Recent Patent Caselaw in Europe

Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012 1

Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012

Overview

• Prometheus – Caselaw in Europe

• Crystalline Polymorphs are Obvious

• Patentability: Tomatoes and Broccoli

• Scope of Protection for Sequences

• Use as Contraceptive not Patentable

• Patentability of Surgical Methods

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Prometheus – Caselaw in Europe

US Supreme Court, Mayo Collaborative Services v. Prometheus Laboratories, Inc. Analysis, 20 March 2012

Related Caselaw in Europe, Patentability of Medical Treatment

photo licensed under the Creative Commons license also for commercial purposes, source: http://www.flickr.com/photos/65193799@N00/37621686

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US Supreme Court – Prometheus – Related European Caselaw

“… If claims to exclusive rights over the body’s natural responses to illness and medical treatment are permitted to stand, the result will be a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care. …”

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US Supreme Court – Prometheus – Related European Caselaw

• Situation in Europe • Exclusion from Patentability for Medical Treatments

(Art. 42 (4) EPC) • Workaround:

• First medical use: • Compound X for use as a medicament.

• Second medical use until 2010: • The use of compound X for the manufacture of a

medicament for treating of disease Y.

• Current second medical use claim language: • Compound X for the treatment of disease Y. • Enlarged Board of Appeal, G 2/08, 19 February 2010

• Inventive step only recognized with shown technical effect or advantage

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Crystalline Polymorphs are Obvious

EPO Boards of Appeal, T 777/08

24 May 2011, published December 2011

Atorvastatin polymorphs / WARNER-LAMBERT

photo licensed under the Creative Commons license also for commercial purposes, source: http://photozou.jp/photo/show/591351/88265693 6


Polymorphs are Obvious

„… When starting from the amorphous form of a pharmaceutically active compound as closest prior art, the skilled person would have a clear expectation that a crystalline form thereof would provide a solution to the problem of providing a product having improved filterability and drying characteristics.

The arbitrary selection of a specific polymorph from a group of equally suitable candidates cannot be viewed as involving an inventive step. …”

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Tomatoes and Broccoli

Patentability of Biotechnology Breeding Techniques

Decisions G2/07 und G1/08 of the Enlarged Board of Appeals

photo licensed under the Creative Commons license also for commercial purposes, photographer: Miguel Angel Pasalodos, source: http://pasalodos.typepad.com

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Tomatoes and Broccoli

“… A non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being "essentially biological" within the meaning of Article 53(b) EPC. … If, however, such a process contains within the steps of sexually crossing and selecting an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then the process is not excluded from patentability under Article 53(b) EPC. …” 9


Scope of Protection for Genetic Sequences

Patent Infringement of Claims Directed to Genetic Sequences

European Court of Justice, Case C-428/08, 6 July 2010

source: public-domain-image.com

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Scope of Protection for Sequences

“… not conferring patent right protection in circumstances …, in which the patented product is contained in the soy meal, where it does not perform the function for which it is patented, but did perform that function previously in the soy plant, of which the meal is a processed product, or would possibly again be able to perform that function after it had been extracted from the soy meal and inserted into the cell of a living organism. …”

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Use as Contraceptive not Patentable EPO Boards of Appeal, T 1635/09

27 October 2010, published November 2011

Composition for contraception/BAYER SCHERING PHARMA AG

source: photo licensed under the Creative Commons license also for commercial purposes, http://www.flickr.com/photos/gnarlsmonkey/263019967/

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“… Use as an oral contraceptive of a composition in which the claimed concentrations of the hormone content are selected at such a low level .. a therapeutic method excluded from patentability ... “

“ ...The conversion of a claim for the use of a substance or composition for a specific purpose into a ... a purpose-related product claim .. results in an extension

of protection. …” • A disclaimer such as "non-therapeutic use" is not

allowable, if the therapeutic effect and the non-therapeutic effect are inseparable.

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Patentability of Surgical Methods

EPO Enlarged Board of Appeal, G 1/07

15 February 2010, published March 2011

Treatment by surgery / MEDI-PHYSICS

source: photo licensed under the Creative Commons license also for commercial purposes, source: http://www.flickr.com/photos/99861378@N00/268627274

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Patentability of Surgical Methods

“… A claimed imaging method, in which, when carried out, maintaining the life and health of the subject is important and which comprises or encompasses an invasive step representing a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise, is excluded from patentability as a method for treatment of the human or animal body by surgery pursuant to Article 53(c) EPC. …”

“ …The exclusion from patentability under Article 53(c) EPC can be avoided by disclaiming the embodiment …”

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Overview

Comparison: Prometheus

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Recent Patent Caselaw in Europe

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