Das Manuskript eines Zeitschriftenartikels (Verfasser: Patentanwälte Dr. Tim Oppermann und Dr. Stefan Golkowsky) ist im Folgenden wiedergegeben. Es handelt sich hierbei um einen einführenden Artikel, der insbesondere für deutsche und europäische Patentanmelder wichtige Spezifika des US-Patentrechts auf dem Gebiet der Medizintechnik aufzeigt.

Umfassender Patentschutz für Medizinprodukte in Europa und den USA

Zur umfassenden patentrechtlichen Absicherung von Medizinprodukten sind Sonderregelungen zu beachten, die von Land zu Land variieren. Dies sollte bereits vor Einreichung einer Patentanmeldung beachtet werden. Die Autoren vertreten deutsche und US-amerikanische Unternehmen im Bereich der Medizintechnik und geben im Folgenden einen ersten Überblick hierzu.

Besonderheiten in den USA und Europa sind zu beachten

Generell gibt es keinen "weltweiten" Patentschutz mit einem einzigen Patent. Patente sind in der Regel die Sache einzelner Staaten. Auch wenn das Patentrecht weltweit relativ ähnlich ausgestaltet ist, gibt es doch nationale Besonderheiten, die bereits bei der ersten Formulierung einer Patentanmeldung beachtet werden sollten.

Besonders augenfällig sind hier Unterschiede zwischen den USA und Europa. Kernproblem für deutsche oder europäische Anmelder ist dabei, dass nach dem relativ restriktiven europäischen Recht medizinische Verfahren (z.B. Verfahren zur chirurgischen oder therapeutischen Behandlung des menschlichen Körpers) vom Patentschutz ausdrücklich ausgeschlossen sind. Ein ähnlicher Ausschluss gilt für computerimplementierte Erfindungen. Kurz gesagt, ist in den USA sehr viel weit reichender Patentschutz möglich als in Europa.

Von daher ist es für die USA sinnvoll, die Beschreibung bzw. die Zeichnungen etwas ausführlicher zu halten als in Europa. Dies sollte bereits bei der Formulierung einer ersten deutschen bzw. europäischen Patentanmeldung beachtet werden, um bei späteren Patent-Nachanmeldungen in den USA den dortigen Mitbewerbern auf gleicher Augenhöhe begegnen zu können.

Auf die Formulierung der Patentansprüche kommt es an

Neben einer Beschreibung der Erfindung bzw. des zu schützenden Gegenstands enthält eine Patentanmeldung so genannte "Patentansprüche". Diese Patentansprüche skizzieren, was unter Schutz gestellt werden soll. Je weniger Merkmale in einem solchen Patentanspruch aufgezählt werden, d. h. je weniger Limitationen der Gegenstand enthält, desto weitreichender ist der Patentschutz.

Für einen möglichst umfassenden Patentschutz sollte überlegt werden, ob neben der Beanspruchung der medizinischen Vorrichtung selbst noch weitere Patentansprüche ergänzt werden, beispielsweise solche, die auf ein Verfahren zur Anwendung des Gegenstandes am Patienten zielen. Außerdem sind bei vielen modernen Medizinprodukten zunehmend Patentansprüche auf die Steuerungselektronik bzw. auf die beispielsweise durch "embedded software" implementierten Steuerungsverfahren sinnvoll.

Insbesondere bezüglich dieser ergänzenden Patentansprüche gibt es erhebliche Unterschiede zwischen dem Patentrecht in den USA und Europa. Nur bei genauer Kenntnis dieser Unterschiede kann in jedem Land der jeweils umfassendste Patentschutz erreicht werden.

Da die ergänzenden Ansprüche in Europa nicht oder ggf. nur eingeschränkt möglich sind, sollte in Hinblick auf möglichen späteren Patentschutz in den USA der entsprechende Sachverhalt in geeigneter Weise zumindest in der Beschreibung einer ersten deutschen bzw. europäischen Patentanmeldung mit aufgeführt werden. Hierauf gestützt können im späteren US-Patentverfahren weitere Patentansprüche formuliert werden, da dort sowohl in Hinblick auf medizinische Verfahren (chirurgische/ therapeutische/ diagnostische Verfahren) als auch in Hinblick auf computerimplementierte Erfindungen das Recht deutlich liberaler ist.

Rechtzeitig an die US-Patentanmeldung denken

Unter dem jetzt geltenden US-Patentrecht kann es vorteilhaft sein, parallel zu der ersten Einreichung einer deutschen oder europäischen Patentanmeldung eine so genannte ?US provisional application? einzureichen. Dies ist auch in deutscher Sprache möglich und relativ kostengünstig, bietet aber vor allem gegenüber Konkurrenten aus den USA Vorteile. Auch kann es vorteilhaft sein, eine nachträgliche ?PCT?-Patentanmeldung, die auch Wirkung für die USA entfaltet, in englischer statt in deutscher Sprache einzureichen. Je nach Wettbewerberstruktur und Kostenbudget muss dies aber im Einzelfall genau abgestimmt sein.

Fazit

Eine Erfolg versprechende Patentanmeldestrategie im Bereich Medizintechnik sollte von vornherein die Spezifika unterschiedlicher Länder berücksichtigen. Nur so kann sichergestellt werden, dass ein europäisches Unternehmen keine Wettbewerbsnachteile gegenüber US-Unternehmen auf dem US-Markt hat.

Das Manuskript für einen weiterführenden Artikel, der sich ganz spezifisch mit der Formulierung von Patentansprüchen auf dem Gebiet der Medizintechnik in Europa befasst (Verfasser: Patentanwälte Dr. Tim Oppermann und Dr. Stefan Golkowsky) finden Sie nachstehend:

Best Practices in Claim Drafting for Medical Devices in View of the Exceptions to Patentability of Surgery, Therapy and Diagnostic Methods under Article 53(c) EPC

I. Introduction

Applicants for patents in the medical device field seek, as every other patent applicant does, the broadest possible scope of protection for their inventions.

This protection includes not only ?classic? device claims but also methods of using these devices, and even computer program product claims associated with them. However, the EPO has quite restrictive regulations for the claim language of medical inventions, especially with regard to method claims.

It seems favorable, especially given the more liberal laws in other countries such as the U.S., to bolster patent protection by adding claims for other categories, i.e., method claims. In the following we will outline the basic relevant legal framework and apply this framework to claim construction to help an applicant achieve the broadest possible protection.

II. Legal Framework

The European Patent Convention (EPC) stipulates in Article 53(c) EPC that

?European patents shall not be granted in respect of: ... (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.?

This general rule needs some interpretation. At first glance, it is clear that patents may be obtained for new apparatuses used in these methods of treatment or diagnosis.

Methods in the sense of Art. 53 (c) are categorized in two different groups. The first group encompasses treatment by surgery or therapy, while the second group encompasses diagnostic methods practiced on the human or animal body. Recent decisions of the Enlarged Board of Appeal have dealt with both groups, namely decision G 01/07 with a principal focus on treatment by surgery, and G 01/04 with diagnostic methods.

Both decisions held that ?whether or not a method is excluded from patentability under Art. 53(c) EPC cannot depend on the person carrying it out.? (cf- G 01/07, Item 3.4.1). Therefore, one cannot argue that the method is, for example, carried out by an automated system, but it is the method steps that decide whether the method is excluded from patentability or not.

Generally speaking, a method claim is considered to cover treatment by surgery and, thereby, excluded from patentability if the claim ?comprises or encompasses an invasive step representing a substantial physical intervention on the body?? (G 01/07; Answer to Question 1). Thus, the presence of a single invasive step renders a method claim unpatentable.

While decision G 01/07 confirmed most aspects of the jurisprudence of the Boards of Appeal, the Enlarged Board did not fail to mention that the obiter dicta of G 01/04?that ?any physical intervention on the human or animal body? is a method of surgery?appeared too broad and disapproved of the practice of the EPO to dismiss any claim referring to an intervention ?irrespective of the underlying mechanism of the intervention (e.g. mechanical, electrical, thermal, chemical).? (cf. G 01/07, Item 3.4.2.1) For example, the Board asserted in decision T 05/04 that a mere catheterization or insertion of device components into the body implied a direct intervention and was considered to be surgical without being invasive or involving tissue penetration. G 01/07 allows the argument that minor interventions (for instance the inhalation of a gas for imaging reasons) are not be considered invasive and, thus, not surgical.

Therapy, as interpreted by the EPO, includes both treatments to prevent or to cure disease: see, inter alia, the broad definition of T 24/91, OJEPO 1995, 512. However, it is established case law that a method for operating a device (even if this operation has a therapeutic purpose) is not excluded from patentability if there is no functional link between the operational steps of the apparatus and the therapeutic effect of the apparatus on the body (see T 245/87, OJEPO 1989, 171)

Unlike the still broad interpretation of Art. 53 (c) EPC that treatment by surgery is excluded from patentability by a single method step, a much narrower interpretation of Art. 53 (c) EPC is applied regarding claims for diagnostic methods, which are inherently and inescapably understood as a multi-step process. Decision G 01/04 clarified that a claim relates to a diagnostic method practiced on the human or animal body if it includes not only (i) the diagnosis, i.e. the deductive medical or veterinary decision phase as a purely intellectual exercise, but also (ii) the preceding steps constitutive for making the said diagnosis, and (iii) the specific interactions with the human or animal body which occur when carrying these out together with the preceding steps, which are of a technical nature. Obviously, the hurdle for a claim being considered to encompass a diagnostic method is much higher than for a claim being considered to encompass a treatment of surgery.

Decisions G 01/04 and G 01/07 of the Enlarged Board of Appeal have clarified some definitions of the terms used in Art 53 (c) EPC and have given the applicant a more reliable concept of how to draft claims. The legal framework pointed out above is based on the latest decisions of the Enlarged Board of Appeal.

However, Examining Divisions of the EPO are bound by the Guidelines for Examination, and not all aspects of the above decisions have made their way into the Guidelines. Moreover, the interpretation of the decisions and their relation to pending applications is still a matter of debate between Examining Divisions and applicants. This leads to frustration on both sides.

III. Filing Strategies

a) Introduction:
In order to keep frustration to a minimum, the authors have adopted different strategic approaches when filing applications or drafting claims concerning the subject matter of medical technology and related methods. The following points are merely one possible starting point for how to approach patent proceedings with the EPO.

b) General Remarks for All Claim Categories:
Decisions G 01/04 and G 01/07 should be considered before drafting any claims relating to the use or application of medical devices. As mentioned above, a single surgical method step may lead to an exclusion of patentability, while an exclusion of a diagnostic method requires all steps as laid out in decision G 01/04. Hence, when drafting the claims one should consider whether to explicitly introduce disclaimers regarding the exclusion of the method in surgical procedures, as the mere non-mention of the surgical step in the claim is sometimes not considered sufficient by Examining Divisions.

Furthermore, one might want to consider whether the method claim necessarily requires the surgical step like the incision or introduction or the like of the medical device into the human or animal body, or whether the claim can be sensibly drafted without mentioning the surgical step. In other words, a claim mentioning a surgical step or a step that might be considered surgical should be drafted so that the surgical step is isolated and can be easily removed if this should become necessary under the EPC. This step should be kept in mind, particularly when coming from a jurisdiction allowing surgical methods, and removing the surgical step is of no importance.

In contrast to the rather strict requirements concerning surgical methods, it appears much easier to circumnavigate an exclusion from patentability due to a diagnostic method. While it is sufficient to simply not mention the step of the diagnosis strictu sensu, decision G 01/04 has made it clear that the method claim needs to be clear and concise in the sense of Art. 84 EPC without the step of diagnosis. At the moment, a common situation in proceedings before the EPO is to omit the diagnostic step only to receive an Art. 84 EPC objection in the next Communication.

As in the case of surgical methods, a claim for a diagnostic method should be drafted so that the actual step of diagnosis strictu sensu is isolated and may easily be removed later on. As an example, instead of diagnosing an arrhythmia by comparing a recorded heart signal with standard values, the recorded signal is simply analyzed by a device including the comparison with standard values. In case of a similarity, a flag is set and sent to a processor. The processor might then initiate therapy, but the diagnostic step is not explicitly mentioned.

As a start, the words, ?diagnosing? or ?detecting? a medical abnormality by comparing detected data with standard values should be avoided, or it should be clear from the description which steps the ?detection? entails. When drafting the claim, it should be considered to isolate the step of diagnosis and mention it in a dependent claim rather than an independent claim. As an added bonus, the scope of the claim is broadened by the omission of the diagnostic step from the independent claim.

c) Apparatus Claims:
It is always advisable to include claims of as many categories as possible. Having in mind that it is normally of the greatest importance to protect the marketed apparatus by a device/system/apparatus claim, these claims should come first. An example of an allowable apparatus claim would be:

?A brain stimulation device comprising a controller which is implantable into the human or animal body, and an electrode which is configured to be connected to a human or animal brain, ...?

Please note that expressions like ?implantable? or ?configured to be connected to a human heart / a human brain?, etc. are normally not excluded from patentability as these terms only cover aspects of the marketed device and do not relate directly to a medical method step.

d) Computer Program Product Claims:
In addition to this, computer program product claims (device-readable medium claims) are also very advisable, especially if the computer program is loadable into the internal memory of the marketable apparatus. In the recent past, the authors? firm received objections (for a client in the semiconductor area) that the device/apparatus claim as well as the computer program product claim were both claims relating to ?physical entities? and therefore would not be acceptable under Rule 43(2) EPC if no interrelation/dependency was claimed. However, one could successfully argue that the wording of Rule 43(2) EPC lists four categories in total (product, process, apparatus or use), and that, at least as long as unity of invention is given, an independent claim of each of these categories should be possible without explicitly claiming an interrelation. Thus, it should always be tried to claim not only the marketed product (e.g., a brain implant) but also a computer program product. An example claim for such a computer program product would be:

?A computer program product that includes a medium readable by a processor, the medium having stored thereon instructions for deep brain stimulation in an implantable device, comprising:
a first sequence of instructions which, when executed by the controller, causes the controller to receive an early paced ... data during deep brain stimulation ... ?

The above claim does not fall under the exclusion of patentability of Art. 53 (c) EPC. The claim construction clarifies that a set of instructions are to be held on a medium readable by a processor and is thus considered an invention. A method claim directed at the set of instructions only would not be considered an invention due to Art. 52 (2)(c) EPC.

e) Method of Operation Claims:
In addition to the above computer software product claim category, the authors normally try to additionally claim a ?method claim?. From the experience we have gained in the field of blood pumps, we can say that a ?method of operation? of the pump/device is normally possible if the steps refer to the pump/device itself and no explicit/necessary interaction with the living human body is literally claimed.

In the neuromodulation field, a favorable line of argumentation is outlined in the Board of Appeal decision T 789/96. In this decision, the Board noted that a method involving the use of a device having an effect on the heart was in principle a method of treatment by therapy, but in the case at issue the claimed method was directed not to cardiac stimulation but to ?controlling stimulation energy in a pacemaker.? The Board held that a method applied to the human or animal body involving the use of a pacemaker with a therapeutic effect was not a therapy within the meaning of Article 52(4) EPC 1973 (= Article 53(c) EPC) if the invention consisted in refining the said method but the refinement did not have the effect of preventing or treating a pathological condition. Therefore, the claimed method had no therapeutic effect on the body and was thus not excluded by Article 52(4) EPC 1973. G 01/07 confirmed the eligibility of method of operation claims explicitly and stated that ??the Boards of Appeal have constantly held that a method which is only concerned with the operating of a device without any functional link between the claimed method and the effects produced by the device on the body does not qualify at all as a method for treatment within the meaning of Article 52(4) EPC 1973 (T 245/87, OJ EPO 1989, 171, point 3.2.3 of the Reasons, T 789/96, OJ EPO 2002, 364, points 2.2.2.1 et seq. of the Reasons). If, on the contrary, there is such a functional link the method is excluded from patentability (T 82/93, OJ EPO 1996, 274, point 1.5 of the Reasons).? In order to clarify that the claimed method does not encompass a surgical step, i.e., the implantation of the device in the human or animal body, expressions like ?predelivered?, ?preimplanted? or the like may be used to essentially disclaim the implantation step in the method claim. It is important to place these terms in the description of the embodiments.

However, whether a method of operation claim is excluded from patentability is still often a ?borderline? decision. However, it is sometimes at least worth trying to claim a method of operation of a device.

In this regard, it should also be kept in mind that the definition of ?treatment / treatment by surgery? is not always straightforward. This is an uncertainty which leaves room for argument but also often leads to frustration.

Whether or not a claimed invention only concerns the operation of a device without any functional link to the effects of the device on the body is not an issue of law but requires an evaluation of the overall technical circumstances of the case and is therefore a matter to be determined by the first instance and the Technical Boards of Appeal in the individual cases under consideration.

An example would be:

??A method of regulating, by means of software, the pacing energy in a cardiac pacemaker by measurement of a capture parameter, comprising the following steps:
  • a capture parameter is defined constituted by the maximum negative amplitude of the cardiac signal obtained after pacing, within a determined period, as a function of the pacing energy;
  • the representative characteristics of the capture parameter as a function of the pacing energy are determined during a calibration phase;
  • a reference value for determining the effectiveness of the pacing operations is defined from these characteristics;
  • the capture threshold value is determined from the reference value during a threshold search phase;
  • and the pacing energy is determined as a function of the value of the capture threshold.?

IV. Summary

It can be seen that, although medical methods per se are excluded under the EPC, there are various possibilities for applicants in the medical device field to draft patent claims with a broad scope of protection.

The principles referred to above are crucial when drafting a European patent application. However, they are also very helpful when prosecuting a European regional phase application of a patent application originating from a jurisdiction where very broad medical method claims are patentable. It has turned out in various cases that the protection gained in Europe when sticking to the principles mentioned above is practically the same as in the U.S. for typical implantable medical devices.

Wankel

Für Rückfragen stehen die Autoren gerne zur Verfügung:
Pfenning, Meinig und Partner - Berlin