Members of the working group: Joseph Schmitz, Jennifer Baltes, Raphaël Zingg, Patrick Merkel (Chair), Beat Rauber, Thomas Kretschmer, Andrea Manola, Gilles Pfend, Oliviana Calin-Eller, Oliver Jeker, and Peter Ling

The english translation of the summary is included on Swisslex and legalis only.

Please answer the below questions with regard to your Group’s current law and practice.

Are Diagnostic Methods generally patentable subject matter in your jurisdiction? Please answer YES or NO.

No.

Exclusion from patentability according to Art. 2(2)(a) Federal Act on Patents and Inventions (PatA)

«2 Also excluded from patentability are:

a.

methods for treatment by surgery or therapy and diagnostic methods practised on the human or animal body»

Are claims to the following considered patent eligible from a subject matter basis, in your jurisdiction? Please answer YES or NO for each.

a) a novel diagnostic apparatus or machine, whose only or primary purpose is diagnostic testing;

b) a novel diagnostic technique or method, whose only or primary purpose is diagnostic testing;

c) correlating the presence, absence, or deviation of expression of a novel biomarker to a disease state;

d) a novel correlation of the presence, absence or deviation of expression of a known biomarker to a disease state;

e) a novel threshold for the expression of a known biomarker as an indicator of a disease state, said biomarker previously already linked to the disease in the prior art;

f) a novel diagnostic apparatus or machine with capacity of correlating data in order to diagnose and/or propose a determined treatment based on such diagnosis;

g) a novel way of sampling or preparing a person for diagnosis;

h) a Diagnostic Method that involves an act of a medical doctor based on results of a novel or known biomarker.

Do your answers to 2 (a)–(h), above, differ if the claim also contains a treatment step?

Yes.

In this case the answers to 2 (a)–(h) are No. Guidelines for the substantive examination 3.2.2.

Do your answers to 2 (a)–(h), above, differ if the method is carried out separately from the human or animal body, e.g. by removing a tissue or blood sample and using the Diagnostic Method on the sample after it has been removed?

Yes, the answers to 2 (c) to (d), (g) and (h) are Yes..

Do your answers to 2 (a)–(h), above, differ if the method does not include a step of the attribution of any specific measured or analyzed value to a particular clinical picture, i.e. does not come to a diagnostic conclusion?

Yes., in this case the answer to 2 (h) is Yes.

Comment: Concerning (c) and (d), it is our view that the step of correlating the presence, absence or deviation of expression of a known/novel biomarker to a disease state includes the step of attribution of any specific measured or analysed value to a particular clinical picture.

Guidelines for the substantive examination 3.2.2.

According to the opinion of your Group, is your current law and practice regarding the patentability of Diagnostic Methods adequate and/or sufficient? Please respond by YES or NO and you may add a brief explanation.

Yes., according to current law and practice it is still possible to protect an invention related to diagnostics that has a commercial value.

According to the opinion of your Group, should Diagnostic Methods be generally patent eligible, from a subject matter basis under your law and practice? Please answer YES or NO.

No.

(To reach this conclusion, we have taken into consideration Art. 9(g) PatA that excludes from the effects of patents medical activities related to a medicinal product, but this Article does not exclude from the effects of patents medical activities related to a diagnostic method. Thus, based on current law and practice, if diagnostic methods were patentable, medical doctors could be held liable for infringing such patented diagnostic methods. We would suggest further discussion of this issue with the whole group.)&cbr;

Specifically, please answer YES or NO to each of the following questions:

Since our response to question 7) is No., we have concluded that our answers to question 8) (a)–(h) should not be different from our answers to question 2) (a)–(h) – Part I.

a) Should a novel diagnostic apparatus or, machine, whose only or primary purpose is diagnostic testing, be patentable subject matter?

b) Should a novel diagnostic technique or method, whose only or primary purpose is diagnostic testing, be patentable subject matter?

c) Should a finding correlating the presence, absence, or deviation of expression of a novel biomarker to a disease state, be considered patentable subject matter?

d) Should a novel correlation of the presence, absence or deviation of expression of a known biomarker to a disease state, be considered patentable subject matter?

e) Should a novel threshold for expression of a known biomarker as an indicator of a disease state, said biomarker previously already linked to the disease in the prior art, be considered patentable subject matter?

f) Should a novel diagnostic apparatus or machine with capacity of correlating data in order to diagnose and/or propose a determined treatment based on such diagnosis, be considered patentable subject matter?

g) Should a novel way of sampling or preparing a person for diagnosis, be considered patentable subject matter?

h) Should a Diagnostic Method that involves an act of a medical doctor based on results of a novel or known biomarker be considered patentable subject matter?

Should the answers to 8 (a)–(h), above, differ if the claim also contains a treatment step?

No.

Should the answers to 8 (a)–(h), above, differ if the method is carried out separately from the human or animal body, e.g. by removing a tissue or blood sample and using the Diagnostic Method on the sample after it has been removed?

Yes.

Should the answers to 8 (a)–(h), above, differ if the method does not include a step of the attribution of any specific measured or analyzed value to a particular clinical picture, i.e. does not come to a diagnostic conclusion?

Yes.

Has the ineligibility of diagnostic claims in any jurisdiction acted as a deterrent to research and development in diagnostics in your jurisdiction? Provide concrete examples if possible.

No.

No pharmaceutical can be marketed any longer without a specific companion diagnostic. R&D in diagnostics will therefore occur irrespective of the ineligibility of diagnostic claims in any jurisdiction. The Swiss group is of the opinion that IP protection for diagnostics is nevertheless an important upside, also under the freedom-to-operate aspect, but does not regard it as a deterrent of diagnostics R&D.

Are there any other policy considerations and/or proposals for improvement to your Group’s current law falling within the scope of this Study Question?

The Swiss group would welcome a concept of acknowledging the patentability of diagnostics per se. The patentability of diagnostics nowadays appears to be a mere question of clever claim drafting to bypass existing limitations. Acknowledging patentability would in our view simplify patent practice in the various jurisdictions and lead to more certainty regarding patentability.

Legal privileges for medical practitioners (e.g. physician or pharmacist privileges, Art. 9(g) and (h) PatA) and their exemption form the effects of patents are seen as a better means to safeguard an unburdened medical practice. In addition, compulsory license models, such as in Art. 40(c) PatA, which set forth a kind of compulsory license for diagnostic tools, can be foreseen in cases of anticompetitive behaviour of a patent holder.

Please consult with relevant in-house/industry members of your Group in responding to Part III.

Do you consider harmonisation regarding the patentability of Diagnostic Methods as desirable in general? Please respond by YES or NO, and you may add a brief explanation.

Yes.&cbr;

Should Diagnostic Methods be patentable subject matter? Please answer YES or NO.

Yes.

Should claims to the following be considered patentable eligible from a subject matter perspective? Please answer YES or NO for each of the below.

a) Should a novel diagnostic apparatus or machine, whose only or primary purpose is diagnostic testing, be patentable subject matter?

b) Should a novel diagnostic technique or method, whose only or primary purpose is diagnostic testing, be patentable subject matter?

c) Should a finding correlating the presence, absence, or deviation of expression of a novel biomarker to a disease state, be considered patentable subject matter?

d) Should a novel correlation of the presence, absence or deviation of expression of a known biomarker to a disease state, be considered patentable subject matter?

e) Should a novel threshold for expression of a known biomarker as an indicator of a disease state, said biomarker previously already linked to the disease in the prior art, be considered patentable subject matter?

f) Should a novel diagnostic apparatus or machine with capacity of correlating data in order to diagnose and/or propose a determined treatment based on such diagnosis, be considered patentable subject matter?

g) Should a novel way of sampling or preparing a person for diagnosis, be considered patentable subject matter?

h) Should a Diagnostic Method that involves an act of a medical doctor based on results of a novel or known biomarker be considered patentable subject matter?

Should the answers to 16 (a)–(h), above, differ if the claim also contains a treatment step?

No.

Should the answers to 16 (a)–(h), above, differ if the method is carried out separately from the human or animal body, e.g. by removing a tissue or blood sample and using the Diagnostic Method on the sample after it has been removed?

No.

Should the answers to 16 (a)–(h), above, differ if the method does not include a step of the attribution of any specific measured or analyzed value to a particular clinical picture, i.e. does not come to a diagnostic conclusion?

No.

Should the patentability of Diagnostic Methods be restricted to the same extent as the patentability of methods of treatment?

Yes.&cbr;

Please comment on any additional issues concerning any aspect of the subject matter eligibility of Diagnostic Methods that you consider relevant to this Study

The Study Group is of the opinion that the aim of the diagnostic method exemption can be achieved through rules relating to patent enforcement, rather than patent eligibility. Patent law should allow diagnostic methods to be patented but foresee a regime under which medical practitioners are subject to a special regime of enforcement that guarantees full medical freedom for the benefit of patients’ well-being.

Please indicate which industry sector views provided by in-house counsels are included in your Group’s answers to Part III.

In vitro diagnostics

Zusammenfassung

Innerhalb der Schweizer Arbeitsgruppe wurden vielfältige Aspekte der Patentierbarkeit diagnostischer Methoden rege diskutiert. Während solche Verfahren nach schweizerischem Recht per se nicht patentfähig sind, bietet die geltende Gesetzgebung und Praxis unter bestimmten Umständen Zugang zur Patentierbarkeit. Insbesondere sind diagnostische Verfahren, die in vitro durchgeführt werden, nicht von der Patentierbarkeit ausgeschlossen. Gleiches gilt für diagnostische Instrumente im Allgemeinen, solange kein therapeutischer Schritt inbegriffen ist.

Die Gruppe ist der Ansicht, dass Forschung und Entwicklung auf dem Gebiet der Diagnostik nicht durch die Patentierbarkeit diagnostischer Verfahren als solcher behindert wurden. Erstens kann Patentschutz durch die Formulierung entsprechender Patentansprüche erlangt werden. Zweitens erfordern Pharmazeutika heutzutage die Entwicklung spezifischer Companion Diagnostics unabhängig von jeglichen IP-Aspekten.

Die Schweizer Arbeitsgruppe würde ein Regime der Patentierbarkeit von diagnostischen Verfahren per se begrüßen und empfehlen. Damit dieser Wandel sinnvoll umgesetzt werden kann, muss die Berufsfreiheit der Heilberufler und Ärzte gleichwohl gewährleistet sein. Dies könnte durch eine spezifische Regelung der Durchsetzung diagnostischer Patente erreicht werden, anstatt diagnostische Verfahren insgesamt von der Patentierbarkeit auszuschließen. Aus verschiedenen Gründen, nicht zuletzt zum Wohle der Rechtssicherheit, sollte auch eine internationale Harmonisierung der Regelungen zu Diagnoseverfahren gefördert werden.

Résumé

Un large éventail d’aspects concernant la brevetabilité des méthodes de diagnostic a été vivement débattu au sein du groupe de travail suisse. Alors que ces méthodes ne sont pas brevetables en soi en vertu du droit suisse, la législation et la pratique actuelles offrent un accès à la brevetabilité dans certaines circonstances. En particulier, tant qu’aucune étape de traitement n’est impliquée, les méthodes de diagnostic réalisées in vitro, ainsi que les instruments de diagnostic en général, ne sont pas exclus de la brevetabilité.

Le Groupe est d’avis que la recherche et le développement dans le domaine du diagnostic n’ont pas été entravés par l’inéligibilité au brevet des méthodes de diagnostic en tant que telles. Premièrement, la protection par brevet peut toujours être obtenue en rédigeant des revendications appropriées. Deuxièmement, les produits pharmaceutiques nécessitent aujourd’hui le développement de diagnostics compagnons spécifiques, indépendamment de tout aspect de propriété intellectuelle.

Le groupe de travail suisse saluerait et recommanderait un régime d’admissibilité au brevet des méthodes de diagnostic en soi. Pour que ce virage s’opère de manière sensée, la liberté d’exercice des professionnelles en soins et des médecins praticiens doit néanmoins être garantie. Cela pourrait être réalisé via une réglementation spécifique de l’application des brevets de diagnostic, plutôt que d’exclure complètement les méthodes de diagnostic de la brevetabilité. Pour diverses raisons, dont la sécurité juridique, l’harmonisation internationale des règles entourant les méthodes de diagnostic est également à encourager.

Summary

A wide range of aspects regarding the patentability of diagnostic methods was vividly discussed within the Swiss Working Group. Whereas such methods are not patent-eligible per se under Swiss law, current legislation and practice offer access to patentability under certain circumstances. In particular, as long as no treatment step is involved, diagnostic methods carried out in vitro, as well as diagnostic instruments in general, are not excluded from patentability.

The Group is of the opinion that R&D in the field of diagnostics has not been hindered by the patent-ineligibility of diagnostic methods as such. Firstly, patent protection can still be achieved by drafting appropriate claims. Secondly, pharmaceuticals nowadays require the development of specific compan-ion diagnostics irrespective of any IP aspects.

The Swiss Working Group would welcome and recommend a regime of patent eligibility for diagnostic methods per se. For this shift to be implemented in a sensible manner, the freedom of practice of healthcare professionals and medical practitioners must nonetheless be ensured. This could be achieved through specific regulation on the enforcement of diagnostic patents, rather than excluding diagnostic methods from patentability altogether. For various reasons, including legal certainty, international harmonisation of the rules surrounding diagnostic methods should be encouraged as well.