Biotech Research Arbitration — Detailed Explanation with Case Laws

1. Meaning of Biotech Research Arbitration

Biotech research arbitration refers to the resolution of disputes arising from biotechnology research, development, technology-transfer, licensing, joint-development, university–industry research, genomic research, drug discovery, gene-editing, biological materials, and related commercialization arrangements through arbitration.

Biotechnology projects are particularly suitable for arbitration because they commonly involve:

• highly technical scientific evidence;
• confidential research data;
• trade secrets and laboratory protocols;
• patents and patent applications;
• ownership of research results;
• licensing and royalty arrangements;
• milestone payments;
• clinical and regulatory-development obligations;
• technology-transfer obligations;
• joint research committees;
• publication and disclosure restrictions; and
• cross-border collaborators.

WIPO's life-sciences arbitration experience specifically includes disputes involving R&D agreements, joint-development agreements, licensing, patents, know-how and data, demonstrating the practical importance of arbitration in this field.

2. Typical Biotech Research Arrangement

A biotech research project may involve:

University / Research Institute
↓
Biotech Company
↓
Pharmaceutical Company / Investor
↓
Clinical-development partner
↓
Manufacturer / Commercialization partner

The contract generally determines:

1. who owns pre-existing IP;
2. who owns newly developed IP;
3. who owns improvements;
4. who may file patents;
5. who controls prosecution of patents;
6. how research costs are shared;
7. development milestones;
8. commercialization obligations;
9. royalty payments;
10. sublicensing;
11. confidentiality;
12. publication rights;
13. termination rights; and
14. dispute resolution.

The arbitration clause becomes particularly important because disputes can arise at virtually every stage.

3. Why Arbitration Is Particularly Useful in Biotechnology

A. Scientific expertise

A conventional court may need extensive expert evidence concerning:

• molecular biology;
• genetics;
• gene editing;
• recombinant DNA;
• antibodies;
• cell lines;
• biologics;
• bioinformatics;
• clinical development;
• manufacturing processes.

An arbitral tribunal can include members with technical or pharmaceutical expertise.

WIPO expressly maintains panels of arbitrators and experts experienced in R&D and technology-transfer disputes.

B. Confidentiality

Biotech companies frequently possess commercially sensitive information concerning:

• DNA sequences;
• biological samples;
• experimental results;
• laboratory methods;
• algorithms;
• cell lines;
• formulations;
• manufacturing processes;
• unpublished patentable inventions.

Public litigation can create disclosure risks.

Arbitration can provide substantially greater procedural confidentiality, although confidentiality should not simply be assumed; the contract and applicable institutional rules should expressly address it.

C. Cross-border disputes

Biotech research is often international.

For example:

Indian university + Swiss biotech + US pharmaceutical company + Japanese manufacturer.

A well-drafted international arbitration clause can provide a neutral forum and facilitate enforcement under the New York Convention.

4. Major Categories of Biotech Research Disputes

4.1 Ownership of Research Results

One of the most important issues is:

Who owns the invention generated during the research programme?

Suppose:

• Company A contributes the research platform;
• University B contributes scientists;
• Company C funds the project.

The research produces a novel antibody.

The contract may say that:

• A owns platform technology;
• B owns academic inventions;
• C receives an exclusive commercial licence.

Disputes may arise concerning whether the antibody constitutes:

• background IP;
• foreground IP;
• jointly developed IP;
• an improvement;
• independently developed IP.

This is an ideal subject for arbitration when the parties have agreed to arbitrate contractual IP disputes.

5. Background IP vs Foreground IP

A well-drafted biotech agreement normally distinguishes:

Background IP

Technology existing before the project.

Example:

A owns a CRISPR platform before entering the collaboration.

Foreground IP

Technology created during the collaboration.

Example:

The parties jointly develop a new therapeutic application using the CRISPR platform.

Improvements

Later modifications or enhancements to existing technology.

Disputes often concern whether an invention is genuinely new foreground IP or merely an improvement to one party's background technology.

6. Patent Ownership Disputes

Arbitration can determine contractual questions such as:

• who must file the patent;
• who pays prosecution costs;
• who receives patent revenues;
• whether a party breached an obligation to assign IP;
• whether an invention falls within the collaboration;
• whether royalties are payable;
• whether a party has breached a patent licence.

However, there is an important distinction:

An arbitrator may determine contractual rights concerning patents, but the effect of an arbitral award on the validity or registration of a patent may depend upon mandatory national patent law.

Thus, the arbitration agreement should carefully distinguish between:

contractual IP disputes and in rem/statutory patent issues.

7. Confidentiality and Trade Secrets

Biotech research depends heavily on confidential information.

A collaboration agreement may prohibit disclosure of:

• experimental protocols;
• biological samples;
• unpublished sequences;
• research notebooks;
• manufacturing processes;
• assay results;
• clinical data;
• negative research results.

A dispute may arise where a collaborator:

transfers research information to an affiliate without authorization.

The tribunal may have to determine:

1. whether the information was confidential;
2. whether it was disclosed;
3. whether disclosure was authorized;
4. whether the receiving party was bound by confidentiality;
5. whether damages resulted; and
6. whether injunctive or other protective relief is appropriate.

8. Research Milestones

Biotech development contracts commonly contain milestones such as:

• completion of preclinical research;
• successful animal studies;
• IND submission;
• clinical-trial commencement;
• Phase I completion;
• Phase II completion;
• regulatory approval;
• commercialization.

A dispute can arise if one party claims:

"The researcher failed to achieve the contractual milestone."

The researcher may respond:

"The milestone became impossible because of scientific uncertainty."

This raises difficult questions concerning:

• reasonable efforts;
• best efforts;
• commercially reasonable efforts;
• scientific feasibility;
• regulatory obstacles;
• causation;
• force majeure;
• risk allocation.

9. Research and Development Efforts

One of the most important biotech arbitration questions is the meaning of a contractual obligation to use:

• reasonable efforts;
• commercially reasonable efforts;
• diligent efforts;
• best efforts;
• reasonable endeavours.

In drug-development contracts, the tribunal may need to assess industry practice and scientific risk.

An ICC pharmaceutical arbitration has involved precisely this type of dispute: whether a licensee had used commercially reasonable efforts to develop and commercialize a drug. The tribunal ultimately concluded that the licensee had not materially breached the agreement.

This illustrates why expert evidence is extremely important in biotech arbitration.

10. Royalties and Milestone Payments

Biotech agreements often provide for:

• upfront payments;
• research funding;
• milestone payments;
• development payments;
• regulatory milestones;
• sales milestones;
• royalties;
• sublicensing revenue.

A tribunal may need to determine:

Does a particular research achievement trigger the contractual payment?

For example:

Contract:
$20 million payable upon regulatory approval.

Dispute:
Does conditional approval qualify as "regulatory approval"?

Such questions are primarily matters of contractual interpretation.

11. Regulatory Compliance

Biotech research is heavily regulated.

Depending on the project, issues may involve:

• clinical-trial regulations;
• biological-material regulations;
• biosafety;
• human-subject research;
• data protection;
• genetic information;
• regulatory submissions;
• drug approvals.

An arbitration clause cannot necessarily remove mandatory regulatory requirements.

Therefore, the tribunal may need to distinguish between:

private contractual obligations

and

non-waivable regulatory obligations.

12. Publication Rights

University–biotech collaborations frequently create tension between:

Academic interest

Researchers want to publish results.

Commercial interest

The company wants to protect:

• trade secrets;
• patentability;
• confidential information;
• commercial strategy.

A typical contract may permit publication after:

1. prior notice;
2. confidentiality review;
3. patent filing;
4. deletion of proprietary information.

Arbitration can determine whether a proposed publication violates the agreement.

13. Case Law

The following cases are particularly useful for understanding biotech research arbitration and closely related biotechnology licensing disputes.

Case 1 — Seagen, Inc. v. Daiichi Sankyo Co., Ltd.

This is one of the most directly relevant modern biotech arbitration examples.

Facts

Seagen, a biotechnology company specializing in antibody-drug conjugate technology, entered into a collaboration agreement with Daiichi Sankyo.

The agreement licensed Seagen's proprietary ADC technology to Daiichi Sankyo for development, manufacturing and commercialization.

After termination of the collaboration, Seagen alleged that Daiichi Sankyo had improperly filed patent applications involving Seagen technology and incorporated the technology into its drug-development programme.

Seagen commenced arbitration.

The arbitrator ultimately issued a substantial final award in 2023 in Daiichi Sankyo's favour. The subsequent US court proceedings concerned the arbitral award.

Significance

The case demonstrates how biotech arbitration can involve:

• proprietary research platforms;
• patent applications;
• ownership disputes;
• technology transfer;
• development programmes;
• collaboration agreements;
• breach of contract.

Lesson

A biotech collaboration agreement should precisely identify:

background technology + collaboration technology + improvements + patent ownership + post-termination rights.

Case 2 — Amgen, Inc. v. Ortho Pharmaceutical Corp.

This is a highly relevant biotechnology arbitration case involving erythropoietin (EPO).

Facts

Amgen and Ortho entered into arrangements concerning the commercialization of EPO.

The parties agreed to arbitrate disputes.

A dispute arose concerning:

• FDA approval strategy;
• use of clinical data;
• marketing;
• supply arrangements;
• contractual responsibilities.

Ortho sought arbitration and judicial relief to preserve the status quo while the arbitration proceeded.

The litigation illustrates the relationship between court-ordered interim protection and an underlying biotech arbitration.

Principle

Biotech arbitration does not necessarily eliminate the role of courts.

Courts may be required to provide:

• interim injunctions;
• preservation of evidence;
• preservation of contractual status quo;
• assistance in support of arbitration.

Significance

This is particularly important where a dispute concerns a drug already approaching regulatory approval.

Case 3 — Matter of Pharmacia & Upjohn Co. (Elan Pharmaceuticals, Inc.)

Facts

Elan and Pharmacia/Pfizer were involved in a pharmaceutical collaboration.

Elan commenced arbitration alleging breaches concerning the research and development collaboration.

The alleged breaches included:

• failure to provide information used to evaluate compounds;
• operation of a separate research programme;
• cessation of scientific experiments;
• disputes concerning patents and know-how;
• rights to continue developing compounds after termination.

The case concerned whether the relevant disputes fell within the parties' arbitration agreement.

Importance

The case demonstrates a fundamental principle:

The first question is whether the particular biotech dispute falls within the arbitration agreement.

A sophisticated R&D agreement should therefore avoid vague language.

Instead of:

"Disputes relating to this agreement shall be arbitrated."

it may be preferable to specify that disputes concerning:

• research performance;
• milestones;
• patents;
• know-how;
• licensing;
• royalties;
• confidentiality;
• termination;
• commercialization

are included, while identifying any matters reserved for courts or regulators.

Case 4 — Medicis Pharmaceutical Corp. v. Anacor Pharmaceuticals, Inc.

This case involved a pharmaceutical R&D and licensing arrangement.

Facts

Medicis and Anacor entered into an agreement concerning development of boron-based compounds for acne treatment.

The agreement contained:

• research obligations;
• development requirements;
• commercialization arrangements;
• arbitration provisions;
• provisions allowing judicial proceedings for certain equitable relief.

A dispute arose concerning the development programme and dispute-resolution mechanism.

Anacor invoked arbitration, while Medicis pursued court proceedings.

The Delaware Court of Chancery examined whether the disputed claims were actually subject to mandatory arbitration under the contract and concluded that they were not within the mandatory arbitration provision.

Significance

This is extremely important for drafting biotech contracts.

A clause should distinguish between:

Arbitrable disputes

and

court remedies expressly preserved by the parties.

Lesson

A biotech company should not assume that an arbitration clause automatically covers every dispute connected with the research programme.

Case 5 — Biotechnology B.V. v. Unicorn GmbH Rahn Plastmaschinen

Although the underlying technology concerned a manufacturing process rather than pharmaceutical R&D, this Indian case is particularly useful because it involved biotechnology entities and arbitration-related interim relief.

The dispute concerned patent and technology rights involving the parties' respective processes.

The Delhi High Court dealt with an application under Section 9 of the Arbitration and Conciliation Act, 1996.

Significance

The case illustrates the importance of judicial interim measures in technology arbitration.

Section 9 can be particularly important in biotech disputes because parties may need urgent protection concerning:

• confidential technology;
• biological materials;
• technical documents;
• equipment;
• research samples;
• patent-related evidence;
• unauthorized commercialization.

Case 6 — National Research Development Corporation v. Chromous Biotech Pvt. Ltd.

This Indian case is highly relevant to biotechnology technology-transfer arrangements.

Facts

NRDC and the respondent entered into a technology/project agreement.

The agreement contained an arbitration clause.

The project involved technology developed under the arrangement and obligations concerning payment of royalty and return/transfer of technology.

The respondent eventually acknowledged an inability to pay royalty and subsequently proposed returning the technology.

Arbitration proceedings were eventually constituted.

Significance

The case demonstrates the relationship between:

• publicly funded research;
• technology development;
• technology transfer;
• commercialization;
• royalty obligations;
• return of technology; and
• arbitration.

Practical lesson

Technology-transfer agreements should expressly state what happens if commercialization fails.

For example:

If the licensee fails to commercialize within X years, specified technology rights revert to the research institution.

Case 7 — National Research Development Corporation v. Saveer Biotech Ltd.

This is another useful Indian authority involving research/technology-transfer arrangements.

The agreement contained a detailed arbitration clause covering disputes concerning:

• interpretation;
• rights;
• liabilities;
• claims;
• demands;
• matters arising under the agreement.

It provided for arbitration under the Arbitration and Conciliation Act, 1996, with Delhi as the venue.

Significance

The case demonstrates the importance of carefully defining the scope of the arbitration clause in research and technology-transfer contracts.

For biotech institutions, the clause should ideally cover:

"any dispute, controversy or claim arising out of or relating to the research, development, technology transfer, licensing, commercialization, confidentiality, intellectual property, royalties or termination of this Agreement."

Case 8 — Dr. Reddy's Laboratories Ltd. v. Chandan M.A.

This case concerned a technology-transfer arrangement between Dr. Reddy's Laboratories and DRDO involving 2-deoxy-D-glucose (2-DG) technology.

The dispute reached the Delhi High Court under Section 34 of the Arbitration and Conciliation Act, 1996, challenging an arbitral award.

The underlying arrangement involved technology developed by DRDO and licensed to Dr. Reddy's Laboratories for manufacturing and sale.

Importance

The case illustrates how arbitration can arise from:

• government research;
• pharmaceutical technology;
• technology-transfer agreements;
• licensing;
• commercialization.

It is particularly relevant to Indian biotech/pharma research institutions.

14. Additional Important Authority — Amyris, Inc. v. Lavvan, Inc.

This dispute is particularly valuable because it demonstrates the limits of arbitration.

Amyris and Lavvan were involved in a research partnership concerning cannabinoid-related biotechnology.

Lavvan brought claims involving patent and trade-secret rights.

The relevant collaboration agreement expressly excluded certain intellectual-property ownership and infringement disputes from arbitration.

The Second Circuit held that the relevant disputes were not required to be arbitrated because the contractual language excluded them from arbitration.

Lesson

This is a critical warning:

A biotech arbitration clause must be drafted together with the IP provisions.

If the contract says:

"IP ownership and infringement disputes shall not be arbitrated,"

a party may be unable to compel arbitration even though the dispute arises from the same research collaboration.

15. Genentech Arbitration — Important European Authority

Another major biotech/pharma arbitration concerned Genentech and Hoechst/Sanofi-Aventis.

Genentech had obtained a licence concerning pharmaceutical patents.

A dispute arose over continuing royalty payments, including the effect of patent revocation.

The dispute proceeded to ICC arbitration seated in Paris and eventually generated litigation concerning the relationship between arbitration, patent licensing and EU competition law.

The European Court of Justice's decision in Genentech Inc. v Hoechst GmbH and Sanofi-Aventis Deutschland GmbH is particularly important for understanding the intersection of:

• patent licences;
• contractual royalties;
• competition law;
• arbitration.

Lesson

Biotech arbitration can involve mandatory public-law regimes.

The tribunal must therefore consider whether the contractual obligation being enforced conflicts with mandatory competition or IP rules.

16. What Issues Can a Biotech Tribunal Decide?

A tribunal can generally determine contractual questions such as:

17. Patent Validity vs Contractual Patent Rights

This distinction is fundamental.

Suppose:

Company A licenses Patent X to Company B.

B stops paying royalties, arguing:

"Patent X is invalid."

The arbitration tribunal may be able to determine:

• whether B owes contractual royalties;
• what the licence agreement means;
• whether termination was valid;
• whether B breached contractual obligations.

But whether the patent itself is legally valid may be reserved to the relevant national patent authority or court.

Therefore:

Arbitrable

"Did B breach the licence agreement?"

Potentially non-arbitrable / jurisdiction-dependent

"Is Patent X legally valid against the world?"

This distinction should be expressly addressed in the arbitration clause.

18. Expert Evidence in Biotech Arbitration

Biotech disputes require specialized evidence.

A tribunal may appoint or hear experts concerning:

Molecular biology

Whether two biological mechanisms are materially equivalent.

Genetics

Whether a claimed sequence falls within a contractual definition.

Pharmaceutical development

Whether a party complied with development milestones.

Regulatory affairs

Whether a regulatory delay was reasonably foreseeable.

Economics

Whether lost royalties or future sales were properly calculated.

Patent technology

Whether a research output derives from pre-existing technology.

19. Joint Research Committee Disputes

Large biotech collaborations often establish a:

Joint Research Committee (JRC).

The JRC may decide:

• research priorities;
• funding;
• compound selection;
• development milestones;
• patent strategy;
• commercialization strategy.

The problem arises when the JRC reaches an impasse.

For example:

Company A: Continue Compound X.

Company B: Abandon Compound X.

The contract may provide:

1. escalation to senior management;
2. expert determination;
3. mediation;
4. arbitration.

A sophisticated dispute-resolution mechanism should therefore distinguish between:

scientific decision disputes

and

legal/contractual disputes.

20. Scientific Disputes vs Legal Disputes

A useful contractual mechanism is:

Stage 1 — Scientific expert determination

An independent scientific expert determines:

whether the research milestone has technically been achieved.

Stage 2 — Mediation

The parties attempt commercial settlement.

Stage 3 — Arbitration

The tribunal determines:

• breach;
• payment;
• termination;
• damages;
• contractual rights.

This can dramatically reduce the technical burden on the arbitral tribunal.

21. Confidentiality During Arbitration

The arbitration agreement should provide for:

• confidential pleadings;
• restricted access to laboratory data;
• sealed exhibits;
• redacted awards where necessary;
• protective orders;
• confidentiality undertakings for experts;
• secure electronic document exchange;
• restrictions on publication;
• treatment of biological samples;
• restrictions on copying genomic data.

This is particularly important where disclosure could destroy patent novelty or reveal trade secrets.

22. Interim Relief

Biotech disputes frequently require urgent relief.

For example:

A departing scientist takes a database containing unpublished genomic research.

Waiting for a final arbitral award may cause irreparable harm.

The party may seek interim relief concerning:

• preservation of data;
• return of confidential material;
• preservation of biological samples;
• injunction against commercialization;
• prohibition on disclosure;
• preservation of laboratory notebooks;
• protection against destruction of evidence.

The precise availability of court or tribunal relief depends on the applicable arbitration law and institutional rules.

23. Damages in Biotech Arbitration

Damages can be extremely complex.

Possible claims include:

Research expenditure

Amount spent developing the technology.

Lost milestone payments

Payments that would have become due.

Lost royalties

Expected royalties from commercialization.

Lost profits

Profits from expected sales.

Development costs

Additional expenditure required to complete development.

IP misuse

Damages arising from unauthorized use.

Cost of replacement technology

Cost of obtaining alternative technology.

Because biotech products may have enormous expected future revenues, damages experts frequently become central to the arbitration.

24. Termination Disputes

Termination is one of the most consequential biotech arbitration issues.

A contract may allow termination if:

• development milestones are missed;
• regulatory approval is refused;
• research becomes commercially unattractive;
• one party commits material breach;
• confidentiality is violated;
• insolvency occurs;
• change of control occurs.

The tribunal may need to determine whether termination was:

contractually justified or merely a strategic withdrawal from an unsuccessful research programme.

25. Post-Termination Rights

A biotech agreement should address:

• ownership of inventions;
• patent prosecution;
• licences;
• sublicences;
• research materials;
• biological samples;
• clinical data;
• regulatory dossiers;
• confidential information;
• continuing royalties;
• improvements;
• surviving confidentiality obligations.

Failure to address these issues often produces complicated arbitration.

26. Indian Legal Framework

For an India-seated arbitration, the primary framework is the:

Arbitration and Conciliation Act, 1996

Important provisions include:

Section 7 — Arbitration agreement.

Section 8 — Reference to arbitration where a valid arbitration agreement exists.

Section 9 — Interim measures by courts.

Section 11 — Appointment of arbitrators.

Section 16 — Kompetenz-kompetenz and tribunal's jurisdiction.

Section 17 — Interim measures by arbitral tribunal.

Section 18 — Equal treatment of parties.

Section 19 — Tribunal not bound by the CPC or Indian Evidence Act in the ordinary manner.

Section 23 — Statements of claim and defence.

Section 28 — Rules applicable to substance of dispute.

Section 31 — Form and contents of arbitral award.

Section 34 — Setting aside.

Section 36 — Enforcement.

For international biotech collaborations, Part II and the New York Convention framework become especially important.

27. Kompetenz-Kompetenz

Under Section 16, an arbitral tribunal can generally determine questions concerning its own jurisdiction.

This is particularly significant in biotech disputes because the respondent may argue:

"This is a patent dispute, not a contractual dispute."

The tribunal may have to determine whether the dispute actually falls within the arbitration agreement.

The cases discussed above, particularly Pharmacia & Upjohn and Medicis v Anacor, demonstrate the importance of precisely identifying the scope of the arbitration agreement.

28. Separability

The arbitration clause is generally treated as separate from the underlying biotech agreement.

Therefore:

Even if a party alleges that the research agreement was terminated or invalid, that does not automatically destroy the arbitration agreement.

This is crucial because biotech contracts frequently contain termination provisions.

29. Multi-Party Biotech Research

Modern biotechnology frequently involves multiple parties:

University
+
Biotech company
+
Pharmaceutical company
+
Investor
+
Contract research organization

This creates problems concerning:

• joinder;
• consolidation;
• compatible arbitration clauses;
• different governing laws;
• inconsistent awards.

The contract should therefore address:

• consolidation;
• joinder;
• appointment mechanism;
• institutional rules;
• confidentiality;
• third-party beneficiaries.

30. Recommended Arbitration Clause for Biotech Research

A useful model could provide:

"Any dispute, controversy or claim arising out of or relating to this Research and Development Agreement, including any dispute concerning research obligations, development milestones, funding, intellectual property ownership, patent rights as between the parties, know-how, confidential information, licensing, sublicensing, royalties, commercialization, termination or alleged breach of this Agreement, shall be finally resolved by arbitration."

The clause should additionally specify:

• seat;
• governing law;
• institutional rules;
• number of arbitrators;
• appointment procedure;
• language;
• confidentiality;
• emergency relief;
• expert evidence;
• consolidation/joinder;
• interim measures;
• treatment of confidential scientific information.

31. Best Structure for a Biotech Arbitration Clause

A sophisticated clause can use a tiered mechanism:

Step 1 — Scientific expert determination

Technical question.

↓

Step 2 — Senior executive negotiation

Commercial dispute.

↓

Step 3 — Mediation

Attempted settlement.

↓

Step 4 — Arbitration

Final legal determination.

This is particularly effective where the underlying dispute combines:

science + contract + intellectual property + commercial valuation.

32. Six Core Case Laws — Quick Revision Table

The additional Amyris v. Lavvan and Genentech v. Hoechst/Sanofi-Aventis authorities are especially useful for understanding the boundary between arbitrable contractual IP issues and disputes excluded from arbitration or affected by mandatory law.

33. Key Takeaways

Biotech research arbitration is particularly valuable because biotech disputes combine scientific complexity with contractual and intellectual-property rights.

The most important disputes concern:

1. ownership of research results;
2. patent ownership;
3. background and foreground IP;
4. research milestones;
5. reasonable/commercially reasonable efforts;
6. royalties and milestone payments;
7. confidentiality and trade secrets;
8. technology transfer;
9. licensing and sublicensing;
10. publication rights;
11. regulatory-development obligations;
12. termination;
13. post-termination IP rights;
14. damages and lost royalties; and
15. the boundary between contractual arbitration and mandatory patent/regulatory law.

The central drafting lesson from the case law is that the arbitration clause must be designed together with the IP, confidentiality, research-performance and termination provisions. A vague clause can produce a preliminary jurisdictional battle before the tribunal ever reaches the scientific merits.

For biotech research, the most effective framework is often expert determination for purely scientific questions + mediation for commercial disagreements + arbitration for final contractual and financial disputes, with carefully preserved court jurisdiction for urgent interim measures and matters that mandatory intellectual-property or regulatory law reserves to national authorities.