{"id":39540,"date":"2026-09-30T10:19:00","date_gmt":"2026-09-30T14:19:00","guid":{"rendered":"https:\/\/www.drugpatentwatch.com\/blog\/?p=39540"},"modified":"2026-09-18T09:02:17","modified_gmt":"2026-09-18T13:02:17","slug":"the-territoriality-trap-why-a-us-patent-win-means-nothing-where-the-molecule-was-never-filed","status":"publish","type":"post","link":"https:\/\/www.drugpatentwatch.com\/blog\/the-territoriality-trap-why-a-us-patent-win-means-nothing-where-the-molecule-was-never-filed\/","title":{"rendered":"The Territoriality Trap: Why a US Patent Win Means Nothing Where the Molecule Was Never Filed"},"content":{"rendered":"\n
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On October 2, 2023, the Patent Trial and Appeal Board refused to institute Mylan’s inter partes review of two Novo Nordisk semaglutide compound patents, U.S. Patent Nos. 8,536,122 and 8,129,343.[1]<\/sup> Novo Nordisk had won. The ‘343 patent’s protection now runs to 2031.[2]<\/sup> Two years later, on December 2, 2025, the Delhi High Court declined to stop Dr. Reddy’s Laboratories from manufacturing semaglutide in India and exporting it “to countries where it doesn’t have patent protection.”[3]<\/sup> On March 20, 2026, more than 40 Indian generic makers launched semaglutide domestically, undercutting Novo Nordisk’s Indian price by up to 80 percent.[4][5]<\/sup><\/p>\n\n\n\n

Same molecule. Same company. A clean litigation win in the United States. None of it mattered in India, because the patent question in India was never the same patent question.<\/p>\n\n\n\n

The Short Answer<\/strong><\/h2>\n\n\n\n

A patent is a national grant. It gives its owner the right to stop specific acts — making, using, selling, importing — inside the country that issued it, and nowhere else.[6]<\/sup> Winning a US infringement suit, surviving an IPR, or beating a Paragraph IV challenge changes nothing about whether the same molecule is protected in Brazil, India, Nigeria, or anywhere the company never filed, filed and lost, or was never required to file at all. This is not a loophole. It is how patent law has worked since the Paris Convention of 1883.[7]<\/sup><\/p>\n\n\n\n

What a US Patent Win Actually Buys You<\/strong><\/h2>\n\n\n\n

Patent rights come from Title 35 of the US Code, and US courts have been consistent for more than fifty years about where that title stops applying: at the border.<\/p>\n\n\n\n

Deepsouth, Microsoft, and WesternGeco: three rulings, one boundary<\/h3>\n\n\n\n

In Deepsouth Packing Co. v. Laitram Corp.<\/em> (1972), the Supreme Court held that the Patent Act does not reach conduct that happens entirely overseas.[8]<\/sup> In Microsoft Corp. v. AT&T Corp.<\/em>, 550 U.S. 437 (2007), the Court applied the “presumption against extraterritoriality” and held that patent law “operates only domestically and does not extend to foreign activities.”[9]<\/sup> In WesternGeco LLC v. ION Geophysical Corp.<\/em> (2018), the Court allowed damages for foreign lost profits in the narrow circumstance where infringing components were exported from the US under 35 U.S.C. \u00a7 271(f) — but it did so by finding a domestic act of infringement to compensate, not by extending US patent rights abroad.[10]<\/sup>[11]<\/sup> Three different outcomes, one constant premise: a US patent’s exclusionary power ends where US jurisdiction ends.<\/p>\n\n\n\n

What a Hatch-Waxman win or a survived IPR actually does<\/h3>\n\n\n\n

A Paragraph IV litigation win blocks a specific ANDA filer from selling a specific generic inside the United States on a specific date. A denied IPR institution — like Mylan’s semaglutide petition — leaves a specific US patent claim standing so it can keep blocking US competitors. Neither event touches the Controller General of Patents in Mumbai, the Delhi High Court, the European Patent Office’s Boards of Appeal, or the National Medical Products Administration in Beijing. Each of those bodies is applying its own country’s patentability law to its own country’s patent application, on its own timeline.<\/p>\n\n\n\n

Patents Are Territorial by Design, Not by Accident<\/strong><\/h2>\n\n\n\n

The Paris Convention’s independence-of-patents principle<\/h3>\n\n\n\n

The Paris Convention for the Protection of Industrial Property, signed in 1883 and administered today by the World Intellectual Property Organization, is the foundational treaty behind this system.[7]<\/sup> WIPO states the rule plainly: patents are territorial rights, and<\/p>\n\n\n\n

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“if a patent has not been granted, or recognized, in a given country, the invention will not be protected in that country.”<\/p>\n<\/blockquote>\n\n\n\n

[6]<\/sup> The Convention gives an applicant a 12-month priority window to file the same invention in other member countries and keep the original filing date — but it does not create a single, self-executing right that follows the molecule across borders.[7]<\/sup>[12]<\/sup><\/p>\n\n\n\n

The PCT: one application, still no world patent<\/h3>\n\n\n\n

The Patent Cooperation Treaty streamlines the paperwork of filing broadly — a single international application can eventually convert into national filings in up to 158 countries — but WIPO is explicit that the PCT itself “does not grant patents.”[12]<\/sup> The applicant still has to enter the “national phase” in each country individually, typically by 30 to 31 months from the earliest priority date, pay each country’s fees, and often supply local translations and a local attorney of record.[13]<\/sup> Skip that step in a given country, and the invention is unprotected there regardless of what happens in the countries where the applicant did follow through.<\/p>\n\n\n\n

TRIPS set a global floor, not a global patent<\/h3>\n\n\n\n

The WTO’s TRIPS Agreement required member countries to make patents available for pharmaceutical inventions, but it left examination, grant, and enforcement to each country’s own patent office and courts, operating under each country’s own patentability standard.[14]<\/sup> Two patent offices examining the same molecule under TRIPS-compliant law can legitimately reach different conclusions, because TRIPS harmonized the floor, not the outcome.<\/p>\n\n\n\n

Four Reasons a Molecule Ends Up Unprotected in a Market That Matters<\/strong><\/h2>\n\n\n\n

Pulling the case law and the patent-office record together, there are four distinct routes by which a molecule that is solidly patented — and successfully defended — in the United States ends up with no enforceable protection somewhere else. This is DrugPatentWatch’s own working taxonomy for classifying territorial exposure; none of these four categories is officially recognized under any single country’s patent statute.<\/p>\n\n\n\n

Type 1 — Never filed<\/h3>\n\n\n\n

The applicant simply did not file a counterpart application in that country, usually because the market was judged too small to justify the filing, translation, prosecution, and 20-year maintenance costs of a separate national patent.<\/p>\n\n\n\n

Type 2 — Filed, then rejected under a different patentability standard<\/h3>\n\n\n\n

The applicant filed, but the national patent office applied a domestic legal standard the US does not use and rejected the claim. India’s Section 3(d), which bars patents on new forms of a known substance absent proof of enhanced therapeutic efficacy, is the best-documented example.[15]<\/sup><\/p>\n\n\n\n

Type 3 — Filed, granted, and then statutorily overridden<\/h3>\n\n\n\n

The applicant filed, prosecuted the case, and received a valid granted patent — and a national compulsory-licensing statute overrode it anyway, on public-interest grounds unrelated to the patent’s validity.<\/p>\n\n\n\n

Type 4 — Never required to be filed at all<\/h3>\n\n\n\n

In the world’s Least Developed Countries, WTO members have voted three times to exempt LDCs from any obligation to grant or enforce pharmaceutical patents, most recently extending that exemption to July 1, 2034.[16]<\/sup> A company can hold an airtight, litigated, Federal-Circuit-affirmed US patent and it will not reach a single one of roughly 44 LDCs, because those countries are not required to recognize pharmaceutical patents in the first place.[17]<\/sup><\/p>\n\n\n\n

Case Study: Semaglutide’s Split Calendar<\/strong><\/h2>\n\n\n\n

Novo Nordisk’s semaglutide franchise is the freshest and most fully documented example of all four dynamics playing out simultaneously across one molecule.<\/p>\n\n\n\n

The US side: a win that held<\/h3>\n\n\n\n

Mylan Pharmaceuticals petitioned for IPR against Novo Nordisk’s two core semaglutide compound patents, U.S. Patent Nos. 8,536,122 and 8,129,343, in early 2023. On October 2, 2023, PTAB ruled that Mylan had not met the threshold to even institute a full review.[1]<\/sup> Novo Nordisk separately faced — and in October 2024 settled, on confidential terms — IPR challenges from Mylan, Dr. Reddy’s, Apotex, and Sun Pharma against its dosing patent, U.S. Patent No. 10,335,462, which does not expire until June 2033.[18]<\/sup>[19]<\/sup> The compound patent, the ‘343, runs to December 2031.[19]<\/sup><\/p>\n\n\n\n

The India side: an expired patent and a court that wouldn’t intervene<\/h3>\n\n\n\n

India tells a different story for the same molecule. Indian Patent No. 275964, covering the composition of semaglutide, expired in September 2024.[20]<\/sup> A second Indian patent, No. 262697 — filed in March 2007 and granted in March 2014, covering formulation and delivery-device claims — was the one Novo Nordisk actually sued on, alleging that Dr. Reddy’s and its contract manufacturer OneSource Specialty Pharma were infringing it by making semaglutide API and finished product without permission.[20]<\/sup> On December 2, 2025, the Delhi High Court dismissed Novo Nordisk’s bid to block that manufacturing, on the basis that Dr. Reddy’s could make and export the drug to countries where Novo Nordisk holds no patent protection at all.[3]<\/sup> A Dr. Reddy’s spokesperson said the ruling<\/p>\n\n\n\n

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“affirms the strength of our position”<\/p>\n<\/blockquote>\n\n\n\n

on accessible, affordable medicine.[3]<\/sup> India’s own patent coverage lapsed entirely on March 20, 2026, and more than 40 domestic manufacturers — Sun Pharma, Dr. Reddy’s, Cipla, Biocon, Lupin, Zydus, Natco, and Mankind among them — launched branded generics that week, some priced up to 80 percent below Novo Nordisk’s list price.[4]<\/sup>[5]<\/sup>[21]<\/sup><\/p>\n\n\n\n

The wider patchwork<\/h3>\n\n\n\n

Reporting from December 2025 put the pattern in blunt terms: semaglutide patent protection was expiring in India, Canada, Brazil, and China in 2026, while holding until the early 2030s in the United States, Europe, and Japan.[22]<\/sup> Novo Nordisk itself has confirmed the China 2026 date publicly.[23]<\/sup> None of the compulsory-license or Section 3(d) mechanisms below were even needed here — ordinary differences in original filing dates and national prosecution timelines were enough to put more than a decade of daylight between when the same molecule loses exclusivity in different countries.<\/p>\n\n\n\n

Jurisdiction<\/th>Key Event<\/th>Date \/ Status<\/th>Source<\/th><\/tr>
United States<\/td>PTAB denies institution of Mylan IPR on compound patents ‘122 \/ ‘343<\/td>Oct. 2, 2023; ‘343 protection runs to 2031<\/td>[1][19]<\/td><\/tr>
United States<\/td>Dosing patent ‘462 IPR settled (confidential terms) after four generics joined<\/td>Oct. 2024; ‘462 expires June 2033<\/td>[18][19]<\/td><\/tr>
India<\/td>Composition patent 275964 expires<\/td>Sept. 2024<\/td>[20]<\/td><\/tr>
India<\/td>Delhi High Court declines to block Dr. Reddy’s manufacture-for-export under formulation patent 262697<\/td>Dec. 2, 2025<\/td>[3]<\/td><\/tr>
India<\/td>Formulation patent coverage lapses; broad generic launch (40+ manufacturers)<\/td>March 20, 2026<\/td>[4][5][21]<\/td><\/tr>
China<\/td>Patent protection expires<\/td>2026<\/td>[22][23]<\/td><\/tr>
Canada, Brazil<\/td>Patent protection expires<\/td>2026<\/td>[22]<\/td><\/tr>
Europe, Japan<\/td>Patent protection expires<\/td>2031<\/td>[22]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Case Study: AZT and the Country That Didn’t Recognize Drug Patents at All<\/strong><\/h2>\n\n\n\n

The most extreme, and oldest, illustration of territoriality is not a rejection or a compulsory license. It is a country that could not have granted the patent even if it wanted to.<\/p>\n\n\n\n

Burroughs Wellcome’s 1994 win in the Federal Circuit<\/h3>\n\n\n\n

Burroughs Wellcome Co. held six US patents covering zidovudine (AZT) and its use against HIV. Barr Laboratories and Novopharm challenged the patents on inventorship grounds, arguing that two NIH scientists should have been named as co-inventors. In Burroughs Wellcome Co. v. Barr Laboratories, Inc.<\/em>, 40 F.3d 1223 (Fed. Cir. 1994), the Federal Circuit affirmed that Burroughs Wellcome’s own scientists — not the NIH researchers — had properly conceived the invention, upholding the patents and blocking Barr’s and Novopharm’s generic AZT from the US market.[24]<\/sup><\/p>\n\n\n\n

India’s process-patent-only regime, 1970 to 2005<\/h3>\n\n\n\n

None of that mattered in India. The Indian Patents Act of 1970 granted patents only on the process<\/em> used to make a pharmaceutical, never on the drug molecule itself — a deliberate policy choice to build a domestic generic industry.[25]<\/sup> India only began accepting product-patent applications for pharmaceuticals as “mailbox” filings in 1995 under its TRIPS transition period, and did not actually grant or enforce pharmaceutical product patents until the Patents (Amendment) Act of 2005 took effect on January 1, 2005.[26]<\/sup>[27]<\/sup> For the entire life of Burroughs Wellcome’s US AZT patents, there was no legal mechanism by which the company could have obtained an enforceable Indian product patent on the molecule. It was not a filing failure. It was a category of protection that did not exist in Indian law.<\/p>\n\n\n\n

What Cipla built in the gap<\/h3>\n\n\n\n

Indian manufacturer Cipla launched its own version of zidovudine in the early 1990s, at roughly one-tenth of the price prevailing in international markets, entirely lawfully under India’s process-patent regime.[28]<\/sup> That manufacturing base is what let Cipla, in February 2001, offer a three-drug antiretroviral combination — stavudine, lamivudine, and nevirapine — to M\u00e9decins Sans Fronti\u00e8res for $350 per patient per year, versus originator prices around $10,000-12,000 at the time.[29]<\/sup>[30]<\/sup> Bristol-Myers Squibb held the US patent on stavudine, GlaxoSmithKline on lamivudine, and Boehringer Ingelheim on nevirapine — all valid, all enforced in their home markets, none of them reaching India.[31]<\/sup><\/p>\n\n\n\n

Case Study: Tenofovir and the Patent That Failed on Two Continents Independently<\/strong><\/h2>\n\n\n\n

Gilead Sciences’ tenofovir disoproxil fumarate (TDF, marketed as Viread) shows the inverse of the AZT story: two separate legal systems independently invalidating overlapping claims, for different reasons, on different timelines — proof that a US outcome does not bind a foreign one even when both land against the patent owner.<\/p>\n\n\n\n

The US reexamination<\/h3>\n\n\n\n

The Public Patent Foundation (PUBPAT) submitted prior art challenging four Gilead TDF patents. On January 23, 2008, the US Patent and Trademark Office rejected all four on reexamination, finding TDF was already a known substance when Gilead’s applications were filed.[32]<\/sup><\/p>\n\n\n\n

The Delhi opposition<\/h3>\n\n\n\n

Gilead’s Indian patent application for TDF (filed with the Delhi patent office in 1998) faced a separate pre-grant opposition from Indian generic manufacturers and patient groups, arguing that adding fumaric acid to an already-known compound, tenofovir disoproxil, was not patentable subject matter.[33]<\/sup> The Indian Patent Office in Chennai\/Delhi rejected the application in August 2009 on that basis — an independent proceeding, on India’s own novelty and inventive-step law, reaching a similar commercial result to the US reexamination but through entirely different legal reasoning and a different timeline.[33]<\/sup>[34]<\/sup> Gilead appealed to India’s Intellectual Property Appellate Board; the rejection meant Gilead forfeited royalty income from the roughly 13 Indian manufacturers it had already licensed to sell generic TDF in 95 other countries under its voluntary-licensing program.[35]<\/sup><\/p>\n\n\n\n

Case Study: Sorafenib and the Patent That Existed but Didn’t Control the Market<\/strong><\/h2>\n\n\n\n

Sometimes the molecule is filed, granted, and fully valid in the market that matters — and a separate statutory mechanism still opens the door to a generic competitor.<\/p>\n\n\n\n

A valid, granted patent<\/h3>\n\n\n\n

Bayer held Indian Patent No. 215758 on sorafenib tosylate, granted March 3, 2008, and launched the drug in India in 2008 under the brand Nexavar, pricing it at roughly INR 280,000 (about $5,500-6,600) for a month’s course.[36]<\/sup><\/p>\n\n\n\n

India’s first compulsory license<\/h3>\n\n\n\n

Natco Pharma applied under Section 84 of India’s Patents Act for a compulsory license, arguing Bayer had not made the drug reasonably available or affordable, nor “worked” the patent locally. On March 9, 2012, India’s Controller of Patents agreed, granting Natco a non-exclusive, non-assignable license to manufacture and sell generic sorafenib at INR 8,800 per month — about 3 percent of Bayer’s price — in exchange for a royalty (later raised from 6 to 7 percent of net sales).[37]<\/sup>[38]<\/sup> The Intellectual Property Appellate Board upheld the license on March 4, 2013, and the Bombay High Court upheld that decision on July 15, 2014.[39]<\/sup> Bayer’s US patent position on sorafenib was never in question. India’s compulsory-licensing statute simply did not care.<\/p>\n\n\n\n

Case Study: Imatinib and the Patent That Was Never Granted at All<\/strong><\/h2>\n\n\n\n

Section 3(d) and the Novartis Supreme Court loss<\/h3>\n\n\n\n

Novartis filed for an Indian patent in 1998 on the beta-crystalline form of imatinib mesylate, the active compound in its cancer drug Glivec (Gleevec), already patented in roughly 35 other countries.[40]<\/sup> India’s patent office rejected the application in January 2006 under Section 3(d), finding the new crystalline form was not shown to have enhanced therapeutic efficacy over the already-known imatinib free base.[41]<\/sup> Novartis fought the rejection through the Madras High Court, the Intellectual Property Appellate Board, and finally the Supreme Court of India, which affirmed the rejection on April 1, 2013, in Novartis AG v. Union of India & Others<\/em>, (2013) 6 SCC 1.[15]<\/sup>[41]<\/sup><\/p>\n\n\n\n

The grandfather clause<\/h3>\n\n\n\n

Because India’s product-patent regime only began on January 1, 2005, its transitional law included a grandfather clause letting generic versions of drugs already on the market before that date — Gleevec among them — continue to be sold, subject to a reasonable royalty to the originator.[42]<\/sup> The combined effect: Indian generic imatinib was available essentially without interruption, while Novartis’s originally filed compound patent held full-term exclusivity in the United States and dozens of other countries where the underlying molecule patent had actually been granted.<\/p>\n\n\n\n

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Patients in Europe, Canada, Japan, and other similar markets benefit from earlier generic entry compared to patients in the U.S. — a gap researchers attribute in part to how many fewer follow-on patents those countries’ systems allow drugmakers to accumulate and enforce.[43]<\/sup><\/p>\n<\/blockquote>\n\n\n\n

What This Means for Freedom-to-Operate Teams<\/strong><\/h2>\n\n\n\n

“Global patent landscape” is a convenient phrase, not a legal reality<\/h3>\n\n\n\n

A freedom-to-operate report that lists a molecule as “patented” without specifying jurisdiction is incomplete by definition. The five case studies above involve the same fact pattern from five different legal angles — never filed, rejected on local law, overridden by statute, or exempt by treaty — and every one of them required jurisdiction-by-jurisdiction verification to catch. A platform like DrugPatentWatch exists precisely because “does Company X hold a patent on Molecule Y” is not one question. It is one question multiplied by every country a business plans to operate in.<\/p>\n\n\n\n

The national-phase decision nobody budgets for<\/h3>\n\n\n\n

The PCT’s 30-31 month national-phase deadline is a decision point, not a formality.[13]<\/sup> Every country entered at that stage means separate filing fees, translation costs, and local counsel, for a 20-year commitment.[44]<\/sup> Every country skipped is a country where, by construction, a company’s future US litigation win — however decisive — will do nothing at all.<\/p>\n\n\n\n

What Happens When the LDC Exemption Expires<\/strong><\/h2>\n\n\n\n

The WTO’s TRIPS Council has extended the Least Developed Countries’ pharmaceutical patent exemption three times: first to 2016, then to January 1, 2033 (decided November 2015), and the broader general TRIPS transition period to July 1, 2034 (decided June 2021).[16]<\/sup>[45]<\/sup> Roughly 44 countries currently have no obligation to grant or enforce a pharmaceutical patent.[17]<\/sup> Nothing requires the Council to extend the exemption again, and nothing prevents it from doing so — the 2021 decision explicitly preserved LDCs’ right to seek further extensions.[45]<\/sup> Until and unless that changes, a molecule fully protected and successfully defended in US courts remains, by design, unprotected across a large bloc of the world’s poorest markets.<\/p>\n\n\n\n

Key Takeaways<\/strong><\/h2>\n\n\n\n
    \n
  • US patent litigation outcomes — IPR denials, Hatch-Waxman verdicts, Federal Circuit rulings — have no legal effect outside the United States; the Supreme Court has affirmed this presumption against extraterritoriality in Deepsouth<\/em>, Microsoft v. AT&T<\/em>, and WesternGeco<\/em>.[8][9][10]<\/sup><\/li>\n\n\n\n
  • Novo Nordisk’s semaglutide compound patents survived a Mylan IPR challenge in the US in October 2023 and run to 2031, while the equivalent Indian composition patent expired in September 2024 and a Delhi High Court ruling in December 2025 let a generic maker manufacture for export to countries with no Novo Nordisk patent protection at all.[1][3][19][20]<\/sup><\/li>\n\n\n\n
  • India granted no pharmaceutical product patents whatsoever from 1970 to 2005, so Burroughs Wellcome’s 1994 Federal Circuit win on AZT could never have reached the Indian market by construction, not by omission.[24][26]<\/sup><\/li>\n\n\n\n
  • Gilead’s tenofovir disoproxil fumarate patents were independently rejected in the US (reexamination, January 2008) and in India (pre-grant opposition, August 2009) on different legal grounds and different timelines.[32][33]<\/sup><\/li>\n\n\n\n
  • Bayer’s Indian sorafenib patent was validly granted and never challenged on validity — India’s 2012 compulsory license to Natco Pharma overrode it anyway, on affordability and local-working grounds under Section 84.[37][38]<\/sup><\/li>\n\n\n\n
  • Novartis’s Indian application for the beta-crystalline form of imatinib was rejected in 2006 and the rejection affirmed by India’s Supreme Court in 2013, while the original imatinib compound patent held full exclusivity in the United States.[15][41]<\/sup><\/li>\n\n\n\n
  • Roughly 44 Least Developed Countries have no obligation to grant or enforce pharmaceutical patents until at least July 1, 2034, regardless of a molecule’s patent status anywhere else.[16][45]<\/sup><\/li>\n<\/ul>\n\n\n\n

    FAQ<\/strong><\/h2>\n\n\n\n

    Does winning a US patent lawsuit protect a drug in other countries?<\/strong>
    No. US patent rights, and US court rulings on them, are confined to the United States under the presumption against extraterritoriality that the Supreme Court applied in Microsoft Corp. v. AT&T<\/em> and WesternGeco v. ION Geophysical<\/em>.[9][10]<\/sup><\/p>\n\n\n\n

    Is there any such thing as a worldwide patent?<\/strong>
    No. WIPO administers the Patent Cooperation Treaty, which simplifies filing in up to 158 countries through one application, but the PCT itself does not grant any patent; applicants must still enter and pay for the national phase in each country individually.[12]<\/sup><\/p>\n\n\n\n

    Why didn’t Burroughs Wellcome’s AZT patent apply in India?<\/strong>
    India’s Patents Act of 1970 granted patents on pharmaceutical manufacturing processes only, not on the drug molecules themselves, and did not begin granting or enforcing pharmaceutical product patents until January 1, 2005.[26][27]<\/sup><\/p>\n\n\n\n

    What is a compulsory license, and does a valid patent stop one?<\/strong>
    A compulsory license lets a government authorize a third party to manufacture a patented product without the patent owner’s consent, typically on affordability or public-health grounds. It does not require the underlying patent to be invalid — India’s 2012 compulsory license on Bayer’s sorafenib was granted against a fully valid, granted patent.[37][38]<\/sup><\/p>\n\n\n\n

    What is Section 3(d) of India’s Patents Act?<\/strong>
    It is a provision barring patents on new forms of an already-known substance unless the applicant proves enhanced therapeutic efficacy. India’s Supreme Court applied it to reject Novartis’s patent application on the beta-crystalline form of imatinib mesylate (Glivec) in 2013.[15][41]<\/sup><\/p>\n\n\n\n

    What happens to semaglutide patent protection in 2026?<\/strong>
    Reported timelines put semaglutide patent expiry in India, Canada, Brazil, and China in 2026, while US, European, and Japanese patents were expected to hold into the early 2030s.[22]<\/sup> India’s own formulation-patent coverage lapsed on March 20, 2026, triggering launches from more than 40 domestic generic makers.[4][5]<\/sup><\/p>\n\n\n\n

    Do Least Developed Countries have to respect pharmaceutical patents?<\/strong>
    Not currently. The WTO’s TRIPS Council has extended LDCs’ exemption from granting or enforcing pharmaceutical patents to January 1, 2033, and the broader TRIPS transition period to July 1, 2034.[16][45]<\/sup><\/p>\n\n\n\n

    Can a molecule be patent-rejected in the US and still be protected elsewhere?<\/strong>
    Yes — territoriality runs both directions. Patent offices apply their own domestic law independently, so a US rejection or invalidation does not bind, and is not bound by, a foreign patent office’s decision on the same molecule.[7]<\/sup><\/p>\n\n\n\n

    How long does a company have to decide which countries to file in?<\/strong>
    Under the Paris Convention, an applicant has 12 months from a first filing to claim priority in other member countries. Filing through the PCT extends that decision window to roughly 30-31 months from the earliest priority date before national-phase fees and local filings are due.[7][13]<\/sup><\/p>\n\n\n\n

    Why does this matter for freedom-to-operate analysis?<\/strong>
    Because “is Molecule X patented” is not a single yes\/no question — it is a separate question in every jurisdiction a company plans to sell, manufacture, or export into, and the answer can differ for reasons that have nothing to do with the molecule’s US patent status.<\/p>\n\n\n\n

    References<\/h2>\n\n\n\n
      \n
    1. Bloomberg Law. “Novo Nordisk Beats Challenge to Wegovy, Ozempic Obesity Patents.” Oct. 2, 2023. https:\/\/news.bloomberglaw.com\/ip-law\/novo-nordisk-beats-challenge-to-wegovy-ozempic-obesity-patents<\/li>\n\n\n\n
    2. Markman Advisors. “What is the patent landscape for Novo Nordisk’s semaglutide products, Ozempic, Wegovy and Rybelsus?” Feb. 7, 2025. https:\/\/www.markmanadvisors.com\/blog\/2025\/2\/7\/what-is-the-patent-landscape-for-novo-nordisks-semaglutide-products-ozempic-wegovy-and-rybelsus<\/li>\n\n\n\n
    3. Dow Jones Newswires. “Indian Court Allows Dr. Reddy’s to Produce Generic Versions of Novo Nordisk’s Blockbuster Drugs.” Dec. 4, 2025. https:\/\/www.marketscreener.com\/news\/indian-court-allows-dr-reddy-s-to-produce-generic-versions-of-novo-nordisk-s-blockbuster-drugs-ce7d51dfdd8bf32c<\/li>\n\n\n\n
    4. FiercePharma. “Generic versions of Novo’s semaglutide launch today in India.” March 20, 2026. https:\/\/www.fiercepharma.com\/pharma\/novos-semaglutide-losing-patent-protection-indian-drugmakers-set-launch-their-generics<\/li>\n\n\n\n
    5. CNBC. “India is launching cheap weight-loss drugs — but Novo Nordisk is betting its brands will stay on top.” March 23, 2026. https:\/\/www.cnbc.com\/2026\/03\/23\/novo-nordisk-cheap-weight-loss-drugs-india-generic-ozempic-wegovy-semaglutide.html<\/li>\n\n\n\n
    6. World Intellectual Property Organization. “Inventions (Patents).” https:\/\/www.wipo.int\/patents\/en\/<\/li>\n\n\n\n
    7. World Intellectual Property Organization. “Patent Law” \/ Paris Convention overview. https:\/\/www.wipo.int\/en\/web\/patents\/law<\/li>\n\n\n\n
    8. Supreme Court of the United States. Deepsouth Packing Co. v. Laitram Corp.<\/em>, 406 U.S. 518 (1972), as discussed in SCOTUSblog, “Argument preview: Justices to grapple again with patent infringement overseas.” https:\/\/www.scotusblog.com\/2018\/04\/argument-preview-justices-to-grapple-again-with-patent-infringement-overseas<\/li>\n\n\n\n
    9. Supreme Court of the United States. Microsoft Corp. v. AT&T Corp.<\/em>, 550 U.S. 437 (2007), as summarized in Buchanan Ingersoll & Rooney PC, “Supreme Court: Patent Owners’ Infringement Damages Can Include Extraterritorial Lost Profits.” https:\/\/www.bipc.com\/supreme-court-patent-owners%E2%80%99-infringement-damages-can-include-extraterritorial-lost-profits<\/li>\n\n\n\n
    10. Supreme Court of the United States. WesternGeco LLC v. ION Geophysical Corp.<\/em> (2018), as summarized in Buchanan Ingersoll & Rooney PC (see note 9).<\/li>\n\n\n\n
    11. SCOTUSblog. “Argument preview: Justices to grapple again with patent infringement overseas.” April 2018. https:\/\/www.scotusblog.com\/2018\/04\/argument-preview-justices-to-grapple-again-with-patent-infringement-overseas<\/li>\n\n\n\n
    12. World Intellectual Property Organization. “PCT FAQs.” https:\/\/www.wipo.int\/en\/web\/pct-system\/faqs\/faqs<\/li>\n\n\n\n
    13. The Law Office of Michael Meyer. “International Patent Protection: PCT, EPO & Global Strategy.” Updated March 2026. https:\/\/www.michaelmeyerlaw.com\/blog\/international-patent-protection\/<\/li>\n\n\n\n
    14. World Trade Organization. “Intellectual property (TRIPS) and pharmaceuticals — technical note.” https:\/\/www.wto.org\/english\/tratop_e\/trips_e\/pharma_ato186_e.htm<\/li>\n\n\n\n
    15. UNCTAD. “Novartis AG v. Union of India & Others,” Indian Supreme Court case summary, 2013. https:\/\/unctad.org\/ippcaselaw\/sites\/default\/files\/ippcaselaw\/2020-12\/Novartis%20AG%20v.%20Union%20of%20India%20&%20Others%20Indian%20Supreme%20Court%202013_0.pdf<\/li>\n\n\n\n
    16. World Trade Organization. “WTO members agree to extend drug patent exemption for poorest members.” Nov. 6, 2015. https:\/\/www.wto.org\/english\/news_e\/news15_e\/trip_06nov15_e.htm<\/li>\n\n\n\n
    17. World Trade Organization. “Responding to least developed countries’ special needs in intellectual property.” https:\/\/www.wto.org\/english\/tratop_e\/trips_e\/ldc_e.htm<\/li>\n\n\n\n
    18. Pearce IP. “Novo Nordisk Settles US Patent Dispute Regarding Semaglutide Patent with Mylan\/Natco, Dr Reddy’s, Apotex and Sun Pharma.” Oct. 2024. https:\/\/www.pearceip.law\/2024\/10\/08\/novo-nordisk-settles-us-patent-dispute-regarding-semaglutide-patent-with-mylan-natco-dr-reddys-apotex-and-sun-pharma\/<\/li>\n\n\n\n
    19. Markman Advisors (see note 2), patent-expiry table for ‘343 and ‘462 patents.<\/li>\n\n\n\n
    20. Kan and Krishme. “A Weighty Dispute: Novo Nordisk’s Semaglutide Patent Clash in Delhi High Court.” July 2025. https:\/\/kankrishme.com\/a-weighty-dispute-novo-nordisks-semaglutide-patent-clash-in-delhi-high-court\/<\/li>\n\n\n\n
    21. Outlook Business. “Novo Nordisk’s Patent Expires, Indian Pharma Lines Up for Ozempic-Like Weight-Loss Drugs.” March 20, 2026. https:\/\/www.outlookbusiness.com\/amp\/story\/corporate\/novo-nordisks-patent-expires-indian-pharma-lines-up-for-ozempic-like-weight-loss-drugs<\/li>\n\n\n\n
    22. C&EN \/ American Chemical Society. “Looming GLP-1 drug patent expirations draw generics firms.” Dec. 2025. https:\/\/cen.acs.org\/pharmaceuticals\/Looming-GLP-1-drug-patent\/103\/web\/2025\/12<\/li>\n\n\n\n
    23. Lexology. “Novo Nordisk Settles Ozempic Patent Case.” https:\/\/www.lexology.com\/library\/detail.aspx?g=2917bc04-1eae-469c-bbfe-151c59331bae<\/li>\n\n\n\n
    24. Justia. Burroughs Wellcome Co. v. Barr Laboratories, Inc.<\/em>, 40 F.3d 1223 (Fed. Cir. 1994). https:\/\/law.justia.com\/cases\/federal\/appellate-courts\/F3\/40\/1223\/508198\/<\/li>\n\n\n\n
    25. LawTeacher.net. “The Need for Section 3(D) of the Indian Patents Act.” https:\/\/www.lawteacher.net\/free-law-essays\/commercial-law\/section-3-of-the-indian-patents-act-commercial-law-essay.php<\/li>\n\n\n\n
    26. The Legal School. “History of Patent Law in India: Evolution, Key Reforms, and Impact.” https:\/\/thelegalschool.in\/blog\/history-of-patent-law-in-india<\/li>\n\n\n\n
    27. AIPLA. “The Global Significance of India’s Pharmaceutical Patent Laws.” https:\/\/www.aipla.org\/list\/innovate-articles\/the-global-significance-of-india-s-pharmaceutical-patent-laws<\/li>\n\n\n\n
    28. Cipla. “HIV\/AIDS.” Corporate history page. https:\/\/www.cipla.com\/our-offerings\/our-therapies\/hiv-aids<\/li>\n\n\n\n
    29. Hoen, E. ‘t et al. “Driving a decade of change: HIV\/AIDS, patents and access to medicines for all.” Journal of the International AIDS Society, 2011. https:\/\/onlinelibrary.wiley.com\/doi\/10.1186\/1758-2652-14-15<\/li>\n\n\n\n
    30. Project Breakthrough \/ UN Global Compact. “Cipla: India’s Robin Hood of drugs.” https:\/\/breakthrough.unglobalcompact.org\/briefs\/cipla-indias-robin-hood-of-drugs-yusuf-hamied\/<\/li>\n\n\n\n
    31. ResearchGate (reproducing a 2001 wire report). “Indian company offers low cost AIDS drugs.” https:\/\/www.researchgate.net\/publication\/11788458_Indian_company_offers_low_cost_AIDS_drugs<\/li>\n\n\n\n
    32. Doctors Without Borders \/ MSF Access Campaign. “Patents rejected on tenofovir.” Jan. 23, 2008. https:\/\/msfaccess.org\/patents-rejected-tenofovir<\/li>\n\n\n\n
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    34. MSF. “MSF supports opposition to Gilead’s tenofovir patent application in India.” https:\/\/www.msf.org\/msf-supports-opposition-gileads-tenofovir-patent-application-india<\/li>\n\n\n\n
    35. Pharmexcil (reproducing wire report). “US’ Gilead appeals against patent rejection of AIDS drug Viread.” https:\/\/pharmexcil.com\/data\/uploads\/US’_Gilead_appeals_against_patent.pdf<\/li>\n\n\n\n
    36. MSF Access Campaign. “Background Information on India’s First Compulsory Licence.” https:\/\/msfaccess.org\/background-information-indias-first-compulsory-licence<\/li>\n\n\n\n
    37. SSRana & Associates. “Compulsory Licensing Of Patents In India – Section 84.” https:\/\/ssrana.in\/ip-laws\/patents\/compulsory-licensing-patents-in-india\/<\/li>\n\n\n\n
    38. KEI. “KEI Statement on India’s granting of compulsory license to patents on cancer drug sorafenib (NATCO Vs. BAYER).” https:\/\/www.keionline.org\/21808<\/li>\n\n\n\n
    39. Bombay High Court. Bayer Corporation vs Union Of India<\/em>, July 15, 2014, via Indian Kanoon. https:\/\/indiankanoon.org\/doc\/28519340\/<\/li>\n\n\n\n
    40. iPleaders. “Novartis A.G. v. Union of India: case analysis.” https:\/\/blog.ipleaders.in\/analysis-novartis-g-vs-union-india\/<\/li>\n\n\n\n
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    43. I-MAK. “Overpatented 2025.” https:\/\/www.i-mak.org\/overpatented\/<\/li>\n\n\n\n
    44. The Law Office of Michael Meyer (see note 13), on national-phase filing, translation, and local-counsel costs.<\/li>\n\n\n\n
    45. World Trade Organization. “Intellectual property (TRIPS) – Responding to least developed countries special needs in intellectual property.” https:\/\/www.wto.org\/english\/tratop_e\/trips_e\/ldc_e.htm<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

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