familiar to a buyer from outside.

But one part of it is squarely within a founder’s control. The rights around the science, who owns them, how far they reach, and what is attached to them, can be built to a standard a distant buyer can actually underwrite. That alone will not make an unfamiliar setting familiar overnight, but it is the most controllable way to give a cautious buyer something concrete to underwrite. Where the gaps exist, they are specific, which is the good news: specific problems can be fixed.

Who really owns it? In much of the region the science starts inside a university or a public research institute, and the rules that govern ownership, employee-invention statutes, university IP policies, inventor-compensation rights, and co-ownership and assignment requirements, vary materially from one jurisdiction to the next. An arrangement that was adequate for an academic spinout in one country may not satisfy a buyer’s diligence under another. What a buyer needs is a documented chain of title running from every relevant inventor and institution, assignments or enforceable obligations to assign that were properly executed, and a clear account of any compensation, license, access, or co-ownership rights that survive. Brilliant science attached to uncertain title is not a clean asset anywhere, and for academically rooted spinouts it is a recurring place where value leaks.

Did you protect it where the buyer sells, not just where you work? A buyer cares about exclusivity in the markets that will drive the asset’s value, often above all, the United States. A national or European filing does not create U.S. patent exclusivity, and a thin patent family with no U.S. coverage can leave a major value-driving market uncovered. For capital-constrained, academically rooted spinouts, smaller filing budgets and academic filing habits make that gap a recurring risk. The claims also must cover the platform and the real commercial product, not the first research construct.

Will the claims survive a challenge? A patent that issues is not the same as a patent that holds up to a potential challenge. The claims a buyer is paying for will be stress-tested by a competitor’s validity challenge or by the buyer’s own diligence modeling. Breadth that cannot withstand that scrutiny is breadth on paper, and a buyer underwriting a decade of development is not paying for the paper kind. Found in diligence, a weak claim is what trims the price, or, if the whole asset leans on it, ends the conversation.

What did your funding and your institutions attach to it? Much of the region’s science is built on EU, national, or institutional grants and on sponsored-research agreements with the labs it came from. Depending on the specific program and the agreements signed, that funding can carry reporting and exploitation obligations, access rights for the funder or consortium partners, state-aid conditions, consent requirements, and restrictions that affect how the results can be licensed or transferred, the kind of terms that travel with the IP into an acquirer’s hands. A buyer may come for the data, but it will read those terms before it takes the asset. Owning the invention is not the same as being free to develop, license, and transfer it.

Can you actually practice it? Owning a patent is not permission to sell the product. The component technologies that make these assets work, the delivery systems, payloads, linkers, vectors, targets, and manufacturing methods, often belong in part to someone else. A blocking third-party position found early can be licensed, designed around, or engineered out; found in diligence, it can become the reason the deal is repriced, restructured, or dropped. The risk is universal, and an under-resourced company cannot chase all of it at once, nor does it have to. The move is to find the consequential blocks early, while there is still time to act on them, a targeted exercise rather than a worldwide opinion, and one within a founder’s reach.

Will the protection last long enough to matter? A preclinical asset may still face many years of development, and the patent term is already running. Exclusivity measured from filing dates that have been live for years, against a long clinical road ahead, can leave less runway than the science deserves. A buyer underwriting that path needs confidence the protection will still be there at the end of it. That is achieved through lifecycle strategy, not luck: sequencing filings, building a patent family that can carry follow-on inventions, and using the term extensions and regulatory exclusivities available, so the runway still reaches the market it is meant to protect.

None of this is a checklist to run the week before a data room opens. It is architecture, built or not built years earlier. Done well, it makes the science legible: it turns a brilliant program into an asset a stranger across an ocean can understand, value, and take control of. For a company in a region a buyer does not know well, that legibility does the work that reputation and track record do elsewhere. It is the difference between science that gets admired and science that gets bought.

For a CEE company, this architecture is what can turn interest into options: raise more, license one program to a global partner and retain the rest, co-develop, divide territorial rights, or stay independent. Without it, a distant buyer’s terms become the only terms, and the unprepared company finds some of those doors shut before it knew they were open. The best time to find an ownership, scope, or freedom-to-operate problem, is while it can still be fixed. The worst time is after someone has offered to buy the asset.

This Is CEE’s to Win

This is the moment CEE is positioned to seize. Most of the money, and most of the competition, still goes to de-risked, clinical-stage programs.5 But some of it moves earlier, toward platforms with validated biology, strong preclinical data, and rights a buyer can control. That selective early activity creates an opening for CEE programs whose science aligns with an existing buyer priority to attract interest before entering the clinic.

For many strong programs, the challenge is not the underlying science alone but the route to a global partner, which often seems to require late-stage clinical data. A selective early-stage market changes that: science aligned with a buyer’s priorities can attract interest years before late-stage data emerge. What makes this window unusual for CEE is not simply the amount of money in motion, but that a selective part of the market is willing to move before late-stage clinical validation, the point that capital-constrained companies in the region may struggle to reach alone. The same opening is there for other overlooked regions; the claim is not that it belongs to Central and Eastern Europe, but that the region is unusually well-placed to use it.

The opportunity is real and rare, but it is not automatic. The buying wave hands nothing to Central and Eastern Europe, but it opens a door, and readiness determines who is equipped to walk through it. The science is there, but the differentiator in this cycle may be whether it arrives in a form a buyer can own, diligence, value, and transact.


[1] EY, Biotech Beyond Borders 2026 (June 9, 2026).

[2] PwC, Pharmaceutical and Life Sciences: US Deals 2026 Midyear Outlook (June 17, 2026).

[3] Markus Gores and Toby House, IQVIA, “Biopharma M&A: Mid-year 2026 update” (July 8, 2026).

[4] Evaluate, “Portfolio Tactics to Scale the $300bn Patent Cliff” (2026).

[5] J.P. Morgan, Q2 2026 Biopharma Licensing and Venture Report (July 2026).

[6] Lauren Martz, BioCentury, “Pharma deals: Embracing disruptive technologies” (Sept. 5, 2026).

[7] Bristol Myers Squibb, “Bristol Myers Squibb Strengthens and Diversifies Cell Therapy Portfolio with Acquisition of Orbital Therapeutics” (Oct. 10, 2025).

[8] Insilico Medicine, “Insilico Medicine Announces Global R&D Collaboration with Lilly” (Mar. 29, 2026).

[9] Madrigal Pharmaceuticals, “Madrigal Expands its MASH Pipeline with Exclusive Global Licensing Agreement for Six Preclinical siRNA Programs” (Feb. 11, 2026).

[10] Myricx Bio, “Myricx Bio to be Acquired by Novartis to Advance Next-Generation ADC Payloads for Oncology with Novel NMTi Platform” (July 6, 2026).

[11] Alector, “Alector Enters Global License Agreement with Genentech for Brain Penetrant GCase Enzyme Replacement Therapy for Parkinson’s Disease and Other Neurodegenerative Diseases” (Oct. 5, 2026).

[12] Alector, Inc., Current Report on Form 8-K, filed Oct. 5, 2026 (agreement dated Sept. 30, 2026).

[13] Orbital Therapeutics, “Orbital Therapeutics Presents Non-Human Primate Data for In Vivo CAR-T Therapy with Potential Best-in-Class Profile for Autoimmune Disease” (July 22, 2025).