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

  Comparison: Prometheus




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

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Recent Patent Caselaw in Europe

  • 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