Pharma Litigation Watch: decisions analysed
Detailed case notes on non-UPC decisions concerning pharmaceutical and biotechnology patents and supplementary protection certificates: European national courts, the Court of Justice of the European Union, the EPO Boards of Appeal and, for comparison, a few decisions from outside Europe. Each note links to the official text.
67 decisions analysed
- ModernaTX v Pfizer (EWCA, [2025] EWCA Civ 1032, 2025)Claim 3 of EP949 (mRNA with 100% replacement of uridine by m1Ψ) is novel over UPenn, which contains no individualised disclosure of the combination selected from two lists, and is not obvious; Pfizer and BioNTech's appeal is dismissed.
- Generics (UK) v AstraZeneca (EWCA, [2025] EWCA Civ 903, 2025)The dapagliflozin patent, which did not make its antidiabetic utility plausible and was an arbitrary selection from WO 128, is invalid for lack of inventive step and insufficiency, and so are the SPCs; G 2/21 does not justify departing from Sandoz v BMS.
- Biogen v Sandoz, Viatris and Mepha (BPatGer, S2024_005 to S2024_007, 2025)Preliminary measures against three dimethyl fumarate generics are refused: the claimed 480 mg daily dose is likely obvious over the Kappos I phase II study.
- Mitsui Chemicals v Borealis (EPO, G 1/23, 2025)A product put on the market before the filing date cannot be excluded from the state of the art solely because its composition or internal structure could not be analysed and reproduced; public technical information about it is also state of the art.
- Philip Morris Products v Yunnan Tobacco International (EPO, G 1/24, 2025)The claims are the starting point and the basis for assessing patentability; the description and drawings must always be consulted to interpret them, not only where a claim is unclear or ambiguous.
- AstraZeneca v Glenmark Pharmaceuticals (EWCA, [2025] EWCA Civ 480, 2025)In the light of new evidence that further generic entry was certain, there was real doubt as to the adequacy of damages for both sides; the status quo was preserved and an interim injunction granted until the form of order hearing.
- Janssen Biotech v Samsung Bioepis (Gerechtshof Den Haag, 200.337.844/01, 2025)The manufacturing for export waiver requires neither a third country marketing authorisation at notification nor a country free of rights, and permits stockpiling for entry as soon as rights expire; the dismissal of the holder's claims is upheld.
- Merck Serono v Comptroller-General of Patents (EWCA, [2025] EWCA Civ 45, 2025)Bound by its decision in Newron, which applied Santen, the Court of Appeal could not depart from Santen and would not have done so in any event; the SPC for cladribine fails under Article 3(d) because of earlier MAs for another indication.
- Teva and Others v Merck Sharp & Dohme and Merck Sharp & Dohme v Clonmel (CJEU, C-119/22 and C-149/22, 2024)Article 3(c) does not preclude an SPC for a combination where one ingredient already had an SPC; under Article 3(a), express mention of a combination in the claims is not enough, as it must necessarily fall under the invention.
- Accord Healthcare v Sanofi (Paris Judicial Court, RG 21/06416, 2024)The French part of EP 2 493 466 (cabazitaxel after docetaxel) is annulled for lack of inventive step, the Tropic trial announced before priority giving a reasonable expectation of success; the infringement action is dismissed.
- Mepha v Bristol-Myers Squibb (BPatGer, O2022_007, 2024)The nullity action against the Swiss apixaban SPC is dismissed: the US priority is valid through a tacit transfer, and the technical effect, derivable from the application within the meaning of G 2/21, supports inventive step.
- Mylan v Merck Sharp & Dohme (CA Paris, RG 22/16673, 2024)The provisional ban on sitagliptin and metformin generics is upheld: the combination being expressly claimed, the Teva v Gilead test is unnecessary, and Article 3(c) refers to a granted certificate, not an earlier application.
- Mylan v Gilead Sciences Finland and Others (CJEU, C-473/22, 2024)Article 9(7) of Directive 2004/48 does not preclude a national regime of no-fault liability of the applicant for provisional measures, provided the court can adjust damages to the circumstances, including the defendant's contribution to its loss.
- Alexion Pharmaceuticals v Novartis (EPO, G 1/22 and G 2/22, 2023)The EPO is competent to assess entitlement to priority; entitlement is presumed, rebuttably and under the autonomous law of the EPC, in favour of an applicant claiming priority under Article 88(1) EPC, including for jointly filed PCT applications.
- Sankyo v Biogaran and others (Cass. com., 21-25.143, 2023)Notification of an SPC lapse to the representative appointed at filing is valid, payment of fees by another firm not amounting to a new appointment; the lapse, being indivisible, benefits all parties to the proceedings.
- BMS v Sandoz and others (Gerechtshof Den Haag, 200.327.532/01, 2023)Under G 2/21 the technical effect relied on for inventive step need only be derivable from the application, without being proven or made plausible there; as the apixaban patent met that test, the court enjoined the generic companies from infringing the SPC.
- Amgen v Sanofi (US Supreme Court, No 21-757, 2023)A claim to an entire class must be enabled across its full scope; Amgen's functional claims, reaching a vast number of undisclosed antibodies beyond the 26 examples, fail section 112(a).
- Sandoz v Bristol-Myers Squibb (EWCA, [2023] EWCA Civ 472, 2023)Plausibility applies to a single compound claim; as the application linked no result to apixaban, its activity was not plausible and the patent was invalid, the outcome being the same under inventive step or sufficiency.
- Sumitomo Chemical v Syngenta (EPO, G 2/21, 2023)Post-published evidence of a technical effect relied on for inventive step may not be disregarded solely because of its date; the proprietor may rely on the effect if the skilled person would derive it from the application as filed as encompassed by the technical teaching and embodied by the same invention.
- Novartis v Mylan (Gerechtshof Den Haag, 200.313.064/01, 2022)The interim injunction was refused: since the therapeutic effect of the 0.5 mg dose was not directly and unambiguously disclosed in the application as filed, and plausibility is not enough, the patent faces a serious risk of invalidity for added matter.
- Lundbeck v Commission (CJEU, C-591/16 P, 2021)The appeal is dismissed: the generic manufacturers were potential competitors of Lundbeck despite its process patents, and the agreements delaying their entry in return for reverse payments are restrictions by object, even if they stay within the scope of the patents.
- Ono Pharmaceutical v INPI (CA Paris, RG 18/10540, 2021)The second SPC for nivolumab is refused: Article 3(c) bars it for Ono, which already holds a certificate for the product, and nivolumab, developed through an independent inventive step, is not protected by the upstream patent under Article 3(a).
- Teva v Merck Sharp & Dohme (CA Paris, RG 18/23642, 2020)The SPC for the ezetimibe and simvastatin combination, a second certificate on the same patent, is invalid under Article 3(a) and (c), the combination not being a distinct product protected as such; insufficiency of the combination claims is rejected.
- Santen v Directeur général de l'INPI (CJEU, C-673/18, 2020)An authorisation covering a new therapeutic application of an active ingredient already authorised for a different application cannot be the first authorisation under Article 3(d); the Court departs from paragraph 27 of Neurim.
- Regeneron v Kymab (UKSC, [2020] UKSC 27, 2020)A product claim covering a range is insufficient if the disclosure does not enable substantially all products within a relevant range to be made at the priority date, even if the invention would benefit the whole range; claim 1 of the 163 Patent is invalid.
- Neurim Pharmaceuticals v Generics UK (EWCA, [2020] EWCA Civ 793, 2020)With trial four months away, damages were an adequate remedy for the patentee: the refusal of an interim injunction against the Circadin generic was upheld.
- Royalty Pharma Collection Trust v Deutsches Patent- und Markenamt (CJEU, C-650/17, 2020)A product within a functional definition is protected under Article 3(a) if it necessarily falls under the invention and is specifically identifiable at the filing or priority date; it is not if it was developed after that date through an independent inventive step.
- Generics (UK) v Competition and Markets Authority (CJEU, C-307/18, 2020)A generic company ready to enter is a potential competitor of the holder of a disputed process patent; a settlement with transfers of value explicable only by the absence of competition is a restriction by object, and a strategy of such settlements may be abusive.
- Teva UK and others v Gilead Sciences (EWCA, [2019] EWCA Civ 2272, 2019)A claim to TD "and optionally other therapeutic ingredients" does not necessarily relate to the TD and emtricitabine combination; the Truvada SPC is invalid under Article 3(a).
- Bayer Pharma v Richter Gedeon and Exeltis (CJEU, C-688/17, 2019)Article 9(7) of Directive 2004/48 does not preclude national rules excluding compensation for harm the injured party failed to avoid by acting as could be expected of it, provided the court can weigh all objective circumstances, including any abuse by the applicant.
- Abraxis Bioscience v Comptroller General of Patents (CJEU, C-443/17, 2019)The authorisation for a new formulation of an old active ingredient cannot be the first authorisation of the product under Article 3(d) where that ingredient has already been authorised; the Neurim exception does not extend to formulations.
- Warner-Lambert v Generics (UK) (UKSC, [2018] UKSC 56, 2018)The Swiss-form claims to pain and neuropathic pain are insufficient, as the specification made pregabalin's efficacy plausible only for inflammatory pain; infringement is rejected, with no majority on the applicable test.
- Teva UK and Others v Gilead Sciences (CJEU, C-121/17, 2018)A combination of active ingredients not expressly claimed is protected under Article 3(a) if the claims relate to it necessarily and specifically: it must necessarily fall under the invention and each ingredient must be specifically identifiable, at the filing or priority date.
- Incyte v Szellemi Tulajdon Nemzeti Hivatala (CJEU, C-492/16, 2017)A first authorisation date fixed without regard to Seattle Genetics is incorrect; under Article 18 of Regulation 469/2009 the holder may obtain rectification of the certificate's duration for as long as it has not expired.
- Merck Sharp & Dohme v Teva Pharma (HR, 15/04934, 2017)All Swiss-type claims, subgroup claims included, are subject to the same test for direct infringement, which a carve-out alone does not generally defeat, and may be indirectly infringed. The appeal judgment was set aside and the case remitted.
- Actavis v Eli Lilly (UKSC, [2017] UKSC 48, 2017)Forms of pemetrexed other than the disodium salt directly infringe the patent as equivalents under the reformulated Improver questions; the prosecution history does not prevent that result.
- Raltegravir (BGH, X ZB 2/17, 2017)Provisional permission to use the raltegravir patent under Sections 24 and 85 PatG is upheld: the licensing efforts were sufficient and the public interest urgently required continued supply for several patient groups.
- Dutch State v Warner Lambert Company (Gerechtshof Den Haag, 200.185.962/01, 2017)The Court of Appeal referred three questions on Article 11 of Directive 2001/83 to the Court of Justice: the effect of a carve-out notice on the marketing authorisation and whether the authority may publish the generic's full label; provisionally, such publication is not infringement.
- Sun Pharmaceutical Industries v Novartis (HR, 15/01813, 2017)Sun's appeal was dismissed: priority was validly claimed and, the question of principle on indirect infringement of Swiss-type claims not being in issue, a generic company knowing its product would be dispensed for osteoporosis had to prove the steps it took to prevent this.
- Bristol-Myers Squibb v Isenbruck Bösl Hörschler and others (EPO, T 488/16, 2017)A bare assertion of activity without data did not make dasatinib's effect plausible at filing; post-published evidence was disregarded, inventive step denied and the referral to the Enlarged Board refused.
- Fujifilm Kyowa Kirin Biologics v AbbVie Biotechnology (EWCA, [2017] EWCA Civ 1, 2017)Nothing in principle bars an Arrow declaration that a product was old or obvious at a given date; its grant is discretionary, and FKB's claims were not struck out.
- Pemetrexed (BGH, X ZR 29/15, 2016)The rule excluding equivalence where only one of several disclosed options is claimed does not apply where the patent discloses a single embodiment and does not name the substituted salt; the Düsseldorf judgment is set aside and the case remitted.
- Seattle Genetics v Österreichisches Patentamt (CJEU, C-471/14, 2015)The date of the first marketing authorisation in the Union under Article 13(1) is determined by EU law; it is the date on which the authorisation decision was notified to its addressee.
- Forsgren v Österreichisches Patentamt (CJEU, C-631/13, 2015)Covalent binding of an active ingredient to other active ingredients does not in principle preclude an SPC; but no SPC may be granted where the substance's effect falls outside the authorised indications, and a conjugated carrier protein is an active ingredient only if it has its own effect covered by those indications.
- International Stem Cell Corporation v Comptroller General of Patents (CJEU, C-364/13, 2014)An unfertilised human ovum stimulated by parthenogenesis is not a human embryo within Article 6(2)(c) of Directive 98/44 if, on current science, it lacks the inherent capacity of developing into a human being, which is for the national court to determine.
- Novartis v Sanofi-Aventis France and others (Cass. com., 13-10.189, 2014)Whether the circumstances require an ex parte provisional prohibition is for the lower courts to assess; they do not where, with the SPC expiring seventeen days later, urgent inter partes proceedings remained possible and damages could compensate the harm.
- Merck Canada v Accord Healthcare (CJEU, C-555/13, 2014)Article 13, read with recital 9, precludes the holder of a patent and an SPC from relying on the full term of the certificate where it would confer more than 15 years of exclusivity from the first MA in the Union.
- Georgetown University v Octrooicentrum Nederland (CJEU, C-484/12, 2013)Article 3(c) does not preclude the holder of an SPC for a combination of active ingredients from obtaining, on the same patent, an SPC for one of those ingredients protected as such by that patent.
- Eli Lilly v Human Genome Sciences (CJEU, C-493/12, 2013)Article 3(a) does not require a structural formula: an active ingredient covered by a functional definition may be protected if the claims, read in the light of the description, relate to it implicitly but necessarily and specifically.
- Actavis v Sanofi (CJEU, C-443/12, 2013)A proprietor who has obtained an SPC for an innovative active ingredient may not obtain, on the same patent and a later MA, a second SPC for a combination of that ingredient with one not protected as such.
- Astrazeneca v Comptroller General of Patents (CJEU, C-617/12, 2013)In the EEA context, a Swissmedic authorisation automatically recognised in Liechtenstein is the first authorisation under Article 13(1) if it predates the other authorisations for the product, regardless of the EMA's refusal or the suspension of the Swiss authorisation.
- Escitalopram (HR, 12/00888, 2013)A known substance that no known process could produce may be protected by a product patent if the claimed process makes it available for the first time in an inventive way; the burden of proving lack of inventive step lies on the invalidity claimant. The appeal judgment was set aside and the case remitted.
- Novartis v Union of India (Supreme Court of India, Civil Appeals 2706-2716/2013, 2013)Imatinib mesylate, known from the Zimmermann patent, is not an invention, and its beta crystalline form, a new form of a known substance, shows no enhanced therapeutic efficacy under section 3(d); the refusal of the patent is upheld.
- AstraZeneca v Commission (CJEU, C-457/10 P, 2012)Misleading representations to patent offices to obtain SPCs and the deregistration of MAs without objective justification to obstruct generics and parallel imports are abuses of a dominant position; the appeal and cross-appeals are dismissed.
- Neurim v Comptroller-General of Patents (CJEU, C-130/11, 2012)An earlier veterinary MA for the same active ingredient does not preclude an SPC for a different application covered by its own MA, if it falls within the protection of the basic patent; the first MA is assessed within the limits of that protection.
- Merck Sharp & Dohme v Deutsches Patent- und Markenamt (CJEU, C-125/10, 2011)An SPC may be granted where less than five years separate the basic patent application from the first MA; its negative term is not rounded up to zero, and the paediatric extension runs from patent expiry less that negative term.
- Medeva v Comptroller General of Patents (CJEU, C-322/10, 2011)Article 3(a) precludes an SPC for active ingredients not specified in the wording of the claims of the basic patent; Article 3(b) allows an SPC for the claimed combination even where the authorised product contains other active ingredients.
- Human Genome Sciences v Eli Lilly (UKSC, [2011] UKSC 51, 2011)The Neutrokine-α patent satisfies Article 57 EPC: its plausible membership of the TNF ligand superfamily suffices to show a use; the cross-appeal on insufficiency was dismissed and the case remitted.
- Brüstle v Greenpeace (CJEU, C-34/10, 2011)A human embryo includes any human ovum from fertilisation and any non-fertilised ovum obtained by nuclear transfer or parthenogenesis; an invention whose implementation requires the prior destruction of human embryos is excluded from patentability, including for research purposes.
- The Scripps Research Institute, disclosed disclaimers (EPO, G 2/10, 2011)A disclaimer excluding subject-matter disclosed in the application as filed infringes Article 123(2) EPC if the subject-matter remaining in the claim is not directly and unambiguously disclosed; this calls for a technical assessment of the case.
- Monsanto Technology v Cefetra (CJEU, C-428/08, 2010)Article 9 of Directive 98/44 does not protect a patented DNA sequence contained in soy meal in which it no longer performs its function; it exhaustively harmonises protection and precludes absolute national protection of the sequence, including for patents predating the directive.
- Abbott Respiratory, dosage regime (EPO, G 2/08, 2010)Article 54(5) EPC does not exclude patenting a known medicament for a different treatment of the same illness, even where the dosage regime is the only novel feature; Swiss-type claims are no longer available where novelty lies only in the new therapeutic use.
- Wisconsin Alumni Research Foundation (EPO, G 2/06, 2008)Rule 28(c) EPC applies to pending applications and forbids the patenting of products which, at the filing date, could be obtained only by destroying human embryos, even if that method is not claimed.
- Johns Hopkins University, GDF-9 (EPO, T 1329/04, 2005)As the application did not make it at least plausible that GDF-9 solved the stated problem, inventive step was denied; post-published evidence cannot be the sole basis for that showing.
- The Salk Institute for Biological Studies v Karo Bio and Astra (EPO, T 609/02, 2004)A therapeutic use claim is insufficiently disclosed where the patent gives only a vague indication of a possible medical use for a compound yet to be identified; later evidence cannot remedy that insufficiency.
- Priority and the “same invention” (EPO, G 2/98, 2001)Priority of an earlier application is acknowledged for a claim only if the skilled person can derive its subject-matter directly and unambiguously, using common general knowledge, from the previous application as a whole.
- Eisai, second medical indication (EPO, G 5/83, 1984)A claim to the use of a substance for the treatment of the human or animal body by therapy cannot be granted; a patent may be granted with claims to the use of a substance for the manufacture of a medicament for a specified new and inventive therapeutic application.