Competition Law and Biological Data Concentration and Antitrust

Competition Law and Biological Data Concentration and Antitrust

1. Introduction

Biological data has become an increasingly important economic asset in healthcare, biotechnology, pharmaceuticals, diagnostics, artificial intelligence, and personalized medicine. It can include genomic and genetic information, sequencing data, biomarker information, laboratory results, clinical datasets, and other information derived from biological samples.

From a competition-law perspective, the central problem is biological data concentration: a situation in which one or a small number of firms obtain control over unusually large, valuable, or difficult-to-replicate biological datasets.

Competition law does not normally prohibit a company merely because it possesses a large dataset. The concern arises when control over biological data, sequencing infrastructure, analytical technology, or related platforms gives a firm the ability and incentive to exclude competitors, reinforce market power, restrict interoperability, discriminate in access, or suppress innovation.

This field therefore sits at the intersection of:

• antitrust and competition law;
• data protection and privacy law;
• biotechnology and pharmaceutical regulation;
• intellectual-property law;
• merger control;
• digital-platform regulation; and
• healthcare regulation.

There is not yet a large body of reported judgments dealing specifically with the expression “biological data concentration.” Consequently, the relevant legal principles must also be drawn from cases concerning genomic technologies, healthcare databases, data-driven platforms, essential inputs, interoperability, and data-related abuses of dominance.

2. Why Biological Data Can Create Market Power

Ordinary commercial data and biological data share some economic characteristics, but biological information can be particularly valuable because it may be difficult or extremely expensive to reproduce.

For example, a company possessing a very large genomic dataset may be able to combine it with machine learning to discover correlations between genetic variations, diseases and treatment responses. A new competitor without comparable data may need many years, substantial financing and access to large populations before developing an equivalent resource.

This creates several possible competitive advantages.

Data-driven network effects

More biological data can improve algorithms and scientific models. Better models can attract more researchers, hospitals, pharmaceutical companies or patients, which can generate still more data.

The cycle may therefore become:

More biological data → better analysis → better products → more users → additional biological data.

Competition authorities may investigate whether this cycle creates barriers that prevent effective entry.

Economies of scale and scope

Biological-data platforms can have high initial costs but relatively lower marginal costs when additional information is processed.

A firm operating genomic sequencing, diagnostics, clinical databases and AI systems may also combine datasets across several services. This may give the firm advantages that smaller competitors cannot readily duplicate.

Data uniqueness

The competition significance of data depends heavily on whether substitutes exist.

A database containing common and easily obtainable information may create little competitive concern. A longitudinal genomic dataset collected from millions of participants, by contrast, could be considerably more difficult to reproduce.

Therefore, competition analysis should examine not simply how much data a firm possesses but its quality, exclusivity, historical depth, diversity, accessibility and reproducibility.

3. Biological Data as a Barrier to Entry

Competition law generally asks whether competitors can realistically enter or expand in the relevant market.

Biological-data concentration can increase barriers where a new company requires:

1. very large datasets;
2. representative population samples;
3. historical or longitudinal observations;
4. regulatory permissions;
5. sequencing infrastructure;
6. complementary intellectual property;
7. sophisticated computational capabilities; or
8. relationships with hospitals, laboratories or research institutions.

Even substantial financial resources may not solve the problem if the relevant dataset cannot simply be purchased.

This distinction is important. A valuable asset is not automatically an antitrust bottleneck. Competition concerns become stronger where the resource is both commercially important and practically difficult to replicate or substitute.

4. Merger Control and Biological Data

Data concentration can become especially significant when companies merge.

Suppose Company A owns a major genomic database while Company B operates an important diagnostic platform. Their merger could create efficiencies by integrating research capabilities.

However, regulators may also investigate whether the transaction would allow the combined company to:

• deny rivals access to important inputs;
• increase rivals' costs;
• obtain competitively sensitive information;
• prioritize its own downstream products;
• reduce interoperability;
• combine previously separate biological datasets;
• eliminate a potential competitor; or
• reduce incentives to develop alternative technologies.

Consequently, modern merger analysis increasingly examines innovation competition in addition to existing prices and market shares.

Important Case Laws

5. FTC v. Illumina, Inc. and GRAIL, Inc. — United States

Illumina/GRAIL is one of the most directly relevant modern antitrust proceedings for understanding competition involving genomic technology.

Illumina supplied next-generation sequencing platforms, while GRAIL developed multi-cancer early detection tests that rely on DNA sequencing. The U.S. Federal Trade Commission challenged Illumina's acquisition of GRAIL.

The FTC's central concern was vertical foreclosure. According to the Commission, competing cancer-test developers depended heavily on Illumina's sequencing technology. Combining the sequencing supplier with one downstream test developer could therefore give the merged company both the ability and incentive to disadvantage GRAIL's competitors.

The case is particularly significant for biological-data competition because the Commission also considered access to technological inputs and competitive intelligence. Its final opinion discussed how information available through relationships with downstream developers could reveal aspects of competitors' investment and technological progress.

The litigation had several stages. An FTC administrative law judge initially dismissed the challenge in 2022, concluding that FTC complaint counsel had not established its asserted prima facie case. The Commission subsequently reversed that decision and ordered divestiture.

In December 2023, the Fifth Circuit concluded that substantial evidence supported the Commission's determination concerning competitive harm, although it vacated and remanded the Commission's order because of its treatment of part of Illumina's rebuttal evidence. Illumina subsequently announced that it would divest GRAIL.

Principle

The case demonstrates that competition law can protect innovation ecosystems surrounding genomic technologies, even where the disputed transaction is vertical rather than a straightforward merger between two direct competitors.

6. Meta Platforms Inc. v. Bundeskartellamt — C-252/21

Although this European case concerned social-network data rather than biological information, it is highly important for understanding how data concentration, privacy and dominance can interact.

The German Bundeskartellamt challenged Meta's practice of combining information obtained from Facebook with data concerning users' activities outside Facebook. The matter eventually reached the Court of Justice of the European Union.

In its judgment of 4 July 2023, the CJEU confirmed that, when examining abuse of dominance, a national competition authority may consider whether conduct complies with the GDPR, while respecting the responsibilities of data-protection authorities and the principle of sincere cooperation.

The judgment is important to biological-data markets because biological and genetic information can involve particularly sensitive personal data.

Principle

Competition and data-protection rules can address different dimensions of the same commercial practice.

A dominant company's treatment of personal information therefore cannot necessarily be viewed only as a privacy issue; data practices can also become relevant to an assessment of market power and abusive conduct.

7. IMS Health GmbH & Co. OHG v. NDC Health GmbH & Co. KG — C-418/01

This EU case concerned pharmaceutical sales information and access to a copyrighted data structure.

IMS Health supplied pharmaceutical-sales information using a particular geographical structure. Competitors sought access to that structure.

The Court examined circumstances in which refusal to license intellectual property by a dominant undertaking could constitute abuse under what became Article 102 TFEU.

The case established a demanding framework. Among other considerations, compulsory access can become relevant where refusal prevents the emergence of a new product for which there is potential consumer demand, lacks objective justification, and reserves the relevant market to the intellectual-property holder.

Relevance to biological data

IMS Health is significant because biological databases may combine:

• proprietary database structures;
• intellectual property;
• commercially valuable information; and
• difficult-to-reproduce datasets.

It shows that ownership of information does not automatically produce a general obligation to share it, but exceptional circumstances can make refusal of access relevant under competition law.

8. Microsoft Corp. v. Commission — T-201/04

The Microsoft case is another important authority concerning dominant platforms, interoperability and access to essential technical information.

The European Commission concluded that Microsoft's refusal to provide certain interoperability information to competitors constituted an abuse of dominance. The General Court substantially upheld the Commission's approach.

Biological-data relevance

Modern biotechnology markets increasingly depend on interoperability between:

sequencing equipment → databases → analytical software → AI models → diagnostic systems.

If a dominant biological-data platform deliberately prevents competing systems from interoperating with its infrastructure, competition authorities may examine whether such conduct improperly protects or extends market power.

Microsoft therefore provides an important conceptual framework for analysing data interoperability and technological foreclosure.

9. Google Search (Shopping) v. European Commission — T-612/17

The Google Shopping litigation concerned the treatment of Google's own comparison-shopping service relative to competing services.

The General Court largely upheld the Commission's decision concerning Google's conduct.

Although the dispute did not involve biological information, its relevance arises from the concept of self-preferencing by a dominant digital intermediary.

Imagine a dominant genomic platform that operates both:

1. an infrastructure through which researchers obtain biological information; and
2. its own downstream diagnostic or pharmaceutical-development service.

If it gives preferential access, ranking, processing speed or data quality to its own downstream service while disadvantaging competitors, similar competition concerns could arise.

Principle

Control over an important platform may become problematic where the operator uses that position to favor its own adjacent services in circumstances constituting abuse under applicable competition law.

10. Slovak Telekom v. European Commission — C-165/19 P

The Slovak Telekom litigation provides additional guidance concerning dominant firms controlling infrastructure or access necessary for downstream competition.

The case involved access to telecommunications infrastructure and abusive practices associated with that access.

Its broader significance for biological-data markets lies in the distinction between a straightforward refusal to provide an indispensable resource and abusive conditions governing access.

A biological-data platform could theoretically provide nominal access while making effective competition difficult through:

• discriminatory pricing;
• inferior data quality;
• technical restrictions;
• delays;
• restrictive contractual conditions; or
• discriminatory API functionality.

Competition analysis therefore does not necessarily end merely because competitors have some form of access.

11. Bronner — C-7/97

Oscar Bronner GmbH & Co. KG v. Mediaprint remains a foundational EU authority concerning compulsory access to infrastructure controlled by a dominant company.

The Court adopted a restrictive approach to compulsory access, emphasizing, among other matters, indispensability and whether realistic alternatives existed.

Relevance

Bronner is important when someone argues:

"This biological dataset is extremely valuable, therefore the owner must give competitors access."

Competition law does not automatically reach that conclusion.

Authorities would need to consider whether the dataset is genuinely indispensable, whether substitutes exist and whether competitors could create alternative resources—even if doing so would be difficult or expensive.

This protects incentives to invest in creating valuable databases while leaving room for intervention in exceptional circumstances.

12. Biological Data as an Essential Facility

The essential-facilities concept is therefore potentially important but should be applied carefully.

A biological database may resemble an essential facility where:

• competitors genuinely require access to compete;
• equivalent information cannot realistically be reproduced;
• the controlling company possesses substantial market power;
• access is technically feasible;
• refusal threatens effective downstream competition; and
• no adequate objective justification exists.

However, competition authorities must balance access against investment incentives.

If every successful company were automatically required to share a valuable dataset, companies could have weaker incentives to invest in expensive biological research.

The legal question is therefore not:

"Is the data valuable?"

It is closer to:

"Has control over this difficult-to-replicate resource become a mechanism for unlawfully excluding competition?"

13. Exclusive Biological-Data Agreements

Another concern involves exclusivity.

A biotechnology company might sign agreements giving it exclusive access to biological information generated by:

• hospitals;
• laboratories;
• universities;
• sequencing facilities;
• healthcare networks; or
• research programs.

An individual agreement may have legitimate reasons, including research investment or quality assurance.

Problems become more plausible when a dominant firm creates a network of agreements that collectively prevents competitors from obtaining the minimum scale or diversity of data required to compete.

Authorities may examine:

• agreement duration;
• market coverage;
• availability of alternative datasets;
• exclusivity clauses;
• termination provisions;
• competitive necessity; and
• efficiencies created by the arrangement.

14. Biological Data and Algorithmic Advantages

Biological datasets increasingly interact with artificial intelligence.

Suppose Firm A possesses 20 years of genomic and clinical information. It trains a disease-prediction model using that information.

Competitors possess much smaller datasets.

Firm A's advantage may therefore arise from a combination of:

data + computing resources + algorithms + expertise + infrastructure.

Competition analysis should consequently avoid treating "data" as an isolated commodity.

Authorities need to determine whether competitors could obtain comparable outcomes through alternative datasets, synthetic information, partnerships, different algorithms or other technologies.

15. Privacy as a Dimension of Competition

Biological-data markets demonstrate particularly clearly why privacy and competition can overlap.

A market dominated by very few firms can potentially reduce consumers' practical ability to choose between different privacy policies.

For example, users might theoretically consent to extensive biological-data processing but have few realistic alternatives if one provider controls the relevant service.

The CJEU's Meta Platforms judgment demonstrates that competition authorities can take data-protection compliance into consideration within a dominance investigation, while coordinating with the authorities responsible for privacy regulation.

This does not mean every privacy violation is an antitrust violation.

Competition law normally requires additional analysis of market definition, dominance, competitive effects and the relevant theory of abuse.

16. Innovation Harm

Biotechnology competition frequently occurs through innovation rather than merely current prices.

Companies may compete to discover:

• new biomarkers;
• cancer-screening methods;
• disease-risk models;
• personalized treatments;
• drug targets;
• genomic diagnostic tools; and
• AI-assisted biological discoveries.

A merger or exclusionary strategy could therefore harm competition even before competing products have fully entered the market.

Illumina/GRAIL is particularly instructive because the FTC's theory emphasized the potential reduction of innovation in multi-cancer early-detection testing.

Thus, antitrust authorities may examine not only:

"Will prices rise tomorrow?"

but also:

"Will this transaction reduce independent pathways of future innovation?"

17. Relevant Market Definition

Defining the relevant market can be unusually difficult in biological-data cases.

Possible markets might include:

• genomic sequencing services;
• genomic databases;
• clinical genomic analytics;
• cancer-detection technologies;
• pharmaceutical research datasets;
• bioinformatics platforms;
• genetic-testing services; or
• particular data-access services.

Authorities must determine whether different datasets are genuine substitutes.

For example, general medical records may not substitute for whole-genome sequencing information when researchers require specific genetic variants.

Market definition therefore depends strongly on the actual scientific and commercial use of the information.

18. Potential Anticompetitive Practices

Biological-data concentration could become relevant to competition law through several forms of conduct:

1. Refusal of access — denying competitors access to an indispensable dataset or infrastructure in exceptional circumstances.
2. Discriminatory access — offering competitors worse prices, speed, quality or technical conditions.
3. Exclusive agreements — locking important hospitals or laboratories into exclusive data arrangements.
4. Self-preferencing — giving the platform owner's products superior access to biological information.
5. Tying and bundling — requiring customers to purchase sequencing, analytics and database services together.
6. Mergers — combining complementary datasets, platforms or infrastructure in ways that may substantially lessen competition.
7. Interoperability restrictions — preventing competing software or diagnostic systems from communicating effectively with the dominant platform.
8. Strategic acquisition of emerging competitors — purchasing firms that might otherwise develop competing technologies.

The legality of each practice depends on jurisdiction, market circumstances, competitive effects and possible objective justifications.

19. Possible Procompetitive Benefits

Biological-data concentration is not inherently harmful.

Large integrated datasets can generate significant benefits.

Combining datasets can increase statistical power, accelerate scientific discovery, improve diagnostic accuracy and make research into rare diseases more practical.

Mergers can also eliminate duplication and allow complementary technologies to work together.

Competition authorities therefore generally need to distinguish between scale that creates legitimate efficiencies and concentration that gives a company the ability to suppress effective competition.

This balancing problem is especially important in biotechnology because scientific research often requires very large datasets.

20. Remedies

Where authorities identify competition problems, potential remedies depend upon the specific violation.

They can include:

• merger prohibition or divestiture;
• non-discriminatory access requirements;
• interoperability obligations;
• restrictions on exclusive contracts;
• information firewalls;
• restrictions on using competitors' confidential information;
• licensing requirements in exceptional circumstances; and
• structural separation in appropriate cases.

Illumina/GRAIL illustrates the structural-remedy approach: the FTC ultimately ordered divestiture, and Illumina later announced that it would divest GRAIL following the appellate litigation.

21. Summary of the Major Cases

22. Conclusion

Competition law and biological-data concentration is likely to become increasingly significant as genomics, biotechnology, artificial intelligence and personalized medicine become more integrated.

The central antitrust concern is not simply that one company possesses a large quantity of biological information. Large datasets can produce substantial scientific and economic benefits.

The stronger competition concern arises where control of biological data, sequencing infrastructure or complementary technology creates durable market power and is then used to foreclose competitors, discriminate in access, restrict interoperability, reinforce dominance or reduce independent innovation.

Cases such as Illumina/GRAIL demonstrate how competition authorities can examine genomic technology through vertical-foreclosure and innovation theories. Meta Platforms v. Bundeskartellamt shows the growing interaction between data protection and competition law, while IMS Health, Microsoft, Bronner, Slovak Telekom and Google Shopping provide broader principles for access, interoperability, discrimination and platform power.

The emerging legal framework therefore requires a careful balance between two objectives: preserving incentives for companies to invest in expensive biological research and preventing control over uniquely valuable biological resources from becoming an unlawful barrier to competitive entry and innovation.