Pharma Litigation Watch
Prepare a launch, protect a product or organise a litigation response.
Based on your answers, the questionnaire compares UPC and national routes, the evidence to gather and the budget by stage. Each option comes with its conditions.
- Plan my strategyYour position, the right, its expiry and the state of the launch. You get the options to examine, their conditions and the priority documents.Start →
- Understand an issueImminent launch, urgency, scientific evidence, exposure after an injunction, SPCs: a short synthesis, then the decisions.Explore →
- Find a decisionOne search: all UPC decisions classified pharma and life sciences and leading decisions from other courts.Open the database →
8 leading non-UPC decisions, commented · all UPC decisions, without editorial selection · sources checked on 29 September 2026 · detailed case notes published on 11 October 2026 · database updated every week, on Friday · Corpus and method
Plan my strategy
Which strategy for your pharmaceutical dispute?
Protect a medicine, prepare a launch or respond to a threat: compare national and UPC routes, required evidence and stage-by-stage budgets. Start with your situation. Add countries and costs for more precise scenarios.
- Answer the essential questions in a few minutes: your position, the right at stake, the timing and your objective.
- Complete the following sections if needed to refine the options.
- Receive a summary, the routes to examine and a downloadable orientation memo that you can share with the firm.
The engine applies explicit rules and does not predict a judgment. Your answers stay in your browser: the tool neither sends them to the firm nor stores them.
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Understand an issue
Key issues in pharmaceutical litigation
Compare decisions on launch, scientific evidence, SPCs and financial exposure from an injunction. Choose a question to find the synthesis and the relevant decisions.
Commented international selection. 12 decisions from 2013 to 2026 (UPC, CJEU, United Kingdom, United States, India and EPO), each with its practical reading and limitations. The selection is not exhaustive.
UPC decisions database. All UPC decisions classified pharma and life sciences, without selection, each with its record and the official decision: find a decision.
CROSS-JURISDICTION SYNTHESIS · EDITORIAL READING
Reconstruct the route to market.
Marketing authorisation tells only part of the story. The refusal in Celltrion (2024), compared with relief in Zentiva and Merz, calls for checking completed steps and country-specific commercial evidence.
For the patent holder
Gather dated pricing, reimbursement, offers, stock or launch communications and explain their practical significance.
For the competitor
Document remaining obstacles and the actual timetable. Distinguish regulatory preparation from a marketing decision.
Differences and uncertainty
France and Portugal are national settings considered by the same UPC Court of Appeal, not two independent national lines of authority or identical launch thresholds.
Read more: Reading a launch letter · At-risk launch · Bolar exemption
CROSS-JURISDICTION SYNTHESIS · EDITORIAL READING
Imminence and urgency are separate questions.
Imminence concerns the defendant’s expected conduct. Urgency also concerns the claimant’s reaction to what it knew, or should diligently have known. The interests at stake, including patients’, must then be assessed.
For the patent holder
Keep a knowledge chronology. Explain investigations and delays. Evidence the practical consequences of launch.
For the competitor
Test the alleged starting point and harm evidence. Document supply issues concretely.
Differences and uncertainty
Two appeals reversing refusals do not measure the UPC’s general propensity to grant injunctions. Rights, acts and proportionality remain separate assessments.
Read more: Merz: urgency and patient interests · Strategic lessons
CROSS-JURISDICTION SYNTHESIS · EDITORIAL READING
Evidence must address the right legal question.
The five decisions apply distinct tests: EPO inventive step, UK sufficiency, US enablement and enhanced therapeutic efficacy in India. Regeneron and Amgen illuminate biotechnology claim breadth. Novartis shows why the same evidence must be adapted to Indian law.
For the patent holder
Link each claimed effect to the original teaching. Explain generalisations and the role of later results.
For the competitor
Identify undisclosed areas, extrapolations and required experimentation. Apply the test of the forum hearing the case.
Differences and uncertainty
“Plausibility” is not a single worldwide test. G 2/21, an insecticide case, is included for its cross-sector relevance, not as a pharmaceutical injunction decision.
Read more: Plausibility · Sufficiency · Second medical use
CROSS-JURISDICTION SYNTHESIS · EDITORIAL READING
Anticipate the consequences of interim relief.
Read Bayer and Mylan together: national compensation rules matter, alongside the circumstances and the parties’ conduct. Revocation alone does not mechanically determine the amount payable.
For the patent holder
Before applying, assess losses the injunction could cause, security and the evidence supporting relief.
For the competitor
Document lost sales, causation and mitigation. Identify the applicable national regime.
Differences and uncertainty
These references concern different national regimes. They do not directly determine the UPC’s compensation regime.
Read more: At-risk launch
CROSS-JURISDICTION SYNTHESIS · EDITORIAL READING
Check the product and basic patent separately.
A supplementary protection certificate (SPC) extends defined protection. For A+B, an existing SPC for A and the connection between A+B and the invention are separate checks.
For the patent holder
Read the claims, description and drawings together at the relevant date.
For the competitor
Identify the protected product and previous SPCs precisely. Test support for the combination in the patent.
Differences and uncertainty
One selected interpretative judgment, not a statistical series. Other grant requirements and national application remain to be examined.
Read more: Firm analysis of combinations
What the decisions say
The jurisdiction filter selects the cards below. The synthesis above remains cross-jurisdictional. Systems without a reference for the selected question are disabled.
UPC · Novartis / Genentech v Celltrion06.09.2024 · First instance · provisional measures refusedMarketing authorisation and congress announcements do not establish sufficiently imminent launch on these facts.
Practical reading
Identify what remains necessary to actually offer the biosimilar on the market.
Keep this limitation
One order counted here. Parallel case 166/2024 is not added, this is not a final validity decision.
United Kingdom · Regeneron v Kymab24.06.2020 · Merits · sufficiencyThe majority finds insufficiency: the teaching does not enable the full relevant range of transgenic mice.
Practical reading
Link claim breadth to what the skilled person could make at priority.
Keep this limitation
The relevant range depends on technical utility. Not every imaginable variation requires a separate example. Dissenting opinion.
India · Novartis v Union of India01.04.2013 · Merits · patent refusalFor this new imatinib form, the enhanced therapeutic efficacy required by section 3(d) is not established.
Practical reading
Distinguish physicochemical properties, bioavailability and demonstrated therapeutic effect.
Keep this limitation
An Indian requirement for new forms of known substances, not the European sufficiency test.
European Union · CJEU · Mylan v Gilead11.01.2024 · Preliminary ruling · compensation after provisional measuresA national strict-liability regime can comply with the Directive if the court adjusts compensation to the circumstances.
Practical reading
Assess loss caused by the measure and any contribution by the defendant.
Keep this limitation
The CJEU permits this regime. It does not mandate it in every State or quantify loss.
European Union · CJEU · Bayer Pharma v Richter / Exeltis12.09.2019 · Preliminary ruling · compensation after provisional measuresCompensation may take account of the defendant’s loss-mitigation conduct and any abuse by the applicant.
Practical reading
Preserve evidence explaining the launch decision and steps taken to limit losses.
Keep this limitation
At-risk launch does not universally bar compensation: read this ruling with Mylan (2024).
European Union · CJEU · Teva / Merck & Merck / Clonmel19.12.2024 · Preliminary ruling · SPC requirementsAn earlier SPC for A does not alone bar an SPC for A+B. The combination must also fall within the invention.
Practical reading
Separate Article 3(a) and Article 3(c) requirements.
Keep this limitation
Mentioning A+B in the claims is insufficient. The ruling does not automatically validate each national SPC.
UPC · Boehringer Ingelheim v Zentiva13.08.2025 · Appeal · provisional measuresThe appeal reverses Lisbon’s refusal and grants an injunction. Marketing authorisation alone is insufficient. Completed preparations in the Portuguese setting establish imminence.
Practical reading
Identify what still needs to happen before actual marketing.
Keep this limitation
An administrative milestone need not have the same effect in every national market.
UPC · Merz v Viatris27.04.2026 · Appeal · provisional measuresParis’s refusal for delay is reversed. French relief is granted until 25 July 2026. Published pricing, knowledge and commercial context are distinguished.
Practical reading
Date both actual knowledge and what reasonable diligence would have revealed.
Keep this limitation
Now historical relief. Validity was not examined after that defence was abandoned. No merits finding of validity.
EPO · Enlarged Board · G 2/2123.03.2023 · Referral · inventive stepEvidence cannot be disregarded solely because it is later. The asserted effect must remain rooted in the technical teaching and originally disclosed invention.
Practical reading
Connect each experimental result to an identified basis in the original application.
Keep this limitation
An insecticide case with cross-sector relevance. Inventive step and sufficiency raise distinct questions (§ 77).
United States · Amgen v Sanofi18.05.2023 · Merits appeal · enablementFunctional antibody genus claims fail enablement: the teaching must support the claimed breadth, allowing reasonable experimentation.
Practical reading
Test the parts of claim scope not directly demonstrated by the examples.
Keep this limitation
US § 112(a), not automatically EPC Article 83, no rule requiring an example for every embodiment.
United Kingdom · Warner-Lambert v Generics14.11.2018 · Merits appeal · second medical useThe majority holds claims 1 and 3 insufficient for lack of support for neuropathic pain use. Subsidiary infringement reasoning differs.
Practical reading
Separate disclosed therapeutic effect, indication breadth and marketing acts.
Keep this limitation
The infringement opinions do not establish a unanimously adopted test.
UPC · Sanofi-Aventis v Amgen16.07.2024 · Central Division, Munich section · patent revokedThe first revocation action decided on the merits by the UPC: an antibody claimed by its function does not derive inventive step from the functional definition alone.
Practical reading
For a biosimilar, the defensive route before the central division clears the ground ahead of launch, without waiting to be sued.
Limit to keep in mind
The decision concerns an antibody patent defined by function. It says nothing about structural claims or supplementary protection certificates.
No reference in this selection. This does not imply an absence of case law.
Developments: three chronological reference points
- 2018 · Warner-Lambert
Claimed therapeutic scope needs sufficient support. The infringement opinions remain distinct.
- 2023 · G 2/21 & Amgen
Two different evidential questions: technical effect for EPO inventive step, enabled breadth of an antibody genus in the US.
- 2025-2026 · JUB / UPC
Zentiva and then Merz refine launch preparations and the applicant’s chronology in distinct national regulatory settings.
Selected developments, not a statistical trend. Subsequent appeals and events require checking for an actual matter.
All 68 decisions analysed in detail, by jurisdiction
Find a decision
Find a pharma decision, all courts
One search covers two sources: all UPC decisions classified pharma and life sciences, without editorial selection, from the UPC Litigation Watch database, and leading decisions from other courts (CJEU, EPO, United Kingdom, United States, India), each commented with its official source.
Open the UPC decisions in the full database
Scope of this search
Sector classification comes from the shared database taxonomy. Results count documents, not disputes or wins. Multiple orders, decisions or versions may involve the same parties on the same date. Titles alone do not establish duplicates. Search covers indexed fields, not necessarily full PDF text. Commented references are a separate, non-exhaustive selection.
Corpus, sources and reading method
The comparator contains 12 decisions across 6 systems: 3 UPC provisional-measure orders (one first-instance order and two appeals), one UPC revocation decision on the merits, 4 merits judgments (UK, US and India), 3 CJEU preliminary rulings and an EPO Enlarged Board decision. Period: 1 April 2013-27 April 2026. A non-exhaustive editorial selection. G 2/21 concerns insecticides and is included for its cross-sector relevance.
Reading unit: one dated decision identified by court and number, copies, translations and multiple claims do not create additional cases. A decision may address several questions, so thematic counts must not be added. Additional worksheet references are not added to the comparator corpus.
Relevant texts and passages were consulted. This is not an exhaustive procedural-status audit. Outcomes are historical. Institutional summaries are not used to code outcomes. No frequency, causation or success probability is inferred from this selection.
Syntheses are predefined editorial analyses selected by your question. The filter does not generate legal advice or search for new cases in real time. Worksheet answers remain in your browser.
Browse the existing international case records: International explorer. UPC documentary database.
Verified UPC outcomes: the small pilot corpus
These separate counts do not measure worldwide trends.
Verified pilot corpus
Outcomes of the reviewed decisions
Two pharmaceutical appeal decisions, 13 August 2025-27 April 2026, selected because they underpin the imminence grid above. Editorial selection of two disputes, neither exhaustive nor representative of all UPC cases.
Grant denominator: two appeal decisions. The two first-instance refusals below provide procedural context only and are not added to the denominator. No merits validity or infringement rate is inferred from these provisional measures.
Boehringer Ingelheim v Zentiva
Court of Appeal · 13.08.2025
UPC_CoA_446/2025 and 520/2025
Provisional injunction granted on appeal. Information request refused.
§§ 94 and 98, operative part I and VII, pp. 18-19. The Lisbon refusal of 08.05.2025 (CFI 41/2025) was set aside. Appeal and cross-appeal are counted as one decision.
Merz v Viatris
Court of Appeal · 27.04.2026
UPC_CoA_917/2025
Provisional injunction granted on appeal. Validity not assessed after waiver of the defence, infringement undisputed.
§ 18 and operative part I, II, p. 20. The Paris refusal of 21.11.2025 (CFI 697/2025), based on delay, was set aside. The injunction ran only to 25.07.2026: this records the historical decision.
Method, deduplication and limitations
Relevant reasons and operative parts reviewed on 28 September 2026. Unit: one dated judicial decision, identified by court, case number(s) and subject matter. Copies, translations, associated records, multiple defendants and cross-appeals disposed of together do not create additional observations.
Issue-level coding: revocation dismissed/allowed, infringement found/not found, injunction granted/refused, separately noting any limitation or undecided question. An injunction with an exclusion counts as granted, with that limitation displayed. No percentage or predictive probability is calculated from this small sample.
The outcomes describe the dated decisions. They do not establish present enforceability or the absence of later developments. The FRAND and Pharma corpora cover different periods and proceedings, so their counts are not directly comparable.
The broader documentary database
The UPC Litigation Watch database lists, under the topic “Life sciences and pharma”, every record classified under that heading, including medical devices and diagnostics (more than one hundred at 15 October 2026), the exact number and the date of the latest integration appear at the top of that database. This is not a count of unique pharmaceutical decisions. The database covers decisions handed down since 1 June 2023. Full deduplication and outcome coding remain necessary before any overall statistics can be produced.
Apply the case law to your matter
Preparing a launch, an injunction application or a validity challenge? Dhenne Avocats advises on pharmaceutical and UPC litigation.
Work and publications of Matthieu Dhenne: Kluwer Patent Blog, SSRN, Google Scholar, LinkedIn.
Latest analysis
- Plausibility and the right of priority: the French court faces apixaban (6 October 2026)
- Preliminary injunctions and patent applications: the French fault line (5 October 2026)
- Dosage inventions and inventive step: the strict reading of the French court (4 October 2026)
Matthieu Dhenne on the Kluwer Patent Blog
Who maintains this watch
Pharma Litigation Watch is maintained by the Dhenne Avocats team, a Paris litigation boutique devoted to patent disputes. The firm acts in life sciences patent litigation, notably pharmaceutical and biotechnology disputes, including supplementary protection certificates and preliminary measures, and regularly comments on the case law at the Kluwer Patent Blog. Each reference links to its source. The practical notes distinguish the decision’s holding, its context and the limits of applying it to other cases.
From the watch to the decision
The imminence of a launch, the strength of a supplementary protection certificate or the case for a preliminary injunction cannot be read off a database: they are assessed on the record, often against a tight calendar. The firm acts in pharmaceutical and regulatory litigation, provides litigation readiness and a second opinion on pending litigation.
Frequently asked questions
What does Pharma Litigation Watch cover?
Decisions of the Unified Patent Court in pharmaceutical and life sciences matters: medicinal product patents, supplementary protection certificates, generics and biosimilars, and preliminary measures, put in perspective with the leading foreign decisions through the international case law explorer.
How does the UPC handle urgency in pharmaceutical cases?
The application for provisional measures plays a central role: the imminence of infringement, the balance of interests and the applicant’s diligence are assessed case by case. Each entry links to the official text of the decision.
Do the tool’s results amount to a risk analysis?
No. The tool organises the useful questions. It replaces neither an analysis of the patents, nor of the record, nor the procedural strategy. For that, contact the firm.
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