Index of contents

• Summary

• How the EPO's Enlarged Boards of Appeal are reshaping the European patent law framework

• Why biotech/pharma patents matter (value & leverage)

• SPCs, regulatory interplay and Italy-specific notes

• Key procedural and formal features that are “biotech-specific”

• Change in the inventorship/ownership patent law in Italy when universities/research institutions are involved

• Patentability: exclusions, diagnostics and second medical uses

• Evidence & enablement: when is experimental data “enough”?

• Portfolio & prosecution tactics

• UPC litigation — a changing landscape for pharma and biotech

• Global considerations & public-health exceptions

• AI, digital health and future directions

• Practical checklist for a pharma or biotech applicant

• Conclusion

Summary

Patents remain the primary instrument to protect and monetise biotech and pharmaceutical innovations in Europe. In these sectors, the value of a single patent application can far exceed that seen in many other industries. This is due to long development timelines, regulatory barriers, and market-exclusivity mechanisms that amplify the commercial and strategic importance of protecting a single invention. But biotech/pharma patenting requires special procedural steps (e.g. sequence listings, biological deposits), rigorous experimental support, and careful claim drafting to navigate EPC exclusions and national/regulatory overlays (SPCs, compulsory licences, regulatory exclusivity). Further, recent EPO case law – G 2/21 and G 1/24 – and the 2023 Italian IP reform (Art. 65)¹ materially change how you must draft, file and manage portfolios.

The strategic challenges for Italian and European innovators are:

1. timing and sufficiency of experimental data;

2. tailoring claims to survive EPO scrutiny on diagnostics, medical methods, sufficiency of disclosure and inventive step;

3. global portfolio coordination given divergent rules (e.g. US case law, India's compulsory licensing); 

4. new complexities from AI and digital health.

Below we explain these points and discuss practical aspects.

How the EPO's Enlarged Boards of Appeal are reshaping the European patent law framework

Two recent EPO's Enlarged Board of Appeal decisions have had a major impact in filing strategy and prosecution of patents in pharma and biotech context.

Decision G 2/21 (plausibility at filing) defines how examiners/boards may (or may not) rely on post-filed evidence: first ask whether the original application made the asserted technical effect plausible; post-filed data can only corroborate an effect that was already credibly disclosed. 

Decision G 1/24 (claims interpreted in light of the description) rules on how to read the claims: the claims are the starting point but must always be interpreted in the light of the description and drawings — i.e. the claims shall be read against the whole specification to decide what was really disclosed and claimed. 

Therefore, generally one must construe the claim in the context of the specification and drawings (G 1/24) and also evaluate whether the specification supports (and makes plausible) the claimed scope. If it is not the case, then post-filed data can only corroborate what was already derivable from the application as filed (G 2/21).

Why biotech/pharma patents matter (value & leverage)

Pharmaceutical active substances and therapeutic inventions typically represent single assets of very high economic value — unlike many mechanical inventions, where broad portfolios of incremental patents often cover a product family. A granted pharmaceutical patent (and related exclusivities such as Supplementary Protection Certificates - SPCs) can determine whether the innovator recoups often-immense clinical and regulatory costs. For these reasons, early strategic patent decisions (when to file, how much experimental evidence to include, and geographic coverage) materially affect commercial outcomes. EPO's provisions on exceptions to patentability, SPC framework, inventorship/ownership law provisions are especially relevant issues to consider.

SPCs, regulatory interplay and Italy-specific notes

What SPCs do: SPCs (Regulation (EC) No 469/2009) compensate for long regulatory approval times to get a market authorization (MA) by extending effective protection for medicinal products that have required long authorisation procedures. SPCs are subject to strict tests (product-MA link, basic patent covering product, correct timing for filing SPC applications). 

Italy practicalities: SPCs may applied for at national level through the Italian Patent and Trademark Office (UIBM) and must comply with EU criteria plus national filing formalities. Applicants and their representatives should track SPC filing windows and maintain documentation of the first MA date and basic patent claims because errors can prove fatal. 

Key procedural and formal features that are “biotech-specific”

Sequence listings: nucleotide and amino-acid sequences must be filed in the correct WIPO standard. For applications filed on or after 1 July 2022 the mandatory required format is WIPO ST.26 (XML); older filings remain in ST.25. Failure to comply can delay or complicate national phase entries. 

Biological deposits (Budapest Treaty / Rule 31 EPC): when an invention requires a biological material not publicly available and cannot be sufficiently described, a deposit at a recognised depository is mandatory for enabling disclosure. Rule 31 EPC implements the Budapest Treaty and sets out timing and documentation duties (e.g. accession number, depositor authorisation if depositor differs from applicant). We recommend making the deposit as early as practicable. Although Rule 31 allows certain limited formalities to be completed within narrow time windows, the safe practice is to obtain a Budapest accession and record the accession number before publication or major national deadlines to avoid Art. 83 objections. Applicants must ensure deposit receipts and authorisations are in order — otherwise Art. 83 EPC objections (insufficiency) are likely. 

Publication / confidentiality: early public disclosures (conference abstracts, preprints) or intervening scientific publications may destroy novelty, according to Europe/Italy patent law. Priority-date preservation is crucial. In Europe (including Italy) an Applicant generally cannot rely on a broad inventor's grace period (unlike the US one-year grace in many cases). The safest and clearest rule of thumb is: no public disclosure before filing, also applying in the case of several follow-on applications within the 12-months priority period (Paris Convention and Art. 87 EPC). Priority only protects subject-matter “directly and unambiguously” disclosed in the earlier filing. If a later claim covers matter not disclosed in the first filing, that part of the claim will not enjoy the earlier priority date. For complex claims covering multiple variants (common in biotech/pharma), priority can be partial: only the parts of the claim disclosed in the priority document get the early date; the remainder is assessed from the later filing date and may be anticipated by intervening disclosures.

Change in the inventorship/ownership patent law in Italy when universities/research institutions are involved

Determine and document inventorship and ownership before filing is crucial, not only in the pharma and biotech sectors, but  these sectors are relevant because often inventions and discoveries are generated in universities and public research institutions. In this respect, a major change in Italian law recently occurred (Law No. 102/2023, amending the Industrial Property Code), reversing the historical “professor's privilege.” Ownership now vests in the research structure (university/public research body/IRCCS) when the invention is made in the execution of a contract or employment relationship with that structure. The reform also requires contractual rules for research financed by third parties (Art. 65(5)) and encourages the establishment of Technology Transfer Offices (Art. 65-bis). Practically, this increases the need for clear invention-disclosure procedures, timely notifications to employers, and explicit funding and foreground allocation clauses in research contracts.

Patentability: exclusions, diagnostics and second medical uses

EPC exclusions (Article 53(c) EPC): methods for treatment by surgery or therapy and diagnostic methods practised on the human or animal body are excluded. The EPO applies these exclusions narrowly. In therapeutics, substances used for therapeutic purpose(s) can be covered (including purpose-limited product claims). In diagnostic (decision of the Enlarged Board in G 1/04), only steps actually practised on the body fall within the exclusion; therefore, many diagnostic inventions survive if drafted as in-vitro methods, kits, detection devices, or claims emphasising technical features beyond mere correlations. The EPO excludes patentability of diagnostic methods practised on the human or animal body only when the technical steps that are essential to make the diagnosis are actually performed on the body; purely intellectual steps (the doctor's “diagnostic decision”) are non-technical. When drafting diagnostic claims, explicitly identify which steps are technical and whether they occur on-body (excluded) or off-body/in-vitro or are implemented by a device or computer (normally not excluded).

Biomarkers & diagnostics — Europe vs US: European practice more frequently allows claims to practical applications of biomarkers (diagnostic methods, kits, personalised-medicine claims) so long as the claim contains technical character and does not fall squarely within Art. 53(c)’s exclusion. By contrast, the US Supreme Court's decision in Mayo v. Prometheus (2012) restricted patentability of claims that merely apply natural correlations (laws of nature) without an inventive technical concept — a difference that needs to be accounted for in global claim drafting and portfolio planning. 

Second medical use claims: Europe recognises second (or further) medical use claims (e.g. “use of compound X for the treatment of disease Y”). This arises when a known substance or composition is found to be suitable for treating a disease or condition that was not disclosed in the prior art. The EPO's legal gateway for protecting such discoveries is the purpose-limited product claim under the EPC — Article 54(5) EPC — which permits a product (substance or composition) to be patented for a specific medical use even if the product per se is already known. 

The Enlarged Board confirmed in G 2/08 that not only new indications, but also novel dosage regimens, new routes of administration, or treatments of a novel patient subgroup can qualify as a patentable second/further medical use — provided the other requirements (novelty, inventive step, sufficiency) are met.

In this context it is important that at filing the Applicant includes at least some experimental evidence, mechanistic rationale, or a credible rationale/roadmap making the new use plausible — otherwise the EPO will be skeptical, and post-filed data cannot create plausibility that was absent at filing; they are admissible only to corroborate an effect already credibly disclosed (G 2/21). Recent Boards of Appeal decisions applying G 2/21 have rejected reliance on later data where the original application was silent or merely speculative.

Ideally a set of claims directed to a second (further) medical use should include narrow claims (specific compound forms, exemplified doses), intermediate claims (patient subgroup, defined biomarker-based selection), and broader purpose-limited product claims. This layering may help survive both novelty/enablement scrutiny and later enforcement.

There is also an interaction between SPCs and second medical uses. SPCs can extend effective exclusivity for medicinal products to compensate for regulatory delays. However, SPC entitlement is tightly linked to the “product” and the first MA; the rules for whether an SPC can be obtained for a new indication or for a later MA are complex and have been the subject of CJEU case law. In practice Applicants should plan SPC strategy together with patent strategy and regulatory filings; national offices implement SPCs under EU rules and local procedure. Do not assume that a second medical-use patent automatically yields a new SPC: check the timing/MA link and case law before relying on SPC extension.

Evidence & enablement: when is experimental data “enough”?

The EPO and national offices require that the patent application enable the skilled person to carry out the invention across the full scope claimed. (Art. 83 EPC and similar national provisions). Enablement is a similar concept in the US patent law.

Enablement and experimental data – Europe vs US: The US Supreme Court's decision in Amgen Inc. v. Sanofi (2023) concerned enablement of very broad functional genus claims to monoclonal antibodies. While it is not primarily a biomarkers/diagnostics case, it has important consequences for biotech broadly — including when applicants claim broadly by function (which can apply to antibodies, enzyme inhibitors, even broadly-defined diagnostic markers) because the Court required the specification to enable the full scope claimed.

EPO's Board of Appeal G 2/21 decided that post-filed evidence is admissible in principle – and could be used for instance to bolster inventive step – but only to the extent it “fits” the teaching that was already plausibly present in the application as filed. This decision also reiterates the limits for sufficiency (Art. 83 EPC): plausibility must exist at filing.

In this context, EPO's Board of Appeal decision G 1/24 is also be relevant, since it stipulates that the claims are the starting point for patentability assessment, but the description and drawings must always be consulted to interpret the claims (not only when the claim language is ambiguous).

Enablement is fact-sensitive. In biotech the above typically means providing representative experimental and comparative data, protocols, and characterization data. Where claims are broad (e.g. functional claims to antibodies or to a class of molecules), applicants must either narrow claims or include robust cross-reactivity/representative examples and reliable general methods for generating the claimed species. The basic question courts and examiners will make is: “What does the application really show?” — and will construe claims against the real experimental support. To answer this, an example package that often makes an effect plausible at filing would include for instance a short in-vitro assay + one in-vivo model + mechanistic rationale + at least one example protocol. In this regard, decision G 2/21 is crucial.

This may translate into a conservative “step-by-step filing” practice: get an early priority for the first set of experiments, then file follow-up patent applications (within the 12-months priority period) as evidence accumulates — but manage the portfolio complexity this creates could be critical, along with keeping an eye on cost tradeoff (filing many priorities increases fees, annuities, complexity). Complexity may even increase when filing divisional(s).

Portfolio & prosecution tactics 

Filing early for priority on the most defensible embodiment you have might be a sensible approach; avoid public disclosure prior to filing.

Consider filing pros and cons of divisional(s)²:

Use biological deposits and correct sequence listings for anything that cannot be enabled by description alone (Rule 31 EPC; ST.26). 

Draft layered claim sets upfront: (i) progressively narrowing and well-supported claims; (ii) fallback functional claims carefully limited to representative species or to defined technical features; (iii) use claims to compositions, formulations, kits, and methods of manufacture where appropriate.

Think globally: adapt claim scope to jurisdictional realities (US subject-matter law; India's public-interest safeguards). Consider early freedom-to-operate analysis and territorial coverage decisions.

UPC litigation — a changing landscape for pharma and biotech

Milan, Italy, is a key venue for pharmaceutical patent litigation within the UPC framework. The Milan UPC Central Division covers mainly revocation action brought against European patents with unitary effect classified under IPC Section A (human necessities), a broad grouping that includes pharmaceuticals, agriculture, food, and consumer goods technologies. Cases involving Supplementary Protection Certificates (SPCs) are excluded from Milan's jurisdiction and are instead allocated to the Paris Central Division, which specialises in SPC matters.

Milan also hosts a relevant UPC Local Division, which deals mainly with infringement-related actions.

So far, the pharmaceutical and biotech sectors have been cautious in engaging with the Unified Patent Court (UPC) since its launch in June 2023, especially in complex SPC matters. 

In particular, revocation actions against pharmaceutical patents have been a recurring early use of the new forum showing how attractive the UPC can be for rapid validity disputes - Astellas challenged patents held by Healios and Osaka University, Sanofi attacked Amgen's Praluent patent, and Pfizer targeted a GSK RSV-vaccine patent.

One of the latest development is a revocation action brought before the Milan UPC Central Division by Gilead against the recently granted European patent EP 3 854 403 owned by the Chinese Academy of Military Medical Sciences based in Beijing, covering the use of compounds for treating SARS-CoV-2 infections. The grant was given unitary effect. The claimed use is a potential threat to sales of remdesivir — Gilead's broad-spectrum antiviral now primarily used for COVID-19. Notably, Gilead responded decisively and on two fronts to the potential threat . First it filed an EPO opposition against the patent and second, it brought the revocation action before the UPC Central division in Milan. This parallel approach is tactical: the UPC's tightly managed timetable (approximately 12 months to reach a final decision, can vary by case and procedural steps) can deliver a substantive decision far faster than the typically slower Opposition Division process at the EPO. Gilead could receive a decision on the patent's validity from the UPC as early as next summer Indeed. In light of the UPC action the EPO has moved to accelerate the opposition procedure.

By contrast pharma companies initially showed restraint in bringing infringement suits at the UPC — understandably cautious given the risks of central revocation and doctrinal uncertainty.

Recent developments, however, indicate a shift. In July 2025, Merz Group secured the UPC's first-ever SPC-based preliminary injunction in the Paris Local Division, enforcing their SPC for the multiple sclerosis drug fampridine (Fampyra) derived from EP 2 377 536 B1, against Viatris. 

Concurrently, GlaxoSmithKline launched several infringement suits over mRNA patents against Moderna, Pfizer, and BioNTech—further evidence of growing UPC adoption in highly strategic areas.

The UPC court itself has worked to be a credible forum for pharma litigation: the UPC Court of Appeal recently reversed a local-division denial and granted Boehringer a preliminary injunction against Zentiva (after Lisbon's earlier refusal), demonstrating that courts will entertain significant interim relief when the legal and factual thresholds are met.

Notably, the Milan UPC Local Division recently saw also Insulet v. EOFlow, a high-profile preliminary injunction case based on EP 4 201 327 B1, covering insulin patch pumps. Initially, both the Milan Local Division declined Insulet's PI requests — citing prima facie doubts over validity and the inadmissibility of auxiliary claim amendments in provisional proceedings — but the UPC Court of Appeal intervened. It held that claim construction is a matter for the court — not expert witnesses — and reversed the lower courts, granting a pan-European injunction and obliging EOFlow to cease sales across all UPC territories (except Romania). This was a watershed moment: a pharma-related device dispute in Milan resulting in UPC PI enforcement.

These cases together suggest that pharmaceutical manufacturers are gradually gaining confidence in the UPC as a viable, powerful forum for pan-European patent enforcement — especially when patents, SPCs, and complex product markets intersect. It could well signal a structural shift in litigation strategy across Europe.

Global considerations & public-health exceptions

Some jurisdictions (notably India) have used compulsory-licence mechanisms and strict patentability standards to address access and pricing concerns (Natco/Bayer is the landmark compulsory licence example). Global patent strategy should therefore incorporate market-by-market legal and policy risk assessments.

AI, digital health and future directions

AI is rapidly reshaping drug discovery and diagnostics. An example is the identification of halicin, a novel antibiotic discovered in 2019 by researchers at MIT using a deep-learning model. The AI screened a digital library of compounds in silico and pinpointed halicin — structurally distinct from existing antibiotics — which was then shown to be effective in vitro and in mouse infection models against a variety of drug-resistant pathogens. More recently, rentosertib (also known as ISM001-055), an inhibitor targeting TNIK for treatment of idiopathic pulmonary fibrosis, became the first fully AI-designed small-molecule drug to enter mid-stage clinical trials — having progressed from target discovery to Phase 2a in under 30 months. These cases highlight how AI-based platforms are transforming both breadth (antibiotics) and precision (novel fibrosis therapies) of contemporary drug discovery. Needless to say, AI-discovered compounds still require robust experimental support to survive patent scrutiny. Ideally, the patent specification should include document training data, model parameters, selection criteria, and experimental validation in the specification to meet plausibility/enablement tests.

Thus, AI in drug discovery and diagnostics is already reshaping which inventions are possible and how broad claims can be justified. 

The EPO and EU are actively grappling with AI's implications for patentability (technical effect, inventiveness, authorship/ownership questions) while the European regulation on artificial intelligence (AI) – EU AI Act – is the first comprehensive regulation on AI by a major regulator anywhere and introduces a new regulatory layer for medical AI systems. Companies should therefore combine IP, regulatory and data governance strategies when protecting AI-assisted life-science inventions. A special mention of DABUS³ case is also noted: up to now courts disagree about AI as inventor — for now, attribute inventorship to human(s).

Practical checklist for a pharma or biotech applicant

• Stop all public disclosure before filing; prepare a prioritized filing plan.

Determine and document inventorship & ownership (university/employer agreements) before filing. 

• File early on a defensible embodiment and, if needed, plan follow-on filings if more data are expected within 12 months from earliest filing date (priority period). Consider filing divisional(s).

• If the invention requires biological material, deposit it with a Budapest Treaty-recognised depository and file the accession details per Rule 31 EPC. 

• If the invention covers nucleotide and amino-acid sequences prepare WIPO ST.26-compliant sequence listings for new filings after 1 July 2022. 

• Consider SPC planning near the time of marketing authorisation; coordinate patent and regulatory teams. 

• Adopt an AI diligence plan if your project uses ML/AI tools (data provenance, reproducibility, algorithm transparency) given the regulatory overlay.

Conclusion

In an era when a single molecular or algorithmic insight can create multi-billion euro value, patents remain the strategic tool that converts scientific promise into patient benefit and commercial reality.

The next future will be defined by cross-disciplinary teams that pair wet-lab rigor with computational creativity and by legal strategies that treat patents as one element in a wider ecosystem of exclusivities and market access. 

Practitioners who build robust, plausibility-anchored specifications - providing forensic-quality disclosure at filing and claim drafting aligning with evolving EPO and national case law - that coordinate globally, and engage proactively with institutional partners and regulators will not only survive the shifting legal landscape  - they will shape it.

[1] GLP news: The new Italian Industrial Property Code: the main changes introduced, 2 August 2023

[2] Divisionals: a strategic and powerful tool for improving and safeguarding your patent rights, GLP

[3] AI and Patents——Innovative Turn or Risk to Innovation?, GLP