{"id":39593,"date":"2026-09-30T10:17:00","date_gmt":"2026-09-30T14:17:00","guid":{"rendered":"https:\/\/www.drugpatentwatch.com\/blog\/?p=39593"},"modified":"2026-09-18T09:02:20","modified_gmt":"2026-09-18T13:02:20","slug":"why-a-drug-off-patent-in-europe-can-still-be-protected-for-three-more-years-in-the-us","status":"publish","type":"post","link":"https:\/\/www.drugpatentwatch.com\/blog\/why-a-drug-off-patent-in-europe-can-still-be-protected-for-three-more-years-in-the-us\/","title":{"rendered":"Why a Drug Off-Patent in Europe Can Still Be Protected for Three More Years in the US"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/www.drugpatentwatch.com\/blog\/wp-content\/uploads\/2026\/09\/image-5-1024x683.png\" alt=\"\" class=\"wp-image-39596\" srcset=\"https:\/\/www.drugpatentwatch.com\/blog\/wp-content\/uploads\/2026\/09\/image-5-1024x683.png 1024w, https:\/\/www.drugpatentwatch.com\/blog\/wp-content\/uploads\/2026\/09\/image-5-300x200.png 300w, https:\/\/www.drugpatentwatch.com\/blog\/wp-content\/uploads\/2026\/09\/image-5-768x512.png 768w, https:\/\/www.drugpatentwatch.com\/blog\/wp-content\/uploads\/2026\/09\/image-5.png 1536w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">On October 16, 2018, adalimumab biosimilars went on sale across Germany, France and the rest of the European Union. On January 31, 2023, the first of those same biosimilars, Amgen&#8217;s Amjevita, finally went on sale in the United States [1][2]. Same molecule, same company, same original research program. A gap of 1,933 days, or five years and change, between the two launch dates.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">That gap is not a fluke of one drug or one company. It is the predictable output of two patent systems, the US Patent Term Extension regime and the EU Supplementary Protection Certificate regime, that compensate for regulatory delay in structurally different ways, layered on top of a US-only mechanism (Patent Term Adjustment) that Europe has no direct equivalent for, and compounded by a European Patent Office that grants secondary patents on dosing, formulation and manufacturing far less readily than the USPTO does. This article walks through the mechanics, quantifies them against peer-reviewed data, and works through three real biosimilar case studies, adalimumab (Humira), etanercept (Enbrel) and trastuzumab (Herceptin), that sit at three different points on the resulting spectrum of gaps.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">The Short Answer<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A drug&#8217;s US patent estate frequently outlives its EU patent estate because the two regions restore lost patent time through different formulas, because the US alone adjusts base patent term for patent-office delay, and because the EPO&#8217;s inventive-step standard rejects far more of the follow-on dosing, formulation and manufacturing patents that a US applicant can still obtain. Individually, each mechanism might add months. Stacked together on a single blockbuster, as happened with Humira and Enbrel, they can add years, and in Enbrel&#8217;s case, they have so far kept every FDA-approved biosimilar off the US market entirely [3][4].<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">The Five Findings That Matter<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The US Biologics Price Competition and Innovation Act gives reference biologics 12 years of regulatory exclusivity; the EU&#8217;s general &#8220;8+2(+1)&#8221; rule gives biologics 10 to 11 years, a statutory floor gap of one to two years before any patent litigation begins [5][6][7].<\/li>\n\n\n\n<li>Patent Term Extension under 35 U.S.C. \u00a7 156 added a median of 2.75 years of exclusivity to the 83 of 170 top-selling US drugs that qualified for it among drugs that faced generic entry between 2000 and 2012, versus a median total exclusivity of 10.0 years for the 87 drugs that did not qualify [1].<\/li>\n\n\n\n<li>Adalimumab (Humira) biosimilars entered the EU market on October 16, 2018, following expiration of the SPC and its six-month pediatric extension, and did not enter the US market until January 31, 2023 at the earliest, under a set of company-specific patent settlements, a five-year gap [2][8].<\/li>\n\n\n\n<li>Etanercept (Enbrel) biosimilars have been sold in the EU since January 2016; two FDA-approved US biosimilars, Erelzi and Eticovo, remain blocked from the US market until 2029 by two later-filed US patents that were never mirrored in Europe [3][4][9].<\/li>\n\n\n\n<li>A peer-reviewed patent-count analysis found nine to twelve times more patents asserted against the same biosimilar molecules in US litigation than in equivalent UK or Canadian litigation [8].<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Two Different Machines: How the US and EU Compensate for Lost Patent Time<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A patent&#8217;s basic term is 20 years from its earliest priority filing date almost everywhere, including the US and the EU [10]. The clock starts before a single patient has been dosed, so years of clinical trials and regulatory review eat into that term before the drug ever generates revenue. Both regions correct for this, but they built two different machines to do it.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Patent Term Extension Under 35 U.S.C. \u00a7 156<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The Hatch-Waxman Act of 1984 created US Patent Term Extension (PTE): a patent owner can add back time lost to FDA testing and review, capped at 5 years of additional term and capped again so the patent cannot run past 14 years from the date of FDA approval [11]. Only one patent per approved product can receive PTE, and the extension is calculated from the specific regulatory review period for that product, not a fixed formula [1][11].<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">The Supplementary Protection Certificate Under EU Regulation 469\/2009<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The EU took a different structural approach in 1992, later consolidated into Regulation (EC) No 469\/2009: rather than extending the patent itself, national patent offices grant a separate, sui generis right called a Supplementary Protection Certificate (SPC) that takes effect only after the underlying patent expires [12][13]. SPC duration equals the time between the patent&#8217;s filing date and the first EU marketing authorization, minus five years, capped at five years, with a further six-month extension available for a completed pediatric investigation plan [13][14]. The policy target is a total of roughly 15 years of exclusivity from first EU marketing authorization [15].<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Patent Term Adjustment: The Layer Europe Doesn&#8217;t Have<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A separate US mechanism, Patent Term Adjustment (PTA) under 35 U.S.C. \u00a7 154(b), adds days directly onto the base 20-year patent term itself, not after FDA approval, to compensate for the USPTO&#8217;s own prosecution delays: missed office-action deadlines, delayed patent issuance, and similar administrative lag [16][17]. The European Patent Office has no equivalent right. As one patent-prosecution guide for US practitioners entering Europe puts it, calculating a European patent&#8217;s expiration looks simple by comparison precisely because &#8220;there is no PTA and no TD&#8221; (terminal disclaimer practice) built into the EPC framework [10]. A US patent application that spends years in prosecution can pick up real term through PTA; the same family&#8217;s European counterpart cannot.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th>Mechanism<\/th><th>Jurisdiction<\/th><th>What it compensates for<\/th><th>Statutory cap<\/th><th>Source<\/th><\/tr><tr><td>Patent Term Extension (PTE)<\/td><td>United States<\/td><td>FDA regulatory review period<\/td><td>5 years; patent cannot exceed 14 years post-approval<\/td><td>35 U.S.C. \u00a7 156 [11]<\/td><\/tr><tr><td>Patent Term Adjustment (PTA)<\/td><td>United States<\/td><td>USPTO prosecution delay<\/td><td>No fixed cap; runs from delay actually incurred<\/td><td>35 U.S.C. \u00a7 154(b) [16]<\/td><\/tr><tr><td>Supplementary Protection Certificate (SPC)<\/td><td>European Union<\/td><td>EU regulatory review period<\/td><td>5 years, plus 6 months pediatric<\/td><td>Regulation (EC) No 469\/2009 [13]<\/td><\/tr><tr><td>No EU equivalent<\/td><td>European Union<\/td><td>EPO prosecution delay<\/td><td>Not available<\/td><td>[10]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Why Biologics Diverge Even Further: BPCIA&#8217;s Twelve Years vs the EU&#8217;s &#8220;8+2(+1)&#8221;<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Patent term is only half the story for biologics. Both regions also grant a separate, patent-independent period of regulatory data and market exclusivity, and here the US and EU numbers are not close.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">The US Small-Molecule Baseline and the Biologics Carve-Out<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Small-molecule drugs in the US typically get 5 years of New Chemical Entity exclusivity (7 years for an orphan indication) [7]. Biologics are different. The Biologics Price Competition and Innovation Act of 2010 (BPCIA) gives a reference biologic 12 years of market exclusivity from first FDA licensure, split into an initial 4-year period during which the FDA cannot even accept a biosimilar application, followed by 8 more years before the FDA can approve one [5][18]. The FDA itself describes this as a 12-year window built specifically &#8220;to encourage innovation&#8221; in biologics [5].<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">What a One-Year Statutory Gap Becomes in Practice<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The EU has no separate biologics statute analogous to the BPCIA. Biosimilars are instead folded into the same general &#8220;8+2(+1)&#8221; data and market exclusivity rule that applies to small molecules under EU pharmaceutical law: 8 years of data exclusivity, plus 2 years of market exclusivity, plus a conditional extra year if the originator obtains authorization for a new therapeutic indication within that window, for a maximum of 11 years [6][19]. Commentators comparing the two systems have called the US framework, at 12 years, the longest biologics exclusivity period in the developed world [6]. On paper the difference is one to two years. In practice, once patent litigation and settlement dynamics are added on top of the statutory floor, the realized gap has been far larger for several major biologics, which is the subject of the case studies below.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\">&#8220;Examining 170 top-selling drugs with a first generic equivalent approved between 2000 and 2012, we found that 49% (83 drugs) received a PTR extension (median extension: 2.75 years) yielding a median total exclusivity period of 13.75 years, compared with 10.0 years for the 87 nonextended drugs.&#8221; \u2014 Beall, Darrow &amp; Kesselheim, <em>Drug Discovery Today<\/em>, 2019 [1]<\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\">The Real Multiplier: Patent Thickets and the EPO&#8217;s Stricter Bar<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Statutory exclusivity differences of one or two years do not, by themselves, explain a five-year gap like Humira&#8217;s or an indefinite one like Enbrel&#8217;s. The bigger multiplier is what happens to secondary patents, the follow-on filings on formulation, dosing schedule, manufacturing process and delivery device that get filed years after the original composition-of-matter patent.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Why the Same Molecule Collects More US Patents Than European Ones<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A patent-landscape report on Enbrel found that Amgen held 57 US patents on the product, versus 20 in Europe and 18 in Japan, and that 72% of Amgen&#8217;s total patent applications on Enbrel were filed after the drug had already received FDA approval [9]. A separate, peer-reviewed comparison of biosimilar litigation across three countries found that nine to twelve times more patents were asserted against the same biosimilar molecules in US litigation than in equivalent UK or Canadian cases, and that roughly 80% of the patents in AbbVie&#8217;s US Humira portfolio were not patentably distinct from one another, meaning they covered overlapping ground linked together through terminal disclaimers, a linking practice permitted under USPTO rules [8].<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Inventive Step at the EPO vs Non-Obviousness at the USPTO<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The two patent offices apply a genuinely different bar to these later filings. The EPO&#8217;s inventive-step examination under Article 56 of the European Patent Convention follows a structured &#8220;problem-solution approach,&#8221; and a formulation or dosage patent that cannot show an unexpected technical effect over the prior art typically fails it [10][20]. A 2025 comparative white paper from the Public Interest Patent Law Institute, a patient-access advocacy nonprofit, reviewed eligibility, inventive step and disclosure standards side by side and concluded that the USPTO consistently applies looser, more permissive standards than the EPO for pharmaceutical, biologic and medical-method patents [20]. Brand manufacturers and their counsel would frame the same underlying difference differently, as the EPO simply setting a higher formal bar for genuine technical contributions rather than the USPTO being &#8220;loose,&#8221; but the practical outcome for patent counts is not in serious dispute: a molecule that ends up with a hundred-plus US patents commonly ends up with a fraction of that number in Europe. Tracking which of those patents are active, which have been invalidated, and which apply only to one jurisdiction is precisely the kind of side-by-side comparison that a tool like DrugPatentWatch&#8217;s expiration and jurisdiction database is built to surface, since a US-only secondary patent has no bearing on European launch timing at all.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Three Case Studies, Three Kinds of Gap<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Not every transatlantic gap looks the same. Three biosimilar histories illustrate three distinct mechanisms for how the gap actually gets created: a negotiated gap, a litigated gap with no fixed end date, and a short settlement-driven gap.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">The Negotiated Gap<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">A patent holder and a wave of biosimilar challengers settle on a single, company-specific date, well before every patent in the thicket would otherwise expire, in exchange for royalty payments. Adalimumab (Humira) is the clearest example.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">The Litigated Gap With No Fixed End Date<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Courts uphold a small number of later-filed patents against every challenger, and no settlement date gets negotiated at all, so the gap simply runs until those patents expire on their own schedule. Etanercept (Enbrel) is the clearest example.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">The Short Settlement Gap<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">A single patent dispute resolves relatively quickly, producing a gap measured in months rather than years. Trastuzumab (Herceptin) is the clearest example.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Humira (Adalimumab): The Negotiated Five-Year Gap<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Humira&#8217;s core European product patent, extended by an SPC and a further six-month pediatric extension, expired across most EU member states on October 16, 2018, fifteen years after the drug&#8217;s initial EU marketing authorization, and biosimilars launched immediately [21]. In the US, AbbVie faced more than 60 asserted patents in litigation with Boehringer Ingelheim alone [22]. Between 2017 and 2019, AbbVie settled with at least nine biosimilar manufacturers, including Amgen, Samsung Bioepis, Sandoz, Mylan, Boehringer Ingelheim and Pfizer, on a consistent template: each company could enter the EU market from October 2018, but had to stay out of the US market until a company-specific date between January 31 and November 20, 2023, in exchange for a royalty-bearing license [21][22]. A resulting antitrust suit, <em>In re Humira (Adalimumab) Antitrust Litigation<\/em>, was dismissed by Judge Manish Shah of the Northern District of Illinois in June 2020 on Noerr-Pennington grounds, and the Seventh Circuit affirmed the dismissal in 2022 [23]. The negotiated gap, in other words, was found lawful, not merely unchallenged.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Enbrel (Etanercept): The Litigated Gap With No End Date Yet<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Enbrel&#8217;s European patent protection, including its SPC, expired in August 2015, and the first EU etanercept biosimilar, Benepali, launched in January 2016 [4][24]. In the US, Amgen (which had acquired the Enbrel patent estate originally developed with Hoffmann-La Roche and Immunex) was granted two later US patents not mirrored in Europe: US Patent 8,063,182, covering the etanercept fusion protein itself and expiring November 22, 2028, and US Patent 8,163,522, covering a manufacturing process and expiring April 24, 2029 [25]. Sandoz&#8217;s biosimilar Erelzi received FDA approval in August 2016 and Samsung Bioepis&#8217;s Eticovo received FDA approval in April 2019, but the US District Court for the District of New Jersey ruled that both would infringe those two patents if launched before 2029, the Federal Circuit affirmed, and the US Supreme Court declined to hear Sandoz&#8217;s appeal in May 2021 [3][25][26]. As of this writing, neither product has ever been sold in the United States, more than nine years after the reference product&#8217;s EU-side patent protection ended.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Herceptin (Trastuzumab): The Short Settlement Gap<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The first EU trastuzumab biosimilar, Samsung Bioepis&#8217;s Ontruzant, launched in the United Kingdom on March 8, 2018 [27]. In the US, the FDA had already approved Mylan and Biocon&#8217;s Ogivri as the first trastuzumab biosimilar in December 2017, but Ogivri did not commercially launch until December 2, 2019, following a separate patent settlement with Genentech\/Roche [28][29]. The resulting gap between first EU launch and first US launch runs to roughly 21 months, an order of magnitude smaller than Humira&#8217;s and far smaller than Enbrel&#8217;s still-open gap.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th>Drug<\/th><th>First EU biosimilar launch<\/th><th>First US biosimilar launch<\/th><th>Gap<\/th><th>Mechanism<\/th><\/tr><tr><td>Trastuzumab (Herceptin)<\/td><td>March 8, 2018 (UK)<\/td><td>December 2, 2019<\/td><td>~21 months<\/td><td>Single settled patent dispute<\/td><\/tr><tr><td>Adalimumab (Humira)<\/td><td>October 16, 2018<\/td><td>January 31, 2023 (earliest)<\/td><td>~5 years<\/td><td>Negotiated settlements across a 100+ patent portfolio<\/td><\/tr><tr><td>Etanercept (Enbrel)<\/td><td>January 2016<\/td><td>Not yet launched; blocked to 2029<\/td><td>9+ years and still running<\/td><td>Litigated infringement rulings on two late-filed patents<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">The Automatic-Stay Problem: Why US and EU Litigation Timelines Diverge<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">The Hatch-Waxman 30-Month Stay<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">When a generic or biosimilar applicant in the US files a Paragraph IV certification asserting that a listed patent is invalid or not infringed, the patent holder can sue and automatically trigger a stay of FDA approval of up to 30 months, regardless of the underlying merits of the patent [11]. That stay is a US-specific procedural feature tied to the Orange Book and Purple Book listing systems.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Europe&#8217;s Absence of an Equivalent Automatic Stay<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The EU has no directly equivalent automatic-stay mechanism triggered by a patent challenge; EMA marketing authorization and national patent enforcement operate on separate tracks, which is part of why European biosimilar litigation, even when it occurs, has generally not held products off the market for as long as US litigation has [4][8]. This is a structural, not incidental, contributor to why the same legal dispute plays out on a different clock in each region.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What This Means for Generic and Biosimilar Entrants<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A challenger evaluating a target molecule cannot treat European loss-of-exclusivity as a leading indicator for the US, or vice versa. The three case studies above sit on three different points of a spectrum, from a 21-month gap to an indefinite one, and the size of that gap correlates less with the statutory exclusivity floor than with how many secondary patents the originator built around the molecule specifically in the US, and whether those patents survived early litigation. Screening a target&#8217;s US patent estate against its EU one, patent by patent, before committing development spend is the practical takeaway.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What This Means for Brand Manufacturers Planning a Global Launch Sequence<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The same asymmetry cuts the other way for originators. A global launch sequence built around a single &#8220;loss of exclusivity&#8221; date will systematically misprice the US opportunity, since US secondary-patent strategy is a distinct, filable lever that the EPO&#8217;s stricter inventive-step bar does not offer in Europe to nearly the same degree. Firms that treat the two regions as a single LOE event on a spreadsheet are the ones most likely to be surprised, in either direction, by how the actual timeline unfolds.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What This Means for Payers and Health Systems<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">An IQVIA analysis of the US biosimilar market noted that some biosimilars, such as Celltrion&#8217;s Yuflymo, launched within weeks of FDA approval, while others, including Amjevita, waited nearly seven years between approval and commercial launch [30]. For a health system budgeting around an anticipated biosimilar discount, the gap between &#8220;FDA approved&#8221; and &#8220;actually on sale&#8221; is the number that matters, and that gap is set by the settlement or litigation outcome described above, not by the approval date itself.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Methodology and Limitations<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Statutory exclusivity figures (PTE, SPC, PTA, BPCIA, EU &#8220;8+2(+1)&#8221;) are drawn from the governing US and EU statutes and regulations and from law-firm and government summaries of those provisions. Case-study dates are drawn from FDA approval records, EMA marketing authorization records, court opinions and contemporaneous trade-press reporting, cross-checked against at least two independent sources where available. The Beall, Darrow and Kesselheim median-extension figure applies specifically to US Patent Term Extension outcomes for 170 top-selling drugs with generic entry between 2000 and 2012 and should not be read as a EU-US comparison in itself; it is cited here as the best available quantification of how much time PTE alone typically adds, a mechanism Europe&#8217;s SPC system does not mirror one-for-one. The Enbrel and Humira patent-count figures come from named third-party analyses (a report cited by Center for Biosimilars, and the peer-reviewed Goode and Chao study) rather than DrugPatentWatch&#8217;s own patent counts, and are attributed accordingly. Forecasted or announced future events, including Enbrel&#8217;s 2028 to 2029 patent expiration dates, are identified as such and not treated as having already occurred.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Frequently Asked Questions<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Why does a drug patent expire at a different time in the US than in Europe?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The base 20-year term usually starts on the same priority filing date, but the US and EU restore lost regulatory-review time through different, non-equivalent mechanisms (PTE vs. SPC), and only the US has a separate patent-office delay mechanism (PTA). Secondary patents are also easier to obtain at the USPTO than at the EPO, so the same molecule often ends up with a larger, longer-lived patent estate in the US [1][10][20].<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Is the three-year gap the same for every drug?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">No. It is an order of magnitude, not a rule. PTE alone added a median of 2.75 years for the top sellers studied by Beall, Darrow and Kesselheim [1]. Real biosimilar gaps have ranged from about 21 months (trastuzumab) to 5 years (adalimumab) to an open-ended gap now running past nine years (etanercept) [3][8][27].<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Does the EU ever protect a drug longer than the US does?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">It can, particularly when a compound&#8217;s EU marketing authorization arrived long after its patent filing date, which produces a larger SPC calculation, or when a company simply pursued a more aggressive secondary-patent strategy in Europe than in the US for that specific product. The pattern described in this article, US protection outlasting EU protection, is the more commonly documented one for major biologics, but it is not universal.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">What is a Paragraph IV challenge, and does Europe have an equivalent?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A Paragraph IV certification is a US generic or biosimilar applicant&#8217;s assertion that a patent listed against the reference product is invalid or not infringed; filing one can trigger a 30-month automatic stay of FDA approval under Hatch-Waxman [11]. The EU has no directly equivalent automatic-stay mechanism tied to a patent challenge [4][8].<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Why did Enbrel biosimilars get FDA approval years before they could actually be sold?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">FDA approval only confirms that a biosimilar is safe, effective and biosimilar to the reference product; it does not clear the product of patent infringement liability. Erelzi and Eticovo were both FDA-approved years before 2029, but a federal court found that selling either product before 2029 would infringe two Amgen patents that were never mirrored in Europe [3][25][26].<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">How many patents can a single biologic have in the US versus Europe?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Enbrel had 57 US patents versus 20 European patents, according to a patent-landscape report cited by Center for Biosimilars [9]. Roughly 80% of AbbVie&#8217;s US Humira patents were found not to be patentably distinct from one another in a peer-reviewed analysis [8].<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Why was AbbVie&#8217;s Humira settlement strategy not found to be illegal?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A federal antitrust suit challenging the Humira settlements, <em>In re Humira (Adalimumab) Antitrust Litigation<\/em>, was dismissed in 2020 on Noerr-Pennington grounds, which protect good-faith litigation and settlement conduct from antitrust liability, and the Seventh Circuit affirmed that dismissal in 2022 [23].<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Does Patent Term Adjustment apply to every US pharmaceutical patent?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">No. PTA depends on the specific prosecution history of each application; it only accrues when the USPTO itself misses statutory deadlines, and applicant-caused delay is subtracted from any accrued PTA [16][17].<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Is the EU&#8217;s &#8220;8+2(+1)&#8221; rule different for biologics than for small molecules?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">No, and that is itself part of the divergence. The EU applies the same general data and market exclusivity framework to both, while the US created a separate, longer statute, the BPCIA, specifically for biologics, giving biologics 12 years of US exclusivity against a maximum of 11 years in the EU [5][6][7].<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Where can I check whether a specific drug&#8217;s US and EU patents actually expire on different dates?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Comparing a molecule&#8217;s FDA Orange Book or Purple Book listings against its EU SPC register entries, patent by patent, is the direct way to see this; aggregated tools such as DrugPatentWatch are built to make that side-by-side comparison faster than pulling each national register independently, though the underlying registers remain the primary source of record.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Key Takeaways<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>US and EU patent-term restoration mechanisms (PTE and SPC) are structurally different, and only the US has a patent-office prosecution-delay mechanism (PTA) with no EU equivalent.<\/li>\n\n\n\n<li>The BPCIA gives US biologics 12 years of regulatory exclusivity against a maximum of 11 years under the EU&#8217;s general &#8220;8+2(+1)&#8221; rule.<\/li>\n\n\n\n<li>PTE alone added a median of 2.75 years of exclusivity to the top-selling US drugs that qualified for it between 2000 and 2012.<\/li>\n\n\n\n<li>The EPO&#8217;s stricter inventive-step bar means the same molecule typically collects far fewer secondary patents in Europe than in the US, which is the largest single driver of the biggest transatlantic gaps.<\/li>\n\n\n\n<li>Real gaps documented for major biologics span a wide range: about 21 months for trastuzumab, about 5 years for adalimumab, and an open-ended gap past 9 years for etanercept.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">References<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Beall, R. F., Darrow, J. J., &amp; Kesselheim, A. S. (2019). Patent term restoration for top-selling drugs in the United States. <em>Drug Discovery Today, 24<\/em>(1), 20-25. https:\/\/doi.org\/10.1016\/j.drudis.2018.07.006<\/li>\n\n\n\n<li>Overview of Humira biosimilars: Current European landscape and future implications. (2021). <em>PubMed<\/em>. https:\/\/pubmed.ncbi.nlm.nih.gov\/33556387\/<\/li>\n\n\n\n<li>NJ court decision means 3 decades of product exclusivity for Enbrel. (2021, December). <em>Center for Biosimilars<\/em>. https:\/\/www.centerforbiosimilars.com\/view\/nj-court-decision-means-3-decades-of-product-exclusivity-for-enbrel<\/li>\n\n\n\n<li>Etanercept biosimilars delayed until 2029 in US. <em>GaBI Online<\/em>. https:\/\/www.gabionline.net\/biosimilars\/news\/etanercept-biosimilars-delayed-until-2029-in-us<\/li>\n\n\n\n<li>Commemorating the 15th anniversary of the Biologics Price Competition and Innovation Act. (2025, March 26). <em>U.S. Food and Drug Administration<\/em>. https:\/\/www.fda.gov\/drugs\/cder-conversations\/commemorating-15th-anniversary-biologics-price-competition-and-innovation-act<\/li>\n\n\n\n<li>USMCA compromise drops key biologics exclusivity provisions. <em>Avalere Health Advisory<\/em>. https:\/\/advisory.avalerehealth.com\/insights\/usmca-compromise-drops-key-biologics-exclusivity-provisions<\/li>\n\n\n\n<li>Exclusivity for biologic products under the USMCA: What is changing, and what happens next? <em>Center for Biosimilars<\/em>. https:\/\/www.centerforbiosimilars.com\/view\/exclusivity-for-biologic-products-under-the-usmca-what-is-changing-and-what-happens-next<\/li>\n\n\n\n<li>Goode, R., &amp; Chao, B. (2022). Biological patent thickets and delayed access to biosimilars, an American problem. <em>Journal of Law and the Biosciences, 9<\/em>(2), lsac022. https:\/\/doi.org\/10.1093\/jlb\/lsac022<\/li>\n\n\n\n<li>Amgen filed nearly 3 times more patents on Enbrel in US than EU or Japan, report finds. <em>Center for Biosimilars<\/em>. https:\/\/www.centerforbiosimilars.com\/view\/amgen-filed-nearly-3-times-more-patents-on-enbrel-in-us-than-eu-or-japan-report-finds<\/li>\n\n\n\n<li>Rocaboy, N. Patent term: How to calculate the expiration date of an EP patent? <em>Plasseraud IP<\/em>. https:\/\/www.plass.com\/en\/articles\/patent-term-how-calculate-expiration-date-ep-patent-obtaining-ep-patent-crash-course-us<\/li>\n\n\n\n<li>35 U.S.C. \u00a7 156, Patent Term Extension, Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act).<\/li>\n\n\n\n<li>Which countries offer the longest data exclusivity for biologics? <em>Synapse (PatSnap)<\/em>. https:\/\/synapse.patsnap.com\/article\/which-countries-offer-the-longest-data-exclusivity-for-biologics<\/li>\n\n\n\n<li>Regulation (EC) No 469\/2009 of the European Parliament and of the Council concerning the supplementary protection certificate for medicinal products. <em>European Commission<\/em>. https:\/\/single-market-economy.ec.europa.eu\/industry\/strategy\/intellectual-property\/patent-protection-eu\/supplementary-protection-certificates-pharmaceutical-and-plant-protection-products_en<\/li>\n\n\n\n<li>Supplementary Protection Certificate (SPC). <em>Franks &amp; Co<\/em>. https:\/\/www.franksco.com\/services\/patents\/supplementary-protection-certificate-spc\/<\/li>\n\n\n\n<li>Supplementary Protection Certificates &#8211; European Patent Term Extensions. <em>Lexology<\/em>. https:\/\/www.lexology.com\/library\/detail.aspx?g=5088728a-5b7d-44f9-860d-3dd40c0c2b82<\/li>\n\n\n\n<li>35 U.S.C. \u00a7 154(b), Patent Term Adjustment, American Inventors Protection Act of 1999.<\/li>\n\n\n\n<li>What is patent term adjustment and how does it protect your patent&#8217;s value? <em>Thompson Patent Law<\/em>. https:\/\/thompsonpatentlaw.com\/what-is-patent-term-adjustment\/<\/li>\n\n\n\n<li>BIOLOGICS, BIOSIMILARS, AND PATENTS. <em>I-MAK<\/em>. https:\/\/www.i-mak.org\/wp-content\/uploads\/2024\/05\/Biologics-Biosimilars-Guide_IMAK.pdf<\/li>\n\n\n\n<li>The Guide to Life Sciences: A comprehensive guide to supplementary protection certificates in Europe as regulation controversy heats up. (2026). <em>IAM Media<\/em>. https:\/\/www.iam-media.com\/guide\/global-life-sciences\/2026\/article\/comprehensive-guide-supplementary-protection-certificates-in-europe-regulation-controversy-heats<\/li>\n\n\n\n<li>Higher patent quality, lower drug prices: USPTO &amp; EPO report. (2025, May 26). <em>Public Interest Patent Law Institute<\/em>. https:\/\/www.piplius.org\/news\/higher-patent-quality-lower-drug-prices-why-the-uspto-needs-to-follow-europes-lead<\/li>\n\n\n\n<li>The expiry of Humira market exclusivity and the entry of adalimumab biosimilars in Europe: An overview of pricing and national policy measures. <em>PMC<\/em>. https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC7839249\/<\/li>\n\n\n\n<li>7th Circuit hears oral arguments in Humira &#8220;patent thicket&#8221; antitrust case. <em>JD Supra<\/em>. https:\/\/www.jdsupra.com\/legalnews\/7th-circuit-hears-oral-arguments-in-9057194<\/li>\n\n\n\n<li>From Humira to Keytruda: The blueprint for surviving the composition of matter cliff. <em>DrugPatentWatch<\/em>. https:\/\/www.drugpatentwatch.com\/blog\/from-humira-to-keytruda-the-blueprint-for-surviving-the-composition-of-matter-cliff\/<\/li>\n\n\n\n<li>Biosimilars of etanercept. <em>GaBI Online<\/em>. https:\/\/gabionline.net\/biosimilars\/general\/biosimilars-of-etanercept<\/li>\n\n\n\n<li>Enbrel biosimilars compared: FDA approvals, patent litigation, and the 2029 market entry. <em>PharmaDossier<\/em>. https:\/\/pharmadossier.com\/blog\/enbrel-biosimilars-compared<\/li>\n\n\n\n<li>Sandoz is 0-3 in Enbrel patent case. <em>Center for Biosimilars<\/em>. https:\/\/www.centerforbiosimilars.com\/view\/sandoz-is-0-3-in-enbrel-patent-case<\/li>\n\n\n\n<li>Celltrion&#8217;s trastuzumab biosimilar launches in Europe. <em>Center for Biosimilars<\/em>. https:\/\/www.centerforbiosimilars.com\/view\/celltrions-trastuzumab-biosimilar-launches-in-europe<\/li>\n\n\n\n<li>FDA approves third trastuzumab biosimilar, Ontruzant. <em>Center for Biosimilars<\/em>. https:\/\/www.centerforbiosimilars.com\/view\/fda-approves-third-trastuzumab-biosimilar-ontruzant<\/li>\n\n\n\n<li>Trastuzumab biosimilar Ogivri launches in United States. (2019, December 2). <em>OncLive<\/em>. https:\/\/www.onclive.com\/view\/trastuzumab-biosimilar-ogivri-launches-in-united-states<\/li>\n\n\n\n<li>Now trending: Biosimilars. (2023, July 12). <em>IQVIA<\/em>. https:\/\/www.iqvia.com\/locations\/united-states\/blogs\/2023\/07\/now-trending-biosimilars<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>On October 16, 2018, adalimumab biosimilars went on sale across Germany, France and the rest of the European Union. On [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":39596,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_lmt_disableupdate":"","_lmt_disable":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[10],"tags":[],"class_list":["post-39593","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-insights"],"modified_by":"DrugPatentWatch","_links":{"self":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/39593","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/comments?post=39593"}],"version-history":[{"count":1,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/39593\/revisions"}],"predecessor-version":[{"id":39757,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/39593\/revisions\/39757"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/media\/39596"}],"wp:attachment":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/media?parent=39593"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/categories?post=39593"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/tags?post=39593"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}