The EU Biotech Act’s Proposed SPC Extension: Trial and Manufacturing Conditions for US and Swiss Sponsors

US biotech sponsors compute the patent term they recover for regulatory delay from dates the agencies record. For an eligible patent, 35 U.S.C. § 156 bases the extension on the regulatory review period after patent issue, reduces it for a lack of due diligence, counts only half of the testing phase and caps it at five years and at fourteen years of remaining term after approval. It imposes no trial-location or manufacturing-location condition.135 U.S.C. § 156, Extension of patent term, § 156(a), § 156(c)(1) to (3), § 156(g)(1)(B) and § 156(g)(6)(A): eligibility, post-issue regulatory review, due-diligence reductions, half the testing phase, and the five-year and fourteen-year limits. The European counterpart, the SPC, runs on a comparable formula with a five-year cap and a conditional six-month pediatric reward. The European Commission's proposal for a European Biotech Act, published on 16 December 2025, would add a year to that formula for qualifying products, subject to four conditions, two of them geographic.2European Commission, Proposal for a Regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act), COM(2025) 1022 final/2 (16 December 2025), procedure 2025/0406(COD), Art. 27(1) to (4) (four cumulative conditions, assessment during the marketing-authorisation procedure, Agency statement and copy in the certificate application); Art. 67(1) to (3) of the European Biotech Act proposal (entry into force and phased application); explanatory memorandum, section 3, ‘Impact assessments’. Alongside the novelty, safety and efficacy criteria, the year would depend on efficacy trials in more than two Member States and a qualifying Union manufacturing step other than packaging, quality testing or certification. For a sponsor whose pivotal program is run from the United States and whose product is made in the United States or in Switzerland, eligibility could therefore turn on operational choices made years before anyone files for a certificate, under a text that the European Parliament's committees were still rewriting in September 2026.

1. What Art. 27 of the Biotech Act Would Grant, and to Whom

The entitlement is drafted as a single sentence with four conditions. Under Art. 27(1) of the proposed Biotech Act, "the holder of a patent or of such certificate" would be entitled to "a 12-month extension of the periods referred to in Article 13, paragraphs (1) and (2)" of the SPC Regulation, which are the formula period and the five-year cap. The marketing authorization applicant would have to demonstrate that the product contains a new active substance "distinctly different" from that of any product authorized in the Union, that it has a mechanism of action "distinctly different" and a level of safety and efficacy at least equivalent to any authorized product for the same disease, that "the clinical trials evaluating the efficacy of the medicinal product and supporting its marketing authorisation were conducted in more than two Member States", and that "at least a manufacturing step, excluding packaging, quality testing and certification is performed in the Union". Under Art. 27(2) and (3) Biotech Act the European Medicines Agency (the Agency) would assess those conditions as part of the marketing authorization procedure and issue a statement where they are met, and Art. 27(4) Biotech Act would require a copy of that statement in the certificate application lodged under Art. 7 SPC Regulation.2 The proposed year would interact with the pediatric reward: Art. 13(3) SPC Regulation extends both periods by six months where Art. 36 of Regulation (EC) No 1901/2006 applies, but the proposal does not expressly resolve their combination.3Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) [2009] OJ L152/1 (SPC Regulation), Art. 3, Art. 5(2), Art. 7(1) to (4), Art. 8(1)(d) and Art. 13(1) to (3) SPC Regulation (certificate eligibility, application, conditional manufacturing waiver and term; pediatric extension subject to Art. 36 of Regulation (EC) No 1901/2006).

The scope is drawn by cross-reference, and the reference points at a regulation that had not been adopted. Art. 27(1) Biotech Act reaches products authorized by the Union that are "developed by means of biotechnological processes referred to in paragraph 1 of Annex I" to the regulation that will replace Regulation (EC) No 726/2004, and advanced therapy medicinal products under paragraph 2 of that Annex, with the number of the replacing regulation left blank. Annex I to that regulation lists the products that must be authorized centrally. In the Council compromise text confirmed on 6 March 2026 its first paragraph names two processes, recombinant nucleic acid technology and controlled expression of genes coding for biologically active proteins, where Annex I to Regulation (EC) No 726/2004 also names hybridoma and monoclonal antibody methods.4Council of the European Union, Final compromise text for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, ST-6366/26 (24 February 2026; agreement confirmed by Coreper on 6 March 2026), Annex I, points 1 and 2, and Art. 181 ST-6366/26 (biotechnology/ATMP scope and general application after twenty-four months). Comparison: Annex I, point 1 Regulation (EC) No 726/2004, as amended. Eligibility therefore turns on how a product is made, read through a list written to route applications to the centralized procedure rather than to identify innovation, and a chemically synthesized peptide or oligonucleotide would appear to fall outside it unless it is an advanced therapy. The compromise text sets the replacing regulation's date of application at twenty-four months after its entry into force, and formal adoption of that regulation and of the revised Directive, together the EU Pharma Package, was still pending as of publication, while Art. 67(2) Biotech Act would apply Art. 27 Biotech Act from the Biotech Act's own entry into force. The proposal does not say which Annex governs in the interval, nor whether a product authorized, or under assessment, on that day can obtain a statement that the Agency had no mandate to issue when it examined the file.

The Holder, the Applicant and the Missing Procedure

The entitlement and the burden sit with different persons. The year would belong to "the holder of a patent or of such certificate", but the conditions would be demonstrated by "the marketing authorisation applicant", and the Agency's statement would issue in a procedure to which the patent holder need not be a party. Where a US licensor holds the patents and a European licensee or partner holds the authorization, the certificate applicant would need a document produced in someone else's file. The Court of Justice held in Biogen, under the regulation that the SPC Regulation later codified, that the authorization holder is not required to give the patent holder a copy of the authorization and that a certificate application may not be refused on that ground alone.5Case C-181/95 Biogen Inc v Smithkline Beecham Biologicals SA [1997] ECR I-357, ECLI:EU:C:1997:32 (23 January 1997), paras 36 to 38 and 44 to 47 and operative part, points 2 and 3: no duty under the SPC legislation to supply the authorisation copy, without prejudice to contractual obligations; refusal not permitted solely because the patent holder cannot supply the copy. The analogy is plausible but not decisive: Biogen treated the authorization copy as formal proof and relied on cooperation between authorities, whereas the proposed statement would certify compliance with four additional conditions. Whether national patent offices could obtain it through an equivalent route is not settled by that judgment.

The procedure has a gap of its own. Art. 7(1) SPC Regulation requires the certificate application within six months of the authorization, and the statement would have to be in that application. For the pediatric reward, Art. 7(3) and (4) SPC Regulation allow an extension to be sought while a certificate application is pending or, for a certificate already granted, no later than two years before it expires. The Commission's text contains no equivalent, so a product whose certificate was applied for before the Biotech Act enters into force, or before a statement issues, has no stated route to the year. Amendments tabled in the Parliament's lead committees in July 2026 would allow the statement to accompany "the application for an extension of the duration of a certificate", which suggests the gap has been noticed, though not closed.6European Parliament, Committee on Public Health and Committee on Industry, Research and Energy, Draft report on the proposal for a regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) (COM(2025)1022, C10-0363/2025, 2025/0406(COD)), rapporteurs Vytenis Povilas Andriukaitis and Wouter Beke, PE789.987v01-00 (15 June 2026), Amendment 386; European Parliament, Amendments 2048 to 2330 to that draft report, PE790.937v01-00 (14 July 2026), Amendments 2048 to 2165 (separately tabled Chapter IV and Art. 27 European Biotech Act alternatives, including deletion, trial thresholds and connectors, EEA/EFTA references, manufacturing conditions and statement applications).

The Commission did not accompany the proposal with an impact assessment. Its explanatory memorandum states that one "could not have been delivered in the timeframe available" and announces an analytical staff working document instead, which is dated 26 May 2026.2 That document estimates, from Agency data, that on average five products a year over the past ten years, and six a year over the past five, would have met all four conditions. Assuming that about 40 percent rely on the certificate as their last protection, its model estimates that two to three products a year would be economically affected. It puts that annual cohort at four to five if sponsors changed their trial and manufacturing geography. For the products whose certificate is the last protection to expire, it puts the cost of one additional year at about EUR 70 million per medicine to public payers and the originator's additional gross profit at about EUR 230 million, on list prices.7European Commission, Commission Staff Working Document, European Biotech Act, accompanying the proposal for a Regulation establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) and the proposal for a Directive amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs, SWD(2026) 450 final (26 May 2026), addendum to COM(2025) 1022 and COM(2025) 1031, section 5.2.3, Intervention 13 (SPC extension for biotechnology medicines), Table 13 and accompanying assumptions and limitations. The model therefore treats trial and manufacturing geography as a material constraint on eligibility, but its projected effect depends on the assumed share of products for which the certificate is the last protection. It does not identify the products in those groups. 35 U.S.C. § 156 has no counterpart to either condition. A US extension compensates qualifying regulatory-review time; the proposed European year would also turn on development geography, alongside its novelty, safety and efficacy conditions.

The proposed year would depend on trial locations and a qualifying manufacturing step as well as the product's novelty, safety and efficacy. Those geographic choices can be made during development, long before a certificate is sought.

2. The Trial-Location Condition Compared With the Pharma Package

The trial condition is shorter than the questions it raises. Point (c) of Art. 27(1) Biotech Act speaks of "the clinical trials evaluating the efficacy of the medicinal product and supporting its marketing authorisation", in the plural and with the definite article, and leaves open whether every pivotal trial must reach the threshold or only the efficacy program taken as a whole. It sets no floor for sites, subjects or share of enrollment in any Member State, so a global phase III trial with a few patients at sites in three Member States and the rest in North America reads, on the text, like one enrolled mostly in the Union. Sites in the United States, in Switzerland or in the United Kingdom count toward nothing. For Norway, Iceland and Liechtenstein the answer depends on incorporation into the EEA Agreement, whose Protocol 1 reads references to the Community's territory as references to the territories of the Contracting Parties, and rights and obligations of Member States as those of the Contracting Parties. Whether the proposed trial threshold would include those EEA states would therefore depend on incorporation and any specific adaptation; Protocol 1 alone does not settle that future outcome.8Agreement on the European Economic Area of 2 May 1992 [1994] OJ L1/3, Protocol 1 on horizontal adaptations [1994] OJ L1/37, introductory paragraph and points 7–8 (horizontal adaptations, subject to any act-specific adaptations on incorporation). Switzerland is neither a Member State nor a party to the EEA Agreement.

A sponsor relying on the Pharma Package's geographic routes could have the same trial program measured against two thresholds. Under the Pharma Package compromise text, Art. 81(2) of the revised Directive prolongs regulatory market protection by twelve months where, for a product containing a new active substance, the applicant demonstrates an evidence-based comparator in line with the Agency's scientific advice and that "clinical trials evaluating the efficacy of the medicinal product and used for the marketing authorisation were conducted in more than one Member State", or combines the multi-Member-State condition with the 90-day filing rule where a comparator trial is justified as not possible or appropriate.9Council of the European Union, Final compromise text for a Directive on the Union code relating to medicinal products for human use and repealing Directive 2001/83/EC and Directive 2009/35/EC, ST-6367/26 (24 February 2026; agreement confirmed by Coreper on 6 March 2026), Art. 80(1) and (2) and Art. 81(2)(b) to (d) ST-6367/26 (baseline protection and alternative twelve-month routes; only the cited (c)/(d) routes require multi-state efficacy trials). How that modulation reshapes the protection clock is examined in the article on biosimilar entry after the Pharma Package, and the definitional questions it leaves open, from minimum enrollment to Member States whose participation is nominal, in the analysis of the 90-day rule. A separate Pharma Package route pairs the comparator condition with Union-first or timely filing without a multi-state trial requirement. For the geographic routes, the Biotech Act would ask the same kind of question with a higher threshold and a different verb: more than two Member States rather than more than one, and trials "supporting" the authorization rather than "used for" it. A program with sites in exactly two Member States could satisfy a regulatory geographic threshold while missing the proposed SPC threshold, provided the other conditions for the regulatory year were met. Both determinations would fall within one centralized authorization procedure, and nothing in either text requires them to read "conducted in" the same way.

A Threshold Still Moving

The threshold is contested, and the Commission's own documents do not hold it steady. The staff working document, in the passage estimating how many more products would qualify if sponsors changed their conduct, describes that change as conducting "clinical trials in more than one Member State", which is the Pharma Package's figure rather than the proposal's.7 Amendments tabled in the lead committees in July 2026 run from trials in more than one Member State, tabled by the rapporteur of the Committee on Industry, Research and Energy (ITRE) with members of his group, to "more than five Member States" with patient populations "sufficiently representative" of those expected to use the product, tabled by the rapporteur of the Committee on Public Health (SANT) and others. Other versions require more than three Member States, including one accounting for less than 3 percent of authorized trials with at least 10 percent of subjects recruited there; at least three Member States, including one with below-average GDP per head; or only "at least one" qualifying trial. Amendments 2110, 2112, 2114 and 2115 also end the trial condition with "or", potentially making the geographic routes alternatives rather than merely changing the trial threshold. Amendment 2111 adds "or in EEA/EFTA countries" to the trial condition. These are competing amendments, not one agreed package.6 The opinion of the Committee on Legal Affairs (JURI), adopted on 7 September 2026, left the trial condition as the Commission wrote it.10European Parliament, Committee on Legal Affairs, Opinion for the Committee on Public Health and the Committee on Industry, Research and Energy on the proposal for a regulation establishing a framework of measures for strengthening Union's biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act), COM(2025)1022, 2025/0406(COD), rapporteur for opinion Tiemo Wölken, PE789.902v02-00 (8 September 2026; adopted 7 September 2026), Amendments 32–36 (proposed SPC-extension conditions), Amendment 52 (biosimilar stockpiling), and p 38 (vote). None of the other versions had been voted on in the lead committees as of publication, and each would change which pivotal programs qualify.

The Biotech Act would also change the procedure by which a third Member State is added. Art. 58 Biotech Act would move the Part I and Part II assessment clocks of the Clinical Trials Regulation (CTR) from validation to submission, as the article on the Nordic fast tracks describes. For an additional Member State, whose existing decision clock already runs from submission, it would replace the 52-day baseline with 47 days, subject to additional-information extensions. These procedural changes would apply six months after entry into force under Art. 67(3)(a) Biotech Act.11Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC [2014] OJ L158/1 (CTR), Art. 14(1) and (3) CTR; European Biotech Act proposal, COM(2025) 1022 final/2 (n 2), Art. 58(5), (6) and (11), and Art. 67(3)(a) of the European Biotech Act proposal. The proposed 47-day period is a baseline subject to additional-information extensions; these procedural changes would apply six months after entry into force. Art. 14 CTR allows that application only after the initial authorization decision. A program designed around one or two Member States that adds a third to reach the threshold therefore does so under the procedure for extending an authorized trial, at a point when enrollment in the pivotal cohort may be well advanced. Whether a late site that enrolls a handful of subjects satisfies "conducted in" is exactly what the text leaves open, and the Agency would answer it years after the site was opened.

3. What Counts as a Manufacturing Step in the Union

Point (d) of Art. 27(1) Biotech Act excludes activities that commonly accompany importation, without positively defining the manufacturing step that would qualify. A product imported from the United States or Switzerland enters under a manufacturing authorization, because Art. 40(3) of Directive 2001/83/EC requires one for imports from third countries, and a qualified person certifies each production batch under Art. 51 of Directive 2001/83/EC, after testing in a Member State unless an arrangement under Art. 51(2) of Directive 2001/83/EC ensures equivalent manufacturing standards and the required controls have been carried out in the exporting country, relieving the qualified person of repeating them.12Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [2001] OJ L311/67, Art. 1(23), Art. 40(2) and (3), and Art. 51(1)(b), (2) and (3) Directive 2001/83/EC (manufacturing/import authorization, immediate packaging, batch testing and certification; conditional relief from repeat controls). Those are the activities the proposal sets aside: "packaging, quality testing and certification". An operation outside those exclusions would still have to constitute a manufacturing step, a boundary the proposal does not define. Art. 40(2) of Directive 2001/83/EC treats "total and partial manufacture" and "the various processes of dividing up, packaging or presentation" alike. The glossary to the EU guidelines on good manufacturing practice (GMP) defines packaging as all operations, "including filling and labelling", that a bulk product undergoes to become a finished product, and then adds that sterile filling "would not normally be regarded as part of packaging".13European Commission, EudraLex Volume 4: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Glossary, pp 3–4 and 6 (“Bulk product” and “Packaging”; sterile-filling qualification; definitions limited to the guide's context). That glossary suggests a distinction between sterile filling in the Union and labeling vials filled elsewhere. Its definitions apply within the GMP guide, however; the proposal does not incorporate them or make sterile filling automatically sufficient for the extension.

The Committee on Legal Affairs proposed an answer taken from a neighboring file. Its opinion would replace point (d) with "at least one manufacturing step is carried out in the Union other than import, repackaging, packaging other than immediate packaging, labelling, quality testing and, where applicable, certification".10 The words are those of the Critical Medicines Act as agreed between the Parliament and the Council. After a provisional agreement on 12 May 2026, the final compromise text that the Committee of Permanent Representatives (COREPER) endorsed on 30 June 2026 uses them to define "manufacturing in the Union" for the procurement preference in Art. 18(2) ST-11059/26 (Critical Medicines Act compromise text) for critical medicines with identified supply-chain vulnerability from high dependence on one or a few third countries, and a recital lets contracting authorities rely on tenderers' claims while taking into account "manufacturing steps that add the most value".14Council of the European Union, Final compromise text for a Regulation establishing a framework to strengthen the security of supply and the availability of critical medicinal products, as well as the availability and accessibility of medicinal products of common interest, and amending Regulation (EU) 2024/795, annexed to ST-11059/26 (30 June 2026), 2025/0102(COD) (Critical Medicines Act), Art. 18(2) and (5) and recital 26b ST-11059/26 (conditional procurement preference, manufacturing exclusions and evidence; compromise, not adopted law). That wording would leave immediate packaging, the container in contact with the product, outside the express exclusions while excluding secondary packaging and labeling. Filling into that container is therefore a stronger candidate for a qualifying step, rather than an expressly settled entitlement. The alignment would give one definition two functions: a patent-term condition assessed once by the Agency, and a procurement criterion applied tender by tender by contracting authorities. Nothing requires the two readings to converge, and the Critical Medicines Act itself still awaited the Parliament's plenary vote as of publication.

Amendments tabled in the lead committees pull the condition in both directions. One would require "at least substantial manufacturing steps" in the Union together with "a substantial part of the development of the medicinal product" there, another "at least two significant manufacturing steps", including manufacture of the active substance or a critical intermediate, several would exclude only "secondary packaging", and one would accept a step performed "in the Union or in EEA/EFTA countries".6 That formulation also appears in the separately tabled trial amendment. Its reach would matter to Swiss sites and plants, but "EEA/EFTA countries" does not expressly resolve the position of Switzerland, which belongs to the European Free Trade Association but not to the European Economic Area.

A Condition Assessed Once, a Year Earned Much Later

The condition is also silent about time. The Agency would assess it during the authorization procedure, and the extra year would run many years later, at the end of the certificate. The Commission's text asks that a step "is performed in the Union", in the present tense, and provides no mechanism for checking that it still is when the year begins and no consequence if it is not. An amendment tabled by the ITRE rapporteur and members of his group would require the step to be performed in the Union "at least for the duration of the supplementary protection certificate", which would turn a fact assessed once into an obligation carried through the life of the product, and another would let the holder meet the condition after authorization, including through a variation, with supporting evidence due no later than two years before the patent or certificate expires, whichever comes first.6 A contract manufacturing agreement signed for a launch has a term, a change-of-control clause and a termination right, and whether any of them was drafted against a patent year that depends on the plant's location is a question that arises only once the text settles.

For a US sponsor the manufacturing condition does not arrive in isolation. The presidential proclamation of 2 April 2026 under section 232 of the Trade Expansion Act of 1962 sets a 100 percent duty on imported patented pharmaceuticals and their ingredients, a 20 percent rate, rising to 100 percent on 2 April 2030, for companies with approved onshoring plans or assessed as likely soon to have them, and a 15 percent rate for products of the European Union and of Switzerland and Liechtenstein jointly, unless a lower rate applies. These tariffs take effect for companies in Annex III to Proclamation 11020 on 31 July 2026 and for others on 29 September 2026. It also provides a zero rate until 20 January 2029 for eligible companies that combine onshoring with an MFN pricing agreement, including those determined likely soon to qualify, and a conditional zero rate for specified categories that include cell and gene therapies.15Proclamation 11020 of 2 April 2026, Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States, 91 Fed Reg 18183 (9 April 2026), clauses (3)(a) to (e) and (4): the 100 percent baseline, conditional onshoring and MFN-pricing reductions, the 15 percent EU/Swiss-Liechtenstein origin rate unless a lower rate applies, specialty-category determinations, and staggered entry dates. The US instrument rewards moving production to the United States, the proposed European year would reward keeping a step of it in the Union, and a Swiss plant, treated at the US border like a plant in the Union, would count for nothing under Art. 27 Biotech Act.

4. The Proposed Extra Year: EU SPC Rules, Pending Reform and Swiss Certificates

The Commission's text does not amend the SPC Regulation. The extension would live in a sectoral regulation and reach into Art. 13 SPC Regulation from outside, and the staff working document states that it "does not affect in any respect the existing legal framework" of Regulation (EC) No 469/2009, nor "the ongoing reform of that framework".7 That reform is itself unfinished. The Commission's proposals of 27 April 2023 for a recast of the SPC Regulation and for a unitary certificate for medicinal products passed the Parliament at first reading on 28 February 2024 and, as of publication, awaited the Council's first-reading position.16European Commission, Proposal for a Regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast), COM(2023) 231 final (27 April 2023), 2023/0130(COD); European Commission, Proposal for a Regulation of the European Parliament and of the Council on the unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013, COM(2023) 222 final (27 April 2023), 2023/0127(COD). Parliament adopted first-reading positions on 28 February 2024; Council positions remained pending. The cross-reference to Art. 13 of the SPC Regulation and the parallel proposal for a unitary certificate would require coordination between the final instruments; their order of adoption alone would not settle the result.

The arithmetic raises its own questions. Art. 13(3) SPC Regulation adds six months to both periods for pediatric compliance and provides that the formula period "may be extended only once". The Biotech Act would add twelve months to the same two periods. On a cumulative reading, the cap would rise from five years to six and, with the pediatric reward, to six and a half, but whether the "only once" sentence, written for the pediatric reward, limits a second extension arriving from another regulation is not addressed. Nor is the product authorized within five years of its patent filing, whose formula period is negative. The Court of Justice held in Merck that a certificate may be granted in that case, and that the pediatric extension then runs from the date obtained by that subtraction.17Case C-125/10 Merck Sharp & Dohme Corp v Deutsches Patent- und Markenamt, ECLI:EU:C:2011:812 (judgment of 8 December 2011), paras. 38 to 45 and operative part: a negative SPC period is not rounded up to zero; the pediatric extension runs from the date obtained by subtracting that deficit from patent expiry. The judgment did not concern the proposed Biotech Act. If a twelve-month extension of "the periods referred to in Article 13, paragraphs (1) and (2)" behaves the same way, some or all of the year could fall before the patent expires, so a twelve-month addition to the formula would not necessarily yield twelve months of post-patent protection.

The Committee on Legal Affairs added a second change that interacts with the first. Its opinion would amend Art. 5(2) SPC Regulation, the manufacturing waiver that Regulation (EU) 2019/933 introduced, so that a maker of biosimilars could make and store in a Member State for the whole certificate term, and not only in the six months before expiry, in order to enter the Union market on the day the certificate ends, with the six-month limit kept for generics and the waiver's other conditions preserved.10 On that text the extra year would also be a year in which biosimilar entrants build stock in the Union. The same opinion's short justification, which is the rapporteur's, states that the Biotech Act "is not the appropriate legislative instrument through which to reopen discussions on additional exclusivity-based incentives". The committee nonetheless adopted amendments that keep the extension and rewrite it, and adopted the opinion by 19 votes to 5 with one abstention.

Switzerland runs its own certificate and would not follow the Union's. Under Art. 140a and Art. 140b PatG the Swiss Federal Institute of Intellectual Property (IGE) grants a certificate on the basis of the first Swiss authorization of a patented product, under Art. 140e PatG it runs for the formula period and at most five years, and Art. 140n PatG adds six months for pediatric work only where the Swiss authorization was applied for no later than six months after the first corresponding application in the European Economic Area.18Bundesgesetz über die Erfindungspatente (Patentgesetz, PatG) vom 25. Juni 1954 (SR 232.14), version in force from 1 July 2025, Art. 140a(1), Art. 140b, Art. 140e(1) and (2), and Art. 140n PatG: the Swiss certificate and pediatric extension. Joined Cases C-207/03 and C-252/03 Novartis AG and Others v Comptroller-General of Patents, Designs and Trade Marks and Ministre de l’Économie v Millennium Pharmaceuticals Inc., ECLI:EU:C:2005:245 (judgment of 21 April 2005), paras. 26 to 33 and operative part: the conditional first-EEA treatment of a Swiss authorization automatically recognized in Liechtenstein. Swiss law already ties one extension to European timing. It has no counterpart to the proposed year, and the proposal would not reach it. The baseline Swiss and European periods may already differ, but distinct authorization dates cannot be assumed: a Swiss authorization automatically recognized in Liechtenstein can count as the first EEA authorization if it is the earliest qualifying authorization there. Whether and when that recognition applies must be checked for the product.18 A Swiss sponsor's European certificates would qualify for the proposed year only on the Union's terms, which count neither Swiss trial sites nor Swiss plants. If the year is adopted and available, it could create a further difference of up to twelve months between the certificates.

5. For US and Swiss Sponsors Planning EU Development

Whether there will be a year at all was not settled as of publication. The rapporteur of the Committee on the Environment, Climate and Food Safety (ENVI) proposed on 1 June 2026 to delete the chapter, observing that the extension "lacks a proper econometric impact assessment",19European Parliament, Committee on the Environment, Climate and Food Safety, Draft opinion for the Committee on Public Health and the Committee on Industry, Research and Energy on the proposal for a regulation of the European Parliament and of the Council establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) (COM(2025)1022, C10-0363/2025, 2025/0406(COD)), rapporteur for opinion Nicolás González Casares, PE788.881v01-00 (1 June 2026), short justification, pp. 3 to 4, and Amendment 20, pp. 18 to 20 (proposed deletion of Chapter IV). and the draft opinion of the Committee on Legal Affairs deleted it a week later.10 The lead committees' draft report of 15 June 2026 left Art. 27 Biotech Act unamended and added the impact of certificate extensions to the evaluation clause, and more than a hundred amendments to the chapter followed in July, among them deletions tabled on behalf of the Greens/EFA group and by the two rapporteurs for opinion.6 The Committee on Legal Affairs then adopted an opinion that keeps the extension, turns the two novelty conditions into alternatives and redefines the manufacturing step. Plenary consideration remained pending. The Council's June action also distinguished the two files: health ministers debated the Regulation on 16 June 2026, but the general approach they adopted that day concerned only the accompanying Directive on genetically modified micro-organisms and the processing of organs.20Council of the European Union, Presidency note, European Biotech Act I Regulation: Policy debate, Council doc ST-9454/26 (29 May 2026); General Secretariat of the Council, note on a general approach on the proposal for a Directive amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs, Council doc ST-9805/26 (8 June 2026), procedure 2025/0405(COD); Council of the European Union, Employment, Social Policy, Health and Consumer Affairs Council (Health), 16 June 2026, main results (Directive general approach; Regulation policy debate). A program whose pivotal trials begin in 2027 is being planned against conditions that may read differently, or not exist, by the time its authorization is granted.

The questions that decide eligibility are, for the most part, questions of record, and records are made in the course of development rather than at the moment an application is filed. Which trials the Agency will treat as "supporting" the authorization, which Member States hosted each of them, how many subjects each enrolled and when each site opened are knowable from the trial master file and the EU clinical trials portal, but only in the form the program happened to take. A site added late to reach a third Member State is a fact the Agency will read as it finds it, not one the sponsor can later characterize. Which step of manufacture takes place where, under whose manufacturing authorization, and whether a fill-finish contract in the Union covers "immediate packaging" or merely "packaging" depends on which text survives. Whether the step is still performed in the Union when the year begins depends on supply contracts that will have been renegotiated several times by then.

Behind those sit questions for the contracts that connect a patent holder to the entity that applies for authorization. A license that defines the royalty term by the last-to-expire patent right, certificates and extensions included, would on its face capture the year. Whether the party that paid for the third Member State's sites, or for the Union manufacturing step, can claim a share of what the year produces depends on clauses drafted before the incentive existed. Where the licensee is the authorization applicant and the licensor holds the certificate, the statement the licensor needs would sit in the licensee's procedure, and Biogen does not itself create a statutory right to demand it, while leaving contractual obligations open. In a co-development with a Swiss partner the same questions arise, with the added fact that the partner's own sites and plants would not count.

For a US-listed sponsor the loop back to US law runs through disclosure. Where a US-listed sponsor's material risk disclosure under Item 105 of Regulation S-K assumes that the proposed year will extend a European loss-of-exclusivity date, that assumption depends on trial allocation and plant location as well as patent protection. It also rests on a legislative text that may change its conditions after the trials have run.2117 C.F.R. § 229.105, Regulation S-K, Item 105, Risk factors, § 229.105(a) and (b): material investment risks and their effects on the registrant or offered securities; no universal requirement to publish a European loss-of-exclusivity date. The location decision itself sits between a US tariff architecture that rewards onshoring and a European proposal that would reward a Union manufacturing step. Swiss production alone satisfies neither production-location incentive, although qualifying Swiss-origin imports benefit from the preferential origin rate under the US proclamation.

For US and Swiss sponsors, a useful starting point is a record of the efficacy trials, their participating countries and the manufacturing steps behind the authorization file. Contracts can allocate who supplies that evidence and the Agency's statement. They cannot establish an entitlement that depends on the final legislation and the product's qualification under it.