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Gianna Perino - Second medical use Patente

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Gianna Perino

Second medical use Patente

Series: Schriften zum geistigen Eigentum und zum Wettbewerbsrecht

Volume 120 2020

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Drittes Kapitel: Second medical use Patente S. 154-288

„… , in: Bühling, Second Medical Uses, S. 15 f. Drittes Kapitel: Second medical use Patente 162 dikation …” „… Second medical use Patente Einführung „Für kaum eine andere Industrie hat der Patentschutz […] eine …” „… Wirkungen sog. second medical use Patente im Arzneimittelrabattvertragssystem. Drittes Kapitel: A. 609 …”

Viertes Kapitel: Second medical use Patente im Arzneimittelrabattvertragssystem S. 289-333

„… Second medical use Patente im Arzneimittelrabattvertragssystem Im folgenden vierten Kapitel sollen …” „… den für second medical use Patente entwickelten Verletzungsmaßstab einzuordnen sind. Darüber hinaus …” „… Herausforderungen eines Zusammentreffens von second medical use Patenten und Arzneimittelrabattverträgen befasst …”

Thesenartige Zusammenfassung der wesentlichen Ergebnisse S. 465-476

„… Gestaltungsmöglichkeiten besteht kein Unterschied zu dem zuvor Gesagten. 6. Second medical use Patente stellen eine …” „… rechtlichen Bedingungen von second medical use Patenten durch eine langjährige wissenschaftliche …” „… wesentlichen Ergebnisse 466 ge eine Rolle bei der Einführung von second medical use Patenten. Sie sollen einen …”

Einleitung S. 27-35

„… Arzneimittelmarkt teilnehmen zu können, wenn ein second medical use Patent und ein Arzneimittelrabattvertrag i.S.v …” „… medical use Patenten, die als Ausnahme vom absoluten Stoffschutz alleine im medizinischen Bereich …” „… die Interessen des Inhabers des second medical use Patents und die dahinterstehenden gesetzgeberischen …”

Titelei/Inhaltsverzeichnis S. 1-26

„… Second medical use Patente Gianna Perino und ihre Bedeutung für die Marktteilnahme von …” „… _7679-5.indd 2 05.10.20 14:17 Gianna Perino Second medical use Patente und ihre Bedeutung für die …” „… – Indikationspatente b) 165 Erste medizinische Indikation – first medical use Patent aa) 166 Zweite medizinische …”

Fünftes Kapitel: Lösungsansätze zur erfolgsversprechenden Gestaltung des Arzneimittelrabattvertrags- und Patentverletzungssystems S. 334-464

„… Kombination mit der Existenz eines second medical use Patents eine rechtlich ungerechtfertigte …” „… medical use Patente gerade dadurch amortisiert werden können, dass kein zusätzliches Arzneimittel auf den …” „… sie eine dem second medical use Patent unterfallende Krankheit behandeln, auch de lege lata eine …”

Literaturverzeichnis S. 477-505

„… ärztlichen Verschreibungsverhaltens bei der Verletzung von Second Medical Use-Patenten, Gewerblicher …” „… , Philipp/Paheenthararajah, Kokularajah: Durchsetzung von Second-Medical- Use-Patenten nach der …” „… Second Medical Use-Patenten II - Entwicklung im Lichte von „Lyrica“, „Pemetrexed“, „Östrogenblocker“ und …”

Erstes Kapitel: Grundlagen S. 36-60

„… wurde. Einführung Die Fragestellung, ob im Zusammenspiel von second medical use Patenten und …” „… Arzneimittelbegriff. Arzneimittel sind Anknüpfungs- und Bezugspunkt für second medical use Patente und …” „… von second medical use Patenten und Arzneimittelrabattverträgen unzulässig erschwert bzw. gänzlich …”

Zweites Kapitel: Arzneimittelrabattverträge nach § 130a Abs. 8 SGB V im System der gesetzlichen Krankenversicherung S. 61-153

„… labelling) nicht möglich, sodass insbesondere second medical use Patente durch die Substitutionspflicht …” „… Weise insbesondere second medical use Patente zu umgehen.331 Nach der aktuellen Rechtslage spielt es …” „… : Meier/Czettritz/Gabriel/Kaufmann, Pharmarecht, § 13 Rn. 8; allerdings kann die Involvierung eines Patents zu durchaus gravierenden …”

doi.org/10.5771/9783748910541

Maximilian W. Haedicke, Henrik Timmann - Patent Law

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Maximilian W. Haedicke (ed.), Henrik Timmann (ed.)

Patent Law

Series: Kooperationswerke Beck - Hart – Nomos

Volume 2014

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Maximilian Haedicke, Henrik Timmann Direct use of a patent S. 786-806

„… sense of the word must be distinguished from usepatents, in which the use of a patent must be judged …” „… section 9 sentence 2 PatG. The precondition for thedirect use of a patent is not only a use action within …” „… liewith someone who has not performed an action of direct use. In the case of the indirectuse of a patent …”

Maximilian Haedicke, Henrik Timmann Indirect use of a patent S. 806-823

„… obtained with the aid of thepatented process.1913. Employing use patents in the form of a “manifest …” „… arrangement”71In use patents, the prevailing opinion is that the protection extends far back into …” „… doesnot only concern patents in the field of medicine, but applies to use patents of all kinds.The case …”

Titelei/Inhaltsverzeichnis S. 1-53

„… ) .............................................................................. 715§ 8. Use of a patentA. General (Haedicke/Tı´mmann …” „… ) ..................................................................................... 733B. Direct use of a patent (Haedicke/Tı´mmann …” „… ) ............................................................ 733C. Indirect use of a patent (Haedicke/Tı´mmann …”

Dietrich Kamlah Injunctive relief (Kamlah) S. 949-957

„… patent-infringing products it establishes a risk of bringing to market, use,possession and, in the presence of …” „… . Legitimate use of a patent that forexample is justified through a licence agreement or exhaustion triggers no …” „… ,s.1 PatG). Patent infringement requires unlawful use of the patent. There is thereforeonly a risk of …”

Dietrich Kamlah Claims for unjust enrichment and claims for compensation S. 974-978

„… 21:45:223B2 9.1.580; Page size: 160.00mm 240.00mmclients use the patent. The damages are therefore to be …” „… requires establishingthe actual extent of the clients’ use of the patent.209140In principle there is a …” „… use that exploits the patent.210 In any case thecreditor can seek concomitant damages such as the cost …”

Felix Landry Opposition proceedings S. 554-595

„… available to the public “by use, orin any other way”.715 Therefore, a patent can be opposed on the basis of …” „… 240.00mm1207 If the patent proprietor contests the prior use in full or at least with respect to …” „… claim directed to the use of the product.1217 If the patent proprietor only requests that the patent be …”

Marco Stief, Dirk Bühler Effects of the patent S. 768-784

„… , this would not constitute an infringement of the patent, but rather a permitted use.462 It is …” „… is relaxed for the benefit of alawful use of the biological material, the danger for the patent …” „… patent.IV. Use for agricultural purposes, § 9 c PatG1. General159The farmer’s privilege of § 9 c PatG is an …”

Dietrich Kamlah Claim for damages (Kamlah) S. 957-974

„… to the patent’s use.Rather, the royalty rate is established according to objective criteria using …” „… beenappropriate for use of the patent, if the infringer had sought a licence. The amount isultimately an objective …” „… image is image transfer,which is not usually based on the patent infringement but on the use of other …”

Maximilian Haedicke Licenses S. 364-386

„… usetheir respective patents of their technology portfolio and where said granting of use is thesole …” „… authorize several individuals to use the patent.59 See in more detail below 4 mn. 86.60 Mes 15 mn. 70.61 …” „… negative license isthe case of a patentee freely granting use of his patent (i. e. technology pools …”

Maximilian Haedicke Patent law and neighbouring legal fields S. 72-81

„… patent proprietor by means of privatelaw, and the inventor’s freedom to make use of it, represent the …” „… crucial forcases of unjustified use of a patent. Compensation for damages according to sec. 139 etseqq …” „… . PatG are aimed at restoring the damage caused to the patent proprietor due to theunjustified use …”

Maximilian Haedicke Patent law and competition law S. 81-107

„… can e. g.prohibit restrictions on competition by means of a patent if the use of the patent hasnothing …” „… means of restricting competition. In general,the use of a patent has to respect the restrictions of …” „… competition law. Competition lawcan, in principle, restrict every possible use of the patent. Even exercising …”

Maximilian Haedicke Ambit, meaning, goals and means of patent law S. 54-60

„… the patent or choose not to use it at all.3 Once a successful application has been filed, a patent …” „… transferred and economically used, as theyare ubiquitous and universally useable. By the same token, patents …” „… globalization, but also from legalauthorities. A general concern has risen questioning the actual use of patent …”

Maximilian Haedicke, Henrik Timmann General S. 784-786

„… 21:41:353B2 9.1.580; Page size: 160.00mm 240.00mm§ 8. Use of a patentContents:Mn.A. General …” „… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1B. Direct use of a patent …” „… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21. Patents as monopoly rights and positive rights of use . . . . . . . 22. Rights of use when …”

Maximilian Haedicke Common foundations of patent transfer and licensing S. 350-360

„… third party. As such, the efficientexploitation of a patent might require the parallel use of the …” „… several “patent families” together with technical know-how, trademarks, the right to the use of the name …” „… disposition – i. e. the patent transfer or the granting of rights of use – are to beassessed separately. This …”

Johannes W. Bukow Prior use law according to Section 12 PatG S. 871-887

„… impact on his position of exclusivity. The prior user is permitted to use theteaching of the patent only …” „… use(possibly with compensation to the patent proprietor).347 The BGH disagreed in principle,pointing out that …” „… patent can only be used in defence ofsomeone who has exclusively used its teaching and has not made use …”

Maximilian Haedicke Relevant sources of law S. 65-72

„… patent law through the use ofregulations has occurred mainly with the extension of patent protection by …” „… 21:24:143B2 9.1.580; Page size: 160.00mm 240.00mmIPRED covers not only patent law but also copyright law …” „… has been passed modernizing the Patent Act.57 This law simplifiesthe procedures before the German …”

Marco Stief, Dirk Bühler Substantive granting prerequisites S. 1099-1108

„… this context, it is irrelevantwhether the basic patent is a product patent or a process or use patent …” „… patent.This so called infringement test was used by the Federal Court in the Sumatriptandecision in which an …” „… scope of protection of the original patent, in thescope of the authorised uses, Art. 4 RegSPC. Thus, the …”

Raph Nack, Joel S.H. Nägerl, Lorenz Walder-Hartmann Differentiation from the state of the art S. 182-260

„… all further specificmedical uses that are new and inventive (known as “second medical use”, Patent …” „… description, by use, or in any other way, before thedate of filing of the patent application (Patent Act …” „… address a manufacturing orworking method or address a use.545, 546 All independent patent claims must be …”

Maximilian Haedicke, Henrik Timmann Liability and imputation S. 823-840

„… of use patents is not an obstacle to at least continuingto apply in full the element of risk …” „… et seq. (destruction andrecall).§ 8. Use of a patent§ 8 128770 Haedicke/Tı´mmannReemers Publishing …” „… Ebay.352 See Leistner GRUR-Beil. 1/2010, p. 4 et seq.§ 8. Use of a patent§ 8 133–135772 …”

Axel Verhauwen Criminal patent law S. 1010-1020

„… restrictive use in those caseswhere at the very least a ruling has been handed down by a patent infringement …” „… patent application is not punishable as a matter of principle,because its use is not unlawful.10 The use …” „… whether literal orequivalent use of the patent has been made. To this extent, the usual …”

Marco Stief, Dirk Bühler General, purpose, history and legal character of the certificate S. 1088-1099

„… merely a new use was discovered.13 The patent issued on this, however, does notconvey an independent …” „… this context, it is irrelevantwhether the basic patent is a product patent or a process or use patent …” „… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6II. Relationship between grant of the patent and authorisationunder pharmaceutical law …”

Marco Stief, Dirk Bühler Rights, limitations and obligations S. 1123-1128

„… the SPC.I. Rights of the certificate holder1. Rights of use and exclusivity118Just like the patent …” „… able to use the subject of the patent just as it did before afterexpiration of the basic patent without …” „… . 11–13 PatG. Prior rights of use in the basic patent continue in theSPC.265138 Limitations due to …”

Marco Stief, Dirk Bühler Introduction and development S. 716-725

„… § 9 sentence 2 no. 1 to 3 PatG. Utility patents, which are alsoreferred to as use patents, are not …” „… too extensive, as in this case, the use wouldgenerally be reserved to the patent holder. This would …” „… animalsand the use of stem cells and embryos are exempted from patent protection in § 2 para. 2nos. 1 to 4 …”

Dietrich Kamlah Claim for recall and destruction S. 993-998

„… indirect patent infringer only infringewhen allocated to patent use, the prior possessors and suppliers …” „… to be drawn between destruction before and after the patent expires. Ifthe marketing or use of the …” „… very low. If atthe time of destruction the patent has already expired the court may use its discretion …”

Maximilian Haedicke Inventor and inventor right S. 294-300

„… applies for the same patent. In this respect theinventor is protected by his right of prior use (sec. 12 …” „… entitles the inventor to use the invention. This right of useremains even when an entitled third party …” „… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10V. Right of invention and right to a patent . . . . . . . . . . . . . . . . . . . . . . . . . . 141 …”

Marco Stief, Dirk Bühler Scope of protection and types of claims S. 748-768

„… use claims.261 In this case, the patent does not protect the substance assuch, but only as related to …” „… the patent.262 Example: “Use of substance Z asantirust agent.”26391The so-called “purpose-bound …” „… mode ofmanufacture or (only) one use is described in the patent description.270259 In this sense BGH …”

Dietrich Kamlah Claims for information and accounts S. 978-993

„… infringement or use. Volume and date of the manufacture, delivery or offering ofthe patent-infringing goods …” „… patent infringer.8. Information on traffic data209If patent infringement involves the use of …” „… compensationfor use of patent applications before grant against indirect patent infringers, insofar noinformation …”

Maximilian Haedicke Multiple owners S. 300-325

„… , thefiling of a patent and the use of the invention based, for example, on the granting of alicence.140 …” „… object in accordance with the patent, as well as use in theform of licensing. If one of the inventors …” „… patent law also overlaps with section 708 BGB.157 In any case, the use ofthe invention by a partner for …”

Marco Stief, Dirk Bühler Subject matter and scope of protection S. 1113-1123

„… themedicinal product for human use and for the veterinary medicinal product, were basedon the same basic patent …” „… than the salt forms specifically authorised are used.185Conversely, by way of the SPC the patent holder …” „… patent; secondly, the protection only coversthe applications listed in the marketing authorisation, Art …”

Henrik Timmann The importance of the patent specification as a source for interpretation S. 671-693

„… may therefore characterise a patent as a use patent.146 The person skilled inthe art will, however …” „… patent delimits itself from the stateof the art precisely by the nature of the use made of the subject …” „… direct use made of the patent onthe part of the distributor.15379In the case of process patents, the …”

Raph Nack, Joel S.H. Nägerl, Lorenz Walder-Hartmann Catalogue of exclusions (Section. 1 para. 3–4 PatG resp. Art. 52 para. 2–3 EPC) S. 143-177

„… ”. Thescope of protection in a corresponding use patent (use of metallic selenium for thepurpose of light …” „… having to develop a novel andreproducible propagation method.187 Patent protection for varieties of …” „… ofimmaterial goods law as a function of patent law aims primarily to increase the publicgood by promoting …”

Maximilian Haedicke Recovery of inventors’ rights (rei vindicatio) S. 325-350

„… rights may also be used as a defencein a patent infringement trial. Relying on section 242 BGB, the …” „… use.VI. Usurpation as a ground for revocation in German opposition proceedings203 In German law …” „… mutandis. In particular, a nullity suit based only on usurpation cannotbe used to have a patent declared …”

Felix Landry Nullity proceedings S. 622-647

„… , IntPatU¨G). The rules as applied toGerman parts of European patents make full use of the competence …” „… International Patent Conventions).943This ground for nullity exists if an act of use can be named which is …” „… claimed953 and the patent is attacked tothe same extent. In this context, it is of no use for the claimant …”

Axel Verhauwen Allegation of entitlement and misleading advertising S. 1036-1044

„… product did not involve the use of said patents.102127 The scope of protection provided by the patent is …” „… The fact that no patent has been found to be infringed can be used in a suit (action forthe cessation …” „… yet enforceable, a reference to a patent may still be used inadvertising.107 This is also the case if …”

Marco Stief, Dirk Bühler Prerequisites for patent registration S. 733-748

„… des Kriteriums der “Totipotenz”, GRUR 2011, 661; Leverve,Patents on Genes, Usefulness and the …” „… discussions in literature.165 Accordingly, EPO case law used to grant socalled manufacture/use claims …” „… be certain exemptions for uses for research purposes. In the course of the “Bru¨stle”-Patent which …”

Maximilian Haedicke Historic development S. 60-65

„… through the use of patent lawremains very improbable. As a whole, the current patent law system has proven …” „… concerning the protection ofimmaterial goods.16 Also, they claim that the adverse effects of patents are …” „… TRIPS-agreement to lightenthe requirements for developing countries and grant them accessibility to patents …”

Johannes W. Bukow Permitted acts under Section 11 PatG S. 840-857

„… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1472. Use after expiry of a patent and effective restitutio inintegrum (Section 123 Para. 5 PatG …” „… . – Klinische Versuche II.16 The effect of the patent after § 11 Nr. 2 a PatG does not extend to: “the use of …” „… series of trials aimed at thenobtaining use patents in respect of the indications discovered in the …”

Marco Stief, Dirk Bühler Calculation of term S. 1108-1113

„… , there is no possibility for a (legal) use of the pharmaceuticalinvention prior to the patent grant …” „… prohibits the grant of multiplecertificates for the same product in case of different basic patents with …” „… only has to transfer one of its basic patents to a third party in duetime in order to achieve this. If …”

Dietrich Kamlah Creditors and debtors of claims for infringement (Kamlah) S. 940-949

„… patent extend as far as his exclusiveright of use. The time, territorial and objective limits to the …” „… benefit from the patent. If the patentee can exploit the patent, he hasnot ceded the right to use the …” „… infringement must be illegal. Legitimate use of a patent that forexample is justified through a licence …”

Johannes W. Bukow Exhaustion S. 857-871

„… of use covered by patent law. The patentproprietor retains only the right to prohibit new manufacture …” „… use the machinery in the first place) on thegrounds that the proprietor of the device patent is also …” „… exclude other competitors, he has already enjoyed the advantagesbestowed by the patent and hence used up …”

Johannes W. Bukow Fraudulant abstraction S. 900-904

„… third route in the form of a right ofcontinued use.F. Objection of a compulsory licence under antitrust …” „… point of view, relating to summary proceedings one has to notethat alleged nullity of the patent cannot …” „… expectedto initiate separate proceedings to attack the validity of the patent. If it would beunreasonable for …”

Axel Verhauwen Claims arising from unjustified warnings of property right infringement S. 1044-1052

„… that thelatter can ascertain the patent use situation with the necessary legal certainty.146Apart from …” „… user may avail himself. For example, the party receiving the warningmay have been granted a prior use …” „… asserted in injunction proceedings. This isconsidered a patent dispute within the meaning of section 143 …”

Marco Stief, Dirk Bühler Protection: Subject-matter and prerequisites S. 1057-1064

„… written description, the same principles as in patent law apply.24 By contrast, the obvious prior use is …” „… literature and jurisdiction use the term inventive step for describing what isrequired to match the patent …” „… manufactured or used in any commercial field including farming. There are nodifferences to patent law (§ 5 PatG …”

Raph Nack, Joel S.H. Nägerl, Lorenz Walder-Hartmann The “Technical Invention” criterion S. 112-143

„… 21:28:083B2 9.1.580; Page size: 160.00mm 240.00mm§ 2. Inventions and their amenability to patent …” „… “technical” art in patent law: Tradition Theory . . . . . . . . . . . . 651. Principle …” „… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182b) Requirement of linkage to a purpose in the patent claim 184VII. Aesthetic creations …”

Raph Nack, Joel S.H. Nägerl, Lorenz Walder-Hartmann Realisability and sufficiency of disclosure for realisability S. 260-294

„… said notion, the disclosureof an application or a patent, at least when used as a prior right, is the …” „… excessive reward to the inventor,which is to be avoided.1521 If general wording used in a patent claim …” „… problem, which are not, however, reflected in the patent claims,then these objectives are not to be used …”

Maximilian Haedicke Full transfer of patents S. 360-364

„… the use of the purchased object.45 In some cases, the lack in usability can lead to a loss of patent …” „… immaterial good. This means, if a work piece asspecified by the patent, which is to be used as template for …” „… 21:31:103B2 9.1.580; Page size: 160.00mm 240.00mmB. Full transfer of patentsI. General35Patents can be …”

Maximilian Haedicke Patent law and the European Single Market S. 107-112

„… of the internal market. Inrecognition of the competition-promoting effect of patents, their use on …” „… theinternal market infringing use of patents and other intellectual property rights is drawnby Art 34, 36 TFEU …” „… from oneanother in a significant way.347201Patents must not be used in a way that contradicts the aims …”

Axel Verhauwen The European Patent with unitary effect S. 1005-1010

„… the European Institutions, will no longer be used.“EU Patent” is misleading anyway because not all …” „… size: 160.00mm 240.00mmcontains substantive provisions on the direct patent use of the invention …” „… (Article 6), itsindirect use (Article 7) and restriction of the unitary patent (Article 8). If these had …”

Johannes W. Bukow Defence of invalidity S. 887-900

„… patent now being used against himbefore starting to use the invention, which usually means before the …” „… infringement courts. An infringercan challenge the validity of the patent being used against him in the …” „… case. If the nullity action is based on public prior use,the threshold for the infringer is higher …”

Felix Landry The proceedings for grant S. 386-554

„… patent claims may also be used to satisfy thisrequirement, which is laid down in Art. 83 EPC, they …” „… 21:36:233B2 9.1.580; Page size: 160.00mm 240.00mm§ 5. Grant and rejection of patentsContents:Mn.A. The …” „… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13a) Two ways to file a European patent application:Direct application and Euro PCT application …”

Henrik Timmann Extension of the scope of protection to equivalents S. 700-716

„… 9.1.580; Page size: 160.00mm 240.00mmif the more recent patent (necessarily) makes use of the teaching of …” „… intended use that gave riseto the allegation of patent infringement.388187 The definition of the state of …” „… teaching described in the patent and placed under protection.Equivalence considerations must not be used to …”

Johannes W. Bukow Objection of a compulsory licence under antitrust law S. 904-933

„… assertedthat the claimant should be obliged to allow it joint use of the patent in suit free ofcharge. The …” „… patent in suit. Indefence of their assertion of a right to joint use, free of charge, the defendant …” „… patent Court.525According to the Federal Court of Justice, there is no exclusive use of these instruments …”

Henrik Timmann Basic outline S. 658-671

„… 21:38:443B2 9.1.580; Page size: 160.00mm 240.00mmclarify the technical terms used in the patent …” „… protection.76 On the other hand, whether and in what way the patent proprietor or his licensees usethe patent …” „… patent is to be understood as that defined by the strict, literal meaning of the wording usedin the …”

Raph Nack, Joel S.H. Nägerl, Lorenz Walder-Hartmann The “industrial applicability” criterion S. 177-180

„… at thattime, patents were granted for inventions “that are novel and allow for industrial use.”301 …” „… Biotechnology Directive 98/44/EG.315The use of an invention by the patent proprietor himself must naturally be …” „… patent law420)295 Appeal Boards have applied the bar to patentability in two cases relating to …”

Raph Nack, Joel S.H. Nägerl, Lorenz Walder-Hartmann Obstacles to protection S. 180-182

„… patent protection, on the otherhand, does not mean that the use of the invention is in any way forbidden …” „… issued in the implementation process for the Biotechnology Directive 98/44/EG.315The use of an invention …” „… by the patent proprietor himself must naturally be within thecompass of the law (section 9 sentence 1 …”

Marco Stief, Dirk Bühler Formation and expiration of the utility model S. 1065-1076

„… and Art. 3no. 2 of the second German Patent Act Amendment Act (2. PatGA¨ndG) of 16 July1998.103 § 4 a …” „… utility model applicants can be obtained from the GermanPatent and Trademark Office (DPMA) which provides …” „… of patent grant proceedings.2. Form and contents of the application48 § 4 GebrMG does not provide for …”

Axel Verhauwen Border seizure proceedings S. 1020-1036

„… a position to verify that the use of the individual features of therelevant patent claims are …” „… a patent use within the meaning of sections 9and 10 PatG.71 BGH GRUR 2009, 1142 – MP3-Player-Import …” „… significantlydifferent to the examination criteria used in patent infringement proceedings. Customsauthorities are not in …”

Felix Landry Lapse without retroactive effect S. 655-658

„… suchlapse.I. Failure to designate the inventor1771 If an applicant for a German patent makes use of the …” „… the scope of examination is thesame as in the granting procedure.1076 Therefore, the Patent Division …” „… by appealabledecision. Reasons for the decision only need to be given if the Patent Division comesto …”

Dietrich Kamlah Publication of a judgment S. 1001-1004

„… penalty against the patent infringer thatneeds to be used extensively for reasons of general prevention …” „… of a judgment268 According to Section 140 e PatG the court in a patent case may if requested grant …” „… and authorities. When being implemented into Patent Actthese measures were mostly defined as claims …”

Marco Stief, Dirk Bühler Content and scope of protection of the utility model S. 1076-1079

„… proceedings101The question of whether the costs for the patent lawyer retained in addition to theacting …” „… cases, e. g. if the legal know-how tobe expected from a patent attorney is not sufficient in case of …” „… use and negative rights to prohibit. The positive right of use isgoverned by § 11 para. 1 sentence 1 …”

Felix Landry Limitation and revocation proceedings S. 647-655

„… . Failure to designate the inventor1771 If an applicant for a German patent makes use of the possibility to …” „… 1718 A patent proprietor may for various reasons be interested in limiting and amendingor even revoking …” „… the patent with retroactive effect at any time after the grant of aGerman or European patent. This is …”

Felix Landry Appeal proceedings S. 595-622

„… character of the appeal procedure. In particular, the Federal PatentCourt may not ex officio make use of any …” „… user acting in goodfaith has the right to continue making use of the invention which is the subject of …” „… 21:37:233B2 9.1.580; Page size: 160.00mm 240.00mmthe patent is transferred to a new proprietor during the …”

Marco Stief, Dirk Bühler General S. 1052-1057

„… Patent-, Gebrauchs- und Geschmacksmusterrechts, GRURInt. 1990, 675; idem., Gebrauchsmusterreform auf …” „… verlangen?, GRUR 1950, 359;v. Falck, Einstweilige Verfu¨gungen in Patent- und Gebrauchsmustersachen, Mitt …” „… , Gebrauchsmustergesetz, GRUR 1998, 749; Rogge, Einstweilige Verfu¨gung in Patent- und Gebrauchsmustersachen, in …”

Marco Stief, Dirk Bühler Unjustly claiming a utility model S. 1086-1088

„… reference to a patent, even though in fact, only a utility modelwas registered.260 It is also misleading to …” „… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6II. Relationship between grant of the patent and authorisationunder pharmaceutical law …” „… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133. The early patent application …”

Marco Stief, Dirk Bühler Definitions, exceptions and special cases regarding biological inventions S. 725-733

„… manufacture and their use. The patent claims and/or claim categoriesmust be chosen depending on the type of …” „… umweltschonendeProzesse, 2008; Ensthalter/Zech, Stoffschutz bei gentechnischen Patenten – Rechtslage nach Erlass …” „… invention, termed as substance, process andutility patents. The granting prerequisites and protective …”

Marco Stief, Dirk Bühler Grant procedure S. 1128-1137

„… of the basic patent are alsosubject to Art. 5 RegSPC. As in the case of the license grant, however …” „… information obligation in the context of unjustly claiming a patent(sec. 146 PatG) is also an obligation …” „… situation, neither the supplementary protectioncertificate nor the basic patent can be granted as a uniform …”

Marco Stief, Dirk Bühler Inventor’s rights and invention ownership S. 1064-1065

„… forthe law of utility models as compared to patent law (in particular because § 13 para. 3GebrMG makes …” „… . In patent law, theprotection of the inventor’s moral rights is illustrated e. g. by the fact that the …” „… . 3 PatG) and in the publication of the patent grant (§ 58 para. 1PatG) […]”. If the inventor is not …”

Marco Stief, Dirk Bühler Utility models in business transactions S. 1079-1080

„… cancellation correspond to those of the partialrevocation in patent law (§ 21 para. 2 PatG). By contrast, cf …” „… prerequisites of the unlawful usurpation.4. Further objections118 Just as in patent law, the infringer may …” „… right of use regarding its own seniorright, a right of prior use or the exhaustion of the utility model …”

Johannes W. Bukow Forfeiture of rights S. 933-940

„… any case,patent protection is limited to a period of 20 years. If this defence were to be used …” „… known from the use of a general objection withrespect to the principle of good faith (Section 242 BGB …” „… ) under “general” civil law and isalso disclosed in patent law.738 It is generally recognised, however …”

Henrik Timmann The importance of sources outside the patent specification S. 693-700

„… 21:38:523B2 9.1.580; Page size: 160.00mm 240.00mmC. The importance of sources outside the patent …” „… specification125 Since a patent contains requirements which are binding on the entire industry andpublic, its …” „… purposes if the patent specification refers to themand bases itself on them for its own understanding261 or …”

Dietrich Kamlah Statute of limitation for the claims S. 998-1001

„… reputation.IV. Recall and destruction claims in the case of indirect patent infringement255The creditor may not …” „… claim destruction against the indirect patent infringer.318 This isbased on the wording of Section 140 a …” „… Paragraph 1 PatG that limits the destructionclaim to products that are “subject matter of the patent”.319 …”

doi.org/10.5771/9783845259024

Monica Donghi - Patent Strategy in Pharmaceutical Industry: Are additional patents valuable?

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Monica Donghi

Patent Strategy in Pharmaceutical Industry: Are additional patents valuable?

Series: Munich Intellectual Property Law Center - MIPLC Studies

Volume 20 2014

Results in this title

Use of Procedural Provisions: Supplementary Protection Certificates (SPCs)/Patent Term Extension S. 27-30

„… , docetaxel is still part of the widely used first line therapy. Cabazitaxel currently finds more use in …” „… patent families dealing with novel derivatives of taxoids.54 This research work successfully led to the …” „… the patent WO 96/30335 (oral formulation WO 00/41482). Despite attempts to switch to the new therapy …”

Innovation Tracks S. 45-62

„… EPO granted to Eisai a patent (in the so-called Swiss-type claim form) for a second pharmaceutical use …” „… patent protection on a compound by means of a second medical use claim might be restricted. The fact that …” „… patent.204 The scope of such patents is also limited to the specific new use. Originator companies might …”

Use of Procedural Provisions S. 37-39

„… unity and was then abandoned.95 Use of Procedural Provisions Divisional of Basic Patent The basic patent …” „… , the patent now claims the use of Xalatan in speficic amounts for a specific indication.98 …” „… paediatric use additional 6 month protection period may be obtained, when the holder of a patent or a …”

Titelei/Inhaltsverzeichnis S. 2-10

„… Processa) 23 Formulationb) 24 Combination Therapyc) 25 New Usesd) 26 Derivativese) 27 Use of Procedural …” „… Usesd) 36 Delivery Devicese) 36 Packaged Productf) 37 Use of Procedural Provisions3. 37 Divisional of …” „… Patent Strategy in Pharmaceutical Industry: Are additional patents valuable? Nomos BUT_Donghi_0991-5 …”

Xalatan SPC Request: a Case for Competition Law? S. 62-66

„… case and the Pfizer case should warn dominant companies that, by making use of the patent and/or …” „… the patents connected to it stem very often by more specialized companies as shown in the Xalatan …” „… case study. As already mentioned,215 QLT inc. was one of the more prolific players regarding patent …”

Patent Portfolio S. 23-27

„… been filed.48 For example, patent application WO 03/097164 A149 covers the use of docc) 42 EP 0593601 B …” „… Patent Portfolio Process The synthetic procedure, disclosed in the basic patent family, while allowing …” „… address this issue as can be seen by the large number of successive patents in this area. E.g. EP 0336841 …”

Patent Portfolio S. 33-37

„… reduction is more tedious being based on the use of protecting groups.80 The last patent of the originator …” „… unity and was then abandoned.95 Use of Procedural Provisions Divisional of Basic Patent The basic patent …” „… however, progressed to a granted patent as they all result to be withdrawn in the European phase. New Uses …”

Lifecycle Management: Criticism and Supports S. 42-45

„… Management: The Link to Drug Delivery, 2 Drug Deliv. Tech. 158, (2002). 110 Leighton Howard, Use of patents …” „… few years, patent exclusivity will expire for drugs with combined annual sales of $140 billion.”108 …” „… companies have the ability to obtain multiple patents on a drug which in turn leads to an effective …”

Summary: Taxotere v Xalatan S. 69-72

„… this way the problem of off label use could be avoided. Finally, because these secondary patents are …” „… trials and market authorisation was obtained. However, the patent family protecting this improvement got …” „… of the patent application and especially its claims which on one hand did not take sufficient account …”

Periodical Materials in English S. 77-80

„… , 31 J. Health Econ. 327, (2012). Leighton Howard, Use of patents in drug lifecycle management, 4 J …” „… /Supplements/EPOsecond-medical-use-claims-The-skinny-SmPC-loophole.html?supplementListId=83781. Christian Sternitzke, Knowledge sources, patent protection, and commercialization of …” „… week 40, 12 Curr. Pat. Gaz. 1, (2009). Anonymous, Patent expiries to hit glaucoma drug market growth …”

Final Remarks S. 73-76

„… , critics of this business model argue that secondary patents prolong the monopoly the originator holds on a …” „… in cases of examples where secondary patents led to commercial success, like the protection of …” „… patent does not constitute a unilateral advantage for the originator company.263 This is for two reasons …”

Conclusion S. 30-32

„… months) for the treatment of solid tumours extended the patent protection of Taxotere to November …” „… 2010.70 Conclusion In its patent strategy Sanofi-Aventis focused mainly on three innovation tracks …” „… : formulations, combinations and process. Use of SPCs was also important to prolong in Europe and in the U.S. the …”

Patent Strategy and Innovation S. 66-69

„… might fall under scrutiny of competition law and incur a fine. The use of certain ways of action …” „… companies to provide such drugs, therefore the ICA point of view cannot be shared and Pfizer’s use of …” „… paediatric extension should have not been penalized. Patent Strategy and Innovation The main criticisms on …”

Conclusion S. 39-41

„… paediatric use additional 6 month protection period may be obtained, when the holder of a patent or a …” „… in Italy, where the patent term was due to expire in September 2009, 20 years after the patent …” „… application had been filed. In the United States latanoprost was covered by the patent US 5,296,504 which had …”

General S. 21-23

„… Case Studies-Facts This section will discuss patent strategies that companies undertake in the …” „… course of developing a drug. This study will be conducted by highlighting the patent portfolio of two …” „… randomly selected successful drugs whose basic patent protection has been expired: Taxotere® and Xalatan …”

Conclusion and Suggestions S. 72

„… of off label use could be avoided. Finally, because these secondary patents are often a weak strategy …” „… in the case of research on combination patents that aim to protect these results would be more useful …” „… studies is that subsequent patent applications by the respective originator companies failed to adequately …”

General S. 32-33

„… Figure 3: Top patent applicants for docetaxel (474 patents)74 Xalatan General Latanoprost (trade …” „… Reddy’s Laboratories and Shanghai Parling Pharma-Techco. Additionally, a number of patent applications …” „… 002.jpg Figure 2: Patent filing trends: docetaxel73 Bilder/image003.jpg Figure 3: Top patent …”

Others S. 83-84

„… Patentgesetz [German Patent Act] (1936, revised 1980, amended 2009) (Ger.); translated in World …” „… Intellectual Property Organization, Patent Law, http://www.wipo.int/ wipolex/en/text.jsp?file_id=238776 …” „… https://www.iqwig.de/download/A11-24_Extract_Cabazitaxel_Benefit_assessment_35a_Social_Code_Book_V.pdf. Sir R. Jacob, Patents and …”

Generic Drugs Approval. S. 19-20

„… for applying for a MA in a Member State do not constitute patent infringement under the so-called …” „… requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for …” „… medicinal products.”. 27 Stéphanie Michiels, Béatrice Holtz, Patent exemption for clinical trials: current …”

New Drug Approval Regulations S. 18-19

„… The different stages of the process exhibited in figure 1 show the registration of a patent …” „… this point it should not be left out of sight, that the filing of a patent application is preceded by a …” „… recognition procedure (MRP) is used.20 Article 3 and the Annex of the Regulation21 define the types of …”

doi.org/10.5771/9783845251288

Jurgita Randakeviciúte - The Role of Standard-Setting Organizations with Regard to Balancing the Rights Between the Owners and the Users of Standard-Essential Patents

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The Role of Standard-Setting Organizations with Regard to Balancing the Rights Between the Owners and the Users of Standard-Essential Patents

Series: Munich Intellectual Property Law Center - MIPLC Studies

Volume 27 2015

Results in this title

„… members and, later, charge excessive royalty fees for the use of the standard. 62 Patent ambush usually …” „… the use of its patents from JEDEC-compliant DRAM manufacturers at a level which, absent its …” „… used in this case, could be the difficult application of the Art. 102 TFEU to patent ambush …”

SSOs and Their Functions in Standardization S. 15-26

„… objectives usually are met. It should be mentioned, that technology developers often use patents to protect …” „… ‘‘Revisiting Standard-Setting Organizations’ Patent Policies’ [2004] 3 Northwestern Journal of Technology and …” „… Intellectual Property 43, 45. 9 Keith Maskus and Stephen A. Merrill (eds), Patent Challenges for Standard …”

Titelei/Inhaltsverzeichnis S. 1-10

„… Between the Owners and the Users of Standard-Essential Patents Jurgita Randakevičiūtė 27 Nomos MIPLC …” „… Regard to Balancing the Rights Between the Owners and the Users of Standard-Essential Patents Nomos …” „… with Regard to Balancing the Rights Between the Owners and the Users of Standard-Essential Patents …”

The Role of SSOs while Improving the Access to SEPs S. 39-56

„… situations that arise in the context of standardization, e.g. patent ambush, broad meaning of FRAND …” „… , which are designed to prevent SEP owners to engage in patent ambush and to maintain a level of …” „… patent owner, at an early stage of the standard-setting process, makes binding commitments on the royalty …”

Introduction S. 11-14

„… within standards.1 However, due to the fact that, usually standards are protected by patents …” „… (standardessential patents (SEPs)), standardization weakens competition and creates entry barriers into the market …” „… , such an attempt to provide implementers with the right to use SEPs while satisfying the financial …”

doi.org/10.5771/9783845264271

Piotr Kostanski - Die Schutzwirkung des Patents nach polnischem Recht

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Piotr Kostanski

Die Schutzwirkung des Patents nach polnischem Recht

Series: Rechtstransformation in der Europäischen Union

Volume 6 2010

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Summary S. 461-472

„… legal language isn’t used to the term of “acting patent right”. Because of this, in my work I will use …” „… be defined as secondary and as practice seems to indicate, they are seldom put to use. Patent …” „… effectively forbidding other persons to use the patent for financial or professional gain. In the essence, the …”

Beurteilung des Versuchsprivilegs nach Maß des internationalen Rechts und des Verfassungsrechts S. 419-425

„… person to make, construct, use or sell the patented invention solely for uses reasonably related to the …” „… infringement of a patent for any person who makes, constructs, uses or sells a patent ed invention in …” „… Art. 30 TRIPS zulässige Beschränkung der Schutzwirkung von Patenten muss der normalen Verwertung des …”

Entwicklung des Versuchsprivilegs S. 382-419

„… Affair”: Rethinking the Experimental Use Exception to Patent Infringement for Biomedical Research Tools …” „… Versuchszwecken“experimental use exception functions to promote progress”249Forschung und Fortschritt in der Wissenschaft und …” „… es in seinem Patent verkörpert ist, dar.“253 Der Patentinhaber darf also seine Erfindung der …”

Bestimmung des relevanten Gebietes S. 296-308

„… 2964. Räumlicher Geltungsbereich des PatentesAnders als Eigentumsrechte an materiellen beweglichen …” „… dem Territorialitätsprinzip ist das Prinzip der Unabhängigkeit3 von Patenten verbunden – nationale …” „… Patente entfalten ihre Wirkung unabhängig voreinander, auch wenn sie sich auf ein und dieselbe Erfindung …”

Beurteilung von Patentbeschränkungen nach Maß des internationalen Rechts und des Verfassungsrechts S. 330-363

„… 3305. Von der Wirkung des Patents ausgenommene BenutzungshandlungenDer Patentinhaber hat ein …” „… stehen die in Kapitel 2. behandelten Befugnisse zu. Der Inhalt des Patents ist durch das materielle …” „… . Ausschließlichkeitsrechte sind jedoch nicht uneingeschränkt4. Wie jedes subjektive Recht5 ist auch das Patent beschränkt …”

Einrichtungen an ausländischen Fahrzeugen und Transitprivileg S. 368-382

„… Privatleute über bestehende Patente nicht informiert sein müssen.Art. 9 Buchstabe a GPVO sieht diese Ausnahme …” „… Staatsautorität erteilt worden ist. Zwar verschafft das Patent seinem Inhaber das ausschließliche Recht, die …” „… im Recht aus dem Patent. Gäbe es kein Verkehrsprivileg, würde dann der Gebrauch der mit einem Patent …”

Literaturverzeichnis S. 487-510

„… ”: Rethinking the Experimental Use Exception to Patent Infringement for Biomedical Research Tools, Washington …” „… . 199, H. 5. Adam T., Der sachliche Schutzbereich des Patents in Großbritannien und Deutschland, Köln …” „… .Avery C. M., Das US- Patent, Leitfaden für Auslandsanmelder, Köln, Berlin, Bonn, München 196.Badowski J …”

Wirtschaftliche Gründe S. 204-211

„… Patent kann rein wirtschaftlich als „Gegenleistung für die Bekanntgabe der Erfindung an die …” „… wirtschaftlichen…, S. 36–3.24 W. Stieger: Das Recht aus dem Patent und seine Schranken, Bamberg 2001, S. 12.25 K …” „… Patenten auf 20 Jahre begrenzt hat. Schickedanz behauptet30, dass die Laufzeit von 20 Jahren noch immer …”

Geschichtliche Entwicklung S. 211-212

„… Erfindungen der ersten Gruppe einen niedrigeren Nützlichkeitsindex53, und der Gewinn aus einem Patent für eine …” „… Entwicklung dieser Institution. In den meisten Ländern Europas hat die Urgeschichte des Patents bei …” „… . T. Penrose: The Economics of the International Patent System, Baltimore 1951, S. 30.54 E. Berkenfeld …”

doi.org/10.5771/9783845226262

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