This document summarizes recent caselaw from Europe related to patentability. It discusses the US Supreme Court case Mayo v. Prometheus and related European cases regarding patentability of medical treatment. It also summarizes cases finding crystalline polymorphs are obvious, excluding patentability of essentially biological processes for plant breeding but allowing processes with technical steps. Additional cases addressed scope of protection for genetic sequences, exclusion of therapeutic methods like contraceptive use from patentability, and exclusion of surgical methods from patentability.

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

2. 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
Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012 2

3. 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
Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012 3

4. 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. …”
Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012 4

5. 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
Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012 5

6. 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
Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012 6

7. 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. …”
Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012 7

8. 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
Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012 8

9. 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. …”
Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012 9

10. 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
Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012 10

11. 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. …”
Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012 11

12. 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/
Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012 12

13. “… 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.
Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012 13

14. 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
Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012 14

15. 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 …”
Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012 15

16. Overview
Comparison: Prometheus
Patents, Trademarks, Designs in Europe
www.freischem.eu
Recent Caselaw in Europe – by Dr. Rolf Claessen – April 2012 16